Development Supplies. The Parties shall in good faith negotiate the terms of one (1) or more supply agreements and corresponding quality agreement(s) pursuant to which the Party assigned a given Manufacturing activity under the Global Manufacturing Plan and Budget shall supply Optioned Molecules and Optioned Products to the other Party (to the extent contemplated in the Global Manufacturing Plan and Budget) for Development activities (the “Clinical Supply Agreement”); provided that the price for such Optioned Molecules and Optioned Products under any such Clinical Supply Agreement (other than a Clinical Supply Agreement supporting Independent Activities) shall reflect […***…]. In the case of Independent Activities, the supplying Party may charge a xxxx-up equal to the lowest of (i) […***…] percent […***…] of the Development Manufacturing Costs, (ii) such Party’s xxxx-up used for […***…] or (iii) the xxxx-up agreed by the Parties in the applicable Clinical Supply Agreement. Any Clinical Supply Agreement required to support the Autotaxin Program shall be agreed and signed by the Parties or their applicable Affiliates no later than […***…] days after the Effective Date.
Development Supplies. Based on Cempra’s final Product formulations, concentration and fill volume and the parties’ agreement to the final Product Specifications, [*] as established pursuant to this Agreement, in effect at the time of manufacture, Hospira will manufacture the Products as media runs and engineering, clinical, registration and process validation batches, or other batches not intended for commercial sale or distribution (“Development Supplies”) at the applicable prices set forth in Exhibit 3.5. The parties acknowledge that Development Supplies include material utilized for development purposes that may be used as clinical trial product and stability testing materials, but do not include materials intended for commercial sale in the market, except as otherwise permitted by Applicable Law. In accordance with a schedule to be mutually agreed by the parties, Cempra shall issue its purchase order(s) for such Development Supplies at least [*] days before any agreed-upon Fill Date. For the sake of clarity, all relevant provisions of Articles 5, 7, 8 and 9 shall apply to the manufacture and delivery of the Development Supplies.
Development Supplies. Based on Xxxxxxx’x final Product formulations, concentration and fill volume and the Parties’ agreement to the final Product Specifications, Pfizer will manufacture the Products as engineering batches, validation batches and stability batches (collectively, the “Development Supplies”) at the prices set forth in the Statement of Work. The Parties acknowledge that Development Supplies may include products utilized for development purposes only (e.g., in media fills, engineering runs, or as stability testing materials), which are not intended for commercial sale in the market; provided, however, that Pfizer will manufacture all validation batches of Product in accordance with cGMP, which, if permitted by Applicable Law, would allow Xxxxxxx to use such validation batches as part of its commercial supply. In accordance with a schedule to be mutually agreed by the Parties, Xxxxxxx shall issue its purchase order(s) for such Development Supplies at least [*] days before any requested delivery date. For the sake of clarity, all relevant provisions of Articles 5, 7, 8 and 9 also shall apply to the manufacture and delivery of the Development Supplies.
Development Supplies. After Company selects its final Product formulation, concentration and fill volume and the parties mutually agree to the final Product Specifications, Hospira may provide to Company development supplies at the prices set forth on Exhibit 5.8. Company shall issue a purchase order for any such development supplies [*] before the requested delivery date. Company and Hospira shall jointly develop and mutually agree upon the formulation, concentration, fill volume and the components for each lot of development supplies.
Development Supplies. 5 ARTICLE III - ADDITIONAL COVENANTS
Development Supplies. Notwithstanding the foregoing, XOMA(US) shall supply ALLERGAN's reasonable requirements of the Compound for all formulation, development, clinical supplies and non-commercial manufacturing at a price of [*]. XOMA(US) shall supply Compound at a quality presently used in XOMA(US)'s clinical studies until ALLERGAN begins the first Phase III clinical trial of Compound in the United States or the equivalent of a Phase III clinical trial in another Major Market Country and, thereafter, Compound will be supplied in accordance with the Compound Specifications and requirements of Section 2.6 hereof.
Development Supplies. Based on Durata’s final Product formulations, concentration and fill volume and the Parties’ agreement to the final Product Specifications, Hospira will manufacture the Products as engineering batches, clinical batches and registration/stability batches (collectively, “Clinical and Development Supplies”) at the prices set forth in Exhibit 3.5. The Parties acknowledge that Clinical and Development Supplies include material utilized for the development purposes that may be used as clinical trial product and stability testing material, but do not include materials intended for commercial sale in the market (provided, however, that, to the extent permitted under Applicable Law, Durata may commercially sell such materials). Except with respect to the first purchase order for Clinical and Development Supplies, Durata shall issue a purchase order for any such Clinical and Development Supplies at least [**] days before the requested delivery date. For the sake of clarity, the provisions of Sections 5.4, 5.6, 5.8, 5.9, 5.11 and 8.2 and all other relevant provisions shall apply to the clinical batches and registration/stability batches included in the Clinical and Development Supplies.
Development Supplies. Based on Kythera’s final Product formulations, concentration and fill volume and the parties’ agreement to the final Product Specifications, Hospira will manufacture the Product as engineering batches, clinical batches, and registration/stability batches and Placebo Product batches (“Development Supplies”) at the prices set forth in Exhibit 3.5. The parties acknowledge that Development Supplies include material utilized for the development purposes such as clinical trial product and stability testing material, but do not include materials intended for commercial sale in the market. Kythera shall issue a purchase order for any such Development Supplies at least one-hundred twenty (120) days before the requested delivery date. If Kythera requests Hospira to manufacture additional clinical batches of the Product and Placebo Product, Hospira shall do so on substantially similar terms and conditions applicable to development supplies.
Development Supplies. Upon Gilead’s request, the Parties shall negotiate in good faith and execute within [***] days following the applicable Option Exercise Closing the terms of one (1) or more written supply agreements and corresponding quality agreement(s) pursuant to which Assembly (itself or through one or more CMOs, in each case, that have passed Gilead’s standard manufacturer quality audit) shall supply Optioned Molecules and Optioned Products to Gilead for Development activities in the Gilead Territory (each, a “Clinical Supply Agreement”); [***]. If the Parties fail to agree to a Clinical Supply Agreement within [***] days following the applicable Option Exercise Closing, then either Party may refer any disputed terms to arbitration pursuant to Section 19.2(c). Until a Clinical Supply Agreement is agreed upon by the Parties or determined in accordance with Section 19.2(c), Assembly (itself or through one or more CMOs) will supply, [***], reasonable quantities of clinical supply of such Optioned Molecules and Optioned Products to Gilead in accordance with Gilead quality requirements and the terms of this Section 8.2.
Development Supplies. The parties mutually agree to the final Product Specifications. Hospira may provide to Company development supplies at the prices set forth on Exhibit 2.1. Company shall issue a purchase order for any such development supplies at least [ * ] before the requested delivery date. Company and Hospira mutually agree to the formulation, concentration, fill volume and the components for each lot of development supplies. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
