EXHIBIT 10.1
SUPPLY AGREEMENT
This agreement ("Agreement") is made as of May 26, 1999, by and between Repligen
Corporation ("REPLIGEN"), a Delaware corporation with principal offices at ▇▇▇
▇▇▇▇▇▇ ▇▇▇., ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ and Amersham Pharmacia Biotech AB ("BIOTECH"), a
corporation incorporated in Sweden with principal offices at ▇▇▇▇▇▇▇▇▇▇ ▇▇,
▇▇-▇▇▇ ▇▇ Uppsala (each a "Party" and collectively "the Parties").
WHEREAS, REPLIGEN possesses capabilities relating to the large scale
manufacture of recombinant proteins including protein A; and
WHEREAS, BIOTECH utilizes a proprietary form of recombinant protein A in a
variety of products marketed and sold by BIOTECH; and [*]
WHEREAS, the Parties wish to enter a long term relationship wherein
REPLIGEN will be the preferred manufacturer of recombinant protein A for
BIOTECH's use.
NOW THEREFORE, for the mutual covenants contained herein, and for other
good and valuable considerations, the Parties agree as follows:
1. DEFINITIONS
For the purpose of this Agreement, the terms set forth hereunder shall be
defined as follows:
a. "Biotech IPA" means those forms of immobilized Biotech rPA which are
manufactured, marketed, and sold to the general public by BIOTECH as
further described in Appendix A attached hereto.
b. "Biotech rPA" means that form of unimmobilized recombinant protein A
which is proprietary to BIOTECH.
c. "Biotech Specifications" means that set of physical, chemical, and
functional characteristics that are reported in the Certificate of
Analysis, attached hereto as Appendix B. Biotech Specifications may
be modified from time to time by mutual agreement of the Parties.
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[*] indicates material which has been omitted and for which confidential
treatment has been requested. All such material has been filed with the
Commission pursuant to rule 24b-2 promulgated under the Securities Exchange Act
of 1934, as amended.
d. "Confidentiality Agreement" shall mean that confidentiality
agreement dated April 20, 1998 entered into by and between the
Parties.
e. "New Product" means that product described in Appendix D.
f. "First Agreement" means that agreement made by and between the
Parties on September 29, 1992.
g. "License Agreement" means that agreement between the Parties made
effective on the execution date of this Agreement in which REPLIGEN
grants to BIOTECH i) a non-exclusive license to US Patent No.
5,084,559 ("Protein A Domain Mutants") and ii) a license to
technology, know-how, and certain other rights relating to New
Product.
h. "Process Technology" means any and all know-how, proprietary
materials and reagents, documentation, trade secrets, and technology
relating to the production of Biotech rPA.
i. "Repligen rPA" means those forms of unimmobilized recombinant
protein A which are proprietary to REPLIGEN.
j. "Master Agreement" means that agreement made by and between the
Parties and dated December 17, 1998.
k. "Contract Year" means each calendar year during the term of the
Agreement.
l. "Article(s)" shall mean either or both of Biotech rPA and New
Product produced by REPLIGEN for BIOTECH under this Agreement.
2. MANUFACTURING
a. During the term of this Agreement, REPLIGEN agrees to manufacture
Biotech rPA in compliance with the Biotech Specifications and those
documented processes or any modification thereto to which the
Parties may mutually agree and to supply it to BIOTECH according to
the terms and conditions herein.
b. During the term of this Agreement, REPLIGEN agrees to manufacture
New Product in compliance with the documented procedures developed
by REPLIGEN and to supply it to
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BIOTECH according to the terms and conditions of this Agreement and
the License Agreement.
c. Any and all subcontractors engaged by REPLIGEN to carry out any
aspect of the manufacture of Biotech rPA will be bound by a
confidential disclosure agreement ("CDA") with terms and conditions
substantially similar to the Confidentiality Agreement. BIOTECH will
have the right to consent to all subcontractors involved in
manufacture of Biotech rPA which consent shall not be unreasonably
withheld. Following consent by BIOTECH and execution by the
subcontractor of a CDA, REPLIGEN may share Process Technology with
such party. BIOTECH may not contact REPLIGEN's sub-contractors with
specific reference to the manufacture of Biotech rPA without the
prior consent of REPLIGEN. REPLIGEN may utilize alternative
facilities under its control in the manufacture of Biotech rPA.
REPLIGEN will give BIOTECH nine (9) months prior written notice of
any intended change in facility or sub-contractor for approval by
BIOTECH, such approval not to be unreasonably withheld by BIOTECH.
d. From time to time, BIOTECH may request that reasonable changes be
made in the process used by REPLIGEN to manufacture Biotech rPA and
REPLIGEN agrees to use best efforts to incorporate such changes. In
the event that requested changes may effect the cost of production,
the Parties shall agree on new firm prices prior to the
implementation of said change.
e. REPLIGEN shall inform BIOTECH nine (9) months in advance of any
changes which it may wish to make in the process used to manufacture
Biotech rPA or any major changes which it may wish to make in the
process used to manufacture New Product and BIOTECH shall have
ninety (90) days to approve such change, such approval not to be
unreasonably withheld. If BIOTECH cannot approve such change,
REPLIGEN agrees to continue to supply Biotech rPA and/or New Product
as manufactured by the mutually agreed upon process.
f. Changes to any aspect of the manufacturing process for New Product
which are not considered to constitute a major
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process change may be made at any time by mutual agreement of the
Parties.
g. REPLIGEN represents that it possesses the resources required
including personnel, machinery and premises, to meet its obligations
under the terms of this Agreement in all material respects provided
that BIOTECH complies with its obligations under this Agreement.
3. PURCHASE AND SALE OF PRODUCT
a. During the term of this Agreement, BIOTECH agrees to purchase and
REPLIGEN agrees to sell Biotech rPA and New Product according to the
terms and conditions set forth herein.
b. During each Contract Year, BIOTECH intends to purchase from REPLIGEN
and REPLIGEN agrees to maintain the ability to manufacture for
BIOTECH no less than [*] of BIOTECH's total requirements for Biotech
rPA. In any Contract Year in which BIOTECH does purchase [*] of said
annual requirements from REPLIGEN, REPLIGEN shall be considered to
be the preferred supplier ("Preferred Supplier") to BIOTECH for
Biotech rPA.
c. BIOTECH shall purchase a minimum quantity of New Product from
REPLIGEN during the first Contract Year, i.e. calendar 1999,
according to the following schedule:
[*]
[*]
as well as such additional quantities which it may elect to
purchase.
d. Within 20 days following the completion of each quarter of a
Contract Year, BIOTECH will inform REPLIGEN as to the status of: i)
the inventory of Biotech rPA and Biotech IPA on hand as well as the
aggregate quantity of Biotech IPA that has been sold during the
preceding quarter, ii) the inventory of New Product on hand, and
iii) the total quantities of BIOTECH rPA ordered from third party
suppliers in said preceding quarter. REPLIGEN will have the right to
audit all relevant records of BIOTECH with respect to this
information, however BIOTECH shall have no
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[*] indicates material which has been omitted and for which confidential
treatment has been requested. All such material has been filed with the
Commission pursuant to rule 24b-2 promulgated under the Securities Exchange Act
of 1934, as amended.
obligation to reveal the terms or conditions of any arrangements
regarding third parties.
4. PRODUCT PRICING
a. The price paid by BIOTECH to REPLIGEN for all Biotech rPA purchased
during the first Contract Year, i.e. calendar 1999, will be
according to the schedule set forth in Appendix C:
b. The price for Biotech rPA purchased by BIOTECH from REPLIGEN in each
Contract Year after the first year of the Agreement will be based
upon the price schedule in Appendix C and adjusted on the basis of
the average yield obtained in the previous year according to the
following formula:
[*]
wherein average yield is the average yield obtained over all
manufacturing runs carried out in the immediately preceding calendar
year of production.
c. The price paid to REPLIGEN by BIOTECH for New Product under the
Agreement will be as set forth in Appendix C:
d. On or before October 31 of each Contract Year, the Parties will
agree upon new, firm pricing for the subsequent Contract Year based
upon: i) any price reduction based on yield according to this
Section 4b herein, ii) any change in the United States Consumer
Price Index as published at the end of the third quarter of the
preceding calendar year or some other index or indices as may be
mutually agreed upon by the parties, and iii) any other factors,
such as justifiable and documented changes in REPLIGEN's cost of
manufacture, altered market conditions, process modifications, etc.
The new, firm prices will be made effective as of January 1 of the
following Contract Year and will remain in effect throughout said
Contract Year. In the event that the Parties cannot agree on any
price changes, the prices shall remain unchanged for the following
Contract Year.
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[*] indicates material which has been omitted and for which confidential
treatment has been requested. All such material has been filed with the
Commission pursuant to rule 24b-2 promulgated under the Securities Exchange Act
of 1934, as amended.
5. ORDERS, FORECASTS, AND PAYMENT
a. On or before September 30, 1999 and thereafter prior to the end of
each calendar quarter while this Agreement is in force BIOTECH shall
deliver a written rolling forecast by quarter of its estimated need
of Articles during the coming twelve-month period, stating Article
numbers, and quantities with reasonable detail. This forecast will
provide a basis for REPLIGEN's resource planning with regard to
component and materiel procurement and production capacity. The
first, third, and fourth quarterly forecast within each rolling
twelve-month forecast shall be non-binding upon either of BIOTECH
and REPLIGEN. The forecast for the second quarter within each
rolling twelve-month forecast ("Set Quarter") will have certain
binding obligations upon each of the Parties with respect to said
second quarter, as set forth in this Section 5 hereunder. Once the
forecast which establishes a Set Quarter has been received by
REPLIGEN, it shall not be changed except by mutual agreement of the
Parties.
b. Commencing January 1, 2000 (i.e. the first Set Quarter to occur
under this Agreement) and thereafter throughout the term of the
Agreement, BIOTECH shall, from time to time and as it deems
appropriate, issue written, binding purchase orders to REPLIGEN,
stating the Article number, quantity, shipping destination, and
shipping date for each Article. Shipping for international
destinations shall be solely on Mondays. The stated shipping date
shall be based on the agreed lead time. Lead time is defined as the
number of days from the date on which BIOTECH issues the order until
the date on which product is delivered by REPLIGEN according to
Section 6 herein.
c. In each Set Quarter during the term of the Agreement, REPLIGEN
agrees to deliver to BIOTECH with a two week lead time up to one
hundred-fifty percent (150%) of the quantity of Articles forecast
for that Set Quarter. If, in any Set Quarter, REPLIGEN does not
deliver Articles up to said 150% of that forecast according to said
two week lead time, BIOTECH is entitled to reduce the price paid for
such Articles by 1% for each week of delay up to a maximum of 10%.
d. For quantities of Articles ordered by BIOTECH in any Set Quarter
that exceed 150% but do not exceed 200% of the
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amount forecasted for that Set Quarter, REPLIGEN shall make best
efforts to deliver said quantities with a lead time of six (6)
weeks. If, in any Set Quarter, REPLIGEN does not deliver Articles in
excess of 150% but less than 200% of that forecast according to said
six week lead time, BIOTECH is entitled to reduce the price paid for
such Articles by 1% for each week of delay up to a maximum of 10%.
For any quantities of Articles ordered by BIOTECH in any Set Quarter
that exceed 200% of the amount forecasted for that Set Quarter,
REPLIGEN shall have no obligation to meet prescribed lead time for
shipping with respect to those excess quantities. REPLIGEN shall,
however, in all cases use reasonable efforts to adhere to a two week
lead time, to keep BIOTECH informed as to expected shipping dates,
and to supply BIOTECH with such excess quantities as promptly as
possible.
e. In the event of the occurrence of Force Majeure or any other event
beyond the reasonable control of REPLIGEN which results in the
inability of REPLIGEN to deliver Articles according to prescribed
lead times of this Section 5, REPLIGEN's sole obligations hereunder
shall be: i) to give BIOTECH prompt notice of said event in writing
and ii) to seek diligently to deliver such Articles at the earliest
opportunity.
f. [*] of the forecast for each Set Quarter shall be binding upon
BIOTECH with respect to purchase of Articles in that quarter. Prior
to the last Monday of any quarter in which BIOTECH has failed to
submit purchase orders that total [*] of the amount which was
forecast for that quarter when it was a Set Quarter, REPLIGEN shall
request that an order be placed by BIOTECH for such quantity of
Articles as represents the difference between the quantity of
Articles ordered for that quarter to date and the amount of Articles
binding on BIOTECH for that Set Quarter. In response to such
request, BIOTECH agrees to place a purchase order in respect of such
quantity prior to the end of said Set Quarter.
g. Nothing in any purchase order submitted by BIOTECH or invoice or
order acknowledgment submitted by REPLIGEN pursuant to this
Agreement shall be construed as superseding or amending the terms of
this Agreement absent
25
[*] indicates material which has been omitted and for which confidential
treatment has been requested. All such material has been filed with the
Commission pursuant to rule 24b-2 promulgated under the Securities Exchange Act
of 1934, as amended.
written agreement by the other Party which specifically references
this Agreement.
h. Payment shall be made in full, in US dollars, thirty (30) days after
invoice. Invoices shall be sent upon delivery of the Articles
i. If BIOTECH fails to make timely payment, REPLIGEN shall be entitled
to charge interest on the aggregate amount of the overdue payment
commencing on the due date at a rate equal to the current discount
rate set by the US Federal Reserve Board plus five (5) percentage
points.
j. Within three (3) days of receipt of a purchase order for Articles,
REPLIGEN shall inform BIOTECH as to when delivery should be made.
REPLIGEN shall further inform BIOTECH at that time as to whether any
delay in delivery may be expected.
6. DELIVERY, SHIPPING, AND TITLE
a. Delivery shall be made as FCA, Repligen, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇. ▇▇▇▇▇▇▇, ▇▇
as defined by Incoterms.
b. The ownership, right to possession, title to and all risk of loss of
all Articles shall pass to BIOTECH at the time of delivery.
7. OTHER OBLIGATIONS
a. For any Contract Year in which REPLIGEN is the Preferred Supplier
under this Agreement, BIOTECH's obligation to pay royalties to
REPLIGEN under the First Agreement shall be waived and no royalties
shall be due.
b. For any Contract Year in which REPLIGEN does not achieve Preferred
Supplier status due to a failure on the part of BIOTECH to submit
purchase orders to REPLIGEN, royalties under the First Agreement
will be retroactively due on all product sales which occurred during
that Contract Year according to terms of the First Agreement. Such
royalties shall be due and payable in full within 90 days of the end
of any Contract Year in which REPLIGEN is not the Preferred Supplier
due to the failure of BIOTECH to submit purchase orders.
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c. For any Contract Year in which REPLIGEN does not achieve Preferred
Supplier status due to a failure on the part of REPLIGEN to deliver
Biotech rPA in response to purchase orders from BIOTECH, BIOTECH's
obligation to pay royalties to REPLIGEN under the First Agreement
shall be waived and no royalties shall be due.
8. SECURITY STOCK AND DISASTER PLAN
a. As part of a comprehensive disaster plan and commencing upon April
1, 2000, REPLIGEN will maintain a security stock of [*] of Biotech
rPA, to be stored under controlled and documented conditions at
▇▇▇▇▇▇▇▇▇▇ Health Care, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ or an
equivalent facility(s) designated by Repligen. This security stock
will be turned over on an annual basis.
b. Within two months of the signing of this Agreement, REPLIGEN and
BIOTECH hereby agree to establish and set in place a detailed action
plan for how REPLIGEN will handle obligations under the Agreement in
case of a disruption of production due to such events as Force
Majeure or due to such similar events not within REPLIGEN's control.
The Parties agree that the establishment, implementation, and/or
maintenance of such disaster plan shall not result in significant
additional costs for REPLIGEN. The basic elements of the disaster
plan will consist of:
o maintenance of a security stock by REPLIGEN
o identification and qualification of a second
fermentation subcontractor before the end of the second
Contract Year
o plan for transfer of purification/finishing within a six
(6) week time frame to an alternative facility for a
period of up to six (6) months in the event that
REPLIGEN's facility becomes incapacitated
c. The presentation of such action plan shall not in any event be
interpreted as to affect BIOTECH's rights to
27
[*] indicates material which has been omitted and for which confidential
treatment has been requested. All such material has been filed with the
Commission pursuant to rule 24b-2 promulgated under the Securities Exchange Act
of 1934, as amended.
other remedies in case of REPLIGEN's breach of the Agreement.
9. QUALITY ASSURANCE, CERTIFICATES, AND INSPECTIONS
a. REPLIGEN shall establish and maintain a quality assurance system
which, after being approved by BIOTECH, will enable REPLIGEN to
issue a Certificate of Analysis (CoA) showing that delivered
Articles are conforming to the Biotech Specifications. BIOTECH is
prepared to accept Articles received as complying with the Agreement
and with this CoA.
b. All Articles delivered by REPLIGEN to BIOTECH shall conform to the
Biotech Specifications and such conformance shall be documented by a
CoA. Articles delivered by REPLIGEN to BIOTECH shall also be in
compliance with all testing which may be required by the agreed and
documented procedures, this Agreement, and applicable law. All
testing procedures shall be in accordance with those documented
quality control procedures developed by the Parties in connection
with the process developed and approved by the Parties. REPLIGEN
shall accompany each shipment of Articles with a CoA evidencing that
the Article being shipped has passed all purity, quality control,
and other tests required hereunder.
c. With reasonable prior notice to REPLIGEN and at BIOTECH's sole
expense, BIOTECH is entitled to inspect and observe REPLIGEN's
manufacture of Articles, to audit REPLIGEN's quality control and
inspection procedures, and to have access to all data from such
control of the Article and to take samples and make such other
investigations as BIOTECH deems necessary. REPLIGEN shall reserve
the right for BIOTECH to perform such inspections on the premises of
subcontractors engaged by REPLIGEN, such inspections to be scheduled
by REPLIGEN following reasonable prior notice by BIOTECH and to be
carried out jointly by representatives of both Parties and at the
sole expense of BIOTECH. BIOTECH's right of inspection under this
head shall not diminish REPLIGEN's obligation to deliver Articles
which comply with the specifications of this Agreement.
10. WARRANTY
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a. Except as otherwise agreed in writing, REPLIGEN warrants that: i)
the Articles delivered to BIOTECH under this Agreement shall be
manufactured and tested in accordance with the documented
procedures, ii) the Articles will conform to the CoA, iii) the
requirements under this Agreement will have been performed and
satisfied, and iv) title to Articles will pass to BIOTECH free and
clear of all liens, charges, and encumbrances save for those which
occur pursuant to this Agreement (Warranty). This Warranty shall
survive receipt of the Articles by BIOTECH for twelve (12) months in
the case of Biotech rPA and for eighteen (18) months in the case of
New Product and no claim for a breach of this warranty may be
brought after the end of the applicable period. Except as otherwise
agreed by REPLIGEN in writing, the foregoing Warranty sets forth
REPLIGEN's sole and exclusive representations with respect to
Articles sold to BIOTECH under this Agreement. BIOTECH's remedies
under this Warranty shall be limited to the replacement of
non-conforming Articles according to the terms and conditions of
this Section 10 with REPLIGEN bearing the cost of shipping and
insurance. The foregoing Warranty shall not apply to defects
resulting from misuse, negligence, or accident on the part of
BIOTECH or any third party.
b. Following notification by BIOTECH that any Articles are
non-conforming under the Warranty, replacement under the Warranty
shall be made as follows:
i. REPLIGEN shall ship requested Articles to BIOTECH within
five (5) days of receipt of the replacement request from
BIOTECH at no cost for BIOTECH at such time.
ii. Within five (5) days of any replacement request, BIOTECH
shall ship a sample of the non-conforming Articles to
REPLIGEN and REPLIGEN shall complete comparative testing
between said non-conforming sample and an archived
sample from the same lot of Articles. If this
comparative testing demonstrates that both the
non-conforming sample and the archived sample do not
conform to the CoA, the Parties agree that the
replacement under i. falls under the Warranty. If,
however, REPLIGEN
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determines that the archived sample is conforming to the
CoA, and REPLIGEN can make it likely that the
non-conformance of the Articles replaced is due to
BIOTECH's handling of said Articles or other
circumstances outside of REPLIGEN's control, BIOTECH
will pay for the replacement Articles in full.
iii. The quantity of Biotech rPA replaced under the Warranty
in any quarter shall be limited to [*]. The quantity of
New Product replaced under the Warranty in any single
quarter shall be limited to [*]. Replacement of Articles
under the Warranty may be made from security stock
maintained pursuant to this Agreement.
c. The Parties agree that the Warranty with respect to Biotech rPA is
based on good faith estimates of expected minimum stability under
defined storage conditions and that stability tests will be
performed by BIOTECH and REPLIGEN to confirm these estimates. Such
stability tests will be completed no later than December 31, 2000
and will be used by the Parties to establish a Warranty period for
the remaining term of the Agreement, which may be different than 12
months. The Parties agree that there is no reason to differentiate
the Warranty periods for Biotech rPA and New Product.
d. If REPLIGEN has made any replacements of Biotech rPA under the
Warranty according to the provisions of Section 10.b.i. and
stability testing conducted according to Section 10.c. indicates
that the non-conformance leading to such replacement occurred as a
result of instability under controlled storage conditions, BIOTECH
shall immediately reimburse REPLIGEN as if such replacement had been
a new sale of Biotech rPA.
11. TERM AND TERMINATION
a. This Agreement will remain in effect from the date of signing until
December 31, 2008 unless terminated earlier according to the
provisions of this Section 11.
b. Either Party may terminate this Agreement upon the material breach
of the other Party's performance pursuant
30
[*] indicates material which has been omitted and for which confidential
treatment has been requested. All such material has been filed with the
Commission pursuant to rule 24b-2 promulgated under the Securities Exchange Act
of 1934, as amended.
to either of this Agreement or the Master Agreement, upon 90 days
written notice. The failure to cure such breach to the other Party's
satisfaction within 90 days will result in the immediate termination
of this Agreement.
c. In the event that BIOTECH issues no purchase orders to REPLIGEN for
Biotech rPA in any two consecutive Contract Years, REPLIGEN may
terminate this Agreement.
12. COLLABORATION
a. The Parties agree to cooperate with each other and to act in good
faith in carrying out the purpose and intent of this Agreement.
Toward that end Parties agree to meet twice each year in the first
two Contract Years and thereafter once during each Contract Year to
analyze results achieved and to take joint action to achieve good
results for both. The site for such meetings will alternate between
REPLIGEN's place of business in Needham, MA and BIOTECH's place of
business in Uppsala, Sweden or such other location as may be
mutually agreed by the Parties.
13. INFRINGEMENT
a. REPLIGEN shall indemnify and hold harmless BIOTECH, its associated
companies and its customers from every claim, lawsuit or action
alleging that the use or maintenance of any Article constitutes
infringement of a patent, copyright or other intellectual right
except in the instance where the infringement is a direct
consequence of a method, design or other instruction furnished by
BIOTECH for manufacture of the Article. During the term of this
Agreement, each Party further agrees not to make any claim for
intellectual rights against the other Party or in respect of a
customers' use or maintenance of BIOTECH rPA, BIOTECH IPA, or
REPLIGEN rPA.
b. If a judgment or injunction concerning infringement has been entered
which: 1) prohibits or prevents any further use or maintenance of an
Article by BIOTECH, and 2) is not a direct consequence of a method,
design, or other
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instruction furnished by BIOTECH for the manufacture of the Article;
REPLIGEN shall at BIOTECH's request and at its own expense use best
efforts to either:
(i) replace or provide another equivalent Article, the use
of which does not to REPLIGEN's knowledge constitute an
infringement, or
(ii) modify the Article so that it no longer constitutes to
REPLIGEN's knowledge an infringement or violates the
judgment or order, provided that such modification does
not affect the function of the Article or its
compatibility with the end product.
The provisions of this Subsection 13b shall not apply to Articles
which have been modified, adapted or otherwise altered by BIOTECH.
c. If either Party learns that an infringement exists or is possible as
a result of use of an Article, the other Party shall be informed as
soon as possible.
14. PRODUCT LIABILITY
a. With respect to Articles manufactured under this Agreement, REPLIGEN
agrees to carry product liability insurance, for a total coverage of
$2 million dollars, to cover claims which may be made against
BIOTECH and/or REPLIGEN as a result of hazardous defects occurring
in such Articles.
b. Upon request from BIOTECH, REPLIGEN shall produce proof of product
liability insurance coverage. In the event that BIOTECH requests
that REPLIGEN increase its insurance coverage, the Parties will
immediately negotiate an adjustment to the price of the Articles
accordingly.
15. GROUNDS FOR EXEMPTION
a. The following circumstances constitute grounds for exemption insofar
as they render compliance with the Agreement impossible or unduly
onerous (Force Majeure):
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Labor dispute and every other circumstance over which the Parties
have no control, such as fire, war, mobilization or unforeseen
callup to military service of comparable extent, requisition,
confiscation, currency restrictions, revolts and riots, scarcity of
means of transportation, general scarcity of goods and limited
availability of motive power, as well as deficiencies and delays in
delivery of goods from subcontractors caused by such exempting
circumstances.
b. It is incumbent upon a Party who wishes to cite Force Majeure to
inform the other Party without delay when the relevant circumstances
have arisen and when they have ceased to prevail.
c. If compliance with the Agreement is delayed for more than six (6)
months by Force Majeure as specified in Subsection 15a above, either
Party shall be entitled to terminate the Agreement by giving thirty
days prior written notice to the other Party.
16. GENERAL
a. This Agreement is not assignable by either Party absent the other
Party's written consent. If REPLIGEN is purchased by a third party
which is a competitor of BIOTECH, BIOTECH has the right to approve
the transfer of the Agreement. For purposes hereof, the term
"purchase" shall mean i) a sale of all or substantially all of the
assets of REPLIGEN or ii) the merger and consolidation of REPLIGEN
with or into another corporation such that the stockholders of
REPLIGEN immediately following such transaction hold, directly or
indirectly, less than 50% of the voting securities of the
corporation surviving such transaction.
b. Any and all information disclosed by one Party to the other under
this Agreement shall be handled in accordance with the terms and
conditions of the Confidentiality Agreement and consequently be
treated as confidential - as agreed therein - for the duration of
the Agreement and for a period of five (5) years thereafter.
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c. Any changes or amendments to this Agreement shall be in writing and
made by mutual agreement of the Parties.
d. REPLIGEN will not sell or transfer Biotech rPA to any party other
than BIOTECH, except with BIOTECH's consent.
e. During the term of the Agreement, BIOTECH will supply REPLIGEN with
any and all requested quantities of chromatography media which are
marketed and sold by BIOTECH and required by REPLIGEN in the
manufacture of Biotech rPA at a [*] discount to the then current
list price.
f. Sepharose 4FF which is used specifically in the manufacture of New
Product for BIOTECH under this Agreement will be provided to
REPLIGEN at no cost. At the time of signing of this Agreement,
BIOTECH will repurchase from REPLIGEN up to 100 liters of Sepharose
4FF at the invoice price paid by REPLIGEN, said Sepharose 4FF to be
used solely for the manufacture of New Product.
g. This Agreement is subject to and shall be construed and enforced in
accordance with the laws of the State of New York. Any disputes
arising hereunder shall be resolved with reference to the English
language version of this Agreement regardless of any translations
made for the convenience of the Parties. All disputes between the
Parties shall be resolved by binding arbitration in accordance with
the rules and regulations of the American Arbitration Association in
the city of New York, NY. Notwithstanding anything herein to the
contrary, the Parties acknowledge and agree that each shall have the
right to obtain equitable relief against the other provided that
each Party hereby agrees to submit to the jurisdiction of the courts
of the State of New York or the federal courts of the United States
located in New York and that the venue for all such proceedings
shall lie in the State of New York.
IN WITNESS WHEREOF, the Parties hereto have hereunto set their hands and seals
and duly executed this Agreement the day and year first written above.
FOR REPLIGEN CORPORATION FOR AMERSHAM PHARMACIA
BIOTECH AB
/s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇ /s/ ▇▇▇▇ ▇▇▇▇▇▇▇
34
[*] indicates material which has been omitted and for which confidential
treatment has been requested. All such material has been filed with the
Commission pursuant to rule 24b-2 promulgated under the Securities Exchange Act
of 1934, as amended.
/s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇ /s/ ▇▇▇▇ ▇▇▇▇▇▇▇
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Name Name
VP, Business Development President
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Title Title
May 26, 1999 June 27,1999
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Date Date
35
