Drug Master File. Licensee shall make certain data generated during the research and development of Testim accessible to Licensor through the preparation and filing of one or more Drug Master Files (“DMF”). Such DMF shall (a) be filed by or on behalf of the Licensee with the United States Food and Drug Administration (“FDA”) on or before June 30, 2004 and (b) shall contain the data listed on the index attached as Exhibit A to this Amendment 4 to the License Agreement (the “Data Index”). Licensee will designate Licensor, or its licensee if requested in writing by Licensor, as having a right of reference with the FDA to the DMF (the “Right of Reference”). Licensor shall treat the Data Index as confidential information of Licensee and may disclose the Data Index only to those persons or third parties who have agreed in writing to maintain its confidentiality and to use the Data Index solely for purposes of evaluation of a potential business opportunity with Licensor.
Drug Master File. XXXXXX shall file and maintain the appropriate Drug Master File (“DMF”) and related reference applications (e.g. Site Master File) for its Production of each Product hereunder in accordance with 21 CFR 314.420, as may be amended from time to time, and other regulatory requirements or required by Regulatory Authorities at XXXXXX’x expense.
Drug Master File. RTU shall produce and maintain a drug master file for Drug Substance made under this Agreement, which shall contain all information necessary to comply with MHLW standards with respect to the applicable manufacturing processes and Drug Product.
Drug Master File. Bayer shall be solely responsible for filing and maintaining the DMFs for the Product and the DMFs shall be in the name of and be owned by Bayer. Bayer shall bear the cost of filing and maintaining the DMFs in the *** (the “DMF Territories”). All costs incurred by Bayer arising out of or related to the filing and maintenance of DMFs outside of the DMF Territories shall be reimbursed to Bayer by Syndax on a time and material basis. Bayer shall invoice Syndax for said costs and Syndax will remit payment therefor to Bayer within thirty (30) days of receipt of such invoice. As soon as practicable after filing of a DMF, and in any case not more than sixty (60) days thereafter, Bayer shall, upon written request from Licensee, grant all applicable Governmental Authorities including, without limitation, ***, the right to cross-reference the DMF for the Product on behalf of Licensee, as required for the Development and Commercialization of the Product in the Territory for use in the Field. Bayer shall retain sole responsibility and ownership of the DMFs even after the transfer of responsibility for the CMC/Process Development and Manufacture of the Product to Licensee, as set forth in Section 4.3.2 below; provided, however, that Bayer shall have the right (but not the obligation), at any time thereafter, to assign and transfer sole responsibility and ownership of the DMFs to Licensee upon twenty (20) days notice to Licensee. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Drug Master File. In mutually agreed countries, Bachem will maintain the Product DMF according to requirements defined by each local Competent Authority. Bachem will provide a letter to the specified Competent Authority at Xeris’ request in accordance with Section 5.2 of the Agreement allowing such Competent Authority to review Bachem’s Product DMF relative to any Xeris submission.
Drug Master File. Unless information equivalent to that incorporated into a DMF is incorporated into or maintained as part of an NDA, or equivalent foreign filing, owned or controlled by Cempra, any Affiliate thereof, or any Cempra Licensee, Cempra shall be responsible (itself or via any Affiliate of Cempra, Cempra Licensee, or Third Party contractor any of the foregoing) for filing and maintaining a DMF with respect to Supplied Compound provided (or to be provided) hereunder for purposes of enabling Toyama to file a Drug Application and obtain Regulatory Approval in the Field in the Territory. If Cempra (itself or via any Affiliate of Cempra, Cempra Licensee, or Third Party contractor of any of the foregoing) shall submit a DMF with respect to Supplied Compound provided (or to be provided) hereunder, Cempra shall provide Toyama (or any appropriate Governmental Authorities in the Territory) access thereto to the extent necessary to enable Toyama to file a Drug Application and obtain Regulatory Approval in the Field in the Territory. If Cempra (itself or via any Affiliate of Cempra, Cempra Licensee, or Third Party contractor any of the foregoing) does not submit or maintain a DMF for purposes of enabling Toyama to file a Drug Application and obtain Regulatory Approval in the Field in the Territory, Cempra shall promptly disclose any information in Cempra’s or its Affiliates’ possession concerning the Supplied Compound provided (or to be provided) hereunder, corresponding to that which would be contained in a DMF therefor, to Toyama (or any appropriate Governmental Authorities in the Territory) that may be required by Governmental Authorities in the Territory for purposes of filing a Drug Application and/or obtaining Regulatory Approval in the Field in the Territory, upon Toyama’s request, and Cempra shall use Commercially Reasonable Efforts to obtain possession of such information from any Cempra Licensees or Third Party contractors of Cempra or its Affiliates with respect to the manufacture of any Supplied Compound provided (or to be provided) hereunder.
Drug Master File. Toray shall be responsible for obtaining, in its name and at its cost and expense, all necessary Regulatory Authority approvals required to Manufacture and deliver Compound and Product to Acologix and any North American *** Confidential treatment request pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. Sublicensee. Toray shall file the Drug Master File for Compound and Product with the FDA for North America no later than [***] and shall maintain the Drug Master File throughout the Term of this Agreement. To the extent required to support Regulatory Requirements of a Product for North America and for Europe if Acologix has the Injection Product Election, Acologix shall have reference rights to use the safety, Manufacturing and other data in such drug master file. Each Party shall be entitled to have the government or Regulatory Authorities cross-reference the information contained in any dossier for a Product filed in any country as may be necessary to obtain and maintain the Regulatory Requirements on a Product in any other country. Except as expressly set forth in this Agreement or as Toray may otherwise agree in writing, Acologix shall not have any right to have the information contained in the drug master file maintained by Toray for the Product.
Drug Master File. If Editas elects a license under Section 3.4(a) and to the extent requested by Editas, Adverum shall on a timely basis establish a Drug Master File with the FDA and provide Editas rights of cross-reference thereto, at Editas’ expense.
Drug Master File. Sicor has prepared a Type II drug master file, as defined by FDA regulations and guidelines, for AD32 (the "Drug Master File") ***.
Drug Master File. Taisho shall be responsible for the preparation and submission of a drug master file with FDA (as set forth in 21 C.F.R Section 314.420(b)), or any similar file required by any Regulatory Agency. Arena shall, upon request by Taisho, give all reasonable assistance to Taisho to enable Taisho to develop, and obtain Marketing Authorization for Drug Product(s).
