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CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.8
(b), 200.83 AND 230.406 * INDICATES OMITTED MATERIAL THAT IS THE
SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST THAT IS FILED
SEPARATELY WITH THE COMMISSION
EXHIBIT 10.29
COLLABORATIVE RESEARCH AND ASSIGNMENT AGREEMENT
THIS AGREEMENT is entered into as of October 15, 1996 (the "Effective
Date") by and among AMYLIN PHARMACEUTICALS, INC., a Delaware corporation having
offices at 0000 Xxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000 ("AMYLIN"),
LONDON HEALTH SCIENCES CENTRE, an institution having offices at Room X000X,
Xxxxxxxxxxx Xxxxx, Xxxxxxxx Campus, P.O. Box 5375, 000 Xxxxxxxxxxxxx Xxxx, Xxxx,
Xxxxxx, Xxxxxxx X0X 0X0 ("LHSC") and DR. XXXX XXXXX ("XXXXX").
WHEREAS, LHSC and XXXXX possess scientific and technical proprietary
technology and resources relating to the use of GLP-1 (*******) in the treatment
of diabetes;
WHEREAS, XXXXX invented a new and useful invention for the treatment of
diabetes, for which an application for patent was filed in Great Britain on May
12, 1994, and assigned Serial No. 9409496.8, and for which an international
patent application (attached hereto as Exhibit A) was filed on May 12, 1995
under the Patent Cooperation Treaty, and assigned International Application
Number PCT/CA95/00287;
WHEREAS, AMYLIN possesses scientific and technical proprietary
technology and resources relating to the discovery, development and
commercialization of drug candidates for the treatment of diabetes, and is
desirous of acquiring the exclusive right, title and interest in and to said
invention and applications, and to the Letters Patent to be granted and issued
pursuant thereto in the United States of America and its territories and
possessions, and all countries foreign thereto;
WHEREAS, LHSC and XXXXX desire to assign to AMYLIN all right, title and
interest in and to said invention and applications, and to the Letters Patent to
be granted and issued pursuant thereto in
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the United States of America and its territories and possessions, and all
countries foreign thereto, and AMYLIN desires to have such invention and
applications, and said Letters Patent to be granted and issued pursuant thereto,
assigned to it by LHSC and XXXXX; and
WHEREAS, the parties desire to establish a collaborative relationship
to perform clinical research to investigate the use of GLP-1 (*************) in
the treatment of diabetes, as more fully set forth below.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants set forth below, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "Affiliate" means an individual, trust, business trust, joint
venture, partnership, corporation, association or any other entity which owns,
is owned by or is under common ownership with a party. For the purposes of this
definition, the term "owns" (including, with correlative meanings, the terms
"owned by" and "under common ownership with") as used with respect to any party,
shall mean the possession (directly or indirectly) of at least 51% of the
outstanding voting securities of a corporation or comparable equity interest in
any other type of entity (or such lesser percentage which is the maximum allowed
to be possessed in a particular jurisdiction).
1.2 "Agreement" means the present agreement together with all exhibits
and schedules.
1.3 "Assigned Patent Applications and Patents" means that certain
patent application attached hereto as Exhibit A, that certain priority
application referenced in Exhibit A as GB 9409496.8, all applications that have
been or may be filed anywhere throughout the world claiming priority from either
said Exhibit A application or said priority application, and all
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Letters Patent (or equivalent rights) that may be granted and issued pursuant to
any of the aforesaid patent applications in any and all countries throughout the
world.
1.4 "Collaboration Patent Rights" means all patent applications and
patents (or equivalents thereof) that claim or cover inventions made by LHSC
and/or XXXXX (or by employees or agents of LHSC or XXXXX or any of their
respective Affiliates) either solely or jointly with AMYLIN (as determined in
accordance with the rules of inventorship under United States patent law) in
connection with the Research.
1.5 "Confidential Information" means all information and materials
received by any party from another party pursuant to this Agreement and all
information and materials developed in the course of the Collaboration,
including, without limitation, Know-How of each party, subject to Section 7.2
hereof.
1.6 "Discontinuation Payments" means those payments made by AMYLIN to
LHSC pursuant to Section 2.5 hereof in the event that AMYLIN ceases pursuing
development of all Royalty-Bearing Products.
1.7 "FDA" means the United States Food and Drug Administration.
1.8 "Field" means the prevention and/or treatment of fuel metabolism
disorders, including but not limited to diabetes.
1.9 "Intellectual Property" means all patents, copyrights, trade
secrets, trademarks and other proprietary rights including Know-How, together
with all related rights, applications, filings, registrations and the like.
1.10 "Know-How" means techniques, data, materials and chemicals
relating to the Field, including, without limitation, inventions, techniques,
practices, methods, knowledge, know-how, skill, experience, test data, including
pharmacological, toxicological and clinical test data, analytical and quality
control data, patent and legal data or descriptions, and marketing, sales and
manufacturing data.
1.11 "Net Sales" shall mean the gross amounts invoiced for sales of
Royalty-Bearing Products by AMYLIN, its Affiliates, licensees or sublicensees,
as applicable, to Third Parties, less (a) discounts and rebates actually
granted, including without
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limitation prompt payment discounts and governmentally mandated rebates, (b)
credits or allowances actually granted upon claims, damaged goods, rejections or
returns of a product, including recalls, (c) freight, postage shipping and
insurance charges actually allowed or paid for delivery of product, and (d)
taxes, duties or other governmental charges (other than income taxes) levied on,
absorbed or otherwise imposed on sale of products.
1.12 "Research" means all work of LHSC and/or XXXXX performed pursuant
to this Agreement during the Research Term.
1.13 "Research Funding" means those payments from AMYLIN to LHSC made
pursuant to Section 5.1 hereof.
1.15 "Research Term" means the period commencing on the Effective Date
and ending on the Termination Date, subject to extension pursuant to Section 3.3
or earlier termination pursuant to Section 4.2.
1.16 "Royalty-Bearing Product" means any product the use or sale or
which is covered by a Valid Claim where said product is used or sold.
1.17 "Royalty Payments" means those payments from AMYLIN to LHSC,
calculated on the basis of Net Sales, made pursuant to Section 5.2 hereof.
1.18 "Termination Date" means the second anniversary of the Effective
Date.
1.19 "Third Party" means any entity other than AMYLIN, LHSC or XXXXX or
an Affiliate, licensee or sublicensee of AMYLIN, LHSC or XXXXX.
1.20 "Valid Claim" means a claim of an issued patent within the
Assigned Patent Applications and Patents, or a claim of an issued patent within
Collaboration Patent Rights, which claim has not lapsed, been cancelled or
become abandoned and has not been declared invalid by an unreversed and
unappealable decision or judgment of a court or other appropriate body of
competent jurisdiction, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer.
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ARTICLE 2
ASSIGNMENT OF PATENT APPLICATION
2.1 Assignment. For good and valuable consideration, receipt of which
by LHSC and XXXXX is hereby acknowledged, LHSC and XXXXX hereby sell, assign and
transfer to AMYLIN all right, title and interest in and to the Assigned Patent
Applications and Patents, and AMYLIN hereby accepts and purchases the Assigned
Patent Applications and Patents from LHSC and XXXXX.
2.2 Assignment Fee. AMYLIN agrees to pay to LHSC a nonrefundable
payment of (*) on the Effective Date, and, as the case may be, Royalty Payments
or Discontinuation Payments under this Agreement. In addition, from and after
the Effective Date, AMYLIN will pay all costs of transfers of the Assigned
Patent Applications and Patents and future costs of filing, prosecuting,
maintaining, enforcing and defending the Assigned Patent Applications and
Patents.
2.3 Documents Relating to the Assigned Patent Applications and Patents;
Transfers of Ownership and Responsibility for Prosecution. As of the Effective
Date, AMYLIN will be responsible for the preparation, filing, prosecution,
maintenance, enforcement and defense of Assigned Patent Applications and
Patents. Within 30 days of the Effective Date, LHSC and XXXXX shall provide
AMYLIN with a copy of the prosecution file wrapper history of the each patent
application within the Assigned Patent Applications and Patents, and will
execute all other documents that may be required to transfer the responsibility
for prosecuting each such application to AMYLIN. The determination of the
countries in which to file and maintain patent applications shall be within the
sole discretion of AMYLIN; provided, however, that AMYLIN shall through the
Exhibit A application file corresponding national stage applications in the
United States, Australia, Canada, the EPO and Japan. AMYLIN will keep LHSC and
XXXXX informed of the status of all Assigned Patent Applications and Patents
and, where appropriate, will seek the advice of XXXXX and LHSC concerning the
preparation, filing prosecution, maintenance, enforcement and defense thereof.
AMYLIN agrees not to diminish the scope of the claims now set forth in the
Assigned
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Patent Applications and Patents without the consent of LHSC. LHSC and XXXXX
further agree to execute all documents and make all filings required by AMYLIN
to effect the assignment of the Assigned Patent Applications and Patents
throughout the world, and agree to cooperate fully with AMYLIN in the
preparation, filing prosecution, maintenance, enforcement and defense of the
Assigned Patent Applications and Patents, which cooperation shall include but
not be limited to review of patent office documents, review of pertinent
literature, and execution by LHSC and/or XXXXX of all such papers and
instruments as are necessary or helpful to AMYLIN in preparing, filing,
prosecuting, maintaining, enforcing, and defending such applications.
2.4 No Assumption of Liabilities. AMYLIN is not assuming any debts,
liabilities, obligations or contracts of LHSC and/or XXXXX and all such debts,
liabilities, obligations and contracts shall be and remain the responsibility of
LHSC and/or XXXXX. Neither LHSC nor XXXXX is not assuming any debts,
liabilities, obligations or contracts of AMYLIN and all such debts, liabilities,
obligations and contracts shall be and remain the responsibility of AMYLIN.
2.5 Product Development in Discretion of AMYLIN; Discontinuation
Payments.
(a) It shall be completely in the discretion of AMYLIN whether and
in what manner to develop and/or proceed with the development of Royalty-Bearing
Products; provided, however, that AMYLIN shall use efforts, consistent with its
sound and reasonable business practices and technical judgment, to effect
introduction of a Royalty-Bearing Product into the commercial market. AMYLIN
may, but need not, discharge this obligation:
(i) by preparing and filing an Investigational New Drug
application for a Royalty-Bearing Product within
three(3) years following the Effective Date; and,
(ii) thereafter, should AMYLIN within its reasonable
business and technical judgment determine that said
Royalty-Bearing Product continues to be a
commercially and technically viable drug candidate,
by completing Phase II clinical trials of said
Royalty-Bearing Product within five
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(5) years following the Effective Date, completing
Phase III clinical trials of said Royalty-Bearing
Product within seven (7) years following the
Effective Date, and filing an application to market
said Royalty-Bearing Product in any of the United
States, Europe, Japan, Canada or Australia within
eight (8) years following the Effective Date.
In the event that AMYLIN determines to pursue the Phase II clinical
trials and Phase III clinical trials described in Section 2.5(a)(ii) above, LHSC
will be given first consideration to be a site for such Phase II and Phase III
clinical trials.
(b) Notwithstanding the provisions of Section 2.5(a) above, in the
event that, and at such time as, AMYLIN determines (which shall in no event take
place before the earlier of Termination Date and the date that the Research Plan
is amended under Section 4.2) to cease pursuing development of all
Royalty-Bearing Products, AMYLIN shall give prompt notice of such intention to
LHSC. Upon the giving of such notice, AMYLIN may elect
(i) to terminate this Agreement, in which case all rights
to the Assigned Patent Applications and Patents will
revert to LHSC, or
(ii) to retain all such rights and pay to LHSC
Discontinuation Payments equal to (*) following the
date of such notice, with the first such payment to
be made one hundred twenty (120) days following such
election by AMYLIN (but subject to Sections 2.5(d)
and (e) below).
(c) In the event that AMYLIN elects to make such Discontinuation
Payments, LHSC shall have ninety (90) days following AMYLIN'S election to notify
AMYLIN in writing whether it wishes:
(i) to accept the aforesaid Discontinuation Payments, or
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(ii) to elect, at LHSC's option, that all rights to the
Assigned Patent Applications and Patents revert to
LHSC, together with a royalty-bearing license to the
Collaboration Patent Rights, as set forth in Section
6.1 below.
(d) In the event that LHSC makes the election set forth in Section
2.5(c)(ii) above, AMYLIN shall thereupon have no obligation to make any
Discontinuation Payments. AMYLIN shall thereupon have a continuing right of
first refusal should, at any time or from time to time after said election, LHSC
and/or XXXXX propose to enter into any agreement with any one or more third
parties to develop and/or commercialize any product or products within the scope
of said Assigned Patent Applications and Patents and/or said Collaboration
Patent Rights. Pursuant to AMYLIN'S continuing right of first refusal, any such
agreement with a third party shall be presented to AMYLIN prior to execution by
said third party, after which AMYLIN shall have sixty (60) days to exercise its
right of first refusal. If AMYLIN notifies LHSC and/or XXXXX that it wishes to
exercise such right, the parties shall then proceed to prepare a contract among
LHSC, XXXXX and AMYLIN pursuant to which AMYLIN would commit to provide
substantially the same development and/or commercialization efforts, resources
and/or funding, as applicable, as such third party had bone fide proposed to
commit pursuant to such third party agreement, provided that AMYLIN shall not be
required to commit or make available technology or other assets that would have
been committed by such third party. In such event, upon execution of such
agreement by AMYLIN, neither LHSC, XXXXX nor such third party shall have any
further rights to enter into such third party agreement.
(e) In the event that LHSC elects to receive Discontinuation
Payments, the first such Discontinuation Payment shall be made within one
hundred twenty (120) days of the date of such notice, and each subsequent
Discontinuation Payment shall be made within one hundred twenty (120) days of
each anniversary of the date of such notice, with the last Discontinuation
Payment being made within one hundred twenty (120) days of the fourth
anniversary of the date of such notice; provided, however, that the
Discontinuation Payments shall be reduced by the aggregate amount of all Royalty
Payments made prior to the date of such notice (with such aggregate Royalty
Payments being applied first against the first such Discontinuation Payment
otherwise due
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following AMYLIN's notice and then in order against each subsequent
Discontinuation Payment otherwise due); provided, further, that so long as
AMYLIN is pursuing development of any Royalty-Bearing Product, no
Discontinuation Payments shall become due.
(f) If, notwithstanding the payment of any Discontinuation
Payments, AMYLIN subsequently determines to develop Royalty-Bearing Products,
further Discontinuation Payments shall cease, and Discontinuation Payments
already made shall be creditable against future Royalty Payments to LHSC.
ARTICLE 3
RESEARCH COLLABORATION
3.1 Scope of Collaboration. LHSC and XXXXX will conduct research to be
jointly designed and agreed upon by the parties in advance in accordance with a
Research Plan (which Research Plan will be appended hereto as Exhibit B and form
a part of this agreement when agreed upon by the parties) for and on behalf of
AMYLIN with the goal of carrying out clinical experiments to evaluate the use of
GLP-1 (*************)in the Field, or such other experiments and studies as may
be mutually agreed upon by the parties after the first year of the Research Term
as set forth in Section 4.2 hereof.
3.2 Exclusivity of Services. During the Research Term, neither XXXXX
nor LHSC nor any of their Affiliates shall enter into any agreement with any
Third Party which relates to the conduct or funding of research, development or
commercialization of GLP-1 (*********) or any related compounds, including but
not limited to analogs, fragments, and chimeras of GLP-1 (*************).
3.3 Duration and Extension of Research Term. The Research Term shall
commence on the Effective Date and shall continue at least until the Termination
Date, unless terminated earlier in accordance with the provisions of Article 9.
Not fewer than 180 days prior to the Termination Date, AMYLIN shall inform LHSC
and XXXXX whether it wishes to continue the Research. Upon such notice by AMYLIN
and the approval of LHSC of such continuation of the Research, the Research Term
may be extended at AMYLIN's
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expense upon such mutually acceptable terms as the parties shall negotiate in
good faith. In the event that AMYLIN does not give notice of its intention to
continue the Research within such 180-day period, the Research Term shall
terminate automatically and without further action on the part of any party on
the Termination Date.
ARTICLE 4
CONDUCT OF RESEARCH
4.1 Research. The parties agree that LHSC and XXXXX shall perform the
Research using their expertise and facilities (a) in accordance with the
Research Plan, and (b) in accordance with the procedures required by the FDA's
current Good Laboratory Practices and Good Clinical Practices regulations.
4.2 Reevaluation After One Year. At the end of the first year of the
Research Term, the parties will review and evaluate the results of the Research
during the first year and will determine whether the second year's portion of
the Research Funding will be used as originally set forth in the Research Plan
or dedicated to some other research to be mutually agreed upon by the parties.
In the event that the parties determine to use the Research Funding otherwise
than as originally set forth in the Research Plan, the parties will execute an
amendment to the Research Plan which will be incorporated by reference in and
become a part of this Agreement.
4.3 Availability of Resources. LHSC will maintain, at its expense,
laboratories, offices and all other facilities necessary to carry out the
Research. Each party agrees to make its employees and non-employee consultants
reasonably available at their respective places of employment to consult with
the other parties on issues arising during the Collaboration and in connection
with any request from any regulatory agency, including, without limitation,
regulatory, scientific, technical and clinical testing issues. Representatives
of AMYLIN may, upon reasonable notice and at times reasonably acceptable to LHSC
and XXXXX (a) visit the facilities where the Research is being conducted; and
(b) consult informally, during such visits and by telephone, with personnel of
LHSC and/or XXXXX performing the Research.
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4.4 Results of Research. LHSC and XXXXX shall, in accordance with their
established practices, keep complete, accurate and authentic accounts, notes,
data and records of the Research performed under this Agreement. LHSC and XXXXX
shall promptly and fully disclose to AMYLIN any and all information, data and
results (the "Results") obtained from, and any and all Know-How and inventions
created or discovered in the course or as a result of, the Research, which
disclosure shall include, without limitation, copies of relevant summaries and
reports. Upon request by AMYLIN and in any event upon the conclusion of the
Research, LHSC and XXXXX shall prepare a summary report detailing the Results
and the underlying data and all Know-How and inventions created or discovered in
the course or as a result of the Research. Upon request by AMYLIN, LHSC and
XXXXX will provide AMYLIN with access to laboratory notebooks and allow AMYLIN
to make copies thereof. Ownership of any and all results of the Research shall
be determined in accordance with Section 6.1 hereof.
4.5 Personnel. LHSC and XXXXX agree that XXXXX will be the principal
investigator for the Research and may be replaced as such only upon the written
consent of AMYLIN. LHSC and XXXXX shall be responsible for securing all
additional clinical personnel involved in the Research and any required
replacements. LHSC and XXXXX shall identify and recruit only qualified
individuals to fill these positions.
ARTICLE 5
COLLABORATION PAYMENT OBLIGATIONS
5.1 Research Funding. AMYLIN agrees to fund the Research during the
Research Term in the amount of (*). Such amount shall be payable in four equal
installments during each year of the Research Term. The first such payment shall
be made on the Effective Date, and subsequent payments shall be made every third
month thereafter during the Research Term.
5.2 Royalty Payments. AMYLIN shall pay to LHSC a royalty of
(**********************************) of Royalty-Bearing Products sold by AMYLIN
or its Affiliates, licensees or sublicensees.
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The Royalty Payments for Royalty-Bearing Products shall be reduced by the amount
of any royalties payable to Third Parties in respect of the manufacture, use or
sale of Royalty- Bearing Products; provided, however, that in any event the
aggregate reduction of Royalty Payments set forth in this Section 5.2
(***********************************************).
5.3 No Royalties on Intercompany Sales. No royalties as set forth in
this Article 5 shall be payable on intercompany sales transactions as between or
among AMYLIN and AMYLIN Affiliates, the final sale by AMYLIN or an AMYLIN
Affiliate to a Third Party, alone, being used for the purposes of determining
the Royalty Payments due hereunder. The Royalty-Bearing Product subject to
Royalty Payments shall be deemed sold when invoiced or, if not invoiced, when
the same shall be delivered to the Third Party.
5.4 Method of Payment. Royalties earned as provided under this Article
5 during each calendar quarter of a year shall be paid in U.S. Dollars by AMYLIN
to LHSC within 45 days after the end of each calendar quarter. Each Royalty
Payment shall be accompanied by a report, certified by a responsible officer of
AMYLIN, of Net Sales of Royalty-Bearing Products in sufficient detail to permit
confirmation of the accuracy of the Royalty Payment made. Exchange conversion of
foreign payments into U.S. Dollars shall be made as necessary at the rate of
exchange reported in The Wall Street Journal on the fourth banking day preceding
the end of the applicable royalty period or, for payments other than Royalty
Payments, the fourth banking day preceding the date of payment. All payments
owed under this Agreement shall be made by wire transfer, unless otherwise
specified by the receiving party.
5.5 Overpayment and Underpayment. Whenever, because of price
adjustments, including allowances for returned goods sold during any period, or
for any other reason, AMYLIN shall have overpaid or underpaid the royalty amount
due for such period, AMYLIN shall, upon determining the amount of overpayment or
underpayment, deduct or add the same from or to the Royalty Payment payable for
the period during which the amount of the overpayment or underpayment is
determined; and if after such adjustment there remains an overpayment, such
overpayment shall be deducted from
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the Royalty Payment payable for the immediately following period or periods or,
if there is no following payment period, such overpayment shall be refunded to
AMYLIN by LHSC.
5.6 Records; Audit Rights. AMYLIN shall keep complete and accurate
records of all sales or other transfers of Royalty- Bearing Products for a
minimum of five years after the sales period to which they pertain. Said records
shall be open during reasonable business hours to a certified public accountant
selected by LHSC and reasonably acceptable to AMYLIN, who shall, at LHSC's
expense (unless such audit discloses a variance of more than
(*************************************************) payments due under this
Agreement, in which case AMYLIN shall bear the full cost of such audit), have
access (but not more often than once each calendar year) to all records deemed
by such accountant as reasonably necessary to verify for LHSC the royalties
accrued, payments made or to be made, and the accuracy of the reports to be
made, as herein provided. However, said accountant shall agree in writing to
treat as confidential and not to disclose to LHSC any information other than
information relating solely to the royalties accrued and the accuracy of the
reports and payments required to be made under this Agreement, and that in no
event will the quantities or prices to individual customers be disclosed to LHSC
by said accountant.
5.7 Taxes. All taxes, assessments, fees and charges, if any, levied on
AMYLIN or an AMYLIN Affiliate under income tax laws or regulations with respect
to payments due to LHSC hereunder shall be for the account of LHSC and will be
deducted by AMYLIN and/or the AMYLIN Affiliate from such payments due to LHSC.
Receipts, if available, for all such taxes, assessments, fees and charges
advanced by AMYLIN and/or an AMYLIN Affiliate to the taxing authorities shall be
secured by AMYLIN or the AMYLIN Affiliate and sent to LHSC. Each party agrees to
assist the other party in claiming exemption from such deductions or
withholdings under any double taxation or similar agreement or treaty from time
to time in force.
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ARTICLE 6
TECHNOLOGY RIGHTS AND INFRINGEMENT
6.1 Ownership of Technology. Ownership of Collaboration Patent Rights
and any and all other Intellectual Property arising out of the Research, whether
or not patentable, shall be the sole and exclusive property of AMYLIN; provided,
however, that LHSC and XXXXX shall retain a continuing nonexclusive,
royalty-free license for non-commercial research purposes solely to Know-How
arising out of the Research. Any assignments necessary to accomplish the
foregoing are hereby made, and each party will execute such further documents
and take such further actions as may be reasonably requested by another party
with respect thereto. LHSC and XXXXX agree and acknowledge that neither LHSC nor
XXXXX shall acquire rights of any kind whatsoever with respect to any
Intellectual Property of AMYLIN as a result of LHSC's and XXXXX'x performance
under this Agreement or otherwise. In the event that LHSC makes the election set
forth in Section 2.5(c)(ii), or in the event that this Agreement is terminated
for material breach by Amylin in accordance with Section 9.3, LHSC shall have an
exclusive, royalty-bearing license to patent applications and patents (or
equivalents thereof) within Collaboration Patent Rights that name as sole
inventors employees or agents of LHSC or XXXXX or any of their respective
Affiliates,
(*******************************
*******************************************************************
**********************), and LHSC shall have a nonexclusive, royalty-bearing
license to other patent applications and patents (or equivalents thereof) within
Collaboration Patent Rights and to Know-How,
(*******************************************************
************************************************************).
6.2 Prosecution and Maintenance of Collaboration Patent Rights. AMYLIN
shall make determinations with respect to what type of patent coverage to seek
and thereafter shall be solely responsible for, and shall bear all expenses
incurred from and after the Effective Date in connection with, prosecuting to
issuance patent applications, for filing and prosecuting all patent reissues and
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re-examinations, for applying for and obtaining any patent term extensions, and
for paying all maintenance fees on all patents, which applications and patents
relate to Collaboration Patent Rights, Know-How or other Intellectual Property
arising out of the Research. In the event that AMYLIN determines to seek such
patent coverage, the determination of the countries in which to file and
maintain patent applications shall be within the sole discretion of AMYLIN;
provided, however, that AMYLIN shall file applications in the United States,
Australia, Canada, the EPO and Japan. AMYLIN will keep LHSC and XXXXX informed
of the status of all such applications and, where appropriate, will seek the
advice of XXXXX and LHSC concerning the preparation, filing prosecution,
maintenance, enforcement and defense thereof.
6.3 Infringement by Third Parties. LHSC and XXXXX shall promptly notify
AMYLIN in writing of any alleged or threatened infringement of any patent
included within the Assigned Patent Applications and Patents, or any patent
included in the Collaboration Patent Rights, of which they become aware. So long
as all rights to the Assigned Patent Applications and Patents have not reverted
to LHSC, AMYLIN shall have the sole right to bring and control any action or
proceeding with respect to infringement of such rights at its own expense and by
counsel of its own choice. Notwithstanding whether all rights to the Assigned
Patent Applications and Patents have reverted to LHSC, AMYLIN shall have the
sole right to bring and control any action or proceeding with respect to
infringement of any patent included within the Collaboration Patent Rights at
its own expense and by counsel of its own choice. In the event AMYLIN brings an
infringement action, LHSC and XXXXX shall cooperate fully, including if required
to bring such action, the furnishing of a power of attorney or agreeing to be
joined as a party, the reasonable costs of which shall be at AMYLIN'S expense.
Any recovery realized as a result of such litigation, after reimbursement of any
and all litigation expenses of AMYLIN, shall be treated as Net Sales for
purposes of the royalty provisions of this Agreement. AMYLIN shall indemnify
LHSC and XXXXX for all damages awarded against them in connection with such
actions.
6.4 Infringement of Third Party Rights. Each party shall promptly
notify the others in writing of any infringement or asserted infringement by
AMYLIN of any Third Party's Intellectual Property (collectively, "Alleged Third
Party Rights") by reason of the manufacture, import, use, sale or offer for sale
of any Royalty-Bearing Product. AMYLIN shall have the right to control
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any defense of any claim of infringement of Alleged Third Party Rights at its
own expense and by counsel of its own choice (subject to AMYLIN's right to
indemnification by LHSC as provided by Section 8.5 hereof), and LHSC and XXXXX
shall have the right, at their own expense, to be represented in any such action
by counsel of their own choice. In the event of any infringement or asserted
infringement of Alleged Third Party Rights, LHSC and XXXXX shall cooperate in
good faith with AMYLIN on a mutual and reasonable basis to negotiate and settle
any dispute with any such Third Party concerning the Alleged Third Party Rights,
and otherwise resolve any such infringement or alleged infringement and secure
AMYLIN's continued rights to the Alleged Third Party Rights, if necessary or
desirable, provided that neither LHSC nor XXXXX shall be required to make any
cash payments.
6.5 Cooperation in Connection with Infringement Disputes. In any suit
or dispute involving infringement or asserted infringement by a Third Party of a
patent included within the Assigned Patent Applications and Patents, or any
patent included in the Collaboration Patent Rights, or infringement or asserted
infringement by AMYLIN of Alleged Third Party Rights, the parties shall
cooperate fully, and upon the request and at the expense of AMYLIN, LHSC and
XXXXX shall make available to AMYLIN at reasonable times and under appropriate
conditions all relevant personnel, records, papers, information, samples,
specimens and the like which are in its possession or control.
ARTICLE 7
CONFIDENTIALITY
7.1 Nondisclosure. During the term of this Agreement and for a period
of five years after termination thereof, each party will maintain all
Confidential Information in trust and confidence and will not disclose any
Confidential Information to any Third Party or use any Confidential Information
for any purpose except as expressly authorized by this Agreement, except as
provided in Section 7.3. Each party may use such Confidential Information only
to the extent required to accomplish the purposes of this Agreement. Each party
will use at least the same standard of care as it uses to protect proprietary or
confidential information of its own to ensure that its employees, agents,
consultants and other representatives do not disclose or make any unauthorized
use of the Confidential Information. Each party will promptly notify
17
the other upon discovery of any unauthorized use or disclosure of the
Confidential Information.
7.2 Exceptions. Confidential Information shall not include any
information which the receiving party can prove by competent written evidence:
(a) is now, or hereafter becomes, through no act or failure to act
on the part of the receiving party, generally known or available;
(b) is known by the receiving party at the time of receiving such
information, as evidenced by its records;
(c) is hereafter furnished to the receiving party by a Third Party,
as a matter of right and without restriction on disclosure;
(d) is independently developed by the receiving party without the
aid, application or use of Confidential Information; or
(e) is the subject of a written permission to disclose provided by
the disclosing party.
7.3 Financial Terms. The parties agree that the material financial
terms of this Agreement will be considered Confidential Information of the
parties. Notwithstanding the foregoing, any party may disclose such terms as are
required to be disclosed by law in its financial statements or under strictures
of confidentiality to bona fide potential licensees or sublicensees. Any party
shall have the further right to disclose the material financial terms of this
Agreement under strictures of confidentiality to any potential acquiror, merger
partner or other bona fide potential strategic partner.
7.4 Publications. Each party to this Agreement recognizes that the
publication of papers regarding results of Research hereunder and other
information resulting from the Collaboration, including oral presentations and
abstracts, may be beneficial to the parties provided such publications are
subject to reasonable controls to protect Confidential Information. In
particular, it is the intent of the parties to maintain the confidentiality of
any Confidential Information included in any patent application until such
patent application has been published. Accordingly, each party shall have the
right to review and approve any paper
18
proposed for publication by the other party, including oral presentations and
abstracts, which utilizes data generated from the Collaboration and/or includes
Confidential Information of the other party. Before any such paper is submitted
for publication, the party proposing publication shall deliver a complete copy
to the other party at least (*******) prior to submitting the paper to a
publisher. The receiving party shall review any such paper and give its comments
to the publishing party within (*******) of the delivery of such paper to the
receiving party. With respect to oral presentation materials and abstracts, the
parties shall make reasonable efforts to expedite review of such materials and
abstracts, and shall return such items as soon as practicable to the publishing
party with appropriate comments, if any, but in no event later than (*******)
from the date of delivery to the receiving party. The publishing party shall
comply with another party's request to delete references to such other party's
Confidential Information in any such paper and agrees to withhold publication of
same for an additional (*******) in order to permit the parties to obtain patent
protection, if any of the parties deem it necessary, in accordance with the
terms of this Agreement.
ARTICLE 8
REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1 Corporate Power. Each party hereby represents and warrants that it
has full power and authority to enter into this Agreement and to carry out the
provisions hereof.
8.2 Due Authorization. Each party hereby represents and warrants that
such party is duly authorized to execute and deliver this Agreement and to
perform its obligations hereunder.
8.3 Binding Agreement. Each party hereby represents and warrants that
this Agreement is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by such party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
* Confidential Treatment Requested
19
8.4 Assigned Patent Applications and Patents. LHSC hereby represents
and warrants that as of the Effective Date it holds good title to the Assigned
Patent Applications and Patents, free and clear of any and all liens, claims and
encumbrances, and that upon assignment to AMYLIN, AMYLIN will be the sole owner
of the Assigned Patent Applications and Patents. LHSC and XXXXX represent and
warrant that they know of no reason why the Assigned Patent Applications and
Patents would be barred, unpatentable, invalid or unenforceable, that they are
not aware of any asserted or unasserted claim or demand of any right in or to
the Assigned Patent Applications and Patents, including but not limited to claim
or demand of inventorship, and that they have disclosed all relevant information
regarding the Assigned Patent Applications and Patents to AMYLIN. LHSC and XXXXX
further represent and warrant that to AMYLIN that (a) to the best of their
knowledge, carrying out the Research or exploiting the Assigned Patent
Applications and Patents will not infringe on any existing patent or proprietary
rights of any third party, and (b) that neither has not received any notice from
any person that carrying out the Research or exploiting the Assigned Patent
Applications and Patents infringes upon a patent or on the proprietary rights of
any third party.
8.5 Indemnification; Limitation of Liability.
(a) LHSC hereby agrees to save, defend and hold AMYLIN and its
officers, directors, employees, consultants and agents harmless from and against
any and all suits, claims, actions, demands, liabilities, expenses and losses,
including reasonable legal expense and attorneys' fees ("Losses") resulting
directly or indirectly from the Research by LHSC or XXXXX or their Affiliates
except to the extent such Losses result from the gross negligence of AMYLIN. In
the event AMYLIN seeks indemnification under this Section 8.5, it shall inform
LHSC of a claim as soon as reasonably practicable after it receives notice of
the claim, shall permit LHSC to assume direction and control of the defense of
the claim (including the right to settle the claim solely for monetary
consideration), and shall cooperate as requested (at the expense of LHSC) in the
defense of the claim.
(b) AMYLIN hereby agrees to save, defend and hold LHSC and its
officers, directors, employees, consultants and agents harmless from and against
any and all suits, claims, actions, demands, liabilities, expenses and losses,
including reasonable legal expense and attorneys' fees ("Losses") resulting
directly or
20
indirectly from the development or sale of Royalty-Bearing Products by AMYLIN or
its Affiliates except to the extent such Losses result from the gross negligence
of LHSC. In the event LHSC seeks indemnification under this Section 8.5, it
shall inform AMYLIN of a claim as soon as reasonably practicable after it
receives notice of the claim, shall permit AMYLIN to assume direction and
control of the defense of the claim (including the right to settle the claim
solely for monetary consideration), and shall cooperate as requested (at the
expense of AMYLIN) in the defense of the claim.
(c) In no event will LHSC's or XXXXX'x liability for any claim or cause
of action including any continuous cause of action exceed the aggregate of the
royalties paid or owed by AMYLIN under this Agreement. AMYLIN acknowledges that
LHSC is a public hospital with limited financing and accordingly agrees that
LHSC will not be obliged to pay any damages or compensation of any kind to
AMYLIN arising out of or related to this Agreement. AMYLIN agrees that its sole
remedy against LHSC for any breach or default of LHSC arising out of or related
to this Agreement which entitles AMYLIN to any damages or compensation of any
kind from LHSC, shall be to deduct such sum from royalties payable to LHSC
hereunder. No deduction may be made without the prior written consent of LHSC or
a final order of a court of competent jurisdiction from which no appeal has been
taken or the time for appealing has expired.
ARTICLE 9
TERMINATION
9.1 Term. Unless otherwise extended pursuant to Section 3.3 hereof or
terminated pursuant to this Article 9, the Research Term shall terminate on the
Termination Date as such term is defined in Section 1.18 hereof.
9.2 Termination by Mutual Agreement. The parties may at any time
terminate this Agreement by written agreement executed by all of the parties.
9.3 Termination for Cause. Any party may terminate this Agreement upon
60 days' written notice upon the occurrence of any of the following:
21
(a) Upon or after the bankruptcy, insolvency, dissolution or
winding up of another party (other than dissolution or winding up for the
purposes of reconstruction or amalgamation); or
(b) Upon or after the breach of any material provision of this
Agreement by the other party if the breaching party has not cured such material
breach within the 90-day period following written notice of termination by the
other party.
9.4 Survival; Effect of Expiration or Termination. The obligations and
rights of the parties under Sections 2.5, 5.2 through 5.7 and 8.5, and Articles
6 and 7 shall survive termination or expiration of this Agreement. Expiration or
termination of this Agreement shall not relieve the parties of any obligation
accruing prior to such expiration or termination. Promptly following termination
or expiration of this Agreement, LHSC and XXXXX shall return to AMYLIN all
Confidential Information of AMYLIN, and AMYLIN shall return to LHSC and XXXXX
all Confidential Information of LHSC and XXXXX.
ARTICLE 10
PUBLICITY
10.1 Publicity Review. AMYLIN will have sole authority and discretion
over the content and timing of any statement to the public regarding the
execution and the subject matter of this Agreement, the Research to be conducted
by the parties under this Agreement, or any other aspect of this Agreement,
except with respect to disclosures required by law or regulation.
ARTICLE 11
MISCELLANEOUS
11.1 Insurance. LHSC and AMYLIN will each maintain appropriate general
liability insurance, including product liability insurance, during the term of
this Agreement and any extensions or renewals thereof. Each party will provide
proof of such insurance to the other annually upon request.
11.2 Currency. All sums due under this Agreement shall be paid in
Canadian dollars. Any conversion of funds required to enable payments to be made
or calculated in Canadian dollars shall be converted at the spot buying rate for
such funds quoted
22
by the Bank of Montreal at its office in Toronto at approximately noon on the
business day immediately preceding the due date of payments.
11.3 Regulatory Approvals. LHSC shall be responsible for, and shall
bear all costs of, obtaining any and all regulatory approvals required by the
Canadian government or any subdivision or agency thereof to carry out the
Research according to the protocols set forth in the Research Plan. AMYLIN shall
be responsible for, and shall bear all costs of, obtaining any and all other
regulatory approvals required for the development and commercialization, if any,
of Royalty-Bearing Products.
11.4 No Assignment Without Prior Written Consent; Effect of Sale of
Assets or Merger. Neither party may assign or otherwise transfer this Agreement
or any of its rights or obligations herein without the prior written consent of
the other party, which consent shall not be unreasonably withheld.
Notwithstanding the foregoing, either party may assign this Agreement in
connection with the sale of all or substantially all of the assets of the party
in connection with a corporate reorganization to an Affiliate of the party or
otherwise, provided that the assignee undertakes in writing to be bound by all
of the provisions of this Agreement; it being further provided, however, that
this Agreement shall survive any merger of AMYLIN with or into another party,
and no consent for a merger or similar reorganization shall be required
hereunder.. In addition, AMYLIN may assign this Agreement following two (2)
years after the Effective Date provided that the assignee undertakes in writing
to be bound to all of the provisions of this Agreement. This Agreement shall
inure to the benefit of and be binding upon the respective successors and
permitted assigns of the parties hereto.
11.5 Force Majeure. No party shall lose any rights hereunder or be
liable to another party for damages or losses on account of failure of
performance by the defaulting party if the failure is occasioned by government
action, war, fire, explosion, flood, strike, lockout, embargo, act of God, or
any other similar cause beyond the control of the defaulting party, provided
that the party claiming force majeure has exerted all reasonable efforts to
avoid or remedy such force majeure.
11.6 Retained Rights. Nothing in this Agreement shall limit in any
respect the right of LHSC to conduct research and
23
development with respect to and market products within or outside the Field
using Intellectual Property owned by or licensed to LHSC as to which AMYLIN has
no rights; provided, however, that LHSC and XXXXX represent and warrant that
there is no conflict of interest with the activities to be performed hereunder
and their other activities and contracts, and that XXXXX will not carry out any
activities or enter into any contracts in the future that would create such a
conflict of interest. Nothing in this Agreement shall limit in any respect the
right of AMYLIN to conduct research and development with respect to and market
products in or outside the Field using Intellectual Property owned by or
licensed to AMYLIN.
11.7 Notices. Any notices or communications provided for in this
Agreement to be made by any of the parties to another shall be in writing, in
English, and shall be made by prepaid air mail with return receipt addressed to
the other at its address set forth below. Any such notice or communication may
also be given by hand, or facsimile to the appropriate designation. Any party
may by like notice specify an address to which notices and communications shall
thereafter be sent. Notices sent by mail, facsimile or cable shall be effective
upon receipt and notices given by hand shall be effective when delivered.
If to AMYLIN: AMYLIN Pharmaceuticals, Inc.
0000 Xxxxx Xxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Attn: Xxxxxxxx X. Xxxx, Esq.
Facsimile No.: (000) 000-0000
If to LHSC: London Health Sciences Centre
Executive Offices, Xxxxxxxxxxx
Xxxxx
Xxxxxxxx Xxxxxx
X.X. Xxx 0000
000 Xxxxxxxxxxxxx Xxxx, Xxxx
Xxxxxx, Xxxxxxx X0X 0X0
Attn: Vice President, Finance
Facsimile No.: (000) 000-0000
24
If to XXXXX: London Health Sciences Centre
University Campus
P.O. Box 5339
Xxxxxx, Xxxxxxx X0X 0X0
Attn: Dr. Xxxx XXXXX
Facsimile No.: (000) 000-0000
11.8 Governing Law. This Agreement shall be governed by the laws of the
State of California, as such laws are applied to contracts entered into and to
be performed within such state.
11.9 Waiver. Except as specifically provided for herein, the waiver
from time to time by any of the parties of any of their rights or their failure
to exercise any remedy shall not operate or be construed as a continuing waiver
of same or of any other of such party's rights or remedies provided in this
Agreement.
11.10 Severability. If any term, covenant or condition of this
Agreement or the application thereof to any party or circumstance shall, to any
extent, be held to be invalid or unenforceable, then (a) the remainder of this
Agreement, or the application of such term, covenant or condition to parties or
circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by law;
and (b) the parties hereto covenant and agree to renegotiate any such term,
covenant or application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant or condition of this Agreement or
the application thereof that is invalid or unenforceable, it being the intent of
the parties that the basic purposes of this Agreement are to be effectuated.
11.11 Independent Contractors. It is expressly agreed that LHSC and
XXXXX shall be independent contractors and that the relationship between AMYLIN
on the one hand and LHSC and XXXXX on the other shall not constitute a
partnership or agency of any kind. Neither AMYLIN on the one hand nor LHSC and
XXXXX on the other shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior written authorization of the party to
do so.
11.12 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an
25
original, but all of which together shall constitute one and the same
instrument.
11.13 Entire Agreement. This Agreement sets forth all of the covenants,
promises, agreements, warranties, representations, conditions and understandings
among the parties hereto and supersede and terminate all prior agreements and
understanding among the parties. There are no covenants, promises, agreements,
warranties, representations conditions or understandings, either oral or
written, among the parties other than as set forth herein and therein. No
subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the parties hereto unless reduced to writing and signed by the
respective authorized officers of the parties.
26
11.14 Further Assurances. Each of the parties hereto shall from time to
time execute and deliver all such further documents and instruments (including
instruments of conveyance) and do all acts and things as the other party may
reasonably require to effectively carry out or better evidence or perfect the
full intent and meaning of this Agreement.
IN WITNESS WHEREOF, the parties have executed this Agreement by their proper
officers as of the date and year first above written.
AMYLIN PHARMACEUTICALS, INC. LONDON HEALTH SCIENCES CENTRE
By: /s/Xxxxxxxx X. Xxxx By: /s/ Xxxx Xxxxxxx
------------------------------- ---------------------------
Name: Xxxxxxxx X. Xxxx Name: Xxxx Xxxxxxx
----------------------------- -------------------------
Title: VP and General Counsel Title: CEO
---------------------------- ------------------------
DR. XXXX XXXXX
/s/Xxxx Xxxxx
-------------------------
27
EXHIBIT A
[International Patent Application No. PCT/CA95/00287, filed May 12, 1995]
