DMFs Sample Clauses

DMFs. 5.1.1 To the extent Supplier has not already done so, Supplier shall file all appropriate DMFs with the applicable Regulatory Authorities in the Recro Territory as soon as reasonably necessary and as agreed mutually between the Parties.
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DMFs. To the extent MERCK KGAA supplies VILAZODONE API to GENAISSANCE, MERCK KGAA will grant GENAISSANCE reasonable access to and a right to cross-reference the technical information contained in the then current drug master file (“DMF”) relevant for VILAZODONE API so that GENAISSANCE can include or cross reference that information in its IND directly or through a GENAISSANCE DMF. If necessary, MERCK KGAA will update and maintain its DMF with VILAZODONE MANUFACTURING TECHNOLOGY before PHASE III CLINICAL TRIALS and again before NDA submission, and as may be otherwise necessary to reflect current manufacturing methods, until such time when GENAISSANCE submits its own IND or DMF.
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DMFs. Chemport shall create and maintain the Drug Master Files for API in the [***] (if designated by Amarin in its reasonable discretion) and other jurisdictions agreed to by the Parties (the “DMFs”). Xxxxxx agrees to assist Chemport by making its Approved Representatives available for consultation and advice to Chemport, as may be reasonably requested by Chemport, regarding preparation and maintenance of the DMFs. Chemport hereby grants to Amarin the right to reference the DMFs in any relevant Drug Application or other documentation to the extent such reference is necessary for the approval and maintenance of a Drug Application. The Approved Representatives may share with Amarin any information they receive or obtain in connection with their activities under this Section 7.5. Additionally, from time to time during the Term, Chemport shall provide such information as Amarin may reasonably request related to the DMFs, which shall be handled by Amarin as Chemport Confidential Information, subject to Article XIII. Chemport shall own all regulatory files with respect to the API including without limitation the DMFs.
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DMFs. Upon King's written request, Supplier shall promptly send a letter in form and substance satisfactory to King to each of Supplier's suppliers that are referenced in the NDA with respect to the Products requesting permission for King to reference such supplier's DMFs, in order to notify such supplier of the transfer of the Products from Supplier to King (pursuant to the General Products Agreement and the Operative Agreements (as such term is defined in the General Products Agreement)) and to obtain appropriate Drug Master File reference authorizations from such supplier.
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DMFs. Supplier shall maintain all DMF(s) in compliance with FDA regulations and shall make reasonable commercial efforts to update such DMF(s) to accommodate any additional references thereto in any amendments that may be made to Endo’s NDA(s) or ANDA(s) or any accompanying supplements. For the avoidance of doubt, Supplier is under no obligation to make any changes to a DMF absent mutual agreement. Supplier shall furnish Endo with a Letter of Authorization granting Endo permission to cite the Supplier’s DMF in filings.
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DMFs. Stellar shall provide reasonable assistance to Xxxxxx in obtaining Device Master File ("DMF") reference authorizations from all approved Stellar suppliers (where available) as soon as possible following the date hereof. At Stellar’s or its supplier’s sole discretion, these DMF reference authorizations may be submitted directly to the FDA in confidence.
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DMFs. 4.2.1 Within ninety (90) days after the Effective Date, Aquestive shall provide, or make available to Haisco all Drug Master Files associated with the Product (each, a “DMF”) in the possession or Control of Aquestive that are required to support application for Regulatory Approval for the Product in the Territory, together with a letter of authorization substantially in the form as attached hereto as Schedule 4.2 (each, a “LOA”). 4.2.2 If the DMF for the API is not in Aquestive’s possession or Control, Aquestive shall instruct the Third Party API supplier to provide or make available to Haisco, within ninety (90) days after the Effective Date the DMF for the API and a LOA. 4.2.3 In the event any other DMF that is necessary for the Development activities to be conducted by Haisco or Commercialization of the Product in the Field in the Territory are Controlled by Third Party(ies) (each, a “DMF Holder”), and to the extent any such DMF is required to support application for the Regulatory Approval for the Product in the Territory, Aquestive shall use Commercially Reasonable Efforts to provide or cause all the applicable DMF Holder to provide or make available to Haisco, no later than ninety (90) days after the receipt of a written request from Haisco, complete copies of any and all such DMF and LOA(s), at Aquestive’s (or such DMF Holder’s) sole cost and expense. 4.2.4 Notwithstanding the foregoing, and only to the extent permitted by the Regulatory Authority in the Territory:
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DMFs. Supplier shall maintain all DMF(s) in compliance with FDA regulations and shall make reasonable commercial efforts to update such DMF(s) to accommodate any additional references thereto in any amendments that may be made to Company’s NDA(s) or ANDA(s) or any accompanying supplements. For the avoidance of doubt, Supplier is under no obligation to make any changes to a DMF absent mutual agreement. Supplier shall furnish Company with a Letter of Authorization granting Company permission to cite the Supplier’s DMF in filings. API Supply Agreement – EXECUTION VERSION 6
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DMFs. Equateq shall file and maintain the Drug Master Files for API in jurisdictions designated by Amarin from time to time (the “DMFs”). Amarin shall [***]. Equateq hereby grants to Amarin the right to reference the DMFs and any other filings held in Equateq’s name in any relevant Drug Application or other documentation to the extent such reference is necessary or useful for the approval and maintenance of a Drug Application.
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Related to DMFs

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  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

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