[*] indicates that a confidential portion of the text of this agreement has been
omitted and filed separately with the Securities and Exchange Commission
LICENSE AGREEMENT
between
XOMA CORPORATION
and
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
U.C. AGREEMENT
CONTROL NUMBER
86-04-0012
TABLE OF CONTENTS
Article No. Title Page
1 DEFINITIONS 3
2 GRANT 7
3 SUBLICENSES 8
4 LICENSE ISSUE FEE 9
5 ROYALTIES 9
6 DUE DILIGENCE 16
7 MOST FAVORED LICENSEE 19
8 QUARTERLY REPORTS 19
9 BOOKS AND RECORDS 20
10 LATE PAYMENTS 22
11 LIFE OF THE AGREEMENT 22
12 TERMINATION BY THE REGENTS 23
13 TERMINATION BY LICENSEE 23
14 DISPOSITION OF THE HYBRIDOMA AND
LICENSED PRODUCTS ON HAND
UPON TERMINATION 24
15 MAINTENANCE OF PROPERTY AND
TRADE SECRET RIGHTS IN THE
HYBRIDOMAS 25
16 PATENT PROSECUTION AND MAINTENANCE 25
17 INFRINGEMENT 27
18 NOTIFICATION AND AUTHORIZATION UNDER
DRUG PRICE COMPETITION AND PATENT
TERM RESTORATION ACT 30
19 EXTENSION OF PATENT TERM UNDER DRUG
PRICE COMPETITION AND PATENT TERM
RESTORATION ACT 31
20 PATENT MARKING 31
21 USE OF NAME, TRADE NAMES, AND
TRADEMARKS 31
22 WARRANTY BY THE REGENTS 32
23 WAIVER 33
24 LICENSE RESTRICTIONS 33
25 ASSIGNABILITY 34
26 INDEMNITY 34
27 FOREIGN LICENSE REGISTRATION 34
28 FORCE MAJEURE 34
29 NOTICES 35
30 GOVERNING LAWS 35
31 MISCELLANEOUS 36
UC Cases: 85-158-1,2; 86-069-1 and 86-073-1 (Young)
082886
U.C. AGREEMENT
CONTROL NUMBER
86-04-0012
LICENSE AGREEMENT FOR MONOCLONAL ANTIBODIES TO GRAM NEGATIVE
SEPSIS-RELATED BACTERIA AND HUMAN DIAGNOSTICS
AND THERAPEUTICS DERIVED THEREFROM
THIS LICENSE AGREEMENT is made and is effective this 3rd day of September
1986 by and between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, a California
corporation having statewide administrative offices at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, hereinafter referred to as "The Regents", and XOMA
CORPORATION, a Delaware corporation having a principal place of business at ▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, hereinafter referred to as
"Licensee".
WITNESSETH:
WHEREAS, certain inventions, generally characterized as MONOCLONAL
ANTIBODIES TO GRAM NEGATIVE SEPSIS-RELATED BACTERIA AND DIAGNOSTICS AND
THERAPEUTICS DERIVED THEREFROM, hereinafter collectively referred to as "the
Invention", were made by ▇▇▇▇▇▇ ▇▇▇▇▇ at the University of California, Los
Angeles and are covered by The Regents' Patent Rights as defined below;
WHEREAS, Licensee has funded the total direct and indirect costs of
research on the Invention at the University of California, Los Angeles under the
Service to Industry Agreement
between Licensee and The Regents entitled "Monoclonal Antibodies Against
Virulent Factors of Gram Negative Bacilli" and dated October 30, 1981 as
amended;
WHEREAS, Licensee agrees that part of the consideration for this Agreement
is the expectancy of receiving access to The Hybridomas as defined in paragraph
1.2 for use by Licensee in developing commercial products prior to the issuance
of a patent and, in the event a patent does not issue, prior to access to The
Hybridomas by other commercial entities, if any.
WHEREAS, the parties have agreed that the royalties established in this
Agreement are appropriate for sales of Diagnostic Kits and Therapeutic Agents,
as defined in paragraphs 1.8 and 1.9, but may not be appropriate for sales of
component parts per se of Diagnostic Kits or Therapeutic Agents; and the parties
have therefore agreed, for their mutual convenience, to calculate all royalties
on the sale of Diagnostic Kits or Therapeutic Agents, whether sold by Licensee
or a third party which purchases component parts from Licensee and then converts
such component parts to Diagnostic Kits or Therapeutic Agents;
WHEREAS, The Regents desire that the Invention be developed and
utilized to the fullest extent so that the benefits can be enjoyed by the
general public; and
WHEREAS, Licensee is desirous of obtaining certain rights from The Regents
for the commercial development, use, and sale of the Invention, and The Regents
are willing to grant such rights.
NOW, THEREFORE, for and in consideration of the covenants, conditions and
undertaking hereinafter set forth, it is agreed by and between the parties, as
follows:
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1. DEFINITIONS
1.1 "Regents' Patent Rights", as used herein, means patent rights to any
subject matter claimed in or covered by any of the following:
1.1(a) Pending U.S. patent application, serial number 781,242, entitled
"Monoclonal Antibody Reactive with Pseudomonas Aeruginosa", filed on
September 27, 1985 by ▇▇▇▇▇▇ ▇▇▇▇▇ and assigned to The Regents; any
continuing applications thereof including divisions; any
continuation-in-part applications thereof which include only such
additional information as can be shown by written records to have been
known to The Regents prior to the effective date of this Agreement;
any patents issuing on said application or continuing applications
including reissues; and any corresponding foreign patents or patent
applications.
1.1(b) Pending U.S. patent application, serial number 855,878, entitled
"Monoclonal Antibodies Binding Determinants of Gram Negative
Bacteria", filed on April 24, 1986 by ▇▇▇▇▇▇ ▇▇▇▇▇ and assigned to The
Regents; any continuing applications thereof including reissues; any
continuation-in-part applications thereof which include only such
additional information as can be shown by written records to have been
known to The
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Regents prior to the effective date of this Agreement; and any
corresponding foreign patents or patent applications.
1.2 "The Hybridomas", as used herein, means the hybridomas designated as
XMMEN-OE5, XMMEN-LY1, XMMEN-LY2, XMMPS-OP1, XMMPSOP2, XMMPS-OP3, XMMPS-OP4,
XMMPS-OP7, XMMEN-JD5, XMMEN-LY7, and XMMPS-605 described in Regents' Patent
Rights and the hybridomas A4.1 and G7.1 (nomenclature of ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇'▇
laboratory) and any progeny or cell line derivatives thereof.
1.3 "Patent Products", as used herein, means any product, apparatus, kit or
component part thereof, or other subject matter whose manufacture, use, or sale
is covered by any claim or claims included within Regents' Patent Rights, except
that The Hybridomas and all cell line derivatives made from The Hybridomas by
Licensee are expressly excluded under this definition of Patent Products.
1.4 "Non-Patent Products", as used herein, means any product, apparatus,
kit, or any component part thereof which is not covered by Regents' Patent
Rights and which contains antibodies or fragments of antibodies which are made
by The Hybridomas or cell line derivatives of The Hybridomas made by Licensee.
1.5 "Licensed Products", as used herein, means both Patent Products and
Non-Patent Products.
1.6 "Patent Method", as used herein, means any method, procedure, process
or other subject matter whose use or practice is covered by any claim or claims
included within Regents' Patent Rights.
-4-
1.7 "...covered by...", as used herein, means Patent Products that when
made, used, or sold or Patent Method which when practiced by Licensee or its
sublicensees would constitute, but for the license granted to Licensee pursuant
to this Agreement, an infringement of any claim or claims of Regents' Patent
Rights.
1.8 "Diagnostic Kits", as used herein, means Licensed Products which are in
a physical form, irrespective of concentration or packaging, which is ready for
use in a clinical laboratory for diagnostic purposes.
1.9 "Therapeutic Agents", as used herein, means Licensed Products which are
in a final formulation, irrespective of concentration or packaging, which could
be administered to a patient for therapy.
1.10 "Affiliate", as used herein, means any corporation which controls, is
controlled by, or is under common control with Licensee. A corporation shall be
regarded as in control of another corporation if it owns or directly or
indirectly controls at least 50% of the voting stock of the other corporation.
1.11 "Net Sales", as used herein, means the gross invoice price of Licensed
Products sold, less the sum of the following deductions where applicable: cash,
trade or quantity discounts, if any; sales, use, tariff, import/export duties or
other excise taxes imposed upon particular sales; transportation charges; free
samples given for marketing purposes; and allowances or credits to customers
because of rejections or returns. Sales between divisions or departments of
Licensee shall not be considered sales for purposes of this paragraph.
-5-
1.12 "Cost of the Hybridoma", as used herein, means the fully allocated
manufacturing or acquisition cost of the supernatant containing antibodies made
from the Hybridoma.
1.13 "Cost of the Final Product", as used herein, means the fully allocated
manufacturing or acquisition cost of a Diagnostic Kit or Therapeutic Agent.
1.14 "Antibody Conjugates", as used herein, means antibodies or antibody
fragments which are associated with biologically active molecules such as, but
not limited to, toxins or radiolabels.
1.15 "the Fraction", as used herein, means (a) for any Therapeutic Agent
containing multiple antibodies or Antibody Conjugates which are sold separately,
the sum of the separate selling prices of all antibodies or Antibody Conjugates
contained in the Therapeutic Agent which are Licensed Products divided by the
sum of the separate selling prices of all antibodies or Antibody Conjugates
contained in the Therapeutic Agent, (b) for any Diagnostic Kit containing
multiple antibodies which are each sold in a separate diagnostic kit containing
only one antibody (Stand Alone Kit), the sum of the separate selling prices of
all Stand Alone Kits which are Licensed Products contained within the Diagnostic
Kit divided by the sum of the separate selling prices of all Stand Alone Kits
contained in the Diagnostic Kit, or (c) for Therapeutic Agents or Diagnostic
Kits which contain parts that are not sold separately, a fraction which shall be
negotiated in good faith by the parties for each such product and which shall
reflect the value of the parts which are Licensed Products relative to the total
value of the product.
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2. GRANT
2.1 Except as otherwise provided herein, The Regents hereby grant to
Licensee an exclusive license under Regents' Patent Rights to make (propagate),
have made, make derivatives and use The Hybridoma and all derivatives made
therefrom by Licensee; to make, have made, use and sell Licensed Products,
including, but not limited to, Licensed Products for both diagnostic and
therapeutic purposes; and to practice the Patent Method throughout the world
where The Regents may lawfully grant such a license.
2.2 Except as otherwise provided herein, The Regents also hereby grant to
Licensee an exclusive license under The Regents' property rights in The
Hybridomas to make (propagate), have made, make derivatives and use The
Hybridomas and all derivatives made therefrom by Licensee and to make, have
made, use and sell Licensed Products, including, but not limited to, Licensed
Products for both diagnostic and therapeutic purposes, throughout the world
where The Regents may lawfully grant such a license.
2.3 Under The Regents' property and Patent Rights, the right to sell,
donate or otherwise irrevocably transfer The Hybridomas to third parties, except
as provided in paragraph 3.1, is expressly excluded from this license.
2.4 The Regents expressly reserve the right to use the Invention and
associated technology for educational and research purposes and to transfer The
Hybridoma to third parties for noncommercial uses according to the conditions
described in paragraph 15.1.
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3. SUBLICENSES
3.1 The Regents also grant to Licensee the right to issue sublicenses with
respect to the licenses granted in paragraphs 2.1 and 2.2 and the right to
transfer The Hybridomas to potential sublicensees under obligations of
confidentiality at least as restrictive as those used by Licensee to transfer
its own biological materials of similar proprietary nature and value. All
sublicenses shall include all of the rights and obligations due The Regents that
are contained in this Agreement with the exceptions that sublicensees shall not
be obligated to pay the License Issue Fee (paragraph 4.1) or minimum annual
royalties (paragraph 5.7) and Licensee shall be solely responsible, either
directly or through its sublicensees, for the attainment of due diligence
obligations under Article 6.
3.2 Licensee shall provide The Regents with a copy of each sublicense
issued hereunder which conveys the right to sell Licensed Products
(identification of sublicensee, financial terms and portions not relevant to The
Regents' license to Licensee may be obliterated); collect and guarantee payment
of all royalties due The Regents from sublicensees; and summarize and deliver
all reports due The Regents from sublicensees.
3.3 Upon termination of this Agreement pursuant to Article 12, Licensee
shall provide The Regents with a complete copy of all sublicenses, and The
Regents agree to negotiate in good faith for a license agreement under Regents'
Patent Rights with any and all of Licensee's sublicensees who have the right to
sell Licensed Products. The resulting license agreements shall
-8-
contain financial terms no less favorable to the sublicensees than those
previously obtained by them from Licensee.
4. LICENSE ISSUE FEE
4.1 Licensee shall pay to The Regents a License Issue Fee of Seven Thousand
Five Hundred Dollars ($7,500.00) upon execution of this Agreement.
4.2 This fee is non-refundable and not an advance against earned royalties.
5. ROYALTIES
5.1 As consideration for this license, Licensee shall pay to The Regents an
earned royalty which shall be calculated by multiplying the royalty rate as set
forth below by the Net Sales of Licensed Products sold by Licensee or its
sublicensees. Such royalties shall accrue and be payable to The Regents,
pursuant to paragraph 5.6, when Licensed Products are sold.
For Licensed Products containing, among other things, a single
antibody, the royalty rate shall be calculated according to
subparagraphs (5.1a) through (5.1d):
(5.1a) For Therapeutic Agents which are Patent Products and do not contain
an Antibody Conjugate, the calculated royalty rate shall equal five
percent (5%) times the Cost of the Hybridoma divided by the Cost of
the Final Product; provided, however, that the immediately above
calculated royalty rate shall in no event be less than three percent
(3%). For Therapeutic Agents which are Patent Products and contain an
Antibody Conjugate, the calculated royalty rate
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shall equal two and one-half percent (2.5%) times the Cost of the
Hybridoma divided by the Cost of the Final Product; provided, however,
that the immediately above calculated royalty rate shall in no event
be less than two and one-quarter percent (2.25%).
(5.1b) For Therapeutic Agents which are Non-Patent Products and do not
contain an Antibody Conjugate, the calculated royalty rate shall equal
three and one-half percent (3.5%) times the Cost of the Hybridoma
divided by the Cost of the Final Product; provided, however, that the
immediately above calculated royalty rate shall in no event be less
than one and one-half percent (1.5%). For Therapeutic Agents which are
Non-Patent Products and contain an Antibody Conjugate, the calculated
royalty rate shall equal one and three-quarters percent (1.75%) times
the Cost of the Hybridoma divided by the Cost of the Final Product;
provided, however, the immediately-above calculated royalty rate shall
in no event be less than one and one-quarter percent (1.25%).
(5.1c) For Diagnostic Kits which are Patent Products, the calculated
royalty rate shall equal four percent (4%) times the Cost of the
Hybridoma divided by the Cost of the Final Product; provided, however,
that the immediately above
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calculated royalty rate shall in no event be less than two and
one-half percent (2.5%).
(5.1d) For Diagnostic Kits which are Non-Patent Products, the calculated
royalty rate shall equal three percent (3%) times the Cost of the
Hybridoma divided by the Cost of the Final Product; provided, however,
that the immediately above calculated royalty rate shall in no event
be less than one and one-half percent (1.5%).
For Licensed Products containing, among other things, multiple
antibodies, the royalty rate shall be calculated according to
subparagraphs (5.1e) through (5.1i):
(5.1e) For Therapeutic Agents which are Patent Products, the calculated
royalty rate shall equal three and one-half percent (3.5%) times the
Fraction; provided, however, that the immediately above calculated
royalty rate shall in no event be less than one percent (1%).
(5.1f) For Therapeutic Agents which are Non-Patent Products, the calculated
royalty rate shall equal two percent (2.0%) times the Fraction;
provided, however, that the immediately above calculated royalty rate
shall in no event be less than one-half percent (0.5%).
(5.1g) For Therapeutic Agents which contain antibodies conjugated to other
biologically active components, the adjusted royalty rate shall equal
one-half (1/2) of the royalty rate
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calculated according to either paragraph 5.1e or 5.1f, as appropriate;
provided, however, that the adjusted royalty rate shall in no event be
less than one percent (1.0%) for Patent Products and one-half percent
(0.5%) for Non-patent Products.
(5.1h) For Diagnostic Kits which are Patent Products, the calculated
royalty rate shall equal two and one-half percent (2.5%) times
the Fraction; provided, however, that the immediately above
calculated royalty rate shall in no event be less than one
percent (1.0%).
(5.1i) For Diagnostic Kits which are Non-Patent Products, the
calculated royalty rate shall equal one and one-half percent
(1.5%) times the Fraction; provided, however, that the
immediately above calculated royalty rate shall in no event be
less than one-half percent (0.5%).
Earned royalties under this paragraph shall be payable in full without deduction
for taxes or levies against such royalty payments by any foreign government
other than taxes levied on the sale of Licensed Products as specified in
paragraph 1.11.
5.2 If Licensee or Licensee's sublicensees sell Licensed Products which are
not Diagnostic Kits or Therapeutic Agents to a third party, the royalties due
The Regents for such sale shall be calculated from the Net Sales by the third
party of Diagnostic Kits or Therapeutic Agents made from the Licensed Products
sold
-12-
by Licensee or Licensee's sublicensees. Net Sales of Licensed Products sold or
transferred to Affiliates shall be the gross invoice price of sales by the
Affiliate to third parties which are not Affiliates less the sum of the
deductions listed in paragraph 1.11, where applicable.
5.3 If the Net Sales by Licensee and Licensee's sublicensees for any
Licensed Product decrease by more than ten percent (10%) over a period of at
least six months and if a competitor offers for sale in the same geographical
market area a product which diagnoses the same disease or treats the same
indication as the Licensed Product throughout the period during which the
decrease in sales occurred, then The Regents and Licensee shall enter into good
faith negotiations to lower the royalty rate on the Licensed Product. The
negotiated royalty rate will be one which places the Licensee in a position to
competitively market the Licensed Product.
5.4 Earned royalties for Patent Products under paragraphs 5.1, 5.2 and 5.3
shall accrue in each country for the duration of Regents' Patent Rights in that
country. After the expiration of all patents within Regents' Patent Rights which
cover a Licensed Product in a country, Licensee shall have an irrevocable
paid-up license in the country under the rights granted in paragraph 2.2
pertaining to the Licensed Product.
5.5 Earned royalties for Non-Patent Products under paragraphs 5.1, 5.2 and
5.3 shall accrue in any country for a period of ten (10) years from the date of
first commercial sale in the U.S. of the Non-Patent Product or, if no sale
occurs in the U.S., for a period of ten (10) years from the date of first
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commercial sale of the Non-Patent Product in the country. After said ten-year
period, Licensee shall have an irrevocable paid-up license in the country to the
rights granted in paragraph 2.2 pertaining to the Non-patent Product.
5.6 Royalties owing on Licensed Products covered by pending patent
applications but not covered by any issued patents within Regents' Patent Rights
shall be assessed at the rate for Nonpatent Products. In the event Regents'
patent applications listed in paragraph 1.1 are denied, royalties owing on
Licensed Products shall be assessed at the rate for Non-patent Products.
5.7 Licensed Products shall be considered sold when invoiced or, if not
invoiced, when delivered to a third party by Licensee or its sublicensees.
5.8 Royalties accruing to The Regents shall be paid to The Regents within
sixty (60) days following the calendar quarter during which they have accrued.
5.9 Licensee shall pay to The Regents a minimum annual royalty of Fifteen
Thousand Dollars ($15,000.00), beginning with either the first full calendar
year after the approval by the FDA of the first Licensed Product or 1993,
whichever is earlier, and continuing in the amount of Twenty-five Thousand
Dollars ($25,000.00) for all subsequent years throughout the life of Regents'
Patent Rights for as long as Licensee has exclusive rights hereunder in the
United States. This minimum annual royalty shall accrue on and be paid to The
Regents by February 28 of each year and shall be credited against earned
royalties for so long as is necessary to amortize the minimum annual royalties
paid.
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5.10 Except as otherwise provided in this paragraph 5.10, all monies due
The Regents shall be payable in United States funds collectible at par in San
Francisco, California. If at any time legal restrictions prevent the prompt
remittance of part or all royalties by Licensee or any sublicensee with respect
to any country where a Licensed Product is sold, Licensee or such sublicensee
shall have the right and option to make such payments by depositing the amount
thereof in local currency to The Regents' account in a bank or other depository
in such country.
5.11 In the event that any patent or any claim thereof included within the
Regents' Patent Rights shall be held invalid in a decision by a court of
competent jurisdiction and last resort from which no appeal has or can be taken,
all obligations to pay royalties based on such patent or claim or any claim
patentably indistinct therefrom shall cease as of the date of such decision.
Licensee shall not, however, be relieved from paying any royalties that accrued
before such decision or that are based on another patent or claim not involved
in such decision or that are based on The Regents' property rights. Royalties
for a Licensed Product which becomes a Non-Patent Product due to patent
invalidation shall accrue for a period of ten (10) years from the date of first
commercial sale of the given Licensed Product, regardless of whether the
Licensed Product was a Patent Product or a Non-patent Product at the time of
first commercial sale.
5.12 A single royalty shall be paid on sales of Licensed Products, no
matter how many items in Regents' Patent Rights or The Regents' property rights
cover such Licensed Products, and
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the royalty shall be assessed at the highest applicable rate for the Licensed
Product.
5.13 No royalty shall be paid on a Patent Product or a Patent Method after
Regents' Patent Rights covering said Licensed Product or Method have expired.
6. DUE DILIGENCE
6.1 Licensee, upon execution of this Agreement, shall diligently proceed
with the development, manufacture and sale of Licensed Products and shall
earnestly and diligently endeavor to market the same within a reasonable time
after execution of this Agreement in quantities sufficient to meet the market
demands therefor.
6.2 Licensee shall be entitled to exercise prudent and justifiable business
judgment in meeting its due diligence obligations hereunder.
6.3 Licensee shall endeavor to obtain all necessary approvals for the
manufacture, use and sale of Licensed Products.
6.4 Subject to the provisions of paragraph 6.2, Licensee agrees to use its
best efforts:
(6.4a) to file a Product License Application (PLA) for a therapeutic
Licensed Product with the U. S. Food and Drug Administration
(FDA) by January 1, 1990;
(6.4b) to market such therapeutic Licensed Product in the United States
within six (6) months after receiving approval from FDA of such
Licensed Product's PLA;
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(6.4c) to file a Premarket Approval Application (PMA) for a diagnostic
Licensed Product with the FDA by January 1, 1991;
(6.4d) to market such diagnostic Licensed Product in the United States
within six (6) months after receiving approval from FDA of such
Licensed Product's PMA;
(6.4e) following commencement of marketing, to reasonably fill the
market demands for Licensed Products in the United States during
the exclusive period of this Agreement.
If Licensee shall fail to fulfill its obligations relative to therapeutic
Licensed Products under subparagraphs (a), (b) and (e) above, then The Regents
shall have the right and option to reduce Licensee's exclusive license for
therapeutic Licensed Products to a nonexclusive license. If Licensee shall fail
to fulfill its obligations relative to diagnostic Licensed Products under
subparagraphs (c), (d) and (e) above, then The Regents shall have the right and
option to reduce Licensee's exclusive license for diagnostic Licensed Products
to a nonexclusive license. These rights, if exercised by The Regents, supersede
the rights granted in Article 2 (▇▇▇▇▇).
6.5 The Regents shall have the right to terminate Licensee's exclusive
license in any country or countries in which Licensee or Licensee's sublicensees
demonstrate a grievous failure to market Licensed Products.
6.6 Licensee shall keep The Regents informed as to the progress in the
development and testing of all Licensed Products
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and the preparing, filing, and obtaining of the approvals necessary for
marketing. Beginning January 1, 1987 and annually thereafter, Licensee shall
submit to The Regents a progress report covering Licensee's activities related
to the development of Licensed Products and the securing of the requisite
approvals. These reports shall be made until the first commercial sale of a
Licensed Product in the U.S.
6.7 At the request of either party, any controversy or claim arising out of
or relating to the diligence provisions of this Agreement shall be settled by
arbitration conducted in San Francisco, California in accordance with the then
current Licensing Agreement Arbitration Rules of the American Arbitration
Association. Judgment upon the award rendered by the Arbitrator(s) shall be
binding on the parties and may be entered by either party in the court or forum,
state or federal, having jurisdiction.
6.8 To exercise the right to either terminate this license or convert this
license to a nonexclusive license for lack of diligence, providing that
arbitration has not been requested, The Regents must give Licensee written
notice of the deficiency. Licensee thereafter has one hundred eighty (180) days
to cure the deficiency or to request arbitration. If The Regents have not
received a written request for arbitration or satisfactory tangible evidence
that the deficiency has been cured by the end of the one hundred eighty-day
period, then The Regents may, at their option, convert Licensee's exclusive
license to a nonexclusive license by giving written notice to Licensee.
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7. MOST FAVORED LICENSEE
7.1 Any provision of this Agreement to the contrary notwithstanding, if
when otherwise permitted by the terms of this Agreement, The Regents grant to a
third party a license under Regents' Patent Rights which contains royalty terms
more favorable than the terms of this Agreement, then The Regents shall notify
Licensee in writing of all royalty terms in such third party license. Licensee
shall have the right and option to substitute all such royalty terms for all the
respective terms of this Agreement. Such option shall be effective for a period
of sixty (60) days from the date of notice by The Regents of the terms of the
third party license and may be exercised by written notice to The Regents.
8. QUARTERLY REPORTS
8.1 Commencing with the calendar quarter in which the first commercial sale
of Licensed Products takes place, Licensee will make quarterly reports to The
Regents on or before each February 28, May 31, August 31 and November 30 of each
year. Each such report will cover Licensee's most recently completed calendar
quarter and will show (a) the gross sales and the Net Sales of Licensed Products
sold by Licensee and its sublicensees during the most recently completed
calendar quarter; (b) the applicable royalty rate and the method by which it was
calculated pursuant to paragraphs 5.1, 5.2 and 5.3, including the calculation of
the Fraction; (c) the royalties, payable in U.S. dollars, which shall have
accrued hereunder with respect to such sales; (d) the exchange rates used in
determining the amount of
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U.S. dollars. If no sales of Licensed Products have been made during any
reporting period, a statement to this effect shall be required.
8.2 With respect to sales of Licensed Products invoiced in U.S. dollars,
the gross sales, Net Sales, and royalty payable shall be expressed in U.S.
dollars. With respect to sales of Licensed Products invoiced in currency other
than U.S. dollars, the gross sales, Net Sales, and royalty payable shall be
expressed in the domestic currency of the party making the sale together with
the U.S. dollar equivalent of the royalty payable, calculated using the
appropriate selling rate for such currency quoted in the Continental terms
method of quoting exchange rates (local currency per U.S. $1) in New York, New
York, on the last day of the reporting period.
8.3 Pursuant to paragraphs 6.4 and 8.1 herein, Licensee also agrees to
report to The Regents the date of first commercial sale in each country of a
Licensed Product within thirty (30) days of its occurrence in each country.
9. BOOKS AND RECORDS
9.1 Licensee shall maintain books and records accurately showing all
Licensed Products manufactured or sold by it under the terms of this Agreement
for at least three (3) years from the end of the calendar year to which the
books and records pertain. Upon written request and after reasonable notice, not
more often than once in each year, Licensee shall permit a representative
selected by The Regents, except one to whom Licensee has some reasonable
objection, to have access during normal business hours to such records of
Licensee as may be reasonably necessary to
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determine, with respect to any calendar year ending not more than thirty-six
(36) months prior to the date of such request, the correctness of any report
and/or payment made under this Agreement. Licensee shall include in each
sublicense granted pursuant to this Agreement a provision requiring the
sublicensee to maintain records of sales made pursuant to such sublicense and to
grant access to such records to The Regents' representative. Upon the expiration
of thirty-six (36) months following the end of any calendar year and absent a
showing of fraud, the calculation of royalties payable with respect to such year
shall be binding and conclusive upon The Regents, and Licensee and its
sublicensees shall be released from any liability or accountability with respect
to royalties for such year.
9.2 Subject to applicable Federal and State laws, the Regents agree that
all information subject to review under paragraph 9.1 is confidential and that
The Regents shall and shall cause their representative to retain all such
information in confidence. In any event, The Regents agree to notify Licensee
prior to the release of any such information pursuant to Federal or State laws,
so as to permit Licensee to take such action as it deems appropriate.
9.3 The fees and expenses of the representatives performing such an
examination shall be borne by The Regents. However, if an error in royalties in
favor of The Regents by more than ten percent (10%) of the total royalties or
one thousand dollars ($1,000.00), whichever is greater, due hereunder for the
calendar year being reviewed is discovered by the representatives of The
-21-
Regents, then all reasonable fees and expenses of these representatives shall be
borne by Licensee.
10. LATE PAYMENTS
10.1 In the event royalty payments or fees are not received by The Regents
when due, Licensee shall pay to The Regents interest charges at the rate of ten
percent (10%) per annum on the total royalties or fees due for the reporting
period.
10.2 In the event of a failure of performance due under the terms of this
Agreement and if it becomes necessary for either party to undertake legal action
against the other on account thereof, then the prevailing party shall be
entitled to reasonable attorney's fees in addition to costs and necessary
disbursements.
11. LIFE OF THE AGREEMENT
11.1 Subject to the provisions of paragraph 11.2, this Agreement shall be
in full force and effect from the date first herein written and shall remain in
effect for the life of the last to expire patent licensed under this Agreement
or for the period of Licensee's royalty obligation as set forth in paragraph
5.4, whichever is longer, or unless otherwise terminated by operation of law or
by acts of the parties in accordance with the terms of this Agreement.
11.2 Upon termination of this Agreement pursuant to Article 11, Article 12
or Article 13, the rights and obligations of the parties shall cease, except
that (a) rights (including Licensee's right to the paid-up irrevocable licenses
granted in paragraphs 5.4 and 5.5), obligations and liabilities of the parties
accrued prior to such termination shall survive such termination; and (b)
-22-
the obligation of The Regents, under paragraph 9.2, to keep certain information
confidential, shall survive termination for period of five (5) years.
12. TERMINATION BY THE REGENTS
12.1 It is expressly agreed that, notwithstanding the provisions of Article
10 concerning late payments, if Licensee should fail to deliver to The Regents
any statement or report when due, or fail to pay any royalty at the time that
the same should be due or if Licensee should violate or fail to perform any
covenant, condition, or undertaking of this Agreement on its part to be
performed hereunder, then and in such event The Regents may give written notice
of such default to Licensee. If Licensee should fail to repair such default
within ninety (90) days from such notice, The Regents shall have the right to
terminate this Agreement and the licenses herein by written notice to Licensee.
Upon delivery of such notice of termination to Licensee, this Agreement shall
automatically terminate. Such termination shall not relieve Licensee of its
obligation to pay any royalty or license fees due or owing at the time of such
termination and shall not impair any accrued right of The Regents.
13. TERMINATION BY LICENSEE
13.1 Licensee shall have the right to terminate this Agreement or any
license granted herein, in whole or as to any specified patent or any claim of
such patent, at any time, and from time to time, by giving notice in writing to
The Regents. Such termination shall be effective ninety (90) days from the
-23-
date of such notice and all Licensee's rights associated therewith shall cease
as of that date.
13.2 Any termination pursuant to the above paragraph shall not relieve
Licensee of any obligation or liability accrued hereunder prior to such
termination, or rescind or give rise to any right to rescind anything done by
Licensee or any payments made (including the payment of the license issue fee)
or other consideration given to The Regents hereunder prior to the time such
termination becomes effective, and such termination shall not affect in any
manner any rights of The Regents arising under this Agreement prior to such
termination.
14. DISPOSITION OF THE HYBRIDOMA AND
LICENSED PRODUCTS ON HAND UPON TERMINATION
14.1 Upon termination of this Agreement by either party Licensee agrees to
dispose of The Hybridomas and Licensed Products in its possession in the
following manner:
(14.1a) The Hybridomas will be destroyed within fifteen (15) days
following the effective date of termination. Licensee agrees to
provide The Regents within thirty (30) days following said
termination date with written notice that The Hybridoma has been
destroyed.
(14.1b) In the case of Licensed Products, Licensee shall provide The
Regents within sixty (60) days following the effective date of
termination with a written inventory of all Licensed Products in
process of manufacture, in use or in stock, and shall dispose of
such
-24-
Licensed Products within one hundred eighty (180) days of the
effective date of termination, provided, however, that all such
Licensed Products shall be subject to the terms of this
Agreement.
15. MAINTENANCE OF PROPERTY AND TRADE SECRET RIGHTS
IN THE HYBRIDOMAS
15.1 The Regents agree to instruct ▇▇▇▇▇▇ ▇▇▇▇▇ to circulate The Hybridomas
to third parties only for noncommercial research purposes and only under the
terms of the biological material transmission letter attached hereto as Appendix
A.
15.2 Licensee shall not be prevented from transferring any of The
Hybridomas to third parties if:
(l5.2a) such Hybridoma is now, or becomes in the future, publicly
available, other than through acts or omissions of Licensee; or
(15.2b) such Hybridoma is lawfully obtained by Licensee from sources
independent of The Regents.
15.3 Licensee agrees to use its best efforts to preserve The Regents"
tangible property and trade secret rights in The Hybridomas.
16. PATENT PROSECUTION AND MAINTENANCE
16.1 The Regents shall diligently prosecute and maintain the above
identified United States patent application using counsel of their choice and
after due consultation with Licensee. The Regents shall provide Licensee with
copies of all relevant documentation so that Licensee may be informed and
apprised of
-25-
the continuing prosecution, and ▇▇▇▇▇▇▇▇ agrees to keep this
documentation confidential.
16.2 The Regents shall use their best efforts to amend any patent
application to include claims reasonably requested by Licensee and required to
protect the Licensed Products contemplated to be sold under this Agreement.
16.3 The cost of preparing, filing and prosecuting all United States patent
applications contemplated by this Agreement shall be borne by Licensee.
16.4 Licensee shall have the right to obtain patent protection on the
Invention in foreign countries if available and if it so desires. Licensee must
notify The Regents within ten (10) months of the filing of the corresponding
United States application of those countries in which it desires to obtain
foreign patents. The absence of a decision in writing from Licensee to The
Regents shall be considered an election by Licensee not to secure foreign patent
rights.
16.5 The preparation, filing and prosecuting of all foreign patent
applications filed in accordance with paragraph 16.4 and the maintenance of all
resulting patents shall be at the sole expense of Licensee. Such patents shall
be held in the name of The Regents and shall be obtained using counsel of The
Regents' choice, provided that Licensee shall have no reasonable objection to
such counsel.
16.6 Licensee's obligation to underwrite and to pay foreign patent
prosecution costs filed at its request shall continue for so long as this
Agreement remains in effect, provided, however, that Licensee may terminate its
obligations with respect to any
-26-
foreign patent application or patent upon three (3) months' written notice to
The Regents. The Regents may continue prosecution and/or maintenance of such
application(s) or patent(s) at their sole discretion and expense; provided,
however, that Licensee shall have no further right or licenses thereunder.
16.7 The Regents shall have the right to file patent applications at their
own expense in any country in which Licensee has not elected to secure such
rights, and such applications and resultant patents shall not be subject to this
Agreement.
17. INFRINGEMENT
17.1 In the event that Licensee shall learn of the infringement of any
patent licensed under this Agreement, Licensee shall call The Regents' attention
thereto in writing. Both Parties to this Agreement agree that during the period
and in a jurisdiction where Licensee has exclusive rights under this Agreement,
neither will notify a third party of the infringement of any of Regents' Patent
Rights without first obtaining the consent of the other Party, which consent
shall not be unreasonably denied. Both Parties shall use reasonable efforts in
cooperation with each other to terminate such infringement without litigation.
17.2 Licensee may request that The Regents take legal action against the
infringement of Regents' Patent Rights. Such request shall be made in writing
and shall include reasonable evidence of such infringement and damages to
Licensee. If the infringing activity has not been abated within ninety (90) days
-27-
following the effective date of such request, The Regents shall have the right
to:
(17.2a) commence suit on their own account; or
(17.2b) refuse to participate in such suit,
and The Regents shall give notice of their election in writing to Licensee by
the end of the one-hundredth (100th) day after receiving notice of such request
from Licensee. Licensee may thereafter bring suit for patent infringement if and
only if The Regents elect not to commence suit (other than as nominal party
plaintiff) and if the infringement occurred during the period and in a
jurisdiction where Licensee had exclusive rights under this Agreement. However,
in the event Licensee elects to bring suit in accordance with this paragraph,
The Regents may thereafter join such suit at their own expense.
17.3 In the case of an infringement of Regents' Patent Rights as defined in
Section 271(e) of Title 35 of the United States Code, Licensee shall provide The
Regents with written notice of such occurrence and shall provide The Regents
with copies of any notice which Licensee receives as required by the Drug Price
Competition and Patent Term Restoration Act (Public Law 98-417, hereinafter "the
Act") to be given by an applicant for an abbreviated PLA or a "paper PLA"
pursuant to section 101 or 103 of the Act to a holder of an approved PLA. If
Licensee wishes action to be taken against such infringement, as provided in the
Act, Licensee shall request such action in written notice to The Regents. Within
thirty (30) days of receiving said request, The Regents will give written notice
to Licensee of its election to:
-28-
(17.3a) commence suit on their own account; or
(17.3b) refuse to participate in such suit.
Licensee may thereafter bring suit for patent infringement as provided by the
Act if and only if The Regents elect not to commence suit (other than as nominal
party plaintiff) and if the infringement occurred during the period that
Licensee had exclusive rights in the United States under this Agreement.
However, in the event Licensee elects to bring suit in accordance with this
paragraph, The Regents may thereafter join such suit at their own expense.
17.4 Any legal action as is brought shall be at the expense of the party by
whom suit is filed. Any damages or costs recovered in connection with a lawsuit
shall belong to the party by whom suit is filed. Nothing herein obligates The
Regents or Licensee to enter into any litigation of any nature whatsoever with
regard to Regents' Patent Rights.
17.5 Each party agrees to cooperate with the other in litigation
proceedings instituted hereunder but at the expense of the party on account of
whom suit is brought. Such litigation shall be controlled by the party bringing
the suit, except when such suit is brought jointly in which case The Regents
shall control. The Regents, at their own expense, may be represented by counsel
of their choice pursuant to The Regents' determination in any suit brought by
Licensee.
17.6 In the event that The Regents refuse to participate in a suit and
Licensee brings same as allowed herein, Licensee may pay royalties at the
applicable rate for Non-patent Products and may withhold the difference between
the rate paid and the rate
-29-
due for Patent Products during the pendency of the suit and until said suit has
been finally concluded. To the extent that Licensee does not recover attorneys'
fees and other out-of-pocket costs as a result of such litigation, such withheld
royalties may be applied to Licensee's expenses (out-of-pocket and in-house)
incurred in connection with such suit and the balance of such withheld royalties
if any, shall be paid to The Regents upon disposition of the suit; provided
however, that if as a result of such suit, all claims of patents included within
Regents' Patent Rights under which Licensee is selling a Licensed Product shall
be held invalid, Licensee may retain the balance of such withheld royalties
which pertain to such Licensed Product until such decision shall be finally
reversed by an unappealed or unappealable decree of a court of competent
jurisdiction and higher dignity.
18. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT
18.1 The Regents shall notify Licensee of (a) the issuance of each U.S.
patent included within Regents' Patent Rights, giving the date of issue and
patent number for each such patent, and (b) each notice pertaining to any patent
included within Regents' Patent Rights which it receives as patent owner
pursuant to the Drug Price Competition and Patent Term Restoration Act, (the
Act), including but not necessarily limited to notices pursuant to Sections 101
and 103 of the Act from persons who have filed an Abbreviated New Drug
Application ("ANDA") or a "paper" New Drug Application (NDA). Such notices shall
be given promptly, but in any event within ten (10) calendar days of each
-30-
such patent's date of issue or receipt of each such notice pursuant to the Act,
whichever is applicable.
18.2 The Regents hereby authorize Licensee (a) to include in any NDA for a
Licensed Product, as Licensee may deem appropriate under the Act, a list of
patents included within Regents' Patent Rights identifying The Regents as patent
owner that relate to such Licensed Product and such other information as
Licensee in its reasonable discretion believes is appropriate to be filed
pursuant to the Act; and (b) in consultation with The Regents, to exercise any
rights that may be exercisable by an exclusive licensee and NDA holder under The
Regents' Patent Rights.
19. EXTENSION OF PATENT TERM UNDER DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT
19.1 The Regents agree as patent owners under the Act to apply for an
extension of the term of any patent included within Regents' Patent Rights, as
permitted by the Act, upon request by Licensee. The Regents agree to cooperate
with Licensee in the exercise of the authorizations granted in Articles 18 and
19 and will execute such documents and take such additional action as Licensee
may reasonably request in connection therewith.
20. PATENT MARKING
20.1 Licensee agrees to mark all Patent Products made, used or sold under
the terms of this Agreement, or their containers, in accordance with the
applicable patent marking laws.
21. USE OF NAMES, TRADE NAMES, AND ▇▇▇▇▇▇▇▇▇▇
21.1 Nothing contained in this Agreement shall be construed as conferring
any right to use in advertising, publicity, or
-31-
other promotional activities any name, trade name, trademark, or other
designation of either party hereto (including any contraction, abbreviation or
simulation of any of the foregoing). The use of the name "The Regents of the
University of California" or the name of any campus of the University of
California is expressly prohibited.
21.2 Each party hereto further agrees not to use or refer to this Agreement
or any license granted hereunder in any promotional activity associated with any
Licensed Product licensed hereunder without the express written approval of the
other party.
22. WARRANTY BY THE REGENTS
22.1 The Regents warrant that they have the lawful right to grant this
license.
22.2 The Regents make no express or implied warranties of merchantability
or fitness of the Invention for a particular purpose.
22.3 Nothing in this Agreement shall be construed as:
(22.3a) a warranty or representation by The Regents as to the validity
or scope of any Regents' Patent Rights; or
(22.3b) a warranty or representation that anything made, used, sold or
otherwise disposed of under any license granted in this
Agreement is or will be free from infringement of patents of
third parties; or
(22.3c) an obligation to bring or prosecute actions or suits against
third parties for patent
-32-
infringement except as provided in Article 17; or
(22.3d) conferring by implication, estoppel or otherwise any license or
rights under any patents of The Regents other than Regents'
Patent Rights as defined herein, regardless of whether such
patents are dominant or subordinate to Regents' Patent Rights;
or
(22.3e) a warranty or representation by The Regents that The Hybridomas
will not be publicly disclosed and that any trade secret covered
by this Agreement will be maintained as such by The Regents,
notwithstanding the provisions of paragraph 15.1 herein.
22.4 No liability, financial or otherwise, shall be incurred by The Regents
as a consequence of any disclosure of The Hybridomas to third parties.
23. WAIVER
23.1 It is agreed that no waiver by either party hereto of any breach or
default of any of the covenants or agreements herein set forth shall be deemed a
waiver as to any subsequent and/or similar breach or default.
24. LICENSE RESTRICTIONS
24.1 It is agreed that the rights and privileges granted to Licensee are
each and all expressly conditioned upon the faithful performance on the part of
Licensee of every requirement herein contained. Each of such conditions and
requirements is a specific license restriction.
-33-
25. ASSIGNABILITY
25.1 This Agreement is binding upon and shall inure to the benefit of The
Regents, their successors and assigns, but shall be personal to Licensee and
assignable by Licensee only with the written consent of The Regents, which
consent shall not be unreasonably withheld.
26. INDEMNITY
26.1 Licensee agrees to indemnify, hold harmless and defend The Regents,
their officers, employees, and agents, against any and all claims, suits,
losses, damages, costs, fees, and expenses resulting from or arising out of
exercise of the licenses granted in this Agreement.
27. FOREIGN LICENSE REGISTRATION
27.1 Licensee agrees to register or give required notice concerning this
Agreement, through itself or through an Affiliate, in each country where there
exists an obligation under law to so register or give notice, to pay all costs
and legal fees connected therewith, and shall otherwise comply with all national
laws applicable to this Agreement.
28. FORCE MAJEURE
28.1 In the event of acts of God, action of the elements, war, invasion,
civil commotion, insurrection, labor disturbance, fire, flood, or government
restriction, which render performance under this Agreement impossible, failure
on that account during each period shall be excused; and any minimum royalty
called for shall not be required during such period or periods of inability to
perform.
-34-
29. NOTICES
29.1 Any payment, notice or other communication required or permitted to be
given to either party hereto shall be deemed to have been properly given and to
be effective (a) upon delivery if delivered in person, or (b) four (4) days
after mailing if mailed by first-class certified mail, postage paid, to the
respective address given below, or to such other address as shall be designated
by written notice given to the other party as follows:
In the case of Licensee: XOMA CORPORATION
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Chief Executive Officer
In the case of The Regents: THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Director, Patent,
Trademark & Copyright Office
All payments, notices or other communications required or permitted to be given
to The Regents will contain the following information:
UC Case Nos.: 85-158-1,2; 86-069-1 and 86-073-1
Inventor: ▇▇▇▇▇▇ ▇▇▇▇▇
30. GOVERNING LAWS
30.1 This Agreement shall be interpreted and construed in accordance with
the laws of the State of California.
-35-
31. MISCELLANEOUS
31.1 The headings of the several sections are inserted for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
31.2 This Agreement will not be binding upon the parties until it has been
signed hereinbelow by or on behalf of each party, in which event, it shall be
effective as of the date first above written.
31.3 No amendment or modification hereof shall be valid or binding upon the
parties unless made in writing and signed as aforesaid.
31.4 This Agreement embodies the entire understanding of the parties and
shall supersede all previous communications, representations or understandings,
either oral or written, between the parties relating to the subject matter
hereof.
31.5 In case 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 hereof, but this Agreement shall be construed as if such
invalid or illegal or unenforceable provisions had never been contained herein.
31.6 Nothing contained herein shall prohibit The Regents or their officers,
agents, employees, or students from publishing results of any research based on
or using The Hybridomas or any other commentary related to The Hybridomas.
-36-
IN WITNESS WHEREOF, both The Regents and Licensee have executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, on the day and year hereinafter written.
XOMA CORPORATION THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA
By /s/▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ By /s/▇▇▇▇▇ ▇. ▇▇▇▇▇▇
By ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ By ▇▇▇▇▇ ▇. ▇▇▇▇▇▇
(Please Print) (Please Print)
Title Chairman and Title Director, Patent,
Chief Executive Officer Trademark & Copyright Ofc
Date September 3, 1986 Date 17 SEPT 86
"License Agreement between Xoma Corporation and The Regents of the University of
California. UC Case Nos.: 85-158-1,2; 86-069-1 and 86-073-1"
-37-
"Appendix A"
UNIVERSITY OF CALIFORNIA
Instructions for Standard Letter
Transmitting Biological Materials
to Universities and Nonprofit Institutions
The attached letter is authorized for use by University of California
Principal Investigators and Administrators only with scientists at other
universities and nonprofit research institutions when transmitting cell lines,
plasmids and the like for non-commercial research purposes.
1. Choose the appropriate form of university or nonprofit research institution
in paragraph 2.
2. Choose whether or not to include the phrase "our cooperative" in paragraph 2.
3. Insert in paragraph 4 the amount of processing charge. If the material is to
be shipped at no charge, insert the words "no charge."
4. Send the letter in duplicate to the other scientist.
5. Do not send biological materials until you receive the duplicate copy
executed by both the scientist and the other institution.
6. Send a copy of the fully executed letter agreement to:
▇▇▇▇▇ ▇. ▇▇▇▇▇▇, Director
Patent, Trademark and Copyright Office
University of California
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
7. Any changes in the wording of this standard letter must be reviewed by the
director of the Patent, trademark and copyright Office before acceptance.
NOTE: Do not use this letter for the exchange of living plants. A separate
"Testing Agreement for Plant Varieties" is available for that purpose.
December 29, 1981
SAMPLE LETTER FOR USE PRIOR TO
TRANSMISSION OF BIOLOGICAL MATERIALS
TO INVESTIGATORS AT OTHER
UNIVERSITIES OR NON PROFIT RESEARCH INSTITUTIONS
(Use UC Letterhead)
(Date)
IN DUPLICATE
To:
This is to [acknowledge receipt of your letter] [confirm our telephone
conversations] in which you requested certain research materials developed in
this laboratory be sent to you for scientific research purposes. The materials
concerned, which belong to The Regents of the University of California, are:
(blank)
I will be pleased to permit your use of these materials within your
[university][non profit research institution]laboratory for [our cooperative]
scientific research. However, before forwarding them to you, I would like your
agreement that the materials will be received by you only for use in [our
cooperative work][scientific research], that you will bear all risk to you or
any others resulting from your use, and that you will not pass these materials,
their progeny or derivatives, on to any other party or use them for commercial
purposes without the express written consent of The Regents of the University of
California. You understand that no other right or license to these materials,
their progeny or derivatives, is granted or implied as a result of our
transmission of these materials to you.
These materials are to be used with caution and prudence in any experimental
work, since all of their characteristics are not known.
As you recognize, there is a processing cost to us involved in providing these
materials to you. We will bill you for our processing costs, which will amount
to $(blank).
Date
Page Two
If you agree to accept these materials under the above conditions, please sign
the enclosed duplicate copy of this letter, then have it signed by an authorized
representative of your institution, and return it to me. Upon receipt of that
confirmation I will forward the material(s) to you.
[Note: Other paragraphs discussing the relevant literature, the nature of the
work, hazards relating to materials to be sent, etc., may be appropriate. These
will vary depending on the individual circumstance and the relationship between
the two parties previously established. Be sure to retain signed copy when
received and send a photocopy of the completed agreement to the University of
California Patent Administrator, Patent Office, Systemwide Administration, ▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.]
Sincerely yours,
------------------------
Accepted:
Research Investigator
--------------------------
Printed Name
--------------------------
Signature
--------------------------
Date
Research University or
Non Profit Institution
--------------------------
Printed Name
--------------------------
By
--------------------------
Date
UNIVERSITY OF CALIFORNIA
Instructions for Standard Letter
Transmitting Biological Materials
To Industrial (for profit) Companies
The attached letter agreement is authorized for use by the University of
California Principal Investigators when transmitting cell lines, plasmids and
like biological materials for non-commercial research purposes to scientists
employed by industrial (for profit) companies, and when no patent application
relating to those materials will be or has been filed.
When to use this letter:
1. For the transmission of biological materials.
2. Materials must be used for research purposes only.
3. For profit taking corporations and companies.
4. When no patent application relating to the materials will be or has been
filed.
When not to use this letter:
1. If a patent application has been filed on the materials, first contact
the University Patent Office at (▇▇▇) ▇▇▇-▇▇▇▇ for instructions.
2. For living plants or portions thereof. A separate "Testing Agreement for
Plant Varieties" is available for use with these materials.
3. For transmission of biological materials to scientists at other
universities and non-profit institutions. A separate letter is used
which is available from the University Patent Office.
4. If a change in the wording of this standard letter is requested. Any
changes in the wording of this standard letter must be reviewed and
approved by the Director of the Patent, Trademark and Copyright Office
before acceptance.
5. If commercial use of the materials is intended, then contact the
University Patent office because a commercial license may be required
and releases from sponsors may be necessary.
How to use this agreement:
1. Choose whether or not to include the phrase "our cooperative" in
paragraph 2.
2. Insert in paragraph 4 the amount of processing charge. If the material
is to be shipped at no charge, insert the words "no charge."
3. Send the letter in duplicate to other scientists.
4. Do not send biological materials until you receive the duplicate copy
executed by both the scientist and the company representative.
5. Send a photocopy of the fully executed letter agreement to:
▇▇▇▇▇ ▇. ▇▇▇▇▇▇, Director
Patent, Trademark and copyright Office
University of California
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
JAN 83
STANDARD LETTER FOR USE PRIOR TO
TRANSMISSION OF BIOLOGICAL MATERIALS
TO SCIENTIFIC INVESTIGATORS AT
INDUSTRIAL (for profit) COMPANIES
(Use UC Letterhead)
(Date)
IN DUPLICATE
To:
This is to [acknowledge receipt of your letter] [confirm our telephone
conversation] in which you requested certain research materials developed in
this laboratory be sent to you for scientific research purposes. The materials
concerned, which belong to The Regents of the University of California, are:
(blank)
We will be pleased to permit your use of these materials by you and within your
company laboratory for [our cooperative] scientific research. However, before
forwarding them to you, we need your agreement and that of your company that the
materials will be received by you only for use in [our cooperative work]
[scientific research], they will not be used on any human subjects, that you and
your company will bear all risk to you or any others resulting from your use,
and that you or your company will not pass these materials, their progeny or
derivatives, on to any other party or use them for commercial purposes without
the express written consent of The Regents of the University of California. You
understand that no other right or license to these materials, their progeny or
derivatives, is granted or implied as a result of our transmission of these
materials to you.
These materials are to be used with caution and prudence in any experimental
work since all of their characteristics are not known. You understand these
materials are experimental in nature and, when delivered to you, are without
warranty of merchantability or fitness for any particular purpose, or any other
warranty of any kind.
As you recognize, there is a processing cost to us involved in providing these
materials to you. We will bill you for our processing costs, which will amount
to $(blank).
Date
Page Two
If you agree to accept these materials under the above conditions, please sign
the enclosed duplicate copy of this letter, then have it signed by an authorized
representative of your company, and return it to me. Upon receipt of that
confirmation I will forward the materials(s) to you.
[Note: Other paragraphs discussing the relevant literature, the nature of the
work, hazards relating to materials to be sent, etc., may be appropriate. These
will vary depending on the individual circumstance and the relationship between
the two parties previously established. Be sure to retain signed copy when
received and send a photocopy of the completed agreement to the University of
California Patent Administrator, Patent office, Systemwide Administration ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.]
Sincerely yours,
------------------------
Accepted:___________________________
(Printed Name of Company)
Research Investigator Authorized Company Representative
-------------------------- ----------------------------------
Printed Name Printed Name
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Signature Signature
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Date Title
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Date
JAN 83