COLLABORATION AND EXCLUSIVE LICENSE AGREEMENT

 

1.5                                “AMAG House Marks” means the AMAG names and logo as set forth in Exhibit B .

 

1.6                                “AMAG Know-How” means all Information that is Controlled by AMAG during the Term and is necessary for the Development or Commercialization of the Product in the Licensed Territory.

 

1.7                                “AMAG Materials” has the meaning set forth in 5.8(a).

 

1.8                                “AMAG Product Marks” means all trademarks in the Licensed Territory related to the Product that are Controlled by AMAG during the Term.  The AMAG Product Marks in existence (or for which AMAG has submitted an application) as of the Effective Date are set forth in Exhibit B .

 

1.9                                “AMAG Territory” means worldwide except the Licensed Territory.

 

1.10                         “Budget” has the meaning set forth in Section 2.2(a)(iii).

 

1.11                         “Claims” has the meaning set forth in Section 11.1.

 

1.12                         “CMC” means chemistry, manufacturing and controls as specified by the FDA.

 

1.13                         “Co-Developed Indication” has the meaning set forth in Section 3.3.

 

1.14                         “Co-Developed Indication Clinical Studies” has the meaning set forth in Section 3.4(b).

 

1.15                         “Co-Developed Indication Phase III Clinical Trials” has the meaning set forth in Section 3.4(b).

 

1.16                         “Collaboration Patents” has the meaning set forth in Section 9.3.

 

1.17                         “Commercialization” , with a correlative meaning for “Commercialize” , means all activities undertaken before and after obtaining Regulatory Approval relating specifically to the pre-launch, launch, promotion, marketing, importation, offer for sale, sale, and distribution of the Product, including: (a) strategic marketing, sales force Detailing, advertising, medical education and liaison, and market and Product support; (b) Phase IV Clinical Trials; and (c) all customer support, Product distribution, invoicing and sales activities.

 

1.18                         “Confidential Information” means, with respect to a Party, all Information of such Party that is disclosed to the other Party under this Agreement, which may include specifications, know-how, trade secrets, technical information, drawings, models, business information, inventions, discoveries, methods, procedures, formulae, protocols, techniques, data, and unpublished patent applications, whether disclosed in oral, written, graphic, or electronic form.  All Information disclosed by either Party pursuant to the Confidentiality Agreement between the Parties, dated October 15, 2007, shall be deemed to be such Party’s Confidential Information disclosed hereunder.

 

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1.19                         “Control” means, with respect to any Information or intellectual property right, the possession (whether by ownership or license, other than pursuant to this Agreement) by a Party of the ability to grant to the other Party access or license as provided herein under such Information or right without violating the terms of any agreement or other arrangement with any Third Party.

 

1.20                         “ Detail ” or “ Detailing ” means, with respect to the Product, the communication by a Sales Representative during a Sales Call (a) involving face-to-face contact, (b) describing in a fair and balanced manner the SFDA-approved indicated uses and other relevant characteristics of the Product, (c) using the Promotional Materials in an effort to increase the prescribing and/or hospital ordering preferences of the Product for its SFDA-approved indicated uses, and (d) made at such medical professional’s office, in a hospital, at marketing meetings sponsored by 3SBio for the Product or other appropriate venues conducive to pharmaceutical product informational communication where the principal objective is to place an emphasis, either primary or secondary, on the Product and not simply to discuss the Product with such medical professional.  For the avoidance of doubt, discussions at conventions or other meetings not specifically sponsored by 3SBio for the Product shall not constitute “Details” or “Detailing”.

 

1.21                         “Develop” or “Development” means all activities relating to preparing and conducting preclinical testing, toxicology testing, human clinical studies, regulatory affairs, manufacturing process development and associated validation, quality assurance and quality control prior to the First Commercial Sale of the Product for a specific indication in the Licensed Territory.

 

1.22                         “Development Plans” has the meaning set forth in Section 3.4.

 

1.23                         “Diligent Efforts” means, with respect to a Party’s obligation under this Agreement to Develop or Commercialize a Product, the level of efforts required to carry out such obligation in a sustained manner consistent with the reasonable efforts that a similarly situated multinational pharmaceutical company would devote to a product of similar market potential, profit potential or strategic value within its portfolio, based on conditions then prevailing.  Diligent Efforts requires, with respect to such an obligation, that the Party:  (a) promptly assign responsibility for such obligation to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis, (b) set and consistently seek to achieve specific, meaningful and measurable objectives for carrying out such obligation, and (c) consistently make and implement decisions and allocate resources designed to advance progress with respect to such objectives, taking into consideration the norms and customs in the geographic region of such Party’s operations.

 

1.24                         “Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.

 

1.25                         “FDA” means the U.S. Food and Drug Administration or its successor.

 

1.26                         “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended.

 

1.27                         “Field” means the treatment of any disease or condition in humans, and expressly excludes diagnostic, imaging and all other non-therapeutic applications.

 

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1.28                         “First Commercial Sale” means the first sale to a Third Party of the Product in a given regulatory jurisdiction after Regulatory Approval has been obtained in such jurisdiction.

 

1.29                         “Generic Entry Trigger” has the meaning set forth in Section 8.4(c).

 

1.30                         “Generic Version” means, with respect to the Product, any Third Party product that [***].

 

1.31                         “Governmental Authority” means any national, federal, state, local, provincial, municipal or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

 

1.32                         “ICC Rules” has the meaning set forth in Section 14.3.

 

1.33                         “Independent Indication” has the meaning set forth in Section 3.3.

 

1.34                         “Information” means any data, results, technology or information of any type whatsoever, in any tangible or intangible form, including, without limitation, know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical, toxicological, preclinical and clinical test data), analytical and quality control data, CMC information, stability data, other study data and procedures.

 

1.35                         “Initial Indication” means the treatment of iron deficiency anemia in patients with chronic kidney disease.

 

1.36                         “Initial Indication Development Plan” means the plan for conducting Development of the Product for the Initial Indication for use in the Licensed Territory, as described in Section 3.2.

 

1.37                         “Initial Indication Studies” has the meaning set forth in Section 3.4(a).

 

1.38                         “Inventions” has the meaning set forth in Section 9.1.

 

1.39                         “Joint Steering Committee” or “JSC” means the committee formed by the Parties as described in Section 2.2(a).

 

1.40                         “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any Governmental Authority.

 

[***] 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.

 

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1.41                         “Licensed Territory” means the People’s Republic of China (excluding Hong Kong SAR, Macau SAR and Taiwan region).

 

1.42                         “Manufacture” , with a correlative meaning for “Manufacturing,” means all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including manufacturing the product in finished form for Development, manufacturing finished product for Commercialization, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests, and regulatory activities related to any of the foregoing.

 

1.43                         “Marketing Authorization Application” or “MAA” means an application submitted to a Regulatory Authority seeking approval for the sale of a pharmaceutical product in the Licensed Territory.

 

1.44                         “Marketing Plan” means each plan for Commercializing the Product for the Initial Indication and each Co-Developed Indication in the Licensed Territory, developed by 3SBio, as described in Section 5.1.

 

1.45                         “Net Sales” means, with respect to a particular time period, the total amounts billed by 3SBio, its Affiliates and their respective permitted sublicensees for sales of Products made during such time period to unaffiliated Third Parties, less the following deductions to the extent actually allowed or incurred with respect to such sales:

 

(a)                                   discounts, including cash and quantity discounts, charge-back payments, and rebates actually granted to trade customers, managed health care organizations, federal, state, or local government and the agencies, purchasers and reimbursers of managed health organizations or federal, state or local government;

 

(b)                                   credits or allowances actually granted upon claims, damaged goods, rejections or returns of such Products, including in connection with recalls;

 

(c)                                   freight, postage, shipping, transportation and insurance charges actually allowed or paid for delivery of Products, to the extent billed; and

 

(d)                                   taxes (other than income taxes), duties, tariffs or other governmental charges levied on the sale of such Products, including, without limitation, value-added taxes.

 

Notwithstanding the foregoing, amounts billed by 3SBio, its Affiliates, or their respective permitted sublicensees for the sale of Products among 3SBio, its Affiliates or their respective permitted sublicensees for resale shall not be included in the computation of Net Sales hereunder.  Net Sales shall be accounted for in accordance with U.S. generally accepted accounting principles, consistently applied.   Any price discounts offered by 3SBio, its Affiliates, or their respective permitted sublicensees to purchasers of a Product will not exceed the discount levels that are reasonable for products that are comparable to such Product at a similar stage in the product life cycle.  3SBio shall apply all terms and conditions applicable to the sale of Products (including any discounts applicable to Products) in a reasonable and non-discriminatory

 

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manner relative to other products sold by 3SBio together with Products.  3SBio shall not bundle or combine the Product for sale together with another pharmaceutical product without the prior written consent of AMAG.

 

1.46                         “New Product Marks” has the meaning set forth in Section 5.7(a).

 

1.47                         “Out-of-Pocket Costs” means any amounts paid by a Party to Third Parties in connection with activities or services conducted by such Third Parties, including but not limited to contract research, laboratory services, consulting services, shipping and distribution, and costs of comparator materials used in any clinical trial.

 

1.48                         “Patents” means (a) pending patent applications, issued patents, utility models and designs; and (b) reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any patents, patent applications, utility models or designs.

 

1.49                         “Phase II Clinical Trial” means a clinical trial of a pharmaceutical product on patients, including possibly pharmacokinetic studies, the principal purposes of which are to make a preliminary determination that such product is safe for its intended use and to obtain sufficient information about such product’s efficacy to permit the design of further clinical trials.

 

1.50                         “Phase III Clinical Trial” means one or more clinical trials on sufficient numbers of patients, which trial(s) are designed to (a) establish that a drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and (c) support Regulatory Approval of such drug.

 

1.51                         “Phase IV Clinical Trial” means a clinical trial of the Product conducted after Regulatory Approval of the Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product ( e.g. , for expansion of Product Labeling or dose optimization), or (b) conducted due to a request or requirement of a Regulatory Authority.  For clarity, a human clinical trial conducted to support a new Regulatory Approval of a Product ( e.g. , for an Additional Indication) shall not be considered a Phase IV Clinical Trial.

 

1.52                         “Pricing Approval” means such approval, agreement, determination or governmental decision establishing prices for the Product that can be charged to consumers and will be reimbursed by Governmental Authorities in countries, territories or possessions where Governmental Authorities or Regulatory Authorities of such country, territory or possession approve or determine pricing of pharmaceutical products for reimbursement or otherwise.

 

1.53                         “ Primary Position Detail ” means a Detail during which (a) the Product is discussed either itself or along with other pharmaceutical products, (b) key product attributes of the Product are verbally promoted in the first position on such Detail, and (c) the Product is given the majority of the emphasis during the presentation.  For clarity, no more than one Detail during a Sales Call shall be considered a Primary Position Detail.

 

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1.54                         “Product” means AMAG’s proprietary iron replacement therapeutic product known as ferumoxytol, as described on Exhibit A , and that (a) is formulated for intravenous delivery and has a dosage of 510 mg/vial, or (b) has any other dosage form, strength or route of administration included in an MAA filed with the FDA for the Initial Indication or a Co-Developed Indication.

 

1.55                         “Product Complaint” means any written, verbal or electronic expression of dissatisfaction regarding the Product, including without limitation reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

 

1.56                         “Product Infringement” has the meaning set forth in Section 9.4(b)(i).

 

1.57                         “Product Labeling” means (a) the full prescribing information for the Product approved by the applicable Regulatory Authority, and (b) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for the Product.

 

1.58                         “Project Manager” has the meaning set forth in Section 2.3.

 

1.59                         “Promotional Materials” means all sales representative training materials and all written, printed, graphic, electronic, audio or video presentations of information, including, without limitation, journal advertisements, sales visual aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings, broadcast advertisements and sales reminder aides (for example, note pads, pens and other such items) intended for use or used by 3SBio or its Affiliates, permitted sublicensees or licensees in connection with any promotion of the Product in the Licensed Territory, but excluding Product Labeling.

 

1.60                         “Regulatory Approvals” means all approvals (including without limitation supplements, amendments, and Pricing Approvals), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture, distribution, use or sale of a pharmaceutical product in a given regulatory jurisdiction.

 

1.61                         “Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction, including without limitation the FDA and SFDA.

 

1.62                         “Regulatory Fees” means all filing and administrative fees required to be made to a Regulatory Authority in connection with obtaining Regulatory Approval for the Product for the Initial Indication or for a Co-Developed Indication, as applicable, in the Licensed Territory.

 

1.63                         “Regulatory Materials” means regulatory applications, submissions, notifications, registrations, Regulatory Approvals and/or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture, market, sell or otherwise Commercialize the Product in a particular country, territory or possession.  Regulatory Materials include, without limitation, MAAs and applications for Pricing Approvals.

 

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1.64                         “ Sales Call ” means a personal visit by a Sales Representative to one or several medical professional(s) having prescribing authority in the Initial Indication or Additional Indications for which such Product has received Regulatory Approval, as well as to other individuals or entities that have significant impact or influence on prescribing decisions in such indications, during which such Sales Representative Details the Product.

 

1.65                         “ Sales Representative ” means a pharmaceutical sales representative engaged or employed by 3SBio or its Affiliate to conduct Detailing and other promotional efforts with respect to the Product and who has been trained by AMAG or 3SBio in accordance with the terms of this Agreement.

 

1.66                         “SFDA” means the State Food and Drug Administration, or any successor thereto, that coordinates the scientific review of human pharmaceutical products in China.

 

1.67                         “Shared Costs” has the meaning set forth in Section 3.7.

 

1.68                         “Term” means the term of this Agreement, as determined in accordance with Article 13.

 

1.69                         “Third Party” means any entity other than AMAG or 3SBio or an Affiliate of either of them.

 

1.70                         “U.S.” means the United States of America and its possessions and territories.

 

ARTICLE 2
MANAGEMENT

 

2.1                                Collaboration Guidelines .  In all matters relating to this Agreement, each Party shall seek to comply with good pharmaceutical and business practices consistent with its own existing practices.  Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.

 

2.2                                Joint Steering Committee.

 

(a)                                   Formation and Role.   The Parties desire to establish a Joint Steering Committee (the “JSC” ) that will monitor and coordinate communication regarding the Parties’ efforts under this Agreement to Develop, obtain Regulatory Approval for, and Commercialize the Product in the Field in the Licensed Territory.  The JSC shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.2.  The role of the JSC shall be:

 

(i)                                     to facilitate the exchange of information between the Parties with respect to the Development and Commercialization activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for the Parties’ Development and Commercialization of the Product hereunder, consistent with this Agreement;

 

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(ii)                                 to review and approve each Development Plan and any amendments thereto;

 

(iii)                             to review and approve in advance the overall budget (each, a “Budget” ) associated with each Development Plan, and any amendment to a Budget that increases by twenty-five percent (25%) or more the total expenditures under such previously-approved Budget;

 

(iv)                                to approve any clinical studies (including related protocols) to be conducted by the Parties for the Initial Indication and each Co-Developed Indication;

 

(v)                                    for the Initial Indication and each Co-Developed Indication, to review and approve all Regulatory Materials and Product Labeling for the Product in the Licensed Territory;

 

(vi)                                to review and approve each Marketing Plan, promotional strategy, and Promotional Materials for the Product, and any updates and amendments thereto;

 

(vii)                            to establish such additional joint subcommittees or committees as the JSC deems necessary to achieve the objectives and intent of this Agreement; and

 

(viii)                        to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties.

 

The JSC shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development and Commercialization of the Product in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of the Product in the Licensed Territory.  The JSC shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the JSC shall not have any power to amend, modify or waive compliance with this Agreement.

 

(b)                                   Membership.  Each Party shall have an equal number of representatives on the JSC.  AMAG and 3SBio shall each initially designate three (3) representatives to serve on the JSC, who shall be the individuals set forth in Exhibit C.   Either Party may designate substitutes for its representatives if one (1) or more of such Party’s designated representatives is unable to be present at a meeting.  To the extent possible, each Party shall maintain the same representatives to the JSC during the Term; provided , each Party may replace its representatives as necessary by written notice to the other Party specifying the prior representative(s) and their replacement(s).  Any such substitutes or replacements shall be designated consistent with the following principles: at least one (1) representative of each Party shall have appropriate expertise in the Development of pharmaceutical products, and at least one (1) representative of each Party shall have appropriate expertise in the Commercialization of pharmaceutical products.  AMAG shall select one (1) of its representatives as the initial chairperson of the JSC.  On each anniversary of the Effective Date, the Parties shall rotate designation of the JSC chairperson for each commencing year.  The chairperson of the JSC shall be responsible for (i) calling meetings, and (ii) preparing and circulating an agenda for the upcoming meeting of the JSC, but shall have no special authority over the other members of the JSC, and shall have no additional voting

 

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rights.  The chairperson, or his or her designee, shall be responsible for preparing and issuing minutes of each such meeting within thirty (30) days thereafter.  Such minutes will not be finalized until the other Party reviews and confirms the accuracy of such minutes in writing.

 

(c)                                   Meetings.  The JSC shall hold at least four (4) meetings per year within thirty (30) days of the end of each calendar quarter.  Meetings shall be effective only if at least two (2) representatives of each Party are present or participating.  The JSC may meet either (i) in person at either Party’s facilities or at such locations as the Parties may otherwise agree, or (ii) by audio or video teleconference, provided that at least one (1) meeting per year shall be in person.  With the prior consent of each Party’s representatives, other representatives of each Party or Third Parties involved with the Product may attend meetings as nonvoting participants.  Additional meetings of the JSC may also be held with the consent of each Party, or as required under this Agreement, and neither Party will unreasonably withhold or delay its consent to hold such an additional meeting.  Each Party shall be responsible for all of its own expenses incurred in connection with participating in the JSC.

 

(d)                                   Meeting Agendas .  The JSC chairperson shall prepare a draft agenda containing the topics for the upcoming meeting.  The chairperson shall disclose to the other members of the JSC (i) the draft agenda no later than ten (10) business days in advance, and (ii) its final agenda (along with appropriate related Information) at least five (5) business days in advance, of each meeting of the JSC; provided, that under exigent circumstances requiring JSC input, the chairperson may provide the draft and final agenda to the other members of the JSC with a lesser period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other JSC members consent to such temporary changes to the general process for distributing the agenda for JSC meetings.

 

(e)                                   Decision-Making.   Actions to be taken by the JSC shall be taken only following unanimous vote, with each Party having one (1) vote.  If the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of ten (10) days, the matter shall be referred to the Chief Executive Officers of the Parties pursuant to Section 14.2.

 

(f)                                     Withdrawal .  At any time during the Term and for any reason, AMAG shall have the right to withdraw from participation in the JSC upon written notice to 3SBio, which notice shall be effective immediately upon receipt (“ Withdrawal Notice ”).  Following the issuance of a Withdrawal Notice and subject to this Section 2.2(f), AMAG’s representatives to the JSC shall not participate in any meetings, nor shall AMAG have any right to vote on decisions within the authority of the JSC.  If, at any time following the issuance of a Withdrawal Notice, AMAG wishes to resume participating in the JSC, AMAG shall notify 3SBio in writing and, thereafter, AMAG representatives to the JSC shall be entitled to attend any subsequent meeting and to participate in the activities of, and decision-making by, the JSC as provided in this Article 2 as if a Withdrawal Notice had not been issued by AMAG.  Following AMAG’s issuance of a Withdrawal Notice pursuant to this Section 2.2(f), unless and until AMAG resumes participation in the JSC in accordance with this Section:  (i) all meetings of the JSC shall be held at 3SBio’s facilities; (ii) 3SBio shall have the right to make the final decision on all matters within the scope of authority of the JSC; and (iii) AMAG shall have the right to continue to

 

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receive all reports and materials provided to the JSC hereunder as well as reasonable advance notice of any pending JSC decisions relating to the matters described in Section 14.2, but shall not have the right to approve the minutes for any JSC meeting held after issuance of such Withdrawal Notice.  For clarity, the withdrawal by AMAG under this Section 2.2(f) shall only limit AMAG’s obligations under this Article 2 with respect to participation in the JSC.

 

2.3                                Project Managers.   Promptly following the Effective Date, each Party shall designate, by written notice to the other Party, a representative to facilitate communication and coordination of the Parties’ activities under this Agreement and to provide support and guidance to the JSC (each, a “Project Manager” ).  Each Project Manager shall be experienced in project management and may also serve as a representative of its respective Party on the JSC.

 

ARTICLE 3
PRODUCT DEVELOPMENT

 

3.1                                Overview .  The Parties shall Develop the Product in the Field in the Licensed Territory as provided in this Article 3 and in accordance with mutually agreed upon development plans, which shall set forth all Development activities to be performed by the Parties under this Agreement.  Except as set forth in this Article 3, 3SBio shall be primarily responsible for conducting all Development activities under this Agreement in the Licensed Territory.

 

3.2                                Initial Indication Development Plan .  An initial plan containing a general description of activities and timelines for Developing the Product for the Initial Indication in the Licensed Territory (the “Initial Indication Development Plan” ) has been agreed upon by the Parties and is attached hereto as Exhibit D and incorporated herein by reference.  Within ninety (90) days after the Effective Date, the Parties shall prepare a comprehensive development plan, consistent in all material respects with the Initial Indication Development Plan, describing the activities to be conducted by the Parties to Develop and seek Regulatory Approval for the Product for the Initial Indication in the Licensed Territory under this Agreement, which plan the Parties shall submit to the JSC for review and approval.  Upon JSC approval, such plan shall become effective as the then-current Initial Indication Development Plan.  From time to time, either Party may submit to the JSC for discussion any proposed modifications to the Initial Indication Development Plan, and the JSC shall discuss such proposed modifications at its next meeting, and any such modification will become effective only upon approval by the JSC as provided in Section 2.2.

 

3.3                                Additional Indications.   AMAG shall notify the JSC of each indication (other than the Initial Indication) for which AMAG is Developing, seeking Regulatory Approval of, or Commercializing the Product in the U.S. (each, an “Additional Indication” ), no later than the first dosing of a patient in a Phase III Clinical Trial for such Additional Indication anywhere in the AMAG Territory.  Within sixty (60) days of the JSC’s receipt of such notice, 3SBio shall notify AMAG, through its JSC representatives, whether 3SBio agrees to Develop the Product for such Additional Indication in the Licensed Territory.  If 3SBio does not so agree, then such Additional Indication shall be an “Independent Indication” and AMAG shall be solely responsible, at its discretion and expense, for Developing and seeking Regulatory Approval of

 

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the Product for the Independent Indication in the Licensed Territory.  3SBio shall have no rights to Develop or Commercialize the Product in any Independent Indication without the prior written consent of AMAG, which may be granted or withheld at AMAG’s sole discretion, and such Independent Indication shall be excluded from the scope of this Agreement.  If 3SBio agrees to Develop the Product for such Additional Indication in the Licensed Territory, then the Additional Indication shall be a “Co-Developed Indication.”   From time to time, 3SBio may propose to the JSC that it Develop, seek Regulatory Approval of, or Commercialize the Product in the Licensed Territory in one or more indications other than the Initial Indication (each, a “3SBio Proposed Indication” ).  Within sixty (60) days of the JSC’s receipt of such notice, AMAG shall notify 3SBio whether AMAG agrees to permit the Development and Commercialization of the Product for such 3SBio Proposed Indication in the Licensed Territory in accordance with the terms of this Agreement, which agreement may be granted or withheld at AMAG’s sole discretion.  If AMAG so agrees, then the 3SBio Proposed Indication shall be a “Co-Developed Indication.”  If AMAG does not so agree, then 3SBio shall have no rights to Develop, seek Regulatory Approval of or Commercialize the Product in such 3SBio Proposed Indication without the prior written consent of AMAG, which may be granted or withheld at AMAG’s sole discretion.  With respect to each Co-Developed Indication, the Parties shall prepare a comprehensive development plan describing the activities to be conducted by the Parties to Develop and seek Regulatory Approval for the Product for the Co-Developed Indication in the Licensed Territory under this Agreement, and a Budget for all such activities (each, an “Additional Indication Development Plan” ).  Unless the JSC has earlier been notified pursuant to this Section 3.3, AMAG shall notify the JSC of each Product (as defined in Section 1.54(b)) for which AMAG has submitted an MAA to the FDA for the Initial Indication or any Co-Developed Indication, within sixty (60) days after the later of (i) such submission or (ii) the adoption of the applicable Co-Developed Indication under this Section 3.3.  Promptly after such notification, the Parties shall prepare amendments to the applicable Development Plan to include Development activities for such Product and shall submit such amendments to the JSC for approval.  Unless the JSC determines otherwise, the allocation of activities and expenses for each Co-Developed Indication and Product shall be as set forth in Sections 3.4 and 3.7.  From time to time, either Party may submit to the JSC for discussion any proposed modifications to an Additional Indication Development Plan, and the JSC shall discuss such proposed modifications at its next meeting, and any such modification will become effective only upon approval by the JSC as provided in Section 2.2.

 

3.4                                Specific Development Activities.   As further described in the Initial Indication Development Plan and each Additional Indication Development Plan (collectively, the “Development Plans” ), the Parties’ responsibilities for conducting Development of the Product in the Field in the Licensed Territory shall be allocated as follows:

 

(a)                                   Initial Indication.   3SBio shall be responsible, at its sole expense, for conducting: (i) those clinical studies described in the Initial Indication Development Plan, including [***], and (ii) any and all other studies required by the Regulatory Authorities in the

 

[***] 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.

 

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Licensed Territory for Regulatory Approval of the Product for the Initial Indication in the Licensed Territory ((i) and (ii), collectively, the “Initial Indication Studies” ).  The Initial Indication Studies will be conducted in accordance with clinical protocols approved by the JSC pursuant to Section 2.2(a)(iv) and shall be conducted in the Licensed Territory.

 

(b)                                   Co-Developed Indications.   3SBio shall be responsible for conducting: (i) clinical proof of concept studies of the Product related to any Co-Developed Indication, [***], (ii) for each Co-Developed Indication, Phase II Clinical Trials of the Product that are required by the Regulatory Authorities in the Licensed Territory for Regulatory Approval of the Product for such Co-Developed Indication in the Licensed Territory, [***], and (iii) for each Co-Developed Indication, Phase III Clinical Trials (the “Co-Developed Indication Phase III Clinical Trials” ) of the Product that are required by the Regulatory Authorities in the Licensed Territory for Regulatory Approval of the Product for such Co-Developed Indication in the Licensed Territory ((ii) and (iii), collectively, the “Co-Developed Indication Clinical Studies” ).  Each Co-Developed Indication Phase III Clinical Trial shall be funded [***].  Each Co-Developed Indication Clinical Study shall be conducted by 3SBio or on its behalf using a local contract research organization in the Licensed Territory.  Each such local contract research organization shall coordinate its activities with and will be managed by AMAG’s global contract research organization that is conducting clinical trials on behalf of AMAG in the AMAG Territory.  Before entering into an agreement with any local contract research organization, 3SBio shall present the qualifications and capabilities of such local contract research organization to the JSC for discussion and approval of such organization.

 

(c)                                   Post-Approval Trials.   3SBio shall be responsible, [***], for conducting in the Licensed Territory any and all Phase IV Clinical Trials of the Product in the Field.

 

3.5                                Principles of Product Development.  3SBio’s Development of the Product in the Field in the Licensed Territory shall be conducted in a manner consistent with the following principles:

 

(a)                                   seeking Regulatory Approvals that include a broad label for the Product;

 

(b)                                   seeking a product profile for the Product with maximum scope of recommended usage and minimum scope of restrictions on use;

 

(c)                                   obtaining Regulatory Approvals for the Product consistent with (a) and (b) in a timely manner; and

 

(d)                                   not adversely impacting AMAG’s own development or commercialization efforts for the Product in the AMAG Territory or outside the Field.

 

[***] 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.

 

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3.6                                The Parties’ Performance .  3SBio shall devote Diligent Efforts to Develop and obtain Regulatory Approval for the Product under this Agreement in the Licensed Territory, in all cases consistent with the then-agreed upon Development Plans and in accordance with this Agreement.  AMAG shall devote Diligent Efforts to perform all activities allocated to AMAG in the then-agreed upon Development Plans in accordance with this Agreement.  The Parties shall conduct their activities under the Development Plans using appropriate scientific practices and in compliance in all material respects with all applicable Laws.  3SBio may not conduct any Development activities that are not set forth in one of the Development Plans or that are inconsistent with this Agreement without AMAG’s prior written consent.

 

3.7                                Development Costs.  3SBio shall be solely responsible for all costs associated with the Development of the Product for the Initial Indication in the Licensed Territory, including without limitation (i) all costs associated with the Initial Indication Studies and (ii) all Regulatory Fees for the Initial Indication in the Licensed Territory.  The Parties [***].  If either Party incurs or anticipates incurring Out-of-Pocket Costs for the Co-Developed Indication Clinical Studies that exceed the applicable amount set forth in the Budget, such Party shall so notify the JSC.  The JSC shall discuss and determine the allocation between the Parties of such Budget overruns, which may include amending the Budget; provided , that each Party shall continue to conduct its activities set forth in the applicable Development Plan, and the Party incurring Budget overruns may thereafter seek reimbursement for such activities.  The JSC shall act promptly to address the issue of Budget overruns, and nothing in this Section 3.7 shall require a Party to [***] or to continue activities in connection with Co-Developed Indication Phase III Clinical Trials for more than thirty (30) days in the event of a Budget overrun, if the other Party’s representatives to the JSC have not acted to address the overrun in such time.

 

3.8                                Records, Reports and Information .   Each Party shall maintain complete, current and accurate records of all work conducted by it under the Development Plans and all data and other Information resulting from such work.  Such records shall fully and properly reflect all work done and results achieved in the performance of the Development Plans in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.  Each Party shall have the right to review such records maintained by the other Party at reasonable times, upon written request.  Each Party shall provide written reports to the JSC on its Development and regulatory activities with the Product in the Licensed Territory, including without limitation any informal meetings between such Party and a Regulatory Authority in the Licensed Territory, on a quarterly basis at the end of each calendar quarter, at a level of detail reasonably sufficient, in the case of 3SBio, to enable AMAG to determine 3SBio’s compliance with its diligence obligation pursuant to Section 3.6.  All such Information and reports shall be the Confidential Information of AMAG.

 

[***] 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.

 

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