Back to top

SUPPLY AGREEMENT

Real Estate License Agreement

SUPPLY AGREEMENT | Document Parties: AMAG PHARMACEUTICALS INC. You are currently viewing:
This Real Estate License Agreement involves

AMAG PHARMACEUTICALS INC.

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: SUPPLY AGREEMENT
Governing Law: New York     Date: 8/7/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

SUPPLY AGREEMENT, Parties: amag pharmaceuticals inc.
50 of the Top 250 law firms use our Products every day

Exhibit 10.2

 

Execution Version

 

SUPPLY AGREEMENT

 

This SUPPLY AGREEMENT (the “Agreement” ) is made and entered into as of the       day of May, 2008 (the “Effective Date” ) by and between AMAG PHARMACEUTICALS, INC. , a Delaware corporation with its principal place of business at 125 CambridgePark Drive, Cambridge, MA 02140, U.S.A. ( “AMAG” ), and 3SBIO INC. , a company incorporated under the laws of the Cayman Islands, with a place of business at No. 3 A1 Road 10, Shenyang Economy & Technology Development Zone, Shenyang, 110027, China ( “3SBio” ).  AMAG and 3SBio are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS , the Parties have entered into that certain Collaboration and Exclusive License Agreement dated as of the Effective Date (the “License Agreement” ), pursuant to which AMAG is granting 3SBio certain rights to Develop and Commercialize the Product in the Licensed Territory;

 

WHEREAS , pursuant to Article 7 of the License Agreement, 3SBio wishes to purchase from AMAG the Product in finished form in unlabeled vials for clinical and commercial use, and AMAG is willing to supply 3SBio with such Product for use in accordance with the terms and conditions of the License Agreement;

 

NOW THEREFORE , in consideration of the mutual promises and covenants set forth below, 3SBio and AMAG mutually agree as follows:

 

1.                                       DEFINITIONS.

 

Capitalized terms not otherwise defined herein shall have the meanings set forth in the License Agreement.  As used in this Agreement, the following capitalized terms shall have the following meanings:

 

1.1                                “Acceptance Tests” means those test methods set forth in Exhibit A to be performed to determine that the Product supplied to 3SBio conforms to the Specifications, as such tests may be amended from time to time by written agreement of the Parties.

 

1.2                                “Capacity Shortage” shall have the meaning set forth in Section 5.3.

 

1.3                                “Certificate of Analysis” shall have the meaning set forth in Section 2.5.

 

1.4                                “Good Manufacturing Practice” or “GMP” means the then-current standards for the preparation of finished pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, including without limitation 21 CFR §§210-211.

 

1.5                                Product ” shall mean any Product (as defined in the License Agreement) then being Developed or Commercialized under the License Agreement pursuant to the terms and conditions of such agreement.

 



 

1.6                                “Product Price” shall have the meaning set forth in Section 4.1.

 

1.7                                “Raw Material Cost” means the amounts paid by AMAG to a Third Party for providing raw materials and packaging materials for producing the Product, to the extent not reimbursed or refunded or credited to AMAG, and net of any discounts or other benefits received by AMAG from Third Party manufacturers, calculated on a per-unit basis and in accordance with U.S. generally accepted accounting principles consistently applied.

 

1.8                                “Quality Agreement” shall mean the Quality Agreement to be negotiated by the Parties as described in Section 3.1.

 

1.9                                “Specifications” shall mean the characteristics and standards pertaining to the manufacture or supply of the Product, as set forth in Exhibit A , as the same may be amended or supplemented from time to time pursuant to Section 2.5.

 

2.                                       PURCHASE AND SUPPLY.

 

2.1                                Purchase and Supply Agreement.   During the term of this Agreement, 3SBio agrees to buy, and AMAG agrees to sell, all of 3SBio’s and its Affiliates’ and permitted sublicensees’ requirements of Product for Development, Commercialization and use in accordance with the terms and conditions of this Agreement and the License Agreement.

 

2.2                                Forecasts.   At least [***] prior to the first requested delivery date for Product under this Agreement, 3SBio shall deliver to AMAG a detailed forecast of 3SBio’s requirements for Product for each calendar quarter during the [***] period beginning with the first requested delivery date for Product under this Agreement.  3SBio shall thereafter update such detailed forecast quarterly, no later than the first day of each calendar quarter, so that each quarter, AMAG shall have been provided with a rolling detailed forecast for each quarter during the [***] period commencing [***] after the date on which such forecast is submitted.  The forecast for the first [***] contained in each such detailed forecast shall be firm and binding on 3SBio and AMAG.  3SBio may order amounts of Product in excess of the amounts forecast for such [***] period, and AMAG shall use commercially reasonable efforts to supply any such additional amounts ordered; provided, that AMAG shall be under no obligation to accept purchase orders for amounts exceeding [***] of the amount forecast for such [***] period.  The quantities indicated for the remaining months of each rolling forecast will be treated as a forecast only and will not create any obligations for either Party.

 

2.3                                Ordering.   All Product ordered under this Agreement shall be pursuant to written purchase orders, each of which shall specify the quantity of Product ordered for Development or Commercialization and the requested delivery date.  The minimum quantity of Product that may be ordered in a given purchase order is [***] vials of Product.  3SBio shall submit each such purchase order to AMAG no later than thirty (30) days prior to the delivery date indicated in

 


[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

2



 

such purchase order.  Any purchase orders for Product submitted by 3SBio shall reference this Agreement and shall be governed exclusively by the terms contained herein.  Any term or condition in any order, confirmation or other document furnished by 3SBio or AMAG that is in any way inconsistent with the terms and conditions of this Agreement is hereby expressly rejected.  Within fifteen (15) days after receipt of a purchase order placed pursuant to this Section 2.3, AMAG shall confirm the date for delivery of the applicable quantity of Product and any quantities in excess of the permissible variance under Section 2.2.  As used in this Agreement, all references to days shall be deemed to be references to calendar days.

 

2.4                                Unordered Product.   For any given quarter, if 3SBio fails to order and complete the purchase of at least the quantities of such Product set forth in the binding forecast for that quarter, then 3SBio shall pay to AMAG an amount equal to: [***].  Following payment of such amount, AMAG shall, at its sole option, either (a) deliver the Unordered Product Units to 3SBio or (b) credit such amount against future orders of Product.

 

2.5                                Product Specifications; Testing.   All Product supplied hereunder will conform to the Specifications at the time of delivery and shall have a remaining shelf life of not less than [***] from the date of delivery to 3SBio.  AMAG will test each batch of Product in accordance with the Acceptance Tests and supply 3SBio with a certificate of analysis ( “Certificate of Analysis” ) confirming that such batch meets the Specifications.  3SBio may then retest the batch of Product as more fully set forth in Section 5.5 to confirm that it meets the Specifications.  The Parties acknowledge that the Specifications and Acceptance Tests may need to be refined and modified as the Parties gain experience with the manufacture, testing and use of Product.  Accordingly, the Parties agree to negotiate in good faith to modify the Specifications and Acceptance Tests from time to time as the Parties’ experience with the manufacture, testing and use of the Product warrants.  3SBio acknowledges that AMAG may be required to modify the Specifications in light of regulatory requirements imposed by the FDA or other Regulatory Authority, and that 3SBio may not unreasonably withhold its agreement from any such modifications.  If any regulatory requirement imposed by the SFDA would require a change to the Specifications or the Acceptance Tests, the Parties will promptly discuss such change and negotiate amendments to the Specifications or the Acceptance Tests in good faith. The Parties agree to allocate on an equitable basis any costs of developing and implementing revised procedures in response to SFDA requirements.

 

3.                                       MANUFACTURE.

 

3.1                                Quality Agreement.   Promptly after the Effective Date, the Parties will negotiate the terms of a quality agreement governing the quality assurance obligations and responsibilities of the Parties with respect to the manufacture and supply of the Product (as amended or modified from time to time according to its terms, the “Quality Agreement” ).  In the event of a discrepancy between the provisions of the Quality Agreement and the provisions of this

 


[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

3



 

Agreement, the provisions of the Quality Agreement shall control with respect to terms governing quality of the Product and the provisions of this Agreement shall control with respect to all other terms.

 

3.2                                Regulatory Inspections.   AMAG specifically agrees to cooperate with any inspection by the SFDA, including without limitation any inspection required for approval of 3SBio’s MAA in the Licensed Territory.  The Parties understand that such assistance and cooperation will not require substantial expenditures by AMAG, and the Parties shall discuss in good faith the equitable allocation of any unexpected expenses resulting from such inspection.  Notwithstanding the foregoing, 3SBio shall be solely responsible for any Out-of-Pocket Costs incurred in connection with the conduct of any inspection by the SFDA, including without limitation travel costs of any SFDA personnel.  AMAG shall promptly inform 3SBio of the findings of any such inspection and notify 3SBio of any corrective action that AMAG may be required to undertake as a result of any such inspection.

 

3.3                                Quality Control Audits.   Upon written request to AMAG, 3SBio shall have the right, no more than once per calendar year, to have representatives visit the manufacturing facilities of AMAG during normal business hours to review manufacturing operations, to assess its compliance with GMP and quality control procedures, and to discuss any related issues with AMAG’s manufacturing and management personnel.  Upon written request to 3SBio, AMAG shall have the right, no more than once per calendar year, to have representatives visit the packaging facilities of 3SBio during normal business hours to review packaging operations, to assess its compliance with GMP and quality control procedures, and to discuss any related issues with 3SBio’s packaging and management personnel.

 

3.4                                Change in Manufacturing Process.   AMAG shall notify 3SBio in writing before it implements any change in the materials, equipment, process or procedures used to manufacture Product that (a) would constitute a major change under GMP or (b) AMAG would be required to report to the FDA under applications laws and regulations.

 

3.5                                Compliance with Laws.   AMAG shall comply with all applicable present and future orders, regulations, requirements and laws of any and all United States federal, state, provincial and local authorities and agencies, including without limitation all laws and regulations of such territories applicable to the transportation, storage, use, handling and disposal of hazardous materials.  AMAG will maintain during the term of this Agreement all government permits, including without limitation health, safety and environmental permits, necessary for the conduct of the actions and procedures that it undertakes pursuant to this Agreement.  3SBio shall provide AMAG with written notice of any additional regulatory requirements of the Licensed Territory that relate to the manufacture of Product for the Licensed Territory.  AMAG shall use commercially reasonable efforts to comply with such additional requirements, and shall provide 3SBio with prompt written notice of any Out-of-Pocket Costs associated with such compliance, which, to the extent not included in the Product Price, shall be borne by 3SBio.

 

3.6                                Documentation and Samples.   AMAG shall maintain complete, accurate and authentic accounts, notes, data and records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the Product in accordance with the applicable laws and regulations in the United States.  AMAG shall retain

 

4



 

samples of Product from each batch of Product supplied under this Agreement after 3SBio’s acceptance of such batch under Section 5.5.  AMAG shall retain such records and samples for a period of three (3) years following the date of manufacture, or longer if required by United States law, and upon 3SBio’s written request shall make available to 3SBio copies of such records and portions of such samples.

 

3.7                                Rework.   AMAG shall not rework any batch of Product without 3SBio’s prior written consent, not to be unreasonably withheld.

 

4.                                       PRICES AND PAYMENT.

 

4.1                                Product Price.

 

a.                                        For all Product delivered to 3SBio pursuant to this Agreement, 3SBio shall pay to AMAG a price (the “Product Price” ) equal to [***], subject to the adjustments described in below in Section 4.1(b) and (c).

 

b.                                        The Product Price will be subject to adjustment by AMAG under this Section 4.1(b) during the term of this Agreement, based [***].  AMAG shall inform 3SBio of any such adjustment to the Product Price prior to implementing such adjustment, which shall apply to all orders from and after the adjustment date.  In the event that [***], then upon adjustment to the Product Price under this Section 4.1(b), the Parties shall use reasonable and good faith efforts to agree, within forty-five (45) days after the adjustment date, to an amendment to this Agreement that provides for a revised Product Price.  If the Parties do not agree on a revised Product Price within such forty-five (45) day period, then the Parties shall refer the matter to the Chief Executive Officers of the Parties, or their designees, for continued good faith negotiations for an additional forty-five (45) day period.  If the Chief Executive Officers of the Parties, or their designees, do not agree on a revised Product Price during such additional forty-five (45) day period, then 3SBio shall have the right, but not the obligation, to terminate this Agreement and the License Agreement, pursuant to Section 13.4 thereof, at will upon thirty (30) days written notice to AMAG.  During such forty-five (45) day negotiation periods and thirty (30) day period prior to such termination of this Agreement and the License Agreement, the adjusted Product Price [***] shall apply to all orders from and after the adjustment date.

 

c.                                        The Product Price will be subject to adjustment under this Section 4.1(c) in the event that [***].

 

4.2                                Method of Payment.   At the time of each shipment of Product hereunder, AMAG shall provide to 3SBio a written invoice for Product supplied in such delivery.  All payments due hereunder to AMAG shall be paid to AMAG in United States dollars not later than thirty (30) days following the receipt of the applicable invoice.  Payment shall be made by wire

 


[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

5



 

transfer of immediately available funds into a deposit account of AMAG designated by AMAG from time to time.  Payment of any such amounts shall be considered effected as of the date on which AMAG’s account is credited with the applicable amount.  In addition to any other remedies AMAG may have, 3SBio shall be solely responsible for any additional costs, or any reduction in value of local currency in relation to Dollars, resulting from untimely payments during any period after amounts payable to AMAG hereunder are due.  Any invoiced amount that is not paid when due shall be assessed a late payment fee at the rate of two percent (2%) per month or the maximum rate permitted by applicable law with respect to such obligations, whichever is less.

 

4.3                                Taxes.   3SBio will make all payments to AMAG hereunder free and clear of any taxes imposed by or under the authority of any government or public authority (including, without limitation, any sums due to be paid to AMAG hereunder that are subject to any withholding or similar tax), but excluding any corporate income tax, partnership tax or other business tax to which AMAG may be subject.  3SBio will pay such additional amount as may be required to ensure that the net amount received by AMAG hereunder will equal the full amount that would have been received by AMAG had not such tax (excluding any corporate income tax, partnership tax or other business tax to which AMAG may be subject) been imposed or withheld, including that 3SBio will be responsible for the payment of all sales taxes due and payable on the purchase of the Product.  AMAG and 3SBio, without prejudice to the foregoing, will use their best endeavors to do all such lawful acts and things and to sign all such lawful deeds and documents as will enable 3SBio to take advantage of any applicable legal provision or any double taxation treaties with the object of paying the sums due to AMAG without imposing or withholding any tax.

 

4.4                                Blocked Currency.   In the event that 3SBio is prohibited or restricted from making payment of any monies at a time when such monies are due and payable to AMAG hereunder by any reason of a legal requirement within the Licensed Territory, 3SBio shall promptly so advise AMAG in writing.  3SBio shall, upon AMAG’s request, deposit any blocked funds to the credit of AMAG in a separate interest-bearing account in a bank or other depository in the


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more