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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ARTICLE 4
REGULATORY MATTERS

 

4.1                                Transfer of Data.

 

(a)                                   AMAG Regulatory Dossier.   Within thirty (30) days after the Effective Date, AMAG shall provide 3SBio with a copy of all MAAs and other Regulatory Materials submitted by AMAG to the FDA in support of its Investigational New Drug Application, Drug Master File and New Drug Application for the Product in the Initial Indication (the “Dossier” ), in each case only as necessary to secure Regulatory Approval in the Licensed Territory.  The Dossier shall be the Confidential Information of AMAG.  The Parties, through their representatives to the JSC, shall discuss the use, disclosure, and protection of Information included in the Dossier, including without limitation any CMC information.  3SBio may use the Dossier in its Regulatory Materials only to the extent expressly authorized in writing by AMAG, not to be unreasonably withheld or delayed.

 

(b)                                   Data Generated by or on Behalf of the Parties.  Each Party shall, in a timely manner and compliant with the reporting requirements of Regulatory Authorities in the Licensed Territory, provide the other Party with copies of all preclinical, non-clinical and clinical data generated by such Party or on behalf of such Party by any Third Party for the Licensed Territory under this Agreement, after the Effective Date on a quarterly basis; provided , that information regarding adverse events and serious adverse events shall be provided promptly as set forth in Section 4.6.

 

(c)                                   Use of Data.  All preclinical, non-clinical, analytical, and clinical data and associated reports generated by 3SBio under this Agreement shall be owned solely by AMAG and shall be AMAG’s Confidential Information (notwithstanding anything in this Agreement to the contrary).   Except as otherwise provided in this Agreement, 3SBio may use such data solely for the purpose of Developing the Product and seeking and obtaining Regulatory Approval of and Commercializing the Product in the Field in the Licensed Territory, subject to Article 12.  Without otherwise limiting its rights under this Agreement, AMAG shall have the right to share any and all such data and other Regulatory Materials received from 3SBio with Regulatory Authorities and with AMAG’s Affiliates and Third Party licensees in the AMAG Territory.

 

4.2                                Regulatory Filings and Approvals.

 

(a)                                   In General.   The Parties intend that the Development Plans will set forth the agreed regulatory strategy for seeking Regulatory Approval of the Product in the Field in the Licensed Territory.  Except as provided in Section 4.2(b), 3SBio shall be responsible, in consultation with AMAG through the JSC, for preparing any and all Regulatory Materials to be used for filing with Regulatory Authorities in the Licensed Territory, and for filing Marketing Authorization Applications, Pricing Approval applications and all other applications in connection with seeking Regulatory Approvals for the Product in the Field in the Licensed Territory in the Initial Indication and all Co-Developed Indications.

 

(b)                                   Manufacturing.   AMAG shall be primarily responsible, at its expense and as required by any Regulatory Authority for the Licensed Territory, for the preparation of any

 

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components of Regulatory Materials to be filed by 3SBio in the Licensed Territory that relate to the Manufacture of the Product.  3SBio shall be primarily responsible for communicating with Regulatory Authorities in the Licensed Territory regarding Manufacture of the Product for the Licensed Territory, provided that 3SBio shall not disclose any CMC Information without AMAG’s prior written approval of the form and content of such disclosure, and if 3SBio receives a communication or request for a meeting from any Regulatory Authority in the Licensed Territory regarding Manufacture of the Product, 3SBio shall promptly notify AMAG, and AMAG shall have the right to attend any such meeting, in accordance with Section 4.2(e)(i), and to review, comment on, and approve any proposed response to the Regulatory Authority.  Upon prior notice to 3SBio and subject to 3SBio’s consent, not to be unreasonably withheld or delayed, AMAG shall have the right to communicate with Regulatory Authorities in the Licensed Territory regarding Manufacture of the Product for the Licensed Territory.  3SBio shall cooperate with AMAG and AMAG’s representatives and take such actions as AMAG may reasonably request in connection with the foregoing activities and communications as necessary to protect the CMC Information and all other Confidential Information related to the Manufacture of the Product for the Licensed Territory.

 

(c)                                   KOL Meeting.   As commercially appropriate for the Development and Commercialization of the Product in the Licensed Territory, 3SBio shall conduct one or more meetings with nephrology key opinion leaders to discuss medical and regulatory strategy for the Product in the Licensed Territory.  3SBio shall provide prior notice to AMAG of such meetings, and AMAG shall have the right to attend such meetings.  Promptly after each meeting, 3SBio shall provide the JSC with a report in English summarizing the meeting.

 

(d)                                   Rights of Reference to Regulatory Materials.   Each Party hereby grants to the other Party a right of reference to all Regulatory Materials filed by such Party in its respective territory for the Product in the Field as follows: AMAG and Affiliates shall have the right to cross-reference any and all data and other Regulatory Materials generated by 3SBio under this Agreement with respect to the Product in AMAG’s MAAs and other Regulatory Materials submitted to Regulatory Authorities in the AMAG Territory, for any indication.  3SBio shall have the right to cross-reference any and all data and other Regulatory Materials generated by AMAG with respect to the Product in 3SBio’s MAAs and other Regulatory Materials submitted to Regulatory Authorities in the Licensed Territory, solely for the purpose of obtaining Regulatory Approval for the Product in the Field for the Initial Indication and all Co-Developed Indications in the Licensed Territory, subject to Section 4.1(a).

 

(e)                                   3SBio’s Rights and Obligations.

 

(i)                                     Except as set forth in Section 4.2(b), 3SBio shall have the sole right and responsibility for preparing, submitting and maintaining Regulatory Materials in the Licensed Territory and for seeking Regulatory Approval for the Product in the Field in the Licensed Territory in the Initial Indication and all Co-Developed Indications.  As part of the foregoing, 3SBio shall be responsible for seeking any necessary approvals of Regulatory Authorities for Product Labeling and Promotional Materials to be used in the Licensed Territory in connection with Commercializing the Product in the Initial Indication and all Co-Developed Indications.  Upon request of AMAG, 3SBio shall allow at least one AMAG representative to

 

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attend all meetings with Regulatory Authorities in the Licensed Territory regarding the Product in the Initial Indication and all Co-Developed Indications, and 3SBio shall inform AMAG sufficiently in advance of any such meetings scheduled.

 

(ii)                                 3SBio shall use Diligent Efforts in compliance with applicable Laws and other regulatory obligations related to Development and Regulatory Approval in the Licensed Territory, to prepare and file the appropriate Regulatory Materials and to seek to obtain Regulatory Approval for the Product in the Initial Indication and all Co-Developed Indications as soon as practicable.

 

(iii)                             All MAAs, Regulatory Materials and Regulatory Approvals for the Product in the Initial Indication and all Co-Developed Indications filed with Regulatory Authorities in the Licensed Territory shall be held in 3SBio’s name and shall be owned solely by 3SBio, subject to AMAG’s rights under this Agreement.

 

(f)                                     Reporting and Review.  3SBio shall provide AMAG with copies of any proposed Regulatory Materials regarding the Product in the Initial Indication and all Co-Developed Indications sufficiently in advance of the intended submission to Regulatory Authorities and shall reasonably consider AMAG’s comments thereto to the extent practicable; provided , that 3SBio shall not submit any Regulatory Materials that relate specifically to the Manufacture of the Product without AMAG’s prior approval of such Regulatory Materials.  3SBio shall consult with AMAG, through the JSC, regarding, and keep AMAG reasonably and regularly informed of, the preparation of all Regulatory Materials, Regulatory Authority review of Regulatory Materials, and Regulatory Approvals for the Product in the Initial Indication and all Co-Developed Indications in the Licensed Territory.  3SBio shall provide AMAG with copies of all Regulatory Approvals it receives for the Product in the Initial Indication and all Co-Developed Indications in the Licensed Territory promptly after receipt thereof.

 

4.3                                Regulatory Expenses.  3SBio shall be responsible for all costs and expenses of preparing, maintaining, formatting, and filing Regulatory Materials for the Product in the Initial Indication and all Co-Developed Indications in the Licensed Territory, including without limitation all Regulatory Fees, and for all other costs and expenses in connection with seeking and maintaining Regulatory Approval for the Product in the Initial Indication and all Co-Developed Indications in the Licensed Territory; provided , that AMAG shall be solely responsible for all costs and expenses of its activities under Section 4.2(b); and provided , further, that 3SBio shall be solely responsible for all Out-of-Pocket Costs associated with any inspections of AMAG’s manufacturing facilities or the facilities of any of AMAG’s contract manufacturers by 3SBio or the SFDA in the Licensed Territory.

 

4.4                                Communications .  Except as required by Law or pursuant to Section 4.2(b), AMAG shall not communicate regarding the Product with respect to the Initial Indication or any Co-Developed Indication with any Regulatory Authority having jurisdiction in the Licensed Territory unless explicitly requested or permitted in writing to do so by 3SBio or unless so ordered by such Regulatory Authority in the Licensed Territory, in which case AMAG shall provide 3SBio prompt notice of such order.  Except as may be required by law, 3SBio shall not communicate with any Regulatory Authority having jurisdiction outside the Licensed Territory regarding the Product unless explicitly requested or permitted in writing to do so by AMAG, or

 

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unless so ordered by such Regulatory Authority, in which case 3SBio shall provide immediately to AMAG notice of such order.

 

4.5                                No Harmful Actions .  3SBio shall not take any action with respect to the Product in the Licensed Territory that could reasonably be expected to have a material adverse impact upon the regulatory status or potential sales of the Product outside the Licensed Territory.  If AMAG believes that 3SBio is taking or intends to take any action that could reasonably have such an impact, AMAG shall bring the matter to the attention of the JSC.  The JSC shall discuss whether any such action that either Party brings to the JSC’s attention reasonably would have such an impact, and potential alternative courses of action that 3SBio could take to avoid such an impact.  If the JSC cannot reach agreement as to such matters, then either Party may refer such matters for resolution pursuant to Section 14.2.  Furthermore, 3SBio will use commercially reasonable efforts to preserve the existence and breadth of any Regulatory Approvals for the Product obtained in the Licensed Territory in the course of reexamination, reevaluation and other post marketing surveillance review procedures required by the SFDA.

 

4.6                                Adverse Event Reporting and Safety Data Exchange.  The Parties agree that 3SBio will be primarily responsible for the monitoring of all clinical experiences and filing of all required reports with Regulatory Authorities in the Licensed Territory throughout clinical Development and Commercialization of the Product in the Licensed Territory; provided , that 3SBio shall provide AMAG with copies of all such required reports with a summary in English at the same time such reports are transmitted to the relevant Regulatory Authorities. The parties also agree that AMAG shall be solely responsible for maintaining the global safety database with respect to the Product and shall provide 3SBio with all relevant information as requested from such global safety database as necessary to comply with Regulatory Authorities in the Licensed Territory.  Specific details regarding the disclosure and management of information of adverse events related to the use of the Product in the Licensed Territory will be delineated in a separate pharmacovigilance agreement that shall be agreed to by the Parties within ninety (90) days after the Effective Date.

 

4.7                                Regulatory Authority Communications.

 

(a)                                   3SBio Disclosures to AMAG.

 

(i)                                     General.   3SBio shall provide AMAG with copies of (A) all correspondence it receives from or submits to Regulatory Authorities in the Licensed Territory that relate to Regulatory Approval of the Product in the Licensed Territory, promptly after receipt or submission (as applicable) thereof; (B) minutes of all meetings related to the Product with Regulatory Authorities in the Licensed Territory; and (C) all other material correspondence it receives from or submits to Regulatory Authorities in the Licensed Territory under this Agreement, in each case promptly after receipt, preparation or submission (as applicable) thereof.

 

(ii)                                 Specific Disclosures.   Without limiting the generality of the foregoing, 3SBio shall keep AMAG informed, in a timely manner compliant with the reporting requirements of Regulatory Authorities in the Licensed Territory of notification of any action by, or notification or other information that it receives (directly or indirectly) from, any Regulatory

 

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Authority in the Licensed Territory that:  (1) raises any material concerns regarding the safety or efficacy of the Product; (2) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (3) is reasonably likely to lead to a recall or market withdrawal of the Product; or (4) relates to expedited and periodic reports of adverse events with respect to the Product, or Product Complaints, and that may have a material impact on Regulatory Approval or the continued Commercialization of the Product.

 

(iii)                             Regulatory Actions and Regulatory Non-Compliance.  In addition to its obligations under subsections (i) and (ii), 3SBio shall promptly disclose to AMAG the following information:

 

(1)                                  All material information pertaining to actions taken by Regulatory Authorities in connection with the Product (and/or its testing, distribution and/or facilities connected thereto) including, without limitation, any notice, audit notice, notice of initiation by Regulatory Authorities of investigations, inspections, detentions, seizures or injunctions concerning the Product (and/or its distribution, and/or facilities connected thereto), notice of violation letter ( i.e. , an untitled letter), warning letter, service of process or other inquiry; and

 

(2)                                  All information pertaining to notices from Regulatory Authorities of non-compliance with Laws in connection with the Product including, without limitation, receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Product.

 

(b)                                   AMAG Disclosures to 3SBio.   AMAG shall keep 3SBio informed, in a timely manner compliant with the reporting requirements of Regulatory Authorities in the Licensed Territory or the AMAG Territory, as applicable, of notification of any action by, or notification or other information that it receives (directly or indirectly) from, any Regulatory Authority in the Licensed Territory or the AMAG Territory that: (1) raises any material concerns regarding the safety or efficacy of the Product; (2) is reasonably likely to lead to a recall or market withdrawal of the Product; or (3) relates to expedited and periodic reports of adverse events with respect to the Product, or Product Complaints, and that may have a material impact on Regulatory Approval or the continued Commercialization of the Product.  In addition, AMAG shall keep 3SBio informed, in a timely manner compliant with the reporting requirements of Regulatory Authorities in the Licensed Territory, of notification of any action by, or notification or other information that it receives (directly or indirectly) from, any Regulatory Authority in the Licensed Territory that indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product.

 

(c)                                   Territory-Specific Obligations.  In addition to the obligations set forth in Sections 4.7(a) and 4.7(b), if AMAG receives any communication or questions from any Regulatory Authority in the Licensed Territory, or if 3SBio receives any communication or questions from any Regulatory Authority in the AMAG Territory, relating to matters set forth in Sections 4.7(a)(ii) and 4.7(b), the receiving Party shall notify the other Party as soon as possible (but in no event later than two (2) business days after receipt of such notice or inquiry) and provide to such other Party copies of all documents, if any, it received from such Regulatory Authorities.  Such other Party will then prepare the response to the communication.  Before

 

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submitting such response to a Regulatory Authority regarding the communication, the Party that originally received the communication will have an opportunity to comment on the response to the extent such response may affect its rights or obligations under this Agreement.  The other Party will fully cooperate with and assist such Party in complying with all such regulatory obligations and communications, including by providing to such Party, within forty-eight (48) hours after a request, such information and documentation in the other Party’s possession as may be necessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority.  If 3SBio is required to respond to any Regulatory Authority in the AMAG Territory, or if AMAG is required to respond to any Regulatory Authority in the Licensed Territory for the Initial Indication or any Co-Developed Indication, the responding Party shall make diligent efforts to seek the input and approval of the other Party before responding.  Each Party will also provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to above.

 

(d)                               Form of Communications.   All communications that are required to be provided by 3SBio to AMAG pursuant to this Section 4.7 shall, to the extent such communications are not written in English, be accompanied by an executive summary written in English that identifies the communication, the date thereof, the identities of the party from whom the communication originated and the party to whom the communication was addressed, and the material contents of such communication, and such other information as is reasonably necessary to allow AMAG to understand the material contents of such communication.

 

4.8                                Regulatory Inspection or Audit.  If a Regulatory Authority desires to conduct an inspection or audit of 3SBio’s facility or a facility under contract with 3SBio with regard to the Product in the Licensed Territory, then 3SBio shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit, and 3SBio shall be solely responsible for all costs associated with any such inspection or audit.  3SBio shall provide advance notice of any such inspection or audit to AMAG, and AMAG shall have the right to be present at such inspection or audit at AMAG’s sole cost and expense.  Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which 3SBio will immediately provide to AMAG), 3SBio will provide a proposed response to any such observations to AMAG for review and comment, and shall consider AMAG’s comments in good faith.  3SBio agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate applicable Laws.

 

4.9                                Recalls and Voluntary Withdrawals .  Each Party shall provide the other Party with its standard operating procedures ( “SOPs” ) for conducting product recalls reasonably in advance of the First Commercial Sale of the Product in the Licensed Territory, and the Parties shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchange.   If either Party becomes aware of information relating to any Product that indicates that a unit or batch of Product may not conform to the specifications therefor, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of the Product, it shall promptly so notify the other Party.  The JSC shall meet to discuss such circumstances and to consider appropriate courses of action, which shall be consistent with the internal SOP of the Party having the right to control such recall pursuant to this Section 4.9.

 

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3SBio shall have the right, at its expense, to control any product recall, field correction, or withdrawal of the Product in the Licensed Territory.  As between the Parties, AMAG shall have the right, at its expense, to control all recalls, field corrections, and withdrawals of the Product in the AMAG Territory.  3SBio shall maintain complete and accurate records of any recall in the Licensed Territory for such periods as may be required by applicable Laws, but in no event for less than three (3) years.

 

ARTICLE 5
COMMERCIALIZATION

 

5.1                                Commercialization in the Licensed Territory .  3SBio shall have sole responsibility for Commercializing the Product in the Field in the Licensed Territory solely in the Initial Indication and each Co-Developed Indication, as provided in this Article 5, in accordance with a detailed marketing plan for the Initial Indication and for each Co-Developed Indication that sets forth 3SBio’s responsibilities with respect to, and budget and promotional strategy for, Commercialization of the Product in the Licensed Territory (each, a “Marketing Plan” ).  At least twelve (12) months prior to the date the JSC anticipates obtaining the first Regulatory Approval for the Product for the Initial Indication and each Co-Developed Indication in the Licensed Territory, 3SBio shall prepare the initial Marketing Plan for the Initial Indication or applicable Co-Developed Indication and submit it to the JSC for review and approval.  As part of its preparation of the Marketing Plan for the Initial Indication, 3SBio shall conduct a market survey of the Product for use in the Initial Indication in the Licensed Territory.  On at least an annual basis, 3SBio shall update and amend, as appropriate, each then-current Marketing Plan.  3SBio shall submit all proposed updates and amendments to the Marketing Plans to the JSC for review and comment, and the JSC shall approve or disapprove such updates and amendments at its next meeting.  3SBio shall bear all costs and expenses it incurs in connection with preparing the Marketing Plans and with all such Commercialization.

 

5.2                                Affiliates and Distributors.   3SBio shall provide the JSC with prior written notice of any and all Affiliates and distributors performing any Commercialization activities on behalf of 3SBio, and shall identify each such Affiliate and distributor and the activities performed by such Affiliates and distributors in the Marketing Plan.  The Marketing Plan shall contain a description of all transfer pricing arrangements between 3SBio and its Affiliates.

 

5.3                                Pricing Approvals in the Licensed Territory.  3SBio shall be responsible, at its own expense, for seeking Pricing Approval for the Product in the Licensed Territory, as set forth in the Marketing Plan.  3SBio shall keep AMAG informed on an ongoing basis of 3SBio’s strategy for seeking, and the results it obtains in seeking, Pricing Approval in the Licensed Territory, including, without limitation, the results of any discussion or other communication with relevant Governmental Authorities regarding Pricing Approval, via regular reports to the JSC no less frequently than such committee is required to meet pursuant to Section 2.2.

 

5.4                                Pricing of the Product in the Licensed Territory.  The Parties, through the JSC, shall discuss the pricing and reimbursement strategies for the Product in the Licensed Territory.  However, 3SBio shall have the sole right to determine all pricing of the Product in the Licensed Territory.  Notwithstanding anything in this Agreement express or implied to the contrary, AMAG shall not have any right to direct, control, or approve 3SBio’s pricing of the Product for

 

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the Licensed Territory.  The provision to AMAG of any pricing data in connection with the Marketing Plan is for informational purposes only.

 

5.5                                3SBio Performance .

 

(a)                                   Commercial Diligence.   3SBio shall devote Diligent Efforts to Commercializing the Product in the Field in the Licensed Territory following each Regulatory Approval of the Product in the Licensed Territory for the Initial Indication and the Co-Developed Indications in accordance with this Agreement.  Without limiting the generality of the foregoing, and subject to timely supply by AMAG pursuant to Article 7 and the Supply Agreement, 3SBio shall achieve First Commercial Sale of the Product in the Licensed Territory promptly after, and in any case not later than two (2) months after, the date on which the SFDA grants approval of the MAA for the Product in the Initial Indication and each Co-Developed Indication in the Licensed Territory and shall file the appropriate Regulatory Materials and seek to obtain Pricing Approval for the Product as soon as practicable.

 

(b)                                   Details.   Without limiting the generality of the first sentence of Section 5.5(a), 3SBio shall provide for a sales force of at least [***] Sales Representatives specializing in nephrology to promote the Product f