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. 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”). Amarin 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. 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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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. 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. 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. 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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Related to DMFs

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • Regulatory Submissions From and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than Jointly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc. respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Regulatory Documentation Avidity and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means all: (a) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (c) supplements or changes to any of the foregoing following Regulatory Approval; and (d) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((a), (b), (c) and (d)) relating to a Collaboration Target and Compounds Directed Against a Collaboration Target.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Promotional Materials In the event that the Fund or the Adviser makes available any promotional materials related to the Securities or the transactions contemplated hereby intended for use only by registered broker-dealers and registered representatives thereof by means of an Internet web site or similar electronic means, the Adviser will install and maintain, or will cause to be installed and maintained, pre-qualification and password-protection or similar procedures which are reasonably designed to effectively prohibit access to such promotional materials by persons other than registered broker-dealers and registered representatives thereof.

  • Marketing Materials (a) During the term of this Agreement, the Sub-Adviser agrees to furnish the Manager at its principal office for prior review and approval by the Manager all written and/or printed materials, including but not limited to, PowerPointÒ or slide presentations, news releases, advertisements, brochures, fact sheets and other promotional, informational or marketing materials (the “Marketing Materials”) for internal use or public dissemination, that are produced or are for use or reference by the Sub-Adviser, its affiliates or other designees, broker-dealers or the public in connection with the Series, and Sub-Adviser shall not use any such materials if the Manager reasonably objects in writing within five business days (or such other period as may be mutually agreed) after receipt thereof. Marketing Materials may be furnished to the Manager by first class or overnight mail, facsimile transmission equipment, electronic delivery or hand delivery.

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than the term of any Patent issuing therefrom. All other records shall be maintained by each Party during the relevant Research Term and for [**] thereafter. All such records of a Party shall be considered such Party’s Confidential Information.

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