Manufacturing Costs. Patheon shall be allowed to adjust the Fees: (i) for costs associated with the conversion of Granulations and Components into Drug Product (the “Conversion Costs”) in respect of the Drug Product based on the most recently available final Producers’ Price Index for Pharmaceutical Product as published by the U.S. Bureau of Labor Statistics or any governmental successor thereto (“PPI”) using the procedure set forth in Section 4.3 and (ii) for Component Costs to pass on the actual amount of any increase or decrease in such costs without xxxx-up. For each Contract Year in which Patheon is entitled to adjust the Fees Patheon shall provide Client with written notice of any change in the Fees within 30 days of receipt by Patheon of the Annual Forecast. The Parties agree that the Fees shall not be adjusted more than once per Contract Year, however this limitation shall not include price adjustments under section 4.3 or 4.4. In addition, notwithstanding anything herein to the contrary, Manufacturing Fees associated with Conversion Costs shall not be increased by greater than [***]% per annum in any Contract Year during the Term. There shall be no similar limitation in terms of increases in Component Costs which shall be passed on to Client in an amount equal to the actual increase paid by Patheon without markup.
Manufacturing Costs. In the event of termination by Merck pursuant to Section 6.3 or 6.7 above, Merck shall be entitled to *** (as defined herein) incurred by Merck for its Compound Delivered for the Study. *** .
Manufacturing Costs. 8.1.2.1. Surface will be responsible for [***] of all Manufacturing Costs relating to T1 Antibody Candidates incurred by or on behalf of Surface to support the T1 Research Program.
8.1.2.2. Novartis will pay to Surface [***] of reasonable Manufacturing Costs relating to the first Phase 1 Safety Study for T1 Antibody Candidates and T1 Licensed Products set forth in the Novartis approved budget for such Phase 1 Safety Study.
8.1.2.3. Other than the first Phase 1 Safety Study for the T1 Antibody Candidates and T1 Licensed Products, Novartis will be responsible for [***] of all Manufacturing Costs relating to T1 Antibody Candidates and T1 Licensed Products for use in the Research, Development and Commercialization of such T1 Antibody Candidates and T1 Licensed Products in the Novartis Territory incurred by or on behalf of Novartis.
Manufacturing Costs. 8.4.2.1. Subject to Section 8.2.3, Surface will be responsible for [***] of all Manufacturing Costs relating to Global Antibody Candidates and Global Licensed Products incurred by or on behalf of Surface to support the first Phase 1 Safety Study for Global Antibody Candidates and Global Licensed Products.
8.4.2.2. Other than the first Phase 1 Safety Study for the Global Antibody Candidates and Global Licensed Products (subject to Section 8.2.3), Novartis will be responsible for [***] of all Manufacturing Costs relating to Global Antibody Candidates and Global Licensed Products for use in the Research, Development and Commercialization of such Global Antibody Candidates and Global Licensed Products by or on behalf of Novartis in the Novartis Territory.
Manufacturing Costs. During the period that HMI is responsible for Manufacturing any Candidate or Product, NVS will be responsible for the documented Manufacturing Costs actually incurred by HMI directly in connection with the Manufacture and supply of such Candidate and Product in accordance with the Research Plans, Development Supply Agreement(s), and Commercial Supply Agreement(s), as applicable; provided, further, that: (a) Manufacturing Costs for Candidates shall (i) continue until the end of [***], (ii) be set forth in the applicable JSC approved Research Budget, and (iii) be subject to the [***]; (b) Candidates and Products Manufactured and supplied pursuant to the applicable Development Supply Agreement shall be supplied to NVS at a transfer price equal to [***]; and (c) Candidates and Products Manufactured for Pivotal Clinical Trials and Commercialization activities and supplied pursuant to the Commercial Supply Agreement shall be supplied to NVS at a transfer price equal to [***].
Manufacturing Costs. Surface will be responsible for [***] of all Manufacturing Costs incurred by or on behalf of Surface relating to Option Target Antibody Candidates, including CD47 Option Target Antibody Candidates, for use in the Option Target Research Programs. For clarity, responsibility for Manufacturing Clinical Study material will be allocated as set forth in under Sections 8.3 or 8.4, as applicable.
Manufacturing Costs. All Manufacturing Costs incurred (a) in furtherance of the CNS Development Plan shall be a Development Cost borne by a Party or a Shared Development Cost shared by the Parties in accordance with Section 7.7 (Cost Profit Sharing); (b) in furtherance of the Co-Commercialization Plan pertaining to Commercialization activities for CNS Products in each country of the Cost Profit Sharing Countries, shall be an Allowable Expense; or (c) in furtherance of (i) any Additional CNS Development Activities, or (ii) other Commercialization activities for the CNS Program not covered in the foregoing clause (b), shall be borne by the Party who incurred such costs; provided that, if Denali exercises the Denali Royalty Option, Sanofi shall, from and after the Co-Funding End Date with respect to the particular Cost Profit Sharing Opt Out Product for sales in the applicable Cost Profit Sharing Opt Out Country, bear all Manufacturing Costs with respect to the applicable Cost Profit Sharing Opt Out Product for sales in the applicable Cost Profit Sharing Opt Out Country (including, for the avoidance of doubt, any CNS Compound(s) contained therein) and, to the extent that Denali Manufactures any such Cost Profit Sharing Opt Out Product or CNS Compound therein for sales in the applicable Cost Profit Sharing Opt Out Country, shall reimburse Denali for its Manufacturing Costs incurred in connection with the Manufacture of such Cost Profit Sharing Opt Out Product or CNS Compound therein for sale in the applicable Cost Profit Sharing Opt Out Country. Sanofi shall bear all Manufacturing Costs for Peripheral Compounds and Peripheral Products and, to the extent that Denali Manufactures any Peripheral Compounds or Peripheral Products, Sanofi shall reimburse Denali for its Manufacturing Costs incurred in connection with the Manufacture of Peripheral Compounds and Peripheral Products.
Manufacturing Costs. (a) DICERNA, at its sole cost, shall manufacture or obtain DsiRNA-Based Compound for the conduct of the Research Collaboration for the Initial Target
Manufacturing Costs. Athersys shall keep, and shall require all Third-Party manufacturers of the Clinical Development Candidates and/or Cell Therapy Products to keep, accurate records in sufficient detail concerning the Manufacturing Costs. Angiotech shall be entitled to engage an independent public accounting firm to audit the Manufacturing Costs as provided in, and in accordance with, Section 7.6. For this purpose, Athersys itself shall keep, and to the extent that Athersys has obtained records or documents from its Third-Party manufacturers shall keep, such account books and related records or documents for a period of at least seven (7) years after the end of the fiscal year to which the Manufacturing Costs relate.
Manufacturing Costs. Company will provide all Licensed Agents and Products under this Section 2.4 at the Manufacturing Cost (with such Manufacturing Costs for Licensed Agents and Products to be used in performing Research Activities and Additional Research Activities to be included in the applicable Research Budget or Additional Research Budget) or as otherwise provided in Section 2.4.3. If requested by Vertex, the Parties will discuss Company’s Manufacturing Costs for all Licensed Agents and Products Manufactured by Company as provided hereunder and [***]. If the Parties agree that [***], Company will use Commercially Reasonable Efforts to [***] and keep Vertex reasonably informed on the progress thereof.
