Common use of Commercial Phase Clause in Contracts

Commercial Phase. (1) After successful completion of the Process Validation Campaign, Amylin shall use commercially reasonable efforts to have Sandoz approved by the FDA as manufacturer of the Product. Subject to such approval, Amylin has the right and obligation to exclusively purchase from Sandoz, and Sandoz shall Manufacture for Amylin, at least [***] of the entire Product demand of Amylin, its Affiliates and Amylin’s Product licensees, pursuant and subject to the terms and conditions of this Agreement. For purposes of satisfying the exclusivity provisions of this Clause 9(1) and subject to the Minimum Fee provisions set forth in Clause 9(3), Amylin shall have the option to purchase Product from Sandoz that has been manufactured in accordance with the terms and conditions of that certain Process Optimization and Manufacturing Agreement, dated June 25, 2010, between Amylin and Sandoz and any other Product manufacturing and/or supply agreement that may be entered into between the parties in writing. (2) For all Commercial Batches of Product ordered by Amylin, Amylin shall pay to Sandoz the purchase price set out in Schedule 7. Pricing model “A” on Schedule 7 shall apply for Firm Orders of [***] or more cGMP Batches per campaign. Pricing model “B” on Schedule 7 will apply for Firm Orders of [***] cGMP Batches per campaign. Notwithstanding the foregoing, if Amylin purchases Product under the terms of any other agreement as provided in Clause 9(1), Amylin shall pay the purchase price set out in such agreement. (3) [***]. (4) Sandoz covenants that: (a) It has and will maintain during the term of this Agreement, a manufacturer’s license. (b) It will perform the Services in accordance with this Agreement. It will Manufacture the Product in accordance with this Agreement, including utilizing the Process and (except for the Engineering Batches) in compliance with cGMP and the Specifications. With respect to Engineering Batches, Sandoz will use commercially, scientifically and technically reasonable efforts to achieve compliance of Engineering Batches with cGMP requirements and Product Specifications (including, for the avoidance of doubt, documentation required by cGMP and Sandoz quality systems), it being understood and agreed that (except for the aforesaid obligations to use commercially, scientifically and technically reasonable efforts) Sandoz shall have no obligation and/or liability whatsoever with respect to compliance of Engineering Batches with cGMP requirements and/or Product Specifications. (c) Any Raw Materials employed by Sandoz in the Manufacture of Product and not supplied by Amylin (directly or through an Amylin supplier) will at the time of use conform to the requirements stated in Clause 8(2). (d) It will maintain complete, accurate and adequate records pertaining to its Manufacture, analysis and distribution of the Product (including the Manufacturing Records) in accordance with the types of records to be maintained as described in cGMP, the format and content of such records to follow Sandoz’ standard form in German language to the extent in compliance with Amylin’s regulatory filing requirements. The Master Batch Records and the site-relevant records will be in English language (or available as translation into English language). For any regulatory support in order to maintain approval in the United States and European Union during commercial phase, Sandoz will use commercially reasonable efforts to assist Amylin in the preparation of such records and documentation to the extent requested by Amylin, and Amylin will compensate Sandoz for such assistance at a rate of [***], based on actual hours worked. Sandoz will provide all manufacturing process documentation during the Commercial Phase for purposes of updating regulatory filings on an ongoing basis. The parties understand that Amylin may license certain of its rights to third parties and such parties may require access to the described documents (including access to original copies of such documents on-site at Sandoz). Accordingly, such licensees shall be provided copies of such documents and prompt access to original copies of such documents on-site during regular business hours and after reasonable prior notice by Amylin, provided that (a) the number of such licensees on-site at Sandoz in any year is reasonable (not to exceed [***] visits in total), (b) Amylin, and not Sandoz, shall be responsible for providing copies of such documents to the licensees, and (c) Amylin shall accompany each licensee during any review of original documents on-site at Sandoz. In such event Amylin shall remain fully responsible to Sandoz regarding compliance of such third parties with the terms of this Agreement, including but not limited to confidentiality obligations. (e) The Product will be labeled, prepared and packed for shipment in accordance with labeling requirements as specified by Amylin from time to time. (f) It will be responsible for the treatment and/or disposal of all waste generated as a result of Manufacturing the Product in accordance with all applicable laws, regulations and directives, and the maintenance of detailed and complete records related thereto. (g) It will not incorporate any Sandoz IP Rights (including but not limited to any Sandoz Background Technology or Sandoz Collaboration IP Rights) into the Process without Amylin’s prior consultation and consent. (5) Sandoz may at any time, with reasonable advance notice to Amylin and in accordance with any applicable provisions of the Quality Agreement, undertake any change (including routine maintenance and repair work) to any of its premises or facilities or equipment directly used in the Manufacture; provided that any such change shall not be a detriment to the Product. (6) Amylin covenants that: (a) It has and will maintain throughout the term of this Agreement appropriate Regulatory Approvals for the Product for any jurisdiction or territory in which Amylin is marketing, distributing or using the Product. (b) Any Raw Materials provided by Amylin (directly or through an Amylin supplier), shall conform to the requirements set forth in Clause 8(3). (c) It shall, as soon as it becomes aware of the same, notify Sandoz of any hazards to the health or safety of any personnel of Sandoz or the possibility of cross contamination of any other products being manufactured or stored by Sandoz. (d) Pilot Batches and non-cGMP (Nonconforming) Batches will not be used for clinical trials.