FDA and Regulatory Support. Kureha will (i) establish and maintain a DMF in accordance with the requirements of the FDA, as well as any comparable files required by regulatory authorities in other countries within the Licensed Territory, (ii) provide Ocera and its Sublicensees letters of authorization to cross‑reference the DMF and any other comparable files and (iii) further provide Ocera and its Sublicensees with all necessary information and data regarding the manufacture of the Compound to the extent necessary for Ocera and its Sublicensees to prepare and defend any inquiries from the FDA or to satisfy regulatory requirements in the Licensed Territory. Kureha further agrees to use commercially reasonable efforts to assist Ocera and its Sublicensees in obtaining FDA approval for its NDA with respect to Product, as well as approvals from any other government or agency which may be required for the marketing of Product in any other country within the Licensed Territory. Kureha specifically agrees to cooperate with any inspection by the FDA or other regulatory agency, including but not limited to any inspection from the FDA prior to approval of Ocera’s NDA for Product. Kureha shall notify Ocera and its Sublicensees in case of any FDA or relevant regulatory agency’s inspection with prior notice promptly upon receipt of notice of inspection, or in case of any FDA or other relevant regulatory agency’s inspection without prior notice, within 3 business days of any FDA or other relevant regulatory agency’s inspection relating to the Compound or any Compound related facility and, at the conclusion of such inspection, shall furnish Ocera and its Sublicensees a copy of any Form 483 or equivalent observations within 24 hours of the receipt of a copy of any Form 483. Ocera and Kureha will formulate the response to the FDA or other regulatory agency regarding 483 or equivalent observations in consultation with each other. Copies of all other documentation, except for any confidential information, including Kureha’s draft response relating to such inspection, shall be provided to Ocera within 5 business days of the conclusion of such inspection for review prior to communicating with the FDA or other regulatory agency for Ocera’s comments on the draft. In addition, Kureha shall notify Ocera and its Sublicensees within 3 business days of any other regulatory actions or communications (other than ministerial, non-substantive communications) relating to the Compound or any Compound related facility....
FDA and Regulatory Support. (a) PCI agrees to establish and maintain a Drug Master File ("DMF") in accordance with the requirements of the FDA, as well as any comparable files required by other Agencies, and to provide Aviron with letters of access to the DMF, any other comparable files and documents regarding its [ * ] Production. Aviron shall have sole [*]= CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
FDA and Regulatory Support. (a) Cardinal Health agrees to provide MedImmune with letters of access to any files and documents required by the FDA or regarding Secondary Production. MedImmune shall have sole responsibility for obtaining from any Agency all permits and/or licenses necessary or required for the sale, marketing or commercialization of Product. MedImmune shall be responsible for all other filings necessary for approval and import of Product into countries outside the United States. Cardinal Health further agrees to use reasonable commercial efforts to assist MedImmune in obtaining any government or Agency approval that may be required for the marketing of Product in any country. MedImmune shall provide Cardinal Health with written notice of any additional regulatory requirements of countries other than the United States that relate to Secondary Production. Cardinal Health shall use its reasonable commercial efforts to comply with such additional requirements and shall provide MedImmune with prompt written notice of whether it is able to do so. Cardinal Health will provide MedImmune copies of all supporting documentation in Cardinal Health's possession required for FDA licensing of the Product. MedImmune will hold the FDA and any other Agency license(s) for the Product.
FDA and Regulatory Support. (a) Manufacturer agrees to establish and maintain a Master Production Record (“MPR”) in accordance with industry standards, and a Drug Master File (“DMF”) in accordance with regulatory authority requirements, as well as any comparable files required by regulatory authorities in the Territory, and to provide Customer with letters of access to the MPR and DMF and comparable files and any other processes and procedures for manufacturing the Bulk Drug Substance. Manufacturer specifically agrees to cooperate with any inspection by, or regulatory requirements of the FDA and the regulatory authorities in the Territory that relate to the manufacture of Bulk Drug Substance. Manufacturer shall use its best efforts to comply with such additional requirements and shall provide Customer with prompt written notice of whether it is able to, and will do so. Manufacturer agrees to maintain these records for at least five (5) years from the date of shipment of the Bulk Drug Substance to which the records relate.
FDA and Regulatory Support. (a) PCI agrees to provide Aviron with letters of access to any files and documents required by the FDA or regarding [ * ] Production. Aviron shall have sole responsibility for obtaining from any Agency all permits and/or licenses necessary or required for the sale, marketing or commercialization of Product. Aviron shall be responsible for all other filings necessary for approval and import of Product into countries outside the United States. PCI further agrees to use reasonable commercial efforts to assist Aviron in obtaining any government or Agency approval that may be required for the marketing of Product in any country. Aviron shall provide PCI with written notice of any additional regulatory requirements of countries other than the United States that relate to [ * ] Production. PCI shall use its reasonable commercial efforts to comply with such additional requirements and shall provide Aviron with prompt written notice of whether it is able to do so. PCI will provide Aviron copies of all supporting documentation in PCI's possession required for FDA licensing of the Product. Aviron will hold the FDA and any other Agency license(s) for the Product.
FDA and Regulatory Support. (a) Manufacturer agrees to establish and maintain a Production Master File ("PMF") in accordance with industry standards, as well as any comparable files required by authorities, and to provide Customer with letters of access to the PMF and any other processes and procedures for Finished Product. Manufacturer further agrees to use its best efforts to assist Customer in obtaining any government or agency approval which may be required for the marketing of Finished Product in any other country. Manufacturer specifically agrees to cooperate with any inspection by or regulatory requirements of regulatory authorities that relate to the manufacture of Finished Product for such territories. Manufacturer shall use its best efforts to comply with such additional requirements and shall provide Customer with prompt written notice of whether it is able to, and will, do so. Any regulatory support by Manufacturer shall be compensated on a per project basis.
FDA and Regulatory Support. Kureha will (i) establish and maintain a DMF in accordance with the requirements of the FDA, as well as any comparable files required by regulatory authorities in other countries within the Licensed Territory, (ii) provide Ocera letters of authorization to cross‑reference the DMF and any other comparable files and (iii) further provide Ocera with all necessary information and data regarding the manufacture of Clinical Supply to the extent necessary for Ocera to prepare and defend any inquiries from the FDA or to satisfy regulatory requirements in the Licensed Territory. Kureha further agrees to use commercially reasonable efforts to assist Ocera in obtaining FDA approval for its NDA with respect to Product, as well as approvals from any other government or agency which may be required for the marketing of Product in any other country within the Licensed Territory. Kureha specifically agrees to cooperate with any inspection by the FDA or other regulatory agency, including but not limited to any inspection prior to approval of Ocera’s NDA for Product. Kureha shall notify Ocera, in case of any FDA inspection with prior notice, promptly upon receipt of notice of inspection from the FDA, or in case of any FDA inspection without prior notice, within 3 business days of any FDA inspection relating to Clinical Supply or any Clinical Supply related facility and, at the conclusion of such inspection, shall furnish Ocera within 5 business days a copy of all documentation, including any Form 483 and Kureha’s response thereto, relating to such inspection. In addition, Kureha shall notify Ocera within 3 business days of any other regulatory actions or communications (other than ministerial, non-substantive communications) relating to the Clinical Supply or any Clinical Supply related facility. The parties shall confer with each other with respect to any response regarding such action or communication and the best means to comply with such action or communication.
FDA and Regulatory Support. (a) Patheon agrees to maintain a Site Master File (“SMF”) in accordance with the requirements of the FDA, if any, as well as any comparable files required by other Regulatory Authorities, and to provide Gilead with letters of access to such SMF (to the extent that they are required by the FDA or other related regulatory bodies) and comparable files and to further provide Gilead with all documents regarding the Processing of such Drug Product. Gilead shall be responsible for all other filings necessary for approval and export of each Drug Product. At Gilead’s reasonable cost, Patheon further agrees to assist Gilead, acting reasonably, in obtaining any government or agency approval which may be required for the marketing of any Drug Product in any country other than the United States. Gilead shall provide written notice of any additional regulatory requirements of countries, in accordance with Section 4.6.
FDA and Regulatory Support. Supplier shall provide SGI, [***]. Supplier further agrees to use its best efforts to assist SGI, [***], in obtaining FDA approval of any [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Investigational New Drug application (“IND”) or New Drug Application (“NDA”) or other applicable regulatory filings with respect to product candidates utilizing or incorporating Products, as well as approvals from any other government or agency which may be required for the conduct of clinical trials or marketing of product candidates utilizing or incorporating Products in any other country. Supplier specifically agrees to cooperate with any inspection by the FDA or other regulatory agency, including but not limited to any inspection of Supplier’s facilities used in the manufacture of or records relating to Products prior to approval of any IND or NDA.
FDA and Regulatory Support. MannKind will provide Sanofi and its Affiliates with necessary information and data regarding the Manufacture of Product to the extent necessary for Sanofi and its Affiliates to prepare and defend any inquiries from the FDA or other Regulatory Authorities to satisfy regulatory requirements with respect to Product in the Territory.
