Exhibit 10.17

STRATEGIC SUPPLIER ALLIANCE AGREEMENT – CONTRACT MANUFACTURING EMEA

GE HEALTHCARE

 

GE Healthcare entity (“GEHC”)    Other Party (the “Supplier”) GE Healthcare
Bio-Sciences AB    Repligen Corporation Address    Address Björkgatan 30, 751 84
Uppsala, Sweden    41 Seyon Street Building #1 suite 100 Registration number   
Waltham, MA 02453 USA 556108-1919    Registration number AGREEMENT    GEHC REF:

The Parties hereby agree that the following terms and conditions shall apply:

 

  A. Purpose

GEHC and the Supplier are entering into this Agreement for the outsourcing by
GEHC of the manufacture of the Products by the Supplier. Pursuant to the terms
and condition of this Agreement, the Supplier shall manufacture and sell to
GEHC, and GEHC shall purchase from the Supplier the Products meeting the
specifications referred to in Attachment C (the “Products”) in such amounts as
GEHC may order from time to time on the terms and conditions set out in this
Agreement. GEHC shall pay the price of the Products specified in Attachment C
(the “Prices”).

 

  B. Documents

The following attachments are an integral part of this Agreement (the
“Attachments”). The provisions of each Attachment shall be incorporated by
reference into and deemed to be part of this Agreement. The order of precedence
shall be as follows, unless otherwise agreed:

QUALITY & INTEGRITY TERMS

Attachment A - Supplier Quality Requirements

Attachment B - Supplier Integrity Statement

BUSINESS TERMS

Attachment C - Products, Prices, Specifications (if any),

Attachment D - Business Terms

GENERAL TERMS

Attachment E - General Terms and Conditions

TECHNICAL TERMS

Attachment F - GEHC Production Know-How

 

  C. Term

Effective Date: 2010-01-01

Agreement Term: This Agreement shall commence on the Effective Date and, subject
to the rights of termination in clause 16 of Attachment E, shall continue for a
period of five (5) years. The Parties shall negotiate eighteen (18) months prior
to the expiration of the Term to decide whether to renew this Agreement.

This Agreement has been duly executed by each of the Parties

 

Signed for and on behalf of GEHC      Signed for and on behalf of the Supplier
Signature   

/s/ Peter Ehrenheim

     Signature   

/s/ Walter C. Herlihy

Name (capitals)   

PETER EHRENHEIM

     Name (capitals)   

WALTER C. HERLIHY

Title   

President and CEO

     Title   

President and CEO

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

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Attachment A

Purchased Material Quality Terms

Supplier Name:    Repligen Corporation

Version No.:

The Parties are committed to quality in the performance of this Agreement.
Accordingly, all Products shall conform to the Purchased Material Quality
Requirements set forth below.

Applicable To All Suppliers:

Section 1 - Quality Systems: The Supplier shall maintain a documented quality
system, and the Supplier shall be in compliance with ISO 9001 or equivalent. Key
components of a robust quality system are properly implemented quality
procedures for collection and processing defects (parts or services),
appropriate statistical techniques to analyze defects and identifying
opportunities for corrective and preventive actions, along with evidence of
validation that actions are effective in eliminating and preventing further
defects. Upon request from GE Healthcare, the Supplier shall provide documented
corrective action plans to prevent future deviations from the specification
within thirty (30) days from receiving a corrective action request from GE
Healthcare.

To ensure products and services provided to GE Healthcare shall meet or exceed
GE Healthcare requirements, GE Healthcare may audit the Supplier’s quality
system at periodic intervals upon 30 days written advance notification, to
inspect and observe the Supplier’s manufacture of Products, to audit the
Supplier’s quality control and inspection procedures, and to have access to all
data and documentation from such control of the Products and to take samples and
make such other investigations as GEHC deems necessary. The Supplier shall
reserve the right for GEHC to perform such inspections on the premises of
subcontractors engaged by the Supplier, such inspections to be scheduled by the
Supplier following reasonable prior notice by GEHC and to be carried out jointly
by representatives of both Parties and at the sole expense of GEHC. GEHC’s right
of inspection under this head shall not diminish the Supplier’s obligation to
deliver Products which comply with the specifications of this Agreement. GE
Healthcare may also request periodic, joint quality assurance meetings at the
Supplier’s facility to discuss and resolve product quality and reliability
issues.

Section 2 - Quality Record Retention: If the Supplier is required to perform
acceptance activities per GE Healthcare written agreement or purchase
specification, the Supplier shall maintain records of the acceptance activities
for the services performed and/or products and services delivered to GE
Healthcare. These records may include as appropriate test/inspection criteria,
revision level of documents/equipment/software used, operating procedures
(planning, routing or traveler sheets), dates of test/inspection, and the
results. The records required shall be retained until GE Healthcare notifies the
Supplier that the product life has ended or for a minimum of ten (10) years,
whichever is longer, unless the required records are submitted to GE Healthcare
by written agreement or purchase specification.

Section 3 - Compliance: The Supplier shall comply with the terms of the Purchase
Order or purchase agreement with GE Healthcare (“Agreement”). The Supplier shall
maintain compliance with any and all laws and government regulations that apply
in the manufacturing and delivery of its products or services. Such laws may
include, but are not limited to, regulations and directives, labor laws,
environmental laws, Custom Trade Partnership Against Terrorism (CTPAT) and
product safety laws. The Supplier shall provide GE Healthcare all information
requested that is necessary to enable GE Healthcare to comply with the laws and
regulations applicable to the GE Healthcare sale and use of GE Healthcare
products. As per GE Healthcare

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    2 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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purchase specifications or for OEM (Original Equipment Manufacturer) items, the
Supplier shall maintain compliance to industry standards and product listings
for all Products delivered to GE Healthcare.

Section 4 - Change Notification: Changes proposed by Supplier, both material and
process or software changes, which may affect form, fit, function, reliability,
serviceability, performance, functional interchangeability, regulatory
compliance, safety, options or spare parts interchangeability or interface
capability with GE Healthcare Product must be submitted along with a written
change notice, for GE Healthcare approval. This includes, but is not limited to,
changes of sources of material and parts, changes in manufacturing processes,
test procedures, manufacturing locations, relocation or replacement of equipment
and any similar changes that are anticipated by Sub-Suppliers. Items affected by
such changes may not be delivered to GE Healthcare until the Supplier has
received written approval for the changes from GE Healthcare. At minimum, the
change notice must include the Supplier’s affected part number or software
revision, date of implementation, serial number effectivity of the assembly that
is changed, reason for the change, specific details of the change and, if
available, supporting data that demonstrates that part reliability has not been
impacted negatively. The change must not be implemented without prior written
consent from GE Healthcare, which shall not be unreasonably withheld. In
addition, GE Healthcare has the right to request samples for evaluation prior to
approval by GE Healthcare of such changes.

Section 5 - Specifications: The Supplier is responsible to meet or exceed the
part requirements and Specifications as referenced in the Agreement. The
Supplier is accountable to ensure that delivered items meet the requirements of
the revisions and/or versions specified on the applicable Agreement.

The Supplier shall ensure that GE Healthcare documentation is controlled and
distributed with the correct revision level to the appropriate personnel that
produce the product for GE Healthcare. The Supplier shall also ensure that all
GE Healthcare documentation is treated as proprietary and confidential.

For GE Healthcare designed Products, the Supplier is responsible for ensuring
that all applicable GE Healthcare documentation is provided to all of the
Supplier’s Sub-Suppliers involved in the supply of product for GE Healthcare.
The Supplier shall ensure that both they and their Sub-Suppliers that use GE
Healthcare engineering documentation are maintained in compliance with all
accepted Engineering Change Requests/Engineering Change Orders issued by GE
Healthcare.

Upon request from GE Healthcare, the Supplier shall ensure that part
qualification is conducted and documents are submitted as required. The part
qualification requirements shall be determined by GE Healthcare and shall
consist of at a minimum a part layout plan, capability study, and a process
control plan.

Section 6 - Electrostatic Discharge: IF ELECTROSTATIC DISCHARGE (ESD) SENSITIVE
DEVICES ARE SUPPLIED TO GE HEALTHCARE, THE SUPPLIER MUST HAVE AN ACTIVE ESD
PROGRAM AND USE PROPER ESD HANDLING AND PACKAGING PROCEDURES. APPLICABLE
COMPONENTS INCLUDE CIRCUIT BOARDS, ELECTRONIC ASSEMBLIES WITH EXPOSED COMPONENTS
OR CONNECTORS, SEMI-CONDUCTORS AND ANY OTHER DEVICES THAT MAY REQUIRE ESD
PROTECTION. SUPPLIERS MUST MAINTAIN RECORDS OF THE TESTING DONE AND TRAINING
PROVIDED.

Section 7 - Packaging and Shipping Methods: The Supplier shall provide packaging
and shipping methods to prevent cosmetic, mechanical and electrical damage to
the Product. The Supplier shall meet or exceed the detailed specifications of
the GE Healthcare packaging requirements found in the Specification

Section 8 - Order of Precedence: This attachment A shall be an addendum to the
Strategic Supplier Alliance Agreement (SSAA) between Supplier and GE Healthcare.
Any conflict between this Attachment A and the other Attachments of the SSAA
regarding the minimum material quality requirements shall be resolved pursuant
to the latter. Any conflict between this Attachment A and the Purchase Order
regarding the minimum material quality requirements shall be resolved pursuant
to the terms of this Attachment A.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    3 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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By signing below, you agree to the terms hereof and consent to meet all
requirements that apply for any and all products and services provided to GE
Healthcare.

 

Agreed to and Accepted by Supplier Signature:  

/s/ Daniel P. Witt, PhD

Printed Name:  

Daniel P. Witt, PhD

Title:  

Vice President, Operations

Date:  

2/2/2010

Supplier Name:  

Repligen Corporation

Agreed to and Accepted by the General Electric Company on Behalf of its
Division, GE Healthcare

Signature:  

/s/ Peter Ehrenheim

Printed Name:  

Peter Ehrenheim

Title:  

President and CEO

Date:  

1/27/2010

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    4 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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Attachment B

Supplier Integrity Statement

Supplier Integrity, Business Conduct, and Compliance Requirements

 

A. Supplier agrees (a) to comply with all applicable legal, as well as GEHC
policy, requirements (including those relating to labor, the environment, health
and safety, wages, hours and conditions of employment, occupational safety,
discrimination, sexual harassment, immigration, minority owned businesses,
intellectual property rights and improper payments); (b) that Supplier is
responsible for ensuring that Supplier’s employees, contractors, representatives
and sub-suppliers understand and comply with the same legal and GEHC policy
requirements; and (c) that the requirements referenced in (a) and (b) above
include the following:

 

(1) Code of Conduct. Maintain and enforce written company policies requiring
high ethical conduct and strict adherence to lawful business practices,
including a prohibition against bribery of government officials.

 

(2) Labor Matters.

 

  (i) Employ only workers above the applicable minimum age requirement or the
age of 16 whichever is higher.

 

  (ii) No use of forced, prison or indentured labor, workers subject to any form
of compulsion or coercion, or labor in violation of minimum wage, hour of
service, or overtime laws in the country of manufacture, and prohibit physical,
sexual or psychological harassment or coercion.

 

  (iii) Allow workers to freely choose whether to organize or join associations
for the purpose of collective bargaining as provided by local law.

 

  (iv) Assure that workers are hired, paid and otherwise subject to terms and
conditions of employment based on their ability to do the job, not on the basis
of their personal characteristics such as race, national origin, sex, religion,
ethnicity, disability, maternity, age, and other characteristics protected by
local law; provided, however, that the foregoing does not bar compliance with
affirmative preferences that may be required by local law.

 

(3) Environmental Compliance. Comply with all applicable environmental laws and
regulations, including: (i) maintaining and enforcing written and comprehensive
environmental management programs that are subject to periodic audit by GEHC or
its representatives; (ii) continuing compliance with all required environmental
permits; and (iii) strictly not negligently permitting any discharge to the
environment in violation of law, or that would otherwise have an adverse impact
on the environment.

 

(4) Health & Safety. Provide workers with a safe workplace that complies with
applicable health and safety standards as well as appropriate living conditions.

 

(5) Improper Payments and Business Dealings. Not offer or provide, directly or
indirectly, anything of value (including cash, illegal political contributions,
bribes or kickbacks or other improper payments) to any GEHC employee,
representative, customer, government official, or other third party in
connection with any GEHC procurement, transaction or business dealing.
Prohibitions include offering or providing (directly or indirectly): (i) any
consulting, employment or similar position to any GEHC employee (or their family
member or significant other) involved with a GEHC procurement; (ii) GEHC
employees and representatives with any gifts, other than gifts of nominal value
to commemorate or recognize a particular GEHC-supplier business transaction or
activity; and/or (iii) GEHC employees and/or representatives with the
opportunity to participate in any contest, game or promotion. In addition to the
foregoing, comply with all applicable laws of the United States and other
countries relating to such matters.

 

(6) Business Entertainment of GEHC Employees and Representatives. Comply with
the business entertainment (including travel and living) policies established by
GEHC and which govern GEHC employees and representatives, including
understanding those business entertainment policies of the applicable GEHC
component or operation before offering or providing any GEHC employee or
representative any form of business entertainment. Never offer to a GEHC
employee or representative any form of business entertainment under
circumstances that would create the appearance of an impropriety.

 

(7) Collusive Conduct and GEHC Procurements. Comply with all applicable
competition laws, including, but not limited to: (i) not engage in prohibited
communications or enter into agreements with competitors that can affect
competition; (ii) not share or exchange any price, cost or other competitive
information, nor engage in any other collusive conduct with any other third
party supplier or bidder to GEHC with respect to any proposed, pending or
current GEHC procurement; and (iii) avoid even the appearance of improper
conduct.

 

(8) Intellectual & Other Property Rights. Respect the intellectual and other
property rights of others, including GEHC’s. Only use GEHC information and
property (including tools, drawings and specifications) for the purpose for
which they are expressly provided and for no other purposes. Take all necessary
steps to safeguard and maintain the confidentiality of GEHC proprietary
information, including maintaining it in confidence, only in secure work areas,
and not disclose it to any third parties without the prior written permission of
GEHC. Only transmit GEHC information over the Internet on an encrypted basis.
Observe and respect all GEHC patents, trademarks, trade secrets, and copyrights,
as well as comply with such restrictions or prohibitions on their use as GEHC
may from time to time establish.

 

(9)

Export and International Trade Controls & Customs Matters. Comply with all
applicable import and export control laws and regulations, including those of
the United States, and not transfer GEHC technical information to any third
party

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    5 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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  without the express prior written permission of GEHC. Without limitation to
the foregoing: (i) comply with all applicable export controls laws and
regulations in the export or re-export of GEHC technical information, including
any restrictions on access and use applicable to non-U.S. nationals; (ii) ensure
that all invoices and any customs or similar documentation submitted to GEHC or
governmental authorities in connection with transactions involving GEHC
accurately describe the goods and services provided or delivered and the price
thereof; and (iii) not participate in any boycotts or restrictive trade
practices prohibited by U.S. laws. Supplier will also obtain all applicable
permits and licenses necessary to perform its obligations under this Agreement,
and upon GEHC’s request, will provide GEHC with copies of such permits and
licenses. Where Products contain United States components, Supplier will also
provide GEHC with details of the United States content value as a percentage of
the Product price upon GEHC’s request. Additionally and upon request, Supplier
will provide ECCN and Harmonized Tariff numbers assigned to Products.

 

(10) Privacy. With respect to data and personal information (including
information of GEHC employees, its customers, suppliers, business partners, and
patient health information handled and processed on behalf of its customers)
(collectively, “PI”): (i) comply with all applicable privacy and data protection
laws globally, or generally acceptable privacy principles where comprehensive
privacy laws are not available; (ii) report any improper use or disclosure of
PI, as well as successful security breaches, immediately upon becoming aware;
(iii) ensure that any employees, contractors, representatives and sub-suppliers
to whom it provides PI and/or access to information systems, agree to the same
restrictions and conditions set forth herein; (iv) facilitate audits by making
its internal practices, books and records relating to the use and disclosure of
PI available to GEHC and government agencies (including, the Secretary of the
Department of Health and Human Services) for purposes of determining compliance
with applicable laws, rules, and regulations; (v) when requested by GEHC,
promptly return or destroy, as well as certify in writing to the return and
destruction of, all PI and information in any form that allows access to GEHC
information systems, and retain no copies of such PI and information;
(vi) safeguard PI upon taking possession or exposure to employees and all third
parties; (vii) ensure that formal security management systems are employed that
eliminates the risk of PI-related security breaches; and (viii) notify GEHC in
writing whenever PI will be exported from jurisdictions with data transfer
restrictions, or transfer PI to countries without comprehensive data protections
laws.

 

(11) Money Laundering Prevention. Comply with all applicable anti-money
laundering laws and regulations and GEHC policies established for money
laundering prevention.

 

(12) Prohibition of Use of Sub-Suppliers or Third Parties to Evade Requirements.
Not use sub-suppliers or other third parties to evade any applicable legal
and/or GEHC policy requirements, including those enumerated above.

 

(13) Security Measures. Supplier warrants and represents that it will review and
adopt industry standard security measures which are consistent with accepted
programs including the US Customs-Trade Partnership Against Terrorism
(“C-TPAT”), the European Union’s Authorized Economic Operator program and other
similar programs where applicable. Supplier furthermore agree that it will make
reasonable efforts to become a member of C-TPAT, or any similar EU/other
organization aimed at strengthening and improving supply chain security, in a
timely manner if it is eligible to do so.

 

(14) Country of Origin. In accordance with and as required by applicable trade
and customs laws, Supplier will mark each Product, as well as Product packaging,
containers, labels, and invoices, with the country of origin for the Product.
Supplier will also provide acceptable and auditable documentation that
establishes the country of origin for all Products, including, without
limitation and as applicable, certifications of origin for Products qualifying
for EFTA/EU and other preferential duty provisions, as applicable. Without
limitation to the foregoing and in marking the Products, Supplier will comply
with the requirements of the custom authorities of the country of receipt.

GEHC policy requirements, including those enumerated above, are subject to
modification by GEHC at any time. Supplier agrees to contact its GEHC
representative if Supplier has any questions about the foregoing and/or their
application to particular circumstances.

 

B. Products provided by Supplier may be subject to environmental, health and
safety laws and regulations. As a result, Supplier agrees to the following
without limitation:

 

(1) Supplier represents, warrants, certifies and covenants that Supplier shall
perform all activities required under this Agreement in compliance with all
applicable national, EU, state/provincial and local labor, environmental, health
and safety laws and regulations.

 

(2) Supplier represents, warrants, certifies and covenants that each chemical
substance constituting or contained in Products sold or otherwise transferred to
GEHC hereunder is on the list of chemical substances compiled and published by
(a) the Administrator of the Environmental Protection Agency pursuant to the
Toxic Substances Control Act (15 USC Section 2601 et seq.) as amended; and
(b) the equivalent lists in the other jurisdictions to which GEHC informs
Supplier or Supplier knows the Products will likely be shipped to or through; or
is exempt from the foregoing lists, in which case Supplier shall provide
adequate documentation of the validity of the claimed exemption if so requested
by GEHC;

 

(3) Supplier will, when relevant, timely provide GEHC with supporting
documentation, including without limitation, (a) the exact weight by weight
percentage of any REACH candidate list substance constituting or contained in
the Products, (b) all relevant information that GEHC requires to meet the
obligations under REACH to communicate safe use to GEHC’s customers.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    6 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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(4) Supplier represents, warrants, certifies and covenants that none of the
Products supplied under this Agreement contain any above limits stated in law:
(i) lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB),
polybrominated diphenyl ethers (PBDE) or any other hazardous substances the use
of which is restricted under EU Directive 2002/95/EC (27 January 2003) (RoHS
Directive), as amended; (ii) arsenic, asbestos, benzene, polychlorinated
biphenyls (PCBs), or carbon tetrachloride; (iii) any chemical restricted under
the Montreal Protocol on ozone-depleting substances; or (iv) any other chemical
or hazardous material the use of which is restricted in any other jurisdictions
to which GEHC informs Supplier or Supplier knows the Products are likely to be
shipped to or through, unless GEHC expressly agrees otherwise in writing to
Supplier referencing this Agreement and Supplier identifies an applicable
exemption from any relevant legal restriction on the inclusion of such chemicals
or hazardous materials in the Products sold or transferred to GEHC. Upon GEHC’s
request and subject to the confidentiality provisions of this Agreement and
GEHC’s ability to meet its compliance obligations, Supplier will provide GEHC
with the chemical composition, including proportions, of any substance,
preparation, mixture, alloy or goods supplied under this Agreement and any other
relevant information or data regarding the properties, including, without
limitation, test data and hazard information.

 

(5) Supplier will use all commercially reasonable efforts to establish and
maintain an effective program to ensure that the activities of any suppliers it
utilizes to provide any chemicals, substances, goods or services that will be
incorporated into the Products supplied under this Agreement will be conducted
in conformance with Sections B(1) to B(4) above.

 

(6) With respect to any Products or other materials sold or otherwise
transferred to GEHC hereunder, Supplier shall provide all relevant information,
including without limitation, safety data sheets in the language and the legally
required format of the location to which the Products will be shipped and
mandated labeling information, required pursuant to applicable requirements such
as: (i) the Occupational Safety and Health Act (OSHA) regulations codified at 29
CFR 1910.1200; or (ii) REACH or EU Directive 67/548/EEC, as amended, if
applicable, and (iii) any other applicable law, rule or regulation or any
similar requirements in any other jurisdictions to which GEHC informs Supplier
that the Products are likely to be shipped.

 

(7) With respect to any Products or other materials sold or otherwise
transferred to GEHC hereunder, Supplier shall notify GEHC in writing of the
presence of any nanoscale material (defined for these purposes as any substance
with at least one dimension of such substance known to be less than 100 nano
meters in length). With respect to all such nanoscale materials, Supplier shall
provide a description of its legal status in the relevant jurisdiction, and any
safety data or other notifications that are appropriate in the EU, US and the
relevant jurisdiction.

 

AGREED TO AND ACCEPTED BY SUPPLIER BY:  

Daniel P. Witt, PhD

TITLE:  

Vice President, Operations

DATE:  

/s/ Daniel P. Witt, PhD 2/2/2010

SUPPLIER NAME:  

Repligen Corporation

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    7 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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Attachment C

Products, Prices and Specifications

 

Currency:    USD Delivery term:    FCA Waltham, Massachusetts Revision date:   
22 January 2010

A.

Product Name    Zäta GEHC Article number    28-4048-76

Supplier Article Number/unit size

 

20-2501-00      [*] 20-2501-01      [*] 20-2501-02      [*] 20-2501-03      [*]
20-2501-04      [*]

 

[*]    Lead time (PO):    [*] Lead Times for Safety Stock Replenishment
Requirement    Lead time Zata [*]   

Level of Supplier’s Safety Stock

[*] based on the average of the [*] of the then current [*] rolling Forecast
distributed by GEHC and the prior [*] by GEHC of each of the Products based on
[*].

 

Shelf life    [*]

B.

Product Name    rPA GEHC Article number    30-6000-60

Supplier Article Number/unit

 

20-1501-00      [*] 20-1501-01      [*] 20-1501-02      [*] 20-1501-03      [*]

[*]

 

Lead time (PO):    [*]

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    8 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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Lead Times for Safety Stock Replenishment

 

Requirement    Lead time rPA

[*]

  

Level of Supplier’s Safety Stock

[*] based on the average of the [*] of the then current [*] rolling forecast
distributed by GEHC and the prior [*] by GEHC of each of the Products based on
[*].

 

Shelf life

   [*]

C. General Price Terms

All prices above are per gram and shall be set [*] based on the [*] in each of
the [*] for the Products that corresponds to the [*] of each of the Products
based on the [*]. The price for each of the Products shall be set on the [*] of
each [*] and shall remain fixed for that [*]. Example:

[*]

The prices agreed herein do not include the costs of transportation, packaging,
shipping or taxes (including VAT) for the Products and will be paid by GEHC. The
costs of packaging will be charged to GEHC by Supplier directly and shall be
clearly specified on the invoice.

Additional charges: Unless otherwise agreed in this Agreement the Prices include
all costs relating to the supply of the Products and GEHC shall not be obliged
to reimburse the Supplier for any additional charges or any other costs relating
to the supply of the Products that are not specified herein or otherwise agreed
in writing by the Parties.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    9 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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Specifications

 

LOGO [g41884ge_logo.jpg]

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

30-6000-60 Ed. AG

Issued by

QA/ A Elb-Jorde

  

Established by

R&D/ J Daicic

  

Valid from

2008-10-17

  

Supersedes

30-6000-60 Ed. AF

  

Page

1 (2)

rProtein A

Code No: 30-6000-60

 

1       Packaging instruction

      The package shall be suitable for storage of the material.

2       Terms of transportation

      At -18 °C or below

3       Storage conditions

      Preserve in a well-closed container at or below -18 °C.

4       Shelf life

     

Estimated shelf life is [*] from the date of manufacture.

Final shelf life is to be decided from stability studies.

5       Other name(s)

      rPa – GE Healthcare

6       Formula and mass

      Theoretical Mr. 34 318 Dalton calculated from amino acid sequence.

7       Description

      rProtein A is a recombinant engineered form of Staphylococcus aureus
Protein A, produced by fermentation of Escherichia coil. The protein is produced
with chemicals and materials of non-animal origin.    The product is supplied as
a clear, amber frozen liquid free from particulates.

70-5043-16 / AB Valid from 2007-01-24

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    10 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

LOGO [g41884ge_logo.jpg]

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

30-6000-60 Ed. AG

                   

Page

2 (2)

8       Requirements on properties

    

Characteristic

  

Tolerance limit

  

Test method

  

Remark

  

1       Visual examination

   [*]    45-2006-68      

2       igG-binding activity: %

   [*]    04-0008-64      

3       Purity by size exclusion chromatography: %

  

[*]

   04-0008-66      

4       SDS-PAGE

  

[*]

   04-0008-65      

5       Protein concentration  (A275); mg/ml

  

[*]

   QCP-1156    1   

6       Microbial contamination CFU/ml

  

[*]

   M-QCP-1003    1   

7       Endotoxin activity EU/mg rProtein A

  

[*]

   M-QCP-1017    1

Comment:

1) Supplier method, to be available by the supplier on request from GE
Healthcare.

 

GE and GE monogram are trademarks of General Electric Company.

© 1999- 2008 General Electric Company - All rights reserved.

GE Healthcare Bio-Sciences AB, a General Electric Company.

   70-5043-16 /AB

 

Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.

--------------------------------------------------------------------------------

LOGO [g41884ge_logo.jpg]

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

14-0037-84 Ed. AC

 

Issued by

QA/ A Elb-Jorde

  

Established by

R&D/ J Daicic

  

Valid from

2008-08-19

  

Supersedes

14-0037-84 Ed. AB

  

Page

1 (2)

ZätA protein 905

Code No: 28-4048-76

 

1       Packaging instruction

      The package shall be suitable for storage of the material.

2       Terms of transportation

      At or below -18 °C

3       Storage conditions

      Preserve in a well-closed container at or below -18 °C.

4       Shelf life

     

Estimated shelf life is [*] from the date of manufacture.

Final shelf life is to be decided from stability studies.

5       Formula and mass

      Theoretical Mr: 26 748 Dalton calculated from amino acid sequence.

6       Description

     

ZätA protein is a recombinant protein produced by a Genetically Modified
Organism (GMO) in a fermentation process.

The substance is a clear, yellowish frozen liquid free from particulates,
supplied in a buffer:

20 mM potassium phosphate

150 mM sodium chloride

2 mM EDTA

pH 7.0

  

The bulk is to be manufactured according to our Base Method, number 14-0040-44.

The protein is produced with chemicals and materials of non-animal origin.

70-5043-16/AB Valid from 2007-01-24

--------------------------------------------------------------------------------

LOGO [g41884ge_logo.jpg]

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

14-0037-84 ED. AC

                   

Page

2 (2)

7       Requirements on properties

    

Characteristic

  

Tolerance limit

  

Test method

  

Remark

  

1       Visual examination

   [*]    45-2006-68      

2       IgG-binding activity; %

   [*]    04-0008-64      

3       Purity by size exclusion chromatography; %

   [*]    04-0008-66      

4       SDS – PAGE

   [*]    04-0008-65      

5       Quantification; mg/ml

   [*]    04-0013-21      

6       Microbial contamination

CFU/ml

   [*]    M-QCP-1003    1   

7       Endotoxin activity

EU/mg ZatA Protein

   [*]    M-QCP-1166    1

Comment:

1) Supplier method, to be available by the supplier on request from GE
Healthcare.

 

GE and GE monogram are trademarks of General Electric Company.

© 2006-2008 General Electric Company – All rights reserved.

GE Health Bio-Sciences AB, a General Electric Company.

   70-5043-16 / AB

--------------------------------------------------------------------------------

Annual Business Attachment / Performance Goals

The purpose of the performance goals are primarily for the Supplier to plan the
operations at the Supplier’s site and take preventive initiatives so that the
set performance goals can be achieved. The results of the Supplier’s performance
in below areas should be a part of the business updates between the two Parties.
While the performance goals are targets and non-achievement of such goals shall
not be considered as material breach of contract the Suppler agrees to use all
commercially reasonable efforts to achieve the performance goals.

Performance goals:

 

1. Deliveries within Specification, agreed lead times and quantities;
performance goal is [*] according to the terms in Attachment C)

 

2. Number of complaint reports sent to the Supplier by GEHC; performance goal is
[*]

 

3. Business contingency plan and or Quality audits performed and with the result
approved; performance goal is [*].

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    14 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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Attachment D

Business Terms

 

1. Specifications

The Products to be supplied in accordance with the terms of this Agreement are
set forth in Products and Prices, Attachment C. A technical specification in
relation to a specific Product is referred to as the “Specification” as set
forth in Attachment C.

 

2. Delivery documentation

With each shipment the Supplier shall deliver the following documents to GEHC:

Certificate of Analysis, Packing slip and the Commercial Invoice.

With each shipment the Supplier shall issue a Shipper’s Letter of Instructions
and an Export Declaration as applicable.

 

3. Prices and Payment Terms

 

  a. Firm Prices. The Prices of the Products are firm for the Term of this
Agreement.

 

  b. Taxes. Unless prohibited by law, the Supplier will separately indicate on
its Invoice any tax that is required to be imposed on the sale of Products.

 

  c. Payment Terms. GEHC shall settle any undisputed invoices arising under this
Agreement [*] ([*]) days after receiving an Invoice prepared in accordance with
the terms of this Agreement. All sums to be paid by GEHC under this Agreement
shall be in the currency specified in Attachment C. Interest for late payments
shall not apply to payments that GEHC contests in good faith and shall in no
event exceed applicable statutory interest rate.

 

  d. Productivity improvement. In the event the Parties have jointly contributed
to productivity improvements or cost savings achieved by the Supplier the
Parties agree to negotiate in good faith a reasonable price adjustment. Price
conditions will be changed only upon mutual agreement.

 

  e. Invoicing requirements. The Supplier’s Invoices shall contain the GEHC
Purchase Order number and other such information as may be required by law or
requested from time to time by GEHC. Each cost item shall be specified in the
invoice. Invoices shall be addressed to GEHC or the GEHC affiliate who has
placed the purchase order with the Supplier.

 

  f. GEHC mandated changes. It is recognized and agreed by the Parties that GEHC
mandated changes in the manufacturing process, quality requirements or standard
or in the components and materials used in the process or any other changes in
the requirements for the Products may result in an increase in the cost of the
Products. The Parties agree to negotiate in good faith to adjust the prices
accordingly, provided that the Supplier notifies GEHC in writing of any possible
cost increases in advance of the initiation of any such changes.

 

4. Components and Materials

At GEHC’s option, GEHC may instruct the Supplier to procure or provide all
materials and components necessary for the manufacture of the Products from an
approved supplier, in which case an approved suppliers list shall be maintained
by the Supplier. GEHC confirms its approval of the currently used suppliers as
notified to GEHC in approved raw material specifications. Any new suppliers
selected by the Supplier in connection with the Agreement must be approved by
GEHC, whereupon they may be

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    15 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

added to such approved suppliers list. The Parties may from time to time agree
on materials that can be sourced by the Supplier from different sub-suppliers
without GEHC’s consent.

 

5. Additional Suppliers

The Supplier shall, at GEHC’s written request, provide reasonable assistance to
GEHC with regard to GEHC’s efforts to have a designated alternative supplier for
the Products (i) by providing GEHC or such designee with copies of all written
SOP’s and access at Suppliers facility to completed batch records or other
tangible forms of recorded manufacturing documentation of the Products, that are
reasonably necessary for the manufacture of the Product, and (ii) by making
relevant personnel available within reason for consultation on the phone or at
Supplier’s facility with respect to clauses (i) above.

 

6. Forecast and Commitment

 

  a. Forecasting. [*] ([*]) days before the end of each quarter, GEHC shall
submit to the Supplier in writing a [*] ([*]) month rolling quarterly forecast
(“Forecast”) for its estimated needs of the Products during the subsequent [*]
([*]) month period. Supplier shall use the Forecast as the basis for its
production planning and shall adjust the Safety Stock according to the new
Forecast within the agreed lead times. In the event that GEHC does not timely
submit a Forecast to the Supplier, Supplier will notify GEHC in writing and GEHC
will have [*] ([*]) business days to provide the Supplier with the updated
Forecast or if GEHC fails to provide the updated Forecast, the Forecast will
revert to [*] ([*]).

 

  b. The Forecast. The [*] of every Forecast provided by GEHC for Products shall
be [*] on GEHC and the Supplier. [*]. The Supplier agrees to use all
commercially reasonable efforts to be responsive and supply Product in excess of
any firm and binding [*] if so requested by GEHC, provided such excess shall not
exceed [*]% of the then firm and binding [*].

 

  c. General Supply Commitment. The Supplier represents and warrants that it has
the capacity and expertise necessary to [*]. In the event that the market demand
exceeds this volume, GEHC and Supplier will work together and make best efforts
to meet the market demand.

 

  d. Purchase Commitment. As a result of this Agreement, the Supplier will
become one of the preferred suppliers of GEHC for the Products. GEHC agrees that
the [*] shall include quantities of the Products, which corresponds to at least
[*] ([*]) percent of GEHC’s total actual requirements in [*] for the Products.
For any year thereafter the requirement in the [*] shall be at least [*] ([*])
percent of GEHC’s total actual requirements in [*] for the Products per year and
at least [*] ([*]) percent of GEHC’s actual requirements in [*] of each of the
Products. While GEHC has to adjust its production levels to market changes GEHC
shall use all reasonable efforts to distribute orders evenly during the year and
to avoid to have quarters without any orders at all. Further, GEHC agrees to
purchase at least [*] ([*]) percent of its total requirements in [*] of the
Products during the years [*] of this Agreement or any shortened period of [*]
in the event this Agreement is terminated in accordance with 16.6 and 16.7 in
Attachment E. In the event GEHC should fail to fulfill its purchase obligations
hereunder it shall as its sole liability immediately issue a purchase order for
the missing quantities upon the Supplier’s written request thereto. The Supplier
agrees to maintain the equivalent ability to manufacture the Products for GEHC.
The Parties may from time to time mutually agree in writing on separate
arrangements for certain time periods in order to accommodate specific
requirement and planning needs which may deviate from the above commitment. GEHC
shall be free to decide on the mix between Products under the above purchase
obligations and in the [*] forecast, provided that the binding part of the
forecast shall be fixed. In the event there is a requirement in excess of [*]%
of the firm and committed [*] and the Supplier is unable to deliver within the
agreed lead times as specified in Attachment C then GEHC shall be free to
purchase any such additional quantities as Supplier is unable to deliver that
[*] from other suppliers.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    16 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

If the Supplier during a certain [*] is unable to timely supply Products
complying with agreed quality standards in quantities specified in GEHC’s
committed Forecast, then GEHC’s purchasing commitment hereunder shall be reduced
with a quantity corresponding to the quantity to which such inability relates.

 

  e. No Obligation. Other than as set out in subsection b) and d) above, it is
the express understanding of the Parties that GEHC shall have no obligation to
purchase Products exclusively from the Supplier or to purchase any minimum
amount of Products, and may use other suppliers for any and all Products, or
similar products.

 

7. Contract Managers and Communication

 

  a. Contract Manager. Both the Supplier and GEHC will appoint a contract
manager to manage their respective obligations under this Agreement, to act as
focal points between the two organizations and review progress on a quarterly
basis. The contract manager shall be as specified below or such other person as
subsequently communicated to the other Party.

 

GEHC:

   [*]

Supplier:

   [*]

 

  b. Legal Notices (as set forth in Section 18 in Attachment E).

 

GEHC:

   Björkgatan 30    751 84 Uppsala, Sweden    Fax No. [*]

Supplier:

   41 Seyon Street Bldg #1 suite 100    Waltham, MA 02453 USA    Phone: 781
250-0111 (main)    Fax: 781 250-0115

 

  c. Crisis Communication. The Supplier must maintain the ability to contact or
receive contact from GEHC on a twenty-four (24) hour per day, seven (7) days per
week basis in order to communicate and manage crisis situations that threaten to
or interrupt the supply chain.

 

8. Insurance and Liability

 

  a. The Supplier undertakes to maintain a comprehensive liability insurance
policy with a reputable insurer including cover for third party liability and
product liability on terms customary to the business. Such insurance shall be
for an insured sum of not less than USD [*] ([*])[*] and the Supplier shall
supply GEHC with a copy of the relevant policy on request.

 

  b. The Supplier shall be liable to compensate GEHC for direct and indirect
damage and loss it has caused GEHC under this Agreement up to USD [*] ([*])[*].
In the event of any loss or damage in excess of this amount the Supplier shall
not be liable to compensate for such excess damage or loss, unless: (i) caused
by its gross negligence or willful misconduct, (ii) caused by its breach of
confidentiality obligations under this Agreement, or (iii) relating to its
intellectual property indemnification obligations under this Agreement.

 

9. Safety Stock and Consignment Stock

The Supplier shall keep a Safety Stock at the Supplier’s premises, corresponding
to the minimum set inventory values and the replenishment times in Attachment C.

The inventory levels stated in Attachment C shall be based on the latest [*]
Forecast distributed by GEHC. In case a new Forecast leads to replenishment
actions for the safety stock the Supplier shall use

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    17 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

all commercially reasonable efforts to replenish the Safety Stock as soon as
practical and always within the agreed lead times set forth in Attachment C.

GEHC is reviewing the possibility to introduce a consignment stock arrangement,
ie having the Supplier to own certain stock of Product at GEHC premises. The
Supplier agrees to negotiate the terms and conditions in good faith.

 

10. Manufacturing Process

For clarity it is stated that all written manufacturing or production
documentation relating solely to the Products, including without limitation the
manufacturing documents specified in Attachment F shall be the sole property of
GEHC. The Supplier shall document and GEHC shall have access to review all
written manufacturing or production records relating to any of the Products at
Suppliers facility and upon request from GEHC, the Supplier is obliged to send
GEHC copies of the requested manufacturing or production documents (including
SOP’s and records) and such a request shall not be unreasonably withheld by the
Supplier.

The Supplier shall keep a master list of production documents showing the name,
identity and version number for each of the production documents that is used in
the production of the Products. The Supplier shall always keep and maintain the
master list of production documentation and shall send upon GEHC’s request an
update of any of the documents included in the master list of production
documentation.

 

11. Business interruption

The Supplier undertakes to keep GEHC informed about any circumstances that might
reasonably impact on the Supplier’s ability to supply the Products, timely and
in accordance with applicable quality standards, including any plans to close or
divest the business relating to all or any of the Products. If such circumstance
should arise or may reasonably be possible to arise the Supplier shall
immediately inform GEHC and propose a plan on how to mitigate the consequences
thereof. The Parties shall then in good faith conduct negotiations concerning
the actions to be taken and the costs to avoid or mitigate the risks.

 

12. Reports

GEHC will provide Supplier within [*] of the close of each [*] period a report
of the total quantity of each of the Products purchased by GEHC from all
suppliers during the period.

The Supplier will provide GEHC with finished goods inventory and Safety Stock
levels of Products within [*] of the close of each [*] period.

 

13. Audit

Supplier shall have the right to have an independent third party reasonably
acceptable to GEHC, such as one of the global auditing firms, to conduct an
annual audit of GEHC’s records to ensure compliance with GEHC’s commitments
according to Section 6 d in this Section of the Agreement.

 

14. Supply of GEHC products for the manufacture of Products

During the term of this agreement the Supplier shall have the right to purchase
the following products from GEHC at following price conditions:

 

Name

  

Article No:

  

Price:

[*]      

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    18 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

Delivery conditions: CIF

Lead time: [*]

Credit term: [*] days from date of invoice

Order handling: all order shall be submitted to the Contract Manager, together
with a declaration of the intended use for the Products.

The sale of the goods to the Supplier shall be subject to GEHC Conditions of
Sale.

The products ordered in accordance with this Clause 15 may only be used in the
manufacture of the Products for delivery to GEHC. Any other use of the products
ordered is strictly forbidden.

 

15. ELISA Kits

GEHC acknowledges that the Supplier manufactures and sells ELISA analytic kits
for protein leakage testing. During the term of this Agreement Repligen shall
have the right to use MabSelect SuRe™ ligands and the MabSelect SuRe trademark,
but only in connection with the manufacture, sale and marketing of ELISA
analytical kits for protein leakage testing. The Supplier agrees to use the GEHC
trademarks in accordance with GEHC’s written instructions from time to time.

 

16. Cell banks

The biological starting material used in the fermentation process originates
from the cell banks kept and owned by GEHC. Such material may only be used in
connection with the manufacture of the Products and shall be returned to GEHC,
alternatively destroyed upon termination of this agreement for what ever
reason. Supplier shall not disclose or provide such material to any third
parties, unless GEHC has given its prior written consent thereto. The Supplier
agrees not to sequence, extract or in any other way use the plasmid, the
chromosome or any of the DNA codes present in the cell banks.

The supplier may order starting material according to the following conditions:

 

  a) Lead time: [*] days, unless otherwise agreed.

 

  b) Orders: written orders in accordance with form provided by GEHC specifying
product, campaign, numbers of vials and requested delivery date. The order will
be sent to:

 

GE Healthcare Bio-Sciences AB

Att: [*]

BL3-2

Björkgatan 30

751 84 UPPSALA

Sweden

tel:    [*] fax:    [*]

 

  c) GEHC will confirm order without delay and provide a notice two weeks before
the estimated delivery date.

 

  d) Supplier shall confirm receipt of the cell bank.

 

  e) Transportation: GEHC will coordinate with Repligen to ensure appropriate
delivery time and arrangements for the cell banks and will arrange and pay for
transportation.

Documentation: The cell banks will be accompanied by a Certificate of Analysis
in accordance with the documents listed in Attachment F.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    19 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

  f) Repligen shall provide GEHC at the beginning of every [*] a report of the
total quantity of seed stock for each of the Products as well as the planned
consumption of the seed stock for the following [*] months. GEHC shall use this
information for their internal planning purposes.

 

17. Other products

The Parties have agreed to enter into a separate agreement covering the
Supplier´s supply of [*]. The Parties intend to enter into a separate agreement
concerning supply of [*].

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    20 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

Attachment E – General Terms and Conditions

ORDER AND SUPPLY

 

1. Purchase Orders

 

1.1 Purchase Order Contents. GEHC shall issue purchase orders to the Supplier
stating the quantity and delivery date for Products (a “Purchase Order”). The
Purchase Orders shall be written and sent through an electronic purchasing
system or by fax, e-mail or other agreed method.

 

1.2 Orders from Affiliates. From time to time Affiliates of GEHC may also issue
purchase orders for Products and, if requested by such GEHC Affiliate, the
Supplier agrees to supply Products to such affiliate on the terms of this
Agreement. The ordering GEHC Affiliate entity shall be solely contractually
liable for such order.

 

1.3 Acceptance of Purchase Order. The Supplier shall be deemed to have accepted
a Purchase Order upon receipt from GEHC so long as the terms are consistent with
those stated in this Agreement. The Supplier shall confirm compliance with the
Purchase Order in writing within [*] ([*]) business days of the receipt of
Purchase Order.

 

2. Transportation; Title and Risk of Loss

 

2.1 Unless otherwise agreed, Products shall be delivered according to the
Incoterms FCA (ICC Incoterms 2000) at the address set out in Attachment D. This
means that the possession and title will transfer upon delivery to the carrier.
The Supplier will be responsible for export declaration and shall arrange for
transportation at GEHC’s cost and in accordance with GEHC’s instructions. GEHC
will take care of the import declaration.

 

2.2 If the delivery term agreed in Products and Prices in Attachment C or
Purchase Order, if any, is an Incoterm such term of delivery shall be construed
according to the edition of Incoterms in force at the Effective Date.

 

3. Delivery

 

3.1 The Supplier shall deliver the Products on the date and in quantity set
forth in the Purchase Order. The Supplier may only deliver prior to the agreed
delivery date with the written consent of GEHC.

 

3.2 Deliveries shall not be regarded as completed until the Delivery
Documentation in Specific Requirements Attachment D has been provided.

 

3.3 The lead time as specified in Attachment C for the Product shall count from
the date of issue of the Purchase Order to receipt of the Products at GEHC
premises, including receipt of any agreed documentation.

 

3.4 In the event that the Supplier anticipates or expects a delay in delivery it
shall immediately notify GEHC and at the same time explain the causes and the
steps that it is taking to minimize the delay. GEHC may, acting reasonably,
require the Supplier to take

  further or other steps, including the deployment of additional resources, at
the Supplier’s cost, to minimize the said delay. If unless otherwise mutually
agreed by the Parties, the delivery is delayed by more than [*] days then GEHC
may: (i) terminate the delayed Purchase Order and, if applicable, return to the
Supplier some or all of the Products that relate to such order at the expense of
the Supplier; and/or either to (ii) purchase substitute Products elsewhere and
charge the Supplier with the increased cost thereof (if any) or (iii) claim as
liquidated damages for such default [*] per cent of the total value of the
delivery for each calendar day delivery is delayed limited to a maximum of [*]
per cent of the total value of the delivery in aggregate. Such rights are
without prejudice to any other rights that GEHC may have in respect of late
delivery by the Supplier.

 

4. Inspection Period

All Products delivered to GEHC by the Supplier must meet the terms and
conditions of this Agreement and the related Purchase Order. All Products shall
be received subject to GEHC’s acceptance or rejection on or before the end of
the Inspection Period. GEHC may reject an entire order based upon a reasonable
sampling of Products. “Inspection Period” means [*] ([*]) business days. Partial
or total payment by GEHC for Products under this Agreement prior to the end of
the Inspection Period shall not constitute its acceptance thereof, nor shall
such payment remove the Supplier’s responsibility for any non-conforming items.

The Supplier acknowledges that GEHC’s inspection of the goods may be based on
the review of the Certificate of Analysis issued by the Supplier and that GEHC
shall not be prevented from raising any claims under the warranty in clause 11
after the expiration of the Inspection Period.

 

5. Safety Stock

Supplier shall maintain at its’ own cost and risk the safety stock agreed as set
forth in Attachment C. The safety stock shall be managed in accordance with
first in - first out principle.

 

6. Changes to Products

 

6.1 GEHC Proposed Changes. GEHC may [*] per year propose changes to the
Specification or the manufacturing method for the Products by submitting the
proposed changes to the Supplier. The Supplier agrees to use all commercially
reasonable efforts to accommodate any such proposals of GEHC and shall respond
in writing to GEHC within [*] ([*]) days after receipt of such changes with the
following information, as

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    21 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

  applicable: (a) time required to implement proposed changes; (b) impact of
proposed changes on pricing of Product; and (c) impact of proposed changes on
the lead time of the Product. If the Parties agree on the changes to the
Specification they shall amend this Agreement accordingly. If the Parties fail
to agree on the amendments to be made to the Agreement to reflect the changes to
the Specification the terms in effect prior to commencement of the negotiations
shall remain in full force and effect and the Supplier shall continue to supply
the Product to the existing Specification.

 

6.2 Supplier’s Proposed Changes. The Supplier may [*] per year propose, a change
to the Specifications (including, but not limited to, changes which may affect
quality, form, fit, function, reliability, regulatory compliance, safety or
interface capability with GEHC products) or a change in its manufacturing method
(including, but not limited to changes of sources of materials and changes in
manufacturing processes or locations) but the Supplier shall not implement such
change without the prior written consent of GEHC, which shall not be
unreasonably withheld. The Supplier shall make such proposals in writing
explaining the reason for the changes and providing reasonable detail sufficient
for GEHC to evaluate the proposal. GEHC agrees to use all commercially
reasonable efforts to accommodate any such proposals. Upon request of GEHC, the
Supplier shall provide samples of the Products manufactured according to the
proposed new specification or manufacturing method for evaluation purposes.

 

7. Packaging and marking

The Supplier shall be responsible for the safe and suitable packaging and
labeling of the Products, for complying with the packaging and marking
requirements in the Specifications, if any, and all applicable laws and
regulations relating to the packaging, marking and transport of the Products.

 

8. Health and Safety

 

8.1 The Supplier shall ensure that all information held by or reasonably
available to it regarding any changes occurring after the Effective Date with
regard to potential hazards known or believed to exist in the transport,
handling, or use of any Products and/or performance of any services shall be
received by GEHC in writing prior to delivery of the Products and/or performance
of the services.

 

8.2 Employees, agents and representatives of the Supplier visiting any of GEHC’s
sites shall be subject to such safety and security regulations as may be in
force on that site.

 

9. Business Contingency Planning

 

9.1 Business Contingency Plan. Upon GEHC’s request, the Supplier shall provide
to GEHC a summary of Suppliers Business Contingency Plan that outlines the
Supplier’s internal contingency arrangements to ensure GEHC continuity of supply
if the Supplier or

  any of the Supplier’s suppliers are unable to provide Products or components
to such Products to GEHC.

 

9.2 GEHC shall have the right to carry out audits of the Supplier’s Business
Contingency Plan on a regular [*] basis with [*] ([*]) days prior notice.

 

10. Compliance

 

10.1 Applicable Laws. The Supplier represents and warrants that its performance
under this Agreement and its manufacture of the Products will comply with all
applicable laws and regulations, and all conventions and standards issued by
relevant authorities and that the Supplier has obtained all applicable permits
and licenses necessary to perform its obligations under this Agreement

 

10.2 Assistance. The Supplier shall at GEHC’s request give reasonable assistance
necessary to obtain any licenses required by GEHC with respect to the
importation, exportation, marketing and use of the Products and provide GEHC
with all information in relation to the Products which may be required by any
regulatory authority.

 

10.3 Regulatory Approvals and other Governmental Registrations. GEHC shall be
responsible for identifying, obtaining, and maintaining at its sole cost and
expense all FDA and other applicable clearances and approvals and corresponding
approvals in other countries that are required for the development, manufacture,
or sale of any Product. The Supplier shall provide GEHC with reasonable support
and assistance in obtaining any such approvals, which may include providing test
reports and data necessary to meet the country specific regulatory requirements.

 

10.4 Regulatory Agency Inquiries. If the FDA or any other regulatory body with
authority over the end products to which the Products form part, provides
written notice to the Supplier to inquire about or investigate any Product or
conduct any audit or inspection of facilities used for the manufacture, storage
or distribution of Products or request any information related to the
manufacture of any Product, the Supplier shall give notice thereof to GEHC
within one working day of receipt of such contact from the FDA or other body.

 

10.5 Security Measures. The Supplier agrees that it will adopt industry standard
security measures which are consistent with accepted programs including the US
Customs-Trade Partnership Against Terrorism (“C-TPAT”), the European Union’s
Authorized Economic Operator program and other similar programs where
applicable.

 

10.6 Export Restrictions. If any Products are subject to export restrictions in
the country of manufacture or shipment the Supplier shall supply GEHC prior to
dispatch with any relevant ECCN and ECN numbers and copies of any export
licenses or other certificates required in the country of manufacture or
shipment and, where Products contain US components, details of the value as a
percentage of the Products price.

 

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/ Version Supply 1.0    22 (30) Portions of this Exhibit were omitted and have
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Company’s application requesting confidential treatment under Rule 24b-2 of the
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10.7 Country of Origin. In accordance with GEHC´s request the Supplier will mark
each Product, and, as appropriate, Product packaging, labels, or invoices with
the country of origin for the Product, in accordance with the applicable trade
and customs laws. The Supplier will also upon request from GEHC provide
acceptable and auditable documentation that establishes the country of origin
for a Product and including the raw materials used to manufacture such Product
for the whole supply chain, including without limitation, certifications of
origin for Products qualifying for NAFTA or EEA preferential duty provisions, as
applicable.

 

10.8 Personal Data Protection. With regard to personal data received from GEHC,
the Supplier agrees (i) not to use it other than for its intended purpose,
(ii) not to disclose it to any third parties, and (iii) not to transfer it to
any countries outside the European Union , unless GEHC has given its prior
written consent thereto. The Supplier shall use appropriate measures to ensure
security and confidentiality of GEHC personal data. Supplier shall notify GEHC
in the most expedient time possible and without unreasonable delay of any
Security Breach involving any GEHC personal data where “Security Breach” is
defined as any event involving an actual, potential or threatened compromise of
the security, confidentiality or integrity of the data, including but not
limited to any unauthorized access or use. GEHC shall have the right to use
personal data received from the Supplier in conformity with applicable data
protection laws. Upon termination of this Agreement, for whatsoever reason,
Supplier shall stop the Processing of GEHC Personal, unless otherwise agreed by
GEHC, and these undertakings shall remain in force until such time as Supplier
no longer possesses GEHC Personal Data. For the purpose of this provision the
definition of “personal data” is that provided in EU Directive 95/46/EC.

WARRANTY, INDEMNIFICATION AND LIABILITY

 

11. Warranty

 

11.1 Product Warranty. The Supplier represents and warrants that the Products
will:

 

  (a) conform strictly to and be manufactured in accordance with the
Specifications referred to in Attachment C;

 

  (b) be free from defects in title, material, and workmanship, whether latent
or otherwise;

 

11.2 Supplier Intellectual Property Warranty. The Supplier represents and
warrants as follows: (i) it owns or has the right to use all of its
Process-Related Technology existing as of the Effective Date that it will use to
manufacture the Products and to sell the Products to GEHC; and (ii) neither the
Supplier’s equipment nor any of its Process-Related Technology used to
manufacture the Products infringes or is alleged to infringe any patent or other
proprietary right of any other person.

 

11.3 GEHC Intellectual Property Warranty. GEHC represents and warrants as
follows: (i) GEHC owns

  or has the right to use all of the Product-Related Technology; and (ii) the
Product-Related Technology does not infringe and is not alleged to infringe any
patent or other proprietary right of any other person.

 

11.4 Execution and Performance of Agreement. The Supplier represents and
warrants that it has the full right, power, and authority to enter into and
perform its obligations under this Agreement. The Supplier further represents
and warrants that the performance of its obligations under this Agreement will
not result in a violation or breach of, and will not conflict with or constitute
a default under any agreement, contract, commitment, or obligation to which
Supplier or any of its affiliates are a party or by which it is bound and that
it has not granted and will not grant during the term of this Agreement or any
renewal thereof any conflicting rights, license, consent, or privilege with
respect to the rights granted herein.

 

11.5 Survival of Warranties. The Supplier agrees that (i) the warranties set
forth in this section shall survive the inspection, acceptance, and use of the
Products by GEHC, its distributors and sub-distributors for a period of the
shorter of either [*] ([*]) months from completion of delivery of the Purchase
Order or the shelf life as specified in Attachment C (“Warranty Period”) and
that they (ii) are for the benefit of GEHC and its successors and assigns; and
(iii) are in addition to any warranties and remedies to which the Supplier may
otherwise agree or which are provided by law. The Supplier agrees to extend to
GEHC any warranties received from the Supplier’s suppliers. The Supplier
warrants Products only as set forth in this Agreement and disclaims all other
warranties.

 

11.6 Returns. GEHC may return to the Supplier any Product that does not conform
to the representations and warranties. Any such Product shall be returned to the
Supplier and then once replaced returned to GEHC at Supplier’s expense
(including all transportation and insurance). The Supplier will, at its cost,
and as soon as reasonably practicable replace the returned Product to bring the
Product in conformance with the warranty, and will return the replacement
Product as soon as possible, but in any event within thirty (30) days, after
receipt of the non-conforming or defective Product. If the Supplier is unable to
return the Product within thirty (30) days, the Supplier shall at GEHC´s request
provide GEHC a refund as defined in section 11.8 below.

 

11.7 Complaints. Any complaint shall be regarded as having been timely lodged if
GEHC notifies the Supplier of the fault at any time during the warranty period.
Within [*] weeks after any complaint lodged by GEHC concerning a defective
Product the Supplier shall make a reasonably detailed report to GEHC on the
corrective and preventive action that has been initiated according to the
Suppliers standard operating procedure.

 

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Company’s application requesting confidential treatment under Rule 24b-2 of the
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11.8 Credits/Refunds. In accordance with this Section 11, the Supplier shall
promptly refund GEHC by wire transfer or check for any payment GEHC made with
respect to such Product. GEHC may elect, at its sole discretion, to take such
credit on any open invoices of the Supplier in the place of such refund.

 

11.9 Set-off. GEHC may set-off any amount owed from the Supplier or any of
Supplier’s affiliates against any amount payable at any time by GEHC.

 

11.10 Remedies. The remedies contained in this Section 11 are in addition to all
other remedies available at law or in equity.

 

11.11 Recalls and Field Corrections. If any recall, product withdrawal or field
correction of any Product is required by a governmental agency or by GEHC for
safety or efficacy reasons resulting from (a) the supply by the Supplier of any
Product not complying with the terms and conditions of the Agreement (including
all warranties included in the Agreement) or (b) the negligent or intentionally
wrongful act or omission of the Supplier or its affiliates or their
representatives, then the Supplier shall bear all costs and expenses, including
but not limited to the costs and expenses related to such recall or field
correction, communications and meetings with all required regulatory agencies,
replacement stock, service labor, installation, travel, notifying customers of
such recall and any replacement product to be delivered to those same customers,
including shipping costs. To the extent that any such recall or field correction
is due in part to the negligent or intentional acts or omissions of GEHC, GEHC
shall be responsible for such costs and expenses equitably in proportion to its
fault.

 

11.12 Testing In the case of disagreement between the Parties concerning the
quality of Products delivered and such disagreement relates to the provisions in
this Section 11, a sample shall be submitted to an independent laboratory to be
agreed upon by the Parties and the report from such laboratory shall finally
settle whether or not the delivery has met the specification or not. The cost
for the laboratory shall be borne by the failing party.

 

12. Indemnification

 

12.1 Supplier Indemnity. Subject to Section 14 below, the Supplier agrees to
defend, indemnify, protect, and hold harmless GEHC and GEHC’s Affiliates,
employees, agents, servants, and representatives from and against any and all
claims, damages, losses, liabilities, and expenses of whatever nature, arising
out of or relating to: (i) the breach by the Supplier of any term of this
Agreement or any term contained in any Attachments or (ii) any negligent act or
omission, or willful misconduct of the Supplier or its agents, employees, or
subcontractors. GEHC shall notify the Supplier of any such claim, suit, or
proceeding, and Supplier will assist (at the Supplier’s expense) in the defense
of the same.

 

12.2 GEHC Indemnity. Subject to Section 14 below, GEHC agrees to defend,
indemnify, protect, and hold harmless the Supplier and its Affiliates,
employees,

  agents, servants, and representatives from and against any and all claims,
damages, losses, liabilities, and expenses of whatever nature, arising out of or
relating to: (i) the breach by GEHC of any term of this Agreement or any term
contained in any Attachments or (ii) any negligent act or omission, or willful
misconduct of GEHC or its agents, employees, or subcontractors. Supplier shall
notify GEHC of any such claim, suit, or proceeding, and GEHC will assist (at
GEHC expense) in the defense of the same.

 

12.3 Intellectual Property Indemnity. With the exclusion of any GEHC Technology,
the Supplier agrees to defend, indemnify, protect, and hold harmless GEHC and
GEHC’s affiliates, employees, agents, servants, and representatives from and
against any and all claims, damages, losses, liabilities, and expenses of
whatever nature, resulting from a claim or allegation that the use (for uses
made known to the Supplier) or sale of a Product infringes or otherwise violates
an intellectual property right of any third party. If GEHC has reason to believe
that (i) the use of any Supplier Process-Related Technology is enjoined by a
court, the Supplier will first use best efforts to either procure the necessary
licenses to continue manufacturing under the Supplier Process-Related Technology
or adjust the manufacturing process at its sole-cost to avoid infringing such
other party’s intellectual property (provided that such an adjustment can be
made by the Supplier without otherwise breaching the Agreement); and (ii) if
after using best efforts, the first two options are not commercially reasonable,
the Supplier may terminate the Agreement, refund to GEHC any amounts paid
thereunder for Products that cannot be sold by GE as a result of the injunction
and reimburse GEHC for any related costs incurred.

CONFIDENTIALITY AND GE PROPERTY

 

13. Confidentiality

 

13.1 During the Term of this Agreement and the supply agreements preceding this
Agreement, each Party (the “Recipient”) may have received or will receive or
have access to certain information of the other Party (the “Discloser”) that is
Confidential Information of the Discloser. For purposes of this Agreement,
“Confidential Information” shall mean any information disclosed by the Discloser
to the Recipient, whether technology-related or business-related, whether
furnished before or after the Effective Date and irrespective of the form of
communication, ; provided, however, that in order for oral information to be
treated as Confidential Information, it must be identified as confidential and
proprietary at the time of disclosure, and the substance of the disclosure must
be provided in writing within [*] ([*]) days of the oral disclosure of such
information. All written information must be clearly marked using words such as
“confidential” or “proprietary” in order to be treated as Confidential
Information, unless of apparent

 

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  confidential nature. The Recipient will protect the Confidential Information
with the same degree of care as the Recipient uses for its own similar
information, but no less than a reasonable degree of care. Confidential
Information may only be used by those employees, contractors and advisors of the
Recipient and its affiliates (“Representatives”) who have a need to know such
information for the purposes related to this Agreement and who are bound by
equivalent confidentiality obligations, and the Recipient shall inform such
Representatives of the confidential nature of such Confidential Information and
the obligations of the Recipient hereunder. The Recipient shall be responsible
for any breach of this Agreement by it or any Representative to the same extent
as though such Representatives were Parties hereto. The Parties acknowledge that
trade secrets are deemed Confidential Information to be protected indefinitely.
The Parties also agree that all other information, including but not limited to
technical information (which is not intellectual property rights) and forecasts
disclosed during the Term or prior to the formation of this Agreement are deemed
Confidential Information to be protected during the term and for a period of [*]
([*]) years thereafter.

 

13.2 Exclusions The undertakings in clause 13.1 shall not apply to information
which:

 

  (a) is publicly available through no fault of the Recipient;

 

  (b) the Recipient can show by reasonable written record was in his possession
at the time of disclosure and which was not acquired directly or indirectly from
the Discloser;

 

  (c) is rightfully received from a third party with no duty of confidentiality;

 

  (d) has been developed by the Recipient independently of the Confidential
Information received from the Discloser; or

 

  (e) the Recipient notifies the Discloser is required to be disclosed by the
Recipient pursuant to a legally enforceable order, direction or other regulation
but any disclosure shall only be so far as necessary to give effect thereto.

 

13.3 Return of Confidential Information. All Confidential Information supplied
to or acquired by each Party and all copies thereof shall be returned to the
other Party within [*] ([*]) days after termination of this Agreement All
information consisting of documents, notes and other writings prepared by one
Party based on non-public data of the other Party shall be destroyed.

 

13.4 Development. The confidentiality terms in this Clause shall not be
construed to limit GEHC’s or Suppliers right to independently develop or acquire
products without use of the other Parties Confidential Information.

 

13.5 Restrictions on Use of Design Materials and Know How. During and after the
Term the Supplier shall be prohibited from selling to any third party any
Product or equivalent product that is either (i)

  developed for GEHC under this Agreement; (ii) incorporates any GEHC
Confidential Information; or (iii) is specifically designed or configured for
use with GEHC’s products using information received or know how developed in
connection with this Agreement.

 

13.6 Previous undertakings of confidentiality. The Parties agree that the
provisions in this Clause 13 shall replace all previous undertakings of
confidentiality and shall apply to all Confidential Information whether
disclosed in connection with this Agreement or any preceding supply agreement
between the Parties concerning any of the Products.

 

14. Indirect Loss

In no event shall GEHC be liable for any indirect or consequential loss or
damage in connection with this Agreement. The Supplier shall not be liable for
any indirect or consequential loss or damage other than what is set forth in
Clause 8 in Attachment D.

 

15. Technology

 

15.1 Definitions.

 

  (a) “Technology” means any idea, invention, technique, modification, process,
or improvement (whether patentable or not), trade secret, industrial design
(whether registerable or not), patent, copyright or work of authorship (whether
or not copyright protection may be obtained for it), excluding, however, any of
the foregoing that is within the public domain.

 

  (b) “Product-Related Technology” means any Technology owned at any time during
the Term (whether owned as of the Effective Date or thereafter acquired or
developed) by either of the parties that is related directly and solely to the
structure of the Products.

 

  (c) “Process-Related Technology” means any Technology owned at any time during
the Term (whether owned as of the Effective Date or thereafter acquired or
developed) by either of the parties that is required for the manufacture of the
Products.

 

15.2 Licenses.

 

  (a) During the Term and only for the purpose of fulfilling its duties and
obligations under the Agreement, GEHC hereby grants to the Supplier a
royalty-free and nonexclusive right and license to use any Product-Related
Technology or Process-Related Technology owned by GEHC that is necessary or
useful to the Supplier for manufacture of the Products. Supplier acknowledges
and agrees that no other use shall be made by the Supplier, its affiliates or
authorized contractors of the GEHC Technology without the express written
authorization of GEHC.

 

  (b) During and after the Term, the Supplier hereby grants to GEHC a
royalty-free and nonexclusive right and license to use any Process-Related
Technology owned by the Supplier that is necessary to GEHC for the manufacture,
either directly or

 

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Company’s application requesting confidential treatment under Rule 24b-2 of the
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  through a third party manufacturer, sale, distribution, and use of the
Products. GEHC acknowledges and agrees that no other use shall be made by GEHC,
its affiliates or authorized contractors of the Process-Related Technology of
the Supplier, without the express written authorization of the Supplier.

 

15.3 Ownership of Technology.

 

  (a) GEHC Property. All tools, dies, drawings, plans, manufacturing aids,
testing or other equipment or materials, and all intellectual property rights in
the foregoing, which GEHC furnishes to the Supplier, or which is developed or
acquired at GEHC’s expense or at its direction in the performance of work
hereunder, shall be GEHC’s property (the “GEHC Property”). The Supplier hereby
assigns and agrees to assign to GEHC, all such property. All such GEHC Property
shall be safely maintained separate from the Supplier’s property, and marked
“Property of General Electric Company.” The Supplier agrees not to substitute
any property for GEHC Property and not to use such property except for
performance of work hereunder or as authorized in writing by GEHC. The Supplier
also agrees to insure any GEHC Property at full replacement cost. GEHC Property
will be held at the Supplier’s own risk, and subject to removal by GEHC at its
written request.

 

  (b) GEHC Technology. Including, but not limited to such GEHC Technology listed
in Attachment F, all GEHC Technology (i) that is provided to the Supplier by
and/or on behalf of GEHC or that is used by the Supplier with respect to the
performance of its obligations hereunder and (ii) that was owned by GEHC prior
to being provided to the Supplier shall be and remain the property of GEHC. The
Supplier shall acquire no right, title or interest in the GEHC Technology as a
result of its performance of its obligations hereunder. At GEHC’s request or
upon termination or expiration of the Agreement for any reason, the Supplier
shall return to GEHC any and all copies of GEHC Technology and remove all copies
of such GEHC Technology from the computers and computer networks of the
Supplier, save for one copy which may be retained for the purpose of monitoring
the Supplier´s compliance with this provision.

 

  (c) Supplier Technology. All Supplier Technology that is both (i) provided to
GEHC by and/or on behalf of the Supplier or that is used by the Supplier with
respect to the performance of its obligations under the Agreement and (ii) owned
by the Supplier prior to the performance of any of its obligations under the
Agreement or acquired by the Supplier thereafter shall remain the property of
the Supplier. GEHC shall acquire no right, title or interest in any such
existing Supplier

  Technology as a result of the Supplier’s performance of its obligations
hereunder.

 

  (d) Newly Created Works. All Technology, that is either Product-Related
Technology or Process-Related Technology, developed by the Supplier as a result
of the Supplier’s manufacture and supply of the Products or otherwise derived
from GEHC Technology (collectively, the “Works”) shall also be deemed GEHC
Technology and solely owned by GEHC. Such Works shall be considered “works made
for hire” pursuant to the Copyright Act of 1976, as amended, and all
intellectual property rights in and to such Works, including any copyright,
trade secret and patent rights, shall be solely and exclusively owned by GEHC.
The Supplier shall disclose to GEHC in a timely manner any and all Works, and
such disclosures by the Supplier shall include a reasonably detailed written
description of such Works. To the extent that all applicable intellectual
property rights in the Works are not deemed “works made for hire” and
transferred and assigned to GEHC by operation of law, the Supplier hereby does
and will transfer and assign, and cause its employees and agents to transfer and
assign, now and in the future, all right, title and interest in the Works to
GEHC. GEHC may transfer such Works to any third party or use the Works for any
purpose without further payment to the Supplier. In the event GEHC decides to
file one or more patent applications covering any such Works, the Supplier shall
at GEHC’s request and expense assist GEHC in the preparation and prosecution of
such patent application(s) and shall execute all documents (and cause its
employees or agents to execute all documents) deemed necessary by GEHC for the
filing thereof and/or the vesting in GEHC of all title thereto. Such Works shall
be deemed GEHC Confidential Information under the Agreement.

 

15.4 No Rights. The Supplier shall acquire no right, title or interest in any of
the trademarks, patents, trade secrets, service marks or copyrights belonging to
GEHC except as otherwise stated in Exhibit D Section 15 herein. No rights are
granted to the Supplier under any GEHC patents, copyrights, trade secrets, or
other property rights except as may be expressly agreed to by GEHC in writing.
The Supplier shall not use or incorporate into Products any intellectual
property of others without their prior written permission.

 

15.5 Removal of Marks. Subject to clause 16 in Attachment D the Supplier agrees
not to sell, transfer, distribute or otherwise convey any part, component,
Product or service bearing or incorporating any GEHC trademark, trade name or
service mark, part numbers or other identifiers, including any GEHC packaging,
copyrights or code (“GEHC Marks”), to any party other than to GEHC or any
affiliate of GEHC except as otherwise stated in

 

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/ Version Supply 1.0    26 (30) Portions of this Exhibit were omitted and have
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Company’s application requesting confidential treatment under Rule 24b-2 of the
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  Exhibit D Section 15 herein. The Supplier shall not have the right to sell
rejected, returned or unpurchased Products to any third parties. The Supplier
will defend and indemnify GEHC against any claims, losses, liabilities, costs or
expenses that GEHC may incur as a result of the Supplier’s breach of this
obligation.

 

15.6 Co-operation. The Supplier shall reasonably cooperate with GEHC to secure
any intellectual property rights developed under this Agreement by, for example,
assisting in the filing and prosecution of patent applications, and executing
such documents as GEHC may reasonably request at GE expense.

 

15.7 Survival. The obligations under this Clause shall survive the termination
of this Agreement.

TERMINATION

 

16. Termination

 

16.1 Mutual Termination. Either Party may terminate this Agreement:

 

  (a) at any time upon written notice if the other Party (the “Defaulting
Party”) materially defaults in the performance of one or more of its obligations
hereunder and the Defaulting Party fails to cure the default within thirty
(30) days after receiving written notice of such, provided that if the default
is not reasonably susceptible to cure within such period, then the
non-defaulting Party shall have the right to terminate this Agreement
immediately upon written notice; or

 

  (b) immediately if any proceeding under the bankruptcy or insolvency laws is
brought against the Defaulting Party, a receiver is appointed for the Defaulting
Party or the Defaulting Party makes an assignment for the benefit of creditors,
except as provided otherwise under applicable law.

 

16.2 GEHC Termination for cause. GEHC shall have the right to terminate this
agreement and/or, at GEHC’s discretion, relevant Purchase Orders, with immediate
effect in the event of (i) material breach by the Supplier of the Minimum
Purchased Material Quality Requirements set forth in Attachment A (ii) a
repeated breach of any term of this Agreement, (iii) consistent failure by the
Supplier to meet required delivery dates, (iv) a delay in delivery that has
exceeded more than [*] ([*]) days, (iv) material breach by the Supplier of the
Supplier Integrity Statement set forth in Attachment B.

 

16.3 Purchase Orders. If GEHC terminates this Agreement in accordance with
clause 16.1 or 16.2 it may also terminate all unfulfilled Purchase Orders
without any liability except for the price of any Products previously delivered
and accepted by GEHC (subject to any set-off available to GEHC). If GEHC
terminates this Agreement in accordance with clause 16.3 or if the Agreement
expires, GEHC and the Supplier agree that any unfulfilled Purchase Orders issued
prior to such termination or expiry

  but not yet delivered shall survive until fully performed.

 

16.4 Any advance termination of this Agreement shall not relieve the Defaulting
Party of its obligations and the non-defaulting Party shall retain all legal and
equitable remedies after such termination.

 

16.5 In the event of termination whether for cause or otherwise, unless
attributable to Suppliers material breach of contract as set forth in Clause
16.1 and 16.2, GEHC shall purchase the remaining Product in the Suppliers Safety
stock and with regard to any other finished goods inventory of the Supplier, up
to three months consumption of each of the Products according to the latest
Forecast., provided the Products comply with at least [*] remaining shelf life
and otherwise fully complies with the applicable specifications.

 

16.6 GEHC shall have the right to terminate the Agreement with eighteen
(18) months written notice if the Supplier or any of its Affiliates markets or
sells any immobilized chromatography products that is functionally substitutable
(based on technical performance) with GEHC’s chromatography products containing
the Products (as exemplified by MabSelect and MabSelect SuRe), provided that
GEHC prior to termination shall give Repligen thirty (30) days written notice of
its intent to terminate the agreement and should Repligen provide reasonable
explanation of compliance or stop selling or marketing such product during the
thirty day period, as certified by Repligen to GEHC in writing, then GEHC shall
not have the right to terminate the agreement referring to such circumstances.

 

16.7 GEHC shall have the right to terminate the Agreement with twelve
(12) months written notice if the control of the Supplier or its non-therapeutic
protein A business is acquired by a company, which is a direct competitor to
GEHC in the field of chromatography media or bioprocess hardware products.

COMMUNICATION AND MISCELLANEOUS

 

17. Electronic Data Interchange

 

17.1 Access. GEHC, in its sole discretion, may permit the Supplier to have
online access to designated computer systems of GEHC in order to facilitate the
Supplier’s ability to perform its obligations under this Agreement. If such
access is granted, the Supplier shall give to GEHC the names of the Supplier’s
employees who have a legitimate business need for such access to GEHC’s computer
systems, and GEHC shall provide a separate user identification code for each
person. The Supplier, at its own expense, shall provide and maintain any
hardware, telecommunications services and software not furnished by GEHC, which
are needed to communicate reliably with GEHC’s computer systems. GEHC, in its
sole discretion, may terminate the Supplier’s access to GEHC’s computer network
at any time.

 

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/ Version Supply 1.0    27 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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17.2 Use Restrictions. The Supplier shall ensure that: (i) computer access is
limited to those employees with a legitimate business need whose names have been
furnished to GEHC; and (ii) such employees with access agree to keep any
information so obtained strictly confidential, to use such information only to
perform the Supplier’s contract obligations to GEHC and to cease accessing
GEHC’s computer systems when no longer required to perform work under this
Agreement. The Supplier shall promptly notify GEHC if it becomes aware of any
unauthorized access to GEHC’s computer systems or unauthorized use of the
information on the systems.

 

18. Notices

 

18.1 All notices expressly required to be in writing (Legal notices) shall be,
if required by either party, in English or at least accompanied by a translation
into English, and shall be sufficiently served if delivered by hand (including
by courier) or if sent by pre-paid first class post, special delivery,
registered mail, or pre-paid air mail or by fax. In all cases notices shall be
delivered to the respective Parties at the addresses specified on the front page
of this Agreement.

 

18.2 A notice shall be deemed to have been received:

 

  (a) if delivered by hand, at the time of delivery;

 

  (b) in the case of pre-paid first class post, special delivery or registered
mail, two business days after the date of posting;

 

  (c) in the case of pre-paid airmail, four business days after the date of
posting.

 

  (d) in the case of fax, upon completion of transmission

 

18.3 For the avoidance of doubt, notices under this Agreement may not be served
by email, unless the Parties agree at the time of service.

 

19. Miscellaneous

 

19.1 Independent Contractor. The relationship of the Parties hereunder shall be
that of independent contractors. Nothing in this Agreement shall be deemed to
create a partnership, joint venture, or similar relationship between the
Parties, and no Party shall be deemed to be an agent of the other Party.

 

19.2 Subcontractors. None of the obligations to be performed by the Supplier
under this Agreement shall be performed by any subcontractor or other third
party unless such performance shall have been approved by GEHC in writing.

 

19.3 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of State of New York without giving effect to the
conflict of law principles thereof. The United Nations Convention on Contracts
for International Sales of Goods shall not apply to this Agreement.

 

19.4 Arbitration. The Parties will attempt to resolve any dispute, controversy
or claim relating to this Agreement through good faith negotiations within [*]
([*]) days, failing which the dispute shall be finally settled by arbitration in
accordance with the Rules of the International Chamber of Commerce,

  which Rules are deemed to be incorporated by reference into this Clause. The
seat of the arbitration shall be Boston in the event the Supplier is the
defendant and Uppsala if GEHC is the defendant. The language of the arbitration
shall be English, if requested by either Party. The cost of the arbitration will
be shared equally by the Parties. The arbitrator will have the authority to
apportion liability between the Parties, but will not have the authority to
award any damages or remedies not available under the express terms of this
Agreement. With regards to any action for breach of confidentiality or
intellectual property obligations, nothing in this section shall preclude either
party from seeking interim equitable relief but such request shall not be deemed
a waiver of the obligation to arbitrate hereunder.

 

19.5 Force Majeure.

 

  (a) The obligations of either Party hereunder shall be excused or suspended to
the extent performance is prevented or delayed by any future condition, which
(i) is beyond the reasonable control, and without the fault or negligence, of
the Party affected thereby, (ii) was not foreseeable by such Party at the time
this Agreement was entered into, and (iii) could not have been prevented by such
Party taking reasonable steps. Such conditions shall include, but not be limited
to, war mobilisation, riots, fire, explosion, flood, insurrection, embargo,
currency restriction, and acts or omissions of governments in their sovereign
capacity.

 

  (b) The Party invoking relief hereunder, shall, within seven (7) days after
commencement of the event of force majeure, give written notice thereof and of
the anticipated consequences thereof, to the other Party.

 

  (c) In the event of any case of force majeure, the Party affected thereby
shall take all reasonable measures to mitigate and minimise the effect of such
case, and to resume as promptly as possible the diligent performance of its
obligations under this Agreement, however GEHC shall be permitted during such
time to acquire substitute or replacement items from one or more alternative
sources. If the delay lasts more than thirty (30) days GEHC may terminate this
Agreement and any applicable Purchase Orders.

 

  (d) Notwithstanding anything in this Agreement to the contrary, no delay or
failure of a Party to perform its obligations hereunder shall be excused if and
to the extent that it is caused by labour problems of such Party, its
subcontractors’ and/or its suppliers such as strikes.

 

19.6 Assignment. This Agreement is personal to the Parties and no Party shall
without the prior written consent of the other Party, assign this Agreement or
any part of it. Any such action shall be declared null and void. No Party shall
sub-contract or

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    28 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

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  delegate in any manner any or all of its obligations under this Agreement to a
third party or agent without the other Party’s consent. Notwithstanding the
foregoing, GEHC may assign its rights and obligations under this Agreement
without the Supplier’s consent: to an affiliate and in conjunction with the
transfer of all or substantially all of its business or that part to which this
Agreement relates. This Agreement shall be binding upon and shall inure to the
benefit of the Parties hereto and their respective heirs, successors, and
permitted assigns. The Supplier may not assign this Agreement to any third
parties unless GEHC gives its written consent thereto in writing.

 

19.7 Publicity. The Supplier shall not issue any press release or announcement,
use any of GEHC’s products or its name or trademarks in promotional activity, or
otherwise publicly announce or comment on this Agreement without GEHC’s prior
written consent except as provided for in Exhibit D section 15 herein or as may
be otherwise required by law. Repligen has right to issue a press release on
completion of this Agreement subject to prior review and approval by GEHC.

 

19.8 Amendment; Waiver; Survival. This Agreement may be modified only by a
writing signed by both Parties. Any failure to enforce any provision of this
Agreement is not a waiver of that provision or of either Party’s right to later
enforce each and every provision. The terms of this Agreement that by their
nature are intended to survive its expiration will continue in full force and
effect after its expiration.

 

19.9 Severability. If any provision of this Agreement is determined to be
legally unenforceable or invalid, it shall not affect the validity or
enforceability of the remainder of the Agreement, and the remaining provisions
will continue in full force and effect. The Parties will substitute a provision
that most closely approximates the economic intent of the invalid provision.

 

19.10 Battle of Forms. This Agreement contains the entire agreement and
understanding of the Parties and supersedes all prior agreements, understandings
or arrangements (both oral and written) relating to the subject matter of this
Agreement. For the avoidance of doubt, the Supply Agreement between the Parties
dated May 26, 1999 as amended and the License Agreement between the Parties
dated May 1, 1999 as amended are both hereby terminated. Any Orders placed under
this Agreement shall be solely governed by the terms and conditions of this
Agreement. No general terms and conditions of either Party referred to in
purchase orders, order confirmations or elsewhere shall apply, unless expressly
agreed in writing.

 

19.11 Affiliate. For the purposes of this Agreement, an Affiliate of a party
shall mean any company controlled by or under common control with the relevant
party where “control” means direct or indirect ownership of at least 50 percent
of the

  voting stock or interest in a company or control of the composition of the
board of directors.

 

19.12 Interpretation. In this Agreement, reference to a clause, section or
Attachment are, except where otherwise stated, a reference to an Attachment of
this Agreement and a clause or section of the relevant Attachment. Clause,
section or Attachment headings in this Agreement and any descriptive notes in
brackets are for convenience only and shall not affect the construction or
interpretation of this Agreement. References to the words “include(s)” or
“including” shall be construed without limitation to the generality of the
preceding words. Unless the context otherwise requires, references to the
singular include the plural and vice versa, references to any gender include all
other genders and references to “persons” shall include individuals, bodies
corporate, unincorporated associations, businesses and partnerships. Any
reference to a day shall be to a calendar day unless specified otherwise. Any
reference to a Business Day shall mean any day which is not a Saturday, Sunday
or public holiday in the country in which GEHC or its relevant Affiliate or the
Supplier is located unless specified otherwise.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    29 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.

--------------------------------------------------------------------------------

Attachment F

GE Technology

Production know-how covering [*] with regard to rPA and ZätA protein, in
particular as described in the following documentation.

 

Documentation – title

  

GEHC Doc No. (when applicable)

rPA

[*]

  

ZätA

[*]

  

For avoidance of doubt, the above is not an exhaustive list of GE Technology,
but describes certain key elements of the manufacturing process and test methods
relating to the Products.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing
/ Version Supply 1.0    30 (30) Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under Rule 24b-2 of the
Exchange Act; [*] denotes omissions.