Attached files
file | filename |
---|---|
EX-31.2 - EX-31.2 - REPLIGEN CORP | d168532dex312.htm |
10-Q - 10-Q - REPLIGEN CORP | d168532d10q.htm |
EX-31.1 - EX-31.1 - REPLIGEN CORP | d168532dex311.htm |
EX-10.1 - EX-10.1 - REPLIGEN CORP | d168532dex101.htm |
EX-32.1 - EX-32.1 - REPLIGEN CORP | d168532dex321.htm |
Exhibit 10.2
STRATEGIC SUPPLIER ALLIANCE AGREEMENTCONTRACT MANUFACTURING GE HEALTHCARE
PARTIES
GE Healthcare entity (GEHC) | Other Party (the Supplier) | |
GE Healthcare Bio-Sciences AB | Novozymes Biopharma Sweden AB | |
Address | Address | |
Björkgatan 30, 751 84 Uppsala, Sweden | St Lars väg 47, 220 09 Lund | |
Registration number | Registration number | |
556108-1919 | 556627-0830 | |
AGREEMENT | ||
GEHC REF: 132145 |
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 and thereby replacing the Contract Manufacturing and Purchasing Agreement, dated Sep 1 2005, between the Parties as specified below.
Pursuant to above prerequisites and the terms and condition of this Agreement, the Supplier shall manufacture and sell to GEHC, and GEHC shall purchase from the Supplier the Products, defined in Attachment C (the Products) in such amounts as GEHC may order from time to time on the terms and conditions set out in the Agreement. GEHC shall pay the price of the Products specified in Attachment C (the Prices). The Parties have agreed to jointly perform technology transfer projects (TT Programs) enabling the Supplier to manufacture Recombinant Products Zäta and rPA as set forth in Attachment L below.
The Parties agree that the scope of the contract manufacturing services performed hereunder (including packaging and quality control) will be specified by Production Documents as defined below.
Effective 12 December 2008 GEHC has granted Suppliers parent company a license to develop, manufacture, use, sell and have sold nPA (as defined herein), and hereunder to purchase chromatography media and receive working cell banks from GEHC for the practice of the license on the terms of the existing contract manufacturing agreement between GEHC and the Supplier. Said purchasing chromatography media and receiving working cell banks shall be governed by this Agreement, once effective.
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
Attachment D Business Terms
Attachment I GEHC initial 24 months rolling forecast starting from effective date
Attachment J Media lead time schedule
GENERAL TERMS
Attachment E General Terms and Conditions
TECHNICAL TERMS
Attachment F GEHC Production know-how of the Recombinant Product
Attachment G GEHC Production know-how Native Products
Attachment H GEHC Production know-how Lego Products
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Attachment K Production Documents generated by the Supplier
Attachment L TT Programs
C. | Term |
Effective Date: The date of the last of the below signatures
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 up to 31st of December 2016. 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 | |||||||
Date: June 30, 2011 | Date: 2011 07 07 | |||||||
Signature | /s/ Magnus Lundgren |
Signature | /s/ Mikael Bundgaard-Nielsen | |||||
Name (capitals) | Magnus Lundgren |
Name (capitals) | Mikael Bundgaard-Nielsen | |||||
Title | Global Sourcing Executive |
Title | Vice President | |||||
Signed for and on behalf of the Supplier | ||||||||
Date: | ||||||||
Signature |
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Name (capitals) |
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Title |
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Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys 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:
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.
SECTION 1 QUALITY SYSTEMS: The Supplier shall maintain a documented quality system, and the Supplier shall be in compliance with ISO9001 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 GEHC the Supplier shall meet or exceed GEHC requirements, GEHC may audit the Suppliers quality system at periodic intervals upon 30 days written advance notification, to inspect and observe the Suppliers manufacture of Products, to audit the Suppliers quality control and inspection procedures, and to have access to all data and documentation from such control of the Products and to receive 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. GEHCs right of inspection under this head shall not diminish the Suppliers obligation to deliver Products which comply with the specifications of this Agreement GEHC may also request periodic, joint quality assurance meetings at the Suppliers facility to discuss and resolve product quality and reliability issues.
SECTION 2 QUALITY RECORD RETENTION: If the Supplier is required to perform acceptance and release activities per GEHC written agreement or purchase specification, the Supplier shall maintain records of the acceptance and release activities for the services performed and/or products and services delivered to GEHC. 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 at the Supplier and available for GEHC upon reasonable notice in advance, for at least ten (10) years from the date of manufacture and after 10 years retention at Supplier, the required records shall be submitted to GEHC with a written notice of 30 days, unless the Parties agree to extend the retention of the records at the Supplier or discord the record.
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 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:
Product changes affecting specifications, quality, form, fit, function, regulatory compliance, etc. proposed by the Supplier are governed by Attachment E, Section 6.2 hereof Product changes affecting specifications, quality, form, fit, function, regulatory compliance, etc. proposed by GEHC are governed by the terms of Attachment E, Section 6.1 hereof.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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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 GEHC documentation is controlled and distributed with the correct revision level to the appropriate personnel that produce the product for GEHC. The Supplier shall also ensure that all GEHC documentation is treated as proprietary and confidential, unless otherwise agreed.
For GEHC designed Products, the Supplier is responsible for ensuring that all applicable GEHC documentation is provided to all of the Suppliers Sub-Suppliers involved in the supply of product for GEHC. The Supplier shall ensure that both they and their Sub-Suppliers that use GEHC engineering documentation are maintained in compliance with all accepted Engineering Change Requests/Engineering Change Orders issued by GEHC.
Supplier shall be responsible for the qualification of all new equipment, computer systems and facilities associated with the manufacture, storage or testing of the Products as required.
SECTION 6 TRAINING:
Supplier shall ensure that all personnel performing the functions to support the critical systems outlined in this Agreement are trained according to Suppliers internal procedures and processes.
SECTION 7 SAMPLES
The Supplier shall retain sufficient samples from each of the Products to perform at least two (2) full retests of the agreed Specification for a period of one (1) year after the expiration of the Product Samples shall be stored at or lower than a temperature of minus 15°C and in standard containers. The Supplier shall advise GEHC before disposal of retained samples.
SECTION 8 PACKAGING AND SHIPPING METHODS: The Supplier shall provide packaging and shipping methods to prevent cosmetic and mechanical damage to the Product. The Supplier shall meet or exceed the detailed specifications of the GEHC packaging requirements found in the Specification
SECTION 9 ORDER OF PRECEDENCE: This attachment A shall be an addendum to the Strategic Supplier Alliance Agreement (SSAA) between Supplier and GEHC. 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 terms of this Attachment A.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys 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/ Mikael Bundgaard-Nielsen |
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PRINTED NAME: | Mikael Bundgaard-Nielsen |
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TITLE: | Vice President |
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DATE: | 2011 07.07 |
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SUPPLIER NAME | Novozymes Biopharma Sweden AB |
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SIGNATURE: |
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PRINTED NAME: |
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TITLE: |
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DATE: |
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SUPPLIER NAME: |
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AGREED TO AND ACCEPTED BY THE GENERAL ELECTRIC COMPANY ON BEHALF OF ITS DIVISION, GE HEALTHCARE | ||||
SIGNATURE: | /s/ Magnus Lundgren |
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PRINTED NAME: | Magnus Lundgren |
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TITLE: | Global Sourcing Executive |
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DATE: | Jun 30, 2011 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys 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 have appropriate policies and governance in place and shall use its best efforts in order to comply with all applicable legal, as well as GEHC policy communicated to the Supplier 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 Suppliers employees, contractors, representatives and sub-suppliers understand and comply with the same legal and GEHC policy (as communicated to the Supplier) 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 required environmental management programs; (ii) establish and maintain safeguards for the continuing compliance with all required environmental permits: and (iii) not permitting any discharge to the environment in violation of law, or that would otherwise have on 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. |
(6) | Business Entertainment of GEHC Employees and Representatives. Comply with the business entertainment (including travel and living] policies established and expressly communicated in writing 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 on impropriety. |
(7) | Collusive Conduct and GEHC Procurements. Establish and maintain policies and safeguards and use best efforts to comply with all applicable competition laws, including, but not limited to: (i) not engage in prohibited communications or enter into agreements with competitors that con 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 GEHCs. 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 reasonable 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. 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. Establish and maintain policies and safeguards and use best efforts to 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 without the |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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express prior written permission of GEHC. Without limitation to the foregoing: (i) Establish and maintain policies and safeguards and use best efforts to 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; and (iii 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. Supplier will also obtain all applicable permits and licenses necessary to perform its obligations under this Agreement, and upon GEHCs 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 GEHCs request. |
(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) Establish and maintain policies and safeguards and use best efforts to comply with all applicable privacy and data protection laws globally, or generally acceptable privacy principles where comprehensive privacy laws are not available; (ii) Establish and maintain policies and safeguards and use best efforts to report any improper use or disclosure of PI, as well as successful security breaches, immediately upon becoming aware; (iii) Establish and maintain policies and safeguards and use best efforts to ensure that any employees, contractors, representatives and sub-suppliers to whom it provides PI and/or access to information systems, agree to the some 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; and (vii) ensure that formal security management systems are employed that eliminates the risk of Pl-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 any reasonable GEHC policies established for money laundering prevention communicated expressly in writing. |
(12) | Prohibition of Use of Sub-Suppliers or Third Parties to Evade Requirements. Not use sub-suppliers or other third parties to illegally evade any applicable legal, including those enumerated above. |
(13) | Security Measures. Supplier warrants and represents that it will review and if relevant seek to reasonably adopt industry standard security measures which are consistent with accepted programs including the US Customs-Trade Partnership Against Terrorism (C-TPAT), the European Unions Authorized Economic Operator program and other similar programs where applicable |
(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 far EFTA/EU and other preferential duty provisions, as applicable. |
(15) | Policy Changes. GEHC policy requirements, including those enumerated above, are subject to modification by GEHC at any time. Such modifications shall only apply with regard the Supplier upon communication in writing and provided the Supplier does not object to such modification, which objection shall be mode in writing within 30 days from receipt of the communication. 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 agrees to comply with all applicable national, EU, state/provincial and local labor, environmental, health and safety laws and regulations in connection with execution of this Agreement. |
(2) | 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 applicable law and regulation. |
AGREED TO AND ACCEPTED BY SUPPLIER | ||||||||
BY: | /s/ Mikael Bundgaard-Nielsen |
BY: |
| |||||
TITLE: | Vice President |
TITLE: |
| |||||
DATE: | 2011 07.07 |
DATE: |
| |||||
SUPPLIER NAME: |
Novozymes Biopharma Sweden AB |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys 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: | SEK | |
Revision date: | April 4th 2011 |
The reference to Products shall include the two recombinant Products, 1) Zäta with the GEHC article number 28-4048-76 and 2) rPA with the GEHC article number 28-9932-16 (Recombinant Products) and the product, serum free Native Protein A, with the GEHC article number 30-6001-21 (Native Product) and the product Native Protein A (Lego Product). All three types of products; Recombinant Products, Native Product and Lego Product are covered by the term Product.
A. | RECOMBINANT PRODUCT: |
Product Name |
Zäta | |
GEHC Article number | 28-4048-76 | |
Supplier Article Number | 6082-221 |
Unit size:
[*] Zäta per [*] meaning that the content per [*] shall be [*]. Each [*] shall be labeled with [*] Zäta. For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label.
Price
SEK/[*] |
[*] | [*] | [*] | [*] | [*] | [*] | ||||||
Zäta ([*] [*]) |
[*] | [*] | [*] | [*] | [*] | [*] | ||||||
Zäta < [*] |
[*] | [*] | [*] | [*] | [*] | [*] |
INCOTERMS: CIP GEHC Uppsala, but for any Purchase Order [*], the parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice.
Lead time (PO):
[*]
Remaining shelf life upon delivery:
[*]
Level of Suppliers Safety Stock:
The safety stock will be [*] based on the average of the [*] of the at any time valid [*] rolling forecast distributed by GEHC and the [*] consumption by GEHC.
For the first year of Zäta supply, [*] safety stock level shall be based solely on the [*] rolling forecast.
Lead Times for Safety Stock Replenishment:
[*], the lead time for replenishment of purchased safety stock will be [*].
Shelf life
[*]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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B. | RECOMBINANT PRODUCT: |
Product Name |
rPA | |
GEHC Article number | 28-9932-16 | |
Supplier Article Number | 6082-271 |
Unit size: [*] rPA per [*] meaning that the content per [*] shall be [*]. Each [*] shall be labeled with [*] rPA. For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label.
Price:
SEK/[*] |
[*] | [*] | [*] | [*] | [*] | [*] | ||||||
Zäta ([*] [*]) |
[*] | [*] | [*] | [*] | [*] | [*] | ||||||
Zäta < [*] |
[*] | [*] | [*] | [*] | [*] | [*] |
[*]
The above prices are based on the prerequisite that the total yield is around [*] starting from [*]. If the yield in the [*] is proven to be [*] higher or lower, the price shall be [*].
INCOTERMS: CIP GEHC Uppsala, but for any Purchase Order less than [*], the parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice
Lead time IPO):
[*]
Remaining shelf life upon delivery:
[*]
Level of Suppliers Safety Stock:
The safety stock will be at least [*] based on the average of the [*] of the at any time valid [*] rolling forecast distributed by GEHC and [*] consumption by GEHC.
For the [*] rPA supply the [*] safety stock level shall be based solely on the [*] rolling forecast.
Shelf life:
[*]
Lead Times for Safety Stock Replenishment:
[*] the lead time for replenishment of purchased safety stock will be [*].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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C. | NATIVE PRODUCT: |
Product Name | Serum free Native Protein A (nPA) | |
GEHC Article number | 30-6001-21 | |
Supplier Article Number | 6082-220 |
Unit size: [*] nPA per [*] meaning that the content per [*] shall be [*]. Each [*] shall be labeled with [*] nPA. For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label.
Price: The price on nPA will be [*].
INCOTERMS: CIP GEHC Uppsala, but for any Purchase Order less than [*], the parties shall share equally the freight/ insurance costs of such shipment subject to the transport invoice.
Lead time (PO)
[*]
Remaining shelf life upon delivery:
[*]
Level of Suppliers Safety Stock:
The safety stock will be [*] based on the average of the [*] of the at any time valid [*] rolling forecast distributed by GEHC and the [*] consumption by GEHC
For [*] the safety stock level shall be [*].
Shelf life
[*]
Lead Times for Safety Stock Replenishment:
[*], the lead time for replenishment of purchase safety stock will be [*].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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D. | LEGO PRODUCT: |
Product Name | Native Protein A (PA) | |
GEHC Article number | N/A | |
Supplier Article Number |
Specification: [*].
Price:
The price on PA will be [*]
INCOTERMS: CIP GEHC Uppsala, but for any Purchase Order less than [*], the parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice.
Lead time (PO):
[*].
Remaining shelf life upon delivery:
[*]
Level of Suppliers Safety Stock:
[*]
Shelf life:
[*]
Lead Times for Safety Stock Replenishment:
[*]
Special Terms for Lego Product:
a) | Lego Product is delivered as an [*]. |
b) | Each Purchase Order shall be firm and binding for GEHC and be for [*] of Lego Product. |
c) | GEHC will provide the Supplier with [*]. |
***
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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GENERAL PRICE TERMS:
Recombinant Products and Native Product:
All prices above are per gram and shall apply for deliveries made in the applicable calendar year.
[*].
In delivery documentation and invoices the stated quantity delivered shall be based on the unit size [*]. For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label, in the delivery note and in the invoice.
Reference samples for the Recombinant Products and the Native Product, covering [*], to be provided to GEHC in the deliveries [*].
Gel Prices:
Throughout the period of the Agreement the below prices are [*].
Protein |
Media | SEK/[*] | ||||||
ZätA* |
[* | ] | [* | ] | ||||
[* | ] | [* | ] | |||||
[* | ] | [* | ] | |||||
nPA |
[* | ] | [* | ] | ||||
[* | ] | [* | ] | |||||
rPA |
[* | ] | [* | ] | ||||
[* | ] | [* | ] |
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.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Specifications
ANALYTICAL SPECIFICATION RAW MATERIAL
30-6000-60 Ed. AH | ||
Issued by QA/ Johanna Ejdersund |
Approved by R&D/ Philippe Busson |
Established by QA/ Kjell Christensson |
Valid from 2001-04-15 | Supersedes 30-6000-60 Ed. AG | PAGE 1(1) |
rProtein A
Code No: 30-600-60, 28-9932-16
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. Remaining Shelf life | Shelf life is [*] from the date of manufacture. | |
5. Other name | 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 coli. 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. |
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) | [*] | 04-0048-69 | ||||
6. Microbial contamination, CFU/ml | [*] | 45-2006-39 | ||||
7. Endotoxin activity EU/mg rProtein A | [*] | 45-0306-72 |
GE and GE monogram are trademarks of General Electric Company.
©1999-2001 General Electric Company All rights reserved.
GE Healthcare Bio-Sciences AB, General Electric Company
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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|
ANALYTICAL SPECIFICATION RAW MATERIAL
30-6001-60 Ed. AH |
Issued by QA/Johanna Ejdersund |
Approved by R&D/ Herbert Baumann |
Established by QA/ Christina Hult-Roos |
Valid from 2010-04-29 |
Supersedes 30-6001-09 Ed. AG |
Page 1(1) |
nProtein A
Code No: 30-6001-09, -20, -21
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 | Established shelf life is [*] from the date of manufacture. | |
5. Formula and mass | Theoretical Mr: 46 762 Dalton calculated from amino acid sequence | |
6. Description | Protein A is produced from a selected strain of Staphylococcus aureus Protein A. The protein binds to the Fc region of the immunoglobulin G and in some cases to immunoglobulin M and A. The substance is supplied as a clear yellowish or yellow-brown frozen liquid free from particles. The protein is produced with chemicals and materials of non-animal origin. |
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. Protein conc (A275): mg/ml) | [*] | 45-2006-14 | ||||
6. Microbial contamination CFU/ml | [*] | 45-2006-39 | ||||
7. Endotoxin activity; EU/ml | [*] | 45-0306-72 | ||||
8. Content of endotoxin B µg/g protein A | [*] | 14-0015-63 |
GE and GE monogram are trademarks of General Electric Company.
©1999-2001 General Electric Company All rights reserved.
GE Healthcare Bio-Sciences AB, General Electric Company
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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ANALYTICAL SPECIFICATION RAW MATERIAL
14-0037-84 Ed. AD |
Issued by QA/ Elb-Jorde |
Approved 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 | Established shelf life is [*] from the date of manufacture. Final shelf life is to be decided by 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. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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ANALYTICAL SPECIFICATION RAW MATERIAL
14-0037-84 Ed. AD |
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 | [*] | 45-2006-39 Ed. AB | ||||
7. Endotoxin activity EU/mg ZätA protein | [*] | 45-0306-72 Ed. AF |
Comment:
GE and GE monogram are trademarks of General Electric Company.
©1999-2001 General Electric Company All rights reserved.
GE Healthcare Bio-Sciences AB, General Electric Company
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
16
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.
3. | Prices and Payment Terms |
a. | Firm Prices. The Prices of the Products are firm for the Term of this Agreement. Prices are quoted excl. VAT and other taxes. |
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 on Invoice prepared in accordance with the terms of this Agreement. Invoices shall be issued upon delivery. 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. | [*]. |
e. | Invoicing requirements. The Suppliers 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. The stated and delivered quantities shall match between the invoice, actual delivery and in the delivery documentation, based on the use of the unit size as specified in Attachment C. Invoices shall be addressed to GEHC or the GEHC affiliate who has placed the purchase order with the Supplier. |
f. | [*] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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4. | Components and Materials |
At GEHCs option, GEHC may instruct the Supplier to procure or provide all materials and components necessary for the manufacture of the Products from on approved supplier, in which case an approved suppliers list shall be maintained by the Supplier. Any new suppliers selected by the Supplier in connection with the Agreement must be approved by GEHC, whereupon they may be added to such approved suppliers list. Any verified change of cost of raw materials resulting from GEHCs instruction to change supplier, shall effect the price of the concerned Product in the same proportion as the change of the Suppliers production cost of the concerned Product.
5. | Additional Suppliers |
The Supplier shall, at GEHCs written request, provide reasonable assistance to GEHC with regard to GEHCs efforts to have back-up manufacturing solutions in place for the Products (i) by providing GEHC or such designee with copies of all written embodiments of Production Document (ii) by making relevant personnel available within reason for consultation. Supplier may charge GEHC a reasonable fee for such services which shall be subject to agreement prior to initiation.
6. | Forecast and Commitment |
a. | Forecasting. [*] ([*]) days before the end of each quarter, GEHC shall submit to the Supplier in writing a [*] month rolling forecast (Forecast) broken down by Product ([*]) and into calendar quarters. 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. The Forecast shall reflect GEHCs best estimate of its need for the Products from the Supplier at the time of the submission, subject to section e) below. If GEHC is unable to provide a timely forecast, GEHC shall upon request be granted an extension of [*] ([*])days from the original Forecast due date. If the Forecast is not submitted at such time then the second quarter from the previous Forecast will be firm and binding on GEHC and the Supplier. |
b. | The Forecast. The [*] of every rolling Forecast provided by GEHC for the Recombinant Product and for the Native Product shall be [*] on GEHC and the Supplier. [*]. Upon receipt of the Forecast, Supplier shall notify GEHC if Supplier is unable to deliver according to said Forecast (including any specific quarter) included in the forecast. Supplier agrees to provide such notification to GEHC within [*] days. |
c. | General Supply Commitment. The Supplier shall use its best commercial efforts to manufacture and deliver the Recombinant Product and the Native Product within [*]. To ensure this is upheld, the Forecast will be assessed as described in section 14. 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. If the Supplier should be unable to meet GEHCs requirements in accordance with the forecast or should fail to accept any orders in excess of the forecast within agreed time limits, the Parties agree GEHC shall be released from such part of its purchase commitment that the Supplier is unable to deliver on the requested delivery times |
d. | Purchase Commitment Recombinant Product. As a result of this Agreement, the Supplier will become a preferred supplier of GEHC for the Recombinant Products. The Parties have agreed that the annual deliveries shall be at least [*] ([*]) percent of GEHCs total actual requirements in [*] for the Recombinant Products. For the avoidance of doubt, the annual deliveries of individual Recombinant Products shall not be lower than [*]% of the total annual requirement for any particular Recombinant Product. |
The purchase commitment for a Recombinant Product shall start and be calculated at such time the following criteria for the Recombinant Product are met as part of the TT Programs:
a) | [*]; |
b) | [*] |
c) | [*], |
d) | [*] |
In the event GEHC should fail to fulfill its purchase obligations hereunder it shall immediately notify Supplier of such failure and as its sole liability immediately issue a purchase order for the missing quantities upon the Suppliers written request thereto. The Supplier agrees to maintain the equivalent ability to manufacture the Recombinant Product for GEHC.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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If the Supplier during a certain [*] is unable to timely supply the Recombinant Product in quantities specified in GEHCs Forecast, then GEHCs purchasing commitment for that quarter shall be reduced with a quantity corresponding to the shortfall.
e. | Purchase commitment Native Product. As a result of this Agreement the Supplier will continue to be the supplier of GEHC for the Native Product. The Parties have agreed that the annual deliveries shall be no less than [*]% of GEHCs total actual requirements in [*] for the Native Product. GEHC reserves the right to develop alternative sources for the Native Product. In the event that such a project is started GEHC agrees to provide the Supplier with at least [*] months notice prior to the commencement of deliveries from an alternative supplier. In such an event the Parties agree to negotiate in good faith acceptable commercial and project management terms. |
f. | No further Obligation. Other than as set out in this Section 6, it is the express understanding of the Parties that GEHC shall have no further obligation to purchase Products exclusively from the Supplier or to purchase any further minimum amount of Products, and may use other suppliers for any and all Products, or similar products in accordance with the stipulated terms herein. |
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 3 | |||
751 84 Uppsala, Sweden | ||||
Fax No. [*] | ||||
Supplier: | St Lars väg 47, | |||
220 09 Lund | ||||
Fax No: |
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 |
During the term of this Agreement and for [*] thereafter each party undertakes to maintain a comprehensive liability insurance policy, products liability inclusive, at terms and conditions customary to the business. Such insurance shall be for on insured sum of not less than [*] Swedish kroner ([*] SEK) (or the equivalent in USD). Each party shall upon request furnish to the other party a certificate evidencing such insurance.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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9. | Safety Stock |
The Supplier shall keep a Safety Stock at the Suppliers 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 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.
The Supplier shall provide GEHC with finished goods inventory levels and Safety Stock levels within [*] days upon request from GEHC
10. | Manufacturing Process |
All written manufacturing or production documentation and records relating to the Products are defined as Production Document(s)
For avoidance of doubt the know how listed in attachments F, G, H and K and the know-how to be generated as part of the TT Programs, are deemed to be Production Documents and shall be the sole property of GEHC and may be only used for the purpose of manufacturing the Products on behalf of GEHC under this Agreement unless otherwise agreed in writing by the Parties.
The Supplier shall document and GEHC shall have access to review all required written manufacturing or production records relating to any of the Products and upon request from GEHC, the Supplier is obliged to send GEHC copies of the requested Production Documents
The Supplier shall always keep and maintain the master list of Production Documents generated by the Supplier, initially stated in Attachment K, and the Supplier shall send upon GEHCs request on update of any of the documents included in the master list of Production Documents.
The approved validation reports for the completion of the tech transfer under the TT programs will act as baseline documents, over the production process for each of the Recombinant Products showing the starting fermentation volume, the yields for each of the process steps and the expected outcome per purification batch, to be used for example as a base in productivity improvement issues.
11. | Business interruption |
The Supplier undertakes to keep GEHC informed about any circumstances that might reasonably impact on the Suppliers 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 |
Reports:
GEHC will provide Supplier within [*] of the close of each [*] period a report of the total quantity of the Recombinant Products purchased by GEHC from all suppliers during the period.
13. | Performance goals |
The purpose of the performance goals are primarily for the Supplier to plan the operations at the Suppliers site and take preventive initiatives so that the set performance goals con be achieved. The results of the Suppliers performance in below areas should be a port of the business reviews 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 Supplier agrees to use all commercially reasonable efforts to achieve the performance goals.
Performance goals as per GEHC:
1. | Deliveries within Specification, agreed lead times and quantities; performance goal is [*] according to the terms in Attachment C |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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2. | Number of complaint reports sent to the Supplier by GEHC; performance goal is [*] |
3. | Business contingency plan audits and GEHC quality audits performed and with the result approved; performance goal is [*] |
14. | Business reviews. |
The Parties shall preferably meet face to face and perform quality business reviews [*] with focus on quality, delivery, joint cost savings projects, change requests, forecasts.
The agenda for the [*] business review meetings should cover:
i. | Performance goals as per GEHC |
ii. | Forecast/Commitment |
iii. | Purchase commitment, both Parties |
iv. | Status on change requests and joint savings projects |
v. | Any other businesses |
15. | 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 GEHCs records to ensure compliance with GEHCs commitments according to Section 6d (minimum purchase) in said Section of the Agreement.
16. | 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 prices stipulated in Attachment C:
Name | Article No: | |||||
[*] |
Delivery conditions: CIP Lead time: Delivery lead times if Purchase Orders are placed in accordance to lead time schedule in Attachment J Credit term: [*] days from date of invoice
Order handling: all order shall be submitted to [*] and copy to the Contract Managers, 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 and the terms herein.
The products ordered in accordance with this Section may only be used in the manufacture of the Products for delivery to GEHC or products produced by Supplier under license to third party.
17. | Cell banks |
The biological starting material used in the fermentation process originates from the cell banks are 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 whatever reason, unless otherwise agreed by the parties in writing. 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.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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The Supplier may order starting material at no cost of Supplier 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 the Supplier 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.
f) | The Supplier 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. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Attachment E General Terms and Conditions
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
23
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
24
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
25
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
26
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
27
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
28
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
29
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
30
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
31
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.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Attachment G.
GE Technology
Production know-how covering [*] with regard to Native Product, in particular as described in the following documentation.
Documentation title | Doc No | |
[*] |
· |
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.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Attachment H.
GE Technology
Production know-how covering [*] with regard to Lego Product, in particular as described in the following documentation.
Documentation title | Doc No | |
[*] |
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.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Attachment I
GEHC initial [*] rolling forecast starting from effective date
[*] | [*] | [*] | [*] | [*] | [*] | [*] | [*] | |||||||||
Zäta ([*]) |
[*] | [*] | [*] | [*] | [*] | [*] | [*] | [*] | ||||||||
nPA ([*]) |
[*] | [*] | [*] | [*] | [*] | [*] | [*] | [*] | ||||||||
rPA ([*]) |
[*] | [*] | [*] | [*] | [*] | [*] | [*] | [*] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
35
Attachment J
Lead time schedule
[*]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
36
Attachment K: Production Documents generated by the Supplier
The below listed documents represent the top documents in hierarchical document structure and will thus in itself reference to all relevant documents for the Suppliers production of the respective Products.
The specific documents are:
NZ Doc No | Title | |
[*] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Attachment L: TT Programs
A. | rPA |
1. | The Parties shall use their respective best efforts to complete the TT Programs without undue delay. The aim with the TT Programs is to transfer GEHCs manufacturing know-how needed to manufacture the rPA. |
2. | The TT Programs consists of the following main activities: |
1. | Transfer of analytical and production methods |
2. | Implementation, including validation of equipment and raw materials |
3. | Validation of process and finished product |
4. | Customer approval |
On the effective date of this Agreement points 1. and 2. above have been completed, and points 3. and 4. are pending.
3. | Each party will bear its own costs as a general principle. GEHC will pay for any productive material (material validated for use in GEHC production of final products) according to the agreed prices herein. |
4. | In case the process does not perform as expected the parties shall in good faith negotiate the cost for the further development needed. |
5. | GEHC shall supply Supplier with full documentation of the process and analytical methods including existing validation reports, provided GEHC is allowed to disclose such documentation considering any third party confidentiality obligations. |
6. | Approved product from the validation batches performed at Supplier shall be bought by GEHC according to the terms and conditions of this Agreement. |
B. | Zäta |
1. | The Parties shall use their respective best efforts to complete the TT Programs without undue delay. The aim with the TT Programs is to transfer GEHCs manufacturing know-how needed to manufacture the Zäta. |
2. | The TT Programs consists of the following main activities: |
1. | Transfer of analytical and production methods |
2. | Implementation including validation of equipment and raw materials |
3. | Validation of process and finished product |
4. | Customer approval |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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On the effective date of this Agreement points 1. to 3. have been completed, and point 4. is pending.
3. | Each party will bear its own costs as a general principle. GEHC will pay for any productive material (material validated for use in GEHC production of final products) according to agreed prices herein. |
4. | In case the process does not perform as expected the parties shall in good faith negotiate the cost for the development needed. |
5. | GEHC shall supply Supplier with full documentation of the process and analytical methods including existing validation reports, provided GEHC is allowed to disclose such documentation considering any third party confidentiality obligations. |
6. | Approved product from the validation batches performed at Supplier shall be bought by GEHC according to the terms and conditions of this agreement. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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Amendment to Strategic Supply Alliance Agreement
This Amendment to the Agreement (as defined below) is made effective on October 27, 2011 (Effective Date), by and between,
1. | Novozymes Biopharma Sweden AB having its address at St Lars Väg 47, 220 09 Lund (the Supplier), and |
2. | GE Healthcare Bio-Sciences AB having its address at Björkgatan 30, S-751 84 Uppsala, Sweden (GEHC). |
Recitals
A. | The Parties have entered into a Strategic Supplier Alliance Agreement (the Agreement) effective July 7, 2011 concerning the supplies of certain protein ligands to GEHC. |
B. | The manufacturing and supply business of cell culture ingredients and protein A affinity ligands for use in industrial cell culture, stem and therapeutic cell culture and biopharmaceutical manufacturing (the Business) run by the Supplier and Novozymes Biopharma DK A/S, a company organized under the laws of Denmark and the sole stockholder of the Supplier (Novozymes Parent), is expected to be sold to an affiliate of Repligen Corporation, a corporation organized under the laws of the state of Delaware in the United States (Repligen), pursuant to a purchase agreement (the Purchase Agreement), entered into on or about the date hereof, by and among Novozymes Parent, Repligen and the other parties thereto (the sale of the Business referred to herein is defined as the Transaction). |
C. | In connection with the Transaction, the Parties wish to have the Agreement amended in accordance with the provisions below. |
Considering the above the Parties have entered into the following amendment to the Agreement (the Amendment).
Amendment
1. | For purposes hereof and the Agreement, the term Transaction shall mean the sale of the manufacturing and supply business of cell culture ingredients and protein A affinity ligands for use in industrial cell culture, stem and therapeutic cell culture and biopharmaceutical manufacturing business run by Supplier and Novozymes Biopharma DK A/S, a company organized under the laws of Denmark and the sole stockholder of Supplier, to an affiliate of Repligen Corporation, a Delaware corporation (Repligen), pursuant to an agreement entered into by and among Novozymes Biopharma DK A/S, Repligen and the other parties thereto. Terms not otherwise defined in this Amendment shall have the meanings defined in the Agreement. |
2. | Except as expressly amended herein, all terms and conditions of the Agreement shall remain in full force and effect. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
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3. | The Amendment shall be effective as from the Effective Date. |
4. | Section 9 of Attachment E of the Agreement shall be amended to include a new Section 9.3 as follows: |
If the Transaction is consummated, the Supplier and GEHC agree to each use commercially reasonable efforts to define Suppliers internal contingency arrangements to support GEHCs continuity of supply regarding both (a) Supplier and its main operating facility as of the date hereof located in Lund, Sweden (the Lund Facility) and (b) Repligen and its main operating facility as of the date hereof located in Waltham, Massachusetts, United States (the Waltham Facility) in order to meet GEHCs customers requirements for documenting security of supply to the extent reasonably practicable. If the Transaction is consummated, the Supplier agrees to provide GEHC with a revised draft of such contingency arrangements for review. GEHC agrees to notify the Supplier in writing of any proposed revisions to such draft contingency arrangements within [*] ([*]) days of receipt, which proposed revisions shall thereafter be considered by Supplier, and mutually discussed by Supplier and GEHC, each acting reasonably, until promptly resolved; provided that if GEHC fails to deliver any such written notice of any proposed revisions to Supplier within [*] ([*]) days of receipt, then GEHC will be deemed to have accepted such contingency arrangements submitted by Supplier.
5. | Section 9 of Attachment E of the Agreement shall be amended to include a new Section 9.4 as follows: |
Until such year as GEHC and its Affiliates purchase from Supplier hereunder and from Repligen, in the aggregate, less than [*]% of the total combined volume of all Recombinant Products Zata and rPA purchased by GEHC and its Affiliates worldwide, the Supplier hereby covenants that [*] percent ([*]%)[*] of the total combined volume of Recombinant Products Zata and rPA manufactured at the Lund Facility and the Waltham Facility shall be manufactured at the Lund Facility.
6. | The first paragraph of Section 16.1 of Attachment E of the Agreement shall be amended and restated in its entirety as follows: |
This Agreement shall commence on the Effective Date and, subject as hereinafter provided, shall continue in effect until December 31, 2016. Notwithstanding the aforementioned, [*] upon [*] ([*]) year prior written notice to Supplier, provided that GEHC may not issue such notice [*] until after 31 December 2013.
7. | Section 16.2 of Attachment E of the Agreement shall be amended and restated in its entirety as follows: |
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 (i) is functionally substitutable (based on technical performance) with GEHC´s chromatography products containing the Products (as exemplified by MabSelect and MabSelect SuRe) or (ii) contains Native Products; provided that GEHC prior to termination shall give the Supplier thirty (30) days written
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
41
notice of its intent to terminate the Agreement and should the Supplier provide reasonable explanation of compliance or stop selling or marketing such product during the thirty day period, as certified by the Supplier to GEHC in writing, then GEHC shall not have the right to terminate the Agreement referring to such circumstances. |
8. | Subject to and contingent upon the consummation of the Transaction, all references to the Novozymes group of companies shall be amended to refer to the Repligen Corporation group of companies (which includes, for the avoidance of doubt, Repligen Corporation and its wholly owned subsidiaries). |
9. | GEHC agrees to waive all rights to terminate the Agreement under Section 16.3 of Attachment E of the Agreement with respect to the Transaction. |
10. | Effect of Amendment. In the event that the Transaction is not consummated by December 31, 2011, GEHC and Supplier shall each have the right to terminate unilaterally this Amendment by giving the other party hereto written notice no later than fifteen (15) days following such date and, if such notice is delivered, this Amendment and the changes to the Agreement contemplated hereby shall be of no force or effect. The parties hereto agree that except as otherwise set forth herein, all terms of the Agreement shall remain in full force and effect. In the event of any inconsistency or conflict between the Agreement and this Amendment, the terms, conditions and provisions of this Amendment shall govern and control. |
11. | Entire Agreement. This Amendment and the Agreement, including the Attachments, exhibits, schedules and other documents referred to therein which form a part thereof, contain the entire understanding of the parties hereto with respect to the subject matter contained herein and therein. Except as provided herein, from and after the execution of a counterpart hereof by the parties hereto, any reference to the Agreement shall be deemed to be a reference to the Agreement as amended hereby. |
12. | Governing Law. This Amendment and any disputes hereunder shall be governed by and construed in accordance with the laws of Sweden 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 Amendment. |
13. | Counterparts. This Amendment may be executed in any number of counterparts and any party hereto may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument. Any signature page delivered by a facsimile machine shall be binding to the same extent as an original signature page with regard to any agreement subject to the terms hereof or any amendment thereto. |
[SIGNATURE PAGES FOLLOW]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
42
This Amendment has been executed in two originals whereof the Parties have taken one each.
NOVOZYMES BIOPHARMA SWEDEN AB | GE HEALTHCARE BIO-SCIENCES AB | |||||||
By: | /s/ Thomas S. Batchelor |
By: | /s/ Magnus Lundgren | |||||
Name: | Thomas S. Batchelor |
Name: | Magnus Lundgren | |||||
Title: | Director, M&A |
Title: | Global Sourcing Exeuctive | |||||
Date: | 27 October, 2011 |
Date: | 27 October, 2011 | |||||
By: | /s/ Niels Münter |
|||||||
Name: | Niels Münter |
|||||||
Title: | Legal Counsel |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
43
Temporary Terms 2013 (The 2013 Amendment)
The following temporary terms shall apply for the Products rPA and Zäta, during the, period 21th of February 2013 up to 31st of December 31st 2013 (the Period) purchased and delivered from the 2 sites Lund and Waltham and accordingly amending the Attachment C in the SSAA between Repligen Corporation and GE Healthcare Bio-Sciences AB, dated 2010-01 01, (the Repligen Agreement) and the Attachment C in the SSAA between Repligen Sweden AB (formerly known as Novozymes Biopharma Sweden AB) and GE Healthcare Bio-Sciences AB, dated 2011-07 07, (the Novozymes Agreement).
1. | Prerequisites: Volume requirements per Product and site including fixed prices for the Products purchased and delivered during the Period as follows: |
Total spend | ||
[*****] Zäta delivered from Waltham @[*****] | [*****] | |
[*****] Zäta delivered from Lund@[*****] | [*****] | |
Total Zäta [*****] | ||
[*****] rPA delivered from Lund @[*****] | [*****] | |
[*****] rPA delivered from Waltham@[*****] | [*****] | |
Total rPA[*****] | ||
Total rPA and Zäta: [*****] |
2. | For total combined volumes of Zäta during the Period that is outside the range [*****] the following mechanisms shall apply for the prices: |
a) | For total combined purchases of such quantities exceeding [*****]: |
Discounts | ||||
Volume exceeding [*****] Zäta | Buy&Pay site Waltham | Buy&Pay site Lund | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] |
For the avoidance of doubt the discounts in the table above do not apply retroactively and only apply to the amounts exceeding [*****] Increments.
b) | For total combined purchases if such combined purchases fall below [*****]: |
GEHC shall pay to Repligen the sum of [*****] for each shortfall of [*****] less than [*****], meaning that if GLTIC purchases only [*****] of Zäta in calendar year 2013; GEHC shall pay to Repligen the sum of [*****] as a true-up with any such payment to be made in 2013 or before [*****].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
44
3. | For total combined volumes of rPA during the Period that is outside the range [*****], the following mechanisms shall apply for the prices: |
a) | For total combined purchases of such quantities exceeding [*****]: |
Discounts | ||||
Volume exceeding [*****] rPA | Buy&Pay site Waltham | Buy&Pay site Lund | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] |
For the avoidance of doubt the discounts in the table above do not apply retroactively and only apply to the amounts exceeding [*****] increments
b) | For total combined purchases if such combined purchases fall below [*****]: |
GEHC shall pay to Repligen the sum of [*****] for each shortfall of [*****] less than [*****], meaning that if GEHC purchases only [*****] of rPA in calendar year 2013; GEHC shall pay to Repligen the sum of [*****] as a true-up with any such payment to be made In 2013 or before [*****].
4. | As a basis for the price to be applied for 2011 for each of the Products the Parties revert to the Terms and Conditions in Repligen Agreement, including that the price ladders in the Repligen Agreement shall be applied using the below agreed cumulated [*****] purchases of Products. |
For the sole purpose to reestablish a basis of the price calculations for [*****], the total cumulated volume of Zäta and rPA delivered from the 2 sites during 1st of January to 31th of December 2013, [*****] shall be deemed as it was delivered from the Waltham site and [*****] shall be deemed as it was delivered from the Lund site.
Furthermore the volume referred to have been delivered from the Waltham site shall be split even over the [*****] in 2013, as shown in the below example;
a) | Assume [*****] of Zäta was delivered from the 2 sites during 1st of January to 31st of December 2013. Then the volume to be deemed to have been delivered from the Waltham site respectively the Lund site during 2013shall be split as follows: |
Q1 | Q2 | Q3 | Q4 | Total | ||||||||||||||||
Waltham |
[***** | ] | [***** | ] | [***** | ] | [***** | ] | [***** | ] | ||||||||||
Lund |
[***** | ] | ||||||||||||||||||
[***** | ] |
b) | Assume [*****] of rPA was delivered from the 2 sites during 1st of January to 31st of December 2013. Then the volume to be referred to have been delivered from the Waltham site respectively the Lund site in 2013 shall be split as follows: |
Q1 | Q2 | Q3 | Q4 | Total | ||||||||||||||||
Waltham |
[***** | ] | [***** | ] | [***** | ] | [***** | ] | [***** | ] | ||||||||||
Lund |
[***** | ] | ||||||||||||||||||
[***** | ] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
45
5. | If any of the production sites; Lund or Waltham, face supply problems for any of the Products during the Period meaning that each of the above volume requirements per site in section 1 cannot be fulfilled, [*****] per Product as stated in section 1 shall be applied. In such a situation and in case the volumes purchased arid delivered are outside the amounts of [*****] Zäta respectively [*****] rPA the price mechanism according to the terms in section 2 and 3 shall be applied. |
Agreed and accepted by Repligen Corporation | ||||||
Signature | /s/ Jonathan Lieber | |||||
Printed name | Jonathan Lieber | |||||
Title | CFO | |||||
Date | 2/21/13 | |||||
Agreed and accepted by GEHC Bio-Sciences AB | ||||||
Signature | /s/ David Raw | |||||
Printed name | David Raw | |||||
Title | Sourcing Manager | |||||
Date | February 22, 2013 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
46
AMENDMENT NO. 3 TO STRATEGIC SUPPLIER ALLIANCE AGREEMENT
This Amendment No. 3 (the Third Amendment) to that certain Strategic Supplier Alliance Agreement dated as of July 7, 2011 (the Supplier Agreement), by and between Repligen Sweden AB, formerly known as Novozymes Biopharma AB, (the Supplier), a company organized under the laws of Sweden and a wholly owned subsidiary of Repligen Corporation (Repligen), and GE Healthcare Bio-Sciences AB, a company organized under the laws of Sweden (GEHC), with the terms hereof being effective from February 22, 2016 (the Effective Date), by and between Supplier and GEHC.
WITNESSETH
WHEREAS, the Supplier Agreement has previously been twice amended in accordance with, in the first instance, an amendment made effective as of October 27, 2011 (the Amendment No. 1), in the second instance, an amendment made effective February 22, 2013 (the 2013 Amendment), together the Previous Amendments; and
WHEREAS, Supplier and GEHC mutually wish to make certain modifications to the terms and conditions of the Supplier Agreement; and
WHEREAS, Section 18.8 of Attachment E to the Supplier Agreement provides that the Supplier Agreement may be modified only by a writing signed by both parties; and
WHEREAS, (i) a certain related Strategic Supplier Alliance Agreement, dated January 28, 2010, (and amended through Addendum No.1, dated Aug 31 2010 Amendment No. 2, dated Oct 27 2011, and Amendment No. 3 (referred to as 2013 Amendment), dated Feb 22, 2013 and the Amendment No.4, dated Jan 1 2016 (jointly hereinafter the Related Agreement), in effect by and between GEHC and Repligen Corporation, the parent company of Supplier.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1. | Defined Terms. Capitalized terms used herein, unless otherwise defined or modified herein, shall have the same meaning as defined in the Supplier Agreement. If not previously defined in the Supplier Agreement terms that are capitalized in this Fourth Amendment shall have the meaning defined herein. |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
47
a) Named Parties. All references to Parties in this Fourth Amendment may include either or both of Supplier and Repligen Corporation together with GEHC. All subsequent references to Repligen in this Fourth Amendment shall be understood to be inclusive of both Supplier and its parent company, Repligen Corporation. Lund Site shall mean Suppliers manufacturing site in Lund, Sweden and Waltham Site shall mean Repligens manufacturing site in Waltham, Massachusetts, USA and Site shall mean either the Lund Site or the Waltham Site and Sites shall mean both of them.
2. | Amendment to the Supplier Agreement. |
a. | The first sentence of Agreement Term under Section C of the Supplier Agreement is hereby amended as follows: |
This Agreement shall commence on the Effective Date and, subject to the rights of termination in Clause 16 of Attachment E, shall continue up to the 31st of December 2019
b. | Attachment C (revision date 04 April, 2011) entitled Products, Prices, and Specifications shall be deleted and replaced in its entirety by Revised Attachment C (revision date Jan 1, 2016) attached hereto. Attachment C shall be a complete a current list of all Products, Prices and Specifications at the time of signing this Amendment. |
c. | The first sentence of Section 3(c) of Attachment D, entitled Payment Terms, is deleted and replaced with the following sentence: |
GEHC shall settle any undisputed invoices arising under this Agreement [*****] after receiving an invoice prepared in accordance with the terms of this Agreement.
d. | Section 3(d) of Attachment D, entitled Cost Reductions, is hereby deleted in its entirety and replaced with the following new Section 3(d): |
[*****]
e. | The first two sentences of Section 6(a) of Attachment D, entitled Forecasting, are hereby amended as follows: |
Forecasting. [*****] days before the end of each quarter, GEHC shall submit to Repligen in writing a [*****] month rolling quarterly forecast (Forecast) for its total estimated needs of the Products during the subsequent [*****] month period from Repligen. Repligen shall use the Forecast as the basis for its production planning and shall replenish the Safety Stock as according to the agreed lead-times set forth in the Revised Attachment C as amended herein. Repligen shall further allocate production between its Sites in accordance with the provisions of Section 6(d) of Attachment D as amended herein.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
48
As a consequence of the Forecast, GEHC will propose and send Repligen a purchase plan, showing the required delivery weeks and specifying the amount to be purchased by GEHC for the first quarter of each said Forecast. If GEHC for any reason doesnt send a purchase plan to the Supplier, GEHC shall instead issue purchase orders reflecting the amount for the binding quarter according to section 6b in Attachment D in the Supplier Agreement. The purchase plan or purchase orders as referred to above shall be deemed accepted in the case where the stated amounts in the purchase plan are within the Safety Stocks reported to GEHC, as per the 4th sentence of Section 9 of Attachment D, as amended. GEHC acknowledges that accepted orders within the inventory levels may require use of safety stock. In case the stated amounts in the purchase plan exceed the Safety Stocks reported for each Site as per the above, the Parties shall negotiate in good faith a new purchase plan and Repligen shall use [*****] to accommodate to such a new purchase plan.
f. | The first sentence of Section 6(c) of Attachment D, entitled General Supply Commitment, is hereby amended as follows (changes underlined): The Supplier shall use its best commercial efforts to manufacture and deliver the Recombinant Product and the Native Product within the [*****] Forecast. |
g. | A new paragraph shall be added to Section 6(d) of Attachment D, entitled Purchase Commitment Recombinant Product, according to the following: |
Supply of Product. As long as GEHC has not used its right to reduce the minimum purchase commitment for any Products, GEHC acknowledges that, pursuant to this Agreement and the Related Agreement: GEHC has an obligation to purchase no less than [*****] of its requirements for each of the two Recombinant Products from the combined Sites, and the purchase orders issued by GEHC for the Recombinant Products, shall be split between the Waltham site and Lund site as follows: [*****] to the Waltham site and [*****] to the Lund site, as close as possible per every [*****], with an allowance to deviate from the above split not more than [*****] per Recombinant Product during any calendar year, measured through the actual invoiced amount in [*****] from the Waltham site and the Lund site. Both Parties shall aim to minimize the above mentioned deviation, through adjustments of the concerned purchase orders and or shipment amounts in the [*****] of the calendar year. Deviations exceeding [*****] per Recombinant Product shall be balanced in the subsequent calendar year. To the extent GEHC uses its right to reduce its minimum purchase commitments for any or all Products from Supplier hereunder [*****] the purchase commitment, as regards the two Recombinant Products shall be reduced accordingly and what is set out in Section 6 d) Attachment D of the Related Agreement shall apply to purchases under the Related Agreement. GEHC hereby agrees and affirms that if GEHC reduces its purchase commitment to purchase below [*****] of its total requirements of Recombinant Products from the Lund Site, Supplier shall have the right to terminate its supply commitment for all Products from the Lund Site with [*****] notice.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
49
Below summarizes the different scenarios of Purchase Commitment and the resulting distribution of Purchase Orders of the Recombinant Products, see also Table 1: Recombinant Products:
Prerequisite scenario 1 is in effect:
| GEHC has not used it right to reduce the Purchase Commitment to Lund or |
| GEHC has used its rights to reduce the Purchase Commitment to Lund to between [*****] |
| GEHC has used its right to reduce the Purchase Commitment to Lund below [*****] however Supplier has not terminated its commitment to supply Products from Lund. |
then the purchase orders of Recombinant Products to Repligen shall on a [*****] basis be distributed as follows:
| [*****] towards the Waltham site |
| [*****] towards the Lund site |
Prerequisite scenario 2 is in effect:
| GEHC has used its right to reduce the Purchase Commitment of Recombinant Products to Lund below [*****] and the Supplier has terminated its commitment to supply Products from Lund Site to GEHC or |
| GEHC has used its right to reduce the Purchase Commitment of Recombinant Products to Lund to [*****] of GEHCs total requirements of Recombinant Products shall be placed as purchase orders to the Waltham site. |
[*****]
GEHC hereby agrees and affirms that Repligen shall have the right to apportion manufacturing of either or both recombinant Products between the Sites as it chooses as Repligen may, in its sole discretion, choose so long as:
a) GEHCs total requirement of recombinant Products as specified in the committed Forecast are timely delivered to GEHC in accordance with the terms and conditions of the Supplier Agreement,
(b) Repligen manufactures each of the Recombinant Products at each of the Lund Site and the Waltham Site respectively with a minimum of [*****] of GEHCs yearly requirement in [*****], at each Site, during each rolling twelve month period commencing with the Effective Date of the Amendment, and
(c) Repligen maintains its required Safety Stock as set out in Attachment C to this Amendment.
Repligen shall apportion and control the safety stocks of Products in accordance with the provisions of Attachment C to this Amendment(d) The Parties have agreed that under the Agreement and the Related Agreement, the Supplier may choose to fulfill the purchase orders issued by GEHC as per the following:
(i) | a purchase order placed to the Waltham Site can be delivered from the Lund site and the concerned invoice shall be issued by the Waltham site, and |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
50
(ii) | a purchase order placed to the Lund site can be delivered from the Waltham site and the concerned invoice shall be issued by the Lund site, |
For clarity,
| any costs incurred associated with the use of the process set out in (e) (i) and (ii) shall be born solely by the [*****] and |
| first in first out (FIFO) principle shall be applied for the total inventory on both Sites |
h. | The second sentence of Section 6(d) of Attachment D, entitled Purchase Commitment Recombinant Product, is hereby amended as follows (changes underlined): Subject to the first paragraph of Section 16.1 of Attachment E, the Parties have agreed that the annual deliveries shall be at least [*****] percent of GEHC total actual requirements in [*****] for the Recombinant Products. |
i. | Section 6e of Attachment D entitled Purchase commitment Native Product, shall be replaced by the following: |
The Parties have agreed that the annual deliveries from the Supplier shall be no less than [*****] percent of GEHCs total actual requirements in [*****] for the Native Product.
In the event that GEHC uses it rights to reduce the purchase commitment for the two Recombinant Products, GEHC may also reduce the aforementioned minimum purchase commitment for the Native Product [*****]. For clarification, if GEHC uses its rights to reduce the purchase commitment of any Recombinant Product, Repligen may reduce its supply commitment of Native Product [*****].
j. | The first sentence of Section 2.1 in Attachment E shall be amended as follows (changes underlined) : |
Unless otherwise agreed Products shall be delivered according to the Incoterms 2010 set out in Attachment C and title shall transfer at the same time as the risk transfer in accordance with such Incoterms.
k. | Section 6.3 in Attachment E is replaced by the following: |
[*****]
l. | The first paragraph of Section 16.1 of Attachment E, as amended by Amendment No. 1, is further amended and restated in its entirety as follows: |
This Agreement shall commence on the Effective Date and, subject as hereinafter provided, shall continue in effect until Dec 31st 2019 Notwithstanding the aforementioned, GEHC may reduce its minimum purchase commitments for any or all Products from Supplier hereunder [*****] upon [*****] written notice to Supplier, provided that GEHC may not issue such notice of reduction until after [*****]. However, in the event GEHC reduces its purchase commitment, what is set out in section 3g shall apply accordingly.
[*****]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
51
m. | Section 16.2 of Attachment E is hereby amended and restated in its entirety as follows : |
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 which is functionally substitutable (based on technical performance) with GEHCs chromatography products containing the Products ( as exemplified by MabSelect and MabSelect Sure) For the avoidance of doubt, GEHC is aware that Repligen markets and sells certain immobilization chromatography media products currently known as IPA-300 and CaptivA, which due to their current product specifications and technical performances, are not functionally substitutable with MabSelect family products and GEHC acknowledges that marketing and sale of such products is not in violation of this Clause 16.2.
n. | Section 16.3 of Attachment E, is amended and restated in its entirety as follows:: |
GEHC shall have the right to terminate the Agreement with twelve (12) months written notice if (i) the control of the Supplier is transferred outside the Repligen group of companies or (ii) its protein manufacturing operation in the Lund Site is transferred outside of the Repligen group of companies or moved outside of Sweden (iii) if the control of Repligen or the Repligen group of companies is taken over by a direct competitor of GEHC in the field of chromatography media or bioprocess hardware products, whereby control shall mean directly or indirectly (i) holding fifty percent (50%) or more of its issued shares, or (ii) of the voting power therein, or (iii) of the interest in the income of such corporation, partnership or other entity, or (iv) having the power to appoint the majority of its directors or (v) otherwise having the power to direct its business activities.
o. | The 4th sentence of Section 9 of Attachment D, is deleted and replaced with the following sentence: |
The Supplier shall in good faith provide GEHC on a [*****] basis with a report of inventory levels of finished goods of the Products, showing the current inventory levels and the planned levels for the forthcoming [*****], no later than the [*****], with the following details:
[*****]
(iii) | Entire Agreement. This Fourth Amendment, together with the Supplier Agreement as amended by the Previous Amendments and the Attachments, exhibits, schedules, |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
52
and other documents referred to therein contain the entire understanding of the Parties with respect to the subject matter contained herein and therein. From and after the Effective Date of this Fourth Amendment, any reference to the Supplier Agreement shall be deemed a reference to the Supplier Agreement as amended hereby. |
(SIGNATURE PAGES FOLLOW)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
53
IN WITNESS WHEREOF, the undersigned have caused this Fourth Amendment to executed and delivered as of the date first above written.
SUPPLIER: | ||||||||
Place and Date: | 3/1/2016 |
2016-03-17 | ||||||
By: | /s/ Howard Benjamin |
/s/ Gustav Silfverdsparde | ||||||
Name: | Howard Benjamin |
Gustav Silfverdsparde | ||||||
Title: | VP, BD |
VP, Operations | ||||||
GEHC | ||||||||
Place and Date: | 2/17/2016 |
|||||||
By: | /s/ Bo Lundström |
|||||||
Name: | Bo Lundström |
|||||||
Title: | Managing Director |
|||||||
GEHC | ||||||||
Place and Date: | 2/17/2016 |
|||||||
By: | /s/ Jan Erneberg |
|||||||
Name: | Jan Erneberg |
|||||||
Title: | Chairman |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
54
Revised Attachment C
Products, Prices, and Specifications
GEHC Biosciences/Repligen Sweden AB SSAA
Currency: | SEK | |
Revision Date: | Jan 1, 2016 | |
A. RECOMBINANT PRODUCT: | ||
Product Name | Zäta | |
GEHC Article number | [*****] | |
Supplier Article Number | [*****] |
Unit size:
[*****] Zäta per bottle meaning that the content per bottle shall be [*****]. Each bottle shall be labeled with [*****] Zäta. For remains achieved during filling the last bottle in each batch the actual quantity in [*****] shall be stated on the bottle.
Price and [*****] Price Adjustment Procedure:
The Actual Price to be paid by GEHC for Zäta in any subsequent [*****] during the Term of the Amendment shall thus be calculated at the end of each actual [*****] in accordance with the following formula based on the [*****] lookback quantities of Zäta purchased from Lund (LKg):
[*****] lookback | Price formula | Slope | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] |
For amounts supplied in aggregate from the Supplier and Repligen Corporation beyond [*****], GEHC and Repligen may agree upon the price mechanisms to get reduced prices for such amounts as may exceed [*****]. Such discussions may include the option of mechanisms to reduce pricing below [*****].
In case the Parties do not reach an agreement on modified prices and/or floors, the current mechanisms will stay in place until the end of the agreement.
INCOTERMS: CIP GEHC Uppsala but for any shipment of Products less than [*****], the Parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
55
Lead Time (PO): Delivery date by Repligen shall be [*****] from acceptance of PO or on mutually agreed delivery date in accordance with Section 6(a) Attachment D (as amended).
Remaining Shelf Life upon delivery: [*****]
Level of Suppliers Safety Stock
Throughout the Term, Repligen shall adjust the level of safety stock which is equal to at least [*****] of the aggregate of the amount of Zäta actually purchased during the preceding [*****] plus the [*****] Forecast The location(s) of said safety stock shall be established by Repligen as long as [*****]of the total safety stock is held in a secure facility in Sweden and the facility is either under the control or contract of Repligen and available for delivery to GEHC in Uppsala, Sweden within [*****].
Shelf Life [*****]
Lead Times for Safety Stock Replenishment Repligen and GEHC undertakes to agree to a plan to replenish safety stock within [*****] so long as GEHC has not purchased more than [*****] of the Lund Site safety stock. If GEHC purchase more than [*****] of the Lund site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal within [*****].
B. RECOMBINANT PRODUCT
Product Name | rPA | |
GEHC Article number | [*****] | |
Supplier Article Number | [*****] |
Unit size: [*****] rPA per bottle meaning that the content per bottle shall be [*****]. Each bottle shall be labeled with [*****] rPA. For remains achieved during filling the last bottle in each batch the actual quantity in [*****] shall be stated on the bottle.
Price and [*****] Price Adjustment Procedure:
The Actual Price to be paid by GEHC for rPA in any subsequent [*****] during the Term of the Amendment shall thus be calculated at the end of each actual [*****] in accordance with the following formula based on the [*****] lookback quantities of rPA purchased from Lund (LKg):
[*****] lookback | Prices | Slope | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] | ||
[*****] | [*****] | [*****] |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
56
For amounts supplied in aggregate from the Supplier and Repligen Corporation beyond [*****], GEHC and Repligen may agree upon the price mechanisms to get reduced prices for such amounts as may exceed [*****]. Such discussions may include the option of mechanisms to reduce pricing below [*****].
In case the Parties do not reach an agreement on modified prices and/or floors, the current mechanisms will stay in place until the end of the agreement.
INCOTERMS: CIP GEHC Uppsala, but for any shipment of Products less than [*****] the Parties shall equally the freight/insurance costs of such shipment subject to the transport invoice.
Lead Time (PO): Delivery date by Repligen shall be [*****] from acceptance of PO or on mutually agreed delivery date in accordance with Section 6(a) Attachment D (as amended).
Remaining shelf life upon delivery: [*****]
Level of Suppliers Safety Stock
Throughout the Term, Repligen shall adjust the level of safety stock to at least [*****] of the aggregate of the amount of rPA actually purchased during the preceding [*****] plus the upcoming [*****] Forecast of rPA. The location(s) of said safety stock shall be established by Repligen as long as [*****] of the total safety stock is held in a secure facility in Sweden and the facility is either under the control or contract of Repligen and available for delivery to GEHC in Uppsala, Sweden within [*****].
Shelf Life [*****]
Lead Times Safety Stock Replenishment:
Repligen and GEHC undertake to agree to a plan to replenish safety stock [*****] so long as GEHC has not purchased more than [*****] of the Lund Site safety stock. If GEHC purchase more than [*****] of the Lund site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal within [*****].
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
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C. NATIVE PRODUCT
Product Name: | Serum free Native Protein A (nPA) | |
GEHC Article number: | [*****] | |
Supplier Article number: | [*****] | |
Unit size |
[*****] nPA per bottle meaning that the content per bottle shall be [*****] Each bottle shall be labeled with [*****] nPA. For remains achieved during filling the last bottle in each batch the actual quantity in [*****] shall be stated on the bottle.
Price: The price on nPA will be [*****] per [*****] during the term of the contract.
INCOTERMS: CIP GEHC Uppsala, but for any shipment of Products less than [*****] the Parties shall equally the freight/insurance costs of such shipment subject to the transport invoice.
Lead time (PO): Delivery date by Repligen shall be [*****] from acceptance of PO or on mutually agreed delivery date in accordance with Section 6(a) Attachment D (as amended)
Remaining shelf life upon delivery: [*****]
Level of Suppliers Safety Stock: The safety stocks at the Supplier will be at least [*****] based on the average of the first [*****] of the, at any time, then valid forecast distributed by GEHC and the prior [*****] consumption by GEHC.
Shelf life: [*****]
Lead Times Safety Stock Replenishment:
Repligen and GEHC undertakes to agree to a plan to replenish safety stock within [*****] so long as GEHC has not purchased more than [*****] of the Lund Site safety stock. If GEHC purchase more than [*****] of the Lund site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal within [*****].
For the avoidance of doubt the Parties have agreed to remove the previous section D governing LEGO product since this is no longer a Product pursuant to the Amended Agreement
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
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E. General Price Terms
Native Product:
Price above is per [*****] and shall apply for deliveries made in the applicable [*****].
Reference samples, covering [*****] samples of [*****] each batch, to be provided to GEHC in the deliveries shall be [*****].
Recombinant Products:
All prices above are per [*****] and shall be set at the beginning of each [*****] based upon the [*****] prior consumption of each of the Recombinant Products based on the purchases received from Lund and accepted by GEHC. The price for each of the recombinant Products shall be set on the [*****] of the [*****] and shall remain fixed for that [*****].
By way of hypothetical examples for Zäta:
GEHC has purchased [*****] of Zäta over the course of [*****] between [*****] and [*****]. The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] SEK per [*****].
[*****]
GEHC has purchased [*****] of Zäta over the course of [*****] between [*****] and [*****]. The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] SEK per [*****].
[*****]
GEHC has purchased [*****] of Zäta over the course of [*****] between [*****] and [*****]. The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] SEK per [*****],
[*****]
By way of hypothetical example for rPA:
GEHC has purchased [*****] of rPA over the course of the [*****] from [*****] and [*****]. The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] SEK.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
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[*****]
Reference samples, covering two samples of [*****] each batch, to be provided to GEHC in the deliveries shall be [*****].
Gel Prices:
During the Term of this Agreement the Supplier shall have the right to purchase the following products from GEHC at the following price conditions:
[*****]
Delivery conditions: CIF
Lead time: normally [*****] but to be confirmed on case by case basis
Credit term: [*****] from date of invoice
The products ordered in accordance with this Attachment C may only be used in the manufacture of Products pursuant to this Agreement.
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.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act - [*****] denotes omissions.
60