LICENSE AND SUPPLY
AGREEMENT
between
GILEAD SCIENCES, INC.
and
PHARMACIA & UPJOHN S.A.
TABLE OF CONTENTS
Page
Table of Contents 1
Background 4
ARTICLE 1 Definitions
1.1 "Affiliate" 5
1.2 "Best Efforts"
1.3 "Cidofovir"
1.4 "Competitive CMV Product"
1.5 "CPMP"
1.6 "EMEA"
1.7 "European Union"
1.8 "First Commercial Sale"
1.9 "Gilead Know-How"
1.10 "Gilead Patents"
1.11 "Gilead Technology"
1.12 "Joint Strategic Committee" 6
1.13 "Licensed Product"
1.14 "Net Sales"
1.15 "Non-Patented Product"
1.16 "P&U Know-How"
1.17 "P&U Patents"
1.18 "P&U Technology
1.19 "P&U Territory
1.20 "Patented Product" 7
1.21 "Proprietary Information"
1.22 "Specifications"
1.23 "Valid Claim"
1.24 "Vistide"
ARTICLE 2 Grant of Rights
2.1 License Grants
2.2 Sublicensing 8
2.3 P&U Right of First Negotiation
2.4 P&U Acquisition of Competitive Product
2.5 P&U Acknowledgement of Other Gilead Products
2.6 Maintenance of Licenses to Gilead of Gilead Patents 9
ARTICLE 3 Development and Regulatory Affairs
3.1 Joint Strategic Committee
3.2 Gilead's Obligations 10
3.3 P&U's Obligations
3.4 Development Costs 11
3.5 Clinical Materials
3.6 Adverse Reactions
3.7 Intraocular Clinical Development
1.
ARTICLE 4 Due Diligence
4.1 Marketing Approval
4.2 Territorial Diligence 12
ARTICLE 5 Compensation
5.1 License Fee
5.2 Milestone Payment
5.3 Royalty Payments on Net Sales
5.4 Quarterly Payment Mechanism: Year-End Reconciliation 14
5.5 Sublicense
5.6 Expiration of Royalty Payment Obligations
ARTICLE 6 Supply and Manufacturing
6.1 Supply of Cidofovir
6.2 Technology Transfer
6.3 Supply of Intraocular Cidofovir 15
6.4 Supply Prices
6.5 Specifications
6.6 Forecasts and Orders
6.7 Acceptance; Shipment and Risk of Loss 16
6.8 Invoices
6.9 Shortages of Supply
ARTICLE 7 Marketing
7.1 Promotion and Marketing Efforts 17
7.2 Pricing
7.3 Trademarks
7.4 Use of the Gilead Name
7.5 Distribution of Licensed Product
7.6 Export Control
ARTICLE 8 Payments; Records; Audit 18
8.1 Payment; Report
8.2 Exchange Rate; Manner and Place of Payment
8.3 Records and Audit
8.4 Withholding Taxes 19
ARTICLE 9 Term and Termination
9.1 Term
9.2 Licenses Upon Expiration
9.3 Termination for Breach
9.4 Termination in Event of Patent Challenge 20
9.5 Unconditional Right to Terminate
9.6 Reversion of Product Rights
9.7 Survival
ARTICLE 10 Intellectual Property
10.1 Prosecution of Patents
10.2 Infringement of Patents by Third Parties
10.3 Infringement of Third Party Rights
2.
10.4 Patent Marking 21
10.5 JSC Review of Patent Strategy
ARTICLE 11 Indemnification
11.1 Indemnification by Gilead
11.2 Indemnification by P&U
11.3 Mechanics 22
11.4 Insurance Coverage
ARTICLE 12 Confidentiality
12.1 Proprietary Information; Exceptions
12.2 Authorized Disclosure 23
12.3 Return of Proprietary Information
ARTICLE 13 Representations and Warranties 24
13.1 Mutual Representations and Warranties
13.2 Gilead Representation and Warranties
13.3 No Other Representations
ARTICLE 14 Dispute Resolutions; Venue and Governing Law 25
14.1 Disputes
14.2 Alternative Dispute Resolution
14.3 Arbitration Procedure
14.4 Jurisdiction 26
14.5 Governing Law
ARTICLE 15 Miscellaneous 27
15.1 Agency
15.2 Assignment
15.3 Disclosure
15.4 Amendment
15.5 Notices
15.6 Force Majeure 28
15.7 Severability
15.8 Cumulative Rights
15.9 Waiver
15.10 Entire Agreement
EXHIBITS Exhibit A: Gilead Patents
Exhibit B: Endispute Rules
3.
LICENSE AND SUPPLY AGREEMENT
THIS LICENSE AND SUPPLY AGREEMENT (the "Agreement"), dated as of August 7,
1996 (the "Effective Date"), is made by and between GILEAD SCIENCES, INC., a
Delaware corporation ("Gilead"), and Pharmacia & Upjohn S.A., ("P&U") a
Luxembourg corporation with reference to the following:
BACKGROUND
WHEREAS, Gilead has developed a proprietary compound previously designated
as HPMPC or GS 504 and now known under the generic name of cidofovir; and
WHEREAS, Gilead has received marketing approval in the United States and
has filed an application for marketing approval in Europe of an injectable form
of cidofovir for intravenous use known as "Vistide-Registered Trademark-
(cidofovir injection)" for the treatment of cytomegalovirus ("CMV") retinitis in
patients with AIDS; and
WHEREAS, Gilead is currently conducting Phase I/II clinical trials for the
delivery of an intraocular formulation of cidofovir to treat CMV retinitis in
patients with AIDS; and
WHEREAS, P&U, through its divisions and/or affiliates, is engaged in the
production, commercialization and sale of pharmaceuticals; and
WHEREAS, Gilead and P&U desire to enter into a license and supply agreement
for the development, manufacture and marketing of injectable formulations of
cidofovir for intravenous and intraocular use; and
WHEREAS, to bring injectable forms of cidofovir to market in the P&U
Territory on a timely basis and maximize the value of such product, P&U
requires, in addition to a license under Gilead's patent rights covering
cidofovir, access to Gilead regulatory approvals, the assurance of product
supply and the transfer of certain know-how related to cidofovir, and also
desires the benefit of Gilead's further efforts to develop cidofovir for
intraocular delivery; and
WHEREAS, Gilead and P&U have entered into a Series B Preferred Stock
Purchase Agreement of even date herewith (the "Stock Purchase Agreement") with a
view to entering into this License and Supply Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the
covenants and obligations set forth in this Agreement, the parties hereby agree
as follows:
ARTICLE 1
DEFINITIONS
As used herein, the following terms will have the following meanings:
4.
1.1 "AFFILIATE" means any entity that directly or indirectly Owns, is
Owned by or is under common Ownership with, a party to this Agreement, where
"Own" or "Ownership" means direct or indirect possession of at least fifty
percent (50%) of the outstanding voting securities of a corporation or a
comparable ownership in any other type of entity, PROVIDED, HOWEVER, that if the
law of the jurisdiction in which such entity operates does not allow fifty
percent (50%) or greater ownership by a party to this Agreement, such ownership
interest shall be at least forty percent (40%).
1.2 "BEST EFFORTS" has the meaning assigned to it in Section 4.1.
1.3 "CIDOFOVIR" means (S)-1-(3-hydroxy-2-phosphonylmethoxypropyl)-
cytosine, also known scientifically as HPMPC, which is the active agent
contained in the Gilead pharmaceutical known as "Vistide-Registered Trademark-
(cidofovir injection)." As used in this Agreement, the term "Cidofovir" excludes
prodrugs the active species of which is HPMPC.
1.4 "COMPETITIVE CMV PRODUCT" has the meaning assigned to it in Section
2.3.
1.5 "CPMP" means the Committee for Proprietary Medicinal Products, which
represents the medicine authorities of the European Community member states.
1.6 "EMEA" means the European Medicines Evaluation Agency, which
coordinates the scientific review of human pharmaceutical products under the
centralized licensing procedure of the European Community.
1.7 "EUROPEAN UNION" or "EU" means the following countries: Austria,
Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,
The Netherlands, Portugal, Spain, Sweden, the United Kingdom, and future members
of the European Union (or its successor), upon their admission for full
membership (with commercial rights and privileges substantially comparable to
those of the foregoing countries).
1.8 "FIRST COMMERCIAL SALE" means, in any particular country, the first
sale for use by the general public of the Licensed Product after required
marketing and pricing approvals have been granted by the governing health
authority of that country.
1.9 "GILEAD KNOW-HOW" means all proprietary inventions, technology,
trade secrets, clinical and preclinical results, and any physical, chemical or
biological material, or other information, owned or acquired with right to
sublicense during the term of this Agreement by Gilead or any Affiliate of
Gilead, which are necessary or useful to P&U in the development, formulation,
use or sale of the Licensed Product.
1.10 "GILEAD PATENTS" mean all patents and patent applications, both
foreign and domestic, which cover Cidofovir and which now or at any time during
the term of this Agreement are owned by or licensed to Gilead or any Gilead
Affiliate with the right to sublicense. Set forth as Exhibit A is a list of the
Gilead Patents as of the Effective Date. Such Exhibit shall be updated no more
frequently than annually upon P&U's request. Gilead Patents expressly excludes
patents and patent applications covering proforms of Cidofovir, or their use or
manufacture, in particular esters or amides of Cidofovir, or cyclic HPMPC (also
known as GS 930).
1.11 "GILEAD TECHNOLOGY" means Gilead Patents and Gilead Know-How.
5.
1.12 "JOINT STRATEGIC COMMITTEE" OR "JSC" means that committee comprised
of three named representatives of Gilead and three named representatives of P&U
whose responsibility shall be as set forth in Section 3.1.
1.13 "LICENSED PRODUCT" means any formulation of Cidofovir manufactured
or sold pursuant to this Agreement exclusively for intravenous or intraocular
administration. Licensed Products may be either Patented Products or Non-
Patented Products. Licensed Products exclude formulations of Cidofovir other
than intravenous and intraocular formulations.
1.14 "NET SALES" means the gross billings for the sale to a third party
of Licensed Product in finished product form made by P&U or its Affiliates or
sublicensees, as appropriate, less the following deductions:
(a) Amounts repaid or credited by reason of timely rejections or
returns;
(b) Taxes, excises or other governmental charges upon or
measured by the production, sale, transportation, delivery or use of goods;
(c) Transportation and delivery charges actually incurred,
including shipping insurance;
(d) Normal and customary trade, cash and quantity discounts,
rebates and allowances granted to third parties, including mandatory rebates to
governmental agencies with discounts etc, which are based on multiple products
to be allocated reasonably; and
(e) Retroactive price reductions imposed by public authorities.
Notwithstanding the foregoing, amounts received by P&U or its Affiliates or
sublicensees for the sale of Licensed Products among P&U and its Affiliates or
sublicensees for resale shall not be included in the computation of Net Sales
hereunder.
1.15 "NON-PATENTED PRODUCT" means any Licensed Product, P&U's activities
with respect to which would not, in the absence of a license granted herein,
infringe a Valid Claim of any Gilead Patent in the country in which such
activity occurs or in a country where no Gilead Patent issues.
1.16 "P&U KNOW-HOW" means all proprietary inventions, technology, trade
secrets, clinical and preclinical results, and any physical, chemical or
biological material, or other information owned or acquired with right to
sublicense during the term of this Agreement by P&U or any Affiliate of P&U,
which are used in the manufacture, use or sale of Licensed Product.
1.17 "P&U PATENTS" means all patents and patent applications, both
foreign and domestic, which result from P&U's work with Licensed Product, or
cover inventions practiced by P&U in the manufacture, use or sale of Licensed
Product, and which now or at any time during the term of this Agreement are
owned by or licensed to P&U or any P&U Affiliate with the right to sublicense.
1.18 "P&U TECHNOLOGY" means P&U Patents and P&U Know-How.
1.19 "P&U TERRITORY" means initially the world excluding the United
States, its territories and possessions subject to subsequent reductions as
provided in Article 4.
6.
1.20 "PATENTED PRODUCT" means any Licensed Product, P&U's activities with
respect to which, absent the license grants set forth herein, would infringe a
Valid Claim of any Gilead Patent in the country in which such activity occurs.
1.21 "PROPRIETARY INFORMATION" means, subject to the limitations set
forth in Section 11.1 hereof, all information received by a party hereto
pursuant to this Agreement to the other party. In particular, Proprietary
Information shall be deemed to include, but is not limited to, any patent
application or drawing, any trade secret, information, invention, idea, samples
of assay components, process, formula, or test data relating to any research
project, work in process, future development engineering, manufacturing,
regulatory, marketing, servicing, financing or personnel matter relating to the
disclosing party, its present or future products, sales, suppliers, clients,
customers, employees, investors or business, whether in oral, written, graphic
or electronic form.
1.22 "SPECIFICATIONS" means those specifications for bulk Cidofovir and
all associated test methods and finished Licensed Product as defined by Gilead.
Such specifications may be modified from time to time by Gilead, as provided in
Section 6.5 below.
1.23 "VALID CLAIM" means a claim of (a) an issued patent, which claim has
not lapsed, been canceled, or become abandoned and which claim has not been
declared invalid or unenforceable by a court of competent jurisdiction in a
final decision from which no appeal has or can be taken, or (b) a patent
application, so long as such application is being diligently prosecuted.
1.24 "VISTIDE" means the intravenous formulation of Cidofovir which is
presently the subject of an application for marketing approval which has been
filed by Gilead with the CPMP under the EMEA's centralized procedure.
ARTICLE 2
GRANT OF RIGHTS
2.1 LICENSE GRANTS.
(a) GILEAD TECHNOLOGY. Subject to the terms of this
Agreement, Gilead hereby grants to P&U an exclusive license to use the Gilead
Technology only for the manufacture, importation, use, sale and offer for
sale of the Licensed Product in the P&U Territory, with a right to sublicense
its Affiliates. Gilead grants no rights to P&U to manufacture bulk cidofovir
or to import, sell or offer for sale Cidofovir in the fifty United States
provided, however, that the foregoing shall not restrict P&U from
manufacturing bulk cidofovir following the expiration of Gilead's supply
obligations under Article 6.
(b) P&U TECHNOLOGY. Subject to the terms of this Agreement,
P&U hereby grants to Gilead and its Affiliates a non-exclusive license to use
the P&U Technology only for the manufacture, importation, use, sale and offer
for sale of (i) Licensed Products outside of the P&U Territory, and (ii)
pharmaceuticals containing Cidofovir which are not Licensed Products, on a
worldwide basis, and (iii) otherwise in the performance of this Agreement.
Such license shall be royalty-free, except that if any such P&U Technology is
in-licensed by P&U and a running royalty obligation to a non-Affiliate of P&U
is applicable thereto, then such running royalty obligation shall be passed
along to Gilead. If Gilead does not agree to pay any such passed-along
amount, then the sublicense for such in-licensed technology shall not be
granted.
7.
2.2 SUBLICENSING. P&U shall have the right to sublicense the rights
granted under Section 2.1(a) to its non-Affiliates with the prior written
consent of Gilead, which consent shall not be unreasonably withheld. Gilead
shall have the right to sublicense the rights granted under Section 2.1(b) to
its non-Affiliates with the prior written consent of P&U, which consent shall
not be unreasonably withheld.
2.3 P&U RIGHT OF FIRST NEGOTIATION. Except as otherwise provided in
this Section 2.3, P&U shall have a right of first negotiation with respect to
any product or potential product in a country of the P&U Territory (other
than a Licensed Product) that Gilead intends to license to a third party
which is, or which can reasonably be expected to be, indicated for the
prevention and/or treatment of CMV infection (a "Competitive CMV Product") as
follows: Gilead shall notify P&U in writing that it intends to seek third
party licensees for a Competitive CMV Product prior to contacting any such
potential third party licensees. Such written notice shall include
sufficient detailed technical information concerning the Competitive CMV
Product as P&U may reasonably require to evaluate its interest in such
product. P&U shall notify Gilead within [ ] after receiving
Gilead's notice of such licensing opportunity whether it is interested in
negotiating with Gilead the terms under which P&U shall license such
Competitive CMV Product from Gilead. If P&U provides such notice, the
parties shall negotiate in good faith for a period of up to [ ]
after Gilead receives P&U's notice of interest (the "Negotiation Period") the
terms of an agreement pursuant to which P&U will license such Competitive CMV
Product from Gilead. Neither Gilead nor P&U shall have any obligation to
actually enter into a license with respect to a Competitive CMV Product.
Gilead shall be free to discuss licensing such Competitive CMV Product to
third parties and to grant such a license (i) if P&U does not respond to
Gilead's notice of intent to license the Competitive CMV Product within
[ ] after P&U's receipt thereof, at any time after expiration
of such [ ] period, or (ii) if Gilead and P&U fail to agree upon
the terms of a possible license to the Competitive CMV Product during the
Negotiation Period, at any time after expiration of the Negotiation Period.
The foregoing right of first negotiation shall not apply to (i) any product
which Gilead is developing and marketing independently for the treatment of
CMV infection, or (ii) any products incorporating PMEA
(9-[phosphonomethoxyethyl] adenine) or its prodrug forms, including
specifically adefovir dipivoxil (also known as GS 840 or bis-POM PMEA).
2.4 P&U ACQUISITION OF COMPETITIVE PRODUCT. In the event P&U
acquires rights to any Competitive CMV Product (either by licensing
technology from, or acquiring, a third party) in the P&U Territory, P&U shall
promptly so inform Gilead. At least [ ] before filing an
application for marketing approval for such Competitive CMV Product, P&U
shall have the option to terminate the license granted to it in Section
2.1(a) with respect to the country or countries where P&U has obtained such
product rights. If P&U does not provide notice of its intent to exercise such
option in such country or countries during such time period, Gilead may elect
at any time thereafter to convert the exclusive license granted to P&U
pursuant to Section 2.1(a) to a non-exclusive license, solely with respect to
such country or countries. Such conversion shall be effective upon receipt
by P&U of Gilead's written notice to P&U of such election. Any such
termination or conversion of P&U's license shall not otherwise affect the
parties' rights and obligations under this Agreement.
2.5 P&U ACKNOWLEDGEMENT OF OTHER GILEAD PRODUCTS. P&U acknowledges
that Gilead has entered into a License and Supply Agreement with American
Home Products for the development and worldwide marketing of topical
ophthalmic formulations of Cidofovir, and that Gilead is developing
independently a topical gel formulation of Cidofovir which is not a
Competitive CMV Product. P&U also confirms its understanding that Gilead
maintains an active program to develop prodrugs of Cidofovir, the most
advanced of which is cyclic HPMPC (or GS 930). P&U confirms its understanding
that these other formulations and products, among others, are not included in
the license granted to P&U under this Agreement.
[*] CONFIDENTIAL TREATMENT REQUESTED
8.
2.6 MAINTENANCE OF LICENSES TO GILEAD OF GILEAD PATENTS. Gilead
shall use diligent efforts to maintain valid licenses to the Gilead Patents
which are in-licensed by Gilead and listed on Exhibit A as of the Effective
Date. Gilead shall give prompt notice to P&U when it becomes aware of the
possibility of a breach or default of any such license. Both parties shall
meet and mutually determine an appropriate course of action to prevent such a
breach or default.
ARTICLE 3
DEVELOPMENT AND REGULATORY AFFAIRS
3.1 JOINT STRATEGIC COMMITTEE.
(a) JSC MEMBERSHIP AND GOVERNANCE. The parties shall establish
a Joint Strategic Committee to coordinate the clinical, regulatory,
manufacturing and commercial activities of the parties with respect to Licensed
Product in their respective territories. Each party shall within thirty (30)
days after the Effective Date select three (3) representatives to serve as
members of the JSC. Each party may select additional representatives to replace
the initial JSC members selected by such party as necessary during the term of
the Agreement. Any JSC members selected by one party shall be subject to the
approval of the other party. P&U shall appoint the Chairperson of the JSC for
the first year of the term of this Agreement, and upon the first anniversary of
the Effective Date, Gilead shall appoint the Chairperson of the JSC for the
following year. The parties will similarly alternate responsibility for
appointing the JSC Chairperson for subsequent one-year terms during the term of
this Agreement. The JSC shall attempt to operate by consensus, and any issues
that the JSC is unable to resolve by consensus shall be submitted for resolution
pursuant to Article 14. The Chairperson of the JSC shall be responsible for
providing an agenda for each JSC meeting at least ten (10) days in advance of
such meeting and shall prepare written minutes of all JSC meetings in reasonable
detail. The Chairperson shall distribute such minutes to all JSC members within
twenty (20) days after the relevant JSC meeting.
(b) JSC MEETINGS AND RESPONSIBILITIES. The JSC shall meet at
least two (2) times per year during the term of this Agreement, provided that
either party may request additional meetings as reasonably required. The JSC
will provide the primary means of communication between the parties regarding
the clinical development, regulatory approval and marketing of Licensed
Products. The parties shall report to the JSC on all material clinical,
regulatory and marketing issues relating to Licensed Products, and the JSC shall
make recommendations and provide strategic guidance with respect to such issues.
Specifically, each party shall submit to the JSC any plan relating to
publications, symposia or marketing meetings, marketing efforts, clinical
development efforts (including any pre- and post-marketing clinical trials),
regulatory plans, advertising and promotional materials relating to Licensed
Products, and the labelling of Licensed Products, in advance of its
implementation thereof. Additionally the JSC shall serve as a forum for
discussion of opportunities for cost sharing where such activities would have
mutual benefit. Each party shall submit to the JSC its plans for any clinical
trials of Licensed Product in advance of the anticipated commencement date
thereof. Neither party shall commence any clinical trial of the Licensed
Product until the JSC has approved the plans therefor; provided, however that
Gilead shall not be required to obtain prior JSC approval of any Phase IV
clinical trial of Vistide which was agreed to by Gilead with the U.S. FDA prior
to the Effective Date in connection with obtaining marketing approval, or any
clinical trial of Licensed Product agreed to by Gilead with clinical
investigators prior to the Effective Date. The parties shall present their
plans for commercializing Licensed Products to the JSC, which shall work with
the parties to help formulate a consistent, worldwide commercialization strategy
for Licensed Products.
9.
3.2 GILEAD'S OBLIGATIONS.
(a) DISCLOSURE OF GILEAD KNOW-HOW. Following the Effective Date
and through the term of this Agreement, Gilead shall make available to P&U,
subject to the terms of this Agreement, all Gilead Know-How, PROVIDED, HOWEVER,
that Gilead shall not be obligated to transfer Gilead Know-How which relates to
the manufacture of bulk Cidofovir, except to the extent required for regulatory
purposes or to satisfy its customary internal requirements for quality control.
(b) REGULATORY FILINGS. Gilead shall provide P&U with letters
of reference to its dossier of regulatory filings for Licensed Products in the
Territory, including the drug master file regarding the manufacture of bulk
Cidofovir and any other comparable files. Gilead shall also provide reasonable
technical assistance required by P&U in connection with the regulatory filings
referred to in Section 3.3, at no additional cost to P&U. Gilead shall provide
additional information as may be required by the regulatory authorities of a
particular country within the P&U Territory if a letter of reference is not
sufficient for that country.
(c) CENTRALIZED CPMP APPROVAL OF VISTIDE; SUBSEQUENT TRANSFER
OF MAA. Gilead, as approved by the JSC, will perform [
]any additional clinical trials and make regulatory filings necessary
to obtain marketing approval of Vistide by the CPMP under the EMEA's
centralized licensing procedure. Gilead shall be the primary party
responsible for all communications with regulatory authorities in connection
with such filings, especially in regard to providing medical expertise,
provided that P&U will have a right to participate in all meetings between
Gilead and such authorities relating to development of Licensed Product under
this Agreement. As provided in Section 3.3, after Gilead has obtained CPMP
approval of Vistide, P&U shall be the primary party responsible for obtaining
any other required national or local reimbursement and pricing approvals and
agreements for Vistide in the European Union countries. Gilead shall
transfer to P&U the marketing authorization application ("MAA"), or resulting
marketing authorization ("MA") covering Vistide, which is presently held by
Gilead Sciences Limited, a U.K. company wholly owned by Gilead. The parties
agree to effect such transfer in the manner most convenient to the parties
which conforms with applicable regulatory requirements. Each party shall
bear its own expenses incurred in connection with such transfer, except that
any transfer-related filing fees shall be divided equally by the parties. If
such transfer occurs by means of the sale of Gilead Sciences Limited, the
purchase price shall be equal to Gilead's invested capital (which is
nominal), P&U shall promptly thereafter change the name of such entity so as
not to include the name of "Gilead", and Gilead shall indemnify P&U for any
liabilities of such company incurred prior to the date of such sale.
3.3 P&U'S OBLIGATIONS.
(a) DISCLOSURE OF P&U KNOW-HOW. Subject to Section 2.1(b), P&U
shall disclose to Gilead any P&U Know-How which is discovered or developed
during the term of this Agreement.
(b) REGULATORY FILINGS. Except as provided in Section 3.2(c),
P&U will file such additional regulatory filings as may be necessary for the
sale of Licensed Product within the P&U Territory in its own name. P&U will be
responsible for all communications with regulatory authorities in connection
with such filings provided that Gilead will have the right to participate in all
meetings between P&U and such regulatory authorities relating to the development
or marketing of Licensed Products under this Agreement. P&U will keep Gilead
informed of the progress of such filings in each country, and will provide
Gilead with at least fifteen (15) days advance notice of the final submission of
an application for marketing approval in any country of the P&U Territory. P&U
will provide Gilead with access to all regulatory filings with respect to
Licensed Product made in the P&U Territory, and will
[*] CONFIDENTIAL TREATMENT REQUESTED
10.
promptly advise Gilead when it has obtained marketing approval, reimbursement
approval, or pricing approval of Licensed Products in each country.
3.4 DEVELOPMENT COSTS. P&U shall be responsible for the [
] clinical trials of Licensed Product in the P&U Territory including
expanded access or compassionate use programs, [
] of all
external development costs which are approved by the JSC and which are (i)
required in order to obtain marketing approval of Licensed Product in countries
of the P&U Territory, or (ii) required in order to improve approved product
labelling. In Japan, [
] subject to advance budget approval by the JSC. [
] From time to time, the parties
may agree to allocate the costs of clinical trials of Licensed Product in a
manner other than that set forth in this Agreement.
3.5 CLINICAL MATERIALS. Gilead shall timely supply P&U with such
quantities of Licensed Product in final form as may be reasonably required by
P&U for the conduct of clinical trials. P&U will reimburse Gilead for its
actual costs of manufacturing such material as set forth in Article 6.
3.6 ADVERSE REACTIONS. The parties agree that, to the extent permitted
by applicable law, Gilead shall be responsible outside of the P&U Territory for
the reporting of adverse events related to the use of Licensed Product, and P&U
shall be responsible inside the P&U Territory for the reporting of such adverse
events. In this regard, each party agrees to advise regulatory authorities of
the other's role and to conform with the adverse event reporting procedures of
the countries in which they are marketing Licensed Products. The parties shall
agree upon standard operating procedures for reporting such adverse events to
governmental regulatory authorities and to each other prior to the date of First
Commercial Sale of Licensed Product in any country in the P&U Territory. Any
modifications to the standard procedure for adverse event reporting shall be
effective only upon the mutual consent of the parties. The provisions of this
Section 3.6 shall survive termination of this Agreement so long as both parties
are marketing Licensed Products.
3.7 INTRAOCULAR CLINICAL DEVELOPMENT. The JSC will meet to agree upon a
clinical development plan for the intraocular formulation of cidofovir which
shall have the same development costs sharing arrangement between the Parties as
for Vistide under Section 3.4.
ARTICLE 4
DUE DILIGENCE
4.1 MARKETING APPROVAL. P&U shall devote its Best Efforts to obtain
marketing approval for Licensed Product in substantially all markets in the P&U
Territory and to achieve First Commercial Sale of Licensed Product on a timely
basis thereafter in each country where approval is obtained. [
]
[*] CONFIDENTIAL TREATMENT REQUESTED
11.
4.2 TERRITORIAL DILIGENCE. Specifically, to maintain its license
rights under Section 2.1(a) in each country of the P&U territory, P&U shall
use Best Efforts to obtain marketing, pricing and reimbursement approval for
each country in the P&U Territory (subject to approval by the JSC and Section
4.2 (b) below) and to achieve First Commercial sale of Licensed Product in
each such country within [ ] of receiving all required
approvals. For Japan the Parties agree to [
]
If P&U fails to satisfy such diligence standards in any particular country
in the P&U Territory, Gilead shall have the right to notify P&U of its intent to
terminate P&U's license in such country. Upon receipt of such notice, P&U shall
have a sixty (60) day period within which to submit to Gilead a specific,
written plan to achieve regulatory and, where required, pricing and
reimbursement approvals and its action steps for First Commercial Sale of
Licensed Product within the country in question within [ ] after
regulatory and, where required, pricing and reimbursement approval. The efforts
of P&U sublicensees shall be treated as efforts of P&U for purposes of this
Section 4.2. If P&U later fails to make the First Commercial Sale of Licensed
Product within such additional [ ] period, the countries shall be
excluded from the definition of P&U Territory upon ninety (90) days' advance
written notice from Gilead, except if such delay is shown to be outside the
control of P&U.
(a) REPORTS. Each Party shall provide regular reports to the
JSC concerning the development and marketing of Licensed Product in the various
countries of the world.
(b) EXCEPTIONS. Nothing in this Section 4.2 shall require P&U
to develop or market the Licensed Product in any country in which by reason of
pricing restrictions, costs of doing business, or other reasons P&U can
demonstrate to Gilead's satisfaction (not to be unreasonably withheld) that P&U
would reasonably not choose to market Licensed Product in view of market
potential, profit potential or strategic purpose in view of conditions then
prevailing in such country (either directly or by reason of the effect that such
activity would have on other markets for the Licensed Product). It is
specifically understood that any request by P&U for relief under this Section
4.2(b) shall be accompanied by a specific and detailed economic analysis
presenting the basis for its conclusion. P&U shall not lose any license rights
for failure of diligence under Article 4 in any territory in which P&U is able
to demonstrate P&U's reasoning to Gilead's satisfaction. In addition, P&U may
propose to the JSC that regulatory approval for Licensed Product not be sought
or obtained in a particular country. P&U shall not be relieved of its
obligations under this Section 4.2 unless Gilead consents to removing such
country from P&U's diligence obligations or delaying the time periods set forth
above to take into account unforeseen circumstances.
ARTICLE 5
COMPENSATION
5.1 LICENSE FEE. P&U shall pay to Gilead a license fee of ten million
dollars ($10,000,000) within ten (10) days of the Effective Date. Such license
fee shall be nonrefundable and noncreditable.
5.2 MILESTONE PAYMENT. P&U shall pay to Gilead a ten million dollar
($10,000,000) milestone payment within thirty (30) days after its receipt of
notice from Gilead that the CPMP has issued a decision granting a marketing
authorization for Vistide. Such milestone payment shall be nonrefundable and
noncreditable.
5.3 ROYALTY PAYMENTS ON NET SALES. P&U shall make royalty payments to
Gilead on Net Sales of Licensed Products in the P&U Territory, payable on a
quarterly calendar basis ("Royalty Payments"). Royalty Payments shall be
calculated on Net Sales of Patented Products as set forth in
[*] CONFIDENTIAL TREATMENT REQUESTED
12.
subsection (a) below and shall be calculated on Net Sales of Non-Patented
Products as set forth in subsection (b) below.
(a) PATENTED PRODUCTS ROYALTY. [
]
(b) NON-PATENTED PRODUCTS ROYALTY. [
]
(c) ADJUSTMENT FOR PACKAGED PRODUCT. In the event Licensed
Product is sold as a package with other products (a "Packaged Product"), then
the Net Sales applicable to such sale of the Packaged Product shall be
determined in a fair and reasonable manner.
(d) PAYMENT FOR NON-PATENT BENEFITS. In establishing a
structure which provides for a lower Royalty Payment for Non-Patented Products,
the parties recognize, and P&U acknowledges, the substantial value of the
various actions being taken by Gilead under this Agreement, in addition to the
grant of a patent license, to enable the rapid and effective market introduction
of the Licensed Products in the P&U Territory. These actions include, by way of
example, the completion of the CPMP approval process and the transfer of the
MAA; ongoing access to Gilead regulatory filings; the supply commitments set
forth in Article 6; the willingness to transfer manufacturing know-how; the
licenses under the Gilead Know-How and trademarks; and ongoing access to
improvements in the Licensed Products made by Gilead during the term of this
Agreement, including the possible introduction of an intraocular formulation of
Cidofovir. The parties agree that the Royalty Payment (plus the license fee,
supply payments, and the cost reimbursements provided for elsewhere herein)
provides fair compensation to Gilead for these
[*] CONFIDENTIAL TREATMENT REQUESTED
13.
additional benefits in the case of the sale of Patented Products, and that
because Gilead is not being otherwise compensated under this Agreement for
such additional benefits, a lesser Royalty Payment is appropriate for the
sale of Licensed Products not covered by Gilead Patents. The parties have
agreed to the payment structure set forth herein as a convenient and fair
mechanism to compensate Gilead for these additional benefits.
5.4 QUARTERLY PAYMENT MECHANISM; YEAR-END RECONCILIATION. For each of
the first three calendar quarters of each calendar year in which a Royalty
Payment is due, P&U shall make a payment to Gilead equal to (i) P&U's total Net
Sales of Patented Products and Non-Patented Products during such quarter
multiplied by (ii) the total Royalty Payment that was due with respect to the
previous calendar year divided by the total Net Sales of Patented Products and
Non-Patented Products during such previous calendar year. During the first
calendar year of this Agreement during which there are Net Sales, the rate under
(ii) above shall be [ ] The payment due with respect to the final calendar
quarter of the year shall be equal to the total Royalty Payment due for such
year less the aggregate Royalty Payments made with respect to the first three
quarters of the year. (Thus, during the first three calendar quarters of each
calendar year, the Royalty Payment shall be made on the basis of the average
rate applicable to Net Sales during the previous year. At the end of the year,
a reconciliation shall occur so that the actual payments for the year as a whole
are equal to the amount due under Section 5.3.)
5.5 SUBLICENSE. In the event P&U sublicenses its right to sell Licensed
Product, such sublicenses shall include an obligation for the sublicensee to
account for and report its Net Sales of Licensed Products on the same basis as
if such sales were Net Sales of Licensed Products by P&U, and P&U shall pay
Royalty Payments to Gilead as if the Net Sales of the sublicensee were Net Sales
of P&U.
5.6 EXPIRATION OF ROYALTY PAYMENT OBLIGATIONS. On a country-by-country
and product-by-product basis, P&U's Royalty Payment obligations (i) with respect
to Patented Products shall expire upon the date on which P&U's activities with
respect to a Licensed Product no longer infringe a Valid Claim of a Gilead
Patent in such country, and (ii) with respect to Non-Patented Products shall
expire on the date which is [ ] after the date of First Commercial
Sale of such product in such country. Upon expiration of P&U's Royalty Payment
obligations in a country with respect to a Licensed Product, P&U's exclusive
license under Gilead Know-How in such country shall convert with no further
action required to a nonexclusive license, and P&U may thereafter continue to
sell such Licensed Product in such country on a royalty-free basis. Thereafter,
Gilead may obtain marketing approval and market such product in such country, at
Gilead's sole expense, with no obligation to P&U.
ARTICLE 6
SUPPLY AND MANUFACTURING
6.1 SUPPLY OF CIDOFOVIR. Subject to the terms and conditions of this
Article 6, Gilead shall supply to P&U all of its requirements of bulk Cidofovir
for sales of Licensed Products in the P&U Territory; P&U shall not obtain bulk
Cidofovir from a third party or manufacture it directly without Gilead's written
consent. Such supply obligation shall terminate upon the expiration of the last
Gilead Patent. P&U will be responsible for obtaining supply of finished
Licensed Product, by manufacturing directly or through a third party. It is
understood by Gilead that P&U wishes to enter into a direct manufacturing
agreement with Ben Venue to provide for at least the initial supply of finished
Licensed Product. Gilead shall assist P&U in consummating this agreement.
6.2 TECHNOLOGY TRANSFER. Gilead shall cooperate in the timely transfer
of Gilead Technology relating to the manufacture of finished Licensed Product to
P&U or its sublicensee approved
[*] CONFIDENTIAL TREATMENT REQUESTED
14.
by Gilead. Gilead will have the right to test and approve samples from the
first three (3) lots of finished Licensed Product manufactured by P&U prior to
release for commercial distribution. Any such transfer of Gilead Technology
shall be subject to the confidentiality obligations of the parties hereunder.
Such technology transfer shall be provided without charge to P&U, except that if
any Gilead or other personnel need to travel in order to effect such transfer,
the costs of such travel and associated lodging and other expenses shall be
borne by P&U.
6.3 SUPPLY OF INTRAOCULAR CIDOFOVIR. The parties intend that Gilead
shall supply P&U with clinical materials for intraocular Cidofovir, but that P&U
will obtain its own source of manufacturing capacity for commercial quantities
of intraocular Cidofovir. In such event, subject to the termination provisions
of Section 9.3, Gilead shall supply such quantities of bulk Cidofovir as may be
ordered by P&U to enable the production of intraocular Cidofovir.
6.4 SUPPLY PRICES. [
]
6.5 SPECIFICATIONS. Promptly following execution of this Agreement,
Gilead shall deliver to P&U its current specifications for bulk Cidofovir (the
"Specifications"), which are consistent with those set forth in the applications
for marketing approval of Vistide filed by Gilead in the United States and
Europe. The parties recognize that Gilead may hereafter make changes to the
Specifications for bulk Cidofovir. Any changes in the Specifications which
requires regulatory approval, or materially and demonstrably adversely affects
the Licensed Product as then being developed or sold by P&U, may be made by
Gilead only with the prior written approval of P&U. Any changes in the
Specifications which do not require regulatory approval, and do not materially
and demonstrably adversely affect the Licensed Product as then being developed
or sold by P&U, may be made by Gilead upon written notice to P&U. In no event
shall Gilead cease to supply P&U with bulk Cidofovir conforming to the old
Specifications until P&U has obtained the necessary approvals provided, however,
that P&U shall make a good faith effort to obtain the necessary approvals in a
timely fashion.
6.6 FORECASTS AND ORDERS. P&U shall provide Gilead with rolling
forecasts of its expected requirements of bulk Cidofovir over the next 18
months. Forecasts shall be due quarterly and shall set forth (i) P&U's actual
requirements for the following two quarters, which portion of the forecast shall
be binding and serve as an order for bulk Cidofovir, and (ii) P&U's best
estimate of its requirements for the following four quarters. Gilead shall
deliver the bulk Cidofovir ordered for delivery by the start of each calendar
quarter, but in no event shall Gilead be required to deliver more Cidofovir in
any given quarter than was estimated for such quarter in the last two applicable
forecasts. In addition, except with the written consent of Gilead, P&U may not
increase its forecast of any material requirements in a
[*] CONFIDENTIAL TREATMENT REQUESTED
15.
particular calendar quarter by more than twenty five percent (25%) from its
forecast for such quarter during its immediately preceding forecast.
6.7 ACCEPTANCE; SHIPMENT AND RISK OF LOSS.
(a) ACCEPTANCE. Gilead (directly or through its supplier) shall
test a portion of each batch in each delivery of Cidofovir and supply P&U with a
sample of bulk Cidofovir and a certificate of analysis ("CERTIFICATE OF
ANALYSIS") confirming that such batch meets the Specifications. P&U may then
retest the Cidofovir to confirm that it meets Specifications. P&U may reject
any batch of Cidofovir for failure to meet Specifications by providing written
notice to Gilead within fifteen (15) days of P&U's receipt of such batch. In
the event that P&U rejects any batch of Cidofovir, Gilead shall use its Best
Efforts to supply P&U with replacement material within thirty (30) days after
Gilead receives P&U's written notice of rejection. If Gilead agrees that the
batch did not meet Specifications, such replacement batch shall be provided
without charge. If Gilead disagrees with P&U's determination that certain
material does not meet the Specifications, such material shall be submitted to a
mutually acceptable third party laboratory. Such third party laboratory shall
determine whether the material in question meets the Specifications and the
parties agree that such laboratory's determination shall be final and
determinative. The party against whom the third party tester rules shall bear
all costs of the third party testing. If the third-party tester rules that the
batch fails to meet Specifications, Gilead's replacement of the batch shall be
at no charge to P&U. If the third party tester rules that the batch did meet
Specifications, P&U shall accept such batch for use or reimburse Gilead's cost
of manufacture. If for any reason P&U does not use a batch of material
delivered to it by Gilead, it shall destroy or return such batch of material, as
directed by Gilead.
(b) SHIPMENT; RISK OF LOSS. Unless otherwise agreed to in
writing, all shipments shall be F.O.B the place of manufacture. Material
supplied under this Article 6 shall be made available for shipment upon
acceptance of the relevant sample in accordance with Section 6.9(a). Shipment
shall occur by such method and carrier as P&U may designate, and all
transportation expenses for the delivery of material to P&U shall be borne by
P&U. P&U shall bear the risk of loss of any material following shipment from
the place of manufacture.
(c) MINIMUM INVENTORIES. P&U acknowledges the inherent risk
that a batch of bulk or finished product may be lost in production or shipment,
and agrees to maintain an inventory of materials it purchases from Gilead
sufficient to supply at least ninety (90) days worth of P&U's requirements in
the event of late delivery by Gilead.
6.8 INVOICES. Gilead will invoice P&U for each batch of material
supplied to P&U under this Article 6. P&U shall pay such invoices within
[ ] of receipt of goods. Any invoiced amount which is not paid
within [ ] period shall be assessed a late payment fee at
the rate of 10% per annum or the maximum rate permitted by applicable law
with respect to such payment obligations, whichever is less.
6.9 SHORTAGES OF SUPPLY. If Gilead is unable to supply quantities of
bulk Cidofovir ordered by P&U in accordance with this Article 6, then, unless
the parties otherwise agree at the time, Gilead shall allocate the available
bulk Cidofovir, as the case may be, between itself and P&U on a pro rata basis
in accordance with the respective utilization of each party of the material in
question in the four calendar quarters immediately preceding the quarter in
which such shortage occurs. In such event, Gilead shall further use its
reasonable efforts to remedy the shortage in question. The product allocation
provided in this Section 6.9 shall be the sole remedy of P&U in the event of
such a supply shortage, and Gilead shall not have monetary liability as a result
of such supply shortage.
[*] CONFIDENTIAL TREATMENT REQUESTED
16.
ARTICLE 7
MARKETING
7.1 PROMOTION AND MARKETING EFFORTS. Upon gaining the necessary
regulatory, pricing and reimbursement approvals, P&U and/or its sublicensees
shall use its Best Efforts to promote and market the Licensed Product in all
countries in the P&U Territory (except in those countries where the provisions
of Article 4 do not require such marketing). Any sublicense of marketing rights
by P&U shall include a covenant for such sublicensee to use Best Efforts to
maintain and increase sales of the Licensed Product in each country covered by
the sublicense.
7.2 PRICING. P&U shall determine, in its sole discretion, the pricing,
discounting policy and other commercial terms relating solely to Licensed
Products.
7.3 TRADEMARKS. P&U shall sell Licensed Product under the mark
"Vistide" and other trademarks selected and owned by Gilead to the extent
allowed by regulatory authorities in the P&U Territory. In the event such
authorities do not permit P&U to use the Gilead trademarks, P&U shall select and
own its own trademarks for the commercialization of Licensed Product. Gilead
hereby grants P&U a limited license to the use of the Gilead marks, trade names
and logos to be designated by Gilead in connection with the commercialization
activities provided for herein (collectively, the "Marks") for the sole purpose
of selling Licensed Products in the P&U Territory. Such license shall be
exclusive so long as P&U is making Royalty Payments to Gilead under Article 5,
and thereafter shall be perpetual with respect to the name "Vistide" and other
product names and logos previously designated by Gilead specifically for
Licensed Product, but shall expire with respect to Marks used more generally by
Gilead. P&U may sublicense its rights under this Section 7.3 to its non-
Affiliates with the prior written consent of Gilead, which consent shall not be
unreasonably withheld. P&U shall submit any materials bearing the Gilead Marks
to Gilead for approval prior to using such materials to commercialize Licensed
Products, and Gilead shall not unreasonably withhold such approval. P&U will
not take any action which may damage the goodwill associated with the Gilead
Marks and will not damage the reputation for quality associated with the Gilead
Marks. Except as provided in this Section 7.3, P&U shall have no right or
interest in any Gilead trademark used in association with any Gilead product.
7.4 USE OF THE GILEAD NAME. Gilead and P&U agree that the packaging and
promotional materials for the Licensed Product marketed by P&U and/or P&U's
sublicensees shall identify Gilead as developer and licensor, to the extent that
P&U can reasonably accommodate same. P&U hereby acknowledges Gilead's ownership
of the Gilead Sciences name. Gilead hereby agrees to indemnify and hold P&U
harmless from any use hereunder of the Gilead Sciences name in connection with
Licensed Product in the P&U Territory which occurs with the consent of Gilead,
provided that P&U provides Gilead prompt notice of any such claim and grants to
Gilead the exclusive ability to defend (with the reasonable cooperation of P&U)
and settle any such claim. If only one name is allowed pursuant to governmental
laws or regulations, then P&U may use its name alone, without identifying Gilead
as developer and licensor.
7.5 DISTRIBUTION OF LICENSED PRODUCT. P&U shall be responsible for
distribution of Licensed Product in the P&U Territory. Gilead shall apply for
exemptions or waivers available under U.S. export control laws applicable to the
shipment of Licensed Products to locations designated by P&U.
7.6 EXPORT CONTROL. This Agreement is made subject to any restrictions
concerning the export of products or technical information from the United
States of America or other countries which may be imposed upon or related to
Gilead or P&U from time to time. Each party agrees that it will not
17.
export, directly or indirectly, any technical information acquired from the
other party under this Agreement or any products using such technical
information to a location or in a manner that at the time of export requires an
export license or other governmental approval, without first obtaining the
written consent to do so from the appropriate agency or other governmental
entity.
ARTICLE 8
PAYMENTS; RECORDS; AUDIT
8.1 PAYMENT; REPORT. All amounts payable to either party under this
Agreement shall be paid in U.S. dollars within [ ] of the end
of each calendar quarter or as otherwise specifically provided herein. Each
payment of Royalty Payments shall be accompanied by a statement, country by
country, of the amount of Net Sales during such quarter and on a cumulative
basis for the current year and the amount of Royalty Payments or other
payments due on such sales. An itemized calculation of [
] as described in
Section 6.4 will also be provided together with quarterly payments.
8.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. All payments due
hereunder from time to time shall be paid in U.S. Dollars. For purposes of
computing such payments, the Net Sales of Licensed Product sold for foreign
(i.e., non-United States) funds shall first be determined in the foreign funds
for which such Licensed Product is sold and then converted to its equivalent in
the U.S. Dollars. Conversion of the amounts of Net Sales from local currencies
to U.S. dollars will be made using the same method by P&U in the normal
conversion of financial statements for internal and external reporting purposes
on a monthly basis using at least three (1st, 15th and end of month) exchange
rates as published by the local country source customarily used by P&U in the
month in which sales were invoiced.
Notwithstanding the foregoing, if by reason of any restrictive
exchange laws or regulations, P&U shall be unable to convert to U.S. Dollars the
amount, determined as above, equivalent to the amount due by P&U hereunder, then
P&U shall so notify Gilead promptly and provide an explanation of the
circumstances. In such event, P&U shall make all such payments or the balance
thereof due hereunder and which is not paid in foreign currency as provided
below, in U.S. Dollars as soon as reasonably possible after and to the extent
that such restrictive exchange laws or regulations are lifted so as to permit
P&U to pay amounts due under this Section 8.2 in U.S. Dollars. P&U shall
promptly notify Gilead if such restrictions are so lifted. At its option Gilead
shall meanwhile have the right to request the payment (to it or to its nominee),
and, upon request, P&U shall pay or cause to be paid amounts due (or such
portions thereof as are specified by Gilead) in the currency of any other
country designated by Gilead and legally available to P&U under the then-
existing laws or regulations. Any payments shall be payable to Gilead by wire
transfer at such bank in the United States as Gilead shall specify from time to
time. Not less than one (1) business day prior to such wire transfer, the
remitting party shall telefax the receiving party advising it of the amount and
of the payment to be made.
8.3 RECORDS AND AUDIT.
(a) P&U shall keep complete and accurate records pertaining to
the sale or other disposition of the Licensed Product and of the Royalty
Payments and other amounts payable under this Agreement in sufficient detail to
permit Gilead and/or its licensors to confirm the accuracy of all payments due
hereunder. Gilead shall have the right to cause an independent, certified
public accountant to which P&U has no reasonable objection to audit such records
to confirm P&U's Net Sales and Royalty Payments including supply price
adjustments as described in Section 6.4 for the preceding year. Such audit
rights may be exercised no more often than once a year, within three (3) years
after the Royalty Payment period
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18.
to which such records relate, upon notice to P&U and during normal business
hours. Gilead will bear the full cost of such audit unless such audit discloses
an underpayment of more than five percent (5%) from the amount of Royalty
Payments due. In such case, P&U shall bear the full cost of such audit. The
terms of this Section 8.3 (a) shall survive any termination or expiration of
this Agreement for a period of three (3) years.
(b) Upon reasonable notice, P&U may perform GMP audits of Gilead
facilities, or contract manufacturers for Gilead, as they are or might be used
in the production of items controlled in the registration applications under
Paragraph 3.2(c) when the registration transfers to P&U or Paragraph 3.2(b) when
P&U successfully gains its own approvals. Expenses for such audits will be
borne by P&U.
8.4 WITHHOLDING TAXES. All payments made by P&U to Gilead under this
Agreement and the Stock Purchase Agreement shall be made free and clear of any
deductions or withholdings except to the extent provided for in this Section
8.4. Any and all taxes levied on account of Royalty Payments paid or owed from
a country in which provision is made in the law or by regulation for withholding
will be deducted from Royalty Payment paid Gilead hereunder. P&U shall
cooperate with Gilead to claim exemption from such deductions or withholdings
under any double taxation or similar agreement in force from time to time and
shall endeavor to secure any such exemptions before Royalty Payments are made
hereunder. If P&U makes any payment without reduction for withholding and it
later transpires that an amount of tax should have been withheld on such Royalty
Payment ("under withheld tax"), P&U shall be entitled to recover the under
withheld tax by an additional withholding from any payment due to Gilead under
this Agreement. Similarly, if P&U withholds an amount of tax which is later
determined to have not been due, P&U shall reimburse Gilead for such over
withheld amounts.
ARTICLE 9
TERM AND TERMINATION
9.1 TERM. The term of this Agreement shall commence upon the Effective
Date and, unless sooner terminated as provided in this Article 9, expire on the
expiration of all the Royalty Payment obligations set forth under Article 5.
9.2 LICENSES UPON EXPIRATION. In the event that the Agreement expires
as set forth in Section 9.1 above without early termination, the license granted
under Section 2.1 with respect to the Gilead Technology shall automatically
become a non-exclusive, irrevocable, fully-paid license to use and/or sublicense
the use of Gilead Know-How to manufacture, use and sell the Licensed Products
worldwide. In any event of termination of this Agreement by reason other than
breach of this Agreement by Gilead, the licenses to Gilead set forth in Section
2.1(b) shall survive.
9.3 TERMINATION FOR BREACH. Each party shall have the right to
terminate this Agreement and its obligations hereunder for material breach by
the other party, which breach remains uncured for ninety (90) days after written
notice is provided to the breaching party, or in the case of an obligation to
pay Royalty Payments or other amounts owing under this Agreement, which breach
remains uncured for thirty (30) days after written notice to the breaching party
unless there exists a bona fide dispute as to whether such Royalty Payments or
other amounts are owing. Notwithstanding any termination under this Section 9.3,
any obligation to pay Royalty Payments which had accrued or become payable as of
the date of termination shall survive termination of this Agreement.
19.
9.4 TERMINATION IN EVENT OF PATENT CHALLENGE. Gilead shall have the
right to terminate this Agreement if P&U challenges the validity of the Gilead
Patents within any country in the P&U Territory effective thirty (30) days after
P&U's receipt of written notice of such termination by Gilead.
9.5 UNCONDITIONAL RIGHT TO TERMINATE. P&U may in its sole
discretion terminate this Agreement in whole but not in part by providing
[ ] written notice to Gilead, provided that such termination
shall not be effective until at least [ ] after the Effective Date.
Termination under this provision will not relieve P&U of any obligation
occurred prior to termination, such as confidentiality, payments and other
provisions which by their nature would survive termination.
9.6 REVERSION OF PRODUCT RIGHTS. In the event that a party terminates
this Agreement pursuant to Sections, 9.3, 9.4 or 9.5 above, all licenses granted
to the other party under Section 2.1 hereof shall terminate. In the event that
P&U permanently loses its right to use and sell the Licensed Product in any
country other than by reason of any action or failure to act on the part of
Gilead or any party acting on behalf of Gilead, all licenses granted under
Section 2.1(a) hereof shall terminate in such country.
9.7 SURVIVAL. Articles 1, 9, 11, 12, 14 and 15 and Section 3.6 of this
Agreement shall survive termination of this Agreement for any reason (subject to
any subsequent dates of termination referred to in such individual Articles).
ARTICLE 10
INTELLECTUAL PROPERTY
10.1 PROSECUTION OF PATENTS. Gilead Patents shall be prosecuted and
maintained by Gilead or its licensors, at Gilead's expense. P&U Patents shall
be prosecuted and maintained by P&U, at its expense. In the event that Gilead
elects not to maintain any issued patent within the Gilead Patents or not to
file any patent term extensions to the Gilead Patents which P&U believes are
appropriate to obtain an extended period of market exclusivity for Licensed
Product, Gilead will offer to assign such patent rights to P&U. If P&U elects
to take over responsibility for such patent rights any license obligations which
specifically relate to such patent rights are terminated, i.e., royalties for
Patented Products.
10.2 INFRINGEMENT OF PATENTS BY THIRD PARTIES.
(a) NOTIFICATION. Each party shall promptly notify the other in
writing of any alleged or threatened infringement of the Gilead Patents of which
it becomes aware.
(b) GILEAD PATENTS. Gilead shall have the right, but not the
obligation, to bring, at Gilead's expense and in its sole control, an
appropriate action against any person or entity infringing a Gilead Patent
directly or contributorily. If Gilead does not bring such action within ninety
(90) days of notification thereof to or by P&U, P&U will have the right to bring
such action at P&U's sole expense and will be entitled to all relief and damages
awarded. In either situation, P&U or Gilead will fully cooperate with the
responsible party at the responsible party's expense. Such cooperation shall
include, if required in order to bring such an action, providing information
relating to infringement.
10.3 INFRINGEMENT OF THIRD PARTY RIGHTS. In the event that any Licensed
Product manufactured, used or sold under this Agreement becomes the subject of a
third party claim for patent or trademark infringement anywhere in the world,
and irrespective of whether Gilead or P&U is charged
[*] CONFIDENTIAL TREATMENT REQUESTED
20.
with said infringement, and the venue of such claim, the parties shall promptly
meet to consider the claim and the appropriate course of action. Unless the
parties otherwise agree, the party against which such third party infringement
claim is brought shall defend against such claim at its sole expense and the
other party shall have the right, but not the obligation, to participate in any
such suit, at its sole option and at its own expense. Such other party shall
reasonably cooperate with the party conducting the defense of the claim,
including if required to conduct such defense, furnishing a power of attorney.
Neither party shall enter into any settlement that affects the other party's
rights or interests without such other party's written consent, which consent
shall not be unreasonably withheld. If in the opinion of P&U's counsel, a
license with respect to such third party patents or trademarks is necessary to
enable P&U to continue to make, use, sell offer for sale or import Licensed
Product, then P&U shall notify Gilead of such conclusion and the basis for it
and give Gilead a reasonable opportunity to oppose such claim. In the event
that Gilead elects not to oppose the claim or does not successfully obtain any
necessary license, P&U shall have the right to negotiate directly with such
third party for a license. Fifty percent (50%) of any royalty payable to a
third party by P&U necessary to make, use or sell Licensed Product will be
deductible from any royalty due Gilead but no such deduction will be more than
fifty percent (50%) of any amount due Gilead in a reporting period. Any third
party royalties not deductible in any one reporting period may be carried over
to the next reporting period until extinguished.
10.4 PATENT MARKING. P&U shall mark Licensed Products with appropriate
patent numbers or indicia at Gilead's instruction and election, as, when and
where P&U may reasonably accommodate same, given packaging, printing schedules
and other factors, in those countries where markings have notice value as
against infringers.
10.5 JSC REVIEW OF PATENT STRATEGY. The JSC will review overall patent
defense and enforcement strategy, and resolve any disagreements between the
parties on patent-related matters.
ARTICLE 11
INDEMNIFICATION
11.1 INDEMNIFICATION BY GILEAD. Gilead hereby agrees to indemnify, hold
harmless and defend P&U against any and all expenses, costs of defense
(including without limitation attorneys' fees, witness fees, damages, judgments,
fines and amounts paid in settlement) and any amounts P&U becomes legally
obligated to pay because of any claim or claims against it to the extent that
such claim or claims (i) arise out of the failure of bulk Cidofovir supplied
hereunder to meet the Specifications, (ii) arise out of the breach or alleged
breach of any representation or warranty by Gilead hereunder, or (iii) are due
to the gross negligence or willful misconduct of Gilead; PROVIDED that (a) P&U
provides Gilead with prompt notice of any such claim and the exclusive ability
to defend (with the reasonable cooperation of P&U) and settle any such claim and
(b) such indemnities shall not apply to the extent such claims are covered by
P&U's indemnity set forth in Section 11.2 below.
11.2 INDEMNIFICATION BY P&U. P&U hereby agrees to indemnify, hold
harmless and defend Gilead against any and all expenses, costs of defense
(including without limitation attorneys' fees, witness fees, damages, judgments,
fines and amounts paid in settlement) and any amounts Gilead becomes legally
obligated to pay because of any claim or claims against it to the extent that
such claim or claims (i) result from P&U's activities under this Agreement, (ii)
arise out of the breach or alleged breach of any representation or warranty by
P&U hereunder, (iii) are due to the gross negligence or willful misconduct of
P&U, or (iv) arise out of the possession, final manufacture, use, sale or
administration of the Licensed Product by P&U or P&U's Affiliates or
sublicensees; PROVIDED that (a) Gilead provides P&U with prompt
21.
notice of any such claim and the exclusive ability to defend (with the
reasonable cooperation of Gilead) or settle any such claim and (b) such
indemnities shall not apply to the extent such claims are covered by Gilead's
indemnity set forth in Section 11.1 above.
11.3 MECHANICS. In the event that the parties cannot agree as to the
application of Sections 11.1 and 11.2 above to any particular loss or claim, the
parties may conduct separate defenses of such claim. Each party further
reserves the right to claim indemnity from the other in accordance with Sections
11.1 and 11.2 above upon resolution of the underlying claim, notwithstanding the
provisions of Sections 11.1 and 11.2 above requiring the indemnified party to
tender to the indemnifying party the exclusive ability to defend such claim or
suit.
11.4 INSURANCE COVERAGE. Both Parties represent and warrant that they
are covered and will continue to be covered by a comprehensive general liability
insurance program which covers all their activities and obligations hereunder.
Each party will provide the other with written notice at least fifteen (15) days
prior to any cancellation or material change in such insurance program. Each
Party will maintain such insurance program, or other program with comparable
coverage, beyond the expiration or termination of this Agreement during (i) the
period that any Licensed Product is being commercially distributed or sold other
than for the purpose of obtaining regulatory approvals by P&U or by a
sublicensee, Affiliate or agent of P&U and (ii) a commercially reasonable period
thereafter.
ARTICLE 12
CONFIDENTIALITY
12.1 PROPRIETARY INFORMATION; EXCEPTIONS. Each party will maintain all
Proprietary Information received by it under this Agreement in trust and
confidence and will not disclose any such Proprietary Information to any third
party or use any such Proprietary Information for any purposes other than those
necessary or permitted for performance under this Agreement. In particular,
neither party shall use any Know-How of the other party for the manufacture or
sale of any product other than the Licensed Product, except as expressly
authorized by this Agreement. Each party may use such Proprietary Information
only to the extent required to accomplish the purposes of this Agreement.
Proprietary Information shall not be used for any purpose or in any manner that
would constitute a violation of any laws or regulations, including without
limitation the export control laws of the United States. Proprietary
Information shall not be reproduced in any form except as required to accomplish
the intent of this Agreement. No Proprietary Information shall be disclosed to
any employee, agent, consultant, Affiliate, or sublicensee who does not have a
need for such information. To the extent that disclosure is authorized by this
Agreement, the disclosing party will obtain prior agreement from its employees,
agents, consultants, Affiliates, sublicensees or clinical investigators to whom
disclosure is to be made to hold in confidence and not make use of such
information for any purpose other than those permitted by this Agreement. Each
party will use at least the same standard of care as it uses to protect its own
Proprietary Information of a similar nature to ensure that such employees,
agents, consultants and clinical investigators do not disclose or make any
unauthorized use of such Proprietary Information, but no less than reasonable
care. Each party will promptly notify the other upon discovery of any
unauthorized use or disclosure of the Proprietary Information.
Proprietary Information shall not include any information which:
(a) is now, or hereafter becomes, through no act or failure to
act on the part of the receiving party in breach hereof, generally known or
available;
22.
(b) is known by the receiving party at the time of receiving
such information, as evidenced by its written 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
any breach of this Agreement; or
(e) is the subject of a written permission to disclose provided
by the disclosing party.
The parties agree that the material financial terms of the Agreement will
be considered Proprietary Information of both parties. Notwithstanding the
foregoing, either party may disclose such terms except for Cost of Goods and
Royalty Payments to bona fide potential corporate partners, to the extent
required or contemplated by this Agreement, and to financial underwriters and
other parties with a need to know such information. All such disclosures shall
be made only to parties under an obligation of confidentiality.
12.2 AUTHORIZED DISCLOSURE. Notwithstanding any other provision of this
Agreement, each party may disclose Proprietary Information if such disclosure:
(a) is in response to a valid order of a court or other
governmental body of the United States or a foreign country, or any political
subdivision thereof; PROVIDED, HOWEVER, that the responding party shall first
have given notice to the other party hereto and shall have made a reasonable
effort to obtain a protective order requiring that the Proprietary Information
so disclosed be used only for the purposes for which the order was issued;
(b) is otherwise required by law or regulation, including SEC
related documents; or
(c) is otherwise necessary to file or prosecute patent
applications, prosecute or defend litigation or comply with applicable
governmental regulations or otherwise establish rights or enforce obligations
under this Agreement, but only to the extent that any such disclosure is
necessary. Under no circumstances will P&U disclose publicly proprietary
features of Gilead manufacturing technology for Cidofovir; PROVIDED, HOWEVER,
that Gilead shall cooperate with P&U to disclose such information to the extent
required to provide P&U with reasonable protection from liability by reason of
this prohibition on disclosure.
12.3 RETURN OF PROPRIETARY INFORMATION. In the event either party loses
a license to Know-How which was granted to it under this Agreement, such party
shall use diligent efforts (including without limitation a diligent search of
files and computer storage devices) to return all Proprietary Information
received by it from the other party, PROVIDED, HOWEVER, that such party may keep
one copy of such Proprietary Information for legal archival purposes. Access to
the copy so retained by a party's legal department shall be restricted to
counsel and no use of such Proprietary Information shall not be used except in
the resolution of any claims or disputes arising out of this Agreement.
23.
ARTICLE 13
REPRESENTATIONS AND WARRANTIES
13.1 MUTUAL REPRESENTATIONS AND WARRANTIES. Each party hereby represents
and warrants:
(a) CORPORATE POWER. Such party is duly organized and validly
existing under the laws of the state or country of its incorporation and has
full corporate power and authority to enter into this Agreement and to carry out
the provisions hereof.
(b) DUE AUTHORIZATION. Such party is duly authorized to execute
and deliver this Agreement and to perform its obligations hereunder.
(c) BINDING AGREEMENT. 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.
13.2 GILEAD REPRESENTATIONS AND WARRANTIES.
(a) Gilead represents and warrants that it is unaware of any
patents or trade secret rights owned or controlled by a third party, to which it
does not already have rights, which would dominate, or be infringed or
misappropriated by the manufacture of Licensed Product or its use or sale, and
is unaware of any claims of such domination, infringement or misappropriation.
(b) Gilead makes the following representations and warranties
with respect to all bulk Cidofovir supplied by it hereunder:
A. Such Cidofovir shall be manufactured in accordance with all
United States federal, state and local statutes, ordinances and regulations,
including but not limited to, the Federal Food, Drug and Cosmetic Act of 1938,
as amended from time to time (the "Act"), and the regulations thereunder,
including Good Manufacturing Practice Regulations which are in force or are
hereafter adopted. Gilead shall also endeavor in good faith to satisfy any
additional requirements of other regulatory agencies with respect to the bulk
Cidofovir supplied by it to P&U hereunder.
B. Cidofovir delivered hereunder shall not be adulterated or
misbranded within the meaning of the Act.
C. Gilead has good and marketable title to, and the right to
sell, the Cidofovir and Licensed Product.
13.3 NO OTHER REPRESENTATIONS. THE EXPRESS REPRESENTATIONS AND
WARRANTIES STATED IN THIS ARTICLE 13 ARE IN LIEU OF ALL OTHER REPRESENTATIONS
AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
24.
ARTICLE 14
DISPUTE RESOLUTIONS; VENUE AND GOVERNING LAW
14.1 DISPUTES. The parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to
either party's rights and/or obligations hereunder or thereunder. It is the
objective of the parties to establish procedures to facilitate the resolution of
disputes arising under this Agreement in an expedient manner by mutual
cooperation and without resort to litigation. To accomplish this objective, the
parties agree to follow the procedures set forth in this Article 14 if and when
a dispute arises under this Agreement.
In the event of disputes between the parties, including disputes among the
members of the JSC which such committee is unable to resolve, either party may,
by written notice to the other, have such dispute referred to their respective
executive officers designated below or their successors, for attempted
resolution by good faith negotiations within fourteen (14) days after such
notice is received. Said designated officers are as follows:
FOR P&U: Secretary
FOR GILEAD: Chief Executive Officer
In the event the designated executive officers are not able to resolve such
dispute, either Party may at anytime after the 14 day period invoke the
provisions of Section 14.2 hereinafter.
14.2 ALTERNATIVE DISPUTE RESOLUTION. Any dispute, controversy or claim
arising out of or relating to the validity, construction, enforceability or
performance of this Agreement, including disputes relating to alleged breach or
to termination of this Agreement, other than disputes which are expressly
prohibited herein from being resolved by this mechanism, shall be settled by
binding Alternative Dispute Resolution ("ADR") in the manner described below:
(a) ADR REQUEST. If a party intends to begin an ADR to resolve
a dispute, such Party shall provide written notice (the "ADR Request") to
counsel for the other Party informing such other Party of such intention and the
issues to be resolved. From the date of the ADR Request and until such time as
any matter has been finally settled by ADR, the running of the time periods
contained in Section 9.3 as to which party must cure a breach of this Agreement
shall be suspended as to the subject matter of the dispute.
(b) ADDITIONAL ISSUES. Within ten (10) business days after the
receipt of the ADR Request, the other party may, by written notice to the
counsel for the party initiating ADR, add additional issues to be resolved.
14.3 ARBITRATION PROCEDURE. The ADR shall be conducted pursuant to
ENDISPUTE Rules A and C (1993), attached hereto as Exhibit B. Notwithstanding
those rules, the following provisions shall apply to the ADR hereunder:
(a) ARBITRATOR. The arbitration shall be conducted by a panel
of three arbitrators ("the Panel"). The Panel shall be selected from a pool of
retired independent federal judges to be presented to the parties by ENDISPUTE.
25.
(b) PROCEEDINGS. The time periods set forth in the ENDISPUTE
rules shall be followed, unless a party can demonstrate to the Panel that the
complexity of the issues or other reasons warrant the extension of one or more
of the time tables. In such case, the Panel may extend such time tables, but in
no event shall the time tables being extended so that the ADR proceeding extends
more than 18 months from its beginning to the Award. In regard to such time
tables, the parties (i) acknowledge that the issues that may arise in any
dispute involving this Agreement may involve a number of complex matters and
(ii) confirm their intention that each party will have the opportunity to
conduct complete discovery with respect to all material issues involved in a
dispute within the framework provided above. Within such time frames, each
party shall have the right to conduct discovery in accordance with the Federal
Rules of Civil Procedure. The Panel shall not award punitive damages to either
Party and the Parties shall be deemed to have waived any right to such damages.
The Panel shall, in rendering its decision, apply the substantive law of the
State of California, without regard to its conflict of laws provisions, except
that the interpretation of and enforcement of this Section 14.3(b) shall be
governed by the Federal Arbitration Act. The Panel shall apply the Federal
Rules of Evidence to the hearing. The proceeding shall take place in the City
of Chicago. The fees of the Panels and ENDISPUTE shall be paid by the losing
Party which shall be designated by the Panel. If the Panel is unable to
designate a losing party, it shall so state and the fees shall be split equally
between the Parties.
(c) AWARD. The Panel is empowered to award any remedy allowed
by law, including money damages, multiple damages, prejudgment interest and
attorneys' fee, and to grant final, complete, interim, or interlocutory relief,
including injunctive relief but excluding punitive damages.
(d) COSTS. Except as set forth in Section 14.3(c), above, each
party shall bear its own legal fees. The Panel shall assess its costs, fees and
expenses against the party losing the ADR unless it believes that neither party
is the clear loser, in which case the Panel shall divide such fees, costs and
expenses according to the Panel's sole discretion.
(e) CONFIDENTIALITY. The ADR proceeding shall be confidential
and the Panel shall issue appropriate protective orders to safeguard each
party's Proprietary Information. Except as required by law, no party shall make
(or instruct the Panel to make) any public announcement with respect to the
proceedings or decision of the Panel without prior written consent of each other
party. The existence of any dispute submitted to ADR, and the award, shall be
kept in confidence by the parties and the Panel, except as required in
connection with the enforcement of such award or as otherwise required by
applicable law.
14.4 JURISDICTION. For the purposes of this Article 14, the parties
acknowledge their diversity (Gilead having its principal place of business in
California and P&U having its principal place of business in Luxembourg) and
agree to accept the jurisdiction of the Federal District Court in San Francisco,
CA for the purposes of enforcing awards entered pursuant to this Article and for
enforcing the agreements reflected in this Article.
14.5 GOVERNING LAW. This Agreement is made in accordance with and shall
be governed and construed under the laws of the State of California, as such
laws are applied to contract entered into and to be performed within such state.
26.
ARTICLE 15
MISCELLANEOUS
15.1 AGENCY. Neither party is, nor will be deemed to be, an employee,
agent or legal representative of the other party for any purpose. Neither party
will be entitled to enter into any contracts in the name of, or on behalf of the
other party, nor will a party be entitled to pledge the credit of the other
party in any way or hold itself out as having authority to do so. This
Agreement is an arm's-length license agreement between the parties and shall not
constitute or be construed as a joint venture.
15.2 ASSIGNMENT. Except as otherwise provided herein, neither this
Agreement nor any interest hereunder will be assignable in part or in whole by
any party without the prior written consent of the other; PROVIDED, HOWEVER,
that either party may assign this Agreement to any successor by merger or sale
of substantially all of its business to which this Agreement relates in a manner
such that the assignor will remain liable and responsible for the performance
and observance of all its duties and obligations hereunder. This Agreement will
be binding upon the successors and permitted assigns of the parties and the name
of a party herein will be deemed to include the names of such party's successors
and permitted assigns to the extent necessary to carry out the intent of this
Agreement. Any assignment which is not in accordance with this Section 15.2
will be void.
15.3 DISCLOSURE. Any public disclosure of this Agreement and the terms
hereof, including but not limited to press releases, will be reviewed and
consented to by each party prior to such disclosure. Such consent shall not be
untimely or unreasonably withheld by either party.
15.4 AMENDMENT. No amendment or modification hereof shall be valid or
binding upon the parties unless made in writing and signed by both parties.
15.5 NOTICES. Any notice or other communication required or permitted to
be given to either party hereto shall be in writing unless otherwise specified
and shall be deemed to have been properly given and to be effective on the date
of delivery if delivered in person or by facsimile or three (3) days after
mailing by registered or certified mail, postage paid, to the other party at the
following address:
In the case of Gilead:
Gilead Sciences, Inc.
353 Lakeside Drive
Foster City, CA 94404
Telephone: (415) 574-3000
FAX: (415) 578-9264
Attention: Chief Executive Officer
In the case of P&U: and copy to:
Secretary V.P. of Business Development
Pharmacia & Upjohn S.A Pharmacia & Upjohn Company
c/o Credit Europeen 7000 Portage Road
52 route d'Esch Portage, Michigan 49001
L-1470 Luxembourg FAX 616-323-6247
27.
Either party may change its address for communications by a notice to the other
party in accordance with this Section 15.5.
15.6 FORCE MAJEURE. Any delay in performance by any party under this
Agreement shall not be considered a breach of this Agreement if and to the
extent caused by occurrences beyond the reasonable control of the party
affected, including but not limited to acts of God, embargoes, governmental
restrictions, strikes or other concerted acts of workers, fire, flood,
earthquake, explosion, riots, wars, civil disorder, rebellion or sabotage. The
party suffering such occurrence shall immediately notify the other party and any
time for performance hereunder shall be extended by the actual time of delay
caused by the occurrence.
15.7 SEVERABILITY. If any term, condition or provision of this Agreement
is held to be unenforceable for any reason, it shall, if possible, be
interpreted, to achieve the intent of the parties to this Agreement to the
extent possible rather than voided. In any event, all other terms, conditions
and provision of this Agreement shall be deemed valid and enforceable to the
full extent.
15.8 CUMULATIVE RIGHTS. The rights, powers and remedies hereunder shall
be in addition to, and not in limitation of, all rights, powers and remedies
provided at law or in equity, or under any other agreement between the parties.
All of such rights, powers and remedies shall be cumulative, and may be
exercised successively or cumulatively.
15.9 WAIVER. No waiver by either party hereto on any breach or default
of any of the covenants or agreements herein set forth shall be deemed a waiver
as to any subsequent or similar breach or default.
15.10 ENTIRE AGREEMENT. This Agreement, the Stock Purchase Agreement and
any and all Exhibits referred to herein and therein embody the entire
understanding of the parties with respect to the subject matter hereof and shall
supersede all previous communications, representations or understandings, either
oral or written, between the parties relating to the subject matter hereof.
IN WITNESS WHEREOF, both Gilead and P&U have executed this Agreement by
their respective officer hereunto duly authorized.
GILEAD SCIENCES, INC. PHARMACIA & UPJOHN, S.A.
By: /s/ John C. Martin By: /s/ Robert C. Salisbury
--------------------------- ---------------------------------------
Name: John C. Martin Name: Robert C. Salisbury
------------------------- -------------------------------------
Title: CEO Title: Chairman, Board of Directors, PUSA
------------------------ ------------------------------------
By: /s/ Carl-Johan Blomberg
---------------------------------------
Name: Carl-Johan Blomberg
-------------------------------------
Title: Finance Director, PUSA
------------------------------------
Date: August 7, 1996
28.
License and Supply Agreement - Gilead Sciences Inc. and Pharmacia & Upjohn SA
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