<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
----------
FORM 10-Q
Quarterly Report Under Section 13 or 15(d)
of the Securities Exchange Act of 1934
For Quarter Ended September 30, 1996 Commission File Number 0-14587
------------------ -------
GENETICS INSTITUTE, INC.
- -------------------------------------------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 04-2718435
- ------------------------------- ------------------------------------
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
87 CambridgePark Drive, Cambridge, MA 02140
- -------------------------------------------------------------------------------
(Address of principal executive offices) (zip code)
Registrant's telephone number, including area code (617) 876-1170
----------------------------
None
- -------------------------------------------------------------------------------
(Former name, former address and former fiscal year if changed since last
report)
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
----- -----
29,589,784 shares of Common Stock, par value $.01 (including 12,752,894 shares
represented by Depositary Shares) were outstanding on November 1, 1996.
<PAGE> 2
GENETICS INSTITUTE, INC.
INDEX
-----
Page
PART I - FINANCIAL INFORMATION Number
- ------------------------------ ------
Item 1 - Financial Statements
Consolidated Condensed Balance Sheets at
September 30, 1996 and December 31, 1995.............................. 3
Consolidated Condensed Statements of Operations
for the Three and Nine Months Ended September 30, 1996 and 1995 ...... 4
Consolidated Condensed Statements of Cash Flows
for the Nine Months Ended September 30, 1996 and 1995................. 5
Notes to Consolidated Condensed Financial Statements.................... 6
Item 2 - Management's Discussion and Analysis of
Financial Condition and Results of Operations........................... 10
PART II - OTHER INFORMATION
- ---------------------------
Item 1 - Legal Proceedings................................................ 14
Item 6 - Exhibits and Reports on Form 8-K................................. 14
Signatures................................................................ 15
-2-
<PAGE> 3
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
<TABLE>
CONSOLIDATED CONDENSED BALANCE SHEETS
(Unaudited - in thousands except share amounts)
<CAPTION>
September 30, December 31,
1996 1995
------------- ------------
ASSETS
<S> <C> <C>
Cash and cash equivalents $106,025 $ 33,164
Marketable securities 232,178 217,670
Accounts receivable 61,636 40,876
Inventories:
Materials and supplies 6,840 5,769
Work in progress 2,292 915
Finished goods 16,872 14,325
-------- --------
26,004 21,009
Other current assets 6,060 5,844
-------- --------
Total current assets 431,903 318,563
Property, plant and equipment 192,617 174,826
Less accumulated depreciation (77,526) (65,710)
-------- --------
115,091 109,116
Other assets 5,720 6,132
-------- --------
$552,714 $433,811
======== ========
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable $ 6,022 $ 8,936
Accrued merger consideration -- 7,615
Other accrued expenses 33,629 27,145
-------- --------
Total current liabilities 39,651 43,696
Shareholders' Equity:
Common stock, par value $.01;
authorized 50,000,000 shares 296 268
Additional paid-in capital 693,454 604,013
Accumulated deficit (180,687) (214,166)
-------- --------
Total shareholders' equity 513,063 390,115
-------- --------
$552,714 $433,811
======== ========
</TABLE>
The accompanying notes are an integral part of these financial statements.
-3-
<PAGE> 4
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
<TABLE>
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited - in thousands except per share data)
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
-------------------- ----------------------
1996 1995 1996 1995
------- ------- -------- --------
<S> <C> <C> <C> <C>
REVENUE
Product sales $35,978 $14,841 $ 98,317 $ 61,350
Royalties 17,044 14,733 60,572 38,692
Collaborative research and development 13,440 2,920 43,935 30,133
------- ------- -------- --------
Total revenue 66,462 32,494 202,824 130,175
OPERATING EXPENSES
Cost of sales 13,395 4,260 37,795 31,140
Research and development 37,659 31,903 107,316 90,448
General and administrative 9,096 5,318 23,380 14,786
------- ------- -------- --------
Total operating expenses 60,150 41,481 168,491 136,374
------- ------- -------- --------
INCOME (LOSS) FROM OPERATIONS 6,312 (8,987) 34,333 (6,199)
OTHER INCOME, NET
Investment income 4,951 3,950 12,629 12,633
(Loss) income of affiliates, net (3,133) (2,054) (7,426) 117
Other, net (298) 785 (1,382) (1,718)
------- ------- -------- --------
Total other income, net 1,520 2,681 3,821 11,032
------- ------- -------- --------
INCOME (LOSS) BEFORE INCOME TAXES 7,832 (6,306) 38,154 4,833
Provision for taxes on income -- (877) (910) (1,147)
------- ------- -------- --------
NET INCOME (LOSS) $ 7,832 $(7,183) $ 37,244 $ 3,686
======= ======= ======== =======
NET INCOME (LOSS) PER COMMON SHARE $ .25 $ (.27) $ 1.22 $ .14
======= ======= ======== =======
Weighted average common and common
equivalent shares outstanding 31,727 26,745 30,551 27,225
------- ------- -------- --------
</TABLE>
The accompanying notes are an integral part of these financial statements.
-4-
<PAGE> 5
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
<TABLE>
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited - in thousands)
<CAPTION>
Nine Months Ended September 30,
-------------------------------
1996 1995
--------- ---------
<S> <C> <C>
OPERATING ACTIVITIES
Net income $ 37,244 $ 3,686
Adjustments to reconcile net income
to net cash provided by (used in) operating
activities -
Depreciation and amortization 12,414 13,386
Equity in loss (income) of affiliates 7,426 (117)
Compensation related to incentive plans 1,231 535
Changes in assets and liabilities (22,401) (22,510)
--------- ---------
Net cash provided by (used in) operating activities 35,914 (5,020)
--------- ---------
INVESTING ACTIVITIES
Purchase of marketable securities (164,536) (168,619)
Proceeds from sale/maturity of marketable securities 146,263 215,054
Payment of merger consideration (7,614) --
Additions to property, plant and equipment (23,306) (18,183)
Investments in affiliates (7,426) (1,720)
Other investing activities 293 993
--------- ---------
Net cash provided by (used in) investing activities (56,326) 27,525
--------- ---------
FINANCING ACTIVITIES
Proceeds from stock issuances 13,149 4,349
Proceeds from sale-leaseback transaction 5,035 --
Proceeds from exercise of warrants 75,089 --
--------- ---------
Net cash provided by financing activities 93,273 4,349
--------- ---------
Net increase in cash and cash equivalents 72,861 26,854
Cash and cash equivalents, beginning of period 33,164 21,793
--------- ---------
Cash and cash equivalents, end of period $ 106,025 $ 48,647
========= =========
</TABLE>
The accompanying notes are an integral part of these financial statements.
-5-
<PAGE> 6
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)
1. Significant Accounting Policies
Basis of Presentation: The accompanying consolidated condensed financial
statements are unaudited. In the opinion of management, all adjustments
necessary for a fair presentation of these financial statements have been
included. Such adjustments consisted only of normal recurring items. Interim
results are not necessarily indicative of results for a full year. Certain
amounts in the prior period financial statements have been reclassified to
conform to the current period presentation. The consolidated condensed
financial statements should be read in conjunction with the Company's audited
consolidated financial statements and related footnotes for the year ended
December 31, 1995.
The consolidated condensed financial statements include all accounts of
Genetics Institute, Inc. and its wholly owned subsidiaries. Investments in
50% owned joint ventures are accounted for on the equity method. Under the
equity method, investments in such affiliated joint ventures are recorded at
cost and adjusted by the Company's share of the income and losses of and the
investments in and distributions from such affiliates. All significant
intercompany balances and transactions have been eliminated in consolidation.
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates.
2. Transactions with American Home Products Corporation
On September 19, 1991, the Company and American Home Products Corporation
("AHP") entered into an Agreement and Plan of Merger (the "AHP Transaction")
that was consummated on January 16, 1992 through which AHP acquired a 60%
interest in the Company. In connection with the AHP Transaction, the Company
issued 9,466,709 new shares of Common Stock to AHP for an aggregate purchase
price of approximately $300.0 million and, for shares of Common Stock owned,
the Company's shareholders received a combination of cash and Depositary
Shares subject to a call option. Under the terms of the call option, AHP has
the right but not the obligation, to purchase the outstanding Depositary
Shares that it does not own, in whole but not in part, at any time until
December 31, 1996, at a call price of $85.00 per share.
Independent of its right to call the Depositary Shares, AHP is permitted to
acquire additional Depositary Shares through open market purchases or
privately negotiated purchases, provided that during the term of the call
option its aggregate holdings do not exceed 75% of the Company's outstanding
equity, subject to certain exceptions. As of September 30, 1996, AHP's total
ownership position in the Company approximated 60%.
The Company is engaged in collaborations with AHP in the development and
commercialization of recombinant human interleukin-twelve (rhIL-12), an
immune system modulatory protein, and the commercialization of
Neumega[Registered Trademark] recombinant human interleukin-eleven
(rhIL-11), a blood cell growth factor. A collaboration with AHP in the area
of cellular adhesion discovery research ended as scheduled during the second
quarter of 1995. Collaborative research and development revenue includes $1.1
million and $6.8 million, respectively, for the three and nine month periods
ended September 30, 1996 and $0.9 million and $8.7 million, respectively, for
the three and nine month periods ended September 30, 1995, relating to these
collaborations with AHP. (Loss) income of affiliates, net, includes losses of
$(1.4) million and $(3.1) million for the three and nine month periods ended
September 30, 1996, and losses of $(0.1) million and $(1.6) million for the
three and nine month periods ended September 30, 1995, relating to these
collaborations with AHP.
-6-
<PAGE> 7
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)
3. Investments in Debt Securities
<TABLE>
The Company's investment portfolio of debt securities consists of cash
equivalents classified as held-to-maturity and marketable securities
classified as available-for-sale. The fair value of cash equivalents
approximated the amortized cost of $105.3 million at September 30, 1996.
Aggregate fair value, amortized cost and average maturity for marketable
securities held at September 30, 1996 and December 31, 1995 are presented
below. The average maturities presented below include estimates of the
effective life for certain securities whose actual maturities will differ
from contractual maturities because the borrowers have the right to call or
prepay the obligations without call or prepayment penalties.
<CAPTION>
Amortized Gross Unrealized Fair
Cost Holding Gains (Losses) Value
--------- ---------------------- --------
<S> <C> <C> <C> <C>
September 30, 1996
(In thousands)
U.S. Government and Agency
securities (average maturity
of 2.8 years) $108,718 $ 689 $ (653) $108,754
Corporate and other debt securities
(average maturity of 2.9 years) 123,453 490 (519) 123,424
-------- ------ ------- --------
$232,171 $1,179 $(1,172) $232,178
======== ====== ======= ========
December 31, 1995
(In thousands)
U.S. Government and Agency
securities (average maturity
of 3.5 years) $138,498 $2,823 $ (266) $141,055
Corporate and other debt securities
(average maturity of 2.6 years) 75,400 1,292 (77) 76,615
-------- ------ ------- --------
$213,898 $4,115 $ (343) $217,670
======== ====== ======= ========
</TABLE>
The fair value of marketable securities at September 30, 1996 was
approximately equal to the amortized cost. For the three and nine month
periods ended September 30, 1996, changes in the net unrealized holding gain
(loss) of $0.5 million and $(3.8) million, respectively, are recorded in
shareholders' equity. Gross realized gains and losses on sales of marketable
securities for the three and nine month periods ended September 30, 1996 and
1995 were not material to the results of operations.
-7-
<PAGE> 8
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)
4. (Loss) Income of Affiliates, Net
(Loss) income of affiliates, net consists of the Company's share of benchmark
payments or license fees received by the joint ventures, net of the Company's
share of research and development expenses incurred by affiliated joint
ventures (excluding any research and development or other services provided
by the Company to the joint ventures). The Company's share of the joint
ventures' revenues, which ranges from 50% to 62.5%, is generally distributed
when received by the joint venture. The Company's share of the joint
ventures' expenses, which ranges from 25% to 50%, is generally funded as
incurred. Investments in such affiliates are accounted for on the equity
method and amounted to $0.9 million and $1.6 million at September 30, 1996
and December 31, 1995, respectively.
The more significant of these affiliates are GI-Yamanouchi, Inc. (GYJ), the
GI-Yamanouchi European Partnership (GYEP) and IL-12 Partners. The GYJ and the
GYEP are joint ventures with Yamanouchi Pharmaceutical Co., Ltd. (Yamanouchi)
formed to develop and commercialize certain of the Company's product
candidates in Japan and Europe, respectively. IL-12 Partners is a joint
venture with AHP formed to develop and commercialize rhIL-12 worldwide except
Japan.
The Company's (loss) income of affiliates, net for the three and nine months
ended September 30, 1996 and 1995 was as follows (in thousands):
<TABLE>
<CAPTION>
Three months ended September 30, Nine months ended September 30,
-------------------------------- -------------------------------
1996 1995 1996 1995
------- ------- -------- --------
<S> <C> <C> <C> <C>
Combined net (loss) of
affiliated joint ventures $(9,015) $(7,461) $(22,494) $(14,305)
======= ======= ======== ========
Company share of joint
ventures' net (loss) based on
ownership percentage share of
revenues and expenses (4,457) (3,448) (11,102) (6,088)
Elimination of Company share
of joint venture expenses
attributable to services provided
by or benchmarks paid to the
Company 1,324 1,394 3,676 6,205
------- ------- -------- --------
(Loss) income of affiliates, net $(3,133) $(2,054) $ (7,426) $ 117
======= ======= ======== ========
</TABLE>
5. Contingencies
The Company is involved in various legal proceedings including patent
litigation of a nature considered normal to its business.
Patent infringement proceedings are pending in Europe between Boehringer
Mannheim GmbH ("Boehringer Mannheim"), the Company's licensee, and Ortho
Pharmaceutical Co., Ltd. and certain Ortho affiliates, licensees of
Kirin-Amgen, Inc.'s recombinant EPO patents, seeking injunctive relief and
damages for infringement of their respective erythropoietin ("EPO") patent
rights.
-8-
<PAGE> 9
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(unaudited)
The patents which are at issue in these suits have also been the subject of
European Patent Office proceedings. In June 1994, a claim in the Company's
European patent covering homogeneous EPO compositions (the '539 patent) was
upheld by the Opposition Division of the European Patent Office. This
decision has been appealed. In September 1994, an appellate hearing was held
before the Board of Technical Appeals of the European Patent Office relating
to oppositions to Kirin-Amgen's European recombinant EPO patent. The Board
ruled that a modified version of certain of Kirin-Amgen's original claims in
the patent filing was valid. However, it is uncertain whether Kirin-Amgen's
claims cover the making, using or selling of Boehringer Mannheim's
recombinant EPO.
The Company can provide no assurance as to the outcome of these European
proceedings. If as a result of these proceedings Boehringer Mannheim is
forced to withdraw from any or all markets, the Company's future royalty
income from Boehringer Mannheim, (which, excluding $11.4 million recognized
in connection with the termination of an escrow arrangement, totaled $17.0
million for the nine month period ended September 30, 1996), could be reduced
or eliminated.
In the opinion of the Company, although the outcome of any currently pending
litigation cannot be predicted with certainty, the ultimate liability of the
Company in connection with pending litigation will not have a material
adverse effect on the Company's financial position but could be material to
the Company's future results of operations in any one accounting period.
6. Acquisition of SciGenics, Inc.
In the fourth quarter of 1995, the Company acquired 100% of the callable
common stock of SciGenics, Inc. ("SciGenics"). The acquisition was made
pursuant to the terms of a cash tender offer in which the Company acquired
approximately 67% of the callable common stock of SciGenics at $14.00 per
share. The remaining equity interest in SciGenics was acquired upon the
merger of a wholly owned subsidiary of the Company into SciGenics, with
SciGenics being the surviving corporation. In the merger, each share of
callable common stock of SciGenics not held by the Company was converted into
the right to receive $14.00 in cash for a total purchase price of $29.3
million for the 2,090,909 shares acquired. As of December 31, 1995, SciGenics
shareholders holding 543,908 shares indicated their intention to demand an
appraisal of the fair value of their shares under Delaware law and the
Company accrued merger consideration of $14.00 per share for those shares.
During the first quarter of 1996, certain of these shareholders elected to
forego the appraisal process and tendered their shares. On April 7, 1996, all
appraisal rights expired without any appraisal actions being filed and,
during the second quarter of 1996, substantially all the remaining SciGenics
shares were tendered for $14.00 per share.
7. Warrants
Approximately 2.1 million warrants for the purchase of the Company's Common
Stock at an exercise price of $35.92 per share were exercised on or before
May 31, 1996, the expiration date of the warrants, providing the Company with
$75.1 million of proceeds. Upon exercise, each warrant was converted into
six-tenths of a Depositary Share and $20.00 in cash, which represented the
same consideration received by shareholders in the AHP Transaction. As a
result of the warrant exercises, the Company issued 836,149 shares of Common
Stock to AHP and 1,254,224 Depositary Shares to warrant holders which
contributed to a decrease in AHP's total ownership position in the Company
from approximately 62% at March 31, 1996 to approximately 60% at September
30, 1996.
-9-
<PAGE> 10
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
Genetics Institute, Inc. and subsidiaries (the "Company") are principally
engaged in discovering, developing and commercializing biopharmaceutical
products using recombinant DNA and related technologies.
The Company and American Home Products Corporation ("AHP") entered into a
transaction (the "AHP Transaction") through which AHP acquired a majority
interest in the Company effective January 16, 1992 (see Note 2 of Notes to
Consolidated Condensed Financial Statements). Under the terms of a call
option, AHP has the right, but not the obligation, to purchase the
outstanding Depositary Shares that it does not own, in whole but not in part,
at any time until December 31, 1996, at a call price of $85.00 per share (the
"Call Option").
RESULTS OF OPERATIONS
Three and Nine Months Ended September 30, 1996 and 1995. The Company reported
net income of $7.8 million for the third quarter ended September 30, 1996 and
net income of $37.2 million for the nine months ended September 30, 1996,
compared with a net loss of $7.2 million for the third quarter ended
September 30, 1995 and net income of $3.7 million for the nine months ended
September 30, 1995.
The Company's revenues include product sales from the supply of recombinant
human antihemophilic factor concentrate ("rhAHF") to Baxter Healthcare
Corporation ("Baxter"), royalties on sales of products by licensees, and
collaborative research and development revenue for activities conducted under
agreements with the Company's joint venture partners and certain licensees.
Revenue for the third quarter of 1996 totaled $66.5 million, an increase of
105%, or $34.0 million, from the third quarter of 1995. Nine month revenue of
$202.8 million increased 56% from the prior year level.
Product sales of $36.0 million for the third quarter of 1996 increased $21.1
million from the third quarter of 1995, and increased 60% for the first nine
months of 1996, due primarily to increases in the unit volume of rhAHF
shipped to Baxter. Royalties increased 16%, or $2.3 million, to $17.0 million
for the third quarter of 1996 primarily due to increases in the volume of
Baxter's sales of Recombinate[Trademark] Antihemophilic Factor (Recombinant)
and in the volume of licensees' sales of erythropoietin ("EPO"). Royalties
for the first nine months of 1996 increased 57% to $60.6 million. The
increase in the volume of EPO sold by licensees was partly offset by a
governmental reduction of the price of EPO products in Japan, which was
effective April 1, 1996. In January 1996, the company expanded and
restructured its license agreement with Boehringer Mannheim GmbH
("Boehringer Mannheim") for EPO. Under the amended agreement, the Company
licensed Boehringer Mannheim to sell EPO in additional countries in the
Asia-Pacific area and Boehringer Mannheim agreed to pay the Company license
fees and future benchmark payments for the expanded territories. The
restructuring also provides Boehringer Mannheim with greater financial
responsibility for and control over the prosecution and settlement of patent
suits against third party infringers, and Boehringer Mannheim agreed to
release from escrow $8.0 million in royalties it previously withheld from
the Company to finance such litigation expenses, and to cease to withhold
any additional royalties for this purpose. The restructuring established a
new royalty rate applicable to Boehringer Mannheim's original territories
that cannot be decreased by any future EPO patent settlement or for any
other reason. Royalties in the first nine months of 1996 included $11.4
million recognized in the first quarter of 1996 (including the $8.0 million
released from escrow) relating to the termination of the escrow arrangement.
Excluding this one-time amount, royalties for the first nine months of 1996
increased 27%, or $10.5 million, to $49.2 million, primarily due to the
increases in the volume of licensees' sales discussed above.
-10-
<PAGE> 11
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Collaborative research and development revenue increased $10.5 million to
$13.4 million for the third quarter of 1996, due primarily to the timing of
benchmark payments under existing collaborative agreements, and increased
46%, or $13.8 million, to $43.9 million for the first nine months of 1996.
Collaborative research and development revenue includes payments of $12.5
million in both the second quarter of 1996 and in the first quarter of 1995
relating to an agreement between the Company and Sofamor Danek Group, Inc. to
commercialize recombinant human bone morphogenetic protein-two ("rhBMP-2") in
North America for use in certain surgical procedures involving the spine.
Collaborative research and development revenue for the first nine months of
1996 includes license fees and benchmark payments totaling $10.0 million,
recorded in the first quarter of 1996, relating to the agreement with
Boehringer Mannheim discussed above. Collaborative research and development
revenue includes $1.1 million and $0.9 million for the third quarters of 1996
and 1995, respectively, and $6.8 million and $8.7 million for the first nine
months of 1996 and 1995, respectively, relating to collaborations with AHP in
the development and commercialization of recombinant human interleukin-twelve
("rhIL-12"), an immune system modulatory protein, and in 1995 in the
commercialization of Neumega[Registered Trademark] recombinant human
interleukin-eleven ("rhIL-11") and in the area of cellular adhesion discovery
research.
Cost of sales includes royalties payable to third parties upon the receipt of
certain royalty revenues from licensees. Such third party royalties totaled
$2.2 million and $2.0 million in the third quarters of 1996 and 1995,
respectively. Cost of sales excluding such third party royalties, as a
percentage of product sales, was 31% and 15% for the third quarters of 1996
and 1995, respectively, and 31% and 43% for the first nine months of 1996 and
1995, respectively. In the third quarter of 1995, the Company recorded an
adjustment to cost of sales as a result of a change in the estimated unit
manufacturing costs of rhAHF for the 1995 production year. Excluding this
adjustment, cost of sales as a percentage of product sales for the third
quarter of 1995 was 39%. The significant improvement in gross margin for the
first nine months of 1996 was primarily due to lower rhAHF unit manufacturing
costs.
Research and development expense increased 18% to $37.7 million in the third
quarter of 1996 as compared with the third quarter of 1995 and increased 19%
for the first nine months of 1996, primarily due to the expansion of certain
clinical development programs and increases in the cost of the Company's
discovery research programs in the genomics field. General and administrative
expenses increased 71% in the third quarter of 1996 to $9.1 million and
increased 58% in the first nine months of 1996, primarily due to expansion of
the Company's commercial operations function and to an increase in market
development and other preparatory activities related to the expected
commercialization of BENEFIX[Trademark] recombinant Factor IX ("rFIX").
General and administrative expenses for 1996 are expected to continue to
exceed those recorded in 1995 as the Company puts in place the commercial
infrastructure necessary to market and sell BENEFIX[Trademark] rFIX in North
America.
Investment income increased 25% in the third quarter of 1996 as compared with
the comparable period of a year ago, primarily due to higher average balances
of cash equivalents and marketable securities. The increase in cash
equivalents and marketable securities relates primarily to the proceeds of
$75.1 million received by the Company upon exercise of warrants in the first
half of 1996.
(Losses) of affiliates, net, of ($3.1) million and ($7.4) million were
recorded in the three and nine months ended September 30, 1996, respectively,
and (losses) income of affiliates, net, of ($2.1) million and $0.1 million
were recorded in the three and nine months ended September 30, 1995,
respectively. Certain of the Company's product development activities in
Japan are being conducted through GI-Yamanouchi, Inc. (the "GYJ"), a joint
venture with Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"). In the
second
-11-
<PAGE> 12
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
quarter of 1995, the GYJ assigned its rights to the development and
commercialization of rhBMP-2 in Japan to Yamanouchi and the Company
recognized income of affiliates of $7.3 million in connection with this
transaction. In addition, the Company is conducting certain rhIL-12 product
development activities through IL-12 Partners, a joint venture with AHP.
(Loss) income of affiliates, net includes $(1.4) million and $(0.1) million
for the third quarter of 1996 and 1995, respectively, and $(3.1) million and
$(1.6) million for the first nine months of 1996 and 1995, respectively,
relating to the rhIL-12 collaboration with AHP.
The Company did not record a provision for income taxes in the third quarter
of 1996 based on management's present estimate that sufficient provision for
1996 income taxes was recorded in the first half of the year.
LEGAL PROCEEDINGS
The Company is engaged in various legal proceedings including patent
litigation of a nature considered normal to its business. See Note 5 of the
Notes to Consolidated Condensed Financial Statements which is incorporated by
reference herein.
LIQUIDITY AND CAPITAL RESOURCES
Cash, cash equivalents and marketable securities (recorded at fair value)
totaled $338.2 million at September 30, 1996, an increase of $87.4 million
from December 31, 1995. For the first nine months of 1996, $35.9 million in
cash was provided by operating activities. In addition, the Company received
proceeds of $75.1 million from the exercise of warrants, $13.1 million from
the issuance of stock (primarily from the exercise of stock options), and
$5.0 million from the sale-leaseback of equipment. These sources of cash were
offset primarily by investments of $23.3 million in plant and equipment, the
payment of merger consideration of $7.6 million to complete the acquisition
of SciGenics, Inc. and investments of $7.4 million in affiliated joint
ventures.
The Company expects that its available cash and marketable securities,
together with operating revenues, investment income and lease and debt
financing arrangements, will be sufficient to finance its working capital and
capital requirements for the foreseeable future. Over the next several years,
the Company's working capital and capital requirements will be subject to
change depending upon numerous factors including the level of capital
expenditures, changes in the amount of expenditures committed to self-funded
research and development programs, results of research and development
activities, competitive and technological developments, the levels of
resources which the Company devotes to the expansion of its clinical testing,
manufacturing and marketing activities and the timing and cost of obtaining
required regulatory approvals for new products.
FINANCIAL OUTLOOK
The Company expects to be profitable for the fourth quarter of 1996 and for
the full year 1997, based principally on the current outlook for existing
core business arrangements. However, the level of the Company's profitability
for the fourth quarter of 1996 and the first quarter of 1997 is expected to
be lower than that in the first three quarters of 1996 due primarily to the
timing of benchmark payments under existing collaborative research and
development agreements. The level of the Company's profitability for those
periods and thereafter depends upon a number of factors including: the volume
and cost of bulk
-12-
<PAGE> 13
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
rhAHF concentrate manufactured by the Company and sold to Baxter; the
Company's ability to manufacture sufficient quantities of bulk rhAHF
concentrate to meet Baxter's requirements; the volume and price of Baxter's
sales of Recombinate[Trademark] Antihemophilic Factor (Recombinant);
licensees' sales of EPO and the impact of infringement litigation on EPO
royalty income (as discussed in "Legal Proceedings" above); the success of
the Company's development collaborations with others (including AHP) and the
achievement of development benchmarks under existing collaborative
arrangements; and the ability of the Company to consummate new collaborative
agreements. For 1997 and for years after 1997, profitability will also depend
on the successful completion of clinical trials, subsequent regulatory
approvals for commercialization of biopharmaceuticals under development,
including BENEFIX[Trademark] rFIX and Nuemega[Registered Trademark] rhIL-11,
and the timing of any such regulatory approvals.
Future sales increases for Baxter's Recombinate[Trademark] and licensees' EPO
are primarily dependent on further penetration of existing markets, the
effects of competitive products and changes in reimbursement rates or the
basis of reimbursement by governmental agencies. Future sales increases for
Baxter's Recombinate[Trademark] may also be dependent on obtaining regulatory
approvals for changes in and improvements to the Company's rhAHF
manufacturing processes. Increases in licensees' sales of EPO are also
dependent on product approvals in and penetration of new markets and the
timing and nature of additional indications for which the product may be
approved. In addition, international sales of Baxter's Recombinate[Trademark]
and licensees' sales of EPO will continue to be subject to changes in foreign
currency exchange rates.
Adverse developments with respect to these matters could have a material
adverse effect on the Company's results of operations. In addition, the
Company's consolidated results of operations have fluctuated from period to
period and may continue to fluctuate as a result of these factors.
Significant volatility of market valuations has been associated with the
business and operations of biopharmaceutical companies. Developments
involving the Company or its competitors concerning discovery research
programs, technological innovations, new commercial products, results of
clinical trials, patents, proprietary rights and related infringement
disputes, results of litigation, and the expense and time associated with
obtaining requisite government approvals may have a significant impact on the
Company's business and on its market valuation. As of September 30, 1996,
four of the Company's proprietary product candidates were in human clinical
trials. Phase I and phase II data are preliminary measurements of a product's
safety and efficacy and do not necessarily assure positive phase III data or
ultimate regulatory approval for commercial sale. The Company's market
valuation could be subject to volatility based upon the outcome of clinical
trials and as investors interpret the results of the Company's current and
future clinical trials. The Company's market valuation could also be subject
to volatility based upon the rate and timing of the cloning of novel genes in
the Company's DiscoverEase[Trademark] Program. In addition, the Call Option
held by AHP, which expires on December 31, 1996, may have an impact on the
volatility of the Company's market valuation.
-13-
<PAGE> 14
Part II - Other Information
---------------------------
Item 1. Legal Proceedings
- ------- -----------------
See Note 5 of Notes to the Consolidated Condensed Financial Statements
provided in Part I of this Quarterly Report on Form 10-Q, which Note is
hereby incorporated by reference.
Item 6. Exhibits and Reports on Form 8-K
- ------- --------------------------------
(a) The Exhibits filed as part of this Form 10-Q are listed on the
Exhibit Index immediately preceding such Exhibits, which Exhibit
Index is incorporated herein by reference.
(b) No reports were filed on Form 8-K during the quarter ended
September 30, 1996.
-14-
<PAGE> 15
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.
GENETICS INSTITUTE, INC.
------------------------
(Registrant)
Date: November 6, 1996 By: /s/ Garen G. Bohlin
---------------- ------------------------------------
Garen G. Bohlin,
Executive Vice President and Chief Financial
Officer
(Principal Financial Officer and
Principal Accounting Officer)
-15-
<PAGE> 16
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.
GENETICS INSTITUTE, INC.
------------------------
(Registrant)
Date: November 6, 1996 By: /s/ Garen G. Bohlin
---------------- ------------------------------------
Garen G. Bohlin,
Executive Vice President and Chief Financial
Officer
(Principal Financial Officer and
Principal Accounting Officer)
-15-
<PAGE> 17
EXHIBIT INDEX
-------------
Exhibit No. Description
- ----------- -----------
10.1 Cross-License Agreement among Genetics Institute,
Stryker Corporation and Creative BioMolecules, Inc.,
dated as of July 15, 1996
11 Computation of Earnings Per Share
27 Financial Data Schedule (EDGAR)
-16-
<PAGE> 1
FINAL 7-11-96
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
CROSS-LICENSE AGREEMENT
THIS CROSS-LICENSE AGREEMENT (together with the attached Schedules, the
"Agreement") is made as of July 15, 1996 (the "Effective Date") by and among
Genetics Institute, Inc., a Delaware corporation (for itself and on behalf of
its Affiliate, the GPDC Partnership, a Delaware general partnership), with a
business address at 87 CambridgePark Drive, Cambridge, Massachusetts 02140
("GI"), Stryker Corporation, a Michigan corporation with a business address at
2725 Fairfield Road, Kalamazoo, Michigan 49002 ("Stryker") and Creative
BioMolecules, a Delaware corporation with a business address at 45 South Street,
Hopkinton, Massachusetts 01748 ("CBM").
1. BACKGROUND.
1.1. PATENTS. GI, Stryker and CBM have each filed patent
applications and obtained patents in the United States and
around the world, or have rights under such applications and
patents, that relate generally to the following subject matter
(the "BMP Subject Matter"): chondrogenic proteins, osteogenic
proteins and/or bone morphogenetic proteins, the DNA encoding
those proteins, vectors and host cells containing that DNA,
methods of making and purifying those proteins, the activities
of those proteins, and methods, devices and compositions for
using those proteins to, inter alia, induce bone and/or
cartilage formation.
1.2. CROSS-LICENSES. Each of the parties has recognized that their
respective patent positions are of a nature that, in the
absence of unblocking cross-licenses, could have a negative
impact on potential competition between the parties and could
block the development and availability of these proteins to
the detriment of all parties generally, and to the substantial
detriment of patients needing treatment with such proteins.
1.3. AGREEMENT. In consideration of the premises and for other good
and valuable consideration, the receipt and sufficiency of
which are acknowledged, the parties, intending to be legally
bound, agree as follows:
<PAGE> 2
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
2. DEFINITIONS AND INTERPRETATION. As used in this Agreement, the
following terms shall have the meanings set forth below and shall be
interpreted in accordance with the provisions of Section 2.20.
2.1. "AFFILIATE" means any corporation, company, partnership, joint
venture, firm and/or other entity which controls, is
controlled by, or is under common control with a Party. For
purposes of this Section 2.1, "control" means (a) in the case
of corporate entities, direct or indirect ownership of at
least fifty percent (50%) of the stock or shares entitled to
vote for the election of directors; and (b) in the case of
non-corporate entities, direct or indirect ownership of at
least fifty percent (50%) of the equity interest with the
power to direct the management and policies of such
noncorporate entities.
2.2. "BASE PROTEIN" means either a GI Base Protein or a CBM/
Stryker Base Protein, as the context so requires.
2.3. "BONE DISEASES" means osteoporosis, osteomalacia and Paget's
Disease.
2.4. "BONE DISEASE FIELD" means the portion of the OP Field
consisting of prevention or treatment of the Bone Diseases
other than (a) by the local application of GI Products, CBM
Products or Stryker Products in an insoluble formulation
directly on bone or joint tissue for local, as opposed to
general or systemic, effect and (b) the treatment of fractures
regardless of whether they result from Bone Disease.
2.5. "CBM/STRYKER BASE PROTEIN" means a polypeptide chain whose *
*********************************** is set forth on Schedule
2.5 to this Agreement.
2.6. "CBM/STRYKER DERIVATIVE PRODUCT" means, with respect to a
particular CBM/Stryker Base Protein:
a. species variant forms thereof;
b. amino acid variant forms of such Base Protein sharing at
least *** amino acid sequence identity with the ********
************************** of such Base Protein ("***
Homologs");
-2-
<PAGE> 3
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
c. ******* variant forms of such Base Protein or such
species variant forms or such *** Homologs, including,
without limitation, polypeptides comprising only the
***************************************
d. homodimeric, heterodimeric and chimeric forms of such Base
Protein and of variant forms thereof identified in the
preceding Subsections (a), (b) and (c), to the extent they
also consist of:
i. such Base Protein or variant forms thereof
identified in the preceding Subsections (a),
(b) or (c),
ii. other CBM/Stryker Base Proteins or variant
forms thereof identified in the preceding
Subsections (a), (b) or (c), or
iii. other polypeptide chains which are not within
the preceding Subsections (i) or (ii), and are
not GI Base Proteins or variant forms thereof
identified in Subsections (a), (b) or (c) of
Section 2.12;
e. polyclonal or monoclonal antibodies to such Base Protein or
to the foregoing proteins;
f. the DNA or RNA encoding such Base Protein or the foregoing
proteins;
g. vectors and host cells containing the foregoing DNA or RNA;
and
h. such Base Protein or the foregoing proteins when combined
with a matrix or other scaffold, and such proteins when
formulated with a delivery vehicle, including a
sequestering agent or other slow release agent or other
carrier.
Determination of "identity" between any two amino acid
sequences is based on that alignment which achieves the
maximum identity between the two sequences.
2.7. "CBM FIELD" means all fields of use outside of the Stryker
Field. The CBM Field includes, without limitation, (a) the
Bone Disease Field and (b) the area of the Dental Field
outside the Stryker Field.
-3-
<PAGE> 4
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
2.8. "CBM/STRYKER PATENTS" means all Patents in which and to the
extent Stryker and/or CBM, as the case may be, has an interest
licensable to GI as of the Effective Date, including without
limitation, those listed on SCHEDULE 2.8 to this Agreement. In
addition "CBM/Stryker Patents" will include all Patents listed
as "*** Patents" on SCHEDULE 2.8 covering ***********,
provided that Stryker and/or CBM has obtained the right to
sublicense such *** Patents to GI under this Agreement.
CBM/Stryker Patents shall not include Patent claims directed
to the polypeptide chains described in Section 2.12(d)(iii),
below.
2.9. "CBM PRODUCTS" means the CBM/Stryker Base Proteins and the
CBM/Stryker Derivative Products with respect thereto.
2.10. "DENTAL FIELD" means the field of treatment, repair or
replacement of the tooth, dentin, alveolar bone, tooth-root
cementum, gingiva and/or periodontal ligament.
2.11. "GI BASE PROTEIN" means a polypeptide chain whose *******
*************************** is set forth on SCHEDULE 2.11 to
this Agreement.
2.12. "GI DERIVATIVE PRODUCT" means, with respect to a particular GI
Base Protein:
a. species variant forms thereof;
b. amino acid variant forms of such Base Protein sharing at
least *** amino acid sequence identity with the **********
***************************** of such Base Protein ("***
Homologs");
c. ********* variant forms of such Base Protein or such
species variant forms or such *** Homologs, including,
without limitation, polypeptides comprising only the
**************************************;
d. homodimeric, heterodimeric and chimeric forms of such Base
Protein and of variant forms thereof identified in the
preceding Subsections (a), (b) and (c), to the extent they
also consist of:
-4-
<PAGE> 5
i. such Base Protein or variant forms thereof
identified in the preceding Subsections (a),
(b) or (c),
ii. other GI Base Proteins or variant forms
thereof identified in the preceding
Subsections (a), (b) or (c), or
iii. other polypeptide chains which are not within
the preceding Subsections (i) or (ii), and are
not CBM/Stryker Base Proteins or variant forms
thereof identified in Subsections (a), (b) or
(c) of Section 2.6;
e. polyclonal or monoclonal antibodies to such Base Protein or
to the foregoing proteins;
f. the DNA or RNA encoding such Base Protein or the foregoing
proteins;
g. vectors and host cells containing the foregoing DNA or RNA;
and
h. such Base Protein or the foregoing proteins when combined
with a matrix or other scaffold, and such proteins when
formulated with a delivery vehicle, including a
sequestering agent or other slow release agent or other
carrier.
Determination of "identity" between any two amino acid
sequences is based on that alignment which achieves the
maximum identity between the two sequences.
2.13. "GI PATENTS" means all Patents in which and to the extent GI
has an interest licensable to Stryker and/or CBM as of the
Effective Date, including without limitation, those listed on
SCHEDULE 2.13 to this Agreement. GI Patents shall not include
Patent claims directed to the polypeptide chains described in
Section 2.6(d)(iii), above.
2.14. "GI PRODUCTS" means the GI Base Proteins and the GI Derivative
Products with respect thereto.
2.15. "OP FIELD" means the field of treatment, repair or replacement
of bone and joint tissue, including, without limitation,
meniscus and articular cartilage, and ligaments and tendons.
-5-
<PAGE> 6
2.16. "ORPHAN DRUG RIGHTS" means the designation of orphan drug,
orphan combination product or orphan device status and the
award of exclusive marketing approval with respect to a GI
Product, a CBM Product or a Stryker Product, as applicable, by
the United States Food and Drug Administration, or any
designation or award by other governments or regulatory
authorities which provides for marketing exclusivity to
promote the development and commercialization of orphan drugs,
orphan combination products or orphan devices with restricted
patient populations for a given indication.
2.17. "PATENTS" means (a) all patent applications filed on or before
the Effective Date of this Agreement and all patents that
issue or have issued from any such application and (b) all
patent applications filed after the Effective Date of this
Agreement and all patents that issue from any such
application, but only to the extent of claims that are
entitled to priority or benefit from a patent application of
Subsection (a), above, regardless of whether such priority or
benefit is claimed. For purposes of this Agreement, patent
applications and patents include U.S. and foreign
applications, patents, divisions, continuations,
continuations-in-part, applications for certificates of
invention and priority rights, certificates of invention,
reissues, re-examination certificates, extensions or other
governmental acts that effectively extend the period of
exclusivity by the patent holder, substitutions, renewals,
supplementary protection certificates, confirmations,
registrations, validations and additions. Patents shall not
include any claims in any patent application or patent
described in the preceding Subsection (a) or (b) to methods,
devices or formulations directed toward specific uses outside
(i) the Stryker Field, (ii) the Bone Disease Field and (iii)
the Dental Field. Patents also shall not include any claims in
any patent application or patent described in the preceding
Subsection (a) or (b) to orthopedic hardware or prosthetic
devices per se, or to methods of making or using such hardware
or prosthetic devices per se.
2.18. "STRYKER FIELD" means the OP Field, but excluding the Bone
Disease Field. The Stryker Field includes, without limitation,
the area of the Dental Field outside the CBM Field.
-6-
<PAGE> 7
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
2.19. "STRYKER PRODUCTS" means the CBM/Stryker Base Proteins and the
CBM/Stryker Derivative Products with respect thereto.
2.20. INTERPRETATION. Notwithstanding the definitions set forth
above, the parties acknowledge that it is possible, for
example, that certain CBM/Stryker Derivative Products or
certain GI Derivative Products may be derived from more than
one of the CBM/Stryker Base Proteins or GI Base Proteins, as
applicable, listed on SCHEDULE 2.5 or SCHEDULE 2.11 hereof,
respectively. In order to assure the parties the benefit of
the licenses granted pursuant to Section 3, it is hereby
agreed that the following rules of interpretation shall apply,
in the order of priority of Subsections (a) through (e) set
forth below:
a. If a particular GI Product, Stryker Product or CBM Product,
as applicable, is a Derivative Product of the Base Protein
HBMP2 and of the Base Protein HBMP7, no rights to such
Derivative Product are granted under this Agreement; and
all parties agree that they shall not make, have made, use,
offer for sale, sell, have sold, import, have imported,
export or have exported (collectively, "exploitation") such
Derivative Product for so long as the exploitation of such
Derivative Product is covered by an unexpired patent
exclusively licensed hereunder.
b. If a particular GI Product, Stryker Product or CBM Product,
as applicable, is a Derivative Product of the Base Protein
***** and of the Base Proteins ***** or *****, no rights to
such Derivative Product are granted under this Agreement.
c. If a particular GI Product, Stryker Product or CBM Product,
as applicable, is a Derivative Product of the Base Protein
HBMP7 and of another Base Protein other than HBMP2, it
shall be deemed to be a Derivative Product of the Base
Protein HBMP7; and rights are granted under this Agreement
to such Derivative Product to the extent, but only to the
extent, that rights are granted under this Agreement to the
Base Protein HBMP7 and Derivative Products with respect
thereto.
-7-
<PAGE> 8
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
If a particular GI Product, Stryker Product or CBM Product,
as applicable, is a Derivative Product of the Base Protein
HBMP2 and of another Base Protein other than HBMP7, it
shall be deemed to be a Derivative Product of the Base
Protein HBMP2; and rights are granted under this Agreement
to such Derivative Product to the extent, but only to the
extent, that rights are granted under this Agreement to the
Base Protein HBMP2 and Derivative Products with respect
thereto.
d. If a particular GI Product, Stryker Product or CBM Product,
as applicable, is a Derivative Product of the Base Proteins
***** or ***** and of another Base Protein other than
HBMP2, HBMP7 or *****, it shall be deemed to be a
Derivative Product of the Base Proteins ***** or *****; and
rights are granted under this Agreement to such Derivative
Product to the extent, but only to the extent, that rights
are granted under this Agreement to the Base Proteins *****
or ***** and Derivative Products with respect thereto.
If a particular GI Product, Stryker Product or CBM Product,
as applicable, is a Derivative Product of the Base Protein
***** and of another Base Protein other than HBMP2, HBMP7,
***** or *****, it shall be deemed to be a Derivative
Product of the Base Protein *****; and rights are granted
under this Agreement to such Derivative Product to the
extent, but only to the extent, that rights are granted
under this Agreement to the Base Protein ***** and
Derivative Products with respect thereto.
e. Notwithstanding the fact that the Base Protein ***** may
have a greater than *** amino acid sequence identity with
the Base Protein HBMP2, the exclusivity of the license
granted to GI shall not apply to the Base Protein ***** and
heterodimeric and homodimeric forms of the Base Protein
***** or to the following Derivative Products: (i) species
variant forms of the Base Protein *****, (ii) polyclonal or
monoclonal antibodies to the Base Protein ***** or species
variants thereof, (iii) DNA and RNA encoding the Base
Protein ***** or species variants thereof, (iv) vectors and
cells containing such DNA or RNA, and (v) the foregoing
-8-
<PAGE> 9
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
when combined or formulated as described in Subsection
2.12(h); and the Base Protein ***** and such Derivative
Products shall not be deemed to be Derivative Products with
respect to Base Protein HBMP2.
Notwithstanding the fact that the Base Proteins ***** or
***** may have a greater than *** amino acid sequence
identity with the Base Protein HBMP7, the exclusivity of
the license granted to Stryker and CBM shall not apply to
the Base Proteins ***** and ***** and heterodimeric and
homodimeric forms of the Base Proteins ***** and *****, or
to the following Derivative Products: (i) species variant
forms of the Base Proteins ***** or *****, (ii) polyclonal
or monoclonal antibodies to the Base Proteins ***** or
***** or species variants thereof, (iii) DNA and RNA
encoding the Base Proteins ***** and ***** or species
variants thereof, (iv) vectors and cells containing such
DNA or RNA, and (v) the foregoing when combined or
formulated as described in Subsection 2.6(h); and the Base
Proteins ***** and ***** and such Derivative Products shall
not be deemed to be Derivative Products with respect to the
Base Protein HBMP7.
3. PATENT LICENSES AND ROYALTIES. Subject to the terms and conditions of
this Agreement, the parties grant the following licenses and, in
consideration thereof, shall pay the following royalties:
3.1. FROM GI TO STRYKER.
a. GRANT. GI grants to Stryker irrevocable, worldwide,
non-exclusive (except as provided below) licenses and
sublicenses, limited to the Stryker Field, under the
Patents listed on SCHEDULE 2.13 (and in addition, those
Patents which are sublicensable to Stryker under the Third
Party License Agreements listed on SCHEDULE 3.1 to this
Agreement), to make and have made, to use, to offer for
sale, to sell and have sold, to import and have imported,
and to export and have exported, the Stryker Products. This
grant shall be exclusive, even as to GI, with respect to
the CBM/Stryker Base
-9-
<PAGE> 10
Products of HBMP7. With respect to heterodimers and
chimeras of any CBM/Stryker Base Protein or any CBM/Stryker
Derivative Product, no right, license or sublicense is
granted with respect to any protein, polypeptide chain or
fragment thereof (alone or as a component of any
heterodimer or chimera) that is not on the list of CBMI/
Stryker Base Proteins set forth on SCHEDULE 2.5, or is not
licensed or sublicensed hereunder as a Derivative Product
of such CBM/Stryker Base Proteins.
b. OPTION TO EXPAND LICENSE. GI grants to Stryker an option,
exercisable by Stryker at any time upon written notice to
GI, to add the following to the licenses/sublicenses
granted to Stryker in Section 3.1(a), above, subject to all
limitations and restrictions set forth therein: (i) any
other GI Patent (or claim thereof) which is necessary or
useful in order for Stryker to make, have made, use, offer
for sale, sell, have sold, import, have imported, export or
have exported the CBM/Stryker Base Proteins, and the
CBM/Stryker Derivative Products referred to in Section
2.6(a) through (h) with respect thereto; or (ii) any other
Patent (or claim thereof) in which GI acquires an interest
sublicensable to Stryker after the Effective Date, which is
strictly necessary in order for Stryker to make and have
made, to use, to offer for sale, to sell and have sold, to
import and have imported, and to export and have exported,
the CBMI/Stryker Base Proteins, and the CBMI/Stryker
Derivative Products referred to in Section 2.6(a) through
(g) with respect thereto.
c. THIRD PARTY LICENSE AGREEMENTS. Stryker agrees to comply
with all applicable terms and conditions of all agreements
with third parties pursuant to which GI acquired or
acquires a sublicensable interest in any Patents
sublicensed to Stryker pursuant to Sections 3.1(a) or
3.1(b), above (the "GI Third Party License Agreements").
-10-
<PAGE> 11
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
above, Stryker will not be deemed to have a sublicense
under any third party Patent with respect to any product or
activity which (i) would not, but for such sublicense,
infringe such Patent, or (ii) is otherwise licensed or
sublicensed by Stryker under such third party's Patents for
such purpose or purposes.
d. COVENANT NOT TO SUE. GI covenants not to sue Stryker or its
Affiliates or sublicensees, or any third party which
acquires Stryker Product from Stryker or its Affiliates or
sublicensees, under any third party Patent licensed to GI
without the right to sublicense Stryker, with respect to
any Stryker Product or any activity related thereto for
which GI would have sublicensed (or would have been
required to sublicense) Stryker under such Patent, if GI
had such sublicensable interest in such Patent.
e. THIRD PARTY ROYALTIES. The licenses to Stryker set forth in
Subsection 3.1(a) shall be royalty-free; provided, however,
Stryker shall pay or reimburse GI for all royalties payable
by GI pursuant to GI Third Party License Agreements on
account of Stryker's sales of any Stryker Product and,
beginning on March 1, 1997, the ******* annual payment
required for GI to maintain exclusivity and sublicensing
rights in the *********** field under the
Stanford/Ringold License Agreement listed on SCHEDULE 3.1
attached to this Agreement. (For such time as both Stryker
and CBM have a sublicense from GI under the
Stanford/Ringold License Agreement, Stryker and CBM each
shall pay one-half of such ******* annual payment.)
Recognizing that GI has limited knowledge of the Stryker
Products and the processes, formulations, matrices and
other matters used by Stryker with respect thereto, GI
represents and warrants, to the best of its knowledge, that
(i) the Patents listed on SCHEDULE 2.13 attached to this
Agreement represent all GI Patents relating to the BMP
Subject Matter
-11-
<PAGE> 12
that would be infringed by Stryker making and having made,
using, offering for sale, selling and having sold,
importing and having imported, or exporting and having
exported, the Stryker Products, and (ii) that SCHEDULE 3.1
attached to this Agreement sets forth all GI Third Party
License Agreements that would require Stryker to pay or
reimburse GI for royalties payable to third parties on
Stryker's sales of the Stryker Products as a result of
receiving a license under Section 3.1(a) to the Patents
listed on SCHEDULE 2.13, together with the corresponding
maximum royalty percentages thereunder.
3.2. FROM GI TO CBM.
a. GRANT. GI grants to CBM irrevocable, worldwide,
non-exclusive (except as provided below) licenses and
sublicenses, limited to the CBM Field, under the Patents
listed on SCHEDULE 2.13 (and in addition, those Patents
which are sublicensable to CBM under the Third Party
License Agreements listed on SCHEDULE 3.1 to this
Agreement), to make and have made, to use, to offer for
sale, to sell and have sold, to import and have imported,
and to export and have exported, the CBM Products. This
grant shall be exclusive, even as to GI, with respect to
the CBM/Stryker Base Protein HBMP7 and the CBM/Stryker
Derivative Products of HBMP7. With respect to heterodimers
and chimeras of any CBM/Stryker Base Protein or any
CBM/Stryker Derivative Product, no right, license or
sublicense is granted with respect to any protein,
polypeptide chain or fragment thereof (alone or as a
component of any heterodimer or chimera) that is not on the
list of CBM/Stryker Base Proteins set forth on SCHEDULE
2.5, or is not licensed or sublicensed hereunder as a
Derivative Product of such CBM/Stryker Base Proteins.
b. OPTION TO EXPAND LICENSE. GI grants to CBM an option,
exercisable by CBM at any time upon written notice to GI,
to add the following to the licenses/ sublicenses granted
to CBM in Section 3.2(a), above, subject to all limitations
and restrictions set forth therein: (i) any other GI Patent
(or
-12-
<PAGE> 13
claim thereof) which is necessary or useful in order for
CBM to make, have made, use, offer for sale, sell, have
sold, import, have imported, export or have exported the
CBM/Stryker Base Proteins, and the CBM/Stryker Derivative
Products referred to in Section 2.6(a) through (h) with
respect thereto; or (ii) any other Patent (or claim
thereof) in which GI acquires an interest sublicensable to
CBM after the Effective Date, which is strictly necessary
in order for CBM to make and have made, to use, to offer
for sale, to sell and have sold, to import and have
imported, and to export and have exported, the CBM/Stryker
Base Proteins, and the CBM/Stryker Derivative Products
referred to in Section 2.6(a) through (g) with respect
thereto.
c. THIRD PARTY LICENSE AGREEMENTS. CBM agrees to comply with
all applicable terms and conditions of all agreements with
third parties pursuant to which GI acquired or acquires a
sublicensable interest in any Patents sublicensed to CBM
pursuant to Sections 3.2(a) or 3.2(b), above (the "GI Third
Party License Agreements"). Notwithstanding Sections 3.2(a)
and 3.2(b), above, CBM will not be deemed to have a
sublicense under any third party Patent with respect to any
product or activity which (i) would not, but for such
sublicense, infringe such Patent, or (ii) is otherwise
licensed or sublicensed by CBM under such third party's
Patents for such purpose or purposes.
d. COVENANT NOT TO SUE. GI covenants not to sue CBM or its
Affiliates or sublicensees, or any third party which
acquires CBM Product from CBM or its Affiliates or
sublicensees, under any third party Patent licensed to GI
without the right to sublicense CBM, with respect to any
CBM Product or any activity related thereto for which GI
would have sublicensed (or would have been required to
sublicense) CBM under such Patent, if GI had such
sublicensable interest in such Patent.
e. THIRD PARTY ROYALTIES. The licenses to CBM set forth in
Subsection 3.2(a) shall be royalty-free; provided, however;
CBM shall pay or reimburse GI for all royalties payable by
GI pursuant to GI
-13-
<PAGE> 14
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
Third Party License Agreements on account of CBM's sales of
any CBM Product and, beginning on March 1, 1997, the
******* annual payment required for GI to maintain
exclusivity and sublicensing rights in the ***********
field under the Stanford/Ringold License Agreement listed
on SCHEDULE 3.1 attached to this Agreement. (For such time
as both CBM and Stryker have a sublicense from GI under the
Stanford/Ringold License Agreement, CBM and Stryker each
shall pay one-half of such ******* annual payment.)
Recognizing that GI has limited knowledge of the CBM
Products and the processes, formulations, matrices and
other matters used by CBM with respect thereto, GI
represents and warrants, to the best of its knowledge, that
(i) the Patents listed on SCHEDULE 2.13 attached to this
Agreement represent all GI Patents relating to the BMP
Subject Matter that would be infringed by CBM making and
having made, using, offering for sale, selling and having
sold, importing and having imported, or exporting and
having exported, the CBM Products, and (ii) that SCHEDULE
3.1 attached to this Agreement sets forth all GI Third
Party License Agreements that would require CBM to pay or
reimburse GI for royalties payable to third parties on
CBM's sales of the CBM Products as a result of receiving a
license under Section 3.2(a) to the Patents listed on
SCHEDULE 2.13, together with the corresponding maximum
royalty percentages thereunder.
3.3. FROM STRYKER TO GI.
a. GRANT. Stryker grants to GI irrevocable,
worldwide, non-exclusive (except as provided below)
licenses and sublicenses in all fields in which
Stryker has a licensable interest under the Patents
listed on SCHEDULE 2.8 (and in addition, those
Patents which are sublicensable to GI under the
Third Party License Agreements listed on SCHEDULE
3.3 to this Agreement), to make and have made, to
use, to offer for sale, to sell and have sold, to
import and have imported, and to export and have
exported, the GI Products. This grant shall be
exclusive, even as to Stryker, with respect to the
GI Base Protein HBMP2 and the GI Derivative
Products of HBMP2. With respect to heterodimers
-14-
<PAGE> 15
and chimeras of any GI Base Protein or any GI Derivative
Product, no right, license or sublicense is granted with
respect to any protein, polypeptide chain or fragment
thereof (alone or as a component of any heterodimer or
chimera) that is not on the list of GI Base Proteins set
forth on SCHEDULE 2.11, or is not licensed or sublicensed
hereunder as a Derivative Product of such GI Base Proteins.
b. OPTION TO EXPAND LICENSE. Stryker grants to GI an option,
exercisable by GI at any time upon written notice to
Stryker, to add the following to the licenses/sublicenses
granted to GI in Section 3.3(a), above, subject to all
limitations and restrictions set forth therein: (i) any
other CBM/Stryker Patent (or claim thereof) which is
necessary or useful in order for GI to make, have made,
use, offer for sale, sell, have sold, import, have
imported, export or have exported the GI Base Proteins, and
the GI Derivative Products referred to in Section 2.12(a)
through (h) with respect thereto; or (ii) any other Patent
(or claim thereof) in which Stryker acquires an interest
sublicensable to GI after the Effective Date, which is
strictly necessary in order for GI to make and have made,
to use, to offer for sale, to sell and have sold, to import
and have imported, and to export and have exported, the GI
Base Proteins, and the GI Derivative Products referred to
in Section 2.12(a) through (g) with respect thereto.
c. THIRD PARTY LICENSE AGREEMENTS. GI agrees to comply with
all applicable terms and conditions of all agreements with
third parties pursuant to which Stryker acquired or
acquires a sublicensable interest in any Patents
sublicensed to GI pursuant to Sections 3.3(a) or 3.3(b),
above (the "Stryker Third Party License Agreements").
Notwithstanding Sections 3.3(a) and 3.3(b), above, GI will
not be deemed to have a sublicense under any third party
Patent with respect to any product or activity which (i)
would not, but for such sublicense, infringe such Patent,
or (ii) is otherwise licensed or sublicensed by GI under
such third party's Patents for such purpose or purposes.
-15-
<PAGE> 16
d. COVENANT NOT TO SUE. Stryker covenants not to sue GI or its
Affiliates or sublicensees, or any third party which
acquires GI Product from GI or its Affiliates or
sublicensees, under any third party Patent licensed to
Stryker without the right to sublicense GI, with respect to
any GI Product or any activity related thereto for which
Stryker would have sublicensed (or would have been required
to sublicense) GI under such Patent, if Stryker had such
sublicensable interest in such Patent.
e. THIRD PARTY ROYALTIES. The licenses to GI set forth in
Subsection 3.3(a) shall be royalty-free; provided, however,
GI shall pay or reimburse Stryker for all royalties payable
by Stryker pursuant to Stryker Third Party License
Agreements on account of GI's sales of any GI Product.
Recognizing that Stryker has limited knowledge of the GI
Products and the processes, formulations, matrices and
other matters used by GI with respect thereto, Stryker
represents and warrants, to the best of its knowledge, that
(i) the Patents listed on SCHEDULE 2.8 attached to this
Agreement represent all CBM/Stryker Patents relating to the
BMP Subject Matter that would be infringed by GI making and
having made, using, offering for sale, selling and having
sold, importing and having imported, or exporting and
having exported, the GI Products, and (ii) that SCHEDULE
3.3 attached to this Agreement sets forth all Stryker Third
Party Agreements that would require GI to pay or reimburse
Stryker for royalties payable to third parties on GI's
sales of the GI Products as a result of receiving a license
under Section 3.3(a) to the Patents listed on SCHEDULE 2.8,
together with the corresponding maximum royalty percentages
thereunder.
3.4. FROM CBM TO GI.
a. GRANT. CBM grants to GI irrevocable, worldwide,
non-exclusive (except as provided below) licenses and
sublicenses in all fields in which CBM has a licensable
interest under the Patents listed on SCHEDULE 2.8 (and in
addition, those Patents which are sublicensable to GI under
the Third Party License Agreements listed on SCHEDULE 3.4
to this Agreement), to make and have made, to use, to offer
-16-
<PAGE> 17
for sale, to sell and have sold, to import and have
imported, and to export and have exported, the GI Products.
This grant shall be exclusive, even as to CBM, with respect
to the GI Base Protein HBMP2 and the GI Derivative Products
of HBMP2. With respect to heterodimers and chimeras of any
GI Base Protein or any GI Derivative Product, no right,
license or sublicense is granted with respect to any
protein, polypeptide chain or fragment thereof (alone or as
a component of any heterodimer or chimera) that is not on
the list of GI Base Proteins set forth on SCHEDULE 2.11, or
is not licensed or sublicensed hereunder as a Derivative
Product of such GI Base Proteins.
b. OPTION TO EXPAND LICENSE. CBM grants to GI an option,
exercisable by GI at any time upon written notice to CBM,
to add the following to the licenses/sublicenses granted to
GI in Section 3.4(a), above, subject to all limitations and
restrictions set forth therein: (i) any other CBM/Stryker
Patent (or claim thereof) which is necessary or useful in
order for GI to make, have made, use, offer for sale, sell,
have sold, import, have imported, export or have exported
the GI Base Proteins, and the GI Derivative Products
referred to in Section 2.12(a) through (h) with respect
thereto; or (ii) any other Patent (or claim thereof) in
which CBM acquires an interest sublicensable to GI after
the Effective Date, which is strictly necessary in order
for GI to make and have made, to use, to offer for sale, to
sell and have sold, to import and have imported, and to
export and have exported, the GI Base Proteins, and the GI
Derivative Products referred to in Section 2.12(a) through
(g) with respect thereto.
c. THIRD PARTY LICENSE AGREEMENTS. GI agrees to comply with
all applicable terms and conditions of all agreements with
third parties pursuant to which CBM acquired or acquires a
sublicensable interest in any Patents sublicensed to GI
pursuant to Sections 3.4(a) or 3.4(b), above (the "CBM
Third Party License Agreements"). Notwithstanding Sections
3.4(a) and 3.4(b), above, GI will not be deemed to have a
sublicense under any third party Patent with respect to any
product or activity
-17-
<PAGE> 18
which (i) would not, but for such sublicense, infringe such
Patent, or (ii) is otherwise licensed or sublicensed by GI
under such third party's Patents for such purpose or
purposes.
d. COVENANT NOT TO SUE. CBM covenants not to sue GI or its
Affiliates or sublicensees, or any third party which
acquires GI Product from GI or its Affiliates or
sublicensees, under any third party Patent licensed to CBM
without the right to sublicense GI, with respect to any GI
Product or any activity related thereto for which CBM would
have sublicensed (or would have been required to
sublicense) GI under such Patent, if CBM had such
sublicensable interest in such Patent.
e. THIRD PARTY ROYALTIES. The licenses to GI set forth in
Subsection 3.4(a) shall be royalty-free; provided, however;
GI shall pay or reimburse CBM for all royalties payable by
CBM pursuant to CBM Third Party License Agreements on
account of GI's sales of any GI Product. Recognizing that
CBM has limited knowledge of the GI Products and the
processes, formulations, matrices and other matters used by
GI with respect thereto, CBM represents and warrants, to
the best of its knowledge, that (i) the Patents listed on
SCHEDULE 2.8 attached to this Agreement represent all
CBM/Stryker Patents relating to the BMP Subject Matter that
would be infringed by GI making and having made, using,
offering for sale, selling and having sold, importing and
having imported, or exporting and having exported, the GI
Products, and (ii) that SCHEDULE 3.4 attached to this
Agreement sets forth all CBM Third Party License Agreements
that would require GI to pay or reimburse CBM for royalties
payable to third parties on GI's sales of the GI Products
as a result of receiving a license under Section 3.4(a) to
the patents listed on SCHEDULE 2.8, together with the
corresponding maximum royalty percentages thereunder.
3.5. SUBLICENSES. GI, Stryker and CBM each shall have the right to
grant sublicenses under the foregoing licenses, to their
respective licensees (including, without limitation, their
respective Affiliates) of the GI Products, Stryker Products or
CBM Products,
-18-
<PAGE> 19
as applicable, provided said sublicensees agree to comply with
all terms and conditions of the foregoing licenses.
Notwithstanding any such sublicense, the licensor party shall
remain primarily liable for all of such sublicensee's duties
and obligations contained in this Agreement.
3.6. ORPHAN DRUG RIGHTS. If GI, Stryker or CBM (or a sublicensee of
such party) receives Orphan Drug Rights for a GI Product, a
Stryker Product or a CBM Product, respectively, for which the
recipient of the Orphan Drug Rights (the "Recipient") has
granted a license hereunder to the other parties, the
Recipient agrees to consent to the approval of the other
parties' (and their respective sublicensees') marketing
approval applications for the GI Product, Stryker Product or
CBM Product, as the case may be, for which such license was
granted by the Recipient, notwithstanding such Orphan Drug
Rights, or to otherwise immediately take such action or grant
such rights as are necessary so that the other parties (and
their sublicensees) are not blocked or delayed by the
designation or award of such Orphan Drug Rights from selling a
GI Product, Stryker Product or CBM Product, as applicable, for
which they received a license from the Recipient hereunder,
including, but not limited to, the submission of a consent
letter to the United States Food and Drug Administration or
applicable foreign government or regulatory authority, with
respect to the other parties (or sublicensees) at the time a
request for Orphan Drug Rights is submitted, or the prompt
execution of any other documents, notices or agreements that
may be necessary to carry out the intent of this Section . In
connection with the grant of a sublicense under Section 3.5,
above, the parties shall have the right to provide such
sublicensees with a consent under the Orphan Drug Rights of
the other parties. Upon request, a party shall immediately
provide a consent to the applicable regulatory authorities
and/or the requesting party under its Orphan Drug Rights for
the benefit of such sublicensee of the requesting party.
-19-
<PAGE> 20
3.7. NO RESTRICTIONS ON LICENSOR PARTY. Stryker and CBM severally,
and not jointly, agree that they and their respective
Affiliates shall not (and shall not grant a license to any
third party to) make, have made, use, offer for sale, sell,
have sold, import, have imported, export or have exported
(collectively, "exploitation") any product comprising the GI
Base Protein BMP2 or any GI Derivative Product with respect to
the GI Base Protein BMP2, for so long as the exploitation of
such GI Base Protein or such GI Derivative Product is covered
by an unexpired patent exclusively licensed hereunder. GI
agrees that it and its Affiliates shall not (and shall not
grant a license to any third party to) make, have made, use,
offer for sale, sell, have sold, import, have imported, export
or have exported (collectively, "exploitation") any product
comprising the CBM/Stryker Base Protein BMP7 or any
CBM/Stryker Derivative Product with respect to the CBM/Stryker
Base Protein BMP7, for so long as the exploitation of such
CBM/Stryker Base Protein or such CBM/Stryker Derivative
Product is covered by an unexpired patent exclusively licensed
hereunder. Except as set forth in the preceding sentences and
except for the exclusive licenses set forth in Section 3,
above, (a) nothing contained in this Agreement shall be deemed
to restrict in any manner whatsoever the right of each of
Stryker and CBM to use the CBM/Stryker Patents, to issue
licenses to others for any purpose under such CBM/Stryker
Patents or to enforce such Patents against third parties, and
(b) nothing contained in this Agreement shall be deemed to
restrict in any manner whatsoever the right of GI to use the
GI Patents, to issue licenses to others for any purpose under
such GI Patents or to enforce such Patents against third
parties.
3.8. TERMINATION OF LICENSES. Unless terminated earlier by a
licensee party, all licenses or sublicenses provided for in
this Agreement shall run to the end of the enforceable term of
the Patents or Third Party License Agreements (other than
sublicenses under Third Party License Agreements which are
sooner terminated by a third party licensor pursuant to the
terms of such agreements) under
-20-
<PAGE> 21
which such licenses or sublicenses are granted and shall
not be terminable by any licensor party or any
successor, assign or any person claiming through a
licensor party under any circumstances or for any
reason. Notwithstanding the foregoing, in the event a
licensor party wishes to terminate a Third Party License
Agreement, it shall give notice to the licensee party or
parties. A licensee party may require the licensor party
to maintain such Third Party License Agreement and the
sublicense to such licensee party thereunder, provided
that such licensee party assumes all of such licensor
party's obligations under such Third Party License
Agreement. Any licensee party may at any time terminate
any license or sublicense granted to it by any other
licensor party under any particular Patent or Patents or
any claim or claims of any particular Patent or Patents
by written notice to the licensor party thereof.
3.9. THIRD PARTY ROYALTY ADMINISTRATION.
a. REPORTS AND PAYMENT. Each party shall deliver to the
licensor party to which third party royalty reimbursement
is payable, within sixty (60) days after the end of each
calendar quarter in which royalty-bearing sales of a GI
Product, a Stryker Product or a CBM Product, as applicable,
have occurred, a written report showing its computation of
royalties due on account of the royalty obligations imposed
by the applicable Third Party License Agreement, upon sales
by such party and its sublicensees during each such
calendar quarter. Simultaneously with the delivery of each
such report, the paying party shall tender payment in
United States Dollars of all royalties shown to be due
therein, by wire transfer to a bank and account designated
by the party to which payment is owed, or by other means
agreed to by the parties.
b. COMPLIANCE WITH TERMS AND CONDITIONS OF THIRD PARTY
AGREEMENTS. In calculating and paying or reimbursing a
party for third party royalty obligations under Subsections
3.1(e), 3.2(e), 3.3(e) and 3.4(e), the parties shall comply
with the applicable terms and conditions of the applicable
Third Party License Agreements which
-21-
<PAGE> 22
impose such royalty obligations, including, without
limitation, calculation of net sales, reporting
requirements, currency conversion, foreign royalties, taxes
and records. Copies of the relevant provisions of such
third party agreements shall be furnished to a paying party
for compliance purposes.
c. RECORDS. Each party shall keep, and shall require all
sublicensees to keep, for a period of at least two (2)
years, full, true and accurate books of accounts and other
records containing all information and data which may be
necessary to ascertain and verify the royalties payable
hereunder. During the term of this Agreement and for a
period of two (2) years following its termination, each
party shall have the right, at its own expense, from time
to time (not to exceed once during each calendar year) to
designate an independent accounting firm to inspect, in
confidence, such books, records and supporting data. In the
event such inspection reveals an underpayment of more than
10% of the royalty due for the period inspected, the party
whose books and records were inspected shall reimburse the
inspecting party for the reasonable cost of the inspection.
4. WARRANTIES AND INDEMNITIES.
4.1. WARRANTIES. Stryker and CBM each severally and not jointly
represents and warrants to GI that (a) Stryker and CBM
collectively have an interest licensable or sublicensable to
GI in all of the Patents listed on SCHEDULE 2.8 attached to
this Agreement and (b) the combination of the rights granted
by them to GI under Sections 3.3(a) and 3.4(a) of this
Agreement represents, in sum, all fields of use under such
Patents. GI represents and warrants to each of Stryker and CBM
that it has an interest licensable or sublicensable to Stryker
and CBM in all of the Patents listed on SCHEDULE 2.13 attached
to this Agreement. Stryker and CBM each severally and not
jointly represents and warrants to GI, and GI represents and
warrants to each of Stryker and CBM, that it has full right,
power and authority to grant the licenses and sublicenses
granted by it under this Agreement.
-22-
<PAGE> 23
Stryker and CBM (and their respective sublicensees, and all of
their respective agents, directors, officers and employees)
jointly and severally harmless, at GI's cost and expense, from
and against any and all losses, costs, liabilities, damages,
fees and expenses, including reasonable attorneys' fees and
expenses (collectively, "Liabilities") arising out of or in
connection with GI's manufacture, promotion, sale or other
disposition of the GI Products, including, but not limited to,
patent infringement or patent validity-related matters, and
any actual or alleged injury, damage, death or other
consequence occurring to any person as a result, directly or
indirectly, of the possession, consumption or use of the GI
Products, regardless of the form in which any such claim is
made.
Stryker shall defend, indemnify and hold GI (and its
sublicensees, and their respective agents, directors, officers
and employees) harmless, at Stryker's cost and expense, from
and against any and all Liabilities arising out of or in
connection with Stryker's manufacture, promotion, sale or
other disposition of the Stryker Products, including, but not
limited to, patent infringement or patent validity-related
matters, and any actual or alleged injury, damage, death or
other consequence occurring to any person as a result,
directly or indirectly, of the possession, consumption or use
of the Stryker Products, regardless of the form in which any
such claim is made.
CBM shall defend, indemnify and hold GI (and its sublicensees,
and their respective agents, directors, officers and
employees) harmless, at CBM's cost and expense, from and
against any and all Liabilities arising out of or in
connection with CBM's manufacture, promotion, sale or other
disposition of the CBM Products, including, but not limited
to, patent infringement or patent validity-related matters,
and any actual or alleged injury, damage, death or other
consequence occurring to any person as a result, directly or
indirectly, of the possession, consumption or use of the CBM
Products, regardless of the form in which any such claim is
made.
-23-
<PAGE> 24
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
In the event an indemnified party is sued, or a claim or
threat of suit is made against the indemnified party, on
account of the indemnifying party's activities with the GI
Products, Stryker Products or CBM Products, as applicable,
then the indemnified party shall promptly notify the
indemnifying party thereof, and at the indemnifying party's
cost, will permit the indemnifying party's attorneys to
handle, fully control, defend and/or settle such claims or
suits; provided, however, that the failure to give prompt
notice shall not relieve the indemnifying party of its
obligations to indemnify the indemnified party unless such
failure significantly prejudices the ability of the
indemnifying party to defend such claim, suit or threatened
suit. The indemnified party may elect to be represented in
such suit by counsel of its own choice at its own expense. The
indemnified party may settle or compromise such suit;
provided, however; the indemnifying party's indemnity
obligations under this Section shall only apply to settlements
or compromises made by the indemnified party with the
indemnifying party's prior written consent. The indemnifying
party may not settle or compromise such suit without the prior
written consent of the indemnified party unless such
settlement imposes no obligation, liability or responsibility
on the indemnified party, including, without limitation, any
obligation to do or refrain from doing any act or thing.
4.3. *** PATENTS. Stryker and CBM each severally and not jointly
covenants and agrees to use its best efforts to obtain the
right to sublicense the *** Patents to GI. If Stryker and/or
CBM have not obtained the right to sublicense the *** Patents
to GI pursuant to Sections 3.3 and/or 3.4, above, Stryker and
CBM shall not (a) enforce, or otherwise assert claims under,
the *** Patents against GI or its Affiliates or sublicensees
or (b) sublicense any rights obtained under this Agreement to
any third party which has the right to enforce, or otherwise
assert claims under, the *** Patents, unless said third party
agrees not to enforce, or otherwise assert claims under, the
*** Patents against GI or its Affiliates or sublicensees, and
GI and its Affiliates and sublicensees shall be named third
party beneficiaries of such agreement in such sublicense.
-24-
<PAGE> 25
5. CONFIDENTIALITY.
5.1. TREATMENT OF CONFIDENTIAL INFORMATION. Each party shall
maintain all information of another party, which is treated by
such other party as proprietary or confidential, in
confidence, and shall not disclose, divulge or otherwise
communicate such confidential information to others, or use it
for any purpose, except pursuant to, and in order to carry
out, the terms and objectives of this Agreement, and hereby
agrees to exercise every reasonable precaution to prevent and
restrain the unauthorized disclosure of such confidential
information by any of its Affiliates, directors, officers,
employees, consultants, subcontractors, sublicensees or
agents.
5.2. RELEASE FROM RESTRICTIONS. The provisions of Section 5.1 shall
not apply to any confidential information disclosed hereunder
which:
a. was known or used by the receiving party or its Affiliates
prior to its date of disclosure to the receiving party, as
evidenced by the prior written records of the receiving
party or its Affiliates; or
b. either before or after the date of the disclosure to the
receiving party is lawfully disclosed without restriction
to the receiving party or its Affiliates by an independent,
unaffiliated third party rightfully in possession of the
confidential information (but only to the extent of the
rights received from such third party); or
c. either before or after the date of the disclosure to the
receiving party becomes published or generally known to the
public through no fault or omission on the part of the
receiving party or its Affiliates; or
d. is required to be disclosed by the receiving party or its
Affiliates to comply with applicable laws, to defend or
prosecute litigation or to comply with governmental
regulations, or the rules of a stock exchange or NASDAQ,
provided that the receiving party provides prior written
notice of such disclosure to the other party and takes
reasonable and lawful actions to avoid and/or minimize the
degree of such disclosure.
-25-
<PAGE> 26
6. MISCELLANEOUS.
6.1. PUBLICITY. Subject to the parties' first obtaining the
authorizations, approvals and consents set forth in Section
6.16, below, the parties shall issue a joint press release
regarding the subject matter of this Agreement, but otherwise,
except as required by applicable law or regulation, no party
shall originate any publicity, news release or other public
announcement, written or oral, relating to this Agreement
without the prior written approval of the other parties, which
approval shall not be unreasonably withheld.
6.2. NO IMPLIED LICENSES. Only the licenses granted pursuant to the
express terms of this Agreement shall be of any legal force
and effect. No license rights shall be created by implication
or estoppel.
6.3. NO AGENCY. Nothing herein shall be deemed to constitute any
party as the agent or representative of the other parties, or
the parties as joint venturers or partners for any purpose.
6.4. NOTICE. All notices required under this Agreement to be given
by one party to another shall be in writing and shall be given
by addressing the same to the other at the address or
facsimile number set forth below, or at such other addresses
or facsimile numbers as the parties may specify in writing.
All notices shall become effective when deposited in the
United States Mail with proper postage for first class
registered or certified mail prepaid, return receipt
requested, or when delivered personally or by one-day courier
service, or, if promptly confirmed by mail or one-day courier
service as provided above, when dispatched by facsimile.
GI: Genetics Institute, Inc.
87 CambridgePark Drive
Cambridge, Massachusetts 02140
Telecopier: (617) 876-5851
Attn: Gabriel Schmergel
Stryker: Stryker Corporation
2725 Fairfield Road
Kalamazoo, Michigan 49002
Telecopier: (616) 385-0030
Attn: John W. Brown
-26-
<PAGE> 27
CBM: Creative BioMolecules, Inc.
45 South Street
Hopkinton, Massachusetts 01748
Telecopier: (508) 435-6951
Attn: Michael Tarnow
6.5. ASSIGNMENT. This Agreement, and the rights and obligations
hereunder, may not be assigned or transferred, in whole or in
part, by any party without the prior written consent of the
other parties, except in connection with the merger,
consolidation or sale of all or substantially all of a party's
assets, or the assets of a party which are directly related to
the performance of its obligations under this Agreement,
provided that the assignee agrees to be bound by the terms and
conditions of this Agreement.
6.6. ENTIRE AGREEMENT. This Agreement constitutes the entire
agreement of the parties with regard to its subject matter,
and supersedes all previous written or oral representations,
agreements and understandings between the parties.
6.7. NO MODIFICATION. This Agreement may be changed only by a
writing signed by the parties.
6.8. HEADINGS. The headings contained in this Agreement are for
convenience of reference only and shall not be considered in
construing this Agreement.
6.9. WAIVER. The waiver by any party of a breach or a default of
any provision of this Agreement by another 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 any 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.
6.10. SEVERABILITY. In the event that any one or more of the
provisions contained in this Agreement shall, for any reason,
be held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall
not affect any other provisions of this Agreement, and all
other provisions shall remain in full force and effect. If any
of the
-27-
<PAGE> 28
provisions of this Agreement is held to be excessively broad
or invalid, illegal or unenforceable in any jurisdiction, it
shall be reformed and construed by limiting and reducing it so
as to be enforceable to the maximum extent permitted by law in
conformance with its original intent.
6.11. SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon
and inure to the benefit of the parties hereto and their
successors and permitted assigns.
6.12. COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but
all of which together shall constitute one and the same
instrument.
6.13. APPLICABLE LAW. This Agreement shall in all events and for all
purposes be governed by, and construed in accordance with, the
law of the Commonwealth of Massachusetts without regard to any
choice of law principle that would dictate the application of
the law of another jurisdiction.
6.14. ARBITRATION.
a. The parties shall attempt to resolve any dispute or
controversy arising under or relating to the interpretation
or meaning of this Agreement, but excluding any disputes or
controversies related to the validity, infringement or
enforceability of any Patents, by good faith negotiations.
Any matter that cannot be resolved by such good faith
negotiation shall be resolved by final and binding
arbitration conducted by three (3) arbitrators in Boston,
Massachusetts, in accordance with the then-current American
Arbitration Association ("AAA") Commercial Arbitration
Rules (the "AAA Rules") as modified by this Section 6.14.
b. The arbitrators shall be selected by mutual agreement of
the parties or, failing such agreement, in accordance with
the aforesaid AAA Rules. At least one (1) member of the
arbitration panel shall be reasonably familiar with the
biotechnology industry. Stryker and CBM shall bear one-half
of the cost of the arbitrators and GI shall bear one-half
of the costs of the
-28-
<PAGE> 29
arbitrators. No arbitrator may be affiliated in any way
with any party.
c. The parties shall have the right of limited pre-hearing
discovery, in accordance with the U.S. Federal Rules of
Civil Procedure, as then in effect, for a period not to
exceed sixty (60) days.
d. As soon as the discovery is concluded, but in any event
within thirty (30) days thereafter, the arbitrators shall
hold a hearing in accordance with the AAA Rules.
Thereafter, the arbitrators shall promptly render a written
decision, together with a written opinion setting forth in
reasonable detail the grounds for such a decision.
e. Judgment may be entered in any court of competent
jurisdiction to enforce the award entered by the
arbitrators.
f. The duty of the parties to arbitrate any dispute thereunder
shall survive expiration or termination of this Agreement
for any reason.
6.15. HART-SCOTT-RODINO FILING. The parties shall cooperate fully
and use their best efforts to comply with the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, and the rules and regulations issued thereunder (the
"HSR Act"), to determine if a Notification Report is required
thereunder, and to file any required Notification Report form
with the Federal Trade Commission and the Department of
Justice in accordance with such rules and regulations with
respect to the transactions contemplated in this Agreement. In
the event such Notification Report is required, this Agreement
shall become effective as of the Effective Date at such time
as the appropriate waiting periods as prescribed by such rules
and regulations have expired.
6.16. CONSENTS. This Agreement shall become effective as of the
Effective Date at such time as the following consents,
approvals and authorizations have been obtained by the
respective parties:
a. GI obtains (i) the waiver of American Home Products
Corporation's right of first refusal under its Governance
Agreement with GI, (ii) the consent of
-29-
<PAGE> 30
GI's joint venture entities with Yamanouchi Pharmaceutical
Co., Ltd. and (iii) the authorization of the Intellectual
Property Committee of GI's Board of Directors, which
consents and authorization will be promptly sought and
provided to CBM and Stryker following receipt thereof.
b. CBM and Stryker each obtain all requisite consents and
approvals, including the authorization of each parties'
respective boards of directors, which consents and
authorization will be promptly sought and provided to GI
following receipt thereof.
[Remainder of Page Intentionally Left Blank]
-30-
<PAGE> 31
IN WITNESS WHEREOF, duly authorized representatives of the parties have
signed this Agreement as a document under seal as of the Effective Date.
GENETICS INSTITUTE, INC.
BY /s/Gabriel Schmergel
_______________________
Gabriel Schmergel
President and CEO
STRYKER CORPORATION
By /s/John W. Brown
_______________________
John W. Brown
Chairman of the Board,
CEO and President
CREATIVE BIOMOLECULES, INC.
By /s/Michael Tarnow
_______________________
Michael Tarnow
CEO and President
ACKNOWLEDGMENT OF CONSENT:
GPDC PARTNERSHIP:
GI JAPAN, INC. YAMANOUCHI USA, INC.
By /s/Tuan Ha-Ngoc By /s/Shigeo Morioka
_____________________ _____________________
-31-
<PAGE> 32
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
Schedule 2.5
CBM/Stryker Base Proteins
(attached)
***********
***************************************************************
***************************************************************
***************************************************************
HBMP7********************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
NOTES:
1 Hbmp7=OP1
************
<PAGE> 33
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
*****
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
-2-
<PAGE> 34
Schedule 2.8
CBM/Stryker Patents
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
-3-
<PAGE> 35
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
Schedule 2.11
GI Base Proteins
***********
Hbmp2 *********************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
***************************************************************
NOTES:
**********
**********
**********
**********
**********
**********
-4-
<PAGE> 36
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
*****
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
*********************************
-5-
<PAGE> 37
Schedule 2.13
GI Patents
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
-6-
<PAGE> 38
Schedule 3.1
GI Third Party License Agreements and
Maximum Royalty Obligations Thereunder
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
<TABLE>
<CAPTION>
Agreement Date Maximum Royalty Obligation
--------- ---- --------------------------
<S> <C> <C>
MetaMorphix Collaboration 12-1-94 ***************
Agreement ***************
***************
***************
Stanford/Ringold 3-1-94 *****
License Agreement
Harvard **************** 8-18-95 *****
License Agreement
Stanford/Cohen and Boyer 12-2-80 **********
License Agreement **********
</TABLE>
-7-
<PAGE> 39
Schedule 3.3
Stryker Third Party License Agreements and
Maximum Royalty Obligations Thereunder
<TABLE>
<CAPTION>
Agreement Date Maximum Royalty Obligation
--------- ---- --------------------------
<S> <C> <C>
--None-- -- --
</TABLE>
-8-
<PAGE> 40
Schedule 3.4
CBM Third Party License Agreements and
Maximum Royalty Obligations Thereunder
<TABLE>
<CAPTION>
Agreement Date Maximum Royalty Obligation
--------- ---- --------------------------
<S> <C> <C>
Stanford/Cohen and Boyer To be To be
License Agreement Completed Completed
</TABLE>
-9-
<PAGE> 1
GENETICS INSTITUTE, INC. AND SUBSIDIARIES
EXHIBIT 11
Computation of Earnings Per Share
(Unaudited - in thousands except per share amounts)
Primary earnings (loss) per share is computed by dividing net income (loss) by
the weighted average number of shares of common stock and common stock
equivalents outstanding.
Common stock equivalents consist of stock options and warrants, and are not
included in the calculation of earnings per share in loss periods because their
effect would be antidilutive.
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
-------------------- -------------------
1996 1995 1996 1995
------- -------- ------- -------
<S> <C> <C> <C> <C>
Primary Earnings per Share
- --------------------------
Weighted average number of shares outstanding 29,571 26,745 28,331 26,690
Shares deemed outstanding from the assumed
exercise of stock options and warrants
reduced by the number of shares
purchased with proceeds 2,156 -- 2,220 535
------- -------- ------- -------
Total 31,727 26,745 30,551 27,225
------- -------- ------- -------
Net income (loss) applicable to common shares $ 7,832 $ (7,183) $37,244 $ 3,686
------- -------- ------- -------
Primary earnings (loss) per common share $ .25 $ (.27) $ 1.22 $ .14
======= ======== ======= =======
Fully Diluted Earnings Per Share
- --------------------------------
Weighted average number of shares outstanding 29,571 26,745 28,331 26,690
Shares deemed outstanding from the assumed
exercise of stock options and warrants
reduced by the number of shares
purchased with proceeds 2,378 -- 2,420 934
------- -------- ------- -------
Total 31,949 26,745 30,751 $27,624
------- -------- ------- -------
Net income (loss) applicable to common shares $ 7,832 $ (7,183) $37,244 $ 3,686
------- -------- ------- -------
Fully diluted earnings (loss) per common share $ .25 $ (.27) $ 1.21 $ .13
======= ======== ======= =======
</TABLE>
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED CONDENSED FINANCIAL STATEMENTS OF GENETICS INSTITUTE, INC. FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND IS QUALIFIED IN ITS ENTIRETY BY
REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<CURRENCY> U.S. DOLLARS
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-START> JAN-01-1996
<PERIOD-END> SEP-30-1996
<EXCHANGE-RATE> 1
<CASH> 106,025
<SECURITIES> 232,178
<RECEIVABLES> 61,636
<ALLOWANCES> 0
<INVENTORY> 26,004
<CURRENT-ASSETS> 431,903
<PP&E> 192,617
<DEPRECIATION> 77,526
<TOTAL-ASSETS> 552,714
<CURRENT-LIABILITIES> 39,651
<BONDS> 0
<COMMON> 296
0
0
<OTHER-SE> 512,767
<TOTAL-LIABILITY-AND-EQUITY> 552,714
<SALES> 98,317
<TOTAL-REVENUES> 202,824
<CGS> 37,795
<TOTAL-COSTS> 37,795
<OTHER-EXPENSES> 107,316
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> 38,154
<INCOME-TAX> 910
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 37,244
<EPS-PRIMARY> 1.22
<EPS-DILUTED> 1.22
</TABLE>
