Exhibit 10.62

 

GILEAD WORLD MARKETS, LTD. and PPG
TENOFOVIR DF MANUFACTURING SUPPLY AGREEMENT

 

THE PARTIES HEREBY ACKNOWLEDGE THE FOLLOWING:

 

THIS SUPPLY AGREEMENT (“Agreement”) is entered into as January 1, 2003 (the
“Effective Date”), by and between  PPG-Sipsy S.A.S., a French company having a
place of business at Z.I. la Croix Cadeau, B.P. 79, 49242 Avrille Cedex, France
(“PPG”) and Gilead World Markets, Ltd., a company operating under the laws of
the Cayman Islands, having its principal place of business at Queensgate House,
South Church Street, PO Box 1234GT, Grand Cayman (“GWM”).   PPG and GWM may be
referred to singly as “Party” and collectively as “Parties” in this Agreement.

 

                WHEREAS, PPG is a known manufacturer of active pharmaceutical
ingredients with expertise in “cGMP” manufacturing, and GWM and its designees
manufacture and market pharmaceutical products for human use, including
tenofovir disoproxil fumarate 300 mg  (“Viread®”);

 

                WHEREAS, PPG and GWM desire to establish mutually agreeable
terms for the commercial supply of tenofovir disoproxil fumarate (“Product”) as
an active pharmaceutical ingredient by PPG to GWM.

 

                NOW, THEREFORE, in consideration of (i) PPG’s agreement to
manufacture Product and supply to GWM for the monetary amounts set forth in this
Agreement; (ii) the promises, covenants, agreements and other valuable
consideration hereinafter set forth, and intending to be legally bound, the
Parties hereby agree as follows:

 

1.               AGREEMENT ACCEPTANCE: PPG has read and understands this
Agreement and understands that it will govern PPG’s written acceptance of any
order for or delivery of any Product.  All terms and conditions with respect to
an order for Product proposed by PPG which are different from or in addition to
this Agreement and are not agreed to in writing by GWM are expressly rejected by
GWM, and shall not become a part of this Agreement or such order.  GWM has read
and understands this Agreement and shall purchase the Product manufactured by
PPG and pay for the supply of the Product in accordance with the terms and
provisions of this Agreement.  With the exception of any Product delivery
pursuant to the ***, and the                        ***         , any delivery
of Product after the Effective Date of this Agreement shall be governed by the
terms of this Agreement.  Any modifications to this Agreement shall, prior to
their implementation, be mutually agreed upon by the parties hereto and shall be
made in accordance with Section 28.

 

Neither the General Sales Conditions of PPG nor the General Purchase Conditions
of GWM shall apply to the supply of the Product by PPG to GWM.

 

2.               TERM:  The term of this Agreement shall begin as of January 1,
2003, and shall remain in effect until December 31, ***       (the “Initial
Term”), and thereafter for subsequent     ***         renewal terms (each a
“Renewal Term”), unless terminated at the end of the Initial Term or any Renewal
Term by either Party with at least       ***         prior written notice or
unless otherwise terminated according to Section 12 “Termination” of this
Agreement.

3.               SUPPLY:  During the term of this Agreement, PPG shall
manufacture Product for GWM for use in Viread®.  During the term of this
Agreement, PPG is obligated to manufacture Product at the location and in the
quantities set forth herein.

a)              PPG will manufacture the Product for GWM only from its facility
located at            ***                         , or such other facilities as
the Parties agree to in writing.

 

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*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.

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b)             During the Initial Term and any Renewal Term GWM will purchase
and PPG shall deliver at least the quantities set forth in Exhibit A.           
***         will result in          ***                         to the    
***         for such                ***         the         ***         the
invoice for which will be issued in the calendar year for which
the                          ***         of the     ***         as described in
Section 12, then         *** will be  ***           to the quantities of Product
ordered                    ***      such    ***           in addition to      
***         as described in Section 12.

c)              Forecasting:   On the first day of each            ***        
GWM shall provide to PPG the projected need for Product for  ***         the
                ***         period commencing            ***         from the
date of forecast.  The quantities indicated in the first   ***         period of
the         ***         projection will be an affirmative obligation for GWM to
purchase, and an affirmative obligation for PPG to supply Product within the
limits of              ***           The quantities indicated in the second  ***
period of the        ***         projection will be considered as a forecast
only.   With the exception of calendar year 2003 for which              
***         , notwithstanding anything in this Agreement, PPG’s    ***        
in any given         ***         period shall be ***             indicated in
                ***         in which the         ***         period falls.

d)             Acceptance:  PPG shall respond to each order received from GWM
within              ***         calendar days of receipt.  The response shall
include PPG’s inability to comply with, or confirmation of the delivery dates
and quantities set forth in the order.

e)              Each shipment of Product hereunder will be delivered to a
facility of GWM, or a GWM designee, and in such quantities as designated by GWM
on its purchase order (the “GWM Purchase Order”), material transfer request, or
by subsequent written instruction given by GWM and in accordance with the
instructions for shipping and packaging included in such GWM Purchase Order
(each facility so designated shall be a “GWM Location”). Any other additional
terms and conditions provided on such GWM Purchase Orders shall not apply as the
terms and conditions of this Agreement shall apply alone.

f)                If PPG is unable to supply sufficient quantities of the
Product to meet either its minimum obligations under Section 3(b), or any GWM
Purchase Order (whether or not accepted by PPG), or should either Party perceive
that a shortfall in delivery of Product by PPG is likely to occur for any
reason, the Parties shall discuss appropriate steps to alleviate such a
shortfall                   ***         .  GWM shall have the right ***        
.  Any quantities ***         to meet such a shortfall shall be      
***         and        ***         in which the shortfall occurs.  If GWM must
      ***         a             ***         any costs beyond the Base Price, as
agreed by the Parties and as described in Exhibit B, for the shortfall quantity,
but limited to a total cost of not more than   ***         of the Base Price.
Repeated shortfalls may be considered a material breach of this Agreement, as
described in section 12 of this Agreement.

g)             If release and/or shipment of any quantity is delayed after PPG
has accepted an order, through the fault of PPG, by more than  
***                the quantity shall be considered a shortfall, and treated as
above in Section 3(f).  If such delay is caused by GWM, GWM shall make
             ***         to remediate the fault as soon as reasonably
practicable.

 

 

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4.               GOOD MANUFACTURING PRACTICES: PPG expressly warrants that all
goods covered by this Agreement will be manufactured in accordance with current
good manufacturing practices (“cGMP”) as established by the United States Food
and Drug Administration (the “FDA”), and the European Agency for Evaluation of
Medicinal Products (“EMEA”) for the manufacture of pharmaceutical materials, as
well as other applicable rules and regulations of the FDA, EMEA, and other
governmental or regulatory agencies of the United States or the European Union. 
Each Party shall promptly notify the other of any new instructions or
specifications required by the FDA, the Federal Food, Drug and Cosmetic Act, the
Federal Public Health Service Act or other applicable rules and regulations of
the United States or the European Union, and shall confer with each other with
respect to the best means to comply with such requirements and shall allocate
any costs of implementing such changes on an equitable basis.  Upon written
request of GWM, PPG will permit representatives of GWM to observe such
manufacture, or any government inspection of PPG’s manufacturing process for the
Product, at mutually agreeable times and PPG shall permit GWM to inspect copies
of PPG’s manufacturing records, including its batch records, for the purposes of
assuring Product quality and compliance with agreed-upon manufacturing
procedures.

 

5.               MANUFACTURING PROCESS AND BATCH RELEASE TESTING: GWM shall make
available to PPG, free of charge, all such know-how, information, and technical
assistance if needed by PPG so as to allow PPG to manufacture TENOFOVIR DF (the
“Product”) to the standard of GWM as will be more precisely described by GWM in
writing to PPG before the start of manufacturing of the Product.  PPG shall
manufacture the Product in conformance with the specifications (the
“Specifications”) set forth in the Gilead Sciences Tenofovir DF Contract
Manufacturing Manual which is in effect on the Effective Date of this Agreement,
and as thereafter amended (the “Contract Manufacturing Manual”), and according
to the manufacturing process description as set forth in the Contract
Manufacturing Manual.  PPG shall test each batch of Product for conformance to
the specifications according to the Standard Test Methods as set forth in the
Contract Manufacturing Manual.

 

6.               RAW MATERIALS: Raw materials used in the manufacture of Product
will conform to the specifications set forth in the Contract Manufacturing
Manual (the “Raw Material Specifications”) and such conformance will be verified
in accordance with the testing standards and procedures specified therein.  PPG
agrees that it will facilitate changes to the Raw Material Specifications that
are necessary or appropriate in light of FDA or other regulatory requirements. 
PPG shall not be liable hereunder if the raw materials meet the Raw Material
Specifications and the Product fails to meet the Specifications because the raw
material specifications are inadequate.

 

7.               CHANGE IN MANUFACTURING PROCESS: PPG shall obtain GWM’s prior
written approval before implementing any planned change in the materials,
equipment, process, or procedures used to manufacture the Product that would
constitute a change under cGMP, would impact the validation status of the
process, or would constitute noncompliance with the manufacturing process set
forth in the Contract Manufacturing Manual.  PPG shall disclose all proposed
changes in such manufacturing materials, equipment, process, or procedure to GWM
at a level sufficient to allow GWM to practice such changed manufacturing
process.  GWM shall notify PPG in writing with reasonable notice of any change
in the materials, equipment, process, analytical methods, specifications, or
procedures to be used in the manufacture of the Product whether such changes are
to be reflected as updates to the Contract Manufacturing Manual or otherwise. 
PPG shall provide GWM with an authentic copy of the current Master Batch Record
for the preparation of the Product.

 

The cost of implementing any amendment or change of whatever nature to the
procedures or specifications described in the Contract Manufacturing Manual as
it exists on the Effective Date of this Agreement, as well as any extra costs
resulting from the implementation of such change, shall be borne by           
***         through an            ***         which the Parties shall negotiate
in good faith.

 

 

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8.               PROCESS IMPROVEMENTS: ***        agrees to communicate promptly
to ***          any idea and substantial improvement (patented or unpatented)
made or developed solely or jointly by *** arising from its activities under
this Agreement and relating to the processing or manufacture of the Product
(“Improvement”).  All rights and title to Improvements that have no foreseeable
uses other than those related to the processing or manufacture of the Product
shall be assigned to              ***, which shall have only the right to
utilize such Improvements in the manufacture of the Product.  All rights and
title to Improvements (patented or unpatentable) that have applications other
than those related to the processing or manufacture of the Product and that do
not contain specific know-how of ***        developed prior to the Effective
Date, shall be assigned to         ***, which shall have only the right to
utilize such improvements in the processing and manufacture of the Product and
any structurally related Gilead pharmaceutical compound.      *** grants to
***        a royalty-free worldwide exclusive license limited to processing or
manufacture of the Product and any structurally related Gilead pharmaceutical
compound for Improvements that have applications other than those related to the
processing or manufacture of the Product, but do not contain specific        ***
know-how developed prior to the Effective Date. If              *** contracts
out the processing or manufacture of the Product, or structurally related Gilead
pharmaceutical compounds to any third party, any Improvement may be disclosed to
such contract manufacturer but rights to use the same shall be restricted to the
processing and manufacture of the Product, or structurally related Gilead
pharmaceutical compounds, and the Parties hereto will discuss in good faith an
appropriate remuneration to            ***         before implementing any such
disclosure to said third party.

 

9.               QUALITY CONTROL SAMPLE AND DOCUMENTATION: Manufacture of the
Product shall at all times be in strict conformance with the Specifications and
such conformance will be verified in accordance with the testing procedures
specified therein.  Prior to the delivery of any batch of Product, PPG shall
provide GWM with (i) a quality control sample of such to be held by GWM for
analytical reference, (ii) written confirmation that the batch records for such
batch have been reviewed and approved by PPG’s quality assurance unit
(Certificate of Compliance), and (iii) a Certificate of Analysis confirming that
such batch meets Specifications.  Quality control sampling, unless otherwise
specified by GWM in writing, shall be in accordance with the most current Drug
Substance Sampling/Testing Plan contained in the Contract Manufacturing Manual.

 

10.         QUANTITY AND PRICE: Subject to adjustment as provided in this
Agreement, GWM shall pay to PPG the prices in Exhibit B.  Using Exhibit B,
“Invoice” price is set on *** of each calendar year for the subsequent calendar
year using the                ***         plus the forecast given by GWM for the
second ***         in accordance with Section 3.c.    Adjustment will be made
        ***         based on         ***         such year, with a corresponding
     ***         of that calendar year based on the   ***         .

 

PPG agrees that if process improvements are discovered and mutually agreed upon
in accordance with Sections 7 and 8, and which have a material effect on Product
manufacturing cost, the Parties will negotiate in good faith               ***.

 

 

 

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11.         SHIPPING, BILLING AND PAYMENT: Unless otherwise agreed by the
Parties in writing, all shipments shall be shipped ***         (Incoterms 2000),
pursuant to written instructions provided by GWM to PPG.  However,            
***         shall be responsible for the     ***.  PPG will package and ship the
Products in accordance with PPG’s customary practices for pharmaceutical
compounds, unless otherwise specified by GWM.  Within     ***         calendar
days of receipt of such shipping instructions from GWM, PPG shall ship the
invoiced amount of Product to its destination.  All invoices from PPG to GWM
covering Product shipped to GWM shall be stated, and all payments to PPG by GWM
shall be made in      ***.  Payments due to PPG shall be made by wire transfer
to the bank account of PPG of which PPG shall advise GWM from time to time.  The
invoices will be issued upon completion of the batches and issuance of the
applicable quality control sample/s in accordance with Section 9.  PPG’s invoice
shall be paid by GWM not later than *** calendar days following the later of (i)
the receipt of the applicable invoice, or (ii) receipt of the Certificate of
Analysis and Certificate of Compliance.  Any invoiced amount which is not paid
within      ***         of its due date shall be assessed a late payment fee at
the rate of             ***    or the maximum rate permitted by applicable law
with respect to such obligations, whichever is less.  At             ***        
credit terms can be adjusted            ***         as justified by      ***.

 

12.         TERMINATION:  Either Party may terminate this Agreement for a
material breach by the other Party. A material breach may be encountered if
either Party: (a) repudiates or breaches a      ***         of this Agreement;
or (b) fails to perform services or deliver goods as provided in this
Agreement.  Termination under this section must be performed by giving the
breaching Party written Notice, specifying the circumstances of the breach,
including the provisions of this Agreement that are breached. The breaching
Party, if such a breach has indeed occurred, has               ***        
calendar days to cure such breach of this Agreement.

 

If the breach has not been cured at the end of the                    ***     
calendar day period or if the breaching Party is not making diligent, good faith
efforts to cure such breach, then, upon immediate Notice to the breaching Party,
the breaching Party shall be in default and the non-breaching Party may
terminate this Agreement.  If the breaching Party is making diligent, good faith
efforts to cure such breach, the breaching Party shall be granted an
additional     ***    calendar day period to cure said breach. Unless the
termination is on the grounds of a material breach resulting     ***         ,
GWM shall purchase raw material and intermediates at PPG’s actual cost and
inventories of the Product at the purchase price then in effect according to
provisions of Appendix B hereto as amended during the performance of this
Agreement.  Otherwise, GWM shall have the right, but not the obligation, to
purchase such raw materials, intermediates and inventories of the Product
pursuant to Section 10 as GWM may determine in its sole discretion.

 

In the event that either Party becomes bankrupt, the other Party may, with
immediate Notice to the first Party, terminate the Agreement with no liabilities
whatsoever, subject to relevant legislation and provisions herein contained.

GWM may terminate this Agreement in whole or in part at any time by giving ***
days written notice to PPG, if GWM, in its sole discretion, determines that
        ***         or if any   ***      a             ***         on         
***         or   *** of the     ***         or           ***        of          
***.  GWM may terminate this Agreement if any ***  that         ***         any
***                the result of which is          ***        the        
***         or to       ***         on the ***.  Should GWM terminate this
Agreement due to the reasons contained in this Article, PPG shall take
reasonable measures to cease any ongoing production and limit further expenses
associated with such ongoing production.  GWM shall purchase raw material and
intermediates at PPG’s actual cost and inventories of the Product at the
purchase price then in effect according to provisions of Appendix B hereto as
amended during the performance of this Agreement, and will reimburse PPG for
reasonable expenses incurred by PPG with respect to the remainder of said GWM
Purchase Order prior to the effective date of the termination.

Except as otherwise set forth in this Agreement, termination of this Agreement
shall not release any Party hereto from any payment, liability or other
obligation existing at the date of termination.

 

 

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13.         LIMITED WARRANTY: PPG warrants that Product delivered hereunder will
(i) be manufactured by PPG in accordance with cGMP and other applicable FDA,
EMEA, and other rules and regulations of the United States or the European
Union, (ii) be manufactured in accordance with the agreed-upon manufacturing
procedures described in the master batch records supplied to GWM in accordance
with the provisions of Section 7, as may be modified and disclosed to GWM in
accordance with the provisions of Section 7, (iii) conform to the 
Specifications set forth in the  Contract Manufacturing Manual at the time of
Product manufacture, and (iv) be provided in compliance with all applicable laws
and regulations as more fully set forth in Section 4 above.  GWM’s remedies and
PPG’s liability with respect to these warranties are set forth below.  These are
the only representations or warranties PPG makes and all other express or
implied warranties, under statute or arising otherwise in law from a course of
dealing or usage of trade, including without limitation, any other warranty of
fitness for a particular purpose or use, are disclaimed by PPG.  If any Product
fails to conform to the warranties herein, PPG’s exclusive obligation and GWM’s
(or GWM’s affiliates’) exclusive remedy (subject to SECTIONS 12 and 17) shall be
as set forth in Section 14.  Except as provided in the immediately preceding
sentence, in no event will PPG be liable under any theory of recovery (whether
based on negligence of any kind, strict liability or tort) for any direct,
indirect, special, incidental, or consequential damages in any way related to,
arising from or resulting from any use made of the Product.  Nothing in this
Section 13 is intended as a limitation of indemnification obligations of PPG
pursuant to Section 15, or the recall obligations of PPG under section 17.

14.         REJECTION:  GWM may reject Product delivered by PPG for failure to
comply with the warranties in Section 13 by giving PPG written notice, upon
which the Parties will cooperate to determine whether rejection was necessary or
justified.  PPG will notify GWM promptly as to whether it accepts GWM’s basis
for any rejection.  If the Parties disagree whether the Product batch did not
comply with the warranties, they will submit a sample of such Product batch and
applicable documentation to a mutually acceptable independent third party
laboratory.  Such third party laboratory shall determine whether such Product
batch conforms with the warranties, and such determination shall be final,
binding and determinative as to whether rejection of such Product batch was
justified.  The Party against whom the third party tester rules shall bear all
costs of the third party testing.  If GWM has given notice of rejection, at
GWM’s request PPG shall use best efforts to replace such rejected Product.  If
the third party tester rules that a rejected batch meets the warranties, GWM
will purchase such batch, irrespective of whether PPG has already replaced it. 
If PPG accepts GWM’s basis for rejection or the third party tester rules that a
rejected batch did not meet the warranties, PPG will not charge GWM for such
batch or for shipping, insurance or freight costs therefor, or shall promptly
refund any such amounts already paid by GWM.  At its election, GWM may    ***,
until and unless it is finally determined that the batch complied with the
warranties in Section 13.

15.         INDEMNIFICATION BY PPG: PPG agrees to indemnify, hold harmless and
defend GWM and GWM’s directors, officers, employees and agents, and the
directors, officers, employees and agents of any GWM parent, subsidiary, or
related company (the “GWM Indemnitees”) from and against any and all losses,
liabilities, judgments, damages, costs, reasonable fees, and expenses, including
reasonable attorneys’ fees (collectively, “Losses”) resulting from any third
party claim, demand, action, suit or proceeding (collectively, “Third Party
Claim”) arising out of (i) PPG’s manufacture of Product which fails to comply
with PPG’s obligations under this Agreement, (ii) the transportation, storage or
use of the Product by PPG while the Product is in its control, or (iii) any
negligent or wrongful act or omission of PPG or any PPG Indemnitee relating to
this Agreement, including without limiting the generality of the foregoing any
Losses whatsoever with respect to Third Party Claims of death or injury to
person or damage to property, provided that GWM provides PPG with prompt notice
of any such Third Party Claim and the exclusive ability to defend (with the
reasonable cooperation of GWM) or settle any such Third Party Claim, except to
the extent that PPG has a right of indemnification or defense with respect to
any such Loss or Third Party Claim pursuant to Section 16.

 

 

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16.         INDEMNIFICATION BY GWM: GWM agrees to indemnify, hold harmless, and
defend PPG and PPG’s directors, officers, employees and agents, and the
directors, officers, employees and agents of any PPG parent, subsidiary, or
related company (the “PPG Indemnitees”) from and against any and all Losses
resulting from Third Party Claims arising out of (i) the
                              ***         relating to the manufacture of the
Product made available by GWM to PPG, (ii) possession, use, transformation, or
sale of the Product by any person other than a PPG Indemnitee, or (iii) any
negligent or wrongful act or omission of GWM or any GWM Indemnitee relating to
this Agreement, including without limiting the generality of the foregoing any
Losses whatsoever with respect to Third Party Claims of death or injury to
person or damage to property, provided that PPG provides GWM with prompt notice
of any such Third Party Claim and the exclusive ability to defend (with the
reasonable cooperation of PPG) or settle any such Third Party Claim, except to
the extent that GWM has a right of indemnification or defense with respect to
any such Loss or Third Party Claim pursuant to Section 15.

 

17.         RECALLS AND ADVERSE EVENTS: If there is a recall or there are
adverse events for Product that may be related to the processing or manufacture
of Product by PPG, PPG shall provide at GWM’s cost any assistance reasonably
requested by GWM in connection with such recall or adverse events. If Product is
recalled due to a breach of the warranty in Section 13, PPG shall be responsible
for reasonable out-of-pocket expenses incurred in connection with such recall or
seizure including loss of Viread®, notification, transportation, destruction
expenses and replacement costs              ***.

 

18.         NO IMPLIED LICENSES: No right, express or implied, is granted by
this Agreement to either Party to use in any manner the name of the other or any
other trade name or trademark or other intellectual property rights of the other
in connection with the performance of the work covered by this Agreement.

 

19.         INDEPENDENT CONTRACTORS: Each Party hereto shall act as an
independent contractor and nothing in this Agreement shall be construed as to
give either Party the authority to act for, bind, or commit the other Party in
any way whatsoever.

 

20.         FORCE MAJEURE: Neither Party shall be liable for failure to perform
or for delay in performing any of its obligations under this Agreement, if such
failure or delay is caused by lack of supply of materials through no fault of
such Party, an act of God, riot, fire, explosion, flood, hostilities of war,
executive legislation or administrative order, or other conditions reasonably
beyond the control of such Party, provided that the Party experiencing the delay
promptly notifies the other Party of the delay and uses and continues to use
best efforts to overcome such cause.  If such cause shall continue for a period
of         ***         and is not overcome by the Party whose performance is
affected, the Party not subject to the force majeure may           ***        
without liability from the date of expiration of such period, except as provided
in           ***. Specifically excluded from this provision is any interference,
caused by         *** or    ***, of the ability of PPG to perform any of its
obligations.  PPG shall inform GWM of such interference, its extent and
duration, without delay.  Any interference, caused by         *** or    ***, of
the ability of PPG to perform its obligations for more than             ***
shall constitute a shortfall, as per Sections 3(f) and 3(g) of this Agreement.

 

 

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21.         NONASSIGNABILITY: Neither Party may assign or transfer this
Agreement or any rights or obligations hereunder without the prior written
consent of the other Party, except that: (a) GWM may make such an assignment or
transfer without the other Party’s consent if such assignment or transfer is to
a successor to substantially all of the business of GWM relating to the Product,
whether in a merger, sale of stock, sale of assets, or other similar
transaction, and (b) PPG may make such an assignment or transfer without prior
written consent, provided that in such event GWM shall have the option to
                               ***         , with a minimum of *** written
notice         ***.        ***        shall leave GWM without liability beyond
the               ***.  Any assignment or transfer or attempted assignment or
transfer by either Party in violation of the terms of this Section 21 shall be
null and void and of no legal effect.  In the case of any permitted assignment
or transfer of or under this Agreement, this Agreement shall be binding upon,
and inure to the benefit of, the successors, executors, heirs, representatives,
administrators, and assigns of the Parties hereto.

 

22.         GOVERNING LAW: This Agreement are made in accordance with and shall
be governed by and construed, interpreted, enforced, and applied under the laws
of           ***, excluding its choice of law rules and excluding the United
Nations’ Convention on Contracts for the Sale of Goods.  Should any part of this
Agreement be in conflict with any applicable law, all other provisions of this
order shall remain in force and the Parties hereto shall mutually and in good
faith modify the invalid or unenforceable provisions so as to maintain
essentially the spirit hereof and the original will of the Parties.

 

23.         SEVERABILITY: In the event any term of this Agreement is held to be
invalid or unenforceable under any statute, regulation, ordinance, executive
order or other rule of law, such term shall be deemed modified or deleted, but
only to the extent necessary to comply with such statute, regulation, ordinance,
order or rule, and the valid or enforceable portion thereof and the remaining
terms of this Agreement will remain in full force and effect, unless the invalid
or unenforceable provisions are of such essential importance to this Agreement
that it is reasonably assumed that the Parties would not have entered into this
Agreement without the invalid terms.

 

24.         WAREHOUSING: After ownership of the Product has transferred to GWM
and upon agreement by both Parties, PPG agrees to hold supplies of the Product
at PPG’s facility ***, until further shipping instructions are available from
GWM.  Storage of the Product shall be in accordance with cGMP and other
applicable FDA, EMEA, and other rules and regulations of the United States, and
the European Union.  *** shall bear the cost of any insurance against loss of
the Product while it is maintained at PPG’s facility. GWM will make all
appropriate efforts to move the Product from PPG’s facility in a reasonable
period of time.

 

25.         NOTIFICATION POLICY: The terms and conditions of the             
***        shall apply the processing and manufacture of Product under this
Agreement, with GWM to be substituted for      *** for such purposes.

 

26.         NOTICES: All notices under this Agreement shall be in writing and
shall be delivered personally, sent for next day delivery by internationally
recognized courier service or transmitted by facsimile (transmission confirmed),
with confirmation by next day delivery by an internationally recognized courier
service, to the following addresses and facsimiles of the respective Parties or
such other address or facsimile as is notified pursuant to this Section 26:

 

 

 

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If to GWM:

 

With a copy to:

 

 

 

Gilead World Markets, Ltd.

 

Gilead Sciences, Inc.

Queensgate House

 

333 Lakeside Drive

South Church Street

 

Foster City, CA  94404

PO Box 1234GT

 

USA

Grand Cayman

 

Attention:  Associate Director, Chemical Manufacturing

Attention:  Gregg H. Alton, Director

 

Facsimile:  ***

Facsimile:  ***

 

 

 

 

 

If to PPG: 

 

With a copy to:

 

 

 

PPG-Sipsy

 

PPG Industries, Inc.

Z.I. la Croix Cadeau

 

One PPG Place, 36 E

B.P. 79

 

Pittsburgh, PA  15272 USA

49242 Avrille Cedex, France

 

Attention:  General Manager, Fine Chemicals

Attention:  European Operations Manager

 

Fax:  ***

Fax: ***

 

 

 

27.         CONFIDENTIALITY: “Confidential Information” means all proprietary or
confidential information, data, know-how, results, trade secrets, techniques,
inventions, ideas, process, formulas, drawings, or diagrams disclosed by one
Party to the other Party in the course of negotiating or performing under this
Agreement, whether or not marked or identified as confidential or proprietary,
and GWM’s Confidential Information shall include all “Confidential Information”
of Gilead Sciences, Inc. as defined in and disclosed to PPG’s predecessor in
interest pursuant to the Confidential Disclosure Agreement made and effective as
of January 1, 1998 by and between Gilead Sciences, Inc. and PPG-Sipsy (as
successor in interest to Sipsy Chimie Fine S.C.A.), except for any such
information that (i) is now, or hereafter becomes, through no act or failure to
act on the part of the receiving Party, its employees or contractors in breach
hereof, generally known or available; (ii) is known by the receiving Party at
the time of receiving such information, as evidenced by its contemporaneous
written records; (iii) is hereafter furnished to the receiving Party by a Third
Party, as a matter of right and without restriction on disclosure; or (iv) is
independently developed by the receiving Party without reference to such
Confidential Information, as shown by independent, contemporaneous, written
records.  During the term of this Agreement,           ***         , each Party
will maintain all Confidential Information of the other Party received by it
under this Agreement in confidence and, without prior written permission of the
other Party, shall not disclose any such Confidential Information of the other
Party to any third party or use any such Confidential Information for any
purposes or to an extent other than as necessary or permitted for performance
under this Agreement. The Parties shall disclose Confidential Information of the
other Party only to its employees, agents, consultants, affiliates, or
sublicensees who need such information for performance under this Agreement and
who are subject to binding obligations to hold in confidence and not make use of
such Confidential Information of the other Party for any purpose other than
those permitted by this Agreement, that are at least as restrictive as those of
this Section 27.  Each Party will protect the confidentiality of the other
Party’s Confidential Information using the same standard of care as it uses to
protect its own confidential information of a similar nature, but no less than
reasonable care.  Each Party will notify the other Party promptly upon discovery
of any unauthorized use or disclosure of the Confidential Information of the
other Party.

 

 

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                        Notwithstanding any other provision of this Agreement,
each Party (or its affiliate, if applicable) may disclose Confidential
Information if such disclosure: (i) 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 receiving 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 Confidential
Information so disclosed be used only for the purposes for which the order was
issued; (ii) is otherwise required by governmental law, rule or regulation,
including without limitation rules or regulations of the U.S. Securities and
Exchange Commission, or by rules of the National Association of Securities
Dealers; provided, however, that the receiving Party shall first have given
notice to the other Party hereto in order to allow such Party the opportunity to
seek confidential treatment of the Confidential Information; or (iii) is
otherwise necessary to prosecute or defend litigation, comply with applicable
governmental regulations, make governmental patent or regulatory filings, or
otherwise enforce obligations under this Agreement, but only to the extent that
any such disclosure is necessary for such enforcement.

 

                        If this Agreement terminates or expires, each Party
will, at the other Party’s election, promptly return or destroy all Confidential
Information received by it from the other Party and shall certify in writing to
such other Party the completion thereof.

 

28.         ENTIRE AGREEMENT; AMENDMENTS: This Agreement together with the
attachments, exhibits, or supplements specifically referenced in this Agreement
constitutes the entire, final, complete, and exclusive agreement between the
Parties and supersedes all previous agreements or representations, written or
oral, with respect to the subject matter of this Agreement. This Agreement may
not be modified, amended, waived, discharged, or terminated orally, but only by
an instrument in writing signed by a duly authorized representative of each
Party. SUBJECT TO SUCH AMENDMENT, THE TERMS AND CONDITIONS SET FORTH HEREIN
CONSTITUTE THE FINAL COMPLETE, EXCLUSIVE, AND ENTIRE AGREEMENT BETWEEN GWM AND
PPG WITH RESPECT TO THE SUBJECT MATTER HEREOF.  ANY TERM OR CONDITION IN ANY
AGREEMENT, CONFIRMATION, OR OTHER DOCUMENT FURNISHED BY GWM OR PPG WHICH IS IN
ANY WAY INCONSISTENT WITH THE TERMS SET FORTH HEREIN IS HEREBY EXPRESSLY
REJECTED.

 

29.         INSURANCE: Each party shall maintain at is own cost insurance
policies with respect to its activities and obligations under this Agreement
that are commercially reasonable as to terms, coverage and coverage limits in
view of the scope of such party’s activities and obligations under this
Agreement.  At the other party’s request, each party will supply certificates of
insurance evidencing such coverages.

 

30.         SURVIVAL: The provisions of Sections 8, 12 (with respect to the last
sentence only), 13, 14, 15, 16, 17, 18, 19, 22, 23, 26, 27, 28, 29 and 30 shall
survive the termination or expiration of this Agreement.

 

 

 

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GILEAD WORLD MARKETS, LTD.

 

 

 

 

 

By:

/s/ Mark L. Perry

 

 

 

 

Name:

Mark L. Perry

 

 

 

 

Date:

January 2, 2003

 

 

 

 

Title:

Managing Director

 

 

 

 

 

Accepted and Acknowledged by:

 

 

 

PPG-SIPSY

 

 

 

 

 

By:

/s/ Rene DeVaumas

 

 

 

 

Name:

Rene DeVaumas

 

 

 

 

Date:

December 18, 2002

 

 

 

 

Title:

President, PPG-Sipsy

 

 

 

 

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Exhibit A

TENOFOVIR DF PURCHASE QUANTITIES

 

 

 

Calendar Year

 

***

 

 

2003

 

***

 

 

2004

 

***

 

 

***

 

***

 

 

 

 

 

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Exhibit B:

Tenofovir DF Base Prices

 

 

 

***

 

Base Price   ***

 

 

 

***

 

***

 

 

***

 

***

 

 

 

Using the above table “Invoice” price is set on                  ***          of
each calendar year for the subsequent calendar year using the      ***   plus
the forecast given by GWM for the second      ***          in accordance with
Section 3(c).    Adjustment will be made         ***                       
based on                                                            
***          such year, with a corresponding      ***       of that calendar
year based on the   ***.

 

***

 

 

 

 

 

 

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*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.

 

 

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