UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
FORM 10-Q
(Mark One)
[ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 1998
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission file number 0-12477
AMGEN INC.
(Exact name of registrant as specified in its charter)
Delaware 95-3540776
------------------------------- -----------------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
One Amgen Center Drive, Thousand Oaks, California 91320-1789
---------------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (805) 447-1000
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90
days. Yes X No
As of March 31, 1998, the registrant had 254,070,280 shares of Common
Stock, $.0001 par value, outstanding.
<PAGE>
AMGEN INC.
INDEX
Page No.
PART I FINANCIAL INFORMATION
Item 1. Financial Statements........................3
Condensed Consolidated Statements of
Operations - three months
ended March 31, 1998 and 1997....................4
Condensed Consolidated Balance Sheets -
March 31, 1998 and December 31, 1997.............5
Condensed Consolidated Statements of
Cash Flows - three months
ended March 31, 1998 and 1997................6 - 7
Notes to Condensed Consolidated Financial
Statements.......................................8
Item 2. Management's Discussion and Analysis
of Financial Condition and Results of
Operations.................................15
PART II OTHER INFORMATION
Item 1. Legal Proceedings..........................23
Item 5. Other Information..........................24
Item 6. Exhibits and Reports on Form 8-K...........24
Signatures ........................................25
Index to Exhibits .................................26
2
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
The information in this report for the three months ended March
31, 1998 and 1997 is unaudited but includes all adjustments
(consisting only of normal recurring accruals) which Amgen Inc.
("Amgen" or the "Company") considers necessary for a fair presentation
of the results of operations for those periods.
The condensed consolidated financial statements should be read in
conjunction with the Company's financial statements and the notes
thereto contained in the Company's Annual Report on Form 10-K for the
year ended December 31, 1997.
Interim results are not necessarily indicative of results for the
full fiscal year.
3
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AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In millions, except per share data)
(Unaudited)
Three Months Ended
March 31,
1998 1997
------- -------
Revenues:
Product sales ........................ $566.8 $536.0
Corporate partner revenues ........... 22.6 27.4
Royalty income ....................... 16.0 12.1
------ ------
Total revenues ................... 605.4 575.5
------ ------
Operating expenses:
Cost of sales ........................ 79.0 72.0
Research and development ............. 152.5 147.7
Marketing and selling ................ 66.8 68.1
General and administrative ........... 46.3 44.4
Loss of affiliates, net .............. 6.2 8.5
------ ------
Total operating expenses ......... 350.8 340.7
------ ------
Operating income ...................... 254.6 234.8
------ ------
Other income (expense):
Interest and other income ............ 15.2 15.9
Interest expense, net ................ (2.2) (0.3)
------ ------
Total other income (expense) ..... 13.0 15.6
------ ------
Income before income taxes ............ 267.6 250.4
Provision for income taxes ............ 80.3 70.1
------ ------
Net income ............................ $187.3 $180.3
====== ======
Earnings per share:
Basic ................................ $0.73 $0.68
Diluted .............................. $0.71 $0.65
Shares used in calculation of earnings
per share:
Basic ................................ 256.2 265.2
Diluted .............................. 264.1 278.1
See accompanying notes.
4
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AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per share data)
(Unaudited)
March 31, December 31,
1998 1997
-------- --------
ASSETS
Current assets:
Cash and cash equivalents ............... $ 104.6 $ 239.1
Marketable securities ................... 775.5 787.4
Trade receivables, net .................. 289.2 269.0
Inventories ............................. 118.1 109.2
Other current assets .................... 124.3 138.8
-------- --------
Total current assets .................. 1,411.7 1,543.5
Property, plant and equipment at cost, net 1,277.5 1,186.2
Investments in affiliated companies....... 119.6 116.9
Other assets.............................. 272.7 263.6
-------- --------
$3,081.5 $3,110.2
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable ........................ $ 114.8 $ 103.9
Accrued liabilities ..................... 674.1 608.0
Current portion of long-term debt ....... 36.0 30.0
-------- --------
Total current liabilities ............. 824.9 741.9
Long-term debt............................ 223.0 229.0
Put warrants.............................. 3.7 -
Contingencies
Stockholders' equity:
Preferred stock; $.0001 par value; 5
shares authorized; none issued or
outstanding ........................... - -
Common stock and additional paid-in
capital; $.0001 par value; 750 shares
authorized; outstanding - 254.1 shares
in 1998 and 258.3 shares in 1997 ...... 1,240.9 1,196.1
Retained earnings ....................... 789.0 943.2
-------- --------
Total stockholders' equity .......... 2,029.9 2,139.3
-------- --------
$3,081.5 $3,110.2
======== ========
See accompanying notes.
5
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AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
Three Months Ended
March 31,
1998 1997
------- -------
Cash flows from operating activities:
Net income ............................... $187.3 $180.3
Depreciation and amortization ............ 36.1 36.4
Loss of affiliates, net .................. 6.2 8.5
Cash provided by (used in):
Trade receivables, net .................. (20.2) 18.9
Inventories ............................. (8.9) (3.0)
Other current assets .................... 15.3 16.8
Accounts payable ........................ 10.9 1.6
Accrued liabilities ..................... 66.1 (27.4)
------ ------
Net cash provided by operating
activities .......................... 292.8 232.1
------ ------
Cash flows from investing activities:
Purchases of property, plant and
equipment .............................. (127.4) (102.5)
Proceeds from maturities of marketable
securities ............................. - 149.3
Proceeds from sales of marketable
securities ............................. 180.1 184.6
Purchases of marketable securities ....... (169.0) (205.7)
Increase in investments in affiliated
companies .............................. (0.4) -
Increase in other assets ................. (12.3) (3.4)
------ ------
Net cash (used in) provided by
investing activities ............... (129.0) 22.3
------ ------
See accompanying notes.
(Continued on next page)
6
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AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(In millions)
(Unaudited)
Three Months Ended
March 31,
1998 1997
------- -------
Cash flows from financing activities:
Repayment of long-term debt .............. $ - $(78.2)
Net proceeds from issuance of common
stock upon the exercise of stock
options ................................ 34.4 24.3
Tax benefits related to stock options .... 13.4 8.6
Repurchases of common stock .............. (337.8) (101.7)
Other .................................... (8.3) (11.9)
------ ------
Net cash used in financing activities .. (298.3) (158.9)
------ ------
(Decrease) increase in cash and cash
equivalents ............................. (134.5) 95.5
Cash and cash equivalents at beginning of
period .................................. 239.1 169.3
------ ------
Cash and cash equivalents at end of period $104.6 $264.8
====== ======
See accompanying notes.
7
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AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 1998
1. Summary of significant accounting policies
Business
Amgen Inc. ("Amgen" or the "Company") is a global biotechnology
company that discovers, develops, manufactures and markets human
therapeutics based on advances in cellular and molecular biology.
Principles of consolidation
The consolidated financial statements include the accounts of the
Company and its wholly owned subsidiaries as well as affiliated
companies for which the Company has a controlling financial interest
and exercises control over their operations ("majority controlled
affiliates"). All material intercompany transactions and balances
have been eliminated in consolidation. Investments in affiliated
companies which are 50% or less owned and where the Company exercises
significant influence over operations are accounted for using the
equity method. All other equity investments are accounted for under
the cost method. The caption "Loss of affiliates, net" includes
Amgen's equity in the operating results of affiliated companies and
the minority interest others hold in the operating results of Amgen's
majority controlled affiliates.
Inventories
Inventories are stated at the lower of cost or market. Cost is
determined in a manner which approximates the first-in, first-out
(FIFO) method. Inventories are shown net of applicable reserves and
allowances. Inventories consist of the following (in millions):
March 31, December 31,
1998 1997
------ -------
Raw materials ...... $ 17.5 $ 18.7
Work in process .... 56.3 53.6
Finished goods ..... 44.3 36.9
------ ------
$118.1 $109.2
====== ======
8
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Product sales
Product sales consist of three products, EPOGEN(R) (Epoetin
alfa), NEUPOGEN(R) (Filgrastim) and INFERGEN(R) (Interferon alfacon-
1).
The Company has the exclusive right to sell Epoetin alfa for
dialysis, diagnostics and all non-human uses in the United States.
The Company sells Epoetin alfa under the brand name EPOGEN(R). Amgen
has granted to Ortho Pharmaceutical Corporation, a subsidiary of
Johnson & Johnson ("Johnson & Johnson"), a license relating to
Epoetin alfa for sales in the United States for all human uses except
dialysis and diagnostics. Pursuant to this license, Amgen does not
recognize product sales it makes into the exclusive market of Johnson
& Johnson and does recognize the product sales made by Johnson &
Johnson into Amgen's exclusive market. Sales in Amgen's exclusive
market and adjustments thereto are derived from Company shipments and
from third-party data on shipments to end users and their usage (see
Note 4, "Contingencies - Johnson & Johnson arbitrations").
Foreign currency transactions
The Company has a program to manage foreign currency risk. As
part of this program, it has purchased foreign currency option and
forward contracts to hedge against possible reductions in values of
certain anticipated foreign currency cash flows generally over the
next 12 months, primarily resulting from its sales in Europe. At
March 31, 1998, the Company had option and forward contracts to
exchange foreign currencies for U.S. dollars of $49.9 million and
$18.2 million, respectively, all having maturities of nine months or
less. The option contracts, which have only nominal intrinsic value
at the time of purchase, are designated and effective as hedges of
anticipated foreign currency transactions for financial reporting
purposes and accordingly, the net gains on such contracts are
deferred and recognized in the same period as the hedged
transactions. The forward contracts do not qualify as hedges for
financial reporting purposes and accordingly, are marked-to-market.
Net gains on option contracts (including option contracts for hedged
transactions whose occurrence are no longer probable) and changes in
market values of forward contracts are reflected in "Interest and
other income". The deferred premiums on option contracts and fair
values of forward contracts are included in "Other current assets".
The Company has additional foreign currency forward contracts to
hedge exposures to foreign currency fluctuations of certain
receivables and payables denominated in foreign currencies. At March
31, 1998, the Company had forward contracts to exchange foreign
currencies, primarily Swiss francs, for U.S. dollars of $22.4
million, all having maturities of two months or less. These
contracts are designated and effective as hedges and accordingly,
gains and losses on these forward contracts are recognized in the
same period the offsetting gains and losses of hedged assets and
liabilities are realized and recognized. The fair values of the
forward contracts are included in the corresponding captions of the
hedged assets and liabilities. Gains and losses on forward
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contracts, to the extent they differ in amount from the hedged
receivables and payables, are included in "Interest and other
income".
Income taxes
Income taxes are accounted for in accordance with Statement of
Financial Accounting Standards ("SFAS") No. 109 (Note 3).
Stock option and purchase plans
The Company's stock options and purchase plans are accounted for
under Accounting Principles Board Opinion No. 25, "Accounting for
Stock Issued to Employees".
Earnings per share
Basic earnings per share is based upon the weighted-average
number of common shares outstanding. Diluted earnings per share is
based upon the weighted-average number of common shares and dilutive
potential common shares outstanding. Potential common shares are
outstanding options under the Company's stock option plans which are
included under the treasury stock method.
The following table sets forth the computation for basic and
diluted earnings per share (in millions, except per share
information):
Three Months Ended
March 31,
1998 1997
------ ------
Numerator for basic and diluted
earnings per share - net income . $187.3 $180.3
====== ======
Denominator:
Denominator for basic earnings
per share - weighted-average
shares ........................ 256.2 265.2
Effect of dilutive securities -
employee stock options ........ 7.9 12.9
------ ------
Denominator for diluted earnings
per share - adjusted weighted-
average shares ................ 264.1 278.1
====== ======
Basic earnings per share .......... $0.73 $0.68
====== ======
Diluted earnings per share ........ $0.71 $0.65
====== ======
Use of estimates
The preparation of financial statements in conformity with
generally accepted accounting principles requires management to make
10
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estimates and assumptions that affect the amounts reported in the
financial statements and accompanying notes. Actual results may
differ from those estimates.
Basis of presentation
The financial information for the three months ended March 31,
1998 and 1997 is unaudited but includes all adjustments (consisting
only of normal recurring accruals) which the Company considers
necessary for a fair presentation of the results of operations for
these periods. Interim results are not necessarily indicative of
results for the full fiscal year.
Reclassification
Certain prior year amounts have been reclassified to conform to
the current year presentation.
2. Debt
As of March 31, 1998, the Company had $259 million of unsecured
debt securities outstanding. Long-term debt consists of the following
(in millions):
March 31, December 31,
1998 1997
-------- --------
Debt securities ........... $259.0 $259.0
Less current portion ...... (36.0) (30.0)
------ ------
$223.0 $229.0
====== ======
The Company has established a $500 million debt shelf
registration statement under which the Company has issued $100
million of debt securities (the "Notes") and established a $400
million medium term note program. The Company may offer and issue
medium term notes from time to time with terms to be determined by
market conditions. The Notes bear interest at a fixed rate of 6.5%
and mature in 10 years. The Company's other outstanding debt
includes $100 million of debt securities that bear interest at a
fixed rate of 8.1% and mature in 2097 and $59 million of notes that
bear interest at fixed rates averaging 5.8% and have remaining
maturities of less than six years.
The Company also has a commercial paper program which provides
for unsecured short-term borrowings up to an aggregate of $200
million. No commercial paper was outstanding under this program at
March 31, 1998. In April 1998, the Company replaced this program
with a new commercial paper program which provides for the same
amount of aggregate short-term borrowings and issued commercial paper
with a face amount of $100 million. These borrowings had maturities
11
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of less than three months and had effective interest rates averaging
5.6%.
As of March 31, 1998, $150 million was available under the
Company's line of credit for borrowing.
3. Income taxes
The provision for income taxes consists of the following (in
millions):
Three Months Ended
March 31,
1998 1997
------ ------
Federal(including U.S. possessions) . $74.9 $65.1
State ............................... 5.4 5.0
----- -----
$80.3 $70.1
===== =====
The increase in the effective tax rate in the current year is the
result of a provision in the federal tax law which caps tax benefits
associated with the Company's Puerto Rico operations at the 1995
income level.
4. Contingencies
Johnson & Johnson arbitrations
Epoetin alfa
In September 1985, the Company granted Johnson & Johnson's
affiliate, Ortho Pharmaceutical Corporation, a license relating to
certain patented technology and know-how of the Company to sell a
genetically engineered form of recombinant human erythropoietin,
called Epoetin alfa, throughout the United States for all human uses
except dialysis and diagnostics. Johnson & Johnson sells Epoetin alfa
under the brand name PROCRIT(R). A number of disputes have arisen
between Amgen and Johnson & Johnson as to their respective rights and
obligations under the various agreements between them, including the
agreement granting the license (the "License Agreement").
A dispute between Amgen and Johnson & Johnson that is the subject
of a current arbitration proceeding relates to the audit methodology
currently employed by the Company for Epoetin alfa sales. The Company
and Johnson & Johnson are required to compensate each other for
Epoetin alfa sales which either party makes into the other party's
exclusive market, sometimes referred to as "spillover". Spillover
occurs when, for example, a hospital or other purchaser buys one brand
for use in both dialysis and non-dialysis indications. The Company
has established and is employing an audit methodology to assign the
12
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proceeds of sales of EPOGEN(R) and PROCRIT in the Company's and
Johnson & Johnson's respective exclusive markets. On September 12,
1997, the arbitrator in this matter (the "Arbitrator") issued an
opinion adopting the Company's audit methodology. For the free
standing dialysis center segment of the Epoetin alfa market, which
accounts for about two-thirds of the Company's EPOGEN sales, the
Arbitrator ruled that the Company's audit accurately determined that
all Epoetin alfa sales to free standing dialysis centers are made for
dialysis. For the other segments of the Epoetin alfa market, the
Arbitrator ruled that the detailed methodology used by Amgen
accurately measured and allocated Epoetin alfa sales for all but the
Hospital and Home Health Care segments, for which he ordered certain
adjustments to the results of the audit for the 1991-94 time period.
The Arbitrator also ruled that no payments are due for the 1989-90
period. Subject to further guidance from the Arbitrator to clarify
his opinion, the Company estimated that the effect of the opinion
would be a net spillover payment to Johnson & Johnson which, after
benefit of income tax effects, was $78 million for the 1991-94 period
and interest in the amount of $18 million after tax. As a result of
the opinion, the Company took a charge of $0.35 per share in the third
quarter of 1997 for the spillover payment and interest.
A hearing before the Arbitrator was held on October 27, 1997 to
clarify, among other issues, the calculation for the amount of the
spillover payment due to Johnson & Johnson for the 1991-94 time
period. As a result of that hearing, the Company will pay an
additional amount to Johnson & Johnson for the 1991-94 period which is
covered by amounts previously provided for by the Company. An
additional hearing relating to the Company's entitlement to
attorneys' fees and costs and audit costs as well as the calculation
of spillover payments, if any, that may be due to the Company or
Johnson & Johnson for 1995, 1996 and 1997 was held on January 7, 1998.
On April 14, 1998, the Arbitrator issued his final order which
confirmed that the Company was the successful party in the arbitration
and, as a result, Johnson & Johnson has been ordered to pay to the
Company all costs and expenses, including reasonable attorney's fees,
that the Company incurred in the arbitration as well as one-half of
the audit costs. The Company currently estimates that it will submit
a bill for such costs incurred over an eight year period of
approximately $100 million; however, the actual amount of the
Company's recovery will be determined by the Arbitrator. The Order
also confirms that for the period 1995 forward, the estimates of usage
of Epoetin alfa in the Hospital segment of the Company's audit
methodology shall be applied without adjustment, subject to the right
of either party to challenge the Hospital survey results for 1995 and
certain subsequent years. The Company does not expect that any such
challenges, if made, would result in any payments to Johnson & Johnson
which would be material to the Company.
Both parties have filed motions seeking reconsideration of
certain aspects of the Arbitrator's final order. Due to remaining
uncertainties, the Company has not taken any benefit for the possible
recovery of attorneys' fees and costs or audit costs and has retained
spillover reserves. If, as a result of these further arbitration
rulings or challenges, any adjustments to the results of the Company's
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audit yield results that are different from the results of the audit
currently employed by the Company, the Company may be required to pay
additional compensation to Johnson & Johnson for sales during 1995,
1996 and 1997, or Johnson & Johnson may be required to pay
compensation to the Company for such prior period sales.
The Company has filed a demand in the arbitration to terminate
Johnson & Johnson's rights under the License Agreement and to recover
damages for breach of the License Agreement. Johnson & Johnson
disputes the Arbitrator's jurisdiction to decide the Company's demand.
The Company has requested a hearing before the Arbitrator on the
Company's termination demand. No trial date on this matter has been
set.
On October 2, 1995, Johnson & Johnson filed a demand for a
separate arbitration proceeding against the Company before the
American Arbitration Association ("AAA") in Chicago, Illinois.
Johnson & Johnson alleges in this demand that the Company has breached
the License Agreement. The demand also includes allegations of
various antitrust violations. In this demand, Johnson & Johnson seeks
an injunction, declaratory relief, unspecified compensatory damages,
punitive damages and costs. On October 27, 1995, the Company filed a
complaint in the Circuit Court of Cook County, Illinois seeking an
order compelling Johnson & Johnson to arbitrate the Company's claim
for termination before the Arbitrator as well as all related
counterclaims asserted in Johnson & Johnson's October 2, 1995 AAA
arbitration demand. The Company is unable to predict at this time the
outcome of the demand for termination or when it will be resolved.
The Company has filed a motion to stay the AAA arbitration pending the
outcome of the existing arbitration proceedings before the Arbitrator
discussed above. The Company has also filed an answer and
counterclaim denying that AAA has jurisdiction to hear or decide the
claims stated in the demand, denying the allegations in the demand and
counter claiming for certain unpaid invoices.
NESP
On June 5, 1997, Johnson & Johnson filed a demand for arbitration
against Kirin-Amgen, Inc. ("Kirin-Amgen"), an affiliate of the
Company, before the AAA. The demand alleges that Amgen's novel
erythropoiesis stimulating protein ("NESP") is covered by a license
granted by Kirin-Amgen to Johnson & Johnson in 1985 for the
development, manufacture and sale of Epoetin alfa in certain
territories outside the United States, Japan and China (the "K-A
License"). In 1996 Kirin-Amgen acquired exclusive worldwide rights in
NESP from Amgen. Kirin-Amgen, in turn, transferred certain rights in
NESP to Kirin and certain rights to Amgen. Johnson & Johnson alleges
that the K-A License effectively grants Johnson & Johnson the same
right to develop, manufacture and sell NESP as granted under the K-A
License with respect to Epoetin alfa. Kirin-Amgen filed its answer to
Johnson & Johnson's complaint on January 12, 1998, denying that
Johnson & Johnson has rights to NESP. Kirin-Amgen also asserted a
counterclaim for the recovery of certain royalty payments which Kirin-
Amgen asserts were improperly withheld. These same disputes exist
between the Company and Johnson & Johnson under the License Agreement
14
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and the parties have agreed that the resolution of these issues in
this arbitration will be binding upon them with respect to the License
Agreement. The trial in this matter is scheduled to commence in July
1998.
While it is not possible to predict accurately or determine the
eventual outcome of the above described legal matters or various other
legal proceedings (including patent disputes) involving Amgen, the
Company believes that the outcome of these proceedings will not have a
material adverse effect on its annual financial statements.
5. Stockholders' equity
During the three months ended March 31, 1998, the Company
repurchased 6.2 million shares of its common stock at a total cost of
$337.8 million under its common stock repurchase program. In October
1997, the Board of Directors authorized the Company to repurchase up
to an additional $1 billion of common stock through December 31, 1998.
At March 31, 1998, $374.4 million of this authorization remained.
Stock repurchased under the program is retired.
6. Comprehensive income
As of January 1, 1998, the Company adopted Statement of Financial
Accounting Standards ("SFAS") No. 130, "Reporting Comprehensive
Income". SFAS No. 130 establishes new rules for the reporting and
display of comprehensive income and its components. SFAS No. 130
requires unrealized gains and losses on the Company's available-for-
sale securities and foreign currency translation adjustments to be
included in other comprehensive income. During the three months ended
March 31, 1998 and 1997, total comprehensive income was $184.3 million
and $178.3 million, respectively.
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations
Liquidity and Capital Resources
Cash provided by operating activities has been and is expected to
continue to be the Company's primary source of funds. During the
three months ended March 31, 1998, operations provided $292.8 million
of cash compared with $232.1 million during the same period last year.
The Company had cash, cash equivalents and marketable securities of
$880.1 million at March 31, 1998, compared with $1,026.5 million at
December 31, 1997.
Capital expenditures totaled $127.4 million for the three months
ended March 31, 1998, compared with $102.5 million for the same period
a year ago. The Company anticipates spending approximately $400
million to $500 million in 1998 on capital projects and equipment to
expand the Company's global operations. Thereafter, over the next few
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years, the Company anticipates that capital expenditures will average
in excess of $400 million per year.
The Company receives cash from the exercise of employee stock
options. During the three months ended March 31, 1998, stock options
and their related tax benefits provided $47.8 million of cash compared
with $32.9 million for the same period last year. Proceeds from the
exercise of stock options and their related tax benefits will vary
from period to period based upon, among other factors, fluctuations
in the market value of the Company's stock relative to the exercise
price of such options.
The Company has a stock repurchase program primarily to offset
the dilutive effect of its employee stock option and stock purchase
plans. During the three months ended March 31, 1998, the Company
purchased 6.2 million shares of its common stock at a cost of $337.8
million compared with 1.7 million shares purchased at a cost of $101.7
million during the same period last year. In October 1997, the Board
of Directors authorized the Company to repurchase up to an additional
$1 billion of common stock through December 31, 1998. At March 31,
1998, $374.4 million of this authorization remained.
To provide for financial flexibility and increased liquidity,
the Company has established several sources of debt financing. The
Company established a $500 million debt shelf registration statement
and in December 1997, pursuant to such registration statement, the
Company issued $100 million of debt securities that bear interest at
a fixed rate of 6.5% and mature in 10 years (the "Notes"). As of
March 31, 1998, the Company had $259 million of unsecured debt
securities outstanding. This amount includes the Notes, $59 million
of debt securities that bear interest at fixed rates averaging 5.8%
and have remaining maturities of less than six years and $100 million
of debt securities that bear interest at a fixed rate of 8.1% and
mature in 2097. The Company also has a commercial paper program
which provides for short-term borrowings up to an aggregate face
amount of $200 million. In April 1998, the Company replaced this
program with a new commercial paper program which provides for the
same amount of aggregate short-term borrowings and issued commercial
paper with a face amount of $100 million. These borrowings had
maturities of less than three months and had effective interest rates
averaging 5.6%. The Company has a $150 million revolving line of
credit for borrowings and to support the commercial paper program.
As of March 31, 1998, no amounts were outstanding under the line of
credit.
The primary objectives for the Company's investment portfolio
are liquidity and safety of principal. Investments are made to
achieve the highest rate of return to the Company, consistent with
these two objectives. The Company's investment policy limits
investments to certain types of instruments issued by institutions
with investment grade credit ratings and places restrictions on
maturities and concentration by type and issuer. The Company invests
its excess cash in securities with varying maturities to meet
projected cash needs.
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The Company believes that existing funds, cash generated from
operations and existing sources of debt financing are adequate to
satisfy its working capital and capital expenditure requirements for
the foreseeable future, as well as to support its stock repurchase
program. However, the Company may raise additional capital from time
to time.
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Results of Operations
Product sales
Product sales were $566.8 million during the three months ended
March 31, 1998, an increase of $30.8 million or 6% over the same
period last year.
EPOGEN(R) (Epoetin alfa)
EPOGEN(R) sales were $304.4 million for the three months ended
March 31, 1998, an increase of $12.8 million or 4% over the same
period last year. This increase was primarily due to growth in the
U.S. dialysis patient population and certain dialysis providers using
a different method of anemia measurement, hemoglobin, instead of
hematocrit. EPOGEN(R) sales continued to be adversely affected by
reimbursement changes (the "HCFA Policy Changes") implemented on
September 1, 1997 by the Health Care Financing Administration
("HCFA"). Prior to the HCFA Policy Changes, fiscal intermediaries
under contract with HCFA were authorized to pay reimbursement claims
for patients whose hematocrits exceeded 36 percent, the top of the
suggested target hematocrit range in the Company's labeling, if
deemed medically justified. Under the HCFA Policy Changes, medical
justification was not accepted for payment of claims of hematocrits
that exceeded 36 percent and, if the current month's hematocrit were
greater than 36 percent and the patient's hematocrit exceeded 36.5
percent on an historical 90-day "rolling average" basis,
reimbursement for the current month would be denied in full.
Beginning in the second quarter of 1997, the Company has experienced
a decline in the growth rate of EPOGEN(R) sales as dialysis providers
attempted to lower hematocrits by lowering or withholding EPOGEN(R)
doses in order to avoid or minimize claim denials under the HCFA
Policy Changes. However, in March 1998, HCFA announced the easing of
restrictions on reimbursement that had been instituted under the HCFA
Policy Changes.
In March 1998, HCFA issued two revisions (the "HCFA Revisions")
to the HCFA Policy Changes in a program memorandum. The first
revision provides that, for a month in which the three month "rolling
average" hematocrit exceeds 36.5 percent, HCFA will pay the lower of
100 percent of the actual dosage billed for that month, or 80 percent
of the prior month's allowable EPOGEN(R) dosage. The second revision
re-establishes authorization to make payment for EPOGEN(R) when a
patient's hematocrit exceeds 36 percent when accompanied by
documentation establishing medical necessity. Dialysis providers are
currently in the process of understanding the HCFA Revisions,
revising their protocols and discerning how fiscal intermediaries
will implement the HCFA Revisions. The Company believes that fiscal
intermediaries are likely to implement the HCFA Revisions at variable
rates which may have an impact on dialysis providers' practice
pattern changes and the rate of change. The Company believes that,
compared with the HCFA Policy Changes, the HCFA Revisions may result
in fewer doses being withheld and that physicians generally are not
likely to reduce doses by more than 20 percent from the previous
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<PAGE>
month's level. Accordingly, it is difficult to predict what effect
the HCFA Revisions will have on EPOGEN(R) sales.
NEUPOGEN(R) (Filgrastim)
Worldwide NEUPOGEN(R) sales were $261.2 million for the three
months ended March 31, 1998, an increase of $16.8 million or 7% over
the same period last year. This increase was primarily due to the
impact of wholesaler stocking, and to a lesser extent, an increase in
underlying demand, which includes price changes. Unfavorable foreign
currency effects and European Union ("EU") government initiatives to
lower health care expenditures reduced growth in reported sales. In
addition, the Company believes that the use of protease inhibitors as
a treatment for AIDS continues to reduce sales of NEUPOGEN(R) for off-
label use as a supportive therapy in this setting. NEUPOGEN(R) is not
approved or promoted for such use, except in Australia and Canada.
Cost containment pressures in the U.S. health care marketplace
have contributed to the slowing of growth in domestic NEUPOGEN(R)
usage over the past several quarters. These pressures are expected
to continue to influence growth for the foreseeable future. In
addition, quarterly NEUPOGEN(R) sales volume is influenced by a
number of factors including underlying demand and wholesaler
inventory management practices.
The growth of the colony stimulating factor ("CSF") market in
the EU in which NEUPOGEN(R) competes has slowed, principally due to
EU government pressures on physician prescribing practices in
response to ongoing government initiatives to reduce health care
expenditures. Additionally, the Company faces competition from
another granulocyte CSF product. Amgen's CSF market share in the EU
has remained relatively constant over the last several quarters,
however, the Company does not expect the competitive intensity to
subside in the near future.
Other product sales
INFERGEN(R) (Interferon alfacon-1) sales were $1.2 million for
the three months ended March 31, 1998. INFERGEN(R) was launched in
October 1997 for the treatment of chronic hepatitis C virus
infection. There are existing treatments for this infection against
which INFERGEN(R) competes, and the Company cannot predict the extent
to which it will penetrate this market.
Cost of sales
Cost of sales as a percentage of product sales was 13.9% and
13.4% for the three months ended March 31, 1998 and 1997,
respectively. In 1998, cost of sales as a percentage of product sales
is expected to be slightly higher than 1997.
Research and development
During the three months ended March 31, 1998, research and
development expenses increased $4.8 million or 3% compared with the
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same period last year. This increase is primarily due to higher
clinical and preclinical expenses, including staff-related costs,
necessary to support ongoing product development activities. In
1998, annual research and development expenses are expected to
increase, but at a substantially lower rate than 1997. This increase
is planned for internal development of product candidates, and for
discovery and licensing efforts.
Marketing and selling/General and administrative
Marketing and selling expenses decreased $1.3 million or 2%
during the three months ended March 31, 1998 compared with the same
period last year. This decrease was primarily due to lower expenses
related to the Johnson & Johnson arbitration and lower European
marketing expenses partially offset by higher U.S. marketing costs.
General and administrative expenses increased $1.9 million or 4%
during the three months ended March 31, 1998 compared with the same
period last year. This increase is primarily due to higher staff-
related expenses, partially offset by lower legal fees.
In 1998, marketing and selling expenses combined with general
and administrative expenses are expected to have little growth.
Income taxes
The Company's effective tax rate for the three months ended March
31, 1998 was 30.0% compared with 28.0% for the same period last year.
The increase in the effective tax rate in the current year is due to a
provision in the federal tax law which caps tax benefits associated
with the Company's Puerto Rico operations at the 1995 income level.
Foreign currency transactions
The Company has a program to manage certain portions of its
exposure to fluctuations in foreign currency exchange rates arising
from international operations. The Company generally hedges the
receivables and payables with foreign currency forward contracts,
which typically mature within six months. The Company uses foreign
currency option and forward contracts which generally expire within 12
months to hedge certain anticipated future sales and expenses. At
March 31, 1998, outstanding foreign currency option and forward
contracts totaled $49.9 million and $40.6 million, respectively.
Year 2000
The Year 2000 issue results from computer programs that do not
differentiate between the year 1900 and the year 2000 because they
were written using two digits rather than four to define the
applicable year; accordingly, computer systems that have time-
sensitive calculations may not properly recognize the year 2000. The
Company has conducted an initial review of its computer systems,
devices, applications and manufacturing equipment (collectively,
"Computer Systems") to identify those areas that could be affected by
Year 2000 noncompliance. Additionally, the Company has appointed a
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<PAGE>
program manager for Year 2000 compliance and is presently assessing
in detail the affected Computer Systems and is developing plans to
address the required modifications. The Company presently intends to
utilize internal and external resources to identify, correct or
reprogram and test its Computer Systems for Year 2000 compliance.
The total cost associated with Year 2000 compliance is not known at
this time. The Company has not communicated with many of its
suppliers, service providers, distributors, wholesalers and other
entities with which it has a business relationship (collectively,
"Third Party Businesses") regarding compliance with Year 2000
requirements, although the Company does intend to communicate with
key Third Party Businesses. In addition, the Company has not
determined the impact, if any, on its operations if Third Party
Businesses fail to comply with Year 2000 requirements. While the
Company has developed plans to complete modifications of its business
critical Computer Systems prior to the year 2000, if modifications of
such business critical Computer Systems, or Computer Systems of key
Third Party Businesses are not completed in a timely manner, the Year
2000 issue could have a material adverse effect on the operations and
financial position of the Company. The Company may also be affected
by the failure of state, federal and private payors or reimbursers to
be Year 2000 compliant if such entities are unable to make timely,
proper or complete payments to sellers of the Company's products.
The Company cannot predict the extent of any such impact.
Financial Outlook
Future NEUPOGEN(R) (Filgrastim) sales growth is dependent
primarily upon further penetration of existing markets, the timing
and nature of additional indications for which the product may be
approved and the effects of competitive products. Although not
approved or promoted for use in Amgen's domestic or foreign markets,
except for Australia and Canada, the Company believes that
approximately 5%-10% of its worldwide NEUPOGEN(R) sales are from off-
label use as a supportive therapy to various AIDS treatments.
Changes in AIDS therapies, including protease inhibitors that may be
less myelosuppressive, are believed to have adversely affected and
are expected to continue to adversely affect such sales. NEUPOGEN(R)
usage is expected to continue to be affected by cost containment
pressures on health care providers worldwide. In addition, reported
NEUPOGEN(R) sales will continue to be affected by changes in foreign
currency exchange rates and government budgets.
The Company expects a high single digit sales growth rate for
EPOGEN(R) in 1998. Although HCFA announced revisions to its
EPOGEN(R) reimbursement policy in March 1998 (see, "Results of
Operations - Product sales - EPOGEN(R) (Epoetin alfa)"), the timing
and magnitude of any EPOGEN(R) sales growth due to increases in dose
cannot be predicted principally due to the timing and variety of
dialysis providers' and fiscal intermediaries' reaction to the HCFA
Revisions; however, the Company believes that increases in the U.S.
dialysis patient population will continue to grow EPOGEN(R) sales in
the near term and long term. Patients receiving treatment for end
stage renal disease are covered primarily under medical programs
21
<PAGE>
provided by the federal government. Therefore, EPOGEN(R) sales may
also be affected by future changes in reimbursement rates or a change
in the basis for reimbursement by the federal government. The
previously disclosed report of the Office of the Inspector General
has been issued, recommending a 10% reduction in the Medicare
reimbursement rate for EPOGEN(R). The Company believes the
recommendation would primarily affect dialysis providers and that it
is difficult to predict the impact on Amgen.
INFERGEN(R) (Interferon alfacon-1) was launched in October 1997
for the treatment of chronic hepatitis C virus infection. There are
existing treatments for this infection against which INFERGEN(R)
competes, and the Company cannot predict the extent to which it will
penetrate this market. The Company is presently engaged in certain
litigation related to INFERGEN(R), as described in "Part I, Item 3.
Legal Proceedings - INFERGEN(R) litigation" in the Company's Annual
Report on Form 10-K for the year ended December 31, 1997.
The Company anticipates a single digit total product sales
growth rate for 1998. Without giving effect to the 1997 legal
assessment, earnings per share in 1998 is expected to grow at a rate
between high single and low double digits. Estimates of future
product sales and earnings per share, however, are necessarily
speculative in nature and are difficult to predict with accuracy.
Following an approximate six-month period, during which Amgen
considered a number of corporate partnering alternatives for its
inflammation program in Boulder, Colorado, Amgen has decided to
pursue separate paths with its inflammation product development
programs and its inflammation discovery research program. Amgen will
retain its principal inflammation product candidates, STNFr-1 and IL-
1ra, and relocate the related development programs to Thousand Oaks,
California. Amgen will not continue the Boulder inflammation
discovery research program; employees are seeking investment capital
in order to continue this research in a new company. If those
efforts are successful, Amgen expects to receive equity in exchange
for its intellectual property. However, there can be no assurance
these efforts will be successful or that an exchange could be
negotiated on acceptable terms.
Except for the historical information contained herein, the
matters discussed herein are by their nature forward-looking.
Investors are cautioned that forward-looking statements or
projections made by the Company, including those made in this
document, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Reference
is made in particular to forward-looking statements regarding product
sales, earnings per share and expenses. Amgen operates in a rapidly
changing environment that involves a number of risks, some of which
are beyond the Company's control. Future operating results and the
Company's stock price may be affected by a number of factors,
including, without limitation: (i) the results of preclinical and
clinical trials; (ii) regulatory approvals of product candidates, new
indications and manufacturing facilities; (iii) reimbursement for
Amgen's products by governments and private payors; (iv) health care
22
<PAGE>
guidelines relating to Amgen's products; (v) intellectual property
matters (patents) and the results of litigation; (vi) competition;
(vii) fluctuations in operating results and (viii) rapid growth of
the Company. These factors and others are discussed herein and in
the sections appearing in "Item 1. Business - Factors That May Affect
the Company" in the Company's Annual Report on Form 10-K for the year
ended December 31, 1997, which sections are incorporated herein by
reference and filed as an exhibit hereto.
Legal Matters
The Company is engaged in arbitration proceedings with one of its
licensees and various other legal proceedings. For a discussion of
these matters, see Note 4 to the Condensed Consolidated Financial
Statements.
PART II - OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
The Company is engaged in arbitration proceedings with one of its
licensees. For a discussion of these and other matters, see Note 4 to
the Condensed Consolidated Financial Statements, "Contingencies".
Other legal proceedings are also reported in Note 4 to the Condensed
Consolidated Financial Statements and in the Company's Form 10-K for
the year ended December 31, 1997, with material developments since
that report described below. While it is not possible to predict
accurately or to determine the eventual outcome of these matters, the
Company believes that the outcome of these proceedings will not have a
material adverse effect on the annual financial statements of the
Company.
Transkaryotic Therapies and Hoechst litigation
On April 15, 1997, Amgen filed suit in the United States District
Court in Boston Massachusetts against Transkaryotic Therapies Inc.
("TKT") and Hoechst Marion Roussel alleging infringement of several
U.S. patents owned by Amgen that claim an erythropoietin product and
processes for making erythropoietin. The suit seeks an injunction
preventing the defendants from making, importing, using or selling
erythropoietin in the U.S. On July 9, 1997, the court denied TKT's
motion to dismiss the lawsuit on the pleadings. On April 15, 1998,
the court issued an order granting the defendants' motion for summary
judgment of non-infringement on the grounds that defendants'
activities to date were protected by the clinical trial exemption.
The court also ruled that Amgen's motion for summary judgment for
infringement would be administratively closed. Although the matter is
administratively closed, it may be re-opened upon motion of either
party for good cause shown.
23
<PAGE>
Item 5. Other Information
The Company's 1999 Annual Meeting of Stockholders will be held on
May 13, 1999.
Item 6. Exhibits and Reports on Form 8-K
(a) Reference is made to the Index to Exhibits included herein.
(b) Reports on Form 8-K
None
24
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned thereunto duly authorized.
Amgen Inc.
(Registrant)
Date: 5/12/98 By:/s/Kathryn E. Falberg
------------------ ------------------------------------
Kathryn E. Falberg
Vice President, Finance,
Chief Financial Officer and
Chief Accounting Officer
25
<PAGE>
AMGEN INC.
INDEX TO EXHIBITS
Exhibit No. Description
3.1 Restated Certificate of Incorporation as amended. (19)
3.2 Amended and Restated Bylaws. (23)
4.1 Indenture dated January 1, 1992 between the Company and
Citibank N.A., as trustee. (8)
4.2 Forms of Commercial Paper Master Note Certificates. (10)
4.3 First Supplement to Indenture, dated February 26, 1997
between the Company and Citibank N.A., as trustee. (16)
4.4 Officer's Certificate pursuant to Sections 2.1 and 2.3
of the Indenture, as supplemented, establishing a series
of securities "8-1/8% Debentures due April 1, 2097."
(18)
4.5 8-1/8% Debentures due April 1, 2097. (18)
4.6 Form of stock certificate for the common stock, par
value $.0001 of the Company. (19)
4.7 Officer's Certificate pursuant to Sections 2.1 and 2.3
of the Indenture, dated as of January 1, 1992, as
supplemented by the First supplemental Indenture, dated
as of February 26, 1997, each between the Company and
Citibank, N.A., as Trustee, establishing a series of
securities entitled "6.50% Notes Due December 1, 2007".
(22)
4.8 6.50% Notes Due December 1, 2007 described in Exhibit
4.7. (22)
4.9* Corporate Commercial Paper - Master Note between and
among Amgen Inc., as Issuer, Cede & Co., as nominee of
The Depository Trust Company and Citibank, N.A. as
Paying Agent.
10.1 Company's Amended and Restated 1991 Equity Incentive
Plan. (23)
10.2 Company's Amended and Restated 1984 Stock Option Plan.
(14)
10.3 Shareholder's Agreement of Kirin-Amgen, Inc., dated May
11, 1984, between the Company and Kirin Brewery Company,
Limited (with certain confidential information deleted
therefrom). (1)
10.4 Amendment Nos. 1, 2, and 3, dated March 19, 1985, July
29, 1985 and December 19, 1985, respectively, to the
Shareholder's Agreement of Kirin-Amgen, Inc., dated May
11, 1984 (with certain confidential information deleted
therefrom). (3)
10.5 Product License Agreement, dated September 30, 1985, and
Technology License Agreement, dated, September 30, 1985
between the Company and Ortho Pharmaceutical Corporation
(with certain confidential information deleted
therefrom). (2)
10.6 Product License Agreement, dated September 30, 1985, and
Technology License Agreement, dated September 30, 1985
between Kirin-Amgen, Inc. and Ortho Pharmaceutical
26
<PAGE>
Corporation (with certain confidential information
deleted therefrom). (3)
10.7 Company's Amended and Restated Employee Stock Purchase
Plan. (14)
10.8 Research, Development Technology Disclosure and License
Agreement PPO, dated January 20, 1986, by and between
the Company and Kirin Brewery Co., Ltd. (4)
10.9 Amendment Nos. 4 and 5, dated October 16, 1986
(effective July 1, 1986) and December 6, 1986 (effective
July 1, 1986), respectively, to the Shareholders
Agreement of Kirin-Amgen, Inc. dated May 11, 1984 (with
certain confidential information deleted therefrom). (5)
10.10 Assignment and License Agreement, dated October 16,
1986, between the Company and Kirin-Amgen, Inc. (with
certain confidential information deleted therefrom). (5)
10.11 G-CSF European License Agreement, dated December 30,
1986, between Kirin-Amgen, Inc. and the Company (with
certain confidential information deleted therefrom). (5)
10.12 Research and Development Technology Disclosure and
License Agreement: GM-CSF, dated March 31, 1987, between
Kirin Brewery Company, Limited and the Company (with
certain confidential information deleted therefrom). (5)
10.13 Company's Amended and Restated 1988 Stock Option Plan.
(14)
10.14 Company's Amended and Restated Retirement and Savings
Plan. (14)
10.15 Amendment, dated June 30, 1988, to Research,
Development, Technology Disclosure and License
Agreement: GM-CSF dated March 31, 1987, between Kirin
Brewery Company, Limited and the Company. (6)
10.16 Agreement on G-CSF in Certain European Countries, dated
January 1, 1989, between Amgen Inc. and F. Hoffmann-La
Roche & Co. Limited Company (with certain confidential
information deleted therefrom). (7)
10.17 Partnership Purchase Agreement, dated March 12, 1993,
between the Company, Amgen Clinical Partners, L.P.,
Amgen Development Corporation, the Class A limited
partners and the Class B limited partner. (9)
10.18* Amgen Inc. Supplemental Retirement Plan (As Amended and
Restated Effective January 1, 1998).
10.19 Promissory Note of Mr. Kevin W. Sharer, dated June 4,
1993. (11)
10.20 Amgen Performance Based Management Incentive Plan. (17)
10.21 Credit Agreement, dated as of June 23, 1995, among Amgen
Inc., the Borrowing Subsidiaries named therein, the
Banks named therein, Swiss Bank Corporation and ABN AMRO
Bank N.V., as Issuing Banks, and Swiss Bank Corporation,
as Administrative Agent. (12)
10.22 Promissory Note of Mr. George A. Vandeman, dated
December 15, 1995. (13)
10.23 Promissory Note of Mr. George A. Vandeman, dated
December 15, 1995. (13)
10.24 Promissory Note of Mr. Stan Benson, dated March 19,
1996. (13)
10.25 Amendment No. 1 to the Company's Amended and Restated
Retirement and Savings Plan. (14)
27
<PAGE>
10.26 Amendment Number 5 to the Company's Amended and Restated
Retirement and Savings Plan dated January 1, 1993. (17)
10.27 Amendment Number 2 to the Company's Amended and Restated
Retirement and Savings Plan dated April 1, 1996. (17)
10.28 First Amendment to Credit Agreement, dated as of
December 12, 1996, among Amgen Inc., the Borrowing
Subsidiaries named therein, and Swiss Bank Corporation
as Administrative Agent. (17)
10.29 Fourth Amendment to Rights Agreement, dated February 18,
1997 between Amgen Inc. and American Stock Transfer and
Trust Company, Rights Agent. (15)
10.30 Preferred Share Rights Agreement, dated February 18,
1997, between Amgen Inc. and American Stock Transfer and
Trust Company, Rights Agent. (15)
10.31 Consulting Agreement, dated November 15, 1996, between
the Company and Daniel Vapnek. (17)
10.32 Agreement, dated May 30, 1995, between the Company and
George A. Vandeman. (17)
10.33 First Amendment, effective January 1, 1998, to the
Company's Amended and Restated Employee Stock Purchase
Plan. (20)
10.34 Third Amendment, effective January 1, 1997, to the
Company's Amended and Restated Retirement and Savings
Plan dated April 1, 1996. (20)
10.35 Heads of Agreement dated April 10, 1997, between the
Company and Kirin Amgen, Inc., on the one hand, and F.
Hoffmann-La Roche Ltd, on the other hand (with certain
confidential information deleted therefrom). (20)
10.36 Binding Term Sheet, dated August 20, 1997, between
Guilford Pharmaceuticals Inc. ("Guilford") and GPI NIL
Holdings, Inc., and Amgen Inc. (with certain
confidential information deleted therefrom). (21)
10.37 Promissory Note of Ms. Kathryn E. Falberg, dated April
7, 1995. (23)
10.38 Promissory Note of Mr. Edward F. Garnett, dated July 18,
1997. (23)
10.39 Fourth Amendment to the Company's Amended and Restated
Retirement and Savings Plan as amended and restated
effective April 1, 1996. (23)
10.40 Fifth Amendment to the Company's Amended and Restated
Retirement and Savings Plan as amended and restated
effective April 1, 1996. (23)
10.41 Company's Amended and Restated 1987 Directors' Stock
Option Plan. (17)
10.42* Amended and Restated Agreement on G-CSF in the EU
between Amgen Inc. and F. Hoffmann-La Roche Ltd (with
certain confidential information deleted therefrom).
10.43 Collaboration and License Agreement, dated December 15,
1997, between the Company, GPI NIL Holdings, Inc. and
Guilford Pharmaceuticals Inc. ("Guilford") (with certain
confidential information deleted therefrom). (24)
27* Financial Data Schedule.
99* Sections appearing under the heading "Business - Factors
That May Affect Company" in the Company's Annual Report
on Form 10-K for the year ended December 31, 1997.
----------------
28
<PAGE>
* Filed herewith.
(1) Filed as an exhibit to the Annual Report on Form 10-K for the
year ended March 31, 1984 on June 26, 1984 and incorporated
herein by reference.
(2) Filed as an exhibit to Quarterly Report on Form 10-Q for the
quarter ended September 30, 1985 on November 14, 1985 and
incorporated herein by reference.
(3) Filed as an exhibit to Quarterly Report on Form 10-Q for the
quarter ended December 31, 1985 on February 3, 1986 and
incorporated herein by reference.
(4) Filed as an exhibit to Amendment No. 1 to Form S-1 Registration
Statement (Registration No. 33-3069) on March 11, 1986 and
incorporated herein by reference.
(5) Filed as an exhibit to the Form 10-K Annual Report for the year
ended March 31, 1987 on May 18, 1987 and incorporated herein by
reference.
(6) Filed as an exhibit to Form 8 amending the Quarterly Report on
Form 10-Q for the quarter ended June 30, 1988 on August 25, 1988
and incorporated herein by reference.
(7) Filed as an exhibit to the Form 8 dated November 8, 1989,
amending the Annual Report on Form 10-K for the year ended March
31, 1989 on June 28, 1989 and incorporated herein by reference.
(8) Filed as an exhibit to Form S-3 Registration Statement dated
December 19, 1991 and incorporated herein by reference.
(9) Filed as an exhibit to the Form 8-A dated March 31, 1993 and
incorporated herein by reference.
(10) Filed as an exhibit to the Form 10-Q for the quarter ended March
31, 1993 on May 17, 1993 and incorporated herein by reference.
(11) Filed as an exhibit to the Form 10-Q for the quarter ended
September 30, 1993 on November 12, 1993 and incorporated herein
by reference.
(12) Filed as an exhibit to the Form 10-Q for the quarter ended
June 30, 1995 on August 11, 1995 and incorporated herein by
reference.
(13) Filed as an exhibit to the Annual Report on Form 10-K for the
year ended December 31, 1995 on March 29, 1996 and incorporated
herein by reference.
(14) Filed as an exhibit to the Form 10-Q for the quarter ended
September 30, 1996 on November 5, 1996 and incorporated herein
by reference.
(15) Filed as an exhibit to the Form 8-K Current Report dated
February 18, 1997 on February 28, 1997 and incorporated herein
by reference.
(16) Filed as an exhibit to the Form 8-K Current Report dated March
14, 1997 on March 14, 1997 and incorporated herein by reference.
(17) Filed as an exhibit to the Annual Report on Form 10-K for the
year ended December 31, 1996 on March 24, 1997 and incorporated
herein by reference.
(18) Filed as an exhibit to the Form 8-K Current Report dated April
8, 1997 on April 8, 1997 and incorporated herein by reference.
(19) Filed as an exhibit to the Form 10-Q for the quarter ended March
31, 1997 on May 13, 1997 and incorporated herein by reference.
(20) Filed as an exhibit to the Form 10-Q for the quarter ended June
30, 1997 on August 12, 1997 and incorporated herein by
reference.
29
<PAGE>
(21) Filed as exhibit 10.47 to the Guilford Form 8-K Current Report
dated August 20, 1997 on September 4, 1997 and incorporated
herein by reference.
(22) Filed as an exhibit to the Form 8-K Current Report dated and
filed on December 5, 1997 and incorporated herein by reference.
(23) Filed as an exhibit to the Annual Report on Form 10-K for the
year ended December 31, 1997 on March 24, 1998 and incorporated
herein by reference.
(24) Filed as Exhibit 10.40 to the Guilford Form 10-K for the year
ended December 31, 1997 and incorporated herein by reference.
30
<PAGE>
EXHIBIT 4.9
CORPORATE COMMERCIAL PAPER - MASTER NOTE
BETWEEN AND AMONG AMGEN INC., AS ISSUER,
CEDE & CO., AS NOMINEE OF THE DEPOSITORY TRUST COMPANY
AND CITIBANK, N.A. AS PAYING AGENT
Date of Issuance
AMGEN INC. (Issuer), for value received, hereby promises to pay
Cede & Co., as nominee of The Depository Trust Company, or to
registered assigns: (i) the principal amount, together with unpaid
accrued interest thereon, if any, on the maturity date of each
obligation identified on the records of Issuer (the Underlying
Records) as being evidenced by this Master Note, which Underlying
Records are maintained by CITIBANK, N.A. (Paying Agent); (ii)
interest on the principal amount of each such obligation that is
payable in installments, if any, on the due date of each installment,
as specified on the Underlying Records; and (iii) the principal
amount of each such obligation that is payable in installments, if
any, on the due date of each installment, as specified on the
Underlying Records. Interest shall be calculated at the rate and
according to the calculation convention specified on the Underlying
Records. Payments shall be made by wire transfer to the registered
owner from Paying Agent without the necessity of presentation and
surrender of this Master Note.
REFERENCE IS HEREBY MADE TO THE FURTHER PROVISIONS OF THIS
MASTER NOTE SET FORTH ON THE REVERSE HEREOF.
This Master Note is a valid and binding obligation of Issuer.
Not Valid Unless Countersigned for Authentication by Paying Agent.
CITIBANK, N.A. AMGEN INC.
By: /s/ Wafaa Orfy By: /s/Larry A. May
Authorized Countersignature Authorized Signature
Guarantor
By: /s/
Authorized Signature
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<PAGE>
At the request of the registered owner, Issuer shall promptly issue
and deliver one or more separate note certificates evidencing each
obligation evidenced by this Master Note. As of the date any such
note certificate or certificates are issued, the obligations which
are evidenced thereby shall no longer be evidenced by this Master
Note.
------------------------------------------------------------------
FOR VALUE RECEIVED, the undersigned hereby sells, assigns, and
transfers unto
(Name, address and Taxpayer Identification Number of Assignee)
the Master Note and all rights thereunder, hereby irrevocably
constituting and appointing attorney to transfer said Master Note on
the books of Issuer with full power of substitution in the premises.
Dated:
Signature(s) Guaranteed: (Signature)
Notice: The Signature on this assignment must correspond with the
name as written upon the face of this Master Note, in every
particular, without alteration or enlargement or any change
whatsoever.
------------------------------------------------------------------
Unless this certificate is presented by an authorized
representative of The Depository Trust Company, a New York
corporation (DTC), to Issuer or its agent for registration of
transfer, exchange, or payment, and any certificate issued is
registered in the name of Cede & Co. or in such other name as is
requested by an authorized representative of DTC (and any payment is
made to Cede & Co. or to such other entity as is requested by an
authorized representative of DTC), ANY TRANSFER, PLEDGE, OR OTHER USE
HEREOF FOR VALUE OR OTHERWISE BY OR TO ANY PERSON IS WRONGFUL
inasmuch as the registered owner hereof, Cede & Co., has an interest
herein.
2
<PAGE>
FORM OF LEGEND FOR
PRIVATE PLACEMENT MEMORANDUM AND NOTES
THE NOTES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933,
AS AMENDED (THE ACT), OR ANY OTHER APPLICABLE SECURITIES LAW, AND
OFFERS AND SALES THEREOF MAY BE MADE ONLY IN COMPLIANCE WITH AN
APPLICABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE ACT
AND ANY APPLICABLE STATE SECURITIES LAWS. BY ITS ACCEPTANCE OF A
NOTE, THE PURCHASER WILL BE DEEMED TO REPRESENT THAT IT HAS BEEN
AFFORDED AN OPPORTUNITY TO INVESTIGATE MATTERS RELATING TO THE ISSUER
AND THE NOTES, THAT IT IS NOT ACQUIRING SUCH NOTE WITH A VIEW TO ANY
DISTRIBUTION THEREOF AND THAT IT IS EITHER (A) AN INSTITUTIONAL
INVESTOR OR SOPHISTICATED INDIVIDUAL INVESTOR THAT IS AN ACCREDITED
INVESTOR WITHIN THE MEANING OF RULE 501(a) UNDER THE ACT (AN
INSTITUTIONAL ACCREDITED INVESTOR OR SOPHISTICATED INDIVIDUAL
ACCREDITED INVESTOR, RESPECTIVELY) AND THAT EITHER IS PURCHASING
NOTES FOR ITS OWN ACCOUNT, IS A U.S. BANK (AS DEFINED IN SECTION
3(a)(2) OF THE ACT) OR A SAVINGS AND LOAN ASSOCIATION OR OTHER
INSTITUTION (AS DEFINED IN SECTION 3(a)(5)(a) OF THE ACT) ACTING IN
ITS INDIVIDUAL OR FIDUCIARY CAPACITY OR IS A FIDUCIARY OR AGENT
(OTHER THAN A U.S. BANK OR SAVINGS AND LOAN) PURCHASING NOTES FOR ONE
OR MORE ACCOUNTS EACH OF WHICH IS SUCH AN INSTITUTIONAL ACCREDITED
INVESTOR OR SOPHISTICATED INDIVIDUAL ACCREDITED INVESTOR (i) WHICH
ITSELF POSSESSES SUCH KNOWLEDGE AND EXPERIENCE OR (ii) WITH RESPECT
TO WHICH SUCH PURCHASER HAS SOLE INVESTMENT DISCRETION; OR (B) A
QUALIFIED INSTITUTIONAL BUYER (QIB) WITHIN THE MEANING OF RULE 144A
UNDER THE ACT WHICH IS ACQUIRING NOTES FOR ITS OWN ACCOUNT OR FOR ONE
OR MORE ACCOUNTS, EACH OF WHICH IS A QIB AND WITH RESPECT TO EACH OF
WHICH THE PURCHASER HAS SOLE INVESTMENT DISCRETION; AND THE PURCHASER
ACKNOWLEDGES THAT IT IS AWARE THAT THE SELLER MAY RELY UPON THE
EXEMPTION FROM THE REGISTRATION PROVISIONS OF SECTION 5 OF THE ACT
PROVIDED BY RULE 144A. BY ITS ACCEPTANCE OF A NOTE, THE PURCHASER
THEREOF ALSO SHALL ALSO BE DEEMED TO AGREE THAT ANY RESALE OR OTHER
TRANSFER THEREOF WILL BE MADE ONLY (A) IN A TRANSACTION EXEMPT FROM
REGISTRATION UNDER THE ACT, EITHER (1) TO THE ISSUER OR TO GOLDMAN,
SACHS & CO. OR ANOTHER PERSON DESIGNATED BY THE ISSUER AS A PLACEMENT
AGENT FOR THE NOTES (COLLECTIVELY, THE PLACEMENT AGENTS), NONE OF
WHICH SHALL HAVE ANY OBLIGATION TO ACQUIRE SUCH NOTE, (2) THROUGH A
PLACEMENT AGENT TO AN INSTITUTIONAL ACCREDITED INVESTOR,
SOPHISTICATED INDIVIDUAL ACCREDITED INVESTOR OR A QIB, OR (3) TO A
QIB IN A TRANSACTION THAT MEETS THE REQUIREMENTS OF RULE 144A AND (B)
IN MINIMUM AMOUNTS OF $250,000.
3
<PAGE>
EXHIBIT 10.18
AMGEN INC.
SUPPLEMENTAL RETIREMENT PLAN
(As Amended and Restated Effective January 1, 1998)
ARTICLE I
INTRODUCTION AND PLAN PURPOSE
The Amgen Supplemental Retirement Plan (the "Plan") was established by
Amgen Inc. (the "Company") effective as of January 1, 1993 and was
amended and restated effective January 1, 1998. The purpose of this
Plan is to provide benefits to employees of the Company and certain of
its affiliates whose Matching Contributions and Core Contributions are
limited under the Amgen Inc. Retirement and Savings Plan (the
"Retirement Plan"). The Company intends that the Plan will aid in
retaining and attracting employees of exceptional ability by providing
them with these benefits.
ARTICLE II
DEFINITIONS
For the purposes of this Plan, the following terms, when capitalized,
have the following meanings, and, except as provided otherwise below,
the terms defined in the Retirement Plan shall have the meanings
provided in the Retirement Plan.
2.1 Account means the Account maintained by the Company in accordance
with Article IV with respect to Matching Credits, Core Credits and
Earnings.
2.2 Beneficiary means the person, persons or entity entitled under
Article VI to receive Plan benefits payable in the event of your
death.
2.3 Board means the Board of Directors of the Company.
2.4 Code means the Internal Revenue Code of 1986, as amended.
2.5 Committee means the Compensation Committee of the Company's
Board.
2.6 Company means Amgen Inc. or any subsidiary or affiliate of Amgen
Inc. selected by the Board or the Committee to participate in the
Plan.
2.7 Compensation has the same meaning as such term has under the
Retirement Plan, except that, for purposes of this Plan, Compensation
is not limited by the Salary Cap and Compensation for purposes of this
Plan will not include any foreign assignment differential, that is, an
amount paid to you to compensate for costs unique to an overseas
assignment.
2.8 Core Credit means the amount credited to your Account under
Section 4.2(a) of the Plan.
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2.9 Deferral Commitment means the election to defer "Participant
Elected Contributions" under the Retirement Plan.
2.10 Earnings means the amount credited to your Account under Article
IV.
2.11 Matching Credit refers to amounts credited to your Account under
Section 4.2(b) of the Plan.
2.12 Normal Retirement Date means the first day of the month
coincident with or next following your attainment of age 65.
2.13 Participation Agreement means the agreement you file with the
Committee acknowledging the terms of the Plan and enrolling in the
Plan.
2.14 Retirement Plan means the Amgen Inc. Retirement and Savings
Plan.
2.15 Salary Cap means the highest level of compensation that can be
considered for the purpose of calculating benefits under Section
401(a)(17) of the Code ($160,000 for 1998).
2.16 Spouse means your wife or husband who is lawfully married to the
you at the time of your death.
ARTICLE III
ELIGIBILITY AND PARTICIPATION
3.1 Eligibility. You are eligible to participate in the Plan if you
are an employee of the Company whose compensation for a particular
year is in excess of the Salary Cap.
3.2 Participation. If you are eligible, you may elect to participate
in the Plan with respect to any calendar year by submitting a
Participation Agreement to the Committee by the last day of the
calendar year in which you are eligible and wish to participate. Your
participation in the Plan will continue unless and until you submit a
new Participation Agreement changing or canceling your participation.
ARTICLE IV
CREDITS TO YOUR ACCOUNT
4.1 Account. For record keeping purposes only, an Account will be
maintained for you. Your Account will be used solely to determine the
amounts to be paid to you under the Plan. Your Account will not
constitute or be treated as a trust fund for your benefit.
4.2 Credits. As of the last day of each calendar month, the Company
will credit your Account with your share of Matching Credits and Core
Credits
(a) Core Credits. The amount of Core Credits to be credited to your
account will be determined by calculating first what you would have
received as a Core Contribution under the Retirement Plan without
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<PAGE>
considering the Salary Cap, less the amount of core contributions that
were actually contributed on your behalf to the Retirement Plan.
(b) Matching Credits. The amount of Matching Credits to be credited
to your account will be the amount of matching contributions that
would have been made on your behalf under the Retirement Plan as if
the Salary Cap were not in effect, based on your Deferral Commitment
in effect at the time the Salary Cap is reached for the year (provided
that you demonstrate to the Company that you have set aside for
investment an amount equal to the amount you were prevented from
deferring because of the Salary Cap) less the amount of matching
contributions that were actually contributed on your behalf to the
Retirement Plan.
4.3 Earnings. On the last day of each calendar month, your Account
will be credited with Earnings with respect to the investments of the
Core and Matching Credits credited to your Account. Notwithstanding
the foregoing, if you terminate service as a result of Normal
Retirement, death or Disability (as defined in the Retirement Plan),
you will be entitled to Earnings up to the date of distribution of
your Account. Earnings will be credited at the rate declared by the
Committee, acting in its sole discretion, after taking into account
the investment performance of the investment vehicles selected by the
Committee, or, if the Committee permits, selected by you from among
the investment vehicles available under the Retirement Plan.
4.4 Vesting of Your Account. Your Account will become fully vested
upon termination of employment with the Company on or after (1) your
Normal Retirement Date, (2) the date you become disabled (as
determined under the terms of the Retirement Plan), or (3) your death.
If your employment with the Company is terminated for any other
reason, your Account will be vested in accordance with the following
schedule:
Years of Service Vested Percentage
Less than 5 0%
5 but less than 6 50%
6 but less than 7 60%
7 but less than 8 70%
8 but less than 9 80%
9 but less than 10 90%
10 or more 100%
However, your entire Account will be subject to the creditors of the
Company in the event of the insolvency of the Company.
4.5 Determination of Accounts. Your Account will consist of all your
credited Matching Credits, Core Credits, and Earnings.
4.6 Statement of Accounts. Prior to March 1 of each year or at such
other time as determined by the Committee, the Committee will
distribute statements to you showing the balance of your Account.
3
<PAGE>
ARTICLE V
DISTRIBUTIONS
5.1 Distributions. Following the termination of your employment with
the Company, the Company will pay you the vested balance in your
Account. The payments will be made to you in cash and may be paid
either in a lump sum or in periodic installments at such time and in
such form as determined by the Committee. If you are paid in periodic
installments, the amount of each installment will be equal to the
vested balance in your Account divided by the number of remaining
installments that you are to receive. Any unpaid balance will
continue to receive Earnings. In the event of your death prior to
receiving your full distribution, the unpaid balance will be paid to
your Beneficiary at such times and in such form as the Committee
determines in its sole discretion.
5.2 Withholding; Payroll Taxes. The Company will withhold any taxes
required to be withheld from payments made from the Plan to satisfy
any federal, state, or local requirements regarding tax withholding.
5.3 Payment to Guardian. If a Plan benefit is payable to a minor, a
person declared incompetent or a person incapable of handling the
disposition of property, the Committee may direct payment of such Plan
benefit to the guardian, legal representative or person having the
care and custody of such minor, incompetent or person. The Committee
may require proof of incompetency, minority, incapacity or
guardianship as may be appropriate prior to distribution of the Plan
benefit. Such distribution completely discharges the Committee and
the Company from all liability with respect to such benefit.
ARTICLE VI
BENEFICIARY DESIGNATION
6.1 Beneficiary Designation. Your Beneficiary under the Plan will be
the same Beneficiary you select under the Retirement Plan. If you
change your Beneficiary designation made under the Retirement Plan you
will automatically change the Beneficiary designation under the Plan.
6.2 No Beneficiary Designation. If you fail to designate a
Beneficiary under the Retirement Plan, or if the Beneficiary you
designate dies before you or before complete distribution of your
benefits, your designated Beneficiary will be the first of the
following classes in which there is a survivor:
(a) your surviving Spouse;
(b) your children, except if any of the children predecease you but
leave surviving issue, then such issue will take by right of
representation the share the parent would have taken if living;
(c) your estate.
6.3 Effect of Payment. The payment to the Beneficiary completely
discharges Company's obligations under this Plan.
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<PAGE>
ARTICLE VII
ADMINISTRATION
7.1 Committee; Duties. This Plan is administered by the Committee.
The Committee is responsible for making such rules, interpretations
and computations as may be appropriate. Any decision of the Committee
with respect to the Plan including, without limitation, any
determination of eligibility to participate in the Plan and any
calculation of Plan benefits, is conclusive and binding on all
persons. The Committee may appoint a panel consisting of any number
of individuals, who may or may not be employees of the Company, to
carry out the Committee's duties and responsibilities under the Plan.
7.2 Agents. The Committee may employ other agents and delegate to
them such administrative duties as it sees fit, and may from time to
time consult with counsel who may be counsel to the Company.
7.3 Binding Effect of Decisions. The decisions or actions of the
Committee with respect to any question arising out of or in connection
with the administration, interpretation or application of the Plan and
the rules or regulations promulgated hereunder will be final,
conclusive and binding upon all persons having any interest in the
Plan.
7.4 Indemnity of Committee. The Company will indemnify and hold
harmless the members of the Committee against any and all claims,
loss, damage, expense or liability arising from any action or failure
to act with respect to this Plan, except in the case of the
Committee's gross negligence or willful misconduct.
7.5 Claims Procedure. The Claims Procedure under the Plan is the
same as that under the Retirement Plan, except that the Committee will
be substituted for the Review Panel.
ARTICLE VIII
AMENDMENT AND TERMINATION OF PLAN
8.1 Amendment. The Committee may at any time amend the Plan in whole
or in part. No amendment may decrease or restrict the amount accrued
in any Account maintained under the Plan through the date of
Amendment.
8.2 Company's Right to Terminate. The Board may at any time
partially or completely terminate the Plan if, in its judgment, the
tax, accounting, or other effects of the continuance of the Plan, or
potential payments thereunder, would not be in the best interests of
the Company.
ARTICLE IX
MISCELLANEOUS
9.1 Unfunded Plan. This Plan is intended to be an unfunded plan for
tax law purposes and for purposes of Title I of the Employee
Retirement Income Act of 1974, as amended ("ERISA"), maintained
primarily to provide benefits for a select group of management or
5
<PAGE>
highly compensated employees. This Plan is not intended to create an
investment contract, but to provide tax planning opportunities and
retirement benefits to eligible individuals who have elected to
participate in the Plan. Eligible individuals are members of
management who, by virtue of their position with the Company, are
uniquely informed as to the Company's operations and have the ability
to materially affect the Company's profitability and operations.
9.2 Unsecured General Creditor. Neither you nor your Beneficiaries,
heirs, successors and assigns will have any legal or equitable rights,
interest or claims in any property or assets of Company, nor will they
be Beneficiaries of, or have any rights, claims or interests in any
life insurance policies, annuity contracts or the proceeds therefrom
owned or which may be acquired by Company. Such policies or other
assets of Company will not be held under any trust for your benefit or
that of your Beneficiaries, heirs, successors or assigns, or held in
any way as collateral security for the fulfilling of the obligations
of Company under this Plan. Any and all of Company's assets and
policies will be, and remain, the general, unpledged, unrestricted
assets of Company. Company's obligation under the Plan will be that
of an unfunded and unsecured promise of Company to pay money in the
future.
9.3 Trust Fund. The Company will pay all Plan benefits. At its
discretion, the Company may establish one or more trusts, with such
trustees as the Board may approve, for the purpose of providing for
the payment of such benefits. Such trust or trusts may be
irrevocable, but the assets thereof will be subject to the claims of
the Company's creditors. To the extent any benefits provided under
the Plan are actually paid from any such trust, the Company will have
no further obligation with respect thereto, but to the extent not so
paid, such benefits will remain the obligation of, and paid by, the
Company.
9.4 Nonassignability. Neither you nor any other person may commute,
sell, assign, transfer, hypothecate or convey in advance of actual
receipt the amounts, if any, payable hereunder, or any part thereof,
which are expressly declared to be nonassignable and nontransferable.
No part of the amounts payable will, prior to actual payment, be
subject to seizure or sequestration for the payment of any debts,
judgments, alimony or separate maintenance owed by you or any other
person (other than amounts owed to the Company's creditors in the
event of the Company's insolvency), nor be transferable by operation
of law in the event of the bankruptcy or insolvency of you or any
other person (other than the Company). Notwithstanding the above,
benefits will be payable to an individual other than you under this
Plan upon the determination by the administrative committee of the
Retirement Plan that a domestic relations order is a Qualified
Domestic Relations Order (as such term is defined in Code Section
414(p)).
9.5 Not a Contract of Employment. The terms and conditions of this
Plan may not be construed to constitute a contract of employment
between you and the Company and you (or your Beneficiary) will have no
rights against the Company except as otherwise specifically provided
herein. Moreover, nothing in this Plan will be deemed to give you the
right to be retained in the service of the Company or to interfere
with the right of the Company to discipline or discharge you at any
time.
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<PAGE>
9.6 Cooperation. You are required to cooperate with the Company by
furnishing any and all information requested by the Company in order
to facilitate the payment of benefits hereunder.
9.7 Terms. Whenever words are used in this Plan in the masculine
they will be construed as though they were used in the feminine in all
cases where they would so apply; and whenever any words are used in
this Plan in the singular or in the plural, they will be construed as
though they were used in the plural or the singular, as the case may
be, in all cases where they would so apply.
9.8 Captions. The captions of the articles, sections and paragraphs
of this Plan are for convenience only and do not control or affect the
meaning or construction of any of its provisions.
9.9 Governing Law. The provisions of this Plan is to be construed
and interpreted according to the laws of the State of California to
the extent that they have not been preempted by federal law.
9.10 Validity. In case any provision of this Plan is found to be
held illegal or invalid for any reason, said illegality or invalidity
will not affect the remaining parts hereof, but this Plan will be
construed and enforced as if such illegal and invalid provision had
never been inserted herein.
Adopted this 16th day of February, 1998.
/s/ Edward F. Garnett
Edward F. Garnett
Vice President, Human Resources
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<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
EXHIBIT 10.42
AMENDED AND RESTATED
AGREEMENT
ON G-CSF IN THE EU
BETWEEN
AMGEN INC.
AND
F. HOFFMANN-LA ROCHE LTD
TABLE OF CONTENTS
ARTICLE PAGE
1. DEFINITIONS 1
2. GRANTS AND OBLIGATIONS 6
3. COLLABORATION IN CLINICAL RESEARCH
DEVELOPMENT, REGISTRATION & MARKETING 14
4. OWNERSHIP, PREPARATION AND FILING
OF CPMP, NDA's and MA/V's 19
5. SUPPLY 22
6. MARKETING 28
7. COMPENSATION 34
8. REPORTS AND PAYMENTS 36
9. WARRANTIES AND INDEMNIFICATION 38
10. PATENT AND TRADEMARK INFRINGEMENT 39
11. TERM AND TERMINATION 40
12. MISCELLANEOUS 42
<PAGE>
AMENDED AND RESTATED
AGREEMENT
ON G-CSF IN THE EU
This Agreement is made and effective as of the 10th day of
April 1997 ("Effective Date") by and between AMGEN INC., a
Delaware corporation located at Thousand Oaks, California, USA
(hereinafter "AMGEN") and F. HOFFMANN-LA ROCHE LTD, a corporation
organized and existing under the laws of Switzerland located at
Basel, Switzerland (hereinafter "ROCHE").
WHEREAS, AMGEN possesses rights in and to a pharmaceutical
product known as G-CSF;
WHEREAS, AMGEN and ROCHE have entered into a contractual
relationship regarding G-CSF in the European Union;
WHEREAS, AMGEN and ROCHE have agreed to modify their present
relationship as set forth herein.
NOW, THEREFORE, for and in consideration of the mutual
covenants contained herein, ROCHE and AMGEN hereby agree as
follows:
ARTICLE 1
DEFINITIONS
1.01 "Affiliate" shall mean:
(a) An organization which owns, directly or indirectly, a
controlling interest in AMGEN or ROCHE by stock ownership
or otherwise; or
(b) An organization in which AMGEN or ROCHE or its
stockholders own, directly or indirectly, a controlling
interest by stock ownership or otherwise; or
(c) An organization having its majority ownership directly or
indirectly common to the majority ownership of AMGEN or
ROCHE.
1.02 "KIRIN" shall mean, collectively, KIRIN BREWERY INC., a
Japanese company and KIRIN-AMGEN, INC., a California
corporation, fifty percent (50%) owned by AMGEN, as the case
may be in the context used in a particular section of this
Agreement.
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
1.03 "Territory" shall mean all countries which are currently
members of the European Union ("EU") together with those
countries that join the EU during the Term of this Agreement.
As soon as any EU member country may withdraw or become
excluded from the EU, then as from the effective date of such
withdrawal or exclusion, such country shall automatically be
considered as a country of the territory of the Agreement on
G-CSF in Certain European Countries dated as of the first day
of January 1989.
1.04 "G-CSF" shall mean a polypeptide of 174 or 175 amino acids,
with an amino acid sequence according to positions +1 to 174
of Table VII of International Patent Application Publication
No. WO 87/01132 with possibly an additional N-terminal
methionine, obtained by recombinant DNA technology, having
the biological properties of naturally-occurring pluripotent
granulocyte colony-stimulating factor.
1.05 "Product" shall mean: (1) any product consisting of or
containing as an active ingredient G-CSF or (2) a Second
Generation Product, if any, that becomes a Product pursuant
to the provisions of Section 2.03 hereof. For illustration,
the term Product shall include, without limitation, bulk
forms of the Product ("Bulk Product") and/or finished and
packaged dosage units of the Product ("Finished Product").
1.06 "Patents" shall mean all patents (including inventor's
certificates) and applications therefor owned and/or
controlled by AMGEN in the countries of the Territory,
including without limitation any substitutions, extensions,
reissues, renewals, divisions, continuations or
continuations-in-part thereof or therefor covering G-CSF or a
Product or inventions, arising from or made during the course
of this Agreement.
Notwithstanding the foregoing, the term "Patents" shall have
the following meaning in reference to a Second Generation
Product that becomes a Product pursuant to Section 2.03:
"Patents" shall mean all patents (including inventor's
certificates) and applications therefor owned and/or
controlled by AMGEN or ROCHE or in which either party has any
interest (including but not limited to the ***********
Patents) in the countries of the Territory, including without
limitation any substitutions, extensions, reissues, renewals,
divisions, continuations or continuations-in-part thereof or
therefore covering a Product or inventions, arising from or
made during the course of this Agreement."
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<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
1.07 "Term of this Agreement" shall mean the period commencing on
the Effective Date of this Agreement and ending, unless
terminated sooner or prolonged in accordance with this
Agreement, on December 31, 2010, or until the date of
*************************************************************
************* in which either party has any right or interest
claiming a Product approved for sale in the EU,
******************. If, however,
*************************************************************
*************************************************************
******, the term of this Agreement **************** until the
*************************************************************
************************************. The latest of any of
the dates in this Section 1.07 is hereinafter referred to as
the "Scheduled Termination Date".
1.08 "Confidential Information" shall mean information which
relates to G-CSF or a Product, including financial
statements, costs and expense data, marketing, distribution
and consumer data, production data, know-how, trade secrets,
secret processes and formulae, technical data and reports
including gene technology, biochemical, toxicological,
pharmacokinetic, manufacturing and formulation data, clinical
data, regulatory correspondence or any other information
which is not generally ascertainable from public or published
information, regardless or whether such information was
provided pursuant to the terms of this Agreement, by request
of the other party or in any other manner.
By way of illustration, Confidential Information shall
include without limitation, all information developed or to
be developed by a party to this Agreement, its Affiliates,
and/or clinicians, and all material and information submitted
to and/or filed with a governmental regulatory agency or any
other equivalent agency covering a Product. Confidential
Information shall also include without limitation all
information related to G-CSF or a Product contained in all
documents submitted in connection with INDs (Investigational
New Drug), NDAs (New Drug Application), CTCs (Clinical Trial
Certificate), AMM (Authorisation de Mise au Marche) and other
regulatory submissions throughout the world covering a
Product.
1.09 "Trademark" shall mean the trademark NEUPOGEN(R) owned by
AMGEN and all other trademarks, if any, adopted, used and/or
owned by AMGEN in connection with a Product.
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<PAGE>
1.10 "CPMP" shall mean either (i) the Committee for Proprietary
Medical Products, (ii) its procedures, including its
"bio/high tech" concertation procedures or (iii) the
marketing authorization applications as per such procedures
as the case may be in the context used in a particular
section of this Agreement.
1.11 "Net Sales" shall mean the gross invoice price billed for
Product to third parties by AMGEN or ROCHE and/or each of its
Affiliates (but not including invoices relating to
transactions between and/or among AMGEN, ROCHE, and/or each
of its Affiliates) with respect to a Product in the
Territory, less those deductions normally made under
generally accepted accounting principles and described in
detail in the Supplementary Agreement.
1.12 "Operating Profit or Loss" shall mean the combined profit or
loss of both companies resulting from the activities
described in this Agreement and described in detail in the
Supplementary Agreement.
1.13 "Operating Costs and Expenses" shall mean those costs and
expenses which are included in the calculation of Operating
Profit or Loss. They are described in detail in the
Supplementary Agreement.
1.14 "Supplementary Agreement" shall mean the supplementary
agreement attached hereto as Appendix 1.14, which is hereby
modified effective as of the Effective Date to (1) change all
references therein from Swiss francs to U.S. Dollars to
reflect the change in the functional currency of this
Agreement from Swiss francs to U.S. Dollars and (2) apply
mutatis mutandis except where the context requires otherwise.
It is the intent of the parties to revise the Supplementary
Agreement as soon as practicable following the execution of
this Agreement in order to memorialize previously agreed
alterations thereto.
1.15 "Scheduled Termination Date" shall have the meaning set forth
in Section 1.07.
1.16 "EMEA" shall mean either (i) the European Agency for the
Evaluation of Medicinal Products, (ii) its procedures and
approval systems, including its centralized approval
procedure or (iii) the marketing authorization applications
as per such procedures as the case may be in the context used
in a particular section of this Agreement.
4
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
1.17 "Second Generation Product" shall mean any product consisting
of or containing as an active ingredient any of the following
************ (other than G-CSF) which
******************************************************:
(i)
*****************************************************
*******************************************;
(ii)*************************************************
*****************************************************
*****;
(iii)*******************************;
(iv)*************************************************
**********************************;
(v)
*****************************************************
**********************; and
(vi)
*****************************************************
*****************************************************
***************************************************.
1.18 "Current GMP Requirements" shall mean those current
practices, as amended from time to time, related to the
manufacture of biotechnology products and their precursors
laid down in guidelines and regulations such as the GMP rules
of the World Health Organization, the United States Code of
Federal Regulations, the Guide to Inspection of Bulk
Pharmaceutical Chemicals (U.S. Department of Health and Human
Services, Revised September 1991), the Pharmaceutical
Inspection Convention, and the European Community Guide to
Good Manufacturing Practice in the production of
pharmaceutical products.
1.19 In the terms defined herein, the singular shall include the
plural and vice versa.
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ARTICLE 2
GRANTS AND OBLIGATIONS
2.01 (a) AMGEN hereby grants to ROCHE and its Affiliates, under
the Patents and Trademarks and the conditions herein imposed,
the ****************** right to formulate and fill Finished
Product in any country of the Territory or in Switzerland,
*******************************.
By mutual agreement between parties hereto, ROCHE shall have
the right to have formulated and/or filled Finished Product
by a particular independent third party in any country of the
Territory or in Switzerland.
All rights of ROCHE and its Affiliates under this subsection
(a) shall terminate with regard to each country (including
with respect to all Products sold in each such country) on
the respective dates set forth in Appendix 2.01 (a) and AMGEN
shall formulate and fill each Finished Product itself.
(b) AMGEN hereby grants to ROCHE and its Affiliates, under
the Patents and the conditions herein imposed, the
*************************************************************
****** right to use and sell (including the right to promote
and detail) each Finished Product in the Territory,
*******************************; provided, however, that
AMGEN and ROCHE have agreed to certain other terms relating
to Spain and Italy which are set forth in Appendix 2.01,
which terms shall supplement (and if in conflict shall
supersede) all other terms of this Agreement. All rights and
obligations specified in Appendix 2.01 shall also apply to
any Second Generation Product that becomes a Product pursuant
to the terms of Section 2.03.
It is, however, understood that AMGEN shall retain the right
to ******************************* with ***** in the
Territory as further described hereinbelow.
All rights of ROCHE and its Affiliates under this subsection
(b) to use and sell (but not the right to ******************)
shall terminate for each Product with regard to the countries
and upon the respective dates set forth in Appendix 2.01 (b).
(c) AMGEN and ROCHE shall each have the right and obligation
to co-develop each Product to be promoted, detailed and sold
in all countries of the Territory, as set forth in more
detail hereinbelow.
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(d) During the Term of this Agreement, AMGEN shall not
either, directly or indirectly or expressly or by
implication,
*************************************************************
*******************************:
(i)
*****************************************************
**************************** in any country in the
Territory or in Switzerland, or
(ii)*********************************************************
****** in any country of the Territory, except where such
arrangements are made primarily for the provision of
logistic or related services or back-up supply.
e) AMGEN hereby grants to ROCHE and ROCHE to AMGEN a
************ right and license in each country in the
Territory to that portion of their respective Confidential
Information, **************, as is necessary to perform their
respective obligations as set forth in this Agreement, such
right and license to continue in each country of the
Territory until the Scheduled Termination Date.
(f) AMGEN hereby grants to ROCHE a ************ right and
license in each country of the Territory to AMGEN's Trademark
for use as set forth in this Agreement in connection with
each Product to which such Trademark is applicable, such
right and license to continue in each country of the
Territory until the Scheduled Termination Date.
Except as necessary to perform ROCHE's obligations set forth
in this Agreement, ROCHE's right and license under this
subsection (f) shall terminate for each Product with regard
to the countries and upon the respective dates set forth in
Appendix 2.01 (b).
2.02 It shall be a material obligation of each party hereunder to
act in accordance with accepted business practices and all
material legal requirements in carrying out its rights and
responsibilities hereunder.
2.03 Second Generation Product.
(a) General
It is the desire of the parties to develop and commercialize
a Second Generation Product for the Territory, subject to and
in accordance with the rights, obligations and conditions set
forth in this Agreement. Any future decision by AMGEN and
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ROCHE to develop a Second Generation Product for the
Territory shall be
*************************************************************
*************************************************************
*************************************************************
*************************************************************
***************, the Second Generation Product shall be
deemed to be a "Product" within the meaning of this Agreement
and development will be governed by the terms of Article 3
hereof. The specific Second Generation Product to be
developed shall be ********************, in accordance with
the Evaluation Plan attached hereto as Appendix 2.03. Prior
to completion of the Evaluation Plan, AMGEN and ROCHE shall
(unless the parties
*****************************************) meet ********* (as
part of the ******************************* meetings) to
discuss matters relating to the Evaluation Plan for a Second
Generation Product for the Territory. Any and all information
exchanged by the parties during the period of the Evaluation
Plan shall be considered Confidential Information of the
party disclosing such information and shall be governed by
the terms of Sections 1.08, 2.01 e), 12.02 and 12.03 of this
Agreement. In order to preserve its rights and satisfy its
obligations under the License Agreement dated January 1, 1996
between ROCHE, Hoffmann-La Roche Inc. and
*************************** ("***********") (the "***********
License"), ROCHE shall inform *********** on the evaluation
process of the Second Generation Product and the respective
results to the extent related to the ***** Product (as
hereinafter defined) or the *********** Patents (as
hereinafter defined); provided, however, that prior thereto
ROCHE shall obtain from *********** (and deliver to AMGEN) a
written agreement in favor of ROCHE and AMGEN whereby
*********** agrees to treat any and all such information as
Confidential Information governed by the terms of Sections
1.08, 12.02 and 12.03 of this Agreement.
Upon selection of a Product for development following
completion of the Evaluation Plan, AMGEN and ROCHE shall use
their best efforts to prepare a Clinical R&D Plan described
in Section 3.03 (c) hereof. Thereafter, AMGEN and ROCHE
shall exercise commercially reasonable efforts to develop and
commercialize the Product in accordance with the Clinical R&D
Plan in the Territory. AMGEN shall control development,
preclinical, clinical, regulatory and marketing of a Second
Generation Product (including preclinical, clinical and other
matters prior to the time it becomes a Product) and shall
distribute, and
*************************************************************
*************************. The Clinical R&D Plan including
launch date shall be mutually agreed upon.
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(b) *********** License
If the agreed upon Second Generation Product includes any
technology claimed in or covered by the *********** PATENTS
(as defined in the *********** License and hereinafter
referred to as the "*********** Patents") in the "***********
License", ROCHE will grant AMGEN an **********************
sublicense for the Territory under any rights ROCHE may have
with respect to the *********** Patents under the ***********
License. ROCHE shall not
****************************************** any of its rights
under the *********** License. ROCHE and its Affiliates will
commercialize a Second Generation Product in the Territory
only under rights granted by AMGEN.
(c) AMGEN Products
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*********************************** This paragraph shall not
apply to G-CSF (Neupogen(R)) or a Second Generation Product
which AMGEN or its licensee/partner brings to the Territory
in a cell therapy, ex-vivo expansion application.
(d) ROCHE Products
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
**********************************
(e) Development Costs
As from the Effective Date, AMGEN and ROCHE shall share, in
accordance with the then current profit split in Article 7,
************************************ in the Territory for a
Second Generation Product or a Product, including:
-
*******************************************************
******************; and
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-
*******************************************************
*************************** License. Such costs shall
include ********* payable to *********** as follows:
i) ***************** of the NET SALES (as defined in
the *********** License) of the
******************************** product described and
claimed by *********** in the *********** Patents as
********** (the "***** Product"), provided, however,
that in the event that
(1)certain ********* have to be paid to a third party
due to a patent issue, in such case the *******
payable to *********** shall be
****************************************************
**********; or
(2)the ***** Product shall face significant competition
from a third party
****************************************************
************************ the ******* payable to
*********** in any such country shall be
****************************************************
*****************;
provided further that the total deduction in the
aggregate from (1) and (2) shall not cause the
************ payable to *********** to be less than
*****************.
If both (1) and (2) are applicable, the calculation in
(1) shall be made first and then (2) shall be
calculated.
ii)For a Second Generation Product other than the *****
Product the making, using, selling, offering for sale,
or importing of which would, but for ***********
License, infringe one or more valid issued claims
included in the *********** Patents, all *************
as per i) will be ****************************.
iii)For a Second Generation Product the making, using,
selling, offering for sale or importing of which does
not infringe one or more valid issued claims included
in the *********** Patents, all ************* as per i)
will be **************.
iv)The ********* under iii) above shall be payable so
long as the *********** License is in full force and
effect.
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Such costs shall also include the ********** payable to
*********** as follows:
(1)************
************************************
********************** shall be payable no later
than **************
(2)********************
*************************************************
shall be payable *********************** after the
first entry of a patient in a ************** with a
Second Generation Product in any EU country or the
****************** as agreed to in the time and
events schedule in the Clinical R&D Plan (to be
established after the completion of the Evaluation
Plan), whichever is earlier.
(3)******************
*************************************************
shall be payable *********************** after 50%
of patients have been enrolled in a ***************
with a Second Generation Product in any EU country,
or to ********************************* as agreed to
in the time and events schedule of Clinical R&D
Plan, whichever occurs earlier.
(4)****************
************************************
*********************************** shall be payable
*********************** after the submission of the
first Second Generation Product license
*********************************** to the Authority
in ********************************** or the
*********************** as agreed to in the time and
events schedule in the Clinical R&D Plan, whichever
is earlier.
(5)With respect to
****************************************************
***** of (3) above and
****************************************************
******************* of (4) above, shall be
creditable against the payment of ******* payable to
***********.
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(f) ********* of Second Generation Products
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
*************************************************************
**************************
i)
*****************************************************
*****************************************************
****
ii)
*****************************************************
*****************************************************
****
iii)***********************************************************
*****************************************************
iv)
*****************************************************
*****************************************************
********************
v)
*****************************************************
*****************************************************
*
(g) Manufacturing
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If the agreed upon Second Generation Product is the *****
Product, ***** shall have the rights to manufacture the bulk
form of the Product for the Territory and supply and deliver
it DDP (Incoterms 1990) at a price equal to
********************************** (as defined in the
*********** License) of the Product in the Territory. Until
such *************** is available, the Product shall be
delivered at the expected average *************** in the
Territory to be agreed by the parties and ***********. All
Second Generation Products other than the *********** Product
will be manufactured, formulated and filled by AMGEN for the
Territory.
(h) Miscellaneous
There is nothing in the Kirin-AMGEN Agreements that restricts
AMGEN from fulfilling its obligations under this Agreement
regarding any Second Generation Product in the Territory.
There is nothing in this Agreement that restricts any party
from commercializing in the ROE *************** and ROW
(throughout the world,
*************************************************************
***************************** a Second Generation Product
that is not being commercialized in the EU.
(i) Applicability of Other Provisions of this Agreement
If and when a Second Generation Product becomes a "Product"
pursuant to this Section 2.03, then in addition to the
provisions of this Section 2.03 the other provisions of this
Agreement shall also apply with respect to such Product.
2.04 AMGEN shall have sole ownership of the G-CSF Product and all
related rights during the Term and following expiration or
termination thereof.
With respect to any Second Generation Product that becomes a
Product pursuant to Section 2.03:
(1) if the Product is the ***** Product or is otherwise
covered by the *********** Patents, then AMGEN shall have
the rights described in Section 2.03(b) for the Term and
the parties shall
********************************************* under the
*********** License (taking into account ROCHE's
obligations to ***********) following expiration or
termination of this Agreement;
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(2) if the Product is covered by any ROCHE Patents, then
ROCHE shall have sole ownership of the Product and all
related rights during the Term and following expiration
or termination thereof but AMGEN shall have an
*********************************************************
***************************************** license to the
Product for the Term and the parties shall
********************************************* following
expiration or termination of this Agreement; and
(3) if the Product is covered by any AMGEN Patents, then
AMGEN shall have sole ownership of the Product and all
related rights during the Term and following expiration
or termination thereof but the parties shall
********************************************* following
expiration or termination of this Agreement.
ARTICLE 3
COLLABORATION IN CLINICAL RESEARCH, DEVELOPMENT,
REGISTRATION AND MARKETING
3.01 AMGEN and ROCHE shall cooperate in reasonable ways to develop
and exchange data and information about each Product so as to
obtain the authorization and to develop the ability to
formulate, ship and sell the Product in the Territory.
Pursuant to the terms of this Agreement, the parties shall
use reasonably diligent efforts consistent with prudent
business practice to
(i) optimally develop each Product,
(ii)obtain rapidly the necessary governmental authorization
and approval to sell each Product in commercial
quantities, and
(iii)sell each Product in all countries in the Territory.
3.02 (a) The parties shall each appoint two (2) authorized
representatives ("Coordinators") between whom communications
will be directed with regard to each Product. Each party will
notify the other as to the name of the individuals so
appointed. Each party may replace its Coordinators at any
time, upon written notice to the other party.
The four (4) Coordinators shall form a joint committee
("Product Management Committee") and shall confer regularly
to discuss and to coordinate the effective performance of the
terms of this Agreement.
14
<PAGE>
The Product Management Committee is expected to meet
regularly to
(i) review pertinent information and data
(ii)approve the budgets proposed by the sub-teams and the
countries.
(iii)resolve differences of opinion within the sub-teams, if
any.
(iv)harmonize and coordinate all efforts in view of obtaining
authorization and ability to market each Product in each
country in the Territory and to further develop, promote
and detail each Product in each country of the Territory
pursuant to Article 6.
(b) The Product Management Committee shall establish one or
more operating dedicated sub-teams for the whole Territory
directed by the Product Management Committee and consisting
of representatives of each party which will meet regularly at
mutually agreeable times and locations.
3.03 (a) One of the sub-teams of subsection 3.02(b), the joint
international clinical development team ("Product Clinical
Team") shall consist of two (2) permanent representatives of
each AMGEN and ROCHE. Each party may replace its
representatives at any time, upon written notice to the other
party.
(b) The Product Clinical Team will be responsible to discuss
and coordinate the generation and exchange of information and
data necessary to obtain and maintain approval of each
Product in each country of the Territory, and formulate the
strategies, the plans and the programs that should be
implemented to most effectively and efficiently obtain such
approvals. Illustratively, the Product Clinical Team shall:
(i) formulate and coordinate plans for the development of
data and information necessary to obtain governmental
approvals of each Product in each country of the
Territory, taking into consideration, if applicable,
AMGEN's development plans for the USA and AMGEN's results
elaborated in the USA, and
(ii)coordinate the preparation and the filing of all
governmental applications for approvals necessary to
distribute and market each Product in each country of the
Territory, taking into consideration, if applicable, and
using to the extent reasonably possible, AMGEN's clinical
development plans as well as any data and submissions to
the FDA on each Product.
(c) The Product Clinical Team shall create and execute a
Joint Clinical Research and Development Plan for the
Territory ("Clinical R&D Plan") which shall describe the
clinical program necessary for the preparation and filing of
15
<PAGE>
the first as well as subsequent NDA's in the Territory and
any additional studies and/or programs required to support
NDA claims and/or to generate scientific publications with
due regard for the overall international plan created by
AMGEN with input from ROCHE and KIRIN and consideration of
pre-clinical and clinical data.
The Clinical R&D Plan will include the description of:
(i) clinical strategies, rationale, objectives, general
program and study designs, location of studies, principal
investigator name, time schedules, number of patients
planned, status of studies and program, responsibility
for monitoring and data handling and any critical issues
and recommendations relative to the clinical development
of each Product, and
(ii)strategies, plans and status of IND, NDA and MAA (or
equivalent documents, including EMEA) preparation and
submission to governmental authorities to obtain
authorization to carry out clinical studies and to obtain
from all necessary governmental authorities marketing
approval of each Product in each country of the
Territory.
(iii)estimates of costs of implementing the approval Clinical
R&D Plan and the AMGEN and ROCHE personnel and external
personnel and resources required to execute the approved
Clinical R&D Plan.
(d) The Product Clinical Team shall, inter alia, be
responsible for the following issues:
(i) assuring that the clinical program is carried out to
mutually acceptable levels of Good Clinical Practice
procedures,
(ii)preparing and approving individual study protocols, case
record forms, final study reports and any other official
clinical research documents,
(iii)establishing and maintaining a compatible international
computerized database on an AMGEN-based computer to
which ROCHE and AMGEN shall have terminal access.
(iv)the appropriate collection and transfer of reportable
adverse event data to satisfy governmental agencies and
post-marketing surveillance throughout the world, and
(v) creating and proposing to the Product Management
Committee a detailed clinical budget, monitoring actual
expenditures versus budget and proposing appropriate
revisions to this budget.
16
<PAGE>
(vi)reviewing and approving the promotional materials of each
country in the Territory to ensure compliance with
approved labeling.
(vii)creating an environment in which the clinical
development of each Product can be harmoniously and
efficiently carried out.
(e) The provisions of the Clinical R&D Plan and any other R&D
matters shall be agreed to by the Product Clinical Team and
approved by the Product Management Committee, and if the
Product Clinical Team cannot reach a consensus agreement,
then the matter(s) in dispute shall be referred to the
Product Management Committee.
(f) In the event that the Product Management Committee is
unable to reach a consensus decision on any R&D matter, the
President of AMGEN shall be entitled to make the final
determination.
3.04 (a) The other of the sub-teams of subsection 3.02(b), the
joint marketing team ("Product Marketing Team") shall also
consist of two (2) permanent members of each AMGEN and ROCHE.
Each party may replace its representatives at any time, upon
written notice to the other party.
(b) The Product Marketing Team shall have the responsibility
for the marketing functions as set forth in Article 6 of this
Agreement.
(c) All items regarding the marketing functions shall be
agreed to by the Marketing Team and approved by the Product
Management Committee, and if the Product Marketing Team
cannot reach a consensus agreement, then the matter(s) in
dispute shall be referred to the Product Management
Committee.
(d) In the event that the Product Management Committee is
unable to reach a consensus decision on marketing matters,
the President of AMGEN shall be entitled to make the final
determination.
3.05 AMGEN and ROCHE shall promptly furnish each other with all
Confidential Information in its possession and control with
respect to each Product in the Territory, which has not been
previously furnished to the other and which may aid the other
in performing its responsibilities under this Agreement.
Moreover, the parties will provide each other, through the
Product Clinical Team, with the results of all of its pre-
clinical and clinical studies on G-CSF throughout the world,
and with
17
<PAGE>
(i) quarterly status reports and data on its clinical
development efforts with respect to G-CSF outside the
Territory to which the other party may not have access
otherwise;
(ii)data and information on animal and human studies relative
to G-CSF known to it; and
(iii)information and data regarding G-CSF which was submitted
or will be submitted by ROCHE or its Affiliates, AMGEN or
its Affiliates, or KIRIN (to the extent possible
according to contractual relations) to governmental
authorities throughout all countries of the world outside
the Territory to obtain authorization to initiate
investigational use in humans and/or to obtain approval
to market G-CSF in commercial quantities in such
countries, including but not limited to control, pre-
clinical and clinical information and data.
3.06 The results of all clinical studies and experiments with
respect to each Product conducted in connection with this
Agreement, and related technical information, shall be
delivered promptly to AMGEN by ROCHE and to ROCHE by AMGEN,
and may be used by each and its Affiliates, as well as KIRIN,
in connection with further development and marketing of each
Product and applications to governmental authorities
throughout the world.
3.07 In accordance with the Clinical R&D Plan, AMGEN (or in the
case of a Second Generation Product that becomes a Product,
either AMGEN or ROCHE, as mutually agreed by the parties)
shall supply quantities of each Product in a form suitable
for clinical trials which would enable the parties to
continue to analyze each Product and to initiate and to
continue tests including, but not limited to,
pharmacological, toxicological, microbiological, and clinical
tests on each Product as well as material for formulation
tests on the Product which in both the Product Clinical
Team's as well as in the Product Marketing Team's reasonable
judgment may be necessary to obtain the authorization and the
ability to formulate the Finished Product in any country of
the Territory as well as to ship and sell each Product in the
Territory.
3.08 AMGEN and ROCHE will promptly seek and use its best efforts
to obtain all necessary FDA, EMEA and other applicable
governmental authorizations throughout the world required for
the party supplying each Product pursuant to Section 3.07 to
manufacture, ship and export each Product from the USA (or
other country of export) to all countries in the Territory
and in Switzerland for the parties to be able to conduct pre-
clinical and clinical trials.
18
<PAGE>
3.09 During the Term of this Agreement, each party shall promptly
furnish the other party with information concerning
unexpected side effects, injury, toxicity or sensitivity
reactions or unexpected incidence and severity thereof
associated with animal or clinical uses, studies,
investigations or tests with each Product, whether or not
determined to be attributable to each Product.
3.10 Each party, free of charge, shall also permit a reasonable
number of representatives of the other party to this
Agreement or its Affiliates at reasonable time and upon
reasonable notice, to observe, review, make copies of, and/or
discuss the results of studies and/or submissions (except
studies or submissions relating to manufacturing the Bulk
Product to the extent not necessary for seeking marketing
approval) to the governmental authorities concerning each
Product with scientists or clinicians employed by it (or its
Affiliates) or doing research under its auspices, at any
location mutually agreeable to the parties hereto.
ARTICLE 4
OWNERSHIP, PREPARATION AND FILING OF
EMEA, CPMP, NDA's and MA/V's
4.01 In connection with its tasks contained in Section 3.03
hereinabove, the Product Clinical Team shall prepare and
complete a marketing application and variations for new
indications and new galenical forms pursuant to the CPMP/EMEA
"bio/high tech" concertation procedure ("MA/V Filing") with
respect to each Product for use in each country of the
Territory.
Such MA/V shall contain all data and information deemed
necessary to obtain and maintain approval of the respective
marketing authorizations (including variations) in each
country of the Territory ("Country MA/V") with respect to the
indications of each Product agreed upon by the Product
Clinical Team.
Notwithstanding the foregoing, if applicable, the MA/V Filing
shall instead be made pursuant to the centralized approval
procedure of the EMEA (or other then applicable and
appropriate procedure) in order to obtain and maintain
approval of the centrally approval marketing authorization
(including variations) for the EU (the "EU MA/V").
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4.02 All data, information, results, etc., including Confidential
Information, contained in the
*************************************************************
*******************************, provided, however, that
*************************************************************
************* and all data, information, results, etc.,
including Confidential Information, as is necessary for ROCHE
to perform its duties as set forth in this Agreement and the
*********** License.
4.03 (a) ***** shall have the ********* in the preparation and
filing of the
*************************************************************
*************************************************************
********, respectively, with the respective authorities of
the rapporteur country of the Territory and lodged with the
CPMP/EMEA secretariat.
*************************************************************
********************************************************,
respectively, with the respective authorities in each country
of the Territory, ************************************.
(b) ************************, respectively, subject to
consultation with and approval by the Product Clinical Team,
shall be responsible for filing responses to questions and
comments received from governmental authorities with respect
to Country MA/V's and for filing reports necessary to
maintain Country MA/V's.
In carrying out such responsibilities, AMGEN and its
Affiliates, and ROCHE and its Affiliates shall advise the
Product Clinical Team of all communications by them with
governmental authorities that may be considered significant
and shall, if requested by the Product Clinical Team, submit
for prior review all proposed filings.
4.04 (a) AMGEN and ROCHE shall, in principle, attend all meetings,
if any, with CPMP, EMEA and other drug regulatory personnel
of the EU. AMGEN shall have the lead role in making
presentations in such meetings.
(b) AMGEN and its Affiliates, respectively, subject to
consultation with and approval by the Product Clinical Team,
shall be responsible for responding to questions and comments
received from governmental authorities.
(c) In the event that the Product Clinical Team or the
parties are unable to reach a consensus decision on any
regulatory matter, AMGEN shall be entitled to make the final
determination.
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4.05 (a) With regard to the countries and upon the respective
dates set forth in Appendix 2.01 (b):
(i) the rights and obligations of
************************ in Sections 4.03 (a) and (b)
shall terminate and thereafter the following shall apply
in lieu thereof with respect to each Product: *****
shall have the lead role in preparation and filing of the
*********** and shall file the *********** in its ****
with the EMEA (or other than applicable regulatory
agency). The parties shall mutually agree on the method
of the filing(s), if any, necessary to enable ***** and
***** to sell each Product in the Territory pursuant to
the terms of this Agreement. ***** shall be the holder of
each **** and *********************************,
respectively, subject to consultation with and the
approval by the Product Clinical Team, shall be
responsible for filing responses to questions and
comments received from any and all regulatory authorities
with respect to the ***********. Following receipt of the
**** or ********************************* will file
reports necessary to maintain the MA/V or EU MA/V and
respond to inquiries and comments from any and all
regulatory authorities. In carrying out such
responsibilities, ************************ shall advise
the Product Clinical Team of all communications by them
with governmental authorities that may be considered
significant and shall, if requested by the Product
Clinical Team, submit for prior review all proposed
filings.
(ii)all data and documents with respect to a
***************************** shall be handed over by
***** to *****, which shall be entitled to use such data
and documents for its own purposes and for the purposes
of this Agreement.
(iii)****** shall cooperate with ***** on a timely basis
and in every proper way to
*********************************************************
************ to ***** and ***** shall seek, and use its
best efforts to obtain, the necessary authorization from
the pertinent governmental authorities
****************************
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(iv) to the extent necessary, applicable governmental
authorizations and approvals in the country shall be
*********** to the extent permitted by laws and
regulations, from ***** to
******************************************** for such
transfer shall be charged to the
************************* provided for hereunder.
Notwithstanding the foregoing, ROCHE shall retain its rights
and obligations under this Article 4 with respect to Italy
(ROCHE-Trademark) (Granulokine(R)) until the Scheduled
Termination Date.
ARTICLE 5
SUPPLY
5.01 With respect to the Territory, AMGEN shall supply ROCHE,
******* and under the terms of this Agreement, with
requirements of Finished Product for clinical purposes and
Bulk Product for all developmental and commercial purposes
for all countries of the Territory and shall obtain
authorization form the FDA to manufacture, ship and export
from the USA Bulk Product and Finished Product for clinical
purposes in and to any appropriate countries of the Territory
or Switzerland.
5.02 (a) For the whole Territory, the Product Marketing Team shall
provide AMGEN (i) within **************** of signing this
Agreement a preliminary ************ forecast of the total
requirements for Bulk Product, and (ii) at least
**************** before the beginning of each calendar year
with a ********* forecast of the total requirements for the
Bulk Product in the respective calendar year.
(b) Thereafter, a revised estimate of the requirements will
be given prior to each calendar quarter for the subsequent
four calendar quarters.
(c) Within *************** before the date ROCHE requires to
receive the amount of Bulk Product as per subsections (a) and
(b) of this Section 5.02, ROCHE shall place firm orders
setting forth the quantities of Bulk Product to be supplied
by AMGEN.
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(d) ROCHE's firm orders shall specify reasonable delivery
dates and instructions for shipping and packaging as
aforesaid. If there is any inconsistency between any of the
terms and conditions of a ROCHE order and the terms and
conditions of this Agreement, the terms and conditions of
this Agreement shall prevail.
5.03 AMGEN will manufacture Bulk Product and ROCHE will formulate
and fill Finished Product strictly
(i) in accordance with established written manufacturing
procedures and Finished Product specifications according
to Current GMP Requirements,
(ii)which will meet the requirements set forth in accordance
with applicable laws and regulations for shipment of the
Bulk Product into any of the countries of the Territory
or into Switzerland, and
(iii)which will meet the requirements set forth in all
governmental submissions filed by ROCHE or AMGEN with
regulatory agencies for the manufacture of the Bulk
Product into Finished Product.
Each party shall promptly advise the other party of any new
instructions or specifications required by the foreign
regulatory agencies and the parties shall confer with respect
to the best mode of compliance with such requirements.
5.04 (a) AMGEN will provide ROCHE with a certificate of analysis
for each lot of Product produced. In order to comply with
Current GMP Requirements, ROCHE requests and AMGEN agrees to
supply ROCHE with all procedures, including SOP's, allowing
ROCHE to perform:
(i) The analyses of the Product upon arrival at ROCHE's
designated facility(ies), and
(ii)The analyses of the finished pharmaceutical form before
ROCHE supplies to the trade or the Clinical Research
Centers.
(b) On receipt of a delivery of the Bulk Product ordered,
ROCHE shall check whether it complies with the
specifications. Any discernible non-compliance has to be
reported in writing to AMGEN immediately, together with all
test data, at the latest within ************* after receipt
of the delivery. At the same time ROCHE sends the written
notification, ROCHE shall also send to AMGEN a sample of the
Bulk Product delivered. Otherwise, it will be assumed that
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the Bulk Product delivered has been approved. In the event of
a duly claimed and justified notice of non-compliance, AMGEN
shall make good the order by delivering new material.
5.05 AMGEN will use its best efforts to comply with the sales
forecasts, estimates and orders provided for under this
Article and to ship Bulk Product in accordance with ROCHE's
firm orders, and ROCHE will use its best efforts to formulate
and fill Product promptly and efficiently so as to ensure
that a sufficient supply of Product is available to commence
and continue distribution of the Product in each country of
the Territory as soon as reasonably practicable with
reasonably adequate inventory. The Bulk Product shall be
shipped "DDP (Incoterms 1990)" to ROCHE's facility. In
addition, AMGEN shall use its best efforts to have
********************************** to it which can produce an
amount of Bulk Product which is at least ********************
over the Product Marketing Team sales estimates for the
forthcoming year.
5.06 Should, at any future time, ROCHE's requirements of Bulk
Product exceed the anticipated requirements for a calendar
year, ROCHE shall provide AMGEN, as soon as practicable,
with reasonable written notice to this effect with an
indication of the total amount of such excess requirements.
AMGEN shall use its best efforts to supply such excess
requirements and shall, within **************** from the
receipt of such notice, advise ROCHE in writing as to AMGEN's
ability to provide such supply.
5.07 (a) AMGEN shall furnish ROCHE full descriptions and
instructions concerning the methods, formulae and standards
to be employed by ROCHE to formulate and fill Finished
Product, including such written procedures, flow sheets,
specifications for raw materials, packaging materials and
finished dosage units as well as in-process control
procedures and other process and control data necessary for
the formulation and filling of the Finished Products. AMGEN
shall provide ROCHE from time to time during the Term of this
Agreement with any modifications or supplements to the
information previously furnished to ROCHE.
(b) As far as possible AMGEN is ready, at the request of
ROCHE, to temporarily delegate AMGEN manufacturing experts to
give advice to ROCHE concerning the analytical methods,
formulation and filling of the Finished Product and to
instruct its personnel.
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5.08 In the event that the Bulk Product cannot be exported out of
the USA and into any of the countries of the Territory or
Switzerland to a facility of ROCHE's designation, AMGEN shall
be responsible, at its cost, for arranging non-U.S.
manufacture and shipping of Bulk Product to ROCHE for
commercial purposes.
(a) In the event that AMGEN is unable or unwilling to supply
an adequate quantity of Bulk Product from its own facilities
or third party facilities, ROCHE will make its manufacturing
facilities available to AMGEN for manufacture of Bulk Product
with priority equal to its other products.
(b) Subsection (a) of this Section 5.08 shall apply mutatis
mutandis if ROCHE is unable or unwilling to formulate and/or
fill or have formulated or filled Finished Product.
5.09 AMGEN will use its best efforts to arrange for shipment of
Bulk Product to ROCHE. If other sources or Product for
clinical trials are unavailable, ROCHE will make its
manufacturing facilities to AMGEN for manufacture of Product
for clinical trials.
5.10 (a) All of ROCHE's rights and obligations under this Section
5 shall terminate with regard to the countries and upon the
respective dates given in Appendix 2.01 (a) and, as from such
dates, AMGEN shall manufacture, fill, formulate, ship and
otherwise supply and invoice all Finished Product in such
countries. Notwithstanding the foregoing, ROCHE shall
continue to invoice the Finished Product in Italy (ROCHE-
Trademark (Granulokine(R)) only) until the Scheduled
Termination Date and in Greece until the time, if any, that
AMGEN assumes primary responsibility for marketing the
Product in Greece.
As from the respective dates and countries in Appendix 2.01
(a) the following provisions shall apply:
(i) ROCHE's overall bulk supply forecasts and delivery
schedules shall be adjusted to exclude Product amounts
targeted for the country;
(ii)ROCHE shall terminate formulating and filling of
Finished Product intended to be sold in the country and
ROCHE's inventory of Finished Product targeted for such
country shall be handled as agreed by the parties;
(iii)Sales revenues and/or out of pocket expenses as well
as direct and indirect internal costs for the country,
accrued until such date but not yet received or paid by
ROCHE, shall be considered to be outstanding.
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(b) The parties have agreed that AMGEN will supply
requirements for Italy and Greece with formulated, filled and
Finished Product on the respective dates set forth in
Appendix 2.01 (a), provided that: (1) AMGEN's production and
distribution facility in The Netherlands must have been
approved as a distribution and production site to the extent
required by regulatory requirements in Italy or Greece, as
the case may be; (2) Finished Product for Greece and Finished
Product (ROCHE - Trademark) (Granulokine(R)) for Italy with
ROCHE make-up in accordance with regulatory requirements in
Italy or Greece, as the case may be, shall be delivered by
AMGEN to ROCHE (CIP) (Incoterms 1990) (ROCHE's warehouse
Basel, Switzerland) for shipping and invoicing by ROCHE to
customers in Italy or Greece, as the case may be; (3)
Finished Product (Neupogen(R)) for Italy with make-up in
accordance with regulatory requirements in Italy shall be
supplied, delivered, shipped and invoiced by AMGEN as
required by arrangements, if any, between AMGEN and any
distributor in Italy; and (4) any changes to the then current
pack, its size and dimensions, its text on the product, pack
and enclosures (i.e.: SmPC and PIL) or other like changes
must have been approved in compliance with regulatory
requirements in Italy or Greece. In addition, as from AMGEN
assuming such supply requirements in Italy (ROCHE-Trademark)
(Granulokine(R)) or Greece, the following terms shall apply:
(i) The Finished Product will be manufactured, formulated
and filled according to Current GMP Requirements and
will conform to the lot release specifications
accepted by the appropriate regulatory authorities
and contained in the Country MA/V or EU MA/V (the
"Specifications"). ROCHE shall notify AMGEN of any
changes to the Specifications required by the rules,
regulations or requirements of the appropriate
regulatory authorities.
(ii)AMGEN will provide ROCHE with a certificate of
analysis for each lot of Finished Product produced.
In order to comply with Current GMP Requirements,
ROCHE requests and AMGEN agrees to supply ROCHE with
all procedures, including SOP's, allowing ROCHE to
perform the analysis of the Finished Product upon
arrival at ROCHE's designated warehouse.
(iii)On receipt of a delivery of the Finished Product
ordered, ROCHE shall check whether it complies with
the Specifications. Any discernible noncompliance has
to be reported in writing to AMGEN immediately,
together with all test data, at the latest within six
(6) weeks after receipt of the delivery. At the same
time ROCHE sends the written notification, ROCHE
shall also send to AMGEN a sample of the Finished
Product delivered. Otherwise, it will be assumed that
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the Finished Product delivered has been approved. In
the event of a duly claimed and justified notice of
non-compliance, AMGEN shall make good the order by
delivering new material.
(iv)AMGEN will use its best efforts to supply Finished
Product promptly and efficiently so as to ensure that
a sufficient supply of Finished Product is available
for distribution as soon as reasonably practicable
with reasonably adequate inventory.
(v) In order to facilitate AMGEN's supply planning, ROCHE
shall provide AMGEN during the first month of every
calendar quarter with the estimate of ROCHE's
requirement of the Finished Product for the next
twenty-four (24) months. ROCHE shall furnish AMGEN
firm purchase orders for its planned requirements not
later than sixty (60) days prior to the requested
shipdate. AMGEN may supply but shall not be obligated
to supply in any one month more than fifty percent
(50%) of ROCHE's quarterly estimate.
(vi)Pricing for the Finished Product delivered by AMGEN
to ROCHE will be established annually by the parties,
but shall include
************************************ and ***********
for the ****************. Freight and insurance will
be paid for by AMGEN but included in AMGEN's variable
costs. ROCHE's payment for Finished Product shall be
made not later than **************** following
ROCHE's receipt of delivery.
5.11 Notwithstanding anything in this Article 5 and in lieu of the
foregoing provisions, the following shall apply to the supply
of any Second Generation Product that becomes a Product
pursuant to the terms of Section 2.03 hereof:
(a) Clinical Supply. The clinical supply of the Product
shall be manufactured and supplied at cost by AMGEN or
ROCHE as mutually agreed and shall be subject to
provisions of Section 3.07 and 3.08.
(b) Commercial Supply. If the Product is the *****
Product, the parties shall negotiate an agreement with
*********** pursuant to which *********** will enter into
a definitive agreement with either AMGEN or ROCHE to
manufacture the Bulk Product for the Territory and supply
it to AMGEN for formulation, filling, labeling and
packaging by AMGEN into Finished Product. If the Product
is not the ***** Product, AMGEN shall manufacture,
formulate, fill, label and package into Finished Product.
In either case, AMGEN shall invoice (except as specified
in Section 2.03(f)) and distribute the Finished Product.
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(c) Standards of Supply. Bulk Product will be manufactured
and Finished Product formulated and filled strictly:
(i)in accordance with established written
manufacturing procedures and Finished Product
specifications according to Current GMP
Requirements,
(ii)which will meet the requirements set forth in
accordance with applicable laws and regulations
for shipment of the Bulk Product or Finished
Product into any countries of the Territory or
into Switzerland, and
(iii)which will meet the requirements set forth in
all governmental submissions by AMGEN with
regulatory agencies for the manufacture of the
Bulk Product into Finished Product.
ARTICLE 6
MARKETING
6.01 (a) ROCHE and AMGEN shall use best efforts consistent with
accepted pharmaceutical business practices and legal
requirements to deploy their sales forces to promote and
detail each Product in the Territory on a country-by-country
basis in such manner and with such expedition as they would
have adopted in launching, promoting, detailing, selling and
marketing a pharmaceutical product of their own innovation
and consistent with the approved country Marketing Plan.
(b) AMGEN shall use its best efforts consistent with accepted
pharmaceutical business practices and legal requirements:
(i) to build a new organization in particular countries
of the Territory which can perform AMGEN's
responsibilities hereunder;
(ii)to promote, detail, sell and market each Product in
each country in the Territory in which it has a sales
force.
6.02 (a) In developing a marketing strategy, the Product Marketing
Team will review and approve the promotion, detailing and
marketing plans of the Product in the Territory and the
strategies and programs to maximize sales of each Product in
each country of the Territory.
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Illustratively, the Product Marketing Team shall
(i) using any AMGEN core program as a guide, review and
approve the prelaunch activities and the launch plans of
each Product in each country in the Territory; and
(ii)make suggestions for continuing promotion and detailing
efforts with respect to each Product in the Territory,
taking into account AMGEN's experience inside and outside
the Territory;
(iii)ensure the exchange of promotional material and
experiences, both within and outside the Territory.
(b) In each country of the Territory, on a country-by-country
basis, ROCHE will have the final responsibility, with the
cooperation and assistance of AMGEN, over marketing matters
provided however, after *************** and upon
****************************** notice to ROCHE prior to the
beginning of a ************************, AMGEN may assume
such final responsibility and control for such
************************ and ****************** thereafter in
Greece or any new EU country.
ROCHE's rights and obligations to assume final responsibility
and control over marketing matters for each Product has or
will terminate with regard to the countries and upon the
respective dates set forth Appendix 6.02 (b) and AMGEN has or
shall therefore assume such final responsibility and control
in such countries and as of such dates, however ROCHE shall
continue to participate in the Product Marketing Team as it
has done before except that ROCHE will not have final
responsibility and control thereover.
(c) The Product Marketing Team shall meet annually in the
Territory or in Switzerland in order to review marketing
plans for specified periods for the Territory ("Marketing
Plan").
A Marketing Plan generally consists of the following
elements:
(i) Prerequisites
- Product Profile
- Patent Status
- Trade Mark
- Price and Reimbursement
- Packaging
- Manufacturing and Logistics
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(ii) Targets
- Unit Sales
- Market Share
(iii) Strategy/Objectives
- Positioning (in therapy)
- Target Audience
- Media Selection
- Marketing Investment
(iv) Implementation
- Priority in Relation to Other Products
- Time Table
- Field Staff (training, sales-time, incentives)
- Medical Marketing and Publications
- Congresses, Symposia, Round-Tables
- Sampling
- Journal Advertising
- Direct Mail
- Public Relations
(v) Budget
(d) The provisions of the Marketing Plan shall be reviewed by
the Product Marketing Team and approved by the Product
Management Committee, and if the Product Marketing Team
cannot reach a consensus agreement, then the matters in
dispute shall be referred to the Product Management
Committee.
(e) ROCHE shall have the final responsibility for the
Marketing Plan; provided, however, that after ***************
and upon ****************************** notice to ROCHE prior
to the beginning of a ************************, AMGEN may
assume such final responsibility and control over the
Marketing Plan for each Product for such
************************ and ****************** thereafter in
Greece or any new EU country.
All of ROCHE's rights and obligations to assume final
responsibility for the Marketing Plan for each Product has or
will terminate with regard to the countries and upon the
respective dates given in Appendix 6.02 (b) and AMGEN has or
shall therefore assume such final responsibility and control
in such countries and on such dates, however ROCHE shall
continue to participate in developing and formulating the
Marketing Plan in that country as it has done before except
that ROCHE will not have final responsibility and control
thereover.
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(f) Notwithstanding who has final responsibility or control,
a party shall have the right to comment upon and make
marketing recommendations to the other party regarding the
other party's activities under this Agreement, which
recommendations the other party shall thoroughly evaluate and
consider, taking into account the other party's expertise and
experience.
6.03 In each country in the Territory and subject to any other
provision of this Agreement, each party will provide the
other with all information helpful for the detailing and
promotion of each Product within a reasonable time after such
information becomes known to the party, provided such
information is not received under a secrecy obligation to a
third party or is otherwise restricted.
6.04 ************************* in which
*********************************************************,
ROCHE and AMGEN shall create and develop through the Product
Marketing Team and under the guidance and supervision of the
Product Management Committee, respectively, core sales and
promotional materials relating to each Product for
distribution to independent third parties of the medical and
health community in the Territory. In so doing, any AMGEN
core program shall be considered.
AMGEN and ROCHE may each develop promotional or sales
training materials intended to be used outside the Territory
and, if such materials are used (or adapted for use) in the
Territory with the prior approval of the Product Marketing
Team, charge an appropriate portion of the related costs to
the Operating Profit and Operating Loss account hereunder. To
the extent that materials developed for the Territory are
modified and used outside the Territory, the party using such
materials outside the Territory shall pay or reimburse to the
AMGEN/ROCHE Operating Profit or Loss ten percent (10%) of the
costs incurred in developing such materials for the
Territory.
ROCHE's Affiliates are requested to use such core materials
as much as possible but are free to adapt them as they see
fit. With just cause, ROCHE's Affiliates can develop their
own materials which will be submitted for review to the
Product Marketing Team.
ROCHE shall provide AMGEN through the Product Marketing Team
and the Product Management Committee, respectively, with such
materials, in amounts which are reasonable under the terms of
the Marketing Plan for the promotion and detailing by AMGEN
in cooperation with ROCHE in a given country to members of
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the medical and health community. It is understood that AMGEN
shall supply, **************, to ROCHE samples of sales and
promotional material which AMGEN intends to use outside the
Territory so that ROCHE, with the assistance and cooperation
of AMGEN through the Product Marketing Team and the Product
Management Committee, respectively, may at its discretion
modify or have modified the material and distribute it to
members of the medical and health community in the Territory;
the same applies to samples of promotional material being
created by ROCHE outside the Territory.
This Subsection 6.04 shall apply mutatis mutandis should
AMGEN assume final responsibility in a country.
6.05 Neither party shall have any responsibility for the hiring,
firing or compensation of the other party's employees or for
any employee benefits. No employee or representative of a
party shall have any authority to bind or obligate the other
party to this Agreement for any sum or in any manner
whatsoever, or to create or impose any contractual or other
liability on the other party without said party's authorized
written approval.
6.06 All of the transition dates referenced in Appendices 2.01 (a)
and (b) shall apply as from such dates regardless of any
delay or inability to transfer any government authorizations
or approvals on or prior to any such dates; provided,
however, that in the event that any required MA/V's cannot be
transferred as of any such dates through no fault of ROCHE,
then AMGEN shall defend ROCHE, its agents, directors,
officers and employees ("Representatives") at its cost and
expense, and will indemnify and hold harmless ROCHE and its
Representatives from and against any and all claims for
losses, costs, damages, fees or expenses incurred by ROCHE as
the MA/V holder to the extent they arise out of or in
connection with any action or failure to act by AMGEN. Any
such claim shall be controlled by the provisions of Section
9.02 (c) hereof.
As from the Effective Date, ROCHE's sales force shall
continue active participation at a reduced level. The parties
shall, as part of the annual budget process, determine the
specific participation and role of the ROCHE sales force on
a country-by-country basis. If the parties are unable to
reach a consensus determination, the President of AMGEN shall
be entitled to make the final determination. The parties have
agreed to the level of ROCHE's sales force participation for
1997 and 1998, with a copy of the 1998 participation set
forth in Appendix 6.06. Beginning in 1998 and thereafter, the
level of ROCHE's sales force participation in the Territory
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as a whole (aggregating the ROCHE sales forces for all
Products in all countries in the Territory) shall roughly
approximate ROCHE's then current profit participation in
Article 7; provided however, that the ROCHE sales force
participation for all Products shall not exceed the level
already established for 1997 on a country-by-country basis.
Notwithstanding the foregoing, following a proposal by ROCHE
to AMGEN of reasonable proposed plans acceptable to AMGEN
(with acceptance by AMGEN not to be withheld arbitrarily) to
include a sales force non-billable to the Operating Profit or
Loss for any Product in any country of the Territory, ROCHE
shall be entitled to have a sales force for any such Product
in any country in the Territory if and for so long as: (1)
it bears all of the costs (direct and indirect) associated
therewith (i.e. - such costs are not included in the
Operating Profit or Loss), (2) the activities of such sales
force are consistent with the approved applicable country
Marketing Plans and (3) any and all sales of each such
Product by such sales force are included in the Operating
Profit or Loss.
Notwithstanding anything in this Agreement, with regard to
the participation rights conferred upon ROCHE in Articles 2
through 6 of this Agreement neither AMGEN nor the Operating
Profit or Loss shall bear any direct or indirect costs (i.e.
- such costs are not included in the Operating Profit or
Loss) relating to or in connection with any of such rights,
except those costs reasonably necessary to support the agreed
ROCHE sales force charged to the Operating Profit or Loss.
6.07 The following provisions of Sections 6.07 (a) and (b) shall
apply on a country-by-country basis only with respect to and
during the period in which ROCHE maintains a sales force in
that country billable to the Operating Profit or Loss (or
non-billable if AMGEN agrees that such provisions shall not
apply) and in all other countries each Product shall be
presented solely as an AMGEN product:
(a) With respect to each Product, AMGEN and ROCHE will be
presented and described, by each party hereto, to the medical
and paramedical communities, investors, the press and the
trade as joining in the development, detailing and promotion
of each Product in the Territory, and all written information
(including, but not limited to, educational materials,
journal advertisements, direct mail, sales pieces and other
promotional material) and, to the extent practicable, all
oral information, disseminated or presented, respectively, to
such communities and trade regarding the detailing and
promoting of each Product in the Territory will state this
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collaboration. Neither party shall distribute or have
distributed any such information which bears the name of the
other without the prior written approval of the other, which
approval shall not be unreasonably withheld. Major public
announcements, especially those of regulatory filing and
approvals, will include the names of both AMGEN and ROCHE and
will recognize the innovative role of AMGEN, the important
contributions of ROCHE and the joint AMGEN/ROCHE efforts to
complete registration and launch. Each Product shall be
represented solely as an AMGEN/ROCHE product.
(b) When packaged, and to the extent permitted under the law
of each country of the Territory, each Product will bear the
Trademark and the label of AMGEN/ROCHE.
(c) Each party at its option may issue press releases or
other public announcements relating to each Product or the
Agreement contemplated by this Agreement, provided, however,
that without the prior approval of the other party, neither
party shall issue a press release or public announcement
which has, as a major focus, either the joint development,
detailing and promotion of any Product in the Territory or
such agreement, which approval shall not be unreasonably
withheld. Moreover, neither party may issue a press release
or other public announcement which mentions the other party
by name, without the prior written approval of the other
party, which approval shall not be unreasonably withheld.
Notwithstanding the foregoing, either party may issue such
press releases or make such public disclosures as may be
required by law or regulation.
ARTICLE 7
COMPENSATION
7.01 (a) In each calendar year during the Term of this Agreement,
AMGEN and ROCHE shall share on the
*************************************************************
****************, the **************** or ************** for
each Product for such calendar year for each country in the
Territory.
**** ***** *****
**** ** **
**** ** **
**** ** **
****** ** **
*********
****************
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(b) "****************" or "**************" for each Product
in a country is determined and further defined in the
Supplementary Agreement and shall be calculated and converted
into Swiss francs prior to the Effective Date and shall be
calculated and converted into U.S. Dollars thereafter.
(c) In determining **************** or
************************************* be considered an
*************************************** with respect to G-CSF
shall mean *************************************** on account
of ********* in a country in the Territory in a calendar
year, which ******* is payable by ***** for the calendar year
to *************** in respect of the making, use or sale of
G-CSF in or for any country in the Territory.
*********************** with respect to a Second Generation
Product that becomes a Product pursuant to Section 2.03 shall
mean *************************************** on account of
*********************** in the case the Product is the *****
Product) in a country in the Territory in a calendar year,
which ******* is payable by ***** or ***** (including the
********* payable to *********** set forth in Section 2.03
(e) necessary to ******************** under the ***********
License) to any *********** in respect of the making, use or
sale of the Product for any country in the Territory.
The ********************* paid prior to the Effective Date
(specified as a percentage of *********) included the
following:
Party *******
***************** ****
*********************** **
******************* ***
The ********************* payable on and after the Effective
Date shall include, but not be limited to, the following
********* (specified as a percentage of *********):
Party *******
***************** ***********************
***************************************************
************
******* **********************
******** ****
*********************** **
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Notwithstanding the foregoing, no other ********* payable to
******************* shall be considered *********************
included in *************** (i.e. ***************** not to
exceed ***), unless otherwise negotiated between the parties
pursuant to Sections 2.03 (c) or 2.03 (d).
Each party will provide documentation satisfactory to the
other to confirm to such other party's reasonable
satisfaction that the ******* payments to such *************
for a calendar year are required pursuant to agreements in
respect of the making, use or sale of each Product in or for
any country in the Territory in the given calendar year.
*************************************************************
*************************************************************
***************************************************.
(d) As from the Effective Date, in determining
************************, included in *************** shall
be ***************************** incurred by ***** in the
Territory (and outside the Territory to the extent benefiting
potential sales reasonably expected by both parties of the
Product in the Territory) for all indications of each
Product. Included in such ***** shall be the following *****
incurred after the Effective Date, some of which were
previously considered ************:
*************************************************************
************************** shall consult with ***** prior to
incurring any ********************************** in
connection with formulation and fill and supply activities.
ARTICLE 8
REPORTS AND PAYMENTS
8.01 During the Term of this Agreement, each party shall provide
to the other party the necessary information so that
************************ may be calculated. Each local ROCHE
Affiliate or AMGEN Affiliate, respectively, will send to
ROCHE and AMGEN, respectively, the
*******************************. ROCHE and AMGEN,
respectively, will each calculate the
***************************. The respective
**************************** by Affiliate and total
************* will be exchanged within one hundred and twenty
(120) days after the end of each calendar year between AMGEN
and ROCHE. AMGEN/ROCHE ************************* will be
*************************************************************
************************** and approved by the party not
responsible for ************* within **************** upon
receipt thereof.
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
Resulting estimated *************************************
calculated in accordance with Section 7.01 will be settled
and paid according to the following schedule:
(a) ********* settlements will be made based on
******************************************* based on the pro
rata budget for said quarter, as determined by party
responsible for reporting. A respective country will be
settled on a ********* basis if the country's
********************** do not exceed significantly the
****************************** of all countries in the
Territory. Cash transfer in connection with the *********
settlements will take place **************** after the end of
each *******.
(b) ********************************** will be made based on
the ************************ as outlined in the Supplementary
Agreement and will consider the prevailing *********
settlements. Cash transfer in connection with the
********************************** will take place within
******** after ******* and *********** of the respective
calendar year.
8.02 As from the Effective Date, all sums due to a party under
this Agreement will be payable by the other party in U.S.
Dollars to the following address:
For AMGEN:
AMGEN INC.
1840 DeHavilland Drive
Thousand Oaks, California 91320 U.S.A.
For ROCHE:
F. HOFFMANN-LA ROCHE LTD
Grenzacherstrasse 124
CH-4070 Basel, Switzerland
or any other place or bank account as AMGEN or ROCHE may
designate in writing. Since sales may be made in another
currency, conversion of sales and Operating Costs and
Expenses to Swiss francs prior to the Effective Date and U.S.
Dollars thereafter shall be at rates determined in
accordance with the Supplementary Agreement calculated by
ROCHE through the 1997 calendar year and AMGEN thereafter,
provided that such rates and methodology shall be subject to
both parties reasonable approval.
37
<PAGE>
8.03 Further, if a law or governmental regulation should require
withholding of taxes, said taxes will be deducted from such
remitted amount and will be paid to the proper taxing
authority, and proof of payment will be secured and sent to
the party receiving the amount as evidence of such payment in
such form as required by the tax authorities have in
jurisdiction thereover.
8.04 Auditing of ROCHE's books and records will be accomplished by
ROCHE's internal auditors and will be documented by means of
certification from the internal audit staff. In addition, the
workpapers of the AMGEN/ROCHE consolidation will be available
to AMGEN's auditors.
Auditing of AMGEN's books and records will be accomplished by
AMGEN's internal auditors and will be documented by means of
certification from the internal audit staff. In addition, the
workpapers of the AMGEN/ROCHE consolidation will be available
to ROCHE's auditors.
ARTICLE 9
WARRANTIES AND INDEMNIFICATION
9.01 Each party warrants and represents to the other that it has
the full right and authority to enter into this Agreement,
and that it is not aware of any impediment that would inhibit
its ability to perform its obligations under this Agreement.
9.02 (a) During the Term of this Agreement, each party will
provide through self insurance or a combination of self
insurance and commercially placed insurance coverage in
respect of product liability. The terms of any insurance
coverage shall include insurance against the obligations
assumed by the parties hereunder. Evidence of the existence
and continuation of such insurance shall be provided, upon
written request, to the other party annually and at such
other times as the other party may reasonably request. A
party shall notify the other of any cancellation of or
material change in any such insurance arrangements prior, if
possible, to such cancellation or material change, but in any
event, as soon as possible.
(b) ROCHE shall defend AMGEN, its agents, directors, officers
and employees at its cost and expense, and will indemnify and
hold harmless AMGEN, its agents, directors, officers and
employees from and against any and all claims for losses,
costs, damages, fees or expenses to the extent they arise out
of or in connection with ROCHE's manufacture or distribution
of each Product and/or delivery of the Product to AMGEN,
provided that the foregoing indemnity shall not apply to the
extent that any actual or alleged losses, costs, damages,
fees or expenses are specifically and proximately due to
AMGEN's failure to properly manufacture and/or delivery the
38
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Bulk Product. In the event of any such claim against AMGEN or
any agent, director, officer or employee, AMGEN shall
promptly notify ROCHE in writing of the claim and ROCHE shall
manage and control, at its sole expense, the defense of the
claim and its settlement. AMGEN shall cooperate with ROCHE
and may, at its option an expense, be represented in any such
action or proceeding. ROCHE shall not be liable for any
litigation costs or expenses incurred be AMGEN without
ROCHE's written authorization.
(c) AMGEN shall defend ROCHE, its agents, directors, officers
and employees at its cost and expense, and will indemnify and
hold harmless ROCHE, its agents, directors, officers and
employees from and against any and all claims for losses,
costs, damages, fees or expenses to the extent they arise out
of or in connection with AMGEN's manufacture or distribution
of each Product and/or delivery of the Product to ROCHE. In
the event of any such claim against ROCHE or any agent,
director, officer or employee, ROCHE shall promptly notify
AMGEN in writing of the claim and AMGEN shall manage and
control, at its sole expense, the defense of the claim and
its settlement. ROCHE shall cooperate with AMGEN and may, at
its option and expense, be represented in any such action or
proceeding. AMGEN shall not be liable for any litigation
costs or expenses incurred be ROCHE without AMGEN's written
authorization.
ARTICLE 10
PATENT AND TRADEMARK INFRINGEMENT
10.01 (a) In the event that AMGEN or ROCHE become aware of any
infringement by a third party of any Trademark or Patents,
each party shall inform the other in writing of all available
evidence and details available concerning said infringement.
AMGEN and ROCHE shall then consult with each other as to the
best manner in which to proceed. AMGEN shall have the sole
right but not the obligation to bring, defend, maintain any
appropriate suit or action or to control the conduct thereof
against the infringer. If ROCHE agrees to equally share all
expenses, ROCHE shall also share the recoveries due to any
such action. If ROCHE does not agree to share all expenses,
AMGEN will receive all recoveries due to any such action. If
AMGEN requests ROCHE to join AMGEN in such suit or action,
ROCHE shall execute all papers and perform such other acts as
may be reasonably required. Should AMGEN lack standing to
bring any such action, then AMGEN may ask ROCHE to do so. If
ROCHE elects to bring suit, AMGEN shall cooperate with ROCHE
in conducting the suit and the parties shall share expenses
and recoveries equally.
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
(b) If AMGEN fails to bring legal action or terminate an
infringing activity within nine (9) months of notification of
infringing activity, ROCHE shall have the right but not the
obligation to bring suit against the infringer in the country
of the Territory. If ROCHE elects to bring suit, AMGEN shall
cooperate with ROCHE in conducting the suit and the parties
shall share expenses and recoveries equally.
10.02 In the event that AMGEN and/or ROCHE are sued or
threatened with suit by a third party who claims that the
manufacture, use or sale of any Product is an infringement of
one or more claims of a patent owned by the third party, the
parties shall consult with each other as to the best manner
to proceed. ROCHE and AMGEN agree to equally share the costs
of such suit or threatened suit. If the settlement of a
lawsuit or threatened lawsuit or other action requires any
payments or license in order to manufacture, use or sell any
Product, AMGEN and ROCHE agree to equally share any such
payments and/or license fees including royalties.
ARTICLE 11
TERM AND TERMINATION
11.01 Either party may terminate this Agreement for "Good
Cause" (as defined in Section 11.03 below), on a country-by-
country basis, effective at any time after providing
**************** written notice; provided that the other
party shall have an opportunity to cure any defect or
omission during such ************** period. Should such cure
be effected, such notice with respect to such Good Cause
shall be null and void.
Should the Agreement be terminated in a country by ***** for
Good Cause,
(i) ***** shall receive its share of **************** or pay
its share of ************** for that country under
Section **** for the calendar year in which termination
occurs,
(ii)For subsequent years, ***** shall receive or pay the
************************************************* it
would have received for that country in accordance with
Section ******* if ****************************.
Should the Agreement be terminated in a country by ***** for
Good Cause,
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
(i) ***** shall receive the amount in U.S. Dollars in that
country up to and including the
********************************************,
(ii)*** shall receive
**************************************************** for
that country.
11.02(a) "Good Cause" shall include
(i) the failure of the other party to comply with any of its
material obligations contained in this Agreement in a
country of the Territory;
(ii)any action or proceeding before any court or governmental
agency or other regulatory or administrative agency or
commission, by any governmental or other regulatory or
administrative agency or commission or by any other
person, successfully challenging this Agreement or the
relationship or actions of the parties contemplated
hereby or otherwise materially and adversely affecting
the business or property (including the goodwill and
business reputation and character) of a party hereto;
(iii)termination (a) by ROCHE or Hoffmann-La Roche Inc. for
any reason, or (b) by AMGEN due to the failure of ROCHE
or any Affiliate of ROCHE (including but not limited to
Hoffmann-La Roche Inc.) to comply with any of its or
their material obligations contained therein, of either
of the License Agreements of even date herewith with
respect to the **************************; or
(iv)(a) ROCHE's failure to obtain ************* consent to
the sublicense referred to in Section 2.03 (b) ; or
(b) ROCHE's subsequent termination of such sublicense; or
(c) termination of the *********** License by ROCHE; or
(d) termination of the *********** License by
*********** due to the failure of ROCHE or any Affiliate
of ROCHE to comply with any of its or their material
obligations thereunder through no fault of AMGEN;
provided, however, that in such event termination of this
Agreement shall not effective until fault is established
or mutually agreed, but if it is established or agreed
that AMGEN is not at fault then termination shall be
effective retroactive to the date AMGEN provided ROCHE
with notice of termination and ROCHE shall receive only
its share of Operating Profit or Loss up to and including
the calendar month of the date of notice of termination.
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11.03 Any other provision of this Agreement notwithstanding,
termination of this Agreement for Good Cause shall be without
prejudice to
(i) any remedies which either party may then or thereafter
have hereunder or at law; and
(ii)either party's right to obtain performance of any
obligations provided for in this Agreement which survive
termination by their terms or by a fair interpretation of
this Agreement.
ARTICLE 12
MISCELLANEOUS
12.01(a) This Agreement shall be governed by and interpreted under
the laws of England and the regulations of the EU.
(b) In the event of any controversy or claim arising out of
or relating to any provision of this Agreement or the breach
thereof, the parties shall try to settle those conflicts
amicably between themselves.
(c) Should they fail to agree, any controversy, dispute or
claim which may arise out of or in connection with this
Agreement, or the breach, termination or validity thereof,
shall be settled by final and binding arbitration pursuant to
the Rules of Conciliation and Arbitration of the
International Chamber of Commerce (Paris) as hereinafter
provided:
(i) The Arbitration Tribunal shall consist of three
arbitrators. Each party shall nominate in the request for
arbitration and the answer thereto one arbitrator and the
two arbitrators so named will then jointly appoint the
third arbitrator as chairman of the Arbitration Tribunal.
If one party fails to nominate its arbitrator or, if the
parties' arbitrators cannot agree on the person to be
named as chairman within sixty (60) days, the Court of
Arbitration of the International Chamber of Commerce
shall make the necessary appointments for arbitrator or
chairman.
(ii)The place of arbitration shall be in London, England, and
the arbitration procedure shall be held in English. The
procedural law of the place of arbitration shall apply
where the said Rules are silent.
(iii)The award of the Arbitration Tribunal shall be final
and judgment upon such an award may be entered in any
competent court or application may be made to any
competent court for judicial acceptance of such an award
and order of enforcement.
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
12.02 For a period commencing September 26, 1988 and ending
************** from the termination or expiration of this
Agreement:
(a) each party agrees not to use Confidential Information
furnished by the other party for any purpose inconsistent
with this Agreement; and
(b) each party will treat Confidential Information furnished
by the other party as if it were its own proprietary
information and will not disclose it to any third party other
than its Affiliates or consultants without the prior written
consent of the other party who furnished such information;
provided, however, that such Confidential Information may be
disclosed if in the reasonable opinion of recipient's counsel
such disclosure is necessary to comply with the requirements
of any law, governmental order (including a court order) or
regulation. Recipient shall notify and consult with the
disclosing party prior to such disclosure of information.
Prior to the oral or written presentation or submission for
publication of any data or information with respect to a
Product or Second Generation Product being evaluated,
developed or commercialized for the Territory, each party
will provide a copy of the proposed presentation or
publication to the other party for review. If the data or
information relates to the ***** Product or is covered by the
*********** Patents then it shall also be submitted to
*********** for review. The proposed manuscript, presentation
outline or other information shall be submitted to the
reviewing party as soon as practicable but in no event less
then fifteen (15) days prior to the proposed presentation or
publication. The parties will cooperate and, if necessary,
delay the publication or presentation to permit patent filing
and any other protections to be instituted to protect any
such proposed disclosure before the disclosure occurs. Upon
request, the presenting or publishing party will remove any
Confidential Information belonging to the other party from
any presentation or publication.
12.03 A party shall be relieved of any and all of the
obligations of Section 12.02 with respect to a specific item
of Confidential Information if:
(a) such Confidential Information was known to the party
receiving the Confidential Information prior to receipt from
the disclosing party; or
(b) such Confidential Information was at the time of
disclosure to the party receiving the Confidential
Information generally available to the public or which became
43
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
generally available to the public through no fault
attributable to the party receiving the Confidential
Information; or
(c) such Confidential Information was made available to the
party receiving the Confidential Information for its use or
disclosure from any third person who was at the time of
transmitting such Confidential Information not under a non-
disclosure obligation to the other party.
12.04 During the Term of this Agreement and for *********
thereafter, for a period of ****************** immediately
after voluntary or involuntary termination of an employee who
was involved in promoting or detailing each Product for a
party to this Agreement, the other party to the Agreement
shall not engage such former employee in any work or other
activity (whether as consultant, employee or otherwise),
involving promoting, detailing or marketing each Product for
such other party, without the prior written approval of the
party who was the employer of the former employee.
12.05 This Agreement shall be binding upon, and shall inure to
the benefit of successors to a party hereto, provided
however, that neither this Agreement nor any of the rights or
obligations hereunder shall be assignable without the prior
written consent of both parties.
12.06 Any notice required to be given hereunder shall be
considered properly given if sent by certified mail, return
receipt requested, to the respective address of each party as
follows:
F. Hoffmann-La ROCHE Ltd
Grenzacherstrasse 124
CH-4070 Basel, Switzerland
Attention: Corporate Law Department
and
AMGEN Inc.
1840 DeHavilland Drive
Thousand Oaks, California 91320 U.S.A.
Attention: Corporate Secretary
with a copy to:
AMGEN (Europe) AG
Alpenquai 30
6002 Luzern, Switzerland
Attention: Vice President, Europe
44
<PAGE>
or such other address as the addressee shall have last
furnished in writing in accordance with this provision to the
addresser.
12.07 If any provision of this Agreement is held to be invalid,
such invalidity shall not affect the validity of the
remaining provisions.
12.08 In the event that either party is prevented from
performing or is unable to perform any of its obligations
under this Agreement due to any act of God, fire, casualty,
flood, war, strike, lockout, failure of public utilities,
injunction or any act, exercise, assertion or requirement of
governmental authority, including any governmental law,
order, regulation permanently or temporarily prohibiting or
reducing the level of research, development or production
work hereunder or the manufacture, use or sale of Product,
epidemic, destruction of production facilities, riots,
insurrection, inability to procure or use materials, labor,
equipment, transportation or energy sufficient to meet
experimentation or manufacturing needs; or any other cause
beyond the reasonable control of the party invoking this
Section 12.08 provided such party shall have used its best
efforts to avoid such occurrence; such party shall give
notice to the other party in writing promptly, and thereupon
the affected party's performance shall be excused and the
time for performance shall be extended for the period of
delay or inability to perform due to such occurrence.
12.09 The waiver by either party of a breach or a default of
any provision of this Agreement by the other party shall not
be construed as a waiver of any succeeding breach of the same
or any other provision, nor shall any delay or omission on
the part of either party to exercise or avail itself of any
right, power or privilege that it has or may have hereunder
operate as a waiver of any right, power or privilege by such
party.
12.10 In the event that any provision of this Agreement is held
by a court of competent jurisdiction to be unenforceable
because it is invalid or in conflict with any law of any
relevant jurisdiction, the validity of the remaining
provisions shall not be affected, and the rights and
obligations of the parties shall be construed and enforced as
if the Agreement did not contain the particular provisions
held to be unenforceable.
12.11 All captions hereunder are for convenience only and shall
not be interpreted as having any substantive meaning.
12.12 All covenants, agreements, representations and warranties
made hereunder shall be deemed to have been relied upon
notwithstanding any investigation heretofore or hereafter
made and shall survive the execution of this Agreement.
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12.13 This Agreement (including all Appendices attached hereto
which shall be considered part of this Agreement) constitutes
the complete and final agreement between the parties hereto
with respect to the within subject matter for the Territory
and cancels and supersedes all prior negotiations,
correspondence, understanding and agreements, whether written
or oral, respecting the subject matter thereof. This
Agreement may be changed only in writing signed by properly
authorized representatives of AMGEN and ROCHE. Any
inconsistency between this Agreement and the Supplementary
Agreement shall be construed in favor of this Agreement.
12.14 This Agreement may be executed in any number of
counterparts, each of which need not contain the signature of
more than one party but all such counterparts taken together
shall constitute one and the same agreement.
12.15 This Agreement is not intended to create a partnership
and except as expressly set forth herein neither party shall
have the power or authority to bind or obligate the other
party.
IN WITNESS WHEREOF, AMGEN INC. AND F. HOFFMANN-LA ROCHE LTD, have
caused this Agreement to be duly executed by their authorized
representatives, in duplicate on the dates written herein below.
Thousand Oaks, California, AMGEN INC.
January 26 , 1998 By: /s/Kevin Sharer
Its: President
Basel, Switzerland, F. HOFFMANN-LA ROCHE LTD
January 26 , 1998 By: /s/Erich Platzer
Its: Business Manager, Oncology
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<PAGE>
Appendix 1.14
SUPPLEMENTARY AGREEMENT TO
AGREEMENT ON G-CSF IN THE EC
BETWEEN
AMGEN INC.
AND
F. HOFFMAN-LA ROCHE & CO. LIMITED COMPANY
This document is the Supplementary Agreement regarding the
definition of Operating Profit or Operating Loss referred to in
Articles 1.18, 1.19 and 7.01(a) of the Agreement on G-CSF in the
EC (European Community) between F. Hoffmann-LaRoche & Co. Limited
Company (Roche) and Amgen Inc. (Amgen), dated September 26, 1988.
In addition, this supplementary agreement covers the financial
planning, accounting policies and procedures to be followed in
determining the Operating Profit and or Loss and related sharing
of profit and expenses. For purposes of this agreement the
consolidated accounting of operations will be referred to as AMRO.
1. Principles of Reporting
The presentation of results of operations will follow the
Roche format of presentation used for distribution to
management, which is as follows:
Sales
Sales Deductions
Cost of Goods Sold
Fixed Production Costs
Commercial Services
Research and Development
Other Operating Inc./Exp.
Technical Services
Administration
Operating Profit (Loss)
Amgen will make the appropriate adjustments to its financial
statements to conform to the Roche format of reporting
results of operations.
2. Frequency of Reporting
Reporting of AMRO will be done twice a year, at the end of 6
months and the end of 12 months. The fiscal year of the
venture will be a calendar year.
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
On an interim basis Roche will supply Amgen with certain
information:
Sales in units, local currency and Swiss francs will be
reported monthly by country.
Key events such as -
Start of clinical trials;
Seminars/Congresses attended or held;
Filings of regulatory documents;
Approvals by regulatory agencies;
will be reported as they occur.
Amgen's European Chief Financial Officer or designee
will meet regularly with Roche's designated financial
controller to review:
Performance Information
Actual Results
Latest Estimates
Consolidated results of operations will be prepared in
accordance with the calendar of financial reporting used by
Roche.
3. Budgeting
The financial responsibility for the budget will rest with
the G-CSF Clinical team and G-CSF Marketing team with final
approval by the G-CSF Management Committee. The timing of
planning will conform to Roche's planning cycle. In broad
terms a preliminary budget will be due at *******
headquarters in ***** on **********. Consolidation will be
completed in November and budget approved in December.
Budgets will be prepared on an annual basis. Sales will be
the only element of the financial plan which will be planned
on a monthly basis.
Budgets will be supplemented with detailed business plans for
clinical trials, registrations applications, and detailed
plans for product introduction.
Budget variances and performance analysis will be done in the
local currency of the country in question. Budgets, as
stated in local currency, cannot be exceeded without formal
approval by the G-CSF Management Committee.
The Management Committee may adjust the budget during the
course of the year.
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4. Definitions
Sales -
Amounts invoiced to third parties
Less: Returns and credits
Rebates
Volume discounts
Sales taxes/other taxes related to sales
Sales deductions -
Consists of direct and variable expenses incurred
in the distribution of goods and services sold.
Which includes:
Outward freight (all outward expenses for
freight in connection with the distribution of
goods sold)
Transportation insurance
Packing materials (for dispatch of goods sold
such as boxes, drums, etc.)
Other direct distribution expenses
Cost of Goods Sold -
Cost of goods sold consists of the direct
production costs which include the following:
Raw materials
Packaging materials
Auxiliary materials
Outside contractors
Personnel costs (Salary and Wages)
Energy (Variable cost)
Workshop (Repairs and maintenance)
(Variable cost primarily preventative
maintenance)
Quality control (Variable cost-related to
product testing)
Waste disposal (Variable cost)
Fixed Production Costs -
Fixed production costs will include those
manufacturing costs which are period costs and do
not vary based on production volume. These costs
include the following:
Production management and planning
Equipment depreciation & rental
Building depreciation & rental
Energy (Boiler rooms, general consumption of
utilities, fixed costs)
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Workshop (repairs and maintenance) (major
replacement not dependent on volume, fixed
costs)
Quality control (fixed costs - process
testing)
Waste disposal (fixed costs)
Commercial Services -
Commercial Services consists of two major areas:
Marketing
Commercial Services Infrastructure
(In Amgen books and records this area is
referred to as Marketing)
Marketing consists of all activities which are
focused on the introduction, promotion and selling
of pharmaceutical products. Within the scope of
this area will be:
Field staff -
Field staff comprises all the costs of the
entire field staff including its management
and support (training, record files, etc.)
Internal Marketing Services -
Internal marketing services comprises the
entire marketing organization with the
exception of the field staff and
infrastructure.
Activities included in this area are as
follows:
Market Research
Pricing
Regional Coordination and Documentation
Product Management
Technical Promotion
Medical Information Services
Marketing Clinicals Studies
C-CSF product specific costs will be chargeable to the
operations of the Product.
The types of costs or expenses to be included in this area
shall be:
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Sales and promotional materials
Seminars, exhibits, and conventions
Advertising in journals, mailings and other media
Post-marketing surveillance
Costs related to institutional promotion, or promotion of the
company which is not product specific, will not be chargeable
to the operations of the Product.
Commercial Services Infrastructure -
Costs in this area include:
Commercial Service Manager (G-CSF Team Manager) and
Secretary
Registration
Strategic and Operational Planning
Marketing Administration
Health Economics
Other staff reporting to the Commercial Services
Manager
Attached to this agreement are the current charts of accounts for
Roche and Amgen concerning Commercial Services (Exhibit I), and
Marketing (Exhibit V), respectively.
Account definitions, where available, are included in Exhibit III.
Research and Development -
Those expenses, direct and indirect, required to obtain the
authorization and/or ability to manufacture, formulate, fill,
ship and/or sell the Product in commercial quantities to
third Parties in the Territory.
Such expense shall include but not limited to:
Costs of research, proposals or studies on the
toxicological, pharmaceutical, formulation or clinical
aspects of the Product conducted internally or by
individual investigators, hospitals or medical centers,
or clinical research organizations, or consultants
necessary for the purpose of obtaining and/or
maintaining approval of the Product by a government
organization in a country in the Territory. In
addition, costs for preparing, submitting, reviewing or
developing data or information for the purpose of
submission to a governmental authority to obtain and/or
maintain approval of the Product in a country.
These costs shall include expenses for data management,
statistical designs and studies, document preparation,
and other similar expenses associated with the clinical
testing program.
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
It is understood that obtaining FDA authorization to ship
product from the USA into the territory or Switzerland shall
be at ******* sole expense.
Attached to this agreement as Exhibit II and Exhibit IV are
the current charts of accounts for Roche and Amgen,
respectively. In addition, account definitions, where
available, are included in Exhibit III.
Other Income/Expense -
Other Income/Expense will include the following items:
Bad debt expenses
Inventory write-offs
Cash discounts
Royalty expense
Technical Services -
Technical services includes the following functions:
Technical Services Admin.
Engineering
Technical Safety & Environment Protection
Materials Management
Costs relating to the Product in this area will be
limited to allocations to support manufacturing.
Administration -
Administration shall consist of the following:
Personnel
Data Processing
General Services - (This cost area covers the
internal postal system, the telephone
exchange, the microfilm office, the in-house
printing shop and central reprography service,
etc.)
Costs relating to the Product in this area will be
limited to expenses that are directly related to the
functional areas of Manufacturing, Commercial Services
and Research and Development.
5. Manufacturing Costs and Cost of Goods Sold -
The elements and characterization of manufacturing costs will
conform to Roche's accounting policies and practices. To the
extent that Amgen has cost elements included in manufacturing
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
costs that do not conform to Roche's accounting practices
such costs will be accounted for as per the category of costs
normally used by Roche.
In order to achieve a proper and acceptable accounting for
manufacturing costs for the Product, standard costs per unit
for direct manufacturing costs and fixed production costs
will be established. Such standards will be established
annually; variances from standard will not be charged or
credited to Cost and Goods Sold.
In addition, annually, a standard cost for samples and
clinical requirements will be developed.
6. Bulk Transfer of Product
Pricing for bulk G-CSF shipped by Amgen to Roche will be at a
cost based on a standard set ********. The bulk transfer
price will be the
*****************************************************.
Payments for bulk shipments will be made on a
*************************************************************
************************************************.
Freight and insurance will be paid for by Amgen and included
in the standard cost of the bulk Product.
Samples required by local Amgen companies will be provided by
local Roche companies and will be billed at cost.
Roche will maintain one inventory to service all bulk
inventory requirements on a worldwide basis.
7. Foreign Exchange -
The functional currency for accounting for operating profit
will be Swiss francs.
Amgen will bill shipments of bulk Product in Swiss
francs.
Roche will maintain the bulk inventory of Product in
Swiss francs.
Roche affiliates will account for inventory in local
currency.
Each statement of operations will be translated into Swiss
francs on an average rate for the reporting period, except
for sales which is translated on a monthly weighted average.
53
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
8. Auditing of Accounts -
Auditing of Roche's books and records will be accomplished by
Roche's internal auditors and will be documented by means of
certification from the internal audit staff. In addition,
the workpapers of the AMRO consolidation will be available to
Amgen's auditors.
Amgen will request that its public accounting firm, Arthur
Young and Co., review its financial records and accountings
of AMRO activities and provide a "comfort letter" to Roche
concerning the accuracy, consistency, and adherence to the
accounting agreement.
9. Interim Compensation Payments of Partners -
Compensation payments for operating income and expense will
be made ********* between the partners based on budget. Such
payments will be made ******* after each fiscal quarter. At
the end of each ********* period a settlement will be made to
adjust budgeted income and expense to actual. Such a
settlement will take into consideration quarterly operating
income and expense compensation, and payments made for
transfer of bulk Product. Settlement payments will be made
as soon as the actual operating expense and income are
consolidated and approved by the partners, but in no event
later than ******** after ******* and ***********.
10. Responsibility for Reporting -
The responsibility for accounting shall be placed with the
company responsible for distribution and invoicing of
customers.
11. Amgen Accounting for Internal R&D and Marketing -
To the extent that Amgen establishes departments that are
wholly dedicated to G-CSF in Europe, such operating costs
will be charged to the operating results of the Product based
on actual, limited by the prevailing budget.
If resources are provided by departments which are not wholly
dedicated to G-CSF Europe, then an hourly rate for that
department will be developed, and applied to time reported by
staff working in that department, to account for internal
operating costs of that department for the purposes of this
agreement. The hourly rate will be based on the current
Amgen budget, adjusted for inflation.
54
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
12. Allocation of Technical Services and Administration -
Roche will conduct an annual study to determine the total
percentage relationship of Technical Services to COGS. The
percentage of Administrative Expense to the total of
Commercial Services and Research and Development will be
calculated similarly.
Amgen will determine a similar percentage of Administration
to the total of Marketing and Research and Development.
Amgen may review the percentage after the initial year to
determine its appropriateness. Amgen will not charge
operations of the Product with "start-up" costs for its
European operations. In addition, administration expenses
associated with operations in the United States will not be
charged to the expenses of the Product.
These percentages will be applied to actual and budgeted
Commercial Services (Marketing) and Research and Development
expenses to determine Technical Services (Roche only) and
Administration expense for the consolidated statement of
operations and budget.
Third party legal expenses or product liability insurance
will not be permitted in the calculation of an administrative
percentage.
13. Definition of Net Sales for Royalty Calculations -
Net Sales for purposes of calculating royalties shall be
Sales, as defined in part 4 of this agreement, less any cash
discounts charged to other income and expenses.
14. Start of Operations -
Operation of AMRO will commence ***************. Costs
incurred, and approved by the Management Committee will be
charged to AMRO operations after ***************. Costs
incurred prior to *************** are not chargeable to AMRO.
Costs for **************** that are in progress at
*************** and directed towards supporting filing in
Europe can be charged to the AMRO operation after approval by
the G-CSF Clinical Team.
15. Guidelines for Charging Costs to AMRO -
55
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
I. If an element of cost is
************************************** to the
development or commercialization of G-CSF as a product
*************, then **** of that element will be
chargeable ******* on the basis agreed to by the
partners.
II. If an expense to a *********** is
****************************************** to the
development or commercialization of G-CSF as a product
within ****** then:
a) If the amount of that element of cost utilized in
the development or commercialization of G-CSF
***************************************************
***************************************************
****** then the amount used may be charged *******.
b) Upon approval by the Management Committee of an
activity or expense which benefits G-CSF in cases
where there is
**************************************** available,
then:
i) If ***************** expense is determined by
the partners to be utilized in the development
or commercialization of G-CSF, then **** of
the element may be charged *******.
ii) If ******************** of the expense is
determined by the partners to be utilized in
the development or commercialization of G-CSF,
then *** of the element may be charged
*******.
iii) If there is
************************************ in the
development or commercialization G-CSF, but it
is also
****************************************, then
** of that expense may be charged *******.
56
<PAGE>
Attest: AMGEN INC.
By /s/ Robert D. Weist By /s/ Lowell E. Sears
Date 1/19/89 Date 1/19/89
F. HOFFMAN-LA ROCHE & CO.,
LIMITED COMPANY
By /s/ Stephan C.J. Walsh
Date 24 January 1989
By /s/[illegible]
Date 24 January 1989
57
<PAGE>
Exhibit I
AMRO
Roche
Commercial Services
Chart of Accounts
COST TYPE TITLE
4219.01 TEMPORARY HELP (from temporary agencies)
4223.02 TRAINING
4311.01 TRAVEL COSTS
4311.51 VISITORS' COSTS
4312.01 RENT - REAL ESTATE, OFFICES
4312.04 LEASING - EDP EQUIPMENT
4314.01 DEPRECIATION
4350.01 ADVERTISING - PRINTING
4350.04 SLIDES, PHOTOS
4350.05 CONGRESSES, CONVENTIONS
4350.15 MARKET RESEARCH
4350.16 AGENCY, CONSULTING EXPENSES
4350.18 OTHER ADVERTISING EXPENSES
4350.19 OTHER MARKETING EXPENSES
4361.03 OUTSIDE PRINTING, PHOTOS
4361.21 ASSOCIATION DUES
4361.54 REGISTRATION FEES - AUTHORITIES
4371.21 BOOKS, PERIODICALS
4371.22 OUTSIDE PROGRAMMING - EDP
4371.31 OP/APPL SOFTWARE
4371.41 SPECIAL SHIPPING COSTS
4371.91 OTHER OUTSIDE WORK
6001.96 SAMPLES
6112.95 ENERGY
6011.02 SALARIES & BENEFITS
6011.03 SALARIES & BENEFITS (Temporaries employed by Roche
on Roche P/R)
58
<PAGE>
Exhibit II
AMRO
Roche
Clinical Research and Development
Chart of Accounts
COST TYPE TITLE
4111.32 CHEMICALS
4219.01 TEMPORARY HELP (from Temporary Agencies)
4223.02 TRAINING
4311.01 TRAVEL COSTS
4311.51 VISITORS' COSTS
4312.07 RENT - REAL ESTATE, OFFICES
4312.04 LEASING-EDP EQUIPMENT
4314.01 DEPRECIATION
4331.02 FEES & GRANTS
4331.03 EXPENSES FOR BIOMETRY (Statistical evaluation of
clinical trials by Third Party)
4361.03 OUTSIDE PRINTING, PHOTOS
4371.21 BOOKS, PERIODICALS
4371.31 OP/APPL SOFTWARE
4371.41 SPECIAL SHIPPING COSTS
4371.91 OTHER OUTSIDE WORK
6001.16 TECHNICAL ARTICLES
6001.95 AUXILIARY MATERIALS
6001.96 SAMPLES
6001.96 SALARIES (Full-time employees)
6011.03 SALARIES (TEMPS) - (Temporaries employed by Roche
on Roche P/R)
6111.95 REPAIR MATERIALS
6112.95 ENERGY
6113.95 QUALITY CONTROL
59
<PAGE>
Exhibit III
Account No.
Description: Personnel Expenses
6011.02 Definition:
6011.03
4219.01 Personnel expenses include all payments made
to employees in the form of wages and
salaries. Also included, are expenses related
to pensions, welfare and other employee
benefits.
Description: Wages and Salaries
6011.02 Definition:
6011.03
4219.01 This position includes all remuneration paid
to employees in the form of:
- Salaries
- Wages
- Overtime pay
- Shift, holiday and other premiums
- Disability payments to employees
- Vacations and other paid absences
- Employee awards and bonuses
- Salesmen's commissions and other employee
commissions.
The above payments made to temporary personnel,
summer employees, etc., are included under this
position. Also included are wages and salaries
paid to outside agencies providing temporary
workers and employees.
Payments made to former employees (pensioners)
are not included under this position.
Description: Pension, Welfare and Other Employee
Benefits
6011.02 Definition:
6011.03
This position includes all costs incurred for
employee benefits, other than direct remuneration
to the employee. Expenses reported under this
position include:
- Company paid insurance premiums (life
insurance, hospital insurance, medical
insurance, etc.)
60
<PAGE>
- Workmen's compensation insurance
- Payments to pension fund, trust or other social
institutions
- Payments to retirement plans and matching
contributions to savings plans
Account No.
Description: Energies
6112.95 Definition:
This position represents the consumption of
purchased energies such as electricity, natural
gas, gasolines, diesel fuel, oil, coal,
pressurized gases, etc., as well as any other
related charges.
Description: Repairs and Maintenance
6111.95 Definition:
Minor repairs and maintenance expenditures
required throughout the economic life of an asset
in order to keep it in efficient operating
condition. The distinguishing characteristics of
such expenditures are that they do not add to the
value or extend the useful life of property.
Repairs and maintenance have to be considered as
current period expenses and should not be
deferred over subsequent periods. This account
contains only invoiced costs for repairs and
maintenance from third parties (incl. material).
Also to be included here are expenses for
material for which no inventory-accounts are
kept.
In addition, any expenditure of a fixed asset
nature, which by local tax regulations may be
regarded as a deductible expense, could be
included here.
Description: Rent and Leasehold
6116.95 Definition:
4312.04
Expenses included in this category are rental and
non-capitalized leasing costs incurred by the
company for:
- Property, buildings and plants
61
<PAGE>
- Machinery and equipment
- Office equipment, furniture and fixtures
- EDP equipment and software licensing
- Parking lots rented for personnel
- Other rental or leasing expenses
Account No.
Description: Travel and Entertainment Expenses
4311.01 Definition:
4311.51
This position includes all costs incurred by
employees (including field staff) while traveling
on company business and/or entertaining business
associates.
Exceptional entertainment expenses (such as
company anniversary celebrations) should be
reported as non-operating expenses.
Description: Advertising and Promotion
4350.01
4350.04
4350.05
4350.15 Definition:
4350.18
4350.19 Items classified in this category include all
costs paid to third parties for advertising and
promotion of company products and/or services.
Types of advertising and promotion include:
- Radio and television advertising
- Samples distributed to outsiders
- Journal advertising
- Promotional material
- Material and space for conventions and
exhibitions
Self-produced and distributed samples are not to
be included here.
If however, inventory accounts for all or certain
promotion materials are maintained, the
corresponding expense should appear under
"Material and Merchandise Expense."
62
<PAGE>
Account No.
Description: Outside Services for Research and
Development
4111.32
4331.02
4331.03 Definition:
4361.02
4371.91 This account includes Third Party expenses
directly related to research and development,
such as:
- Fees and grants
- Research chemicals
- Clinical trials
- Test animals (including inward freight,
transportation, insurance, etc.)
- Animal feed
- Printing, photocopying, photography, etc.
- All other expenses directly related to the
research activity.
Note:
Under outside expenses, we understand expenses
paid to third party only.
Description: Depreciation of Property, Plant and
Equipment
4314.01 Definition:
Depreciation is a systematic charge against
income which distributes the cost or other basic
values of fixed assets over the estimated useful
life of the asset. Depreciation expense for the
year is that portion of the decrease in book
value of the asset charged during the current
period (cost value and revaluation value).
63
<PAGE>
Account No.
Description: Other Outside Services
4371.21
4223.02
4371.31
4371.41
4361.21
4361.03
4361.54 Definition:
4371.91
4350.16 This account includes all other operational
expenses that cannot be assigned to one of the
above mentioned positions. Expenses in this
category include:
Office Supplies
Office supplies are charged directly to operating
expenses. If however, inventory accounts for all
of certain office supplies are maintained, the
corresponding expense should appear under
"Material and Merchandise Expense."
Books and Periodicals
All expenses for books, professional literature,
magazines and newspapers.
Printing, Photocopying, etc.
All outside expenses for printing, photocopying
and other reprographic services except those
pertaining directly and exclusively to either
research and development or sales and promotion
activities.
Translations
Fees and expenses for translations performed by
outsiders except those pertaining directly and
exclusively to sales and promotion activities.
Telephone, Cable and Telex Expense
All regular and incidental (including
installation) expenses for telephone, cable and
telex services.
Postage
All outside postage costs, except those relating
to sales and promotion activities (sending out
samples, sales literature, etc.). These are to
be recorded under "Advertising and Promotion."
64
<PAGE>
Account No.
Description: Other Outside Services (cont.)
Definition: (cont.)
Association and Membership Dues
Items such as dues paid to trade, industry and
employers' associations, and membership fees paid
to private clubs on behalf of certain employees.
Management Consultancy Expenses
Apart from the usual items, this account should
also include software development services in
connection with electronic data processing.
Not to be included are payments made to or
received from the other parties as a result of
the outcome of such proceedings. These payments
are to be shown under non-operating income and/or
expenses.
Notarial and Registration Fees
All notarial and registration fees and expenses
incurred in connection with verifications,
attestations, etc. Examples of such costs are
the legitimization of contracts.
Public Permits and Dues
Building, driving, road, radio and other such
permits or dues which are issued or levied by
public authorities.
Outside Contractors' Fees
All fees and expenses by outside manufacturers
for work performed on saleable goods.
Other Personnel Expenses
Outside expenses in connection with: hiring of
staff, recruitment and relocation of personnel,
personnel training, welfare activities and staff
relations, contract transport for daily
conveyance of employees to and from work and
payments or provisions for dismissal indemnities.
Miscellaneous
Such general outside service expenses that cannot
be charged to one of the above accounts.
65
<PAGE>
Account No.
Description: Royalty Expense - Third Parties
Definition:
This position represents expenses charged against
the current operating period for amounts paid or
payable to third parties in the form of license
fees or royalties for the use of patents,
trademarks, copyrights, and other similar
intangible rights.
Description: Cash Discounts
Definition:
This position represents cash discounts granted
to third parties customers upon payment of their
account(s) within a stipulated period.
Description: Bad Debt Expense
Definition:
This position represents the total amount of
write-offs or amounts reserved against future
write-offs of trade accounts or notes receivable
or other short-term receivables, which the
company records as expense during the current
operating period. Bad debt expense is charged
with specific accounts that have been written off
during the year, as well as after establishing
the new balances for the allowance for doubtful
accounts with third parties.
Description: Inventory Write-Offs
Definition:
This position represents the total current period
inventory write-offs that should not be charged
to production cost. The various types of
inventory adjustments are obsolescence (e.g.
inventory which exceeds quality control
expiration date and represents not further
value), book-to-physical adjustments, damages
occurred in warehouses and other similar reasons.
When inventory adjustments occur as a direct
result of production activity, these adjustments
would normally be charged to production cost.
The position here would usually include only
those inventory adjustments which cannot be
related to manufacturing or other direct
activities of the current operating period.
66
<PAGE>
Exhibit IV
AMRO
Amgen
Chart of Accounts
Research and Development
Type of Expense
Salaries and Wages (included Temporaries)
Overtime
Employee Benefits
Employer taxes, Workers Comp. Ins.
and Annual Leave
Health insurance, other benefits
Recruiting and Relocation
R&D Operating Expense
Chemicals and reagents
Supplies
Animal Studies
Maintenance and repair
Equipment rental
Contract filling
Chemical analysis
Contract services
Internal lectures
Professional meetings
Society memberships
R&D consulting
Misc. supplies and expenses
Cost of sales absorption
Technology rights
Library
Grants
SAB expenses
Clinical and pre-clinical expenses
Data processing
Occupancy
Travel and entertainment
Telephone
Depreciation
Other expenses (Business Insurance)
67
<PAGE>
Functions included in R&D:
Research
Pilot plant operations
Quality assurance
Process development
Regulatory affairs
Clinical affairs
68
<PAGE>
Exhibit V
AMRO
Amgen
Major Cost Elements
Marketing
Type of Expense
Salaries and Wages (included Temporaries)
Overtime
Employee Benefits
Employer taxes, Workers Comp. Ins.
and Annual Leave
Health insurance, other benefits
Recruiting and Relocation
Occupancy
Travel and entertainment
Telephone
Depreciation
Marketing -
Advertising
Direct mail
Literature preparation
Medical education
Symposium/Lectures
Trade shows/exhibits
Sales training
Market research
Marketing consultants
Functions included in Marketing -
Marketing staff
Sales management
Detailing staff
Customer service
Order entry
Training
69
<PAGE>
Appendix 2.01
Certain Other Rights in Spain and Italy
I. Spain
1. General Understanding
In addition to what is set forth in the Agreement AMGEN grants
to ROCHE the right to have marketed the Product in Spain under a
trademark owned by ROCHE (for the time being, ROCHE intends to use
the trademark GRANULOKINE(R)) (hereinafter referred to as the
"ROCHE-Trademark") and the right to sublicense such right to
market the Product in Spain to Laboratorios Pensa, Av. Mare de Deu
de Montserrat, Barcelona, Spain (hereinafter referred to as
"PENSA") under the ROCHE-Trademark, in accordance with the terms
herein.
2. Marketing by ROCHE Under the Trademark
ROCHE shall have the right to market the Product under the
Trademark in Spain until the Scheduled Termination Date (as
defined in the Agreement).
3. Sublicense to PENSA
a) AMGEN hereby grants ROCHE the limited right as set forth
herein to enter into a co-marketing agreement with PENSA for the
Product in Spain. Such co-marketing agreement will consist of a
license agreement between Productos ROCHE, S.A., Carretera de
Carabanchel a la de Andalucia s/n, E-28025 Madrid, Spain
(hereinafter referred to as "ROCHE-Spain") and PENSA ("License
Agreement") and a supply agreement between ROCHE and PENSA
("Supply Agreement") as well as a trademark license agreement
("ROCHE-Trademark Agreement") (the License Agreement, the Supply
Agreement and the ROCHE-Trademark Agreement are collectively
referred to as the "ROCHE-PENSA Agreements") copies of which have
been provided to AMGEN.
b) ROCHE and ROCHE-Spain will obtain AMGEN's written consent with
respect to the ROCHE-PENSA Agreements prior to entering into such
ROCHE-PENSA Agreements and, with respect to any future amendments
or waivers under ROCHE-PENSA Agreements, prior to any such
amendment or waiver. ROCHE and AMGEN agree that AMGEN is a third
party beneficiary of the ROCHE-PENSA Agreements. ROCHE agrees to
indemnify and hold AMGEN harmless from any damages suffered by
AMGEN by reason of any action taken by ROCHE or ROCHE-Spain or any
failure of ROCHE or ROCHE-Spain to act other than in accordance
with the terms hereof or the ROCHE-PENSA Agreements, respectively.
c) PENSA will market the Product under the ROCHE-Trademark for
the term of the ROCHE-PENSA Agreements. The term of the ROCHE-
PENSA Agreements shall last from January 1, 1992 until December
31, 1997. During such term the following shall apply:
70
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
(i) While PENSA markets the Product under the ROCHE-Trademark
in Spain, the proceeds from the sale of the Product under
the ROCHE-Trademark will be included in the calculation of
Operating Profit or Loss.
(ii) ROCHE will send all reports as further described in Art.
6.1 of the ROCHE-PENSA License Agreement to AMGEN promptly
upon receipt by ROCHE or ROCHE-Spain.
(iii) ROCHE herewith declares that in the event ROCHE notifies
PENSA as per Art. 5.2 of the ROCHE-PENSA Supply Agreement
to interrupt the supply of the Product, ROCHE will appoint
AMGEN as the third party supplier as described in said
Art. 5.2 of the ROCHE-PENSA Supply Agreement, should AMGEN
so request.
(iv) With regard to Art. 3.2.9 Sections c) and d) of the
ROCHE-PENSA License Agreement, AMGEN will be accorded all
the rights and titles resulting from clinical trials as
per said Art. 3.2.9 Section c) and d) of the ROCHE-PENSA
License Agreement as anticipated in the EC-Agreement.
(v) ROCHE agrees that prior to the release of confidential
information by PENSA to third party collaborators under
Art. 7.1 of the ROCHE-PENSA License Agreement, PENSA will
receive written consent from ROCHE and ROCHE will receive
prior written consent from AMGEN, which will not be
unreasonably withheld.
(vi) ROCHE hereby warrants and represents that ROCHE-Spain
and PENSA will not modify the ROCHE-PENSA Agreements
without AMGEN's prior written consent, and that ROCHE will
cause ROCHE-Spain to perform its obligations contemplated
herein and as set forth in the ROCHE-PENSA Agreements.
(vii)
********************************************************
**********************************************************
**.
d) Upon the termination of the ROCHE-PENSA Agreements on December
31, 1997, the following shall apply:
(i) PENSA's right to use the ROCHE-Trademark will immediately
cease and PENSA will immediately transfer to ROCHE all
rights in the ROCHE-Trademark, including all goodwill
associated therewith;
(ii)ROCHE's right to use the ROCHE-Trademark in the Territory
will immediately cease;
(iii)ROCHE will grant to AMGEN all of ROCHE's rights in the
ROCHE-Trademark including all goodwill associated
therewith;
(iv)ROCHE will have no rights whatsoever to use the ROCHE-
Trademark in the Territory.
(v) AMGEN shall have the sole right to market the Product in
Spain under the Trademark.
71
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
(vi)Notwithstanding Section 2.01(d) of the Agreement, AMGEN
shall grant to PENSA the rights set forth in Section I.3
(a) of this Appendix 2.01 for a term of **************.
The net proceeds received by AMGEN from the sale of the
Product by PENSA (or any subsequently appointed
distributor or AMGEN) will be included in the calculation
of Operating Profit and Operating Loss for the Term of the
Agreement.
**********************************************************
**********************************************************
********************************************.
Notwithstanding anything to the contrary contained in the
foregoing, ROCHE will continue to supply PENSA with the
Product until April 13, 1998 by extending its Supply
Agreement with PENSA until such date. The supply price
between January 1, 1998 and April 13, 1998 shall be agreed
by ROCHE, PENSA and AMGEN. Subject to the exception
contained in this provision (v), Section 2.01 (d) of the
Agreement shall remain in full force and effect.
II. Italy
1. General Understanding
In addition to what is set forth in the Agreement AMGEN grants
to ROCHE the right to market the Product in Italy (as used herein
Italy shall include the Vatican City and the Republic of San
Marino) under a trademark owned by ROCHE and the right to
sublicense such right to market the Product in Italy to Dompe
Biotech, S.p.A. Via S. Lucia, 4-20122 Milano, Italy, (hereinafter
referred to as "DOMPE") under the Trademark, in accordance with
the terms hereof.
2. Marketing by ROCHE Under ROCHE-Trademark
a) ROCHE will market the product under a trademark (for the time
being, ROCHE intends to use the trademark GRANULOKINE(R) owned by
ROCHE (hereinafter referred to as "ROCHE-Trademark").
b) ROCHE shall market the Product under the ROCHE-Trademark in
Italy until the Scheduled Termination Date (as defined in the
Agreement).
c) The Operating Profit or Loss from the sales of the Product
under the ROCHE-Trademark in Italy will be apportioned as set
forth in Art. 7.01(a) of the Agreement.
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<PAGE>
d) The parties agree to discuss revisions of the terms of the
Agreement in the event of any new indications or dosage forms
which significantly expand clinical and marketing resources needed
to adequately market and sell the Product under the ROCHE-
Trademark in Italy.
e) Following the termination of the marketing of the Product by
ROCHE under the ROCHE-Trademark in Italy, ROCHE will transfer the
ROCHE-Trademark to AMGEN or an Affiliate of AMGEN.
f) With respect to the marketing or promotion of the Product in
Italy by ROCHE (1) ROCHE shall provide AMGEN with all information
reasonably requested by it; (2) the Marketing Plan for the Product
shall be generally consistent with the Marketing Plans in the
other countries of the Territory; and (3) ROCHE may (but shall not
be obligated to) provide at least the comparable level of
marketing and promotion effort then being provided by other
companies distributing similar products in Italy, provided that
such right shall not change the level of ROCHE's billable sales
force participation in the Territory as a whole.
3. Sublicense to DOMPE
a) AMGEN hereby grants ROCHE the limited right as set forth
herein to enter into a co-marketing agreement with DOMPE for the
Product in Italy. Such co-marketing agreement will consist of a
license agreement between Prodotti ROCHE S.p.A., Piazza Durante
11. I-20131 Milano (hereinafter referred to as "ROCHE-Italy") and
DOMPE ("License Agreement") and a supply agreement between ROCHE
and DOMPE ("Supply Agreement") (both the License Agreement and the
Supply Agreement are collectively referred to as the "ROCHE-DOMPE
Agreements"), copies of which have been provided to AMGEN.
b) ROCHE and ROCHE-Italy will obtain AMGEN's written consent with
respect to the ROCHE-DOMPE Agreements prior to entering into such
ROCHE-DOMPE Agreements and, with respect to any future amendments
or waivers under the ROCHE-DOMPE Agreements, prior to any such
amendment or waiver. ROCHE and AMGEN agree that AMGEN is a third
party beneficiary of the ROCHE-DOMPE Agreements. ROCHE agrees to
indemnify and hold AMGEN harmless from any damages suffered by
AMGEN by reason of any action taken by ROCHE or ROCHE-Italy or any
failure of ROCHE or ROCHE-Italy to act other than in accordance
with the terms hereof or the ROCHE-DOMPE Agreements, respectively.
c) DOMPE will market the Product under the Trademark for the term
of the ROCHE-DOMPE Agreements. The ROCHE-DOMPE Agreements shall
terminate effective as from December 31, 1997.
Upon the termination of the ROCHE-DOMPE Agreements, AMGEN will
have the sole right to market the Product in Italy under the
Trademark.
d) Upon the termination of the ROCHE-DOMPE Agreements, the
following shall apply:
73
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
(i) DOMPE's rights to use the Trademark will immediately cease
and DOMPE will immediately transfer to ROCHE all rights in
the Trademark, including all goodwill associated
therewith;
(ii)ROCHE's right to use the Trademark in the Territory will
immediately cease;
(iii)ROCHE will grant to AMGEN all of ROCHE's rights in the
Trademark including all goodwill associated therewith; and
(iv)ROCHE will have no rights whatsoever to use the Trademark
in the Territory.
e) While DOMPE markets the Product under the Trademark in Italy,
the proceeds from the sale of the Product under the Trademark will
be included in the calculation of Operating Profit or Operating
Loss.
f) Notwithstanding Section 2.01(d) of the Agreement, following
termination of the ROCHE-DOMPE Agreements on December 31, 1997,
AMGEN shall grant to DOMPE rights to distribute the Product in
Italy under the Trademark. Similar to the prior arrangements under
the ROCHE-DOMPE agreements,
******************************************************************
******************************************************* shall be
included in the calculation of Operating Profit and Operating Loss
for the Term of the Agreement.
g) The ************************ paid by DOMPE to ROCHE-Italy
under the ROCHE-DOMPE License Agreement will be included in the
calculation of Operating Profit or Operating Loss. Such *******
paid by DOMPE (or any other third party licensee or distributor)
to AMGEN after December 31, 1997 shall also be included in the
calculation of Operating Profit or Operating Loss. If no such
******* is paid, AMGEN shall contribute the financial equivalent
of such royalty to the Operating Profit.
h) ROCHE will send all reports as further described in Art. 7.2
and 6.1 of the ROCHE-DOMPE License Agreement to AMGEN promptly
upon receipt by ROCHE or ROCHE-Italy.
i) ROCHE agrees that prior to the release of confidential
information by DOMPE to third party collaborators under Art. 8.1
of the ROCHE-DOMPE License Agreement, DOMPE will receive written
consent from ROCHE and ROCHE will receive prior written consent
from AMGEN, which will not be unreasonably withheld.
j) The parties agree that at the end of the ROCHE-DOMPE
Agreements, ROCHE-Italy will promptly appoint AMGEN or its
designee as the transferee of the official registration for the
74
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
Product in Italy and under the Trademark and all relevant
documentation as further described in Art. 10.4 of the ROCHE-DOMPE
License Agreement.
k) If the ROCHE-DOMPE License Agreement terminates as set forth
in Art. 10.5 of the ROCHE-DOMPE License Agreement, the parties
agree that ROCHE-Italy will promptly appoint AMGEN or a third
party mutually agreed upon by ROCHE and AMGEN as the transferee of
the official registration for the specialty and all relevant
documentation as further described in Art. 10.5 of the ROCHE-DOMPE
License Agreement.
l) ROCHE hereby warrants and represents that ROCHE-Italy and
DOMPE will not modify the ROCHE-DOMPE Agreements without AMGEN's
prior written consent, and that ROCHE will cause ROCHE-Italy to
perform its obligations contemplated herein and as set forth in
the ROCHE-DOMPE Agreements.
m) The compensation due by ROCHE-Italy to DOMPE as per Art. 10.3
of the ROCHE-DOMPE License Agreement shall be paid by ROCHE-Italy
or ROCHE respectively and will be included in the calculation of
Operating Profit or Operating Loss.
Appendix 2.01 (a)
Dates of Formulation, Fill and Supply Transition
Country Date
*************** *********
******* *********
******* *********
****** *********
************** *********
******* *********
******* ********
********** ********
******* ********
******** *********
***** *********
***** ********
****** **********
******* **********
****** **********
****************** *****************************
************
75
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
Appendix 2.01 (b)
Transition Dates
Country Date
**************************************** ********
******************************* ********
*************** *********
******* *********
******* *********
****** *********
************** *********
******* **********
******* ********
********** ********
******* ********
******** *********
******************************* *********
****** ********
******* ********
**************************** ******************************
*****************************
**************************
***********************
*******************************
**************************
76
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
Appendix 2.03
Evaluation Plan
******* - **********************************
-
*******************************
***********************************
***********************************
***********************************
****************
-
*******************************
***********************************
***********************************
********
************************** -
***********************************
************
-
***********************************
******************************
-
***********************************
****
- ******************************
- ***********************************
-
***********************************
********
-
***********************************
******************
-
***********************************
***********************************
***********************************
***
****************** -
***********************************
*****************
- ***************************
-
***********************************
***********************************
*****
-
***********************************
**************************
77
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
****************************- ******************************
***************
*******************************
***********************************
***********************************
***********************************
************
-
************************************
************************************
************************************
*******************
********************
************************************
******************************
**********
************************************
*********************************
**********************
************************************
**************************************
**************************************
**************************************
**************************************
**************************************
**********************************
78
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
Appendix 6.02 (b)
Assumption of Marketing Responsibility by AMGEN
- ********************************
*******
******
*****
*******
**************
***************
********
*******
**********
*******
*******
******
- ********************************
*******
*******************************
79
<PAGE>
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
Exhibit 6.06
***********************************
***************
******** ********
******* *******
******** ******** ******** ******** ********
******* * ** ** ******* *****
****** *** *** *** ****** ******
***** * **** **** ****** ******
********** * *** *** ******* *****
******* * * * ******* *****
** * * * ******* *****
****** * * * ***** *******
******** * * * ******* *****
******* *** * *** ****** ******
****** * * * ******* *****
******* * * * ******* *****
******* * * * ******* *****
******** * * * ***** *****
******** **** *** ***** ****** ******
*********
****** **** * **** ***** *******
************ **** *** ***** ****** ******
80
<PAGE>
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM
THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS CONTAINED IN THE COMPANY'S
QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 1998 AND IS
QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000,000
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> MAR-31-1998
<CASH> 105
<SECURITIES> 776
<RECEIVABLES> 304
<ALLOWANCES> 15
<INVENTORY> 118
<CURRENT-ASSETS> 1,412
<PP&E> 1,794
<DEPRECIATION> 516
<TOTAL-ASSETS> 3,082
<CURRENT-LIABILITIES> 825
<BONDS> 223
0
0
<COMMON> 0
<OTHER-SE> 2,030
<TOTAL-LIABILITY-AND-EQUITY> 3,082
<SALES> 567
<TOTAL-REVENUES> 605
<CGS> 79
<TOTAL-COSTS> 79
<OTHER-EXPENSES> 272
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 2
<INCOME-PRETAX> 268
<INCOME-TAX> 80
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 187
<EPS-PRIMARY> .73
<EPS-DILUTED> .71
</TABLE>
EXHIBIT 99
AMGEN INC.
FACTORS THAT MAY AFFECT THE COMPANY
Factors That May Affect the Company
Amgen operates in a rapidly changing environment that involves a
number of risks, some of which are beyond the Company's control. The
following discussion highlights some of these risks and others are
discussed elsewhere herein.
Product development
The Company intends to continue an aggressive product development
program. Successful product development in the biotechnology industry
is highly uncertain, and only a small minority of research and
development programs ultimately result in the commercialization of a
product. Of the candidates that are selected for product development,
all will not be successfully commercialized. Product candidates that
appear promising in the early phases of development may fail to reach
the market for numerous reasons, including, without limitation, results
indicating lack of effectiveness or harmful side effects in clinical or
preclinical testing, failure to receive necessary regulatory approvals,
uneconomical manufacturing costs, the existence of third party
proprietary rights, failure to be cost effective in light of existing
therapeutics, or other factors. There can be no assurance that the
Company will be able to produce future products that have commercial
potential. Additionally, success in preclinical and early clinical
trials does not ensure that large scale clinical trials will be
successful. For example, the Company has previously announced product
development failures in connection with BDNF (for subcutaneous
injection for ALS), a product candidate that did not produce acceptable
clinical results in a specific indication with a specific route of
administration after a Phase III trial; although this product candidate
had demonstrated acceptable preclinical and earlier clinical trial
results sufficient to warrant advancement to a later stage clinical
trial. Further, clinical results are frequently susceptible to varying
interpretations which may delay, limit or prevent further clinical
development or regulatory approvals. The length of time necessary to
complete clinical trials and receive approval for product marketing by
regulatory authorities varies significantly by product and indication
and is often difficult to predict. See "- Regulatory approvals".
Regulatory approvals
The Company's research and development, preclinical testing,
clinical trials, facilities, manufacturing, pricing, and sales and
marketing of its products are subject to extensive regulation by
numerous state and federal governmental authorities in the U.S., such
as the FDA, HCFA, as well as by foreign countries, including the EU.
The success of the Company's current products and future product
candidates will depend in part upon obtaining and maintaining
regulatory approval to market products in approved indications. The
regulatory approval process can be both a long and complex process,
both in the U.S. and in foreign countries, including countries in the
1
<PAGE>
EU. Even if regulatory approval is obtained, a marketed product and
its manufacturer are subject to continued review. Later discovery of
previously unknown problems with a product or manufacturer may result
in restrictions on such product or manufacturer, including withdrawal
of the product from the market. Failure to obtain necessary approvals,
or the restriction, suspension or revocation of any approvals or the
failure to comply with regulatory requirements could have a material
adverse effect on the Company.
Reimbursement; Third party payors
In both domestic and foreign markets, sales of the Company's
products are dependent in part on the availability of reimbursement
from third party payors such as state and federal governments (for
example, under Medicare and Medicaid programs in the United States) and
private insurance plans. In certain foreign markets, pricing and
profitability of prescription pharmaceuticals are subject to government
controls. In the United States, there have been, and the Company
expects there to continue to be, a number of state and federal
proposals to implement price controls. In addition, an increasing
emphasis on managed care in the United States has and will continue to
increase the pressure on pharmaceutical pricing and usage. Further,
significant uncertainties exist as to the reimbursement status of newly
approved therapeutic products and current reimbursement policies for
existing products may change. Changes in reimbursement or failure to
obtain reimbursement may reduce the demand for, or the price of, the
Company's products which could have a material adverse effect on the
Company including results of operations. For example, patients in the
U.S. receiving EPOGEN(R) in connection with treatment for end stage
renal disease are covered primarily under medical programs provided by
the federal government. Therefore, EPOGEN(R) sales may be affected by
future changes in reimbursement rates or the basis for reimbursement by
the federal government. As the Company previously announced, in early
1997, HCFA instituted a reimbursement change for EPOGEN(R) which has
adversely affected the Company's EPOGEN(R) sales. See "Item 7.
Management's Discussion and Analysis of Financial Condition and Results
of Operations - Results of Operations - Product Sales - EPOGEN(R)
(Epoetin alfa)".
Guidelines
In addition to government agencies that promulgate regulations and
guidelines directly applicable to the Company and its products,
professional societies, practice management groups, private
health/science foundations and organizations involved in various
diseases may also publish, from time to time, guidelines or
recommendations to the health care and patient communities. These
organizations may make recommendations that affect the usage of certain
therapies, drugs or procedures, including the Company's products. Such
recommendations may relate to such matters as usage, dosage, route of
administration and use of concomitant therapies. Recommendations or
guidelines that are followed by patients and health care providers and
that result in, among other things, decreased use of the Company's
products could have a material adverse effect on the Company's results
of operations. In addition, the perception that such recommendations
or guidelines will be followed could adversely affect prevailing market
prices for the Company's common stock.
2
<PAGE>
Intellectual property and legal matters
The patent positions of pharmaceutical and biotechnology companies
can be highly uncertain and often involve complex legal, scientific and
factual questions. To date, there has emerged no consistent policy
regarding breadth of claims allowed in such companies' patents.
Accordingly, there can be no assurance that patents and patent
applications relating to the Company's products and technologies will
not be challenged, invalidated or circumvented or will afford
protection against competitors with similar products or technology.
Patent disputes are frequent and can preclude commercialization of
products. The Company currently is, and may in the future be, involved
in patent litigation. Such litigation, if decided adversely, could
subject the Company to competition and/or significant liabilities,
could require the Company to enter into third party licenses or could
cause the Company to cease using the technology or product in dispute.
In addition, there can be no assurance that such licenses will be
available on terms acceptable to the Company, or at all.
The Company is currently involved in arbitration proceedings with
Ortho Pharmaceutical Corporation, a subsidiary of Johnson & Johnson
("Johnson & Johnson"), relating to a license granted by the Company to
Johnson & Johnson for sales of Epoetin alfa in the United States for
all human uses except dialysis and diagnostics. See Note 4 to the
Consolidated Financial Statements, "Contingencies - Johnson & Johnson
arbitrations".
Competition
Amgen operates in a highly competitive environment. The Company
competes with pharmaceutical and biotechnology companies, some of which
may have technical or competitive advantages for, among other things,
the development of technologies and processes and the acquisition of
technology from academic institutions, government agencies and other
private and public research organizations. There can be no assurance
that the Company will be able to produce or acquire rights to products
that have commercial potential. Even if the Company achieves product
commercialization, there can be no assurance that one or more of the
Company's competitors will not achieve product commercialization
earlier than the Company, receive patent protection that dominates or
adversely affects the Company's activities, or have significantly
greater marketing capabilities.
Fluctuations in operating results
The Company's operating results may fluctuate from period to
period for a number of reasons. Historically the Company has planned
its operating expenses, many of which are relatively fixed in the short
term, on the basis that revenues will continue to grow. Accordingly,
even a relatively small revenue shortfall may cause a period's results
to be below Company expectations. Such a revenue shortfall could arise
from any number of factors, including, without limitation, lower than
expected demand, changes in wholesaler buying patterns, changes in
product pricing strategies, increased competition from new and existing
products, fluctuations in foreign currency exchange rates, changes in
government or private reimbursement, transit interruptions, overall
economic conditions or natural disasters (including earthquakes).
3
<PAGE>
Rapid growth
The Company has adopted an aggressive growth plan that includes
substantial and increased investments in research and development and
investments in facilities that will be required to support significant
growth. This plan carries with it a number of risks, including a
higher level of operating expenses and the complexities associated with
managing a larger and faster growing organization.
Stock price volatility
The Company's stock price, like that of other biotechnology
companies, is subject to significant volatility. The stock price may
be affected by, among other things, clinical trial results and other
product development related announcements by Amgen or its competitors,
regulatory matters, announcements in the scientific and research
community, intellectual property and legal matters, changes in
reimbursement policies or medical practices or broader industry and
market trends unrelated to the Company's performance. In addition, if
revenues or earnings in any period fail to meet the investment
community's expectations, there could be an immediate adverse impact on
the Company's stock price.
4
<PAGE>
