Drug Application Documentation Clause Samples
Drug Application Documentation. Prometheus shall maintain all United States Drug Applications with respect to the Products, including, without limitation, Phase IV post approval commitments (such as Patient Surveys), semi-annual reports of FDA commitments and Adverse Event reporting and shall take all actions, pay all fees and conduct all communications with the appropriate Governmental Authority and Regulatory Authorities required by Applicable Laws in respect of each Product. For the avoidance of doubt, Prometheus shall bear all costs incurred in connection with compliance with this Section 7.3.
Drug Application Documentation. (a) Amarin shall draft the CMC section of the Drug Application for the Product based on information to be provided by Chemport as follows: (i) the Quality Section for API manufacturing (in the CMC section) will be drafted by Chemport in the form of a DMF that will be sent to the FDA Documentation room by Chemport; (ii) Chemport will make available to Amarin information in the DMF that does not constitute Chemport Confidential Information; and (iii) such access to the DMF will be only through a letter of access issued to Amarin by Chemport. Once the CMC section of the Drug Application for the Product is drafted by Amarin, if requested by Amarin, Chemport shall assist Amarin by critically reviewing and providing corrections to any relevant section of the Amarin’s CMC in a timely fashion. Chemport agrees that Amarin may reference Chemport as the manufacturer of the API in Amarin’s Drug Application and any other documentation required under any regulatory filings for the API, and Chemport will provide the relevant Government Body with all required documentation, including development and analytical reports to support such filings. Amarin shall own all regulatory files (excluding the DMFs) with respect to the API including without limitation regulatory data and documentation prepared by Chemport under this Section 7.4 respecting the manufacture of the API, including without limitation the CMC section of any Drug Application filed with the FDA related to the API. For the avoidance of doubt, (i) the DMFs shall be owned by Chemport, and (ii) all process information related to the manufacture of API, whether contained in a DMF or otherwise, shall, subject to Section 13.4, constitute Chemport Confidential Information and shall not be disclosed to Amarin under any circumstances, notwithstanding anything herein to the contrary; provided, however, Chemport shall provide the relevant Governmental Body with all information necessary to support Amarin’s Drug Application filings in a timely manner.
(b) Upon reasonable request from Chemport, Amarin shall provide Chemport with information regarding Drug Applications, or discrete sections thereof, to the extent available and necessary for Chemport to perform its obligations under this Agreement; provided, however, that information provided hereunder shall not be provided or disclosed to any other Person without Amarin’s prior Consent. In the event that any Governmental Body makes an inquiry of or provides any information to C...
Drug Application Documentation. Upon reasonable request from Equateq, Amarin shall provide Equateq with information regarding Drug Applications, or discrete sections thereof, to the extent available and necessary for Equateq, or as reasonably requested by Equateq, to perform its obligations under this Agreement; provided, however, that information provided hereunder shall not be provided or disclosed to any other party without Amarin’s prior consent. In the event that any Governmental Body makes an inquiry of or provides any information to Equateq that is or may be related to a Drug Application, Equateq shall promptly forward such inquiry or information to Amarin.
Drug Application Documentation. Purchaser shall maintain all Drug Applications with respect to the Finished Products. Upon request from FIS, Purchaser shall provide FIS with information regarding the CMC sections of such Drug Applications, or discrete sections thereof.
Drug Application Documentation. Upon reasonable request from Novasep, Inspire shall provide Novasep with information regarding Drug Applications, or discrete sections thereof, to the extent available and necessary for Novasep to perform its obligations under this Agreement; provided, however, that information provided hereunder shall not be provided or disclosed to any other party without Inspire’s prior consent. In the event that any Governmental Body makes an inquiry of or provides any information to Novasep that is or may be related to a Drug Application, Novasep shall promptly forward such inquiry or information to Inspire.
Drug Application Documentation. NOVACEA shall maintain all Approvals with respect to the Finished Product in the Territory. On a timely basis, NOVACEA shall provide ▇▇▇▇▇▇ ▇▇▇▇▇ with all information regarding Approvals or portions thereof.
Drug Application Documentation. Cadence shall be responsible for submitting a Drug Application to the FDA and to Health Canada, with respect to the addition of the Facility as a source for the Product. Grifols shall provide all documents, information, data and technical assistance required by Cadence to complete and obtain approval for such Drug Applications.
Drug Application Documentation. XenoPort will maintain Drug Applications at such location as XenoPort determines in its discretion from time to time. XenoPort will provide Patheon with information regarding Drug Applications, or discrete sections thereof, including copies of the up-to-date Chemistry and Manufacturing Controls (“CMC”) section, to the extent reasonably needed by Patheon to perform its obligations under this Agreement. But information provided hereunder will not be provided or disclosed to any other Person without XenoPort’s prior consent. If any Governmental Authorities or Regulatory Authorities make an inquiry of or provide any information to Patheon that is or may be related to a Drug Application, Patheon will promptly forward the inquiry or information to the XenoPort.
Drug Application Documentation. GSK shall maintain Drug Applications at such location as GSK determines, in its discretion from time to time. Upon reasonable request from Draxis, GSK shall provide Draxis with information regarding Drug Applications, or discrete sections thereof, to the extent reasonably needed by Draxis to perform its obligations under this Agreement; provided, however, that information provided hereunder shall not be provided or disclosed to any other party without GSK’s prior consent.