Document:

Exhibit 10.19

 

[***] 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.

 

TERMINATION AGREEMENT

 

This Termination Agreement (“Termination Agreement”) is made and entered into as of December 29, 2014 (the “Termination Agreement Date”) by and between AMAG PHARMACEUTICALS, INC., a Delaware corporation with its principal place of business at 1100 Winter Street, Waltham, MA 02451, USA (“AMAG”) and TAKEDA PHARMACEUTICAL COMPANY LIMITED, a company organized under the laws of Japan, with its principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645, Japan (“Takeda”).  AMAG and Takeda are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

WHEREAS, AMAG and Takeda are parties to that certain License, Development and Commercialization Agreement, dated as of March 31, 2010, as amended by that certain Amendment to the License, Development and Commercialization Agreement, dated June 22, 2012 (as amended, the “Agreement”), pursuant to which AMAG granted Takeda an exclusive license to develop and commercialize AMAG’s proprietary product ferumoxytol in Europe, Canada and other countries;

 

WHEREAS, pursuant to its rights under the Agreement, Takeda has been commercializing ferumoxytol in Canada, the European Union and Switzerland;

 

WHEREAS, the Parties have agreed to terminate the Agreement and that Takeda will transition the commercialization of the Product to AMAG, which termination will be effective in a particular territory upon effectiveness of the transfer of the marketing authorization for such territory to AMAG;

 

WHEREAS, the Parties anticipate that AMAG will require certain services from Takeda, which services Takeda has agreed to conduct, for a period of time following the termination of each territory to facilitate the transition of the Product to AMAG; and

 

NOW, THEREFORE, in consideration of the foregoing premises, the mutual promises and covenants of the Parties contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

 

1.                                      DEFINITIONS

 

1.1                               Capitalized terms used but not otherwise defined in this Termination Agreement have the meanings provided in the Agreement.

 

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[***] 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.

 

1.2                               “CHMP” means the EMA Committee for Medicinal Products for Human Use.

 

1.3                               “CHMP Opinion” means a decision by the CHMP on [***].

 

1.4                               “EMA” means the European Medicines Agency.

 

1.5                               “EU” means the European Union as constituted as of the Termination Agreement Date.

 

1.6                               “PRAC” means the Pharmacovigilance Risk Assessment Committee of the EMA.

 

1.7                               “Terminated Territory” means one of the following: (a) Canada, (b) Switzerland, (c) those countries in the Licensed Territory under the regulatory jurisdiction of the European Commission, and (d) all countries in the Licensed Territory not included in the preceding clauses (a)-(c) (the “Non-Commercial Territory”).

 

1.8                               “Territory Termination Effective Date” means, with respect to a Terminated Territory, the earlier of the following:  (i) the date on which Takeda’s Withdrawal of the marketing authorization for such Terminated Territory is effective pursuant to Section 5.6 or Exhibit A or (ii) the date on which the transfer of the marketing authorization for such Terminated Territory from Takeda or its Affiliate to AMAG, its Affiliate or its designee is effective, except that the Territory Termination Effective Date for the Non-Commercial Territory is the Termination Agreement Date.

 

1.9                               “Withdraw”, with a correlative meaning for “Withdrawal” means to permanently revoke the marketing authorization for the Product in the Terminated Territory.

 

2.                                      TERMINATION AND MARKETING AUTHORIZATION TRANSFER

 

2.1                               The Parties hereby agree to terminate the Agreement, which termination will be effective with respect to each Terminated Territory upon the Territory Termination Effective Date for such Terminated Territory.  The Agreement will be terminated in its entirety upon the third Territory Termination Effective Date (“Termination Date”).

 

2.2                               As of the Termination Agreement Date, Takeda’s right to terminate the Agreement under Section 13.2(a) of the Agreement on [***] prior written notice for a good faith determination that the continued Development or Commercialization of Product is not in the best interest of patient welfare is terminated; provided, however, that notwithstanding any other provision of this Termination Agreement, Takeda retains all rights under the Agreement, prior to

 

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[***] 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.

 

the Territory Termination Effective Date for the applicable Terminated Territory, to take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems in such Terminated Territory.

 

2.3                               From and after the Termination Agreement Date, each Party shall cooperate with the other Party in good faith to take all actions reasonably necessary for AMAG to assume, as soon as reasonably practicable after the applicable Territory Termination Effective Date, all operations pertaining to the Product in each Terminated Territory; provided, however that nothing in this paragraph will be interpreted as requiring Takeda to take any actions or provide any support beyond the scope of its obligations under this Termination Agreement, including the Transition Services and other pre-termination activities set forth in Exhibit A.

 

2.4                               Upon each Territory Termination Effective Date, all rights and licenses granted under the Agreement to Takeda for the applicable Terminated Territory will terminate, and Takeda shall cease all Development and Commercialization activities with respect to the Product in such Terminated Territory, including all investigator-sponsored research, and shall have no further obligations thereafter to Develop and Commercialize the Product in such Terminated Territory, except for the Transition Services set forth in Exhibit A.

 

2.5                               The effects of termination set forth in Sections 13.2(b) and 13.6 of the Agreement are superseded by the terms of this Termination Agreement.

 

2.6                               Takeda shall not, prior to the termination of the Agreement in its entirety, take any action that could reasonably be expected to have a material adverse impact on the further Development and Commercialization of the Product in or outside the Licensed Territory; provided, however, that Takeda shall have the right to take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems.  For the avoidance of doubt, the preceding sentence will not be interpreted as restricting Takeda’s right to exercise Commercially Reasonable Efforts with respect to Development and Commercialization of the Product in a Terminated Territory prior to the applicable Territory Termination Effective Date.

 

3.                                      TRANSFERS AND ASSIGNMENTS

 

3.1                               Regulatory Matters.  Promptly after the Termination Agreement Date, in accordance with the timelines set forth in Exhibit A, Takeda shall, in consultation with AMAG and as further described below, prepare all Regulatory Materials that are necessary to be filed with a Regulatory Authority to transfer (or Withdraw pursuant to Section 5.6 or Exhibit A) the marketing authorization in each Terminated Territory to AMAG.  In connection with such activities, Takeda shall provide AMAG with draft submissions of Regulatory Materials, sufficiently in

 

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[***] 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.

 

advance of filing to allow AMAG to review and comment on such drafts, and AMAG shall respond in a timely manner, and shall consider in good faith all reasonable comments of AMAG prior to filing the applicable Regulatory Materials.  Takeda shall promptly provide AMAG with copies of all communications received from a Regulatory Authority in connection with such transfers, and will notify AMAG within one (1) business day of receipt of approval and effectiveness of the transfer or Withdrawal of each marketing authorization.  Takeda undertakes not to provide any response to communications from a Regulatory Authority in relation to transfer or Withdrawal of each marketing authorization without first consulting with AMAG for AMAG’s comments concerning such response. Each Party shall bear all expenses it incurs to conduct its activities under this Section 3.1.

 

a.                                      EMA.  AMAG shall provide Takeda with all information required and requested by Takeda to transfer the European Commission marketing authorization to AMAG, including information regarding AMAG’s EU legal entity, Qualified Person for Pharmacovigilance, pharmacovigilance system, named person for scientific services, site of manufacture of Product for import and batch release in the EU and Qualified Person for batch release of Product.  Takeda shall notify the EMA product team leader prior to transfer, shall prepare and file with the EMA the Letters of Transfer and shall file the Marketing Authorization Transfer Application with EMA.

 

b.                                      Canada.  AMAG shall provide Takeda with all information required and requested by Takeda to transfer the Health Canada marketing authorization to AMAG, including information regarding AMAG’s Canadian legal entity, establishment license, pharmacovigilance system and letter of consent.  Takeda shall prepare and file with Health Canada the Administrative New Drug Submission for the Product.

 

c.                                       Switzerland.  AMAG shall provide Takeda with all information required and requested by Takeda to transfer the SwissMedic marketing authorization to AMAG, including information regarding AMAG’s Swiss legal entity, wholesaler license, Qualified Person, quality management system, medical information, Qualified Person for Pharmacovigilance, pharmacovigilance system and legally signed statements of transferee.  Takeda shall prepare the application for marketing authorization transfer for filing by AMAG.

 

d.                                      CHMP Opinion.  Notwithstanding anything in this Termination Agreement to the contrary, AMAG shall be obligated to conduct all reasonably necessary activities in connection with the transfer of the marketing authorization for the Product for the EU as provided hereunder, but shall not be obligated to incur any material third party costs unless and until the Parties receive the CHMP Opinion [***].

 

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[***] 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.

 

3.2                               New Product Marks and Intellectual Property Licenses.

 

a.                                      Effective upon each Territory Termination Date: (a) Takeda hereby assigns to AMAG all of Takeda’s right, title and interest in the New Product Marks for the applicable Terminated Territory, (b) Takeda hereby assigns to AMAG all of Takeda’s right, title and interest in all Takeda Know-How that is clinical data related to the Product, if any, and (c) Takeda hereby grants to AMAG an exclusive, irrevocable, transferable, royalty-free license, with the right to grant multiple tiers of sublicenses, under the Takeda Technology existing and actually used and applied as of the Territory Termination Effective Date, if any, to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Product in the applicable Terminated Territory.

 

b.                                      AMAG hereby grants to Takeda a non-exclusive license under the AMAG Technology solely to the extent necessary for Takeda to complete the Transition Services and any other obligation for which it is responsible under this Termination Agreement or the Agreement.

 

3.3                               Product Transfer.  As soon as reasonably practicable, and in any event within [***], after each Territory Termination Effective Date, Takeda shall provide to AMAG or its designee and assign to AMAG, as applicable, each of the following with respect to the applicable Terminated Territory, in each case to the extent Controlled by Takeda and related to the Product as of such Territory Termination Effective Date and permitted under any applicable Third Party contract and applicable Laws:

 

a.                                      all Regulatory Materials for such Terminated Territory, including material regulatory documentation, filings, submissions and approvals, including pricing and reimbursement approvals;

 

b.                                      all unlabeled vial form of Product inventory then in Takeda’s possession for such Terminated Territory unless AMAG requests that Takeda destroy such Product inventory; provided, however that AMAG will be responsible for the cost of transporting such Product inventory and samples to AMAG’s facility (if requested by AMAG) and for any subsequent destruction thereof, to the extent not included in the Transition Services;

 

c.                                       all material marketing and commercial materials for the Product for such Terminated Territory;

 

d.                                      all material medical affairs materials for such Terminated Territory;

 

e.                                       all drug safety information collected and maintained by Takeda or its Affiliates (e.g., safety and clinical databases) for such Terminated Territory;

 

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[***] 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.

 

f.                                        all material documentation regarding distribution and prescribing patterns in the Terminated Territory (e.g., shipments by wholesaler, distributor, and top prescribers by country);

 

g.                                       all material documentation pertaining to the foregoing in clauses (a)-(f), in each case to the extent pertaining to the Product existing as of the Territory Termination Effective Date and reasonably necessary for the continued Development and Commercialization of the Product.

 

The foregoing information, documents and materials, along with the clinical data assigned pursuant to Section 3.2(a) (“Assigned Information”) will, upon assignment to AMAG, be deemed AMAG’s (and not Takeda’s) Confidential Information subject to the confidentiality provisions of the Agreement, and Takeda shall have the right to retain copies thereof for record retention purposes or to the extent required by applicable Laws. Notwithstanding the foregoing, any (i) personally identifiable information of the employees, agents, contractors or representatives of Takeda, its Affiliates or their respective third party contractors or (ii) information related to the business operations of Takeda or its Takeda’s Affiliates, or (iii) information not specifically related to the Product contained in such Assigned Information shall continue to be the Confidential Information of Takeda and will be subject to the confidentiality provisions of the Agreement.

 

3.4                               Third Party Contracts.  Upon AMAG’s written request within [***] after the applicable Territory Termination Effective Date and as agreed by the Parties, Takeda shall assign to AMAG any Third Party contracts that primarily relate to the Product in a Terminated Territory to the extent such Third Party contract is assignable by Takeda, provided that Takeda shall remain responsible for the performance of any obligations or liabilities under such contract that accrued prior to such assignment.  Takeda shall promptly terminate all Third Party contracts that primarily relate to the Product in a Terminated Territory that AMAG has not requested to be assigned to AMAG pursuant to this Section 3.4, provided that if such Third Party contracts involve ongoing services to Takeda that are unrelated to the Product, Takeda’s obligation to terminate such Third Party contracts will only extend to that portion of such contracts related to the Product. This Section 3.4 sets forth Takeda’s entire obligation with respect to the assignment of any Third Party contracts to AMAG in connection with the termination of the Agreement.

 

3.5                               Costs for Regulatory Commitments.  AMAG will be solely responsible for paying all costs associated with any commitments made by Takeda or its Affiliate in any submission to a Regulatory Authority related to the Product in a Terminated Territory provided that AMAG has approved such commitments in writing before the submission is filed (“Future Costs”).

 

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[***] 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.

 

4.                                      TRANSITION SERVICES

 

4.1                               Takeda shall provide to AMAG the transition services set forth in the schedules attached as Exhibit A to assist AMAG with assuming responsibility for all operations pertaining to the Product in each Terminated Territory (“Transition Services”).  The Parties shall use commercially reasonable efforts to transfer to AMAG responsibility for all operations pertaining to the Product in the Terminated Territory within sixty (60) days after the applicable Territory Termination Effective Date, extendable by thirty (30) days upon AMAG’s request and Takeda’s consent. Except as set forth herein, each Party shall bear its own costs in connection with performing its obligations to complete the transfer of Product operations to AMAG.

 

4.2                               Takeda shall perform (and cause its Affiliates to perform) the Transition Services in a timely and professional manner and in accordance with industry standards for services of the type performed.  Takeda shall comply (and cause its Affiliates to comply) with all applicable Laws, and shall maintain all applicable permits and licenses, in connection with the Transition Services.  At any time, AMAG may request by written notice that Takeda cease conducting any particular Transition Services, and thereafter the Parties will cooperate to wind down such Transition Services as soon as reasonably practicable.  Takeda may delegate or subcontract the provision of any Transition Services to any Third Party that Takeda employed to provide the same type of services in connection with its commercialization of the Product prior to the Termination Agreement Date.  Takeda shall provide AMAG with reasonable advance notice of any such delegation or subcontracting unless such Third Party is already providing such services to Takeda as of the Termination Agreement Date.  Takeda shall remain responsible for the performance of any Transition Services it delegates or subcontracts to a Third Party.

 

4.3                               Takeda shall provide Transition Services to AMAG for each Terminated Territory for a period of up to one hundred eighty (180) days after the Territory Termination Effective Date for such Terminated Territory (the “Transition Services Period” for such Terminated Territory); provided that AMAG may extend the Transition Services Period for a Terminated Territory by written notice to Takeda (the “Extension Notice”) delivered no later than thirty (30) days before the expiration of such Transition Services Period, for the period of time reasonably necessary to complete any services that cannot be reasonably transitioned to AMAG during the initial one hundred eighty (180)-day period, which extension will not exceed an additional one hundred eighty (180) days, and provided that Takeda consents to such extension in writing, which consent Takeda shall not unreasonably withhold or delay.  AMAG shall specify in the Extension Notice the services that will be conducted during the extension and the duration of

 

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[***] 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.

 

such services, on a per-country and per-function basis.  AMAG shall use commercially reasonable efforts during the Transition Services Period and any extension thereof to complete the transition of all operations pertaining to the Product in the applicable Terminated Territory to AMAG as soon as practicable.

 

4.4                               Takeda shall be solely responsible for all costs it incurs to provide the Transition Services during the Transition Services Periods (including extensions thereof under Section 4.3).  If AMAG requests and Takeda agrees, in its sole discretion, to conduct additional transition services for any Terminated Territory after the end of the applicable Transition Services Period, as may be extended, (the “Reimbursed Services”) AMAG shall reimburse Takeda at Takeda’s fully-burdened cost for such Reimbursed Services plus five percent (5%) of such costs.

 

4.5                               The transition services obligations set forth above in this Article 4 supersede the transition assistance set forth in Section 13.6(c) of the Agreement.

 

4.6                               Unless agreed otherwise by the Parties in writing, Takeda will invoice AMAG on a monthly basis for the costs described in Section 4.4 for Reimbursed Services conducted in the preceding month.  AMAG shall pay each such invoice, unless subject to a bona fide dispute, within [***] after receipt thereof.  All payments will be made in Dollars.  Takeda will maintain (and, as applicable, cause its Affiliates to maintain) accurate and complete records regarding the Reimbursed Services in sufficient detail for AMAG to confirm the accuracy of payments under this Section 4.6.    Upon [***] notice to Takeda, AMAG will have the right, through an independent certified public accountant selected by AMAG and reasonably acceptable to Takeda, to inspect and audit such records of Takeda and its Affiliates for the sole purpose of verifying the accuracy of all payments made or to be made by AMAG under this Section 4.6.  Any such audit will be conducted during regular business hours at the facilities of Takeda or its Affiliates, and in a manner that does not unreasonably interfere with the normal business activities of Takeda or its Affiliates.  The auditor shall execute a standard non-disclosure agreement with Takeda or its Affiliates, as applicable, and shall not disclose Takeda’s Confidential Information to AMAG except to the extent such disclosure is necessary to verify the accuracy of the payments made by AMAG.  If any audit reveals an overpayment by AMAG, Takeda will promptly refund any overpayment.  In addition, if any audit reveals an overpayment by AMAG exceeding [***] during the audited period, Takeda will reimburse AMAG for the reasonable out-of-pocket costs of conducting the audit.

 

5.                                      FINANCIAL TERMS

 

5.1                               All sales of the Product and receivables in a given Terminated Territory before the applicable Territory Termination Effective Date shall belong to Takeda, subject to royalty payments to AMAG under Section 8.4 of the Agreement.

 

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[***] 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.

 

Takeda shall be solely responsible for all costs, whether incurred before or after the applicable Territory Termination Effective Date, arising out of the distribution of Product under Takeda’s label by or on behalf of Takeda (including samples and Product distributed by or on behalf of Takeda in connection with investigator-sponsored trials) before the applicable Territory Termination Effective Date, including costs for recalls, refunds, rebates, chargebacks, return processing and destruction.

 

5.2                               AMAG shall be responsible for any liabilities relating to Product distributed by or on behalf of AMAG in a Terminated Territory after the applicable Territory Termination Effective Date, except to the extent resulting from Takeda’s breach of, or indemnity obligations under, this Termination Agreement.

 

5.3                               In consideration for early termination of the Agreement and activities to be performed by AMAG earlier than contemplated under the Agreement, and in lieu of any future cost-sharing and future milestone payments contemplated by the Agreement, Takeda shall make the non-refundable, non-creditable payments to AMAG set forth in Exhibit B, subject to the following terms and conditions:

 

a.                                      For item 5(a), Takeda shall pay such amount by wire transfer as soon as practicable, but by no later than [***] after the Termination Agreement Date.

 

b.                                      For items 1, 2, 3 and 4, and 5(b), and except as provided in the last sentence of item 5(b) in Exhibit B, Takeda shall pay such amounts [***] after the Termination Date.

 

c.                                       For item 6, Takeda shall pay such amount [***] after the earlier of: (i) a CHMP Opinion [***], or (ii) the Termination Date if the CHMP Opinion has not yet been issued.

 

5.4                               Notwithstanding the provisions of Section 5.3, in the event that Takeda or a Regulatory Authority recalls or suspends the Product in the interest of patient welfare after this Termination Agreement is executed by the Parties but prior to the Termination Date (a “Recall”), Takeda’s obligation to make the payments set forth in Exhibit B will be limited to the payment of item 5(a) and the payment of the documented out-of-pocket costs incurred through the date of the Recall for items 1, 2, 3, 4 and 6.  For the avoidance of doubt, in the event of a Recall, Takeda will have no obligation to make the payment under item 5(b) in the amount of $3 million.

 

5.5                               Except for the payments set forth in Exhibit B, Takeda has no liability for any expenses related to any past, pending or future clinical or non-clinical studies related to the Product.

 

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[***] 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.

 

5.6                               Notwithstanding any other provision of this Termination Agreement or Exhibit A, if the marketing authorization for the Product is suspended in a Terminated Territory and the Parties are prevented from completing the transfer of such marketing authorization to AMAG within one hundred twenty (120) days after such suspension due to applicable Laws or any requirements or restrictions imposed by a Regulatory Authority, Takeda will have the right, in Takeda’s sole discretion, to Withdraw such marketing authorization.

 

6.                                      REPRESENTATIONS AND WARRANTIES

 

6.1                               Mutual Representations and Warranties.  Each Party hereby represents and warrants to the other Party as follows, as of the Termination Agreement Date:

 

a.                                      it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated;

 

b.                                      it has the corporate power and authority and the legal right to enter into this Termination Agreement and perform its obligations hereunder;

 

c.                                       it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Termination Agreement and the performance of its obligations hereunder; and

 

d.                                      this Termination Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

 

6.2                               Additional Representations and Warranties of Takeda.  Takeda hereby represents and warrants to AMAG as follows, as of the Termination Agreement Date:

 

a.                                      Takeda has the full legal right, power and authority to grant the rights and make the assignments as set forth in Article 3; and

 

b.                                      to Takeda’s Best Knowledge, Takeda has made available to AMAG all material written information in Takeda’s possession or Control as of the Termination Agreement Date relating to the safety or Commercialization of the Products in the Field in the Licensed Territory, and to Takeda’s Best Knowledge all such information is true and correct in all material respects.

 

6.3                               DISCLAIMER OF WARRANTY.  AMAG HEREBY ACKNOWLEDGES THAT TAKEDA AND ITS AFFILIATES DO NOT ORDINARILY PROVIDE THE TRANSITION SERVICES TO THIRD PARTIES AS PART OF THEIR BUSINESS ACTIVITIES.  EXCEPT AS EXPRESSLY STATED IN THIS

 

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[***] 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.

 

TERMINATION AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

 

6.4                               EXCEPT FOR A PARTY’S OBLIGATIONS UNDER SECTION 7.2 (INDEMNIFICATION), AND ANY BREACH OF SECTION 8.1 (CONFIDENTIALITY), IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY (OR THE OTHER PARTY’S AFFILIATES) IN CONNECTION WITH THIS TERMINATION AGREEMENT FOR LOST REVENUE, LOST PROFITS, LOST SAVINGS, LOSS OF USE, DAMAGE TO GOODWILL, OR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR INDIRECT DAMAGES UNDER ANY THEORY, INCLUDING CONTRACT, NEGLIGENCE, OR STRICT LIABILITY, EVEN IF THAT PARTY HAS BEEN PLACED ON NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

 

7.                                      MUTUAL RELEASES; INDEMNIFICATION

 

7.1                               Mutual Releases.

 

a.                                      AMAG, for itself and on behalf of its Affiliates, and each of their respective current or past directors, officers, stockholders, employees, agents, and insurers and their respective successors, heirs, assigns and representatives, or anyone claiming through any of the foregoing (all of whom are hereinafter collectively called the “AMAG Releasors”), hereby completely, irrevocably, fully, finally, and forever release, relinquish, waive and discharge Takeda and its Affiliates, and each of them, including their present and former parents, subsidiaries, predecessors, successors, assigns, and any of their respective current or past officers, directors, employees, agents, insurers, and their respective successors, heirs, assigns and representatives (all of whom are hereinafter collectively called the “Takeda Releasees”), of and from (i) any and all losses, claims, actions, causes of action, liabilities, damages, judgments, demands, costs and expenses of any kind, whether known or unknown (collectively, “Losses”), that the AMAG Releasors, or any of them, had, has, may have or may ever claim to have against the Takeda Releasees, or any of them, under or directly or indirectly related to the Agreement, based upon facts and circumstances arising or existing on or before the Termination Agreement Date and (ii) any Losses the AMAG Releasors, or any of them, has, may have or may ever claim to have against the Takeda

 

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[***] 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.

 

Releasees, or any of them, arising out of or related to (a) any response, filing or other submission related to the Product, whether oral or in writing, and whether or not based upon, including or excluding any information, position, recommendation or request from either Party as to the content thereof, made by either Party to the PRAC or CHMP (the “Committees”) or (b) any opinion, ruling, recommendation, order, directive or decision made or issued by the Committees or EMA affecting the status of the marketing authorization or label for the Product while Takeda or its Affiliate is the holder of such marketing authorization in the EU, in each of (a) or (b), arising after the Termination Agreement Date and (iii) any Losses the AMAG Releasors, or any of them, has, may have or may ever claim to have against the Takeda Releasees, or any of them, arising out of or related to Takeda’s Withdrawal of a marketing authorization in a Terminated Territory under Section 5.6 or Exhibit A; provided, however, that the foregoing release shall not extend to any royalties owing by Takeda to AMAG pursuant to Section 8.4(a) of the Agreement immediately prior to the effectiveness of this Termination Agreement and any surviving indemnity obligations under Article 11 of the Agreement.

 

b.                                      Takeda, for itself and on behalf of its Affiliates, and each of their respective current or past directors, officers, stockholders, employees, agents, and insurers and their respective successors, heirs, assigns and representatives, or anyone claiming through any of the foregoing (all of whom are hereinafter collectively called the “Takeda Releasors”), hereby completely, irrevocably, fully, finally, and forever release, relinquish, waive and discharge AMAG and its Affiliates, and each of them, including their present and former parents, subsidiaries, predecessors, successors, assigns, and any of their respective current or past officers, directors, employees, agents, insurers, licensors, and their respective successors, heirs, assigns and representatives (all of whom are hereinafter collectively called the “AMAG Releasees”), of and from any (i) and all Losses that the Takeda Releasors, or any of them, had, has, may have or may ever claim to have against the AMAG Releasees, or any of them, under or directly or indirectly related to the Agreement, based upon facts and circumstances arising or existing on or before the Termination Agreement Date and (ii) any Losses the Takeda Releasors, or any of them, has, may have or may ever claim to have against the AMAG Releasees, or any of them, arising out of or related to any response, filing or other submission related to the Product, whether oral or in writing, and whether or not based upon, including or excluding any information, position, recommendation or request from either Party as to the content thereof, made by either Party to the Committees; provided, however, that the foregoing release shall not extend to any surviving indemnity obligations under Article 11 the Agreement.

 

12

 

[***] 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.

 

c.                                       Notwithstanding any provision of this Termination Agreement to the contrary, nothing herein shall be deemed to release, acquit or discharge any Takeda Releasee or any AMAG Releasee from its obligations (if any) under this Termination Agreement or any claim arising from any breach of such obligations.

 

7.2                               Indemnification.

 

a.                                      The Parties’ indemnification rights and obligations under the Agreement will remain in effect following termination of the Agreement, and are hereby amended as follows: AMAG’s obligations under Section 11.1(b) of the Agreement will expand to include (a) breaches of its obligations, representations, warranties and covenants under this Termination Agreement, (b) Takeda’s Withdrawal of a marketing authorization in a Terminated Territory pursuant to Section 5.6 or Exhibit A of this Termination Agreement, and (c) any distribution, sale or other use or disposal by or on behalf of AMAG of any unlabeled inventory or samples of the Product transferred by Takeda to AMAG pursuant to Section 3.3(b) of this Termination Agreement; and Takeda’s obligations under Section 11.2(b) of the Agreement will expand to include breaches of its obligations, representations, warranties and covenants under this Termination Agreement.

 

b.                                      In addition, AMAG’s obligations under Section 11.1 of the Agreement will expand to include any and all Claims to the extent that such Claims arise out of, are based on, or result from the manufacture, use, handling, storage, sale or other disposition of Product by or on behalf of AMAG or its Affiliates, including their respective licensees and distributors, in or for any Terminated Territory after the applicable Territory Termination Effective Date, but shall exclude any costs for which Takeda is responsible under Section 5.1.  The provisions of Sections 11.3 of the Agreement shall apply to AMAG’s indemnification obligations under this Section 7.2. The foregoing indemnity obligation shall not apply to the extent that (i) the Takeda Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 of the Agreement and AMAG’s defense of the relevant Claims is materially prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity for which Takeda is obligated to indemnify the AMAG Indemnitees under Section 11.2 of the Agreement, as amended by Section 7.2(a) above.

 

8.                                      CONFIDENTIALITY

 

8.1                               All information disclosed by one Party to another Party under this Termination Agreement will be deemed the disclosing Party’s Confidential Information under the Agreement and subject to Article 12 thereof, except as provided in the last sentence of Section 3.3.  In addition, the terms of this Termination Agreement will be deemed the Confidential Information of each Party under the terms of Article 12 of the Agreement.

 

13

 

[***] 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.

 

8.2                               The Parties shall make a joint public announcement of the execution of this Termination Agreement in the form attached as Exhibit C, which shall be issued at a time to be mutually agreed by the Parties.

 

8.3                               Section 12.3(b) of the Agreement will apply to any press releases either Party desires to make related to the terms of this Termination Agreement.  After the Termination Date, AMAG will not be required to obtain Takeda’s approval or to notify Takeda of any press release related to AMAG’s development or commercialization of Product that does not refer to this Termination Agreement or the Agreement or directly or indirectly to Takeda.

 

9.                                      SURVIVING PROVISIONS

 

9.1                               Except as expressly modified by the terms of this Termination Agreement, and subject to Section 7.1 above, all provisions identified in Section 13.8 of the Agreement as surviving the termination or expiration thereof will survive such termination pursuant to this Termination Agreement.

 

10.                               MISCELLANEOUS

 

10.1                        Dispute Resolution.  All disputes arising under this Termination Agreement will be resolved in accordance with Article 14 of the Agreement.

 

10.2                        Entire Agreement; Amendments.  This Termination Agreement and the Agreement constitute the entire, final and exclusive agreement between the Parties with respect to the subject matter hereof and thereof.  In the event of any conflict between the terms of this Termination Agreement and the Agreement, the terms of this Termination Agreement will control.  No amendment, modification, release or discharge with respect to this Termination Agreement will be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.

 

10.3                        Notices. Any notice required or permitted to be given under this Termination Agreement shall be in writing, shall specifically refer to this Termination Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 10.3, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or sent by a reputable courier service, or (b) five (5) business days after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested.

 

	
If to AMAG:
    	
AMAG Pharmaceuticals, Inc.
    
	
 
    	
100 Winter St.
    
	
 
    	
Waltham, MA 0245
    

 

14

 

[***] 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.

 

	
 
    	
USA
    
	
 
    	
Attn: General Counsel
    
	
 
    	
 
    
	
With a copy to:
    	
Cooley LLP
    
	
 
    	
One Freedom Square
    
	
 
    	
Reston Town Center
    
	
 
    	
11951 Freedom Drive
    
	
 
    	
Reston, VA 201910-565
    
	
 
    	
Attn: Kenneth J. Krisko, Esq.
    
	
 
    	
 
    
	
If to Takeda:
    	
Takeda Pharmaceutical Company Limited
    
	
 
    	
1-1, Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645,
    
	
 
    	
Japan
    
	
 
    	
Attn: Head, Global Licensing and Business Development Department
    
	
 
    	
 
    
	
With copies to:
    	
Takeda Pharmaceutical Company Limited
    
	
 
    	
1-1, Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645,
    
	
 
    	
Japan
    
	
 
    	
Attn: Global General Counsel
    
	
 
    	
 
    
	
 
    	
Takeda Pharmaceuticals International Inc.
    
	
 
    	
One Takeda Parkway
    
	
 
    	
Deerfield, IL 60015
    
	
 
    	
Attn: Vice President, R&D Transactions
    
	
 
    	
 
    
	
 
    	
Takeda Pharmaceuticals U.S.A., Inc.
    
	
 
    	
One Takeda Parkway
    
	
 
    	
Deerfield, IL 60015
    
	
 
    	
Attention: General Counsel
    

 

10.4                        No Strict Construction; Headings. This Termination Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party. Ambiguities, if any, in this Termination Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Termination Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. Except where the context otherwise requires, the use of any gender shall be applicable to all genders, and the word “or” is used in

 

15

 

 

[***] 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.

 

the inclusive sense (and/or). The term “including” as used herein means including, without limiting the generality of any description preceding such term.

 

10.5                        Assignment. Neither Party may assign or transfer this Termination Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party’s consent to its Affiliates or to a Third Party successor to substantially all of the business of such Party in connection with a Change of Control of such Party. Any successor or assignee of rights and/or obligations permitted hereunder shall, in writing to the other Party, expressly assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 10.5 shall be null, void and of no legal effect.

 

10.6                        Performance by Affiliates. Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Termination Agreement, and shall cause its Affiliates to comply with the provisions of this Termination Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Termination Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

 

10.7                        Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Termination Agreement.

 

10.8                        Severability. If any one or more of the provisions of this Termination Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Termination Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Termination Agreement may be realized.

 

10.9                        No Waiver. Any delay in enforcing a Party’s rights under this Termination Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Termination Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

 

16

 

[***] 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.

 

10.10                 Independent Contractors. Each Party shall act solely as an independent contractor, and nothing in this Termination Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

 

10.11                 English Language; Governing Law. This Termination Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Termination Agreement. This Termination Agreement and all disputes arising out of or related to this Termination Agreement or any breach hereof shall be governed by and construed under the laws of the State of New York, United States of America, without giving effect to any choice of law principles that would require the application of the laws of a different state.

 

10.12                 Counterparts. This Termination Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[SIGNATURE PAGE FOLLOWS]

 

17

 

[***] 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.

 

IN WITNESS WHEREOF, the Parties have executed this Termination Agreement in duplicate originals by their duly authorized officers as of the Effective Date.

 

	
TAKEDA PHARMACEUTICAL COMPANY LIMITED
    	
 
    	
AMAG   PHARMACEUTICALS, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:     
    	
/s/Shinji   Honda
    	
 
    	
By:     
    	
/s/   Scott B. Townsend
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Shinji Honda
    	
 
    	
Name:
    	
Scott B. Townsend
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title: 
    	
Senior Managing Director,
    	
 
    	
Title:
    	
General   Counsel
    
	
 
    	
Corporate Strategy Officer
    	
 
    	
 
    	
Senior   Vice President
    
	
 
    	
 
    	
 
    	
of   Legal Affairs
    
	
 
    	
 
    	
 
    	
and   Secretary
    

 

[Signature Page to Termination Agreement]

 

 

[***] 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.

 

Exhibit A

Transition Services

 

Europe

 

This section outlines the activities agreed by AMAG and Takeda prior to and after the marketing authorization (MA) transfer, and the expected timelines, to occur for the Europe territory.

 

Prior to MA Transfer

 

·                  Should the CHMP pass a positive opinion for the IDA Type II variation, the application to transfer MA will be submitted by Takeda with cooperation by AMAG immediately following the decision of the European Commission. The MA transfer from Takeda to AMAG would be effective as soon all necessary regulatory approvals are obtained for the transfer.

·                  Should the CHMP pass a negative opinion for the IDA Type II variation, the application to transfer MA will be submitted by Takeda with cooperation by AMAG no later than [***], with notification to EMA to occur 30 days prior to submission of the application. In this instance the MA transfer from Takeda to AMAG would be effective as soon as all necessary regulatory approvals are obtained for the transfer.

·                  Until the transfer of the MA by the European Commission is effective, Takeda will continue to perform its obligations as specified in the Agreement and the Termination Agreement. Subject to the terms of the Termination Agreement and during the Transition Services Period, Takeda agrees to provide AMAG and its designated third parties with reasonable assistance for them to prepare for and assume as soon as reasonably possible all responsibility for operational activities that will be required to be in place at the time of MA transfer effectiveness and thereafter.

·                  Notwithstanding any of the above considerations, Takeda will have the right, in its sole discretion and without any liability to AMAG, to Withdraw the MA should AMAG not fulfill all conditions required to initiate MA transfer by [***], provided that such deadline will be extended by one day for each day that AMAG is prevented from fulfilling such conditions as a result of Takeda’s action or inaction if AMAG notifies Takeda in writing (via email or fax to Takeda’s legal counsel and alliance manager) prior to such deadline of the reason(s) that AMAG is not able to fulfill such conditions by such deadline. If Takeda Withdraws the MA in Europe in light of the preceding sentence or in accordance with the provisions of Section 5.6 of the Termination Agreement, the date of such MA Withdrawal will be deemed to be the Territory Termination Effective Date for Europe.

 

A-1

 

[***] 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.

 

After MA Transfer

 

Once the MA has been transferred to AMAG, Takeda agrees to provide the following transition services for the periods as specified below.

 

	
Activity
    	
 
    	
Takeda responsibility post-MA
   transfer
    	
 
    	
Period
    
	
Technical   Operations and Quality
    	
 
    	
1. Label and packaging

2. Retain storage

3. Release testing for new lots

4. Recalls and returns for product sold into the   channel by Takeda
    	
 
    	
1.   For 180 days

2.   For 180 days

3.   For 180 days

4.   For 180 days
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Pharmacovigilance
    	
 
    	
Takeda   to hold no responsibility in PV- related activities post-MA transfer (assumes   all required information has been transferred to AMAG or its third party   vendor by time of MA transfer)
    	
 
    	
Not   applicable
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Finance
    	
 
    	
1. Billing and collections support for product   sold into the channel by Takeda

2. Receivables and rebate services for product   sold into the channel by Takeda
    	
 
    	
1.   For 180 days

2.   For 180 days
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Regulatory
    	
 
    	
Takeda   to hold no responsibility in regulatory-related activities post-MA transfer   except in relation to Product held in Takeda’s inventory prior to Termination   Date.
    	
 
    	
Not applicable
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Commercial
    	
 
    	
1. Product returns for product sold into the   channel by Takeda or held in Takeda’s inventory prior to Termination Date.
    	
 
    	
1.   For 180 days
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Medical   Affairs
    	
 
    	
Takeda   to complete its commitments to Investigator-sponsored trials
    	
 
    	
Through   completion of trials
    

 

A-2

 

[***] 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.

 

Canada

 

This section outlines the activities agreed by AMAG and Takeda prior to and after the marketing authorization (MA) transfer, and the expected timelines, to occur for the Canada territory.

 

Prior to MA Transfer

 

·                  AMAG and Takeda to jointly prepare the required materials for submission to Health Canada to request transfer of the MA to AMAG. This activity will occur in [***]; and the materials will be submitted to Health Canada by no later than [***]. This step assumes that the MA transfer can occur prior to AMAG establishing its own Drug Establishment License (DEL) or via a third party with a valid DEL.  Takeda will provide upon AMAG’s request continued use of Takeda’s DEL for up to [***] following the transfer of the MA, as permissible under local laws and regulations.

·                  A decision on the MA transfer request from Health Canada is expected within 90 days after the formal application is submitted.

·                  Assuming the timelines as described here, the MA transfer from Takeda to AMAG may be effective in [***].

·                  Until the MA transfer is effective, Takeda will continue to perform its obligations as specified in the Agreement and the Termination Agreement. Subject to the terms of the Termination Agreement and during the Transition Services Period, Takeda agrees to provide AMAG and its designated third parties with reasonable assistance for them to prepare for and assume as soon as possible all responsibility for operational activities that will be required to be in place at the time of MA transfer effectiveness and thereafter.

·                  Notwithstanding any of the above considerations, and assuming that the MA transfer can occur prior to AMAG establishing its own DEL, Takeda will have the right, in its sole discretion and without any liability to AMAG, to Withdraw the MA should AMAG not fulfill all conditions to initiate MA transfer by [***], provided that such deadline will be extended by one day for each day that AMAG is prevented from fulfilling such conditions as a result of Takeda’s action or inaction if AMAG notifies Takeda in writing (via email or fax to Takeda’s legal counsel and alliance manager) prior to such deadline of the reason(s) that AMAG is not able to fulfill such conditions by such deadline.  If Takeda Withdraws the MA in Canada in accordance with the preceding sentence, the date of such MA Withdrawal will be deemed to be the Territory Termination Effective Date for Canada.

 

After MA Transfer

 

Once the MA has been transferred to AMAG, Takeda agrees to provide the following transition services for the periods as specified below.

 

A-3

 

[***] 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.

 

	
Activity
    	
 
    	
Takeda responsibility post-MA
   transfer
    	
 
    	
Period
    
	
Technical   Operations and Quality
    	
 
    	
1.         Label and   packaging

2.         Import of   product

3.         Storage and   distribution

4.         Recalls
    	
 
    	
1.   For 180 days

2.   For 180 days

3.   For 180 days

4.   For 180 days
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Pharmacovigilance
    	
 
    	
Takeda   to hold no responsibility in PV- related activities post-MA transfer (assumes   all required information has been transferred to AMAG or its third party vendor   by time of MA transfer)
    	
 
    	
Not   applicable
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Finance
    	
 
    	
1.         Consultation   regarding structuring Canada tax set up (informational only and may not be   relied upon by AMAG or any third party)

 

2.         Billing and   collections support

 

3.         Receivables   and rebate services
    	
 
    	
1.   For 60 days

 

2.   For 180 days

 

3.   For 180 days
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Regulatory
    	
 
    	
Takeda   to hold no responsibility in regulatory-related activities post-MA transfer
    	
 
    	
Not   applicable
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Commercial
    	
 
    	
1.         Product   returns for product sold into the channel by Takeda
    	
 
    	
1.   For 180 days
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Medical   Affairs
    	
 
    	
Takeda   to complete its commitments to Investigator-sponsored trials
    	
 
    	
Through   completion of trials
    

 

Switzerland

 

This section outlines the activities agreed by AMAG and Takeda prior to and after the marketing authorization (MA) transfer, and the expected timelines, to occur for the Switzerland territory.

 

Prior to MA Transfer

 

·                  AMAG and Takeda to jointly prepare the required materials for submission to Swiss Medic to request transfer of the MA to AMAG. The materials will be submitted to Swiss Medic by no later than [***].

·                  A decision on the MA transfer request from Swiss Medic is expected within 90 days after the formal application is submitted.

 

A-4

 

[***] 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.

 

·                  Assuming the timelines as described here, the MA transfer from Takeda to AMAG may be effective in [***].

·                  Until the MA transfer is effective, Takeda will continue to perform its obligations as specified in the Agreement and the Termination Agreement. Subject to the terms of the Termination Agreement and during the Transition Services Period, Takeda agrees to provide AMAG and its designated third parties with reasonable assistance for them to prepare for and assume as soon as possible all responsibility for operational activities that will be required to be in place at the time of MA transfer effectiveness and thereafter.

·                  Notwithstanding any of the above considerations, Takeda will have the right, in its sole discretion and without any liability to AMAG, to Withdraw the MA should AMAG not fulfill all conditions to initiate MA transfer by [***], provided that such deadline will be extended by one day for each day that AMAG is prevented from fulfilling such conditions as a result of Takeda’s action or inaction if AMAG notifies Takeda in writing (via email or fax to Takeda’s legal counsel and alliance manager) prior to such deadline of the reason(s) that AMAG is not able to fulfill such conditions by such deadline.  If Takeda Withdraws the MA in Switzerland in accordance with the preceding sentence, the date of such Withdrawal will be deemed to be the Territory Termination Effective Date for Switzerland.

 

·                  After MA Transfer

 

Once the MA has been transferred to AMAG, Takeda agrees to provide the following transition services for the periods as specified below.

 

	
Activity
    	
 
    	
Takeda responsibility post-MA
   transfer
    	
 
    	
Period
    
	
Technical   Operations and Quality
    	
 
    	
1. Label and packaging

2. Distribution of product

3. Retain storage

4. Release testing for new lots

5. Recalls
    	
 
    	
1.              For 180 days

2.              For 180 days

3.              For 180 days

4.              For 180 days

5.              For 180 days
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Pharmacovigilance
    	
 
    	
Takeda   to hold no responsibility in PV- related activities post-MA transfer (assumes   all required information has been transferred to AMAG or its third party   vendor by time of MA transfer)
    	
 
    	
Not   applicable
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Finance
    	
 
    	
1.         Consultation   regarding structuring Swiss tax set up (informational only and may not be   relied upon
    	
 
    	
1.              For 180 days

2.              For 180 days

3.              For 180 days
    

 

A-5

 

[***] 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.

 

	
 
    	
 
    	
by   AMAG or any third party)

2.         Billing and   collections support

3.         Receivables   and rebate services
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Regulatory
    	
 
    	
Takeda   to hold no responsibility in regulatory-related activities post-MA transfer
    	
 
    	
Not   applicable
    

 

A-6

 

[***] 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.

 

MA Suspension

 

The parties acknowledge that in the event of a voluntary recall or suspension of the MA in a Terminated Territory prior to MA transfer to AMAG, the type and duration of transition services to be provided by Takeda under this Exhibit A will be reduced to reasonably required levels.

 

A-7

 

Exhibit B

Termination-Related Payments to AMAG

 

1.              Takeda obligations for MRI associated with the FACT study:  $[***] for projected costs for 2015

 

2.              Expenditures associated with regulatory filings and variations in EU, Canada, and Switzerland, planned through October 2015:  $[***]

 

3.              Expenditures associated with analytical methods transfer, packaging, labeling, audit, drug establishment fees:  $[***]

 

4.              Takeda’s FTE Costs associated with Legal and Regulatory support planned through October 2015:  $[***]

 

5.              Consideration for Takeda’s planned commercialization and back office support of the Product in Canada:   a) $[***] payable upon execution of the Termination Agreement;   and b) $3,000,000 payable within [***].

 

6.              Consideration for Pharmacovigilance activities in the Territory through October 2015:  $[***]

 

B-1

 

Exhibit C

Press Release

 

	

    

 

AMAG Pharmaceuticals and Takeda Announce Mutual Termination of Agreement to License, Develop and Commercialize Ferumoxytol in Ex-U.S. Territories, Including Europe

 

WALTHAM, Mass. and OSAKA, Japan December 29, 2014 -  AMAG Pharmaceuticals (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (Takeda) announced today that they have entered into an agreement to mutually terminate the March 2010 license, development and commercialization agreement, which granted Takeda exclusive rights to market ferumoxytol in Canada, the European Union (EU) and Switzerland, as well as certain other geographic territories (under the trade name Rienso® outside of Canada where the product’s trade name is Feraheme®).

 

Under the terms of the termination agreement, AMAG will regain all worldwide development and commercialization rights for Feraheme/Rienso.  Takeda will make a payment to AMAG in connection with the termination and will provide certain transition services to AMAG for up to 180 days after the marketing authorization transfer in each territory.  In addition, both parties will undertake a transfer of the regulatory files for the product in each respective territory, and Takeda will not participate in any future development or commercialization activities.

 

Takeda has been commercializing Feraheme in Canada and Rienso in the EU for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). In both of these territories, Takeda has submitted applications to expand the product’s current label to include all patients with IDA regardless of underlying cause. AMAG will be assessing alternative commercialization strategies for Feraheme in Canada and Rienso in the EU based, in part, on the pending regulatory decisions which are expected in 2015.

 

About Feraheme® (ferumoxytol)/Rienso

 

Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult CKD patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by five issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book, the last of which expires in June 2023.

 

Ferumoxytol received marketing approval in Canada in December 2012, where it has been marketed by Takeda as Feraheme, and in the European Union in June 2013 where it has been marketed by Takeda as Rienso® Ferumoxytol received marketing approval in Switzerland in August 2013.

 

Feraheme/Rienso is contraindicated in patients with known hypersensitivity to Feraheme/Rienso or any of its components. Serious hypersensitivity reactions, including anaphylactic-type reactions, have been

 

C-1

 

reported in patients receiving Feraheme/Rienso. Serious adverse reactions of clinically significant hypotension have been reported in the post-marketing experience of Feraheme/Rienso.

 

For additional U.S. product information, including full prescribing information, please visit www.feraheme.com.

 

About AMAG

 

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on maternal health, anemia and cancer supportive care. The primary goal of AMAG and its maternal health division, Lumara HealthTM, is to bring to market therapies that provide clear benefits and improve patients’ lives. In addition to continuing to pursue opportunities to make new advancements in patients’ health and to enhance treatment accessibility, AMAG intends to continue to expand and diversify its portfolio through the in-license or purchase of additional pharmaceutical products or companies. For additional company information, please visit www.amagpharma.com.

 

AMAG PHARMACEUTICALS® is a registered trademark of AMAG Pharmaceuticals, Inc. LUMARA HEALTHTM is a trademark of Lumara Health Inc.

 

AMAG Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including among others, statements regarding Takeda’s payments and services to AMAG, worldwide development and commercialization rights for Feraheme/Rienso for IDA and/or CKD, the transfer of regulatory files by Takeda in each respective territory and AMAG’s assessment of commercialization strategies for Feraheme/Rienso in Canada and the EU are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

 

Such risks and uncertainties include, among others: (1) limitations on AMAG’s ability to invest in the development and commercialization of Feraheme/Rienso outside the U.S., especially in light of AMAG’s being highly leveraged, (2) AMAG may not be able to successfully commercialize Feraheme/Rienso using alternate strategies in Canada and the EU, or may choose not to do so, (3) uncertainties regarding the likelihood and timing of potential approval of Feraheme/Rienso in the U.S., the EU and Canada in the broader IDA indication in light of the complete response letter AMAG received from the FDA informing AMAG that its supplemental new drug application (sNDA) for the broader indication could not be approved in its present form and stating that AMAG has not provided sufficient information to permit labeling of Feraheme/Rienso for safe and effective use for the proposed broader indication and similar concerns raised by European and Canadian regulators, (4) the possibility that following review of post-marketing safety data, including reports of serious anaphylaxis, cardiovascular events, and death, and/or in light of the label changes requested by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) and confirmed by the Committee for Medicinal Products for Human Use (CHMP), the FDA, European or Canadian regulators will request additional technical or scientific information, new studies or reanalysis of existing data, on-label warnings, post-marketing requirements/commitments or risk evaluation and mitigation strategies (REMS) in the current CKD indication for Feraheme/Rienso, or cause Feraheme/Rienso to be withdrawn from the market, and the additional costs and expenses that will or may be incurred in connection with such activities, (5) whether AMAG’s proposed label changes will be acceptable to the FDA or other regulatory authorities and what impact such changes, or such additional changes as U.S. and/or non-U.S. regulators may require, will have on sales of Feraheme/Rienso, (6) AMAG’s ability to successfully compete in the IV iron replacement market both in the U.S. and outside the U.S. as a result of limitations, restrictions or warnings in Feraheme’s/Rienso’s current or future label, including the changes recommended by PRAC and confirmed by CHMP that Rienso be administered to patients by infusion over at least 15-minutes

 

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(replacing injection) and that it be contraindicated for patients with any known history of drug allergy, (7) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso and in turn affect sales, or AMAG’s ability to market the product both in the U.S. and outside of the U.S., (8) AMAG’s patents and proprietary rights both in the U.S. and outside the U.S., (9) the risk of an Abbreviated New Drug Application (ANDA) filing for Feraheme, especially following the FDA’s draft bioequivalence recommendation for ferumoxytol published in December 2012, (10) the impact on sales if AMAG disseminates future Dear Healthcare Provider letters in the U.S., Europe, Canada or other markets, (11) AMAG’s ability to execute on its long-term strategic plan or to realize the expected results from its long-term strategic plan, (12) the possibility that AMAG will not realize expected synergies and other benefits from its acquisition of Lumara Health, as well as AMAG’s ability to pursue additional business development opportunities, especially in light of AMAG’s being highly leveraged and (13) other risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 and subsequent filings with the SEC. Any of the above risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. Use of the term “including” in the two paragraphs above shall mean in each case “including, but not limited to.” AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

 

AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

 

About Takeda Pharmaceutical Company Limited

 

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

 

Takeda Forward-Looking Statements

 

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda’s plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “assume,” “continue,” “seek,” “pro forma,” “potential,” “target,” “forecast,” “guidance,” “outlook” or “intend” or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

 

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda’s business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

 

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The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

 

###

 

Contact:

AMAG Pharmaceuticals, Inc.:

Katie Payne, 617-498-3303

 

Takeda Pharmaceuticals Company Limited:

Corporate Communications Dept.

+81-3-3278-2037

 

C-4Exhibit 10.31

 

[***] 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.

 

DEVELOPMENT AND SUPPLY AGREEMENT

 

THIS DEVELOPMENT AND SUPPLY AGREEMENT (this “Agreement”) is made as of this 17 day of September, 2009 (the “Effective Date”) by and between Hologic, Inc, having a principal place of business at 250 Campus Drive, Marlborough, MA 01752 (“Hologic”) and Hospira Worldwide, Inc., having a principal place of business at 275 North Field Drive, Lake Forest, Illinois, 60045, (U.S.A.) (“Hospira”).

 

WITNESSETH:

 

WHEREAS, Hologic is pursuing FDA approval for Hydroxyprogesterone Caproate Injection, 250 mg/mL (“17P”, also referred to as “Gestiva”), and wishes to develop and market Gestiva in a standard flip top vial and/or [***] delivery system as defined by Hologic;

 

WHEREAS, Hologic and Hospira desire that Hospira assist Hologic in the development and commercialization of Gestiva; and

 

WHEREAS, after Hologic has received an approved NDA as Hospira as a manufacturer from the United States Food and Drug Administration (the “FDA”), the parties desire that Hospira manufacture and sell to Hologic [***] of Gestiva for the United States market, subject to Hologic’s obligations to [***].

 

NOW, THEREFORE, in consideration of the premises and the mutual promises and agreements contained herein, Hologic and Hospira agree as follows:

 

Article 1.                                                DEFINITIONS

 

The following words and phrases when used herein with capital letters shall have the meanings set forth or referenced below:

 

1.1                               “Active Pharmaceutical Ingredient” or “API” shall mean the active pharmaceutical ingredient of the Drug (as hereinafter defined) in bulk form that Hologic shall deliver to Hospira for incorporation into Product (as hereinafter defined) and meeting the applicable Active Pharmaceutical Ingredient Specifications (as hereinafter defined).

 

1.2                               “Active Pharmaceutical Ingredient Specifications” shall mean the detailed description and parameters of the API set forth on Exhibit 1.2.

 

1.3                               “Affiliate” shall mean any corporation or non-corporate business entity which controls, is controlled by, or is under common control with a party to this Agreement. A corporation or non-corporate business entity shall be regarded as in control of another corporation or non-corporate business entity if it owns, or directly or indirectly controls, in excess of fifty percent (50%) of the voting stock of the other corporation, or (a) in the absence of

 

 

[***] 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.

 

the ownership of in excess of fifty percent (50%) of the voting stock of a corporation or (b) in the case of a non-corporate business entity, if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non-corporate business entity, as applicable.

 

1.4                               “cGMP” shall mean the current good manufacturing practices as set forth in 21 C.F.R. Part 210 and Part 211, policies or guidelines then in effect during the term of this Agreement for the manufacture and testing of pharmaceutical products as applied to the Products,.

 

1.5                               “Confidential Information” shall mean all information disclosed hereunder in writing and identified as being confidential or, if disclosed orally, visually or through some other media, is identified as confidential at the time of disclosure and is summarized in writing within [***] days of such disclosure and identified as being confidential, except any portion thereof which:

 

(a)         is known to the recipient at the time of the disclosure, as evidenced by its written records or other competent evidence;

 

(b)         is disclosed to the recipient by a third person lawfully in possession of such information and not under an obligation of nondisclosure;

 

(c)          is or becomes patented, published or otherwise part of the public domain through no fault of the recipient;

 

(d)         is developed by or for the recipient independently of Confidential Information disclosed hereunder as evidenced by the recipient’s written records or other competent evidence; or

 

(e)          is required by law to be disclosed by the recipient, provided that the recipient gives the other party hereto prompt notice of such legal requirement such that such other party shall have the opportunity to apply for confidential treatment of such Confidential Information.

 

1.6                               “Contract Year” shall mean a period of twelve (12) consecutive months which, for the first Contract Year of this Agreement, shall commence on the first day of the month after the month of Hologic’s first bona fide sale of Product to a non-Affiliate customer after Product has received an approved NDA from the FDA and each Contract Year thereafter shall consist of twelve (12) consecutive months following the end of the preceding Contract Year.

 

1.7                               “Drug” shall mean the human pharmaceutical Hydroxyprogesterone Caproate.

 

2

 

[***] 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.

 

1.8                               “Product” shall mean the Drug in final dosage form, filled in a vial and/or [***] to be determined by Hologic as set forth herein, including labeling, and secondary packaging meeting the Product Specifications.

 

1.9                               “Product Specifications” shall mean those product, labeling and performance specifications for Product filed with the FDA including Product formula, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Exhibit 1.9, which specifications may be amended from time to time by the written agreement of the parties.

 

1.10                        “Regulatory Authority” shall mean any federal, state or local regulatory agency, department, bureau or other governmental entity including without limitation the FDA which is responsible for issuing approvals, licenses, registrations or authorizations necessary for the manufacture, use, storage, import, transport or sale of the Products in the United States.

 

1.11                        “Third Party” shall mean a party other than Hospira or the Hologic and their respective Affiliates or assignees.

 

1.12                        “Waste” shall mean all rejects, improper goods, garbage, refuse, remainder, residue, waste water or other discarded material, including solid, liquid, semisolid, or contained gaseous material that arises from the manufacture of Product, including but not limited to, rejected, excess or unsuitable materials, API and Products.

 

Article 2.                                                PRODUCT DEVELOPMENT PROJECT

 

2.1                               General. Promptly following the Effective Date, the parties shall undertake a product development project (the “Project”) consisting of the development activities set forth in Exhibit 2.1. The objective of the Project shall be for Hospira to assist in the development of the Product and to assist Hologic in obtaining an approved FDA filing covering the Product. Hospira then shall manufacture and deliver Product to Hologic for sale by Hologic as a human pharmaceutical product, as herein provided. The current scope of the development project is limited to the flip top vial presentation. If requested by Hologic, the Parties will mutually agree to amend Exhibit 2.1 to include the [***] presentation, clinical product, placebo product and clinical stability testing and to amend Exhibit 3.1 to include the additional fees related thereto, and Exhibit 5.8 with respect to the price therefore.

 

2.2                               Commercially Reasonable Efforts. Each party shall use its commercially reasonable efforts to successfully complete the Project. However, the parties agree and understand that neither party hereto guarantees that the Project will be successful, nor warrants or guarantees that a marketable product will result from the Project.

 

3

 

[***] 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.

 

Article 3.                                                PAYMENT FOR HOSPIRA’S DEVELOPMENT EFFORTS

 

3.1                               Development Fee. To reimburse Hospira for its participation in the Project, Hologic shall pay to Hospira a nonrefundable development fee of [***] (the “Development Fee”) representing the sum of [***]. The Development Fee shall be paid to Hospira in accordance with the payment schedule set forth in Exhibit 3.1.

 

3.2                               Changes in Project Scope. If Hologic elects to proceed with the [***] presentation, or if changes occur in the Project, API Specifications or Product Specifications, or if technical difficulties require that Hospira perform either additional work or repeat work, and such additional work or repeat work is not required due to Hospira’s fault or negligence, Hospira shall provide Hologic with cost estimates for such work. If Hologic approves such costs, Hospira shall perform such work and Hologic shall pay Hospira’s costs for such work within [***] days of completion of such work. Reimbursement for such additional work or repeat work shall be at the rate of [***], plus out-of-pocket costs for reasonable travel and sustenance, materials and supplies.

 

3.3                               Development Supplies. After the parties mutually agree to the final Product Specifications, Hospira shall provide to Hologic development supplies at the prices set forth on Exhibit 5.8. Hologic shall issue a purchase order for any such development supplies at least [***] days before the requested delivery date. Hologic and Hospira shall jointly develop and agree mutually to the formulation, concentration, fill volume and the components for each lot of development supplies.

 

3.4                               Development Stability Studies. If Hologic chooses to have Hospira perform the registration stability studies, Hospira will complete the registration stability studies for Product as outlined in Exhibit 2.1 and according to the Payment Schedule outlined in Exhibit 3.1. Hologic shall be responsible for supplying to Hospira (from lots that Hologic purchases from Hospira under the terms of this Agreement at the applicable prices set forth herein) the number of units of Product(s) reasonably requested by Hospira to perform the stability studies. Hologic shall provide such units from stability supplies that Hospira shall provide to Hologic.

 

Article 4.                                                HOLOGIC’S REGULATORY SUBMISSIONS

 

4.1                               Hospira’s Right to Review. Hospira shall have the right to review and consult on those portions of Hologic’s proposed regulatory submissions relating to Hospira’s packaging or manufacturing procedures before the submissions are filed with the FDA. Hospira shall complete its review of the submissions as quickly as commercially reasonable but no later than [***] days after receipt of a proposed regulatory submission. Hospira shall consult with and advise Hologic in responding to questions from Regulatory Authorities regarding Hologic’s submission(s) for Product. Hologic shall be the sole owner of any regulatory submission filed pursuant to this Agreement. Exhibit 3.1 includes Hospira’s costs of review for one FDA filing and associated amendments. Hologic shall provide to Hospira for its files a final copy of the CMC section of any such regulatory submission(s).

 

4

 

[***] 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.

 

4.2                               Access to Drug Master Files. Hospira shall grant Hologic reference rights to all Drug Master Files (“DMFs”) necessary to support Hologic’s filings of Product. To effect this, Hospira shall execute certain documentation (“Letters of Authorization”) which shall be delivered to the appropriate Regulatory Authorities permitting such Regulatory Authorities to consult Hospira’s DMFs in their review of Hologic’s Product marketing applications. Hospira shall send copies of such Authorization Letters to Hologic. Hospira shall update its DMFs annually and shall inform Hologic prior to any modifications thereto in order to permit Hologic to amend or supplement any affected regulatory applications and filings for Product.

 

4.3                               User Fees. Hologic shall pay any FDA (or foreign equivalent) user fees which may become payable for Product.

 

Article 5.                                                MANUFACTURE AND SUPPLY OF PRODUCT

 

5.1                               Purchase and Sale of Product. [***].

 

5.2                               Government Approvals. Notwithstanding any other provision of this Agreement, Hospira shall have no obligation to manufacture, sell or deliver Product to Hologic and Hologic shall have no obligation to purchase and take delivery of Product for commercial sale until Hologic has obtained all necessary Regulatory Authorities’ approvals required to sell Product. However, Hospira agrees to manufacture and supply those quantities of Product requested in firm purchase orders by Hologic that are necessary to build Hologic’s inventory in anticipation of commercial launch of the Product in the United States and Hologic shall be required to pay for such Products irrespective of whether the Product ultimately receives all necessary Regulatory Authorities’ approvals.

 

5.3                               Active Pharmaceutical Ingredient

 

(a)         Supply. Hospira shall manufacture Product for Hologic from API that Hologic shall supply to Hospira [***]. Hologic shall supply API to Hospira in quantities sufficient to satisfy Hospira’s gross manufacturing requirements of Product. Hospira’s use of API received from Hologic shall be limited to development contemplated by this Agreement and the manufacture of Product for Hologic. Hologic shall deliver API FOB Destination for deliveries originating in the United States, and D.D.P. (Incoterms 2000) for deliveries originating outside the United States, to Hospira’s manufacturing plant [***] pursuant to [***] purchase orders that Hospira issues to Hologic. Within [***] days of Hospira’s receipt of any API supplied by Hologic hereunder, Hospira shall (i) perform all testing required to be performed by Hospira as specified in Exhibit 1.2 on the API and confirm the shipment quantity, and (ii) notify Hologic of any inaccuracies with respect to quantity or of any claim that any portion of the shipment fails any test required to be performed by Hospira specified in Exhibit 1.2. In the event Hospira notifies Hologic that an API shipment does

 

5

 

[***] 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.

 

not conform to the Active Pharmaceutical Ingredient Specifications, Hologic shall have the right to confirm such findings at Hospira’s manufacturing location. If the findings are confirmed by Hologic, Hologic shall notify the API supplier and Hologic will work to resolve the matter with the API supplier. Hospira will reasonably assist Hologic to resolve the discrepancies between the results of the API supplier and Hospira.

 

(b)         Title. Hologic shall retain title to the API while it is in the Hospira facility. Subject to the limitation in Section 5.3(c), Hospira shall assume responsibility and risk for the safekeeping, storage and handling for all shipments of API delivered hereunder and accepted by Hospira.

 

(c)          Replacement. In the event of any loss or damage of any API delivered hereunder or the failure of Product to meet Product Specifications, Hologic shall supply to Hospira at [***] API according to the terms set forth in Section 5.3(a). If any loss, damage or replacement of such API results from a grossly negligent act or omission by Hospira in the manufacture, handling or storage of the API or the Product, Hospira shall reimburse Hologic for its cost of such API in [***]. In no event shall Hospira’s aggregate liability for replacement of API exceed [***] per occurrence or [***] per calendar year. This section states Hologic’s sole remedy, and Hospira’s sole liability, for any loss, damage, or misuse of API.

 

(d)         Storage. Hospira shall store at no charge the lesser of (i) [***] kgs or (ii) [***] pallets of API under controlled room temperature at the [***] manufacturing facility.

 

5.4                               Dedicated Equipment Costs. If non-standard, specialized equipment is required to manufacture Product for Hologic, Hospira shall pay the cost of such equipment, subject to Hologic’s prior approval of such costs, which approval shall not be unreasonably withheld. Hospira shall advise Hologic of specialized equipment required and the estimated costs associated with the purchase, installation and validation of such equipment. After Hologic approves such costs, Hospira shall install and validate the equipment and bill Hologic for the costs of purchasing, installing and validating the equipment. Hologic shall make payment to Hospira no later than [***] days after Hologic receives an invoice from Hospira. Title to the equipment shall be in Hologic’s name. If Hospira wishes to use the specialized equipment for manufacture of a product other than Product for Hologic, Hospira and Hologic shall meet and discuss the technical and practical ramifications of such use and appropriate compensation to Hologic.

 

5.5                               Product Labeling. Hospira shall label Product in accordance with label copy that Hologic provides. Such copy may be modified from time to time by agreement of the parties. Hologic shall reimburse Hospira for Hospira’s actual costs of making any label copy changes and for the cost of any labeling that Hospira is unable to use due to such label copy changes not

 

6

 

[***] 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.

 

to exceed the amount of labels reasonably required by Hospira based on the first [***] months of the most recent [***] rolling forecast provided under Section 6.1 or such other amount as mutually agreed upon in writing.

 

5.6                               Delivery. Hospira shall deliver Product to Hologic, FOB origin Hospira’s manufacturing plant at [***] or such other facility as may be agreed upon in writing by the parties. Title and risk of loss shall pass to Hologic at such point. Shipment shall be via a carrier designated by Hologic. Hospira shall make up to [***] shipments to Hologic of Product per batch at [***]. Any other shipments requested shall be at [***].

 

5.7                               Storage. Products generated from any engineering, registration or process validation or verification batches will be stored at no charge at Hospira’s [***] facility at controlled room temperature until FDA Approval of the Product.

 

5.8                               Price and Payment.

 

(a)         Price. [***].

 

(b)         Payment. [***].

 

(c)          Taxes. Any federal, state, county or municipal sales or use tax, excise, customs charges, duties or similar charge, or any other tax assessment (other than that assessed against income), license, fee or other charge lawfully assessed or charged on the manufacture, sale or transportation of Product sold pursuant to this Agreement, and all government license filing fees and Prescription Drug User (PDUFA) annual establishment fees with respect to all Product shall be paid by Hologic.

 

(d)         Process Rework. Process rework created as a result of Hologic’s changes shall be billed separately at a reasonable fee mutually agreed upon in writing.

 

(e)          Sub-lots. Should Hologic desire Hospira to split a manufacturing lot of Product into several sub-lots during packaging, there will be a split fee of [***] for each sub-lot packaged.

 

5.9                               Annual Marketed Product(s) Stability Supplies and Studies: If Hologic requests, Hospira will perform Annual Marketed Product Stability (AMPS) studies (one lot per calendar year per Product configuration) at service prices set forth in Exhibit 5.8. AMPS studies will be based on the storage conditions specified in Exhibit 5.8. Billing for the service cost of each AMPS will be at the time each study commences. Hologic shall be responsible for supplying to Hospira (from lots that Hologic purchases from Hospira under the terms of this Agreement at the prices set forth in Section 5.8) the number of units of Product reasonably requested by Hospira to perform the AMPS.

 

7

 

[***] 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.

 

5.10                        Replacement of Nonconforming Shipment. Hologic shall have a period of [***] days from the date of its receipt of a shipment of Product to inspect and reject such shipment for nonconformance with the Product Specifications. If Hologic rejects such shipment, it shall promptly so notify Hospira and provide to Hospira samples of such shipment for testing. If Hospira tests such shipment and determines that it did conform to the Product Specifications, the parties shall submit samples of such shipment to a mutually acceptable independent laboratory for testing. If such independent laboratory determines that the shipment conformed to the Product Specifications, Hologic shall bear [***] expenses of shipping and testing such shipment samples. If Hospira or such independent laboratory confirms that such shipment did not meet the Product Specifications, Hospira shall replace, [***], that portion of the Product shipment which does not conform to the Product Specifications, and shall bear [***] expenses of shipping and testing the shipment samples. Any nonconforming portion of any shipment shall be disposed of as directed by Hospira, at Hospira’s expense. Any Product that Hologic does not reject pursuant to this Section 5.10 shall be deemed accepted, and all claims with respect to Product not conforming with Product Specifications shall be deemed waived by Hologic, except as to latent defects which are not reasonably discoverable, render the Product not conforming to Product Specifications, and are solely caused by Hospira.

 

Article 6.                                                COMMERCIAL ORDERS AND FORECASTS

 

6.1                               Commercial Orders. For the sake of clarity, the provisions of the Article 6 apply only to commercial Products and not to Products to be used in clinical trials (Development Supplies).

 

(a)         First Firm Order. Hologic shall place its first firm order approximately six (6) months in advance of the desired Product availability date. At the same time, Hologic shall provide to Hospira Hologic’s estimate of its [***] requirements of Product to be supplied by Hospira for the next succeeding [***] period.

 

(b)         Rolling Forecast. After issuing the first firm order in accordance with Section 6.1(a), Hologic shall be required to issue rolling forecast to Hospira in accordance with this Section. For the first [***] Contract Years, Hologic shall provide monthly to Hospira a rolling [***] month forecast of requirements of Product to be supplied by Hospira. The first [***] months of such forecast shall constitute a binding commitment upon Hologic to purchase such quantities and Hologic shall issue, concurrently with such forecast, a purchase order for the month of that forecast which was not included in the firm order period of the previous forecast. The remaining [***] months of such forecast shall consist of Hologic’s best estimate projection of its Product requirements. After the first [***] Contract Years, Hologic shall provide quarterly to Hospira a rolling [***] month forecast of requirements of Product to be supplied by Hospira. The first [***]of such forecast shall constitute a binding commitment upon Hologic to purchase

 

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[***] 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.

 

such quantities and Hologic shall issue, concurrently with such forecast, a purchase order for the quarter of that forecast which was not included in the firm order period of the previous forecast. The remaining [***] of such forecast shall consist of Hologic’s best estimate projection of its Product requirements.

 

(c)          Purchase Order Acceptance. Within [***] days after receipt of Hologic’s firm purchase orders for Product issued in accordance with Section 6.1, Hospira shall accept or reject of the purchase order, delivery date and quantity of Product ordered by Hologic.

 

(d)         Firm Commercial Order Changes or Cancellations. If, due to significant unforeseen circumstances, Hologic requests changes to firm purchase orders of Product within the firm purchase order timeframe, Hospira shall attempt to accommodate the changes within reasonable manufacturing capabilities and efficiencies. If Hospira can accommodate such change, Hospira shall advise Hologic of the costs associated with making any such change and Hologic shall be deemed to have accepted the obligation to pay Hospira for such costs if Hologic indicates in writing to Hospira that Hospira should proceed to make the change. Hospira shall charge Hologic the amount previously agreed upon in writing by Hologic for making any such change. If Hospira cannot accommodate such change, Hologic shall be bound to the original firm purchase order. If Hologic cancels a firm purchase order, Hospira shall be relieved of its obligation relating to such order but Hologic will not be relieved of its obligation of payment unless Hospira agrees to waive Hologic’s obligation of payment in writing. If Hologic does not supply sufficient API to manufacture such order or acts in any other manner to effectively interfere with Hospira’s ability to perform, which shall be deemed to be a breach of this Agreement, Hologic shall remain liable for the full amount of the firm purchase order regardless of whether such Product is manufactured by Hospira or whether Hologic takes delivery of any such manufactured Product. Notwithstanding anything to the contrary contained herein, all Product paid for by Hologic shall count toward the Minimum Commercial Purchase Requirement (as described in Section 6.3) of Product including, without limitation, any payments made in the event of a cancellation.

 

(e)          Purchase Order Terms. Each purchase order or any acknowledgment thereof, whether printed, stamped, typed, or written shall be governed by the terms of this Agreement and none of the provisions of such purchase order or acknowledgment shall be applicable except those specifying Product and quantity ordered, delivery dates, special shipping instructions and invoice information.

 

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[***] 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.

 

6.2                               [***] Year Product Supply Forecast. For capacity planning purposes, at the time of filing approval, Hologic shall provide Hospira with a written forecast of Hologic’s annual requirements of Product for the first [***] calendar years. Thereafter, by September 1st of each calendar year Hologic shall update such rolling [***] forecast of its requirements of Product for the period commencing on January 1st of the next calendar year.

 

6.3                               Minimum Purchase Requirement. [***].

 

6.4                               Best Efforts to Supply. Should Hologic order additional quantities of Product in excess of [***] over the previously forecasted amount for any month or quarter, as applicable, Hospira shall not be under any obligation to supply said additional quantities; provided, however, that Hospira shall, use reasonable commercial efforts to produce and deliver to Hologic said additional quantities within [***] of issuance of the purchase order for such additional quantities.

 

Article 7.                                                QUALITY

 

7.1                               Quality Control. Hospira shall apply its quality control procedures and in-plant quality control checks on the manufacture of Product for Hologic in the same manner as Hospira applies such procedures and checks to products of similar nature manufactured for sale by Hospira. In addition, Hospira will test and release Product in accordance with the test methods described in Exhibit 7.1 to ensure that Product conforms to the Product Specifications. The parties may change the test methods from time to time by mutual agreement.

 

7.2                               Quality Agreement. The parties shall enter into a quality agreement substantially in the form of the agreement attached hereto as Exhibit 7.2 within [***] days following the Effective Date.

 

7.3                               Audit Rights.

 

(a)               General. Hologic shall have the right, upon [***] days prior written notice to Hospira, to conduct, at its sole expense and during normal business hours, a quality assurance audit and inspection of Hospira’s records and production facilities relating to the manufacturing, assembly and/or packaging of Product. Such audits shall (a) be limited to not more than [***] auditors appointed or representing Hologic, (b) last for not more than [***] days and (c) may be conducted not more than [***] per calendar year. Any auditors that are not employees of Hologic shall be required to enter into confidentiality agreements with Hospira and Hologic containing terms of confidentiality at least as stringent as those set forth in Article 11 hereof.  Visits by Hologic to Hospira production facilities may involve the transfer of Confidential Information, and any such Confidential Information shall be subject to the terms of Article 11 hereof.  The results of such audits and inspections shall be considered Confidential Information

 

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[***] 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.

 

under Article 11 and shall not be disclosed to Third Parties, [***] unless required by law and only then upon prior written notice to Hospira.

 

(b)         Third Party. Hospira also agrees to allow the FDA to conduct any audit which they require and Hospira agrees to reasonably cooperate with the FDA authority in connection with such audit.

 

(c)          For-Cause Audits. Will be permitted as described in the Quality Agreement.

 

7.4                               Customer Representative in Plant.

 

(a)         In addition to the audit rights stated in Section 7.3, Hospira shall also permit a representative of Hologic (“Customer Representative”) to be present in the [***] production facilities to view certain Product manufacturing steps via closed circuit television during periods of time when the Product is being manufactured, provided that such Customer Representative complies with: (i) all applicable state and federal laws prior to and during such visits; and (ii) generally, all applicable Hospira corporate and security policies and procedures. While at the [***] facility, the Customer Representative shall have access solely to such areas of the facility that are: (i) reasonably related to view the manufacturing steps via closed circuit television; (ii) food-service areas; (iii) designated office space as may be allocated to the Customer Representative; (iv) public areas within the facility; or (v) as otherwise authorized by Hospira. Hologic acknowledges and agrees that such Customer Representative visiting the [***] facility shall be bound by terms of confidentiality no less restrictive than those set forth in Article 11.

 

(b)         With respect to any Customer Representative, Hospira shall provide at no cost to Hologic: (i) access to an on-site office; (ii) a conference room (if necessary for meetings), access to which shall be available per the scheduling process used by Hospira employees; (iii) parking facilities and toilet facilities; as well as (iv) reasonable access to and use of telephone, facsimile and photocopying services as necessary.

 

7.5                               Notification of Complaints. Hologic shall notify Hospira promptly of any Product complaints involving Hospira’s manufacture or packaging in sufficient time to allow Hospira to evaluate the complaints and assist Hologic in responding to such complaints.

 

7.6                               Product Recalls. In the event (a) any Regulatory Authority or other national government authority issues a request, directive or order that Product be recalled, (b) a court of competent jurisdiction orders such a recall, or (c) Hologic or Hospira reasonably determines that Product should be recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. In the event that such recall results from the breach of Hospira’s express warranties under Section 8.2(a) or (b) of this 

 

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[***] 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.

 

Agreement, Hospira shall be responsible for the expenses of the recall up to a maximum of [***]. In the event that the recall does not result from the breach of Hospira’s express warranties under this Agreement, Hologic shall be responsible for the expenses of the recall. For purposes of this Agreement, the expenses of the recall shall include, but not be limited to, the expenses of notification and destruction or return of the recalled Product, cost of the recalled Product, and any costs associated with the distribution of the replacement Product, but shall not include lost profits of either party.

 

Article 8.                                                WARRANTIES; COVENANTS AND INDEMNIFICATION

 

8.1                               Hologic’s Warranties.

 

(a)         Hologic represents and warrants to Hospira that all API delivered to Hospira pursuant to this Agreement shall, at the time of delivery, not be adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, as amended, (the “Act”) or within the meaning of any applicable state or municipal law in which the definitions of adulteration and misbranding are substantially the same as those contained in the Act, as the Act and such laws are constituted and effective at the time of delivery and will not be an article which may not under the provisions of Sections 404 and 505 of the Act be introduced into interstate commerce.

 

(b)         Hologic further warrants to Hospira that API supplied to Hospira hereunder shall meet the API Specifications set forth on Exhibit 1.2.

 

(c)          Hologic further warrants that all specifications including Active Pharmaceutical Ingredient Specifications and Product Specifications Hologic provides to Hospira shall conform with the appropriate NDA Hologic files with the FDA.

 

(d)         Hologic further represents and warrants to Hospira that Hologic’s performance of its obligations under this Agreement will not result in a material violation or breach of any agreement, contract, commitment or obligation to which Hologic is a party or by which it is bound and will not conflict with or constitute a default under its corporate charter or bylaws.

 

(e)          Hologic further represents and warrants that it will not sell Product into any jurisdiction unless and until it receives the necessary Regulatory Authority approvals. For the sake of clarity, Hologic may not market, sell, or distribute any Product supplied by Hospira under this Agreement outside of the United States without Hospira’s prior written consent.

 

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[***] 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.

 

8.2                               Hospira’s Warranties and Covenants.

 

(a)         Hospira represents and warrants to Hologic that Product Hospira delivers to Hologic pursuant to this Agreement shall, at the time of delivery, not be adulterated or misbranded within the meaning of the Act or within the meaning of any applicable state or municipal law in which the definitions of adulteration and misbranding are substantially the same as those contained in the Act, as the Act and such laws are constituted and effective at the time of delivery and will not be an article which may not under the provisions of Sections 404 and 505 of the Act be introduced into interstate commerce.

 

(b)         Hospira further represents and warrants to Hologic that Product Hospira delivers to Hologic pursuant to this Agreement shall, at the time of delivery, be free from defects in material and workmanship and shall be manufactured: (a) in accordance and conformity with the Product Specifications; and (b) in compliance with all applicable statutes, laws, rules or regulations, including those relating to the environment, food or drugs and occupational health and safety, including, without limitation, those enforced or promulgated by the FDA (including, without limitation, compliance with cGMPs).

 

(c)          Hospira further represents and warrants to Hologic that Hospira’s performance of its obligations under this Agreement will not result in a material violation or breach of any agreement, contract, commitment or obligation to which Hospira is a party or by which it is bound and will not conflict with or constitute a default under its Certificate of Incorporation or corporate bylaws.

 

(d)         The foregoing warranties shall not extend to any nonconformity or defect which relates to or is caused by API supplied by Hologic to Hospira. Subject to Section 8.3, the replacement provisions of Sections 5.3(c) shall be Hologic’s sole and exclusive remedy for nonconforming or defective Product.

 

(e)          HOSPIRA MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY HOSPIRA.

 

8.3                               Indemnification by Hospira. Hospira shall indemnify and hold harmless Hologic, its Affiliates, officers, directors and employees from and against all claims, causes of action, suits, costs and expenses (including reasonable attorney’s fees), losses or liabilities of any kind related to this Agreement and asserted by third parties to the extent such arise out of or are attributable to: (a) Hospira’s breach of any representation or warranty set forth in Section 8.2(a)

 

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[***] 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.

 

(b) or (c); (b) any violation of any proprietary right of any Third Party relating to Hospira’s manufacturing processes used in the manufacture of Product pursuant to this Agreement (excluding the Active Pharmaceutical Ingredient Specifications, Product Specifications, API, Drug or Product); or (c) any negligent or wrongful act or omission on the part of Hospira, its employees, agents or representatives and which relate to Hospira’s performance hereunder.

 

8.4                               Indemnification by Hologic. Hologic shall indemnify and hold harmless Hospira, its Affiliates, officers, directors and employees harmless from and against all claims, causes of action, suits, costs and expenses (including reasonable attorney’s fees), losses or liabilities of any kind related to this Agreement and asserted by third parties to the extent such arise out of or are attributable to (a) Hologic’s breach of any representation or warranty set forth in Section 8.1; (b) any violation of any proprietary right of any Third Party relating to the Active Pharmaceutical Ingredient Specifications, Product Specifications, API, Drug or Product, other than Hospira’s manufacturing processes used in the manufacture of Product pursuant to this Agreement; (c) the use of or lack of safety or efficacy of Drug or Product; and (d) any negligent or wrongful act or omission on the part of Hologic, its employees, agents or representatives and which relate to Hologic’s performance hereunder.

 

8.5                               Conditions of Indemnification. If either party seeks indemnification from the other hereunder, it shall promptly give notice to the other party of any such claim or suit threatened, made or filed against it which forms the basis for such claim of indemnification and shall cooperate fully with the other party in the investigation and defense of all such claims or suits. The indemnifying party shall have the option to assume the other party’s defense in any such claim or suit with counsel reasonably satisfactory to the other party. No settlement or compromise shall be binding on a party hereto without its prior written consent, such consent not to be unreasonably withheld.

 

8.6                               No Consequential Damages. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF THIS AGREEMENT EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

Article 9.                                                INTELLECTUAL PROPERTY RIGHTS

 

9.1                               Hospira’s Proprietary Rights. Hospira has granted no license, express or implied, to Hologic to use Hospira proprietary technology, know-how or other proprietary rights (i) existing as of the Effective Date, or (ii) developed by or for Hospira on or after the Effective Date outside the scope of any Project undertaken by Hospira pursuant to this Agreement. Hospira shall be the sole owner of any proprietary technology, know-how or other proprietary rights developed by or for Hospira pursuant to any Project undertaken by Hospira (the “Project Inventions”). However, Hospira shall grant to Hologic, and does hereby grant to Hologic, an exclusive (even as to Hospira), royalty-free, paid up, worldwide, perpetual license under such Project Inventions to make, have made, use, offer for sale, sell, and/or import Drug and Product.

 

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[***] 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.

 

9.2                               Hologic’s Proprietary Rights. Hologic has granted no license, express or implied, to Hospira to use Hologic’s proprietary technology, know-how or other proprietary rights other than for the purposes of this Agreement.

 

Article 10.                                         TERM AND TERMINATION

 

10.1                        Term. [***].

 

10.2                        Termination of Product Development Project. [***].

 

10.3                        Failure to Obtain Regulatory Approval. Either party may terminate this Agreement by giving to the other party [***] months prior written notice if the Product has not received FDA regulatory approval by July 1, 2012.

 

10.4                        General Termination Rights. Either party may terminate this Agreement as follows:

 

(a)         Immediately by providing written notice upon the bankruptcy or the insolvency of the other party; or

 

(b)         By giving to the other party [***] days’ prior written notice upon the breach of any warranty or any other material provision of this Agreement by the other party if the breach is not cured within [***] days after written notice thereof to the party in default. Notwithstanding the previous sentence, Hospira shall not have the right to terminate this Agreement based on a breach of Hologic’s representations and warranties under Section 8.1(a) or (b) of this Agreement if (i) at the time of such breach Hospira still has a sufficient amount of remaining inventory of API, which meets the warranties under Section 8.1(a) and (b), to satisfy Hospira’s gross manufacturing requirements of Product under this Agreement or (ii) Hologic is using reasonable commercial efforts to cure the breach as soon as reasonably possible.

 

10.5                        Accrued Payment Obligations. Upon termination pursuant to this Article 10, Hologic shall reimburse Hospira for Hospira’s cost of all supplies purchased and on hand or on order, if such supplies were ordered by Hospira based on firm purchase orders or Hologic’s estimates of its requirements of Product, and such supplies cannot be reasonably used by Hospira for other purposes. Hospira shall invoice Hologic for all amounts due hereunder. Payment shall be made pursuant to Section 5.8.

 

10.6                        Return of Inventory. In the event of any termination, Hospira shall return any remaining inventory of API and Product to Hologic at Hologic’s expense, unless such termination shall have been as a result of a breach of this Agreement by Hospira, in which case such inventory shall be returned at Hospira’s expense.

 

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[***] 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.

 

10.7                        Survival. Expiration or early termination of this Agreement shall not relieve either party of any obligations that it may have incurred prior to expiration or early termination and all covenants and agreements contained in this Agreement, which by their terms or context are intended to survive, will continue in full force and effect for a period of [***] years unless a different time period is indicated in this Agreement.

 

Article 11.                                         CONFIDENTIAL INFORMATION

 

11.1                        Nondisclosure. It is contemplated that in the course of the performance of this Agreement each party may, from time to time, disclose Confidential Information to the other. Hospira agrees that, except as expressly provided herein, it shall not disclose Confidential Information received from Hologic, and shall not use Confidential Information disclosed to it by Hologic, for any purpose other than to fulfill Hospira’s obligations hereunder. Hologic agrees that, except as expressly provided herein, it shall not disclose Confidential Information received from Hospira, and shall not use Confidential Information disclosed to it by Hospira, for any purpose other than to fulfill Hologic’s obligations hereunder.

 

11.2                        Exceptions to Duty of Nondisclosure. Notwithstanding the above, nothing contained in this Agreement shall preclude Hologic or Hospira from utilizing Confidential Information as may be necessary in prosecuting patent rights of either party pursuant to Article 9, obtaining governmental marketing approvals, manufacturing Product pursuant to the terms and conditions of this Agreement, or complying with other governmental laws and regulations or court orders (provided that the party disclosing such information uses reasonable efforts to seek confidential treatment of such information, except as required to file and prosecute such patent applications). The obligations of the parties relating to Confidential Information shall expire [***] years after the termination of this Agreement.

 

11.3                        Public Announcements. Neither party shall make any public announcement concerning the transactions contemplated herein, or make any public statement which includes the name of the other party or any of its Affiliates, or otherwise use the name of the other party or any of its Affiliates in any public statement or document, except as may be required by law or judicial order, without the written consent of the other party, which consent shall not be unreasonably withheld. Subject to any legal or judicial disclosure obligation, any such public announcement proposed by a party that names the other party shall first be provided in draft to the other party.

 

11.4                        Injunctive Relief. The parties acknowledge that either party’s breach of this Article 11 may cause the other party irreparable injury for which it would not have an adequate remedy at law. In the event of a breach, the non-breaching party may be entitled to injunctive relief in addition to any other remedies it may have at law or in equity

 

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Article 12.                                         MISCELLANEOUS

 

12.1                        Force Majeure and Failure of Suppliers.

 

(a)         Excusable Delay. Any delay in the performance of any of the duties or obligations of either party hereto (except the payment of money) shall not be considered a breach of this Agreement and the time required for performance shall be extended for a period equal to the period of such delay, provided that such delay has been caused by or is the result of any acts of God, acts of the public enemy, insurrections, riots, embargoes, labor disputes, including strikes, lockouts, job actions, boycotts, fires, explosions, floods, shortages of material or energy, or other unforeseeable causes beyond the control and without the fault or negligence of the party so affected. The affected party shall give prompt notice to the other party of such cause, and shall take promptly whatever reasonable steps are necessary to relieve the effect of such cause.

 

(b)         Transfer of Production. If Hospira becomes subject to an event of force majeure which interferes with production of Product at Hospira’s [***] plant, the parties shall mutually agree on implementation of an agreed-upon action plan to transfer production of Product to another Hospira plant. The parties shall, after the execution of this Agreement and at the request of either party, meet to discuss and define such an action plan.

 

(c)          Failure of Suppliers. The parties understand and agree that Hologic has chosen the excipient and primary container packaging component suppliers listed in the Product Specifications. Under no circumstances shall Hospira have any liability to Hologic, nor shall Hospira be deemed to be in breach of this Agreement, if Hospira is unable to supply Product to Hologic due to a failure of such suppliers to provide such excipients and/or primary container packaging components to Hospira.

 

12.2                        Notices. All notices hereunder shall be delivered as follows: (a) personally; (b) by registered or certified mail (postage prepaid); or (c) by overnight courier service, to the following addresses of the respective parties:

 

If to Hologic:
 35 Crosby Drive
 Bedford Massachusetts 01730
 Attention: General Counsel

 

If to Hospira:
 Hospira, Inc.
 275 North Field Drive
 Lake Forest, Illinois 60045
 Attn: VP & GM Contract Manufacturing Services

 

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[***] 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.

 

With copy to:
 Hospira, Inc.
 Attention: General Counsel
 Building HI; Department NLEG
 275 N. Field Drive
 Lake Forest, IL 60045

 

Notices shall be effective upon receipt if personally delivered, on the third business day following the date of registered or certified mailing or on the first business day following the date of or delivery to the overnight courier. A party may change its address listed above by written notice to the other party.

 

12.3                        Choice of Law. This Agreement shall be construed, interpreted and governed by the laws of the State of New York, excluding its choice of law provisions. The United Nations Convention on the International Sale of Goods is hereby expressly excluded.

 

12.4                        Dispute Resolution. The parties recognize that bona fide disputes may arise which relate to the parties’ rights and obligations under this Agreement. In the event of a dispute, the parties mutually agree that except as provided in Section 5.10 and 11.4, any such dispute shall be resolved by alternative dispute resolution in accordance with the procedure set forth in Exhibit 12.4..

 

12.5                        Assignment. Neither party shall assign this Agreement nor any part thereof without the prior written consent of the other party; provided, however; (a) either party may assign this Agreement to one of its wholly-owned subsidiaries or its parent corporation without such consent; and (b) either party, without such consent, may assign this Agreement in connection with the transfer, sale or divestiture of all or substantially all of its business to which this Agreement pertains or in the event of its merger or consolidation with another company. Any permitted assignee shall assume all obligations of its assignor under this Agreement. No assignment shall relieve any party of responsibility for the performance of any accrued obligation which such party then has hereunder. Hologic shall ensure that any and all distributors and wholesalers who have the right to distribute and/or sell the Product in the United States shall acquire the Products from Hologic the Products supplied by Hospira under the terms of this Agreement and that in the event that Hologic, sells, assigns, licenses or otherwise conveys, in any manner, any of its rights or interests into Gestiva, Hologic will assign this Agreement as part of such transfer.

 

12.6                        Entire Agreement. This Agreement, together with the Exhibits referenced and incorporated herein, constitute the entire agreement between the parties concerning the subject matter hereof and supersede all written or oral prior agreements or understandings with respect thereto.

 

12.7                        Severability. This Agreement is subject to the restrictions, limitations, terms and conditions of all applicable governmental regulations, approvals and clearances. If any term or 

 

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provision of this Agreement shall for any reason be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other term or provision hereof, and this Agreement shall be interpreted and construed as if such term or provision, to the extent the same shall have been held to be invalid, illegal or unenforceable, had never been contained herein.

 

12.8                        Waiver-Modification of Agreement. No waiver or modification of any of the terms of this Agreement shall be valid unless in writing and signed by authorized representatives of both parties. Failure by either party to enforce any such rights under this Agreement shall not be construed as a waiver of such rights, nor shall a waiver by either party in one or more instances be construed as constituting a continuing waiver or as a waiver in other instances.

 

12.9                        Insurance. Each party will procure and maintain, at its own expense, for the duration of the Agreement, and for [***] years thereafter if written on a claims made or occurrence reported form, the types of insurance specified below with carriers rated A- VII or better with A. M. Best or like rating agencies:

 

a.              Workers’ Compensation accordance with applicable statutory requirements and shall provide a waiver of subrogation in favor of the other party;

 

b.              Employer’s Liability with a limit of liability in an amount of not less than $[***];

 

c.               Commercial General Liability including premises operations, products & completed operations, blanket contractual liability, personal injury and advertising injury including fire legal liability for bodily injury and property damage in an amount not less than $[***] per occurrence and $[***] in the aggregate;

 

d.              Commercial Automobile Liability for owned, hired and non-owned motor vehicles with a combined single limit in an amount not less than $[***] each occurrence;

 

e.               Excess Liability including products liability with a combined single limit in an amount of not less than $[***] per occurrence and in the aggregate;

 

Each party shall include the other party and its Affiliates, directors, officers, employees and agents as additional insureds with respect to Commercial General Liability, Commercial Automobile Liability and Excess Liability but only as their interest may appear by written contract. Prior to commencement of services, and annually thereafter, each party shall furnish to the other party certificates of insurance evidencing the insurance coverages stated above and shall require at least [***] days written notice to the other party prior to any cancellation, non-renewal or material change in said coverage. In the case of cancellation, non-renewal or material change in said coverage, each party shall promptly provide to the other party with a new 

 

19

 

[***] 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.

 

certificate of insurance evidencing that the coverage meets the requirements in this Section. Each party agrees that its insurance shall act as primary and noncontributory from any other valid and collectible insurance maintained by the other party. Each party may, at its option, satisfy, in whole or in part, its obligation under this Section through its self- insurance program.

 

12.10                 Exhibits. All Exhibits referred to herein are hereby incorporated by reference.

 

12.11                 Debarment Warranty. Hospira and Hologic represent and warrant that neither party uses nor will use in the future use in any capacity the services of any person debarred under Section (a) or (b) of 21 U.S.C. Section 335a.

 

20

 

[***] 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.

 

IN WITNESS WHEREOF, the parties intending to be bound by the terms and conditions hereof have caused this Agreement to be signed by their duly authorized representatives as of the date first above written.

 

	
HOSPIRA   WORLDWIDE, INC.
    	
HOLOGIC,   INC
    
	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/   Tony Cacich
    	
 
    	
By:
    	
/s/   Robert A. Cascella
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Tony   Cacich
    	
 
    	
Name:
    	
 Robert A. Cascella
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
VP   & GM Contract Manufacturing Services
    	
 
    	
Title:
    	
President
    

 

21

 

[***] 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.

 

Exhibit 1.2

 

Active Pharmaceutical Ingredient, Hydroxyprogesterone Caproate [***], Specifications

 

	
Test Method
    	
 
    	
Acceptance

Criteria
    	
 
    	
Method of
   Acceptance
    
	
Appearance   (Visual)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Color   (Visual)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Visible   impurities (Visual)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Identification   (USP 31 <197K>; FTIR, BPS SOP 303-08-03-001)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Assay   (USP 31 UV Spectroscopy)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Free   Caproic Acid (USP 31 Titrimetric Assay)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Melting   Point (USP 31 <741> Class Ia)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Related   Substances (Ordinary Impurities)- total (USP 31 <466>TLC)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Residual Solvents (Gas Chromatography)

Cyclohexane

Hexane

Methanol

Methylene chloride
    	
 
    	
[***]

 

 
    	
 
    	
Hospira to Test
    
	
Specific   Rotation (USP 31 <781S>; 25°C/1% in chloroform/anhydrous substance)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Water   (USP 31 Method I <921>; KF)
    	
 
    	
[***]
    	
 
    	
Hospira to Test
    
	
Bioburden   [EP 2.6.12; Microbial Examination of Non-Sterile   Products (Total Viable Aerobic Count)]
    	
 
    	
[***]
    	
 
    	
Vendor CoA
    
	
Endotoxin

(USP   31 <85>; Gel-Clot Limit Test)
    	
 
    	
[***]
    	
 
    	
Vendor CoA
    

 

22

 

[***] 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.

 

Exhibit 1.9

 

17P Drug Product Specifications

 

	
Finished Product Test
    	
 
    	
Specification
    
	
Assay   (Hydroxyprogesterone Caproate content)*
    	
 
    	
[***]
    
	
Identification
    	
 
    	
[***]
    
	
Purity*

Total

1.   17 alpha-Hydroxyprogesterone (RRT: 0.35)

2.   Specified (RRTs: 0.49,
   0.76, 0.83 and 1.24)

3.   Unspecified
    	
 
    	
[***]
    
	
Benzyl   Alcohol*
    	
 
    	
[***]
    
	
Water   Content
    	
 
    	
[***]
    
	
Volume   Recovery
    	
 
    	
[***]
    
	
Visual   Inspection (Appearance)*
    	
 
    	
[***]
    
	
Particulate   Matter*
    	
 
    	
[***]
    
	
Bacterial   Endotoxin*
    	
 
    	
[***]
    
	
Sterility*
    	
 
    	
[***]
    

 

* [***]

 

23

 

[***] 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.

 

Exhibit 2.1

 

Project Development Activities

 

	
Milestone I
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Project Initiation
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Product   and process evaluation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Identify   filling line requirements
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Initiate   technical transfer
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
X
    	
 
    	
 
    
	
Project   management
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Price:
    	
 
    	
$[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Payment:
    	
 
    	
Following   kick-off
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Timing:
    	
 
    	
July   2009
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

	
 
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Equipment
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Dedicated   compounding tank
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
[***]
    
	
Dedicated   solution path parts
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Other   dedicated equipment
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Filling   needles, cams as determined from feasibility study
    
	
Price:
    	
 
    	
Approximately   $[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

24

 

[***] 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.

 

	
Milestone II
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Project Development
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Formulation   development
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Lyophilization   cycle development
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Sterilization   cycle development
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Develop   analytical methods (incoming API, excipients, in-process, release)
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
[***]
    
	
Validate   analytical methods
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
Hologic   to provide [***] validation packages
    
	
Transfer   analytical methods
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
X
    	
 
    	
$[***]
    
	
Develop   product cleaning method
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
Provide   [***] validation package
    
	
Validate   product cleaning method
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
[***]
    
	
Material   contact study
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Review   [***] study to determine if it’s acceptable for substitution $[***]
    
	
Incoming   API BET method development/validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
Provided   on [***]
    
	
Incoming   API aerobic microbial count method development/validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
Provided   on [***]
    
	
In-process   bioburden method development/validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    
	
Finished   product BET method development/validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]
    
	
Finished   product sterility method development/validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]
    
	
Perform,   freeze/thaw study
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Perform   ad-mixture study
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Perform   stopper extractable studies
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
X
    	
 
    	
Hospira   to complete study for [***]- $[***]
    
	
Perform   stopper moisture studies and drying process development
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]
    

 

25

 

[***] 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.

 

	
Milestone II
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Project Development
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Generate   test method and specification documentation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Hologic   to provide [***] TM validation reports - $[***]
    
	
Prepare   batch records
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Hologic   to provide copy of [***] MBR - $[***]
    
	
Prepare   new commodity specifications (vial, stopper, seal)
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]
    
	
Price:
    	
 
    	
$[***]
    	
 
    	
 
    	
 
    	
 
    
	
Payment:
    	
 
    	
On   approved product monograph for Gestiva. Product monograph consists of the   [***].
    	
 
    	
 
    	
 
    	
 
    
	
Timing:
    	
 
    	
October   2009
    	
 
    	
 
    	
 
    	
 
    

 

26

 

[***] 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.

 

	
Milestone   III

Engineering   and
   Registration Batch 
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    	
 
    	
 
    
	
Production
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Price
    	
 
    	
Comment
    
	
R&D   pilot plant batch
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Engineering   batch
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
[***]   L-

$[***]

 

[***]   L-

$[***]
    	
 
    	
[***]   L completed prior to exhibit batches, [***] L completed prior to PV batches
    
	
Clinical   batch
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Price   is batch size dependent
    
	
Placebo   batch
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Price   is batch size dependent
    
	
Registration   batch
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
[***]   L Split Fill - $[***]

 

[***]   L
   No split - $[***]
    	
 
    	
Split   fill one registration batch with [***] and [***] stopper. Other two   registration batches will be with [***] stopper.  Analytical testing to be completed by [***]   if tech transfer not completed.
    
	
Payment:
    	
 
    	
Prior   to each lot production
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Timing:
    	
 
    	
Engineering   [***] L - September 2009  
   Exhibit Batch [***] L - October 2009  
   Engineering [***] L - Q2 2010  
   Process Validation/Commercial - Q2 2010
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

27

 

[***] 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.

 

	
Milestone   IV

Process   Validation
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
and   Review
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Develop   product validation plan
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]
    
	
Equipment   cleaning validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]
    
	
Freezer   validation
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Tank   validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Includes   tank, dispenser, and all fill line components - $[***]
    
	
Lyophilization   validation
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
D/z   determination
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Filter   validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    
	
Shipping   validation studies
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    
	
Container   closure study (3 runs)
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]
    
	
Media   fill validation (3 runs)
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Solution   hold time validation (3 runs)
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Hologic   to provide [***] process validation package - $[***]
    
	
Mix   time/full uniformity validation (3 runs)
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Hologic   to provide [***] process validation package - $[***]
    
	
Stopper   Drying Validation
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
Complete   for the [***] and [***] stopper - $[***]
    
	
Price:
    	
 
    	
$[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Payment:
    	
 
    	
1⁄2   upon approval of protocols 
   1⁄2 upon approval of validation report
    	
 
    	
 
    
	
Timing:
    	
 
    	
Q2   2010
    	
 
    	
 
    

 

	
Milestone   V

Regulatory   Filing
   Preparation and 
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Submission
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Prepare   and review regulatory filings (specify # of filings in comments)
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
Original   NDA CMC sections, amendments, including April, September 2008 and   June 2009 IND
    
	
Prepare/review   deficiency responses
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
X
    	
 
    	
United   States Only
    
	
Support   quality assurance reviews and audits
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
United   States Only
    

 

28

 

[***] 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.

 

	
Milestone   V

Regulatory   Filing
   Preparation and 
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Submission
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Perform   readiness assessment prior to pre-approval inspection
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
United   States Only
    
	
Support   regulatory agency inspection
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
United   States Only
    
	
Post-approval   support of filings
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
United   States Only
    
	
Quality   agreement development
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
United   States Only
    
	
Price:
    	
 
    	
$[***]
    	
 
    	
If   additional support required, Hospira will bill at a rate of $[***].
    
	
Payment:
    	
 
    	
Upon   submission
    	
 
    	
 
    
	
Timing:
    	
 
    	
Q2   2010
    	
 
    	
 
    

 

29

 

[***] 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.

 

	
Milestone   VI 
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Commercialization
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Comment
    
	
Final   product — primary labeling development
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Final   product - product insert development
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Final   product — unit carton development
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Revise   monographs, specifications, and batch records
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    
	
Price:
    	
 
    	
$[***]
    	
 
    	
 
    
	
Payment:
    	
 
    	
Upon   shipment of first commercial batch
    	
 
    	
 
    
	
Timing:
    	
 
    	
Q4   2010
    	
 
    	
 
    

 

	
 
    	
 
    	
 
    	
 
    	
Not
    	
 
    	
 
    	
 
    	
Responsibility
    	
 
    	
 
    
	
Stability
    	
 
    	
Req.
    	
 
    	
Req.
    	
 
    	
N/A
    	
 
    	
Hospira
    	
 
    	
Client
    	
 
    	
Price
    	
 
    	
Comment
    
	
Engineering   stability
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Clinical   stabilities
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
TBD
    	
 
    	
To   be determined once conditions are known.
    
	
Registration   batch stability
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
X
    	
 
    	
$[***]/   batch
   $[***] ([***] batches) $[***] ([***] batches)
    	
 
    	
If   HSP does not complete tech transfer prior to batch manufacture, [***] to   complete testing.
    
	
Commercial   product stability
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
$[***]/   batch
    	
 
    	
 
    
	
Photo   stability
    	
 
    	
 
    	
 
    	
X
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Price:
    	
 
    	
$[***]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Payment:
    	
 
    	
Mutually   agreed upon yearly schedule
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Timing:
    	
 
    	
As   manufacture of batches require
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

30

 

[***] 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.

 

Stability Program for Gestiva Registration batches will be performed on 1) product utilizing [***] stopper, 2) product utilizing [***] stopper and 3) [***] filled product. The stability testing program consists of the following (reference Exhibit 1.9 for stability indicating test methods):

 

[***]

 

Developmental Stability Program Pricing - Gestiva [***] Vial

 

	
Program
    	
 
    	
Cost
    	
 
    
	
Registration Stability (per batch)
    	
 
    	
$
    	
[***]
    	
 
    
	
Registration Stability ([***] batches   simultaneously)
    	
 
    	
$
    	
[***]
    	
 
    
	
Registration Stability ([***] batches   simultaneously)
    	
 
    	
$
    	
[***]
    	
 
    
	
Clinical Stability
    	
 
    	
TBD
    	
 
    
	
Placebo Stability
    	
 
    	
TBD
    	
 
    

 

Developmental Stability Testing Pricing by Time Point - Gestiva [***] Vial

 

	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

31

 

[***] 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.

 

Exhibit 3.1

 

Payment Schedule

 

Payment of the Development Fee shall be in accordance with the following schedule:

 

(a) [***] upon execution of kickoff meeting and receipt of Hospira’s invoice for the amount due (Milestone I);

 

(b) [***] within [***] days after Hospira has an approved product monograph for Gestiva. The Product monograph consists of the commodities, specifications, and methods used for the manufacture of Gestiva and the invoice for the amount due from Hospira (Milestone II);

 

(c) [***] within [***] days of approval of validation protocols (Milestone IV);

 

(d) [***] within [***] days of approval of validation reports (Milestone IV);

 

(e) [***] within [***] days of submission of regulatory filing (Milestone V); and

 

(f) [***] within [***] days of shipment of first commercial batch (Milestone VI).

 

32

 

[***] 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.

 

Exhibit 5.8

 

Product and Stability Testing Prices

 

Developmental Product (Milestone III)

 

[***] Vial

 

	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    

 

Commercial Product

 

[***] Vial

 

	
 
    	
[***]
    
	
[***]
    	
[***]
    	
[***]
    	
[***]
    	
[***]
    	
[***]
    
	
[***]
    	
[***]
    	
[***]
    	
[***]
    	
[***]
    	
[***]
    
	
[***]
    	
[***]
    	
[***]
    	
[***]
    	
[***]
    	
[***]
    
	
    *
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

* Price is based on Hologic not purchasing [***] of its requirements of the Product from Hospira as may be permitted under Section 5.1 of the Agreement.

 

[***]

 

	
Total Annual Volume   
    	
 
    	
Price per Unit
    
	
TBD
    	
 
    	
TBD
    

 

33

 

[***] 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.

 

Commercial Stability Testing

 

Stability Program for Gestiva Commercial Product consists of the following (reference Exhibit 1.9 for stability indicating test methods):

 

[***]

 

Commercial Stability Program Pricing - Gestiva [***] Vial

 

	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    

 

Commercial Stability Testing Pricing by Time Point - Gestiva [***] Vial

 

	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

34

 

[***] 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.

 

Exhibit 7.1

 

Product Test Methods

 

In consultation with Hologic, no later than [***] days after the Effective Date, Hospira will use all reasonable efforts to prepare and complete documentation describing the procedures, methods and protocols by which the Products will be tested and released, as specified in Section 7.1 of the Agreement. Upon completion, such documentation shall be attached to this Exhibit 7.1 and shall be made an integral part of this Agreement.

 

35

 

[***] 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.

 

Exhibit 7.2

 

Form of Quality Agreement

 

[Omitted.]

 

36

 

[***] 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.

 

Exhibit 12.4

 

Alternative Dispute Resolution

 

The parties recognize that bona fide disputes as to certain matters may arise from time to time during the term of this Agreement which relate to either party’s rights and/or obligations. To have such a dispute resolved by this Alternative Dispute Resolution (“ADR”) provision, a party first must send written notice of the dispute to the other party for attempted resolution by good faith negotiations between their respective presidents (or their designees) of the affected subsidiaries, divisions, or business units within [***] days after such notice is received (all references to “days” in this ADR provision are to calendar days).

 

If the matter has not been resolved within [***] days of the notice of dispute, or if the parties fail to meet within such [***] days, either party may initiate an ADR proceeding as provided herein. The parties shall have the right to be represented by counsel in such a proceeding.

 

1.                                      To begin an ADR proceeding, a party shall provide written notice to the other party of the issues to be resolved by ADR. Within [***] days after its receipt of such notice, the other party may, by written notice to the party initiating the ADR, add additional issues to be resolved within the same ADR.

 

2.                                      Within [***] days following receipt of the original ADR notice, the parties shall select a mutually acceptable neutral to preside in the resolution of any disputes in this ADR proceeding. If the parties are unable to agree on a mutually acceptable neutral within such period, either party may request the President of the CPR Institute for Dispute Resolution (“CPR”), 366 Madison Avenue, 14th Floor, New York, New York 10017, to select a neutral pursuant to the following procedures:

 

(a)                                 The CPR shall submit to the parties a list of not less than [***] candidates within [***] days after receipt of the request, along with a Curriculum Vita for each candidate. No candidate shall be an employee, director, or shareholder of either party or any of their subsidiaries or Affiliates.

 

(b)                                 Such list shall include a statement of disclosure by each candidate of any circumstances likely to affect his or her impartiality.

 

(c)                                  Each party shall number the candidates in order of preference (with the number one (1) signifying the greatest preference) and shall deliver the list to the CPR within [***] days following receipt of the list of candidates. If a party believes a conflict of interest exists regarding any of the candidates, that party shall provide a written explanation of the conflict to the CPR along with its list showing its order of preference for the candidates. Any party failing to return a list of preferences on time shall be deemed to have no order of preference.

 

37

 

[***] 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.

 

(d)                                 If the parties collectively have identified fewer than [***] candidates deemed to have conflicts, the CPR immediately shall designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference. If a tie should result between two candidates, the CPR may designate either candidate. If the parties collectively have identified three (3) or more candidates deemed to have conflicts, the CPR shall review the explanations regarding conflicts and, in its sole discretion, may either (i) immediately designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference, or (ii) issue a new list of not less than five (5) candidates, in which case the procedures set forth in subparagraphs 2(a)-2(d) shall be repeated.

 

3.                                      No earlier than [***] days or later than [***] days after selection, the neutral shall hold a hearing to resolve each of the issues identified by the parties. The ADR proceeding shall take place at a location agreed upon by the parties. If the parties cannot agree, the neutral shall designate a location other than the principal place of business of either party or any of their subsidiaries or Affiliates.

 

4.                                      At least [***] days prior to the hearing, each party shall submit the following to the other party and the neutral:

 

(a)                                 a copy of all exhibits on which such party intends to rely in any oral or written presentation to the neutral;

 

(b)                                 a list of any witnesses such party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;

 

(c)                                  a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed rulings and remedies shall not contain any recitation of the facts or any legal arguments and shall not exceed one (1) page per issue.

 

(d)                                 a brief in support of such party’s proposed rulings and remedies, provided that the brief shall not exceed twenty (20) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

 

Except as expressly set forth in subparagraphs 4(a)-4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents.

 

5.                                      The hearing shall be conducted on [***] consecutive days and shall be governed by the following rules:

 

(a)                                 Each party shall be entitled to [***] hours of hearing time to present its case. The neutral shall determine whether each party has had the [***] hours to which it is entitled.

 

38

 

[***] 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.

 

(b)                                 Each party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the party conducting the cross-examination.

 

(c)                                  The party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address not only issues it raised but also any issues raised by the responding party. The responding party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.

 

(d)                                 Except when testifying, witnesses shall be excluded from the hearing until closing arguments.

 

(e)                                  Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the neutral shall have sole discretion regarding the admissibility of any evidence.

 

6.                                      Within [***] days following completion of the hearing, each party may submit to the other party and the neutral a post-hearing brief in support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidence and shall not exceed [***] pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

 

7.                                      The neutral shall rule on each disputed issue within [***] days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one of the parties on each disputed issue but may adopt one party’s proposed rulings and remedies on some issues and the other party’s proposed rulings and remedies on other issues. The neutral shall not issue any written opinion or otherwise explain the basis of the ruling.

 

8.                                      The neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:

 

(a)                                 If the neutral rules in favor of one party on all disputed issues in the ADR, the losing party shall pay [***] of such fees and expenses.

 

(b)                                 If the neutral rules in favor of one party on some issues and the other party on other issues, the neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the parties. The neutral shall allocate fees and expenses 

 

39

 

[***] 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.

 

in a way that bears a reasonable relationship to the outcome of the ADR, with the party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.

 

9.                                      The rulings of the neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.

 

10.                               Except as provided in paragraph 9 or as required by law, the existence of the dispute, any settlement negotiations, the ADR hearing, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed Confidential Information. The neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.

 

12.                               The neutral may not award punitive damages. The parties hereby waive the right to punitive damages.

 

13.                               The hearings shall be conducted in the English language.

 

40

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