SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 10-Q
{X} QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 1996
Commission File No. 0-19131
MEDIMMUNE, INC.
(Exact name of registrant as specified in its charter)
Delaware 52-1555759
(State or other jurisdiction of (I. R. S. Employer
incorporation or organization) Identification No.)
35 West Watkins Mill Road, Gaithersburg, MD 20878
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (301) 417-0770
Indicate by check mark whether the Registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the Registrant was required to
file such reports) and (2) has been subject to such filing
requirements for the past 90 days.
Yes [X] No [ ]
As of June 30, 1996, 21,655,284 shares of Common Stock, par value
$0.01 per share, were outstanding.
MEDIMMUNE, INC.
Index to Form 10-Q
Part I Financial Page
Item 1. Financial Statements
Balance Sheets 1
Statements of Operations 2
Condensed Statements of Cash Flows 3
Notes to Financial Statements 4
Item 2. Management's Discussion and Analysis
of Financial Condition and Results
of Operations 5-7
Part II Other Information 8-9
Item 1. Legal Proceedings
Item 2. Changes in Securities
Item 3. Defaults upon Senior Securities
Item 4. Submission of Matters to a Vote of Security
Holders
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
CytoGam is a registered trademark and
RespiGam is a trademark of the Company.
<TABLE>
<CAPTION>
ITEM 1. FINANCIAL STATEMENTS
MEDIMMUNE, INC. BALANCE SHEETS
(in thousands, except share data)
<S> <C> <C>
June 30, December 31,
1996 1995
---------- ----------
ASSETS: (Unaudited)
Cash and cash equivalents $9,743 $14,165
Marketable securities 71,324 23,874
Trade and contract receivables, net 7,573 3,919
Inventory, net 6,173 6,027
Other current assets 885 1,005
---------- ----------
Total Current Assets 95,698 48,990
Property and equipment, net 10,445 8,255
Other assets 152 87
---------- ----------
Total Assets $106,295 $57,332
========== ==========
LIABILITIES AND SHAREHOLDERS' EQUITY:
Accounts payable $1,367 $2,318
Accrued expenses 6,526 6,538
Product royalties payable 1,743 1,776
Other current liabilities 114 111
---------- ----------
Total Current Liabilities 9,750 10,743
Long term debt 1,926 1,984
Other liabilities 925 826
---------- ----------
Total Liabilities 12,601 13,553
---------- ----------
Commitments and Contingencies
SHAREHOLDERS' EQUITY:
Preferred stock, $.01 par value; authorized -- --
5,524,525 shares; none issued or outstanding
Common stock, $.01 par value; authorized 216 177
30,000,000 shares; issued and outstanding
21,655,284 at June 30, 1996 and
17,706,137 at December 31, 1995
Paid-in capital 171,919 113,435
Accumulated deficit (78,441) (69,833)
---------- ----------
Total Shareholders' Equity 93,694 43,779
---------- ----------
Total Liabilities and Shareholder's Equity $106,295 $57,332
========== ==========
</TABLE>
The accompanying notes are an integral part of these financial
statements.
Page 1
<TABLE>
MEDIMMUNE, INC.
STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands except per share data)
For the three For the six
months ended months ended
June 30 June 30,
1996 1995 1996 1995
-------- -------- -------- --------
<S> <C> <C> <C> <C>
REVENUES:
Product Sales $6,830 $4,236 $13,454 $7,300
Contracts 97 3,624 4,907 6,487
-------- -------- -------- --------
Total revenues 6,927 7,860 18,361 13,787
-------- -------- -------- --------
COSTS AND EXPENSES:
Cost of sales 4,063 2,911 8,122 5,468
Research and development 6,849 7,991 12,242 14,559
Selling, administrative and 4,202 2,138 8,559 4,658
general
-------- -------- -------- --------
Total expenses 15,114 13,040 28,923 24,685
-------- -------- -------- --------
Operating Loss (8,187) (5,180) (10,562) (10,898)
Interest income 1,206 374 2,074 690
Interest expense (59) (63) (120) (127)
-------- -------- -------- --------
Net Loss ($7,040) ($4,869) ($8,608) ($10,335)
======== ======== ======== ========
Loss Per Common Share ($0.33) ($0.32) ($0.42) ($0.69)
======== ======== ======== ========
Shares Used in Computing
Loss Per Share 21,386 15,436 20,340 15,029
======== ======== ======== ========
</TABLE>
The accompanying notes are an integral part of these financial
statements.
PAGE 2
<TABLE>
<CAPTION>
MEDIMMUNE, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
For the
six months ended
June 30,
1996 1995
-------- ---------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES: ($8,608) ($10,335)
Net loss
Noncash items:
Depreciation and amortization 881 767
Amortization of discount on marketable (302) (167)
securities
Other changes in assets and liabilities (4,646) 1,838
-------- ---------
Net cash used in operating activities (12,675) (7,897)
-------- --------
CASH FLOWS FROM INVESTING ACTIVITIES:
(Increase)decrease in marketable securities (47,148) 2,143
Capital expenditures (3,071) (412)
-------- ---------
Net cash (used in)/provided by (50,219) 1,731
investing activities -------- ---------
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common 58,523 17,233
stock and exercise of stock options
Decrease in long term debt (51) (46)
-------- ---------
Net cash provided by financing 58,472 17,187
activities
-------- --------
Net (decrease) increase in cash and cash (4,422) 11,021
equivalents
Cash and cash equivalents at beginning 14,165 6,350
of period -------- ---------
Cash and cash equivalents at end of period $9,743 $17,371
======== =========
</TABLE>
The accompanying notes are an integral part of these financial
statements.
PAGE 3
MEDIMMUNE, INC.
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
General
The financial information presented as of June 30, 1996 and 1995,
and for the periods then ended is unaudited, but in the opinion
of the Company's management contains all adjustments (which
consist only of normal recurring adjustments) necessary for a
fair presentation of such financial information.
Inventory
Inventory is comprised of the following (in thousands):
June 30, 1996 December 31, 1995
------------ ---------------
Raw Materials 1,433 $2,193
Work in Process 3,653 2,510
Finished Goods 1,087 1,324
------ ------
6,173 $6,027
====== ======
SUBSEQUENT EVENTS
The Company broke ground on August 12, 1996 on its approximately
$50 million manufacturing facility. On July 31, 1996, the Company
purchased two adjacent parcels of land in Frederick, Maryland,
totaling 26 acres, for $1.5 million. Additionally, on August 9,
1996, the Company signed an Engineering, Procurement, Construc-
tion and Validation Agreement with Fluor Daniel to design, build,
equip and validate the facility. The financing for the new
facility is expected to be provided by a combination of $13
million of State, Frederick County and Frederick City loans and
the proceeds from the recently completed convertible debt
offering.
The Company also has begun work on a $6 million expansion of its
Gaithersburg, Maryland pilot plant facility for production of
products undergoing human clinical evaluation. Construction of
the pilot plant is expected to be completed in 1997.
PAGE 4
ITEM 2.
MEDIMMUNE, INC.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 1996 AND 1995
Product sales grew to $6.8 million in second quarter 1996 from
$4.2 million in second quarter 1995, an increase of 61%. CytoGam
sales increased to $6.3 million, or 49%, primarily as a result of
a 44% increase in vials sold, as well as a price increase which
took effect in mid-1995. Sales of the Company's second product,
RespiGam, amounting to $0.5 million, are expected principally
during the RSV season which typically occurs from November
through April. Contract revenue in the 1996 second quarter
decreased to $0.1 million from $3.6 million in the 1995 quarter,
reflecting the completion of milestone and research funding
payments under the Company's strategic alliance with American
Home Products ("AHP"), formerly American Cyanamid Company. Under
the terms of the alliance, the Company and AHP will share in the
profits or losses of RespiGam, sales for which commenced January,
1996; reimbursements or payments under this arrangement are
deducted from or added to operating expenses.
Cost of sales increased to $4.1 million in second quarter 1996
from $2.9 million in second quarter 1995 an increase of 40%.
This increase was primarily attributable to a 44% increase in
unit volume for CytoGam and the addition of cost of sales for
RespiGam, offset by a reduction in the royalty paid on CytoGam
sales in the 1996 period as a result of an amendment to the
agreement with Connaught Laboratories, Inc. ("Connaught")
Research, development and clinical spending was $6.8 million in
this year's quarter compared to $8.0 million in the 1995 quarter,
a decrease of 14%. Research and development expenses incurred in
1996 include costs of conducting the Company's MEDI-493 (RSV
monoclonal antibody) and MEDI-500 (T10B9) clinical trials, while
1995 expenses included the costs of conducting RespiGam Phase 3
clinical trials. The 1996 quarter also includes a $0.5 million
payment to Rockefeller University for a worldwide exclusive
license to commercialize Rockefeller's Streptococcus pneumoniae
technology. Selling, administrative and general expenses
increased to $4.2 million in this year's quarter versus $2.1
million in the 1995 quarter, an increase of 97%. This increase
was primarily a result of marketing expenses incurred for
RespiGam and the first full quarter of expenses associated with
the expanded sales force, partially offset by reimbursement from
AHP of their share of RespiGam product line loss for the quarter,
as well as a $0.6 million increase in general and administrative
expenses primarily due to charges of $0.4 million for costs
PAGE 5
incurred in connection with the Company's proposed manufacturing
facility.
Interest income of $1.2 million was earned in the 1996 second
quarter, compared to $0.4 million in the second quarter of 1995
reflecting higher cash balances available for investment,
partially offset by a decrease in interest rates which lowered
the overall portfolio yield. Interest expense of $0.1 million
was incurred in both the 1996 and 1995 quarters.
The net loss incurred in the 1996 second quarter of $7.0 million,
or $.33 per common share, compared to a net loss for the second
quarter of 1995 of $4.9 million, or $.32 per common share.
Shares used in computing loss per share were 21.4 million and
15.4 million for the 1996 and 1995 quarters, respectively.
These results were consistent with the Company's objectives for
the quarter and with the continued development of its
immunotherapeutic and vaccine products. Quarterly financial
results may vary significantly due to seasonality of RespiGam
product sales, fluctuation in sales of CytoGam, research funding
and expenditures for research, development and marketing
programs. RespiGam sales are expected to occur primarily during,
and in proximity to, the RSV season, which typically occurs
between November and April in the United States. In the third
and fourth quarters of 1996, the Company anticipates substantial
increases in research and development expenses, primarily
reflecting costs of MEDI-493 and MEDI-500 clinical trial
programs. Production capacity may impose constraints on finished
product availability of CytoGam and RespiGam.
SIX MONTHS ENDED JUNE 30, 1996 AND 1995
Total revenue for the six months ended June 30, 1996 was $18.4
million compared to $13.8 million in the 1995 first half. Sales
of CytoGam increased to $10.5 million in this year's first half
from $7.3 million in the 1995 period, reflecting a 37% increase
in units sold as well a price increase in mid-1995. RespiGam
sales were $3.0 million in the first half of 1996 following
receipt of marketing approval from the U. S. Food and Drug
Administration ("FDA") on January 18, 1996. Contract revenue in
the 1996 first half decreased to $4.9 million from $6.5 million
in the 1995 period, primarily reflecting funding provided under
the Company's strategic alliance with American Home Products.
Cost of sales in the 1996 first half rose to $8.1 million from
$5.5 million in the 1995 period, reflecting a 37% increase in
unit volume of CytoGam and the addition of cost of sales for
RespiGam. Cost of sales for both periods include the purchase of
certain finished product inventory from a third party at a higher
PAGE 6
per-unit cost in order to meet product demand due to supply
shortages. Research, development and clinical spending decreased
16% to $12.2 million in this year's first half versus $14.6
million in the 1995 period. Expenses in the 1996 period include
the costs of conducting MEDI-493 (RSV monoclonal antibody) and
MEDI-500 (T10B9) clinical trials. Expenses in the 1995 period
included the costs of Phase 3 RespiGam clinical trials. Selling,
administrative and general expenses increased to $8.6 million in
first half 1996 versus $4.7 million in first half 1995 primarily
reflecting costs of marketing RespiGam and the expansion of the
sales force, partially offset by AHP reimbursement of their share
of RespiGam product line loss. Administrative expenses for first
half 1996 included a charge of $0.4 million associated with the
Company's proposed manufacturing facility.
Interest income of $2.1 million was earned in the 1996 first
half, compared to $0.7 million in the first half of 1995,
reflecting higher cash balances available for investment,
partially offset by a decrease in interest rates which lowered
the overall portfolio yield. Interest expense of $0.1 million
was incurred in both the 1996 and 1995 periods.
The net loss incurred in the 1996 first half of $8.6 million, or
$0.42 per common share, compared to a net loss for the first half
of 1995 of $10.3 million, or $0.69 per common share. Shares used
in computing loss per share were 20.3 and 15.0 million for 1996
and 1995, respectively.
LIQUIDITY AND CAPITAL RESOURCES
Cash and marketable securities at June 30, 1996 were $81.1
million compared to $38.0 million at 1995 year end. Net cash
used in operating activities in the six months ended June 30,
1996 was $12.7 million, reflecting primarily the net loss for the
period, an increase in accounts receivable, and a $2.7 million
contractual payment to Connaught, offset by increased accruals
for clinical trial expenses. Capital expenditures of $3.1
million for the six months were primarily for lab equipment and
initial design of a new manufacturing facility. The Company
expects to invest approximately $56 million in expansion of its
pilot plant facility and on construction of a manufacturing
facility during 1996 and 1997. In February 1996, the Company
completed a public offering of 3.45 milion shares of common stock
resulting in net proceeds of $58 million. Additionally, on
July 8, 1996, the Company completed a convertible subordinated
note offering for net proceeds of $58.0 million. The 7% notes,
due 2003, will be used for the construction of the manufacturing
facility, the development pilot plant and general corporate
purposes.
PAGE 7
____________________
THE STATEMENTS IN THIS QUARTERLY REPORT THAT ARE NOT DESCRIPTIONS
OF HISTORICAL FACTS MAY BE FORWARD-LOOKING STATEMENTS. SUCH
STATEMENTS REFLECT MANAGEMENT'S CURRENT VIEWS, ARE BASED ON
CERTAIN ASSUMPTIONS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES,
INCLUDING BUT NOT LIMITED TO, FACTORS SUCH AS PRODUCT DEMAND AND
MARKET ACCEPTANCE RISKS, THE EARLY STAGE OF PRODUCT DEVELOPMENT,
COMMERCIALIZATION AND TECHNOLOGICAL DIFFICULTIES, CAPACITY AND
SUPPLY CONSTRAINTS AND OTHER RISKS DETAILED IN THE COMPANY'S
FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. ACTUAL
RESULTS COULD DIFFER MATERIALLY FROM THOSE CURRENTLY ANTICIPATED
AS A RESULT OF THE FOREGOING OR OTHER FACTORS.
PART II
OTHER INFORMATION
Item 1. Legal Proceedings - None
Item 2. Changes in Securities - None
Item 3. Defaults upon Senior Securities - None
Item 4. Submission of Matters to a Vote of Security Holders -
[Change in number of authorized shares]
Item 5. Other Information - None
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits:
10.57 Plasma Supply Agreement dated effective as
of February 8, 1996, by and between DCI Management
Group, Inc. and MedImmune, Inc.
10.58 License and Research Suport Agreement dated
as of April 16, 1996, between The Rockefeller
University and MedImmune, Inc.
(b) Reports on Form 8-K:
Report Date Event reported
4/18/96 MedImmune and Rockefeller University
Establish Collaboration to Discover
and Commercialize Products for
Prevention and Treatment of
PAGE 8
Streptococcus Pneumoniae
4/25/96 MedImmune Reports Product Sales
Increase 116% for Q1 1996
6/6/96 MedImmune Secured Broad Patent
Coverage for Human B19 Parvovirus
Vaccine
6/20/96 MedImmune Announces Proposed Private
Offering of Convertible Debt
MedImmune Reports Data on New Lyme
Disease Vaccine Candidate at
International Lyme Meeting -
Antibodies to Newly Discovered Decorin
Binding Protein Prevent Infection in
Animals
6/20/96 MedImmune In-Licenses Key Human
Papillomavirus Vaccine Intellectual
Property from German Cancer Research
Center
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.
MEDIMMUNE, INC.
(Registrant)
Date: August 14, 1996 /s/David M. Mott
President and
Chief Operating Officer
(Principal accounting and
financial officer)
PAGE 9
PORTIONS OF THE FOLLOWING DOCUMENT HAVE DELETED
DUE TO THE CONFIDENTIAL NATURE OF THE INFORMATION CONTAINED
THEREIN. SUCH DELETIONS ARE INDICATED AS FOLLOWS:
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
THE CONFIDENTIAL INFORMATION HAS BEEN FILED
SEPARATELY WITH THE COMMISSION
EXHIBIT 10.57
PLASMA SUPPLY AGREEMENT
This Plasma Supply Agreement, dated effective as of the
6th day of February, 1996 by and between DCI Management
Group,Inc., a New Mexico Corporation, c/o G.W. Matlin, 71 South
Bedford Road, Mount Kisco, New York, ("Supplier") and
Medimmune, Inc., a Delaware corporation with offices at 35
West Watkins Mill Road, Gaithersburg, Maryland 20878
("Purchaser").
WITNESSETH:
WHEREAS, Purchaser desires to purchase Source Plasma (as
defined by Title 21 CFR 600.01 et seq) from Supplier in
connection with a program requiring plasma with acceptable
neutralizing titers for respiratory syncytial virus (RSV)
(hereafter termed "Product"); and
WHEREAS, Supplier is willing to supply Purchaser's
requirements for Product, up to specified levels;
NOW THEREFORE, in consideration of the premises and of
the mutual covenants and agreements herein set forth, the
parties hereto agree as follows:
1.0 TERM AND RENEWAL
1.1 The initial term (the "Initial Term") of this
Agreement shall begin on the effective date noted above and
unless sooner terminated as provided herein shall continue
for a period of three (3) years from the date of this
Agreement. In anticipation of the parties extending this
Agreement beyond the Initial Term, the parties agree that
during the month of November, 1996 and annually thereafter
they shall meet for the purpose of negotiating volumes and
prices for the 12-month period three years into the future.
For example in November, 1996 the parties shall meet to
discuss volumes and prices for months 37-48.
2.0 PRODUCTS AND PRICES
2.1 Supplier shall supply to Purchaser for the Initial
Term, and any extension thereof, Product in accordance with
the specifications attached as Exhibit A hereto (hereafter
the "Specifications") .
2.2 During the first twelve months of this agreement,
Purchaser shall pay for Product purchased hereunder at a
price equal to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) per
liter of plasma, F.O.B. Louisville, KY or Aberdeen, MD, or any
destination in continental U.S. as directed by Purchaser. The
price for months 13-24 will be reviewed on or before November 1,
1996, and on or before November 1, 1997 for months 25-36 of the
contract. Based on existing plasma market prices for all
source plasma types in the domestic and international market
places there shall be a price increase each year. The minimum
increase of the price hereunder for each 12 month period
shall be the percentage change in the Consumer Price Index
(All Urban Consumers CPI-U/United States City Average/All
Items Indexed) over the previous twelve month period as
determined and published by the United States Department of
Labor/Bureau of Labor Statistics and the maximum shall be
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED). In no event shall
the price ever be less than the initial price hereunder. The
parties shall negotiate such price increase in good faith. If the
parties cannot agree by December 15th on a new price, each party
shall select a proposed price within the above parameters for
submission to an arbitrator who shall select one party's
proposal. The arbitrator shall be selected by the parties, and
the arbitration shall be conducted, according to the rules of the
American Arbitration Association, and the arbitrator's decision
shall be final and non-appealable. Each party shall pay its own
costs and expenses, including attorneys fees and costs incurred
in any proceedings in court to confirm the arbitration decision.
Pending the decision of the arbitrator, Purchaser shall pay one-
half of Supplier's proposed price increase per liter for each
liter of plasma purchased during the year and upon determination
by the arbitrator of the applicable price for such year the
parties shall promptly adjust their accounts retroactively,
including interest on the amount owed at the prime rate as
published daily in the Wall Street Journal (the "Prime Rate").
The actual price paid by Supplier for any tests required or
recommended by the US FDA or adopted by the Plasma Industry which
are not set forth in Section 5.2 shall be added to the agreed
upon price and shall not be considered as part of the price
increase for purposes of this Section. Such additional test costs
which may occur during any period where the price has already
been established shall automatically be added to the price per
liter effective on test implementation date. Supplier shall use
its best efforts to keep such cost to a minimum.
3.0 PAYMENT
3.1 Purchaser shall pay for Product at the price set
forth in Section 2.2 Terms of payment are net thirty (30)
days from date of shipment.
3.2 The price set forth in Section 2.2 includes
manufacturing, packaging, quality control and holding of
Product and does include the cost of shipment to the F.O.B.
point.
3.3 Each invoice will include the following details:
a) shipment number
b) cost per shipment
c) volume per shipment
d) bill of lading number of each shipment
e) center name
f) number of cartons
g) carton sequence
h) cost per liter
i) total volume
j) total cost for the invoice
4.0 ORDER AND DELIVERY
4.1 Supplier shall provide Purchaser (through
Purchaser's designee laboratory) at no cost to Purchaser
plasma samples in amounts and at times mutually agreed upon
by Purchaser and Supplier. In the event that a Plasmapheresis
center is supplying plasma for two (2) of the Purchaser's
plasma programs, the Supplier shall, as directed by the
Purchaser provide two (2) separate plasma samples, one for
each program to the same or different locations as designated
by Purchaser. These samples shall enable Purchaser to test
and identify plasma donors and/or plasma lots suitable for
producing Product for Purchaser in accordance with the
Specifications.
4.2 All sales of Product by Supplier to Purchaser
hereunder shall be subject to the provisions of this
Agreement and shall not be subject to the terms and
conditions contained in any purchase order of Purchaser or
confirmation of Supplier except insofar as any such purchase
order or confirmation establishes Product ordered or sold
thereunder and the delivery date and carrier thereof.
4.3 During the initial 24-month term of this Agreement
Purchaser shall accept all material from identified
acceptable RSV donors up to the following maximum volumes:
for the period covering months 1 thru 12 -(CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED); for the period covering months 13 thru 24 -
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)and for the period
covering months 25 thru 36- (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED). Notwithstanding the aforesaid, after the initial 24
month period if Purchaser determines that its total annual
volume needs of RSV plasma is less than the amount then
currently being supplied by Supplier, Purchaser shall notify
Supplier in writing of its anticipated total volume
requirement from all vendors for months 25-36 of the Initial
Term of the Agreement and in such event Supplier shall cease
sending new donor samples for screening to Purchaser's
laboratory in order to limit growth in RSV plasma production.
Purchaser however, shall continue to purchase all material
produced from previously approved donors for the period
covering months 25 thru 36 up to a maximum of(CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED). If at any time during the 25th -
36th months the average volume of plasma produced from previously
approved donors drops below (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED)of the needed total volume of material required by
Purchaser from all Suppliers, then in such event Supplier shall
resume sending samples of new donors plasma to Purchaser's
laboratory for testing and approval, and Purchaser shall accept
such RSV plasma from Supplier up to a level equal to
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of Purchaser's total
RSV annual volume requirements.If at any time during the initial
36-month period of thiscontract or any extension period Purchaser
is unable toproduce finished product from the RSV plasma being
suppliedas a result of U.S. Food and Drug Administration
suspension or revocation of Purchaser's license or Purchaser's
voluntary withdrawal of all finished product from the market
place,then in such event Purchaser may elect to suspend this
Agreement until such time as the production and sale of
finished product is reinstated provided Purchaser accepts and
timely pays for all RSV plasma from approved donors which
was drawn from donors prior to the date of the Food and Drug
Administration's suspension or revocation of Purchaser's
license or Purchaser's voluntary withdrawal of all finished
product from the market place. This paragraph shall not be
interpreted as in any way being in conflict with Section 16.0
of this Agreement.
4.4 Supplier shall arrange insured common carrier
transportation of Product to Purchaser's designated
destination. Such carrier shall be a qualified shipper of
perishable medical products and shall be approved in advance
by both Purchaser and Supplier. Title to and risk of loss of
Product shall pass to Purchaser at the time of delivery to
the carrier at the F.O.B. point. Supplier shall use its best
efforts to deliver quantities of the Product specified
herein, it being understood that Purchaser shall accept
Supplier's total RSV production from acceptable approved
donors during the initial period of this contract up to the
maximum herein before set forth sub section 4.3. Supplier's
failure to supply quantities of RSV plasma equal to
Purchaser's production needs or maximum volumes herein before
set forth shall not be deemed a breach of contract, it being
understood and agreed that the Supplier has no control over
the volume of RSV plasma to be collected at various
facilities. Supplier shall invoice Purchaser for Product no
earlier than the date of shipment.
4.5 Supplier shall schedule the timely shipment of
Product pursuant to Purchaser's requirements as established
by Purchaser in writing. For the purpose of this Agreement, a
timely shipment shall be a shipment that leaves the F.O.B.
point not later than two weeks after approval from Purchaser
to ship product. No shipment, however, shall be for less than
40 liters of material. It is also agreed that Supplier can
ship prior to receipt of shipping authorization from
Purchaser's designee laboratory; conditioned upon the
following:
A - Purchaser pays for material when units are
authorized. Supplier can bill without authorization if
authorization has not been received three (3) weeks from date
of shipment of samples.
B - Supplier will issue a credit memo to Purchaser for
any unauthorized units that are shipped in error.
4.6 Supplier shall supply Purchaser a list of all
centers covered by this Agreement. (Exhibit B) Supplier shall
have the right to add additional centers to said list with
prior written approval of Purchaser, so long as Purchaser is
not then currently purchasing plasma from said additional
centers.
5.0 QUALITY CONTROL
5.1 Supplier and its subcontractors and vendors shall
manufacture Product in accordance with the Specifications.
All plasma collection facilities shall be currently QPP
certified by the American Blood Resources Association.
5.2 Plasma shipments will be accompanied by a plasma
packing list that records for each unit shipped a unit
number, donor identification number, draw date, volume and
test results for HBsAg, ALT, Anti HIV I & II and Anti HCV. A
six-month "look back" program on Donors reactive to HBsAg and
Anti HIV I & II will remain in effect on all units shipped to
Purchaser. The tests used for screening plasma shipped to
Purchaser shall conform to the most current technology
available for use in the plasma collection industry and shall
conform to FDA requirements for such tests.
5.3 Supplier agrees that all Product supplied hereunder
and the manufacture and delivery thereof shall be in
compliance with all applicable laws and regulations (21 CFR
211.606 and 640).
5.4 Supplier shall provide Purchaser's Quality Control
Department with a reasonable number of production samples of
Product for QC testing by Purchaser.
5.5 All product manufactured and sold hereunder is
subject to Purchaser's inspection, prior to acceptance
pursuant to Section 6.1.
5.6 Purchaser shall have the right upon reasonable
advance notice during normal business hours to inspect each
facility at which Product is produced for the purpose of
observing production and quality control and inspecting all
documents applicable to manufacture, processing and holding
of Product. Such inspections shall be limited to a frequency
of no more than once every 12 months unless quality deviations
occur, in which case Purchaser shall have the right to
inspect more often. All source documents concerning
laboratory testing shall be retained in accordance with FDA
regulations and they shall be available for inspection by
Purchaser.
5.7 Purchaser and Supplier shall immediately notify
each other with respect to any "Look Back" and adverse Drug
Reaction Reports with respect to Acceptable Donors and
resulting Product.
6.0 ACCEPTANCE AND REJECTION
6.1 If upon receipt and inspection of Product by
Purchaser at the destination specified in the shipping
instructions, the shipment, or any portion thereof, does not
conform to the order or the Specifications, Purchaser shall
promptly notify Supplier of such condition and afford
Supplier a reasonable opportunity to inspect the Product and
make any appropriate adjustment or replacement. Supplier
shall complete the adjustment or replacement within sixty
(60) days of notification by Purchaser. The cost of any
replacement shall be at the sole expense of Supplier
including any return shipment or reshipment. During this
period and at all times prior to shipment by Supplier, plasma
is to remain stored at temperatures specified by FDA
regulations.
6.2 In the event Purchaser experiences an over supply
of Product resulting in excess inventory, upon reasonable
written request by Purchaser, Supplier shall use its best
efforts to assist Purchaser in selling such excess Product
through Supplier's existing distribution channels.
7.0 COLLECTION SITES
7.1 Supplier and Purchaser will determine by mutual
agreement the plasmapheresis locations which will provide
samples and/or plasma for the program herein mentioned.
Centers chosen will remain in the program until all Donors
from a center are removed from the program due to antibody
titer loss or the program comes to an end. Before admittance
to the program all centers must provide to the Purchaser a
completed Plasmapheresis Center Information Form, as supplied
by the Purchaser or Purchaser's designee laboratory. It is
agreed that no proprietary questions will be answered by
Supplier. In addition, it is agreed that a general company
overview can be utilized to answer questions that have the
same answers for all centers. It is understood and agreed
that the identification of donors by Purchaser as meeting
Purchaser's specification for production of RSV Hyperimmune
Globulin is proprietary information and that although
Supplier does not know Purchaser's exact specifications
Supplier is aware that once a donor has been identified as
meeting such specifications, such plasma could potentially be
sold to third parties for manufacture by such third parties
into RSV Hyperimmune Globulin. Accordingly, it is agreed that
supplier will not, during the term of this agreement and for
twelve months thereafter, knowingly sell plasma from any
approved donor identified by Purchaser as having RSV Antibody
to any other purchaser for the intended use by such other
purchaser in the manufacturing of RSV Hyperimmune Globulin.
8.0 TERMINATION
8.1 In addition to any other remedy it may have, either
party shall have the right to terminate this Agreement if the
other party fails to remedy and make good any material
default in the performance of any material condition or
obligation under this Agreement within sixty (60) days of
written notice thereof.
8.2 The failure of either party to terminate this
Agreement by reason of the breach of any of its provisions by
other party shall not be construed as a waiver of the rights
or remedies available for any subsequent breach of the terms
or provisions of this Agreement.
8.3 The exercise of one remedy by a party shall not
preclude such party from exercising additional remedies.
8.4 Upon termination of this Agreement, Purchaser must
pay for any Product already delivered.
8.5 Either party may terminate this Agreement effective
immediately upon giving notice of termination, if the other
party shall file a petition in bankruptcy, shall be
adjudicated as bankrupt, shall take advantage of the
insolvency laws of any state, territory or country, shall
make an assignment for the benefits of creditors, shall be
voluntarily dissolved, or shall have a receiver, trustee or
other court officer appointed for its property.
8.6 Purchaser further covenants and agrees that during
the term of this Agreement and any renewal or extension
period and for twelve (12) months thereafter, Purchaser shall
not, without the express written consent of Supplier
purchase any plasma of the same or similar specifications as
set forth in Exhibit "A" directly or indirectly from any
parties who have supplied such plasma to Supplier and which
Supplier sold to Purchaser. It is agreed and understood that
any breach by Purchaser of this covenant set forth in this
sub paragraph 8.6 shall cause irreparable harm to Supplier
and Supplier shall be entitled to obtain an injunction
against Purchaser in addition to any other legal or equitable
remedies available to Supplier.
9.0 WARRANTIES AND INDEMNIFICATIONS
9.1 Supplier warrants and represents that at the time
of shipment, Product covered by this Agreement shall conform
to the applicable Specifications and the other requirements
expressly set forth in this Agreement and that the Supplier
shall deliver Product to Purchaser free from claims or liens
of third parties that may affect title to the Product.
9.2 Purchaser shall indemnify and hold Supplier
harmless from any and all third party claims of disease
related liability arising from the use in manufacturing of
Product provided by Supplier, except those which result from
Supplier's negligence or willful misconduct. Supplier shall
promptly notify Purchaser of any such claims. Where Purchaser
acknowledges that the indemnification is applicable with
respect to such claims Purchaser shall control the defense,
settlement or compromise of any such claims.
10.0 NOTICES
10.1 Any and all notices permitted or required to be
given hereunder shall be sent by registered or certified
mail, postage and fees paid, with return receipts requested,
addressed as on the first page of this Agreement or at such
other address as to which a party gives notice under this
Section 10.1. Notice shall be deemed given as of the date of
mailing.
11.0 ASSIGNMENT
11.1 Neither party shall assign this Agreement in whole
or in part other than as part of the sale of all or
substantially all of its business assets without the prior
written consent of the other. Upon a permitted assignment,
all of the provisions of this Agreement and all rights and
obligations of the parties hereunder shall be binding upon
and inure to the benefit and be enforceable by the successors
and assigns of Supplier and Purchaser.
12.0 ENTIRE AGREEMENT
12.1 This Agreement, including the Exhibits attached
hereto constitutes the sole and entire Agreement between the
parties with respect to the sale of Product by Supplier to
Purchaser and may not be altered or modified except in
writing and signed by duly authorized officers of both
parties.
13.0 INDEPENDENT CONTRACTOR
13.1 In all activities under this Agreement, Supplier
shall act and be deemed an independent contractor with no
authorization to in any way obligate or bind Purchaser. This
Agreement shall not be deemed held or construed as creating a
copartnership between Supplier and Purchaser for any purpose
whatsoever.
14.0 SEVERABILITY
14.1 If any terms or provisions of this Agreement shall
be invalid or unenforceable, the remaining terms hereof shall
not be affected, but shall be valid and enforced to the
fullest extent permitted by law, unless such invalid or
unenforceable term or provision materially affects a party's
rights or expected rights under this Agreement.
15.0 HEADINGS
15.1 The headings used in this Agreement are intended
for guidance only and shall not be considered part of the
written understanding between the parties hereto.
16.0 FORCE MAJEURE
16.1 Neither party shall be liable for non-performance
caused by factors beyond that party's direct control, said
factors including but not being limited to:
(i) natural disasters or other "Acts of God";
(ii) riots, wars, or insurrection; or
(iii) actions of any governmental agency, including
rules, laws, orders, regulations and
restrictions.
17.0 APPLICABLE LAW
17.1 This Agreement shall be construed and enforced in
accordance with the law of the State of New York without
reference to choice of law principles.
IN WITNESS WHEREOF, the parties have caused this
Agreement to be executed by their duly authorized officers
as of the day and year first above written.
MEDIMMUNE, INC. DCI MANAGEMENT GROUP, INC.
BY: David M. Mott BY: Ira London
President Secretary
2/7//96 2/7/96
EXHIBIT A
SPECIFICATIONS FOR RSV SOURCE PLASMA
1. PURCHASER'S DESIGNEE
Plasma samples and plasma units are to be shipped for
screening and processing to such persons or entities
designated by Purchaser from time to time. Purchaser's
designee for receipt of plasma samples shall be the
Massachusetts Public Health Biologics Laboratory
(MPHBL). Purchaser shall notify Supplier in writing of
any change in such designee.
2. LICENSES
Supplier shall supply Medimmune and its designee with
documentation that each Source Plasma center of Supplier
selected by Supplier for producing Product is currently
licensed by the FDA for collection of Source Plasma
(i.e. copy of FDA license).
3. PLASMA SAMPLES
A 0.5 ml sample of plasma from each donation from donors
for whom Supplier seeks qualifications must be submitted
and received by Medimmune or its designee.
4. ACCEPTABLE RSV DONORS
Medimmune or its designee will advise Supplier of donor
acceptable for contributing to the RSV plasma supply
program ("Acceptable Donors") based on the donor's RSV
antibody titers. Acceptable Donors must also meet the
FDA requirements for Source Plasma. Acceptable Donors
will continue to remain acceptable based on their RSV
titers until Medimmune or its designee notifies Supplier
in writing that the donor is no longer acceptable.
Acceptable Donors shall be removed from the RSV program
immediately upon receiving such notification from
Medimmune or its designee. Plasma from Acceptable Donors
drawn up to the day after notification date will be
accepted.
5. ACCEPTABLE RSV PLASMA UNITS
All plasma drawn from Acceptable Donors (see item #4
above) will be accepted as long as the Donor remains an
Acceptable Donor and the plasma meets all FDA
requirements for Source Plasma. If a Donor becomes
unacceptable, all plasma units collected up to the day
after notification will be accepted but units drawn
after that date will not be accepted (see item #4
above). Before shipping plasma units, Supplier must send
a copy of the proposed "Plasma Packing List" (see item
#6 below) to Medimmune or its designee for verification.
6. LABELLING AND TESTING
Plasma shipments must be accompanied by a "Plasma
Packing List" that records for each unit shipped in
identification (i.e. "Control") number of the unit, a
donor identification number, signature of pheresis
center Manager, date plasma was drawn, volume and
results of the HBsAg, Anti HIV I & II and Anti HCV, and
ALT tests.
7. "LOOK BACK"
Purchaser must be informed of any donor becoming
positive for Anti HIV I & II or HBsAg, if plasma from
that donor has been shipped to Purchaser anytime during
the preceding 6 months, so the Purchaser can judge if
previous donations are acceptable for fractionation.
8. DELIVERY AND SHIPPING
A. Until Supplier is notified otherwise as
contemplated in item #1 above, plasma should be
shipped to:
Baxter Hyland Protein Control
4501 Colorado Blvd.
Los Angeles, CA 90039
B. Invoice should be sent to:
Medimmune, Inc.
35 West Watkins Mill Road
Gaithersburg, MD 20878
C. Plasma should be shipped frozen in suitable
containers so that the plasma is maintained at
temperatures specified by FDA regulations or
required for product integrity. The requirement for
product integrity of RSV is minus 20 degrees
Celsius.
D. Plasma is to be shipped in containers with
cardboard dividers. Each case will have a barcode
affixed on the outside of the carton. The exact
details of information on barcode will be mutually
agreed to.
E. DCI will provide Medimmune a copy of Bill of Lading
and Packing List for each unit within 48-hours of
shipment.
F. DCI will have management reports for Medimmune to
review material expected, material received,
material processed, and material cleared for
shipment. It is agreed that DCI and MedImmune's MIS
staff will review the best format for reports. DCI
and MedImmune will review the ability for MedImmune
to have access to certain data on the RSV computer
system. At a minimum the information required would
include, but not be limited to, the following data
which might be accessed either weekly, monthly or
quarterly: number of screens sent, number of donors
enrolled, number of units authorized, number of
units picked up/sent (broken down by shipment and
volume), number of new donors enrolled, number of
screens sent to enroll those donors, number of
donors dropped from the program, enrollment dates,
number of units sent since enrollment, date dropped
from the program, and number of units sent weekly,
monthly and/or quarterly. Data will be provided on
any kind of ASCii file, preferably, delimited, with
a standard output that is on PC accessible media.
It is agreed that all donor information is
confidential in addition, it is agreed that all
software design, including Data Base structures and
other proprietary information be confidential to
the extent that such information is not already in
Purchaser's possession or is not now hereafter
entered in the public domain, such information is
supplied only for Purchaser's internal use. At no
time can it be discussed with any Third Party
without prior written approval of Supplier.
9. The following are the procedures to cover all RSV
Plasma collected from approved donors.
A. DCI will send RSV confirm samples and paperwork for
complete cartons only. The samples will be sent
with an electronic packing form disk.
B. The cover sheet will be modified (example attached)
to indicate the number of cartons, individual
carton numbers, and total units from each
individual center.
C. Mass Laboratory will inspect each incoming sample
shipment and advise if the shipment was complete or
which units are missing sample tubes. There will be
a place on the coversheet for Mass Lab to confirm
the number of samples received from each center. If a
sample is missing, Mass will indicate in the space
provided, the details indicating which bleed is
missing a sample. It is understood that Mass has
agreed that it will confirm within three days from
receipt of the samples.
D. DCI will give its best effort to obtain the missing
sample and send it with the following weeks
confirmed samples package. It is agreed that the
packing list for the entire carton will be sent
with the sample. Mass has agreed to give their best
effort to release single unit shipments at the same
time as the entire lot.
E. Mass will advise DCI of any problem units within
any individual carton. DCI will arrange for the
corrected paperwork for the individual carton
involved to be faxed to Mass.
F. Within a two week period, it is Purchaser's and
Supplier's understanding Mass will issue to DCI
confirmation shipment verification. The
verification will reflect the details of the
original paperwork or the paperwork with any
changes that were required by Mass prior to
verification. We expect Mass to issue confirmation
by entire lots, same as they receive them,
confirmation including lot numbers.
G. DCI Centers will ship to Bio Med when confirmation
shipment verification is received. All paperwork
will be modified if required to remove any problem
units. The paperwork will be sent with shipping
disk the same as always. A copy of the Bill of
Lading will be included with paperwork.
H. All Nabi and contract centers will send in modified
paperwork to reflect any changes required by Mass
prior to receipt of verification. Upon verification
notice, DCI will submit corrected paperwork and
shipping disk to Mass. The actual shipment will not
leave the Queens Village warehouse until shipping
approval is received. It is Purchaser's and
Supplier's understanding that Mass will issue
shipping approval within a two week period after
date of shipment of samples to Mass. DCI may ship
and bill MedImmune if approval is not received
within the time period defined in section 4.5A of
the RSV Agreement.
EXHIBIT B
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
PORTIONS OF THE FOLLOWING DOCUMENT HAVE DELETED
DUE TO THE CONFIDENTIAL NATURE OF THE INFORMATION CONTAINED
THEREIN. SUCH DELETIONS ARE INDICATED AS FOLLOWS:
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
THE CONFIDENTIAL INFORMATION HAS BEEN FILED
SEPARATELY WITH THE COMMISSION
EXHIBIT 10-58
LICENSE AND RESEARCH SUPPORT AGREEMENT
AGREEMENT made as of the 16th day of April, 1996 by
and between MEDIMMUNE, INC. ("LICENSEE"), a corporation organized
and existing under the laws of the State of Delaware, having an
office at 35 West Watkins Mill Road, Gaithersburg, Maryland
20878, and THE ROCKEFELLER UNIVERSITY ("ROCKEFELLER") a nonprofit
education corporation organized and existing under the laws of
the State of New York, having an office at 1230 York Avenue, New
York, New York 10021.
W I T N E S E T H:
WHEREAS, ROCKEFELLER scientists have developed valuable
technology and know-how related to methods and compositions
for preventing and treating pneumococcal disease, which
technology is described and/or otherwise identified in this
Agreement and its attachments;
WHEREAS, ROCKEFELLER wishes to conduct a program of
continuing research in connection with such technology and is
willing to grant a license for a fair and reasonable remuneration
to the sponsor of such research, such license to cover both the
existing technology which is the initial subject matter of this
Agreement and to include an option to expand such license to
include any new inventions or improvements developed in the
course of such continuing research sponsored by the LICENSEE
pursuant to the provisions of this Agreement; and
WHEREAS, LICENSEE wishes to obtain such license and
option rights and to sponsor the research program proposed by
Rockefeller, all in the manner and subject to the term,
conditions and understandings described herein;
NOW, THEREFORE, the Parties hereto agree as follows:
1. DEFINITIONS
The following terms will have the meanings assigned
to them below when used in this Agreement.
1.1 "PARTY" shall mean either LICENSEE or ROCKEFELLER
and "PARTIES" shall mean both COMPANY and LICENSEE.
l.2 "LICENSED PATENT RIGHTS" shall mean
(a) all patent application(s) concerning the
subject matter of this Agreement which are listed on Exhibit "A"
attached hereto and all patents which may issue thereon;
(b) any patent and patent application covering
any New Invention(s) defined below as to which the LICENSEE shall
have exercised its option rights provided for in Paragraphs 2.5
and 4.2 of this Agreement; and
(c) all patent applications which are divisions,
continuations, continuations-in-part, reissues, renewals, foreign
counterparts, extensions or additions of the patents and
applications described in (a) and (b) hereof, and all patents
which may issue thereon.
1.3 "NEW INVENTION(S)" shall mean all invention(s)
made in the course of the Research Project, which inventions(s)
are made by ROCKEFELLER faculty members, employees, agents or
others working under ROCKEFELLER'S control, whether patentable or
not.
1.4 "TECHNICAL INFORMATION" shall mean the technical
data, information, materials and know-how owned by ROCKEFELLER
and existing in a tangible form, at the date of this Agreement
arising from the laboratories of DRS. ELAINE TUOMANEN and/or
ROBERT MASURE at Rockefeller as set forth in Exhibit "A" or
developed in the course of the RESEARCH PROJECT sponsored by
LICENSEE hereunder, and which is needed in the practice of
LICENSED PATENT RIGHTS.
1.5 "RESEARCH PROJECT" shall mean the program of
research to be conducted by DRS. ELAINE TUOMANEN and ROBERT
MASURE referred to in Paragraph 2 of this Agreement and described
in further detail in Exhibit "B" attached hereto or in any
amendment thereof that may be agreed to by the Parties, and which
is sponsored by LICENSEE pursuant to the provisions of this
Agreement.
1.6 "BUDGET" shall mean the budget for the RESEARCH
PROJECT provided for in Paragraph 2.2 of this Agreement.
1.7 "TERRITORY" shall mean the entire world.
1.8 "PRODUCTS" shall mean any and all Products, the
manufacture, use or sale which is or later becomes covered by a
valid claim of LICENSED PATENT RIGHTS.
1.9 "NET SALES" shall mean all gross revenues
recognized in accordance with generally accepted accounting
principles from the sale of PRODUCTS by LICENSEE or any
sublicensee of LICENSEE, less only returns and allowances
actually paid or allowed, including, but not limited to, prompt
payment and volume discounts, charge-backs from wholesalers and
other allowances granted to customers or wholesalers of the
PRODUCT, whether in cash or trade, freight packing, insurance,
rebates, and sales and other taxes based on sales prices when
deducted from the gross amount actually received by the selling
company, but not including taxes when assessed on income or gross
receipts derived from such sales.
1.10 "EFFECTIVE DATE" shall mean the date on which this
Agreement has been executed by both PARTIES.
1.11 "VALID CLAIMS" shall mean a claim of an issued
patent which has not lapsed or become abandoned or been declared
invalid or unenforceable by a court of competent jurisdiction or
an administrative agency from which no appeal can be or is taken.
1.12 The term "AFFILIATE" as applied to LICENSEE shall
mean any company or other legal entity other than LICENSEE in
whatever country organized, controlling or controlled by
LICENSEE. The term "control" means possession, of the power to
direct or cause the direction of the management and policies
whether through the ownership of voting securities, by contract
or otherwise.
2. RESEARCH PROJECT
2.1 The RESEARCH PROJECT consists of a program of
research described in Exhibit "B" to be conducted by DRS. ELAINE
TUOMANEN and ROBERT MASURE and their colleague scientists at
ROCKEFELLER. The RESEARCH PROJECT may be modified by written
agreement of the PARTIES. The PARTIES agree to cooperate with
each other to the extent that they are reasonably able to do so
in providing access to needed gene sequences of S. pneumoniae as
soon as they become available to LICENSEE, needed reagents and
similar materials as well as in the continuing review, redesign
and/or redirection of the RESEARCH PROJECT, and will keep each
other currently advised of the progress and results thereof
during the period of sponsored research. The RESEARCH PROJECT is
initially envisioned to be carried out over a three-year period.
The PARTIES contemplate its renewal for an additional two-year
period but only by mutual written consent.
2.2 LICENSEE agrees to provide funding to
ROCKEFELLER for the RESEARCH PROJECT in accordance with the
following BUDGET:
Funding for the RESEARCH PROJECT shall be payable
by LICENSEE to ROCKEFELLER quarterly in advance, in the amount of
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) per year for each of
the three (3) years initially contracted for (which annual amount
includes overhead), with the direct cost to increase
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)each year (i.e.,
second year and beyond).
2.3 DRS. ELAINE TUOMANEN and ROBERT MASURE will be the
Principal Investigators of the RESEARCH PROJECT and shall have
full and complete control over the conduct and direction thereof.
In the event that DRS. ELAINE TUOMANEN and ROBERT MASURE should
leave ROCKEFELLER, or be unable or unwilling, for any reason, to
continue with the RESEARCH PROJECT before its completion,
ROCKEFELLER may propose one or more new Principal Investigators
for LICENSEE'S consideration. If LICENSEE does not wish to
continue the RESEARCH PROJECT under such circumstances, it may
terminate its commitment for further research support, subject
only to payment of any pro rated amount of the BUDGET that may be
due up to the date of DRS. ELAINE TUOMANEN and ROBERT MASURE'S
cessation of involvement in the RESEARCH PROJECT.
2.4 The Principal Investigator or another RESEARCH
PROJECT Investigator designated by the Principal Investigator
will supply LICENSEE with a reasonably detailed written report
periodically as agreed between the Principal Investigators and
the LICENSEE during the term of the sponsored RESEARCH PROJECT.
Subject only to their terms of Paragraphs 2.6 and 2.7 herein,
LICENSEE shall have the unrestricted right to use all results and
data from the RESEARCH PROJECT for any purpose and in its
internal research programs or in required governmental reports,
without prior written approval of ROCKEFELLER.
2.5 ROCKEFELLER agrees that any NEW INVENTIONS made in
the course of the RESEARCH PROJECT shall be promptly disclosed by
ROCKEFELLER to LICENSEE, and the LICENSEE shall have the option
to acquire an exclusive license to such NEW INVENTIONS, in the
manner set forth in Paragraph 4.2 below.
2.6 ROCKEFELLER and LICENSEE recognize the traditional
freedom of all scientists to publish and present promptly the
results of the RESEARCH PROJECT. ROCKEFELLER and LICENSEE also
recognize that exclusive patent rights can be jeopardized by
public disclosure prior to the filing of suitable patent
applications. Therefore, ROCKEFELLER agrees that each proposed
publication, before submission to a publisher, will be submitted
to LICENSEE for review in connection with preservation of
exclusive patent rights. COMPANY shall have thirty (30) days in
which to review each publication, which may be extended for an
additional thirty (30) days when LICENSEE provides substantial
and reasonable need for such extension. By mutual agreement,
this period may be further extended for not more than an
additional three (3) months. When requested by ROCKEFELLER in
advance, LICENSEE, at its discretion, may allow for simultaneous
submission of the publication to the publisher. Any publication
by LICENSEE personnel will also be subject to similar pre-review
by ROCKEFELLER before publication. Scientists at both
ROCKEFELLER and LICENSEE will be expected to treat matters of
authorship in a proper collaborative spirit, giving credit where
it is due and proceeding in a manner which fosters cooperation
and communication, but will not to do anything in this regard
which will jeopardize the issuance of a valid patent.
2.7 ROCKEFELLER and LICENSEE agree to hold in
confidence all information received from the providing party
which is identified as confidential or proprietary information,
and agree not to disclose it to any third party or use it for any
purpose except as provided herein. The foregoing restrictions on
use and disclosure shall not apply to any such information which:
(a) is or later becomes generally available to
the public by use, publication or the like, through no fault of
the other PARTY; or
(b) is obtained from a third party who had the
legal right to disclose the same to the PARTY; or
(c) the PARTY already possesses, as evidenced by
its written records, predating receipt thereof from the other
PARTY; and
such restrictions shall survive termination of this Agreement.
Notwithstanding the foregoing, LICENSEE shall have the
right to disclose Confidential Information of ROCKEFELLER to a
third party who undertakes an obligation of confidentiality and
non-use with respect to such information, at least as restrictive
as LICENSEE'S obligation under this Section.
2.8 During the period which Licensee is funding the
RESEARCH PROJECT under this Agreement, the Principal Investigator
may not seek or accept funding from a commercial sponsor using
any information or materials developed or expected to be
developed in the RESEARCH PROJECT.
2.9 (a) During the period in which LICENSEE holds a
license, ROCKEFELLER and Principal Investigator shall not,
without LICENSEE'S prior written approval, distribute or
knowingly allow Materials developed in the RESEARCH PROJECT
("Materials") to be distributed to for-profit entities or persons
known to be employed thereby or consulting or performing research
therefor other than under a license permitted under this
Agreement.
(b) ROCKEFELLER and Principal Investigator shall
have the right to transfer Materials to not-for-profit entities
or persons known to be affiliated therewith provided that such
entities or persons sign the Material Transfer Agreement set
forth as Exhibit "C".
3. PATENTS
3.1 Prior Patent Expenses: Within five (5) business
days following the execution of this Agreement, LICENSEE shall
reimburse ROCKEFELLER for all unreimbursed out-of-pocket amounts
expended by ROCKEFELLER, prior to the date hereof for the
preparation, filing, prosecution and maintenance of LICENSED
PATENT RIGHTS being licensed to LICENSEE pursuant to Paragraph
4.1 of this Agreement, said amount being(CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED).
3.2 LICENSEE shall promptly decide whether or not it
wishes ROCKEFELLER to file U.S. and/or foreign patent
applications on any NEW INVENTION which may be patentable.
ROCKEFELLER shall select qualified independent patent counsel to
file and prosecute any such NEW INVENTION applications, including
divisionals, continuations, continuations-in-part, reissues, and
corresponding foreign applications. LICENSEE shall bear the
reasonable cost of filing, prosecution, and maintenance of each
such NEW INVENTION application to which LICENSEE has exercised
its option provided in Paragraphs 2.5 and 4 hereof.
3.3 ROCKEFELLER shall arrange for LICENSEE
representatives to meet with patent counsel at a reasonable
time(s) and place(s). Upon request, ROCKEFELLER shall promptly
deliver to LICENSEE copies of any patentability search reports
made by patent counsel including any patents located, a copy of
each Project Patent application, and a copy of each Project
Patent that issues thereon.
3.4 LICENSEE shall promptly advise ROCKEFELLER of any
decision not to continue to finance the filing, prosecution, or
maintenance of any LICENSED PATENT RIGHTS in adequate time to
allow ROCKEFELLER, at its own cost, to effectuate such filing,
prosecution, or maintenance if it so desires; and shall, at the
request of Rockefeller, take whatever steps may be necessary to
return to ROCKEFELLER all rights which LICENSEE may have thereto.
Nothing herein is intended or shall be construed as obligating
ROCKEFELLER to apply for any U.S. or foreign patent at its own
expense, or to defend, enforce, or support any LICENSED PATENT
RIGHTS against any third party.
4. LICENSE
4.1 ROCKEFELLER grants to LICENSEE, an exclusive
license, including the right to grant sublicenses, under LICENSED
PATENT RIGHTS and TECHNICAL INFORMATION, for the full term of any
patent issuing thereon, said exclusive license being a license to
make, have made, use and sell PRODUCTS in any country of the
TERRITORY, except to the extent that ROCKEFELLER'S right to do so
may be subject to the provisions of
35 United States, Section 20l et seq.,
and regulations and rules promulgated
thereunder and any agreements implementing
the provisions of such Federal Laws and
regulations and rules,
none of which prevent the grant of the license herein described.
4.2 ROCKEFELLER grants to LICENSEE the exclusive right
and option to add to the exclusive license granted in Paragraph
4.1, any NEW INVENTIONS. LICENSEE may exercise such option by
notice in writing to ROCKEFELLER, at any time within three (3)
months of receipt by LICENSEE of a written invention disclosure,
which may be extended by an additional three (3) months when
LICENSEE provides a reasonable basis for such extension. In the
event that LICENSEE does not exercise such right and option with
respect to a particular NEW INVENTION within the period
specified, ROCKEFELLER shall be free to license such New
Invention to a third party or parties.
4.3 LICENSEE'S license shall continue until the last
to expire LICENSED PATENT RIGHT, after which LICENSEE shall have
a fully paid up, non-cancelable license.
Nothing herein is intended or shall be construed as
obligating ROCKEFELLER to file or maintain any U.S. or foreign
patents at its own expense, or to defend, enforce, or support any
patent or patent applications which may be included in LICENSED
PATENT RIGHTS to which it has granted license right to LICENSEE;
provided, however, that ROCKEFELLER will cooperate with LICENSEE
in its activity in applying for U.S. or foreign patents or in the
defense or enforcement of LICENSED PATENT RIGHTS.
Nothing herein is intended or shall be construed as
obligating LICENSEE to maintain its license with respect to any
patent or application licensed hereunder and to finance the
preparation, filing, prosecution or maintenance of any patent
application in any country or jurisdiction in which it believes
it is not in the best business interest of LICENSEE to do so.
4.5 LICENSEE, or any Affiliate or Sublicensee of
LICENSEE, shall have the right but not the obligation to
institute patent infringement proceedings against third parties
based on any LICENSED PATENT RIGHTS licensed hereunder.
ROCKEFELLER agrees to give Notice to LICENSEE promptly, in
writing, of each infringement of LICENSED PATENT RIGHTS of which
ROCKEFELLER is or becomes aware during the term of this
Agreement. If LICENSEE does not institute infringement
proceedings against such third parties, ROCKEFELLER shall have
the right, but not the obligation, to institute such proceedings
within thirty (30) days of Notice of its intention to commence
such proceedings given to LICENSEE, in writing, and provided that
LICENSEE does not, within such thirty (30) day period, institute
its own proceedings. The expenses of such proceedings, including
lawyers' fees, shall be borne by the PARTY instituting suit. The
PARTY instituting suit shall have the right to select counsel to
conduct the suit. Each PARTY shall execute all necessary and
proper documents and take all other appropriate action, including
but not limited to being named as a participating party, to allow
the other PARTY to institute and prosecute such proceedings. Any
award paid by third parties as a result of such proceedings
(whether by way of settlement or otherwise) shall first be
applied toward reimbursement for the legal fees and expenses
incurred, and the excess, if any, shall be shared on a pro rata
basis based on the expenses incurred by each PARTY.
5. ROYALTIES AND OTHER LICENSE CONSIDERATION
5.1 As further consideration for the license grant
provided in Paragraph 2.1, Licensee agrees to pay ROCKEFELLER the
following amounts in the nature of royalties:
(a) Initial License Fee: A one-
time non-refundable payment of (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED) shall be due
and payable upon the execution of this
Agreement
(b) Royalties on Net Sales of
Products, as follows:
(i) For NET SALES of
PRODUCTS up (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED) in any calendar year a
royalty at the rate of (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED) of NET
SALES; and
(ii) For NET SALES of
PRODUCTS in excess thereof, a royalty
at the rate of (CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED) of NET SALES
The obligation to pay royalties hereunder is
imposed only once with respect to the sale, lease or disposition
of PRODUCTS regardless of the number of Valid Claims which cover
such PRODUCTS. Additionally, there shall be no obligation to pay
royalties on the sale, lease or disposition of PRODUCTS by
LICENSEE to its AFFILIATES or sublicensees for resale, but in
such instances, the obligation to pay royalties shall arise upon
the sale by its LICENSEES, AFFILIATES or sublicensees to
unrelated third parties.
In the event that LICENSEE is required to pay
royalties to a third party(s) for a PRODUCT covered by claims of
the license herein granted, (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) of such royalties payable to such third party(s) will
be creditable against royalties owed to ROCKEFELLER hereunder.
In no event, however, will ROCKEFELLER'S royalty be reduced by
more than (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) of that
provided hereunder.
(c) Milestone payments as follows:
(i) (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED) payable
within sixty (60 days of the first
approved submission of an IND in any
country of the TERRITORY on a PRODUCT,
(ii) (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED) payable
within sixty 60 days of the start of the
first Phase III clinical trial in any
country of the TERRITORY,
(iii) (CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED) payable
within sixty (60) days of the first FDA
approval or its equivalent in any country
of the TERRITORY on a PRODUCT.
5.2 Upon commencement of NET SALES of PRODUCTS which
generate a royalty to the ROCKEFELLER pursuant to this Agreement,
LICENSEE shall, within sixty (60) days of the close of the
calendar quarter in which such Net Sales begin, make quarterly
reports to the ROCKEFELLER indicating the total NET SALES of
PRODUCTS in the quarter and the calculation of royalties due
thereon. Any royalty then due and payable shall be included with
such report.
LICENSEE'S records shall be open to inspection by
the ROCKEFELLER or a certified public accountant designated by
the ROCKEFELLER, at reasonable times, and from time to time (but
no more than once each calendar year), for the sole purpose of
verifying the accuracy of the reports and the royalty payments.
ROCKEFELLER shall bear the costs of such inspection unless the
inspection establishes an error in the ROCKEFELLER'S favor of
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) or more of the amount
payable for the period of inspection.
5.3 LICENSEE agrees to provide to ROCKEFELLER
periodically, but no more frequently than annually, which
progress in research and development involving the LICENSED
TECHNOLOGY and regulatory approvals, manufacturing and
sublicensing information.
6. PUBLICITY
LICENSEE will not use ROCKEFELLER'S name or the
name of any member of its faculty or its staff for any public,
commercial or advertising purposes without the prior written
approval of the ROCKEFELLER and faculty or staff member involved;
provided, however, that it is expressly agreed that LICENSEE may
reveal or identity ROCKEFELLER or any member of its faculty or
staff as the inventor, source or origin of any Technology,
TECHNICAL INFORMATION or any PRODUCT or process for its own
internal records or in any disclosures or filings required by
governmental law or regulation.
7. PRODUCT LIABILITY
(a) LICENSEE agrees to indemnify and hold
harmless ROCKEFELLER and its trustees, officers, agents, faculty,
employees, and students from any and all liability arising from
injury or damage to person or property resulting directly or
indirectly from LICENSEE'S use, manufacture, or sale of any
PRODUCT covered by any Licensed Patent Rights or Technical
Information. LICENSEE further agrees to obtain and maintain in
force product liability and comprehensive general liability
insurance against any claims or expenses for which it is
obligated to indemnify as provided above in amounts not less than
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) per incident and
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) annual aggregate.
The policies representing such insurance shall specify
ROCKEFELLER as named insured.
(b) LICENSEE'S indemnification under (a) shall
not apply to any liability, damage, loss or expense to the extent
that it is directly attributable to the negligent activities or
intentional misconduct of the Indemnitees.
(c) LICENSEE shall have the right to control the
defense, settlement or compromise of any such action.
(d) ROCKEFELLER shall promptly give the LICENSEE
Notice of any claim asserted or threatened on the basis of which
the Party giving such Notice intends to seek indemnification from
LICENSEE as herein provided and shall fully cooperate with all
reasonable requests of LICENSEE in the respect thereto.
8. TERMINATION
8.1 The licenses herein granted shall continue for the
full term of any patents licensed hereunder as the same or the
effectiveness thereof may be extended by any governmental
authority, rule or regulation applicable thereto.
8.2 Either PARTY may terminate this Agreement in the
event of a material breach by the other PARTY, provided only that
the breaching PARTY is given Notice of the breach and a
reasonable time, not to exceed thirty (30) days, in which to cure
such breach, excepting, however, that the failure of LICENSEE to
meet any payment of laboratory support provided for in Paragraph
2 hereof (or for any further term that may be agreed upon by the
Parties) shall be deemed a material breach for which LICENSEE
shall have but ten (10) days to cure or automatically forfeit all
license rights hereunder and remain liable for damages for breach
of contract.
8.3 ROCKEFELLER agrees that in the event this
Agreement and/or the rights and licenses granted under this
Agreement to LICENSEE are terminated, any sublicense granted
under this Agreement, which provides for royalty rates payable to
ROCKEFELLER at least equal to those provided for in Paragraph
5.1(b), shall remain in full force and effect as a direct license
between ROCKEFELLER and the sublicensee under the terms and
conditions of the sublicense agreement, subject to the
sublicensee agreeing to be bound to ROCKEFELLER under such terms
and conditions within thirty (30) days after ROCKEFELLER provides
written notice to the sublicensee of the termination of
LICENSEE'S rights and licenses under this Agreement. At the
request of LICENSEE, ROCKEFELLER will acknowledge to a
sublicensee, ROCKEFELLER'S obligations to the sublicensee under
this Agreement.
9. TIMES AND CURRENCIES OF PAYMENT
9.1 Royalty payments shall be made in United States
Dollars or, if sales are made in the currency of other countries,
royalties shall be calculated in the currency of such other
country and be converted into United States Dollars using the
applicable exchange rate published in The Wall Street Journal on
the last day of the applicable reporting period.
9.2 If at any time, legal restrictions prevent the
prompt remittance of part or all royalties by Licensee with
respect to any country where a PRODUCT is sold, LICENSEE shall
have the right and option to make such payment by depositing the
amount in local currency to ROCKEFELLER'S account in a bank or
other depository in such country.
10. NOTICES
Any Notice required to be given pursuant to this
Agreement shall be made by personal delivery or, if by mail, then
by registered or certified mail, return receipt requested, with
postage and fees prepaid, by one PARTY to the other PARTY at the
addresses noted below, or to such other address as such PARTY may
designate in writing from time to time to the other PARTY.
In the case of the LICENSEE, Notice should be sent to:
MedImmune, Inc.
35 West Watkins Mill Road
Gaithersburg, Maryland 20878
Attention: CEO
In the case of ROCKEFELLER, Notice should be sent to:
The Rockefeller University
1230 York Avenue
New York, New York 10021
Attention: Office of the General Counsel
11. ASSIGNMENT; SUCCESSORS
This Agreement shall not be assignable by either of the
parties without the prior written consent of the other party
(which consent shall not be unreasonably withheld), except that
LICENSEE without the consent of ROCKEFELLER may assign this
Agreement to an AFFILIATE or to a successor in interest or
transferee of all or substantially all of the portion of the
business to which this Agreement relates.
11.2 Subject to the limitations on assignment herein,
this Agreement shall be binding upon and inure to the benefit of
said successors in interest and assigns of LICENSEE and
ROCKEFELLER. Any such successor or assignee of a party's
interest shall expressly assume in writing the performance of all
the terms and conditions of this Agreement to be performed by
said party and such Assignment shall not relieve the Assignor of
any of its obligations under this Agreement.
12. GOVERNING LAW
This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, without regard
to choice of law principles.
13. FURTHER ACTION
At any time and from time to time, each PARTY
agrees, without further consideration, to take such actions and
to execute and deliver such documents as may be reasonable
necessary to effectuate the purposes of this Agreement.
14. SEVERABILITY
If any provision of this Agreement is invalid, illegal,
or unenforceable, the balance of this Agreement shall remain in
effect, and if any provision is inapplicable to any person or
circumstance, it shall nevertheless remain applicable to all
other persons and circumstances.
15. 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.
16. FORCE MAJEURE
The PARTIES shall not be liable in any manner for
failure or delay in fulfillment of all or part of this Agreement,
directly or indirectly caused by acts of God, governmental order
or restrictions, war, war-like condition, revolution, riot,
looting, strike, lockout, fire, flood or other similar or
dissimilar causes or circumstances beyond the non-performing
PARTY'S control. The non-performing PARTY shall promptly notify
the other PARTY of the cause or circumstance and shall recommend
its performance of its obligations as soon as practicable after
the cause or circumstance ceases.
17. ENTIRE UNDERSTANDING
This Agreement, together with the Exhibits hereto and
the concurrently executed Agreement constitute the entire
agreement between the PARTIES with respect to the subject matter
hereof, supersedes all prior understanding and agreement by the
PARTIES with respect to the subject matter hereof and may be
modified only by written instrument duly executed by each PARTY.
IN WITNESS WHEREOF, the parties have caused this
Agreement to be duly executed as of the day and year first above
written.
MEDIMMUNE, INC.
By: David M. Mott
President
THE ROCKEFELLER UNIVERSITY
By: William H. Griesar
Vice President and General Counsel
EXHIBIT A
Patent, Patent Applications and
KNOW-HOW TECHNOLOGY
EXHIBIT A-1
TITLE INVENTORS SERIAL NO.
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
BACTERIAL EXPORTED H. Robert Masure, PCT/94/09942
PROTEINS AND ACELLULAR Barbara J. Pearce and (EP,AU,CA,FI,JP,NO,
VACCINES BASED THEREON Elaine Tuomanen NZ, US)
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
EXHIBIT A-2
TITLE INVENTORS SERIAL NO.
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
EXHIBIT A-3
Pneumococcal genes of importance to disease and drug
discovery
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
EXHIBIT B
RESEARCH PROGRAM
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
EXHIBIT C
MATERIAL TRANSFER AGREEMENT
THIS MATERIAL TRANSFER AGREEMENT ("Agreement") is entered
into by and between The Rockefeller University, 1230 York Avenue,
New York, New York 10021-6399 ("ROCKEFELLER") ________________
("Institution").
Whereas, Rockefeller and MedImmune, Inc. ("MI") have entered
into a License Agreement dated April __, 1996 under which
ROCKEFELLER has exclusively licensed to MI rights in Materials
(defined below) and technology based on Materials;
Whereas, Rockefeller is willing to provide to you
Rockefeller's proprietary ________________ and mutually agreed
additional materials (collectively "Material") in accordance with
the following terms:
Research Program. Institution shall undertake a research program
("Research Program") as described in Appendix A. Institution
agrees that the Research Program shall be conducted by or under
the direct supervision of ______________ ("Investigator"). The
Research Program may be modified, upon mutual written agreement
of Rockefeller and Institution.
Reports. Institution shall furnish Rockefeller with a final
written report summarizing the results of the Research Program
within thirty (30) days of completion of the Research Program or
termination of this Agreement. The final report will be sent to
the person at Rockefeller who sent the Material or a designee
thereof at Rockefeller. Rockefeller and MI shall have the
unrestricted right to utilize all data and information developed
under the Research Program in internal research.
Research Materials. In consideration of the services provided by
institution and the rights obtained by Rockefeller and MI under
this Agreement, Rockefeller shall provide Investigator with
mutually agreed upon quantity of the Material. The Materials and
all other materials arising out of the conduct of the Research
Program ("Program Materials") shall be used for the sole purpose
of conducting the Research Program. Any Material or Program
Materials remaining upon conclusion of this Agreement shall be
returned to Rockefeller or at Rockefeller's option, destroyed,
within thirty (30) days following completion of the Research
Program or termination this agreement, or upon request of
Rockefeller prior to the completion of the Research Program.
Institution shall not provide either Materials or Program
Materials to any third party without the prior written approval
of Rockefeller.
Confidentiality. For the term of this Agreement, and any
subsequent extension, and for a period of five (5) years
thereafter, Institution will not use, except as necessary for
purposes of the Research Program, or disclose or provide to any
third party without the prior written consent of Rockefeller any
Confidential Information. For purposes of this Agreement,
"Confidential Information" means all information, reagents,
procedures, results, conclusions, and the like which are
disclosed or provided to Institution by Rockefeller in connection
with the Research Program. Institution shall have no obligation
with respect to any portion of such Confidential Information
which:
(a) is or later becomes generally available to the public
by use, publication or the like, through no fault of
Institution; or
(b) is obtained from a third party who had the legal right
to disclose the same to Institution; or
(c) Institution already possesses, as evidenced by its
written records, predating receipt thereof from
Rockefeller; or
(d) was information that Institution believes in good faith
is required to be disclosed to comply with any
applicable law, regulation or order of a government
authority or court of competent jurisdiction, in which
event Institution shall use all reasonable efforts to
advise Rockefeller in advance of the need for such
disclosure.
Publications. Institution shall submit all scientific articles,
manuscripts, abstracts, and posters or summaries of any oral
presentations relating to the Research Program to Rockefeller
thirty (30) days prior to submission for publication or
presentation. Rockefeller shall have thirty (30) days to review
and comment on each proposed presentation or publication.
Institution shall delete any Confidential Information and
postpone publication or presentation for up to forty-five (45)
days upon request by Rockefeller in order to allow appropriate
patent applications to be filed. These periods can be extended
by mutual agreement of the parties.
Intellectual Property. Any inventions or discoveries made in
performance of the Research Program solely by Investigator and/or
any other personnel affiliated with institution ("Sole
Inventions"), will belong to Institution. Institution shall have
the right to obtain patent protection for Sole Inventions, at its
expense. Any inventions or discoveries made in performance of
the Research Program jointly by Investigator and/or other
personnel affiliated with Institution and by Rockefeller's
employees or affiliated personnel (collectively, "Joint
Inventions"), shall belong jointly to Institution and
Rockefeller. Rockefeller shall have the right to obtain patent
protection for any Joint Inventions involving Rockefeller
personnel, at its expense, unless otherwise agreed upon by
Rockefeller. Institution shall promptly notify Rockefeller of
all inventions and discoveries developed as a result of the
Research Program.
Rockefeller and MI shall have an exclusive option for the term of
this Agreement and one (1) year thereafter to obtain an exclusive
worldwide license, with the right to sublicense, for any such
patent application, or patent issued thereon, filed for Sole
Inventions and/or for Institution's interest in Joint Inventions.
The license shall be negotiated in good faith by the parties and
provide for appropriate compensation to Institution. In the
event the parties fail to reach a mutually acceptable licensing
arrangement within one hundred eighty (180) days after commencing
negotiations, Institution shall grant to MI a royalty-free non-
exclusive license under any Sole Invention and thereafter
Institution shall be entitled to negotiate in good faith with a
third party for a license to any patent application or patent on
Sole Inventions or Institution rights in Joint Inventions.
Warranty. Institution warrants that it is permitted to enter
into this Agreement and that this Agreement is not inconsistent
with other contractual arrangements of Institution.
Term. The term of this Agreement shall be for a period of one
(1) year from the date of execution of this Agreement, unless
extended by written agreement between the parties. Any rights or
obligations set forth herein which of their nature are intended
to extend beyond the termination of this Agreement including but
not limited to the confidentiality and option provisions, shall
survive any such termination.
Indemnification. Institution agrees to indemnity, defend, and
hold Rockefeller harmless from any liability (including
attorney's fees) resulting from any claim or demand arising from
use of the Material by Institution.
IN WITNESS WHEREOF, the parties hereto have caused this
instrument to be executed by their respective duly authorized
officers or representatives on the respective dates indicated
below.
Institution Rockefeller University
BY:____________________ By:____________________
Title:_________________ Title:_________________
Date:__________________ Date:__________________
AGREED:
Investigator
BY:_____________________
Title:__________________
Date:___________________
1. Consultant is a member of the faculty of The Rockefeller
University and heads a major laboratory there engaged in ongoing
programs of scientific research. Nothing herein is intended or
shall be construed as granting to the Company any rights or
licenses to any inventions, developments or scientific data or
technology arising out of research at The Rockefeller University.
2. If and to the extent Dr. Tuomanen completes the partial
sequence information, while acting as a consultant under this
contract, any technology describing the complete sequence and
deemed under United States Patent law as belonging at least in
part to The Rockefeller University shall be deemed a New
Invention as that term is defined in the Research and License
Agreement between The Rockefeller University and MedImmune, Inc.
dated 4/16/96 and be subject to those option rights described in
Paragraph 4.2 of such Agreement.
