9.07DO â â â Integration â Integration. This Agreement constitutes the entire agreement between the parties with respect to the subject matter of this Agreement and supersedes all prior written or oral agreements. This Agreement may only be amended in writing, signed by duly authorized representatives of each of the Parties. f) Customer agrees to purchase at least [***] of its product requirements per year, up to a maximum of [***] from Pfizer. `quality agreement` means an agreement between the Parties describing the responsibilities of the Parties for quality control, technology, quality assurance and regulation with respect to the manufacture and dissemination of medicinal ingredients in bulk manufactured under this Agreement. [***] from the Product to customer in accordance with the terms of this Agreement. If Customer`s demand for a Pfizer product exceeds [***], Customer shall notify Pfizer in advance of this requirement [***] in order to give Pfizer sufficient time to make commercially reasonable efforts to allocate production capacity to manufacture and supply products that exceed [***], but not more than a maximum [***]; provided, however, that the manufacturer is not required to purchase new equipment, install equipment purchased or requested by the customer, or add additional manufacturing or storage capacity for manufacturing and other activities to be carried out by the manufacturer under this Agreement. If Customer`s request for a Pfizer product exceeds [***], Customer shall notify Pfizer in advance of this requirement [***] in order to give the parties time to meet and have discussions in good faith on how the parties can develop their ability to deliver products beyond [***]. a) Pfizer or Pfizer`s designated affiliate will use Diligent Efforts to Manufacturing, and Customer must purchase Customer`s requirements for the bulk drug substance API from Pfizer or its designated affiliate and in accordance with initial supply forecasts and continuous supply forecasts. Taking into account the reciprocal agreements and arrangements contained in this Agreement between the Parties who wish to be legally bound herein, the Parties therefore agree as follows: (b) Quality Agreement. Representatives of the quality assurance services of the Contracting Parties shall meet to prepare and approve a quality agreement. In the event of any conflict between the terms of the Quality Agreement and this Delivery Agreement, the terms of this Supply Agreement shall apply. The quality agreement may be amended from time to time by mutual written agreement.
Once the Quality Agreement has been signed by both Parties, it shall be incorporated into this Agreement by that reference and shall form an integral part of this Agreement. g) Â Â but is not responsible for its inability to do so. Orders may be modified by mutual agreement between the parties. Subject to section 2.02(e), Pfizer will provide quantities of the bulk drug substance API, in all cases as specified in the applicable order received by Pfizer in accordance with this Section 2.02 and in accordance with the delivery schedule set forth therein. In the event of any conflict between the terms of this Agreement and any order, confirmation, invoice, cancellation, acceptance xxxx or other pre-printed form provided by either party, the terms of this Agreement shall prevail. If, due to a Pfizer internal production problem, Pfizer is unable to deliver the order within [*] from the requested delivery date, Customer is entitled to purchase more than [*] of its annual requirements for the Product from a supplier other than Pfizer, provided that such purchase can be made beyond the [***] annual requirements only for the period, in which Pfizer is temporarily unable to meet the customer`s requirements and is immediately discontinued. the termination of such incapacity and, finally, also provided that the customer`s requirements, which PFIZER has not met, are normal and ordinary requirements as determined by the customer`s ordinary purchases of the product from Pfizer in the preceding months. b) The parties` quality assurance representatives will discuss in good faith to attempt to resolve such a disagreement, and the customer and Pfizer will follow their respective standard operating procedures to determine the compliance of the bulk drug substance API with the specifications. If the foregoing discussions do not resolve the disagreement within a reasonable period of time (which will not exceed [***]), a sample of the usFDA sample retained by Pfizer and a sample of the bulk drug substance API in question will be submitted side by side by Pfizer and the customer for reconsideration to determine definitively whether this API bulk drug substance meets the specifications. Such new testing will be performed at a laboratory designated by the Customer and agreed to by Pfizer using the test methods specified in the specifications of this Agreement and with representatives of both parties who will be present at all repeated testing.
The determination of compliance or non-compliance by such a review in respect of all or part of such a medicinal product based on bulk active substance shall be final and binding on the parties. The costs of such a new test shall be borne by Pfizer if the test confirms non-compliance and otherwise at the customer`s expense if the test confirms compliance. c) The purchase and sale of all API Bulk Drug Substances under this Agreement will be made by issuing individual written orders to Pfizer for certain quantities of API Bulk Drug Substances (each, a “Purchase Order”) at least [***] prior to the commencement of each subsequent [***] [***]. Each order contains the desired quantities of API bulk drug substance, the place of shipment and the delivery dates, these delivery dates must not be earlier than [***] and at the latest at [***] after delivery of this order. In addition, for each binding [***] of a rolling supply forecast, the sum of the API bulk drug substance quantities in the orders shall be the quantity (c)If Customer terminates this Agreement, Customer shall reimburse Pfizer within [***] of such termination (i) Pfizer reasonable and non-cancellable costs for work in progress, including, but not limited to, raw materials, used to manufacture the Product and inventory of all intermediaries used in the manufacture of the Product, including 1TTB and TTU, which Pfizer may not use for any other use by commercially reasonable effort, and (ii) purchase all Pfizer Products. Stock of products that must not exceed quantities exceeding the quantities covered by orders or binding forecasts. a) The purchase price of the Bulk Pharmaceutical Substance sold to the Customer under this Agreement is set out below, depending on the quantities of the Product purchased during a calendar year: This Agreement shall enter into force on the effective date of the Supply Contract and, unless terminated earlier in accordance with this Article VIII or renewed pursuant to a written agreement between the parties, will survive the third anniversary of the coming into force of the Supply Agreement (the “Agreement”). At the end of the Initial Term, the Contract is automatically renewed for one (1) additional contract year, which may not exceed three renewals (each a “Renewal Period”). The parties may terminate the Contract by terminating the other party at least (1) one year before the expiry of the then current term. d) Except during the pre-approval period or step-by-step quantities of the API bulk pharmaceutical substance stock up to the delivery date specified in this order and the customer`s binding obligation to purchase the api bulk drug substance quantity specified in it. .
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