Example ContractsClausesControl of Manufacturing Changes.
Control of Manufacturing Changes.
Control of Manufacturing Changes. contract clause examples

Changes to Manufacturing. [[Surmodics:Organization]] shall notify Abbott in writing at least ​ prior to # making any proposed change or relocation of the manufacturing site for the Product or # engaging or substituting any Third Party to perform any of [[Surmodics:Organization]]’ obligations hereunder. Relocation of the manufacturing site or engagement or substitution of a Third Party to perform any of [[Surmodics:Organization]]’ obligations hereunder shall require the prior written consent of Abbott. Upon receipt by Abbott of any such request for consent, Abbott shall respond in writing within ​ following its receipt of notice from [[Surmodics:Organization]]. Any new facility or Third Party to be utilized by [[Surmodics:Organization]] shall be subject to a new and separate audit by Abbott quality assurance personnel in accordance with [Section 4.1.8], and [[Surmodics:Organization]] shall use Commercially Reasonable Efforts to have the new manufacturing site or Third Party become acceptable to Abbott quality policies within ​ of relocating Product Manufacture or engaging such Third Party. Except as otherwise provided herein, no relocation or engagement or substitution of a Third Party to perform any of [[Surmodics:Organization]]’ obligations hereunder shall relieve CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Manufacturing Changes requested by Takeda. Takeda may request Manufacturing Changes. Takeda shall provide Company with written notice providing details and reason for any such requested Manufacturing Changes. Costs related to such Manufacturing Changes shall solely borne by Takeda.

Manufacturing. Upon EISAI’s request, [[EPIZYME:Organization]] shall, as part of the transition plan to be mutually agreed by the Parties under clause (e) below, at EISAI’s expense, transfer to EISAI (or its designee) any processes, documents, materials and other Know-How, to the extent the foregoing is Controlled by [[EPIZYME:Organization]] as of the effective date of termination and used in the Manufacture of Licensed Products in the Field as they exist as of the date of termination; provided that, upon EISAI’s request and pursuant to a supply agreement to be negotiated in good faith by the Parties, at a purchase price equal to [[EPIZYME:Organization]]’s Cost of Goods for clinical supplies and ​ of [[EPIZYME:Organization]]’s Cost of Goods for commercial supplies, supply EISAI with clinical and commercial quantities of the Licensed Products for the [[EPIZYME:Organization]] Territory in the dosage strengths, formulations and presentations under Development or being Commercialized by [[EPIZYME:Organization]], in either case, as of the effective date of termination, until the earlier of: # ​ months after the effective date of termination; or # establishment by EISAI of an alternative supply for such Licensed Products on commercially reasonable terms.

Manufacturing. Subject to the terms and conditions of this Agreement (including Section 5.3 and Annex 2) and the Manufacturing and Supply Agreement, Bioeq shall have the sole responsibility for the Manufacturing and supply of the Licensed Products to Licensee for Commercialization in the Field in the Territory.

Changes to Manufacturing. Each Party may make changes from time to time to its Compound or the Manufacturing Site; provided that such changes shall be in accordance with the Quality Agreement.

Manufacturing. During the Term, [[FibroGen:Organization]] will have the exclusive right to Manufacture and supply the Licensed Compounds and Licensed Products itself or through one or more Affiliates or [[FibroGen:Organization]] CMOs for Exploitation in the Field in the Territory.

Manufacturing. Upon [[EPIZYME:Organization]]’s request, EISAI shall, as part of the transition plan to be mutually agreed by the Parties under [clause (c) above], at [[EPIZYME:Organization]]’s expense, transfer to [[EPIZYME:Organization]] (or its designee) any processes, documents, materials and other Know-How, to the extent the foregoing is Controlled by EISAI as of the effective date of termination and used in the Manufacture of Licensed Products in the Field as they exist as of the date of termination.

Supplier and Verrica acknowledge and agree that Supplier will procure the raw materials to be used for the Manufacture of the Material and contract with Manufacturer(s) to perform the Manufacturing of the Material. Supplier shall ensure that no changes shall be made to the Material Specifications, Material, Manufacturing methods or solvents and other processing chemicals, processing equipment and aids used by any Manufacturer or any other party in the Manufacture of Material without notifying Verrica of such proposed changes at least one (1) year in advance and obtaining Verrica’s prior written consent before implementing such changes. In addition, Supplier agrees that it will not change any Manufacturer utilized in the Manufacture of the Material without notifying Verrica at least one (1) year in advance and without obtaining Verrica’s prior written consent to use the new Manufacturer. Supplier agrees that it will not request Verrica’s approval of a new Manufacturer more often than once per each calendar year.

Manufacturing Changes requested by Takeda. Takeda may request Manufacturing Changes. Takeda shall provide Company with written notice providing details and reason for any such requested Manufacturing Changes. Costs related to such Manufacturing Changes shall solely borne by Takeda.

Manufacturing. Subject to the terms and conditions of this Agreement, # Nurix, at its sole cost and expense, will Manufacture, itself or through Third Parties, Research supplies (other than GLP tox supplies) for the Parties’ use of the respective CTMs, Target Binders and Development Candidates in the Field in the Territory under the Collaboration, provided that ​, provided, further, that Research supplies for Sanofi shall be limited to those specified in any Research Plan for Sanofi activities or otherwise as permitted under [Section 2.7.4] (Activities to be Performed by Sanofi), and # Sanofi will have the sole and exclusive right to Manufacture (and will solely and exclusively control, at its discretion, the Manufacture of), itself or with or through its Affiliates, Sublicensees or other Third Parties, the GLP tox supplies, and supplies to support Development or Commercial activities for the respective Development Candidates, backups thereto and Licensed Products in the Field in the Territory. Subject to the Co-Development/Co-Commercialization Agreement and Profit/Loss Share Agreement (if executed), all such Manufacturing described in clause (b) will be at Sanofi’s sole cost and expense. Notwithstanding the foregoing, Sanofi shall have the right, but not the obligation, to Manufacture, itself or through Third Parties, Research supplies of ​ to enable Sanofi’s activities with respect to the Research of Collaboration ​, as assigned to Sanofi under the ​. Upon request, Nurix shall provide Sanofi with ​ for Sanofi to be able to Manufacture such Research supplies, including, without limitation, ​ for the relevant

Next results

Draft better contracts
faster with AllDrafts

AllDrafts is a cloud-based editor designed specifically for contracts. With automatic formatting, a massive clause library, smart redaction, and insanely easy templates, it’s a welcome change from Word.

And AllDrafts generates clean Word and PDF files from any draft.