FDA and Regulatory Support Sample Clauses

FDA and Regulatory Support. Xxxxxx Xxxxx agrees (i) to establish and maintain a Type II FDA Drug Master File (“DMF”) in accordance with the requirements of the FDA, as well as any comparable files required by regulatory authorities in other countries within the Territory, (ii) to provide Forest and its sublicensees with letters of authorization to the DMF and any other comparable files, (iii) to further provide Forest and its sublicensees with all necessary Information and data regarding the manufacture of Bulk Compound to the extent necessary for Forest and its sublicensees to prepare and defend any inquiries from the FDA and any other regulatory agencies in the Territory or to the extent necessary to Forest to exercise the Manufacturing Right set forth in Section 7.11, and to satisfy regulatory requirements in the Territory, and (iv) at Forest’s request, to provide Forest and its sublicensees with all Information and data regarding the manufacture and testing of Compound to the extent necessary for Forest and its sublicensees to prepare and submit the chemistry, manufacturing and controls section of the NDA for the Product and any corresponding sections of Regulatory Approvals submitted in other jurisdictions. Xxxxxx Xxxxx further agrees to use Commercially Reasonable Efforts to assist Forest and its sublicensees in obtaining FDA approval for its NDA with respect to the Product, as well as approvals from any other government or agency which may be required for the marketing of the Product in any other country within the Territory. In addition, Xxxxxx Xxxxx 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 Forest’s NDA for the Product. Xxxxxx Xxxxx shall notify Forest and its sublicensees of which Xxxxxx Xxxxx is aware within two business days of any Regulatory Authority inspection relating to Compound or any Compound related facility and, at the conclusion of such inspection, shall be promptly furnished with a copy of all documentation, including any Form 483 or comparable form and Xxxxxx Xxxxx response thereto, relating to such inspection. In addition, Xxxxxx Xxxxx shall promptly notify Forest and its sublicensees of any other regulatory actions or communications (other than ministerial, non-substantive communications) relating to 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. 8. 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 which 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 of Product. 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) 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. (b) Upon request, Cardinal Health shall allow access to the MedImmune Facility and inspection of the Secondary Area by FDA or other Agency officials. In the event that the Secondary Area is audited or inspected by an Agency, Cardinal Health will notify MedImmune immediately by telephone and will provide MedImmune with prompt written notice of such audit. MedImmune will have, at its option, the opportunity to observe the audit for inspection, and to jointly cooperate with Cardinal Health in any response. Cardinal Health will also promptly provide MedImmune with copies of any correspondence or reports relating to such audit or inspection.

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.

FDA and Regulatory Support. Gensia Sicor shall provide SEATTLE GENETICS with all documents SEATTLE GENETICS reasonably requests regarding its manufacturing processes and procedures for the Product. Gensia Sicor further agrees to use reasonable commercial efforts to assist SEATTLE GENETICS in obtaining FDA approval of any Investigational New Drug application ("IND") or New Drug Application ("NDA") with respect to the Product. Where practicable and in accordance with the rates set forth on Exhibit B, Gensia Sicor may assist SEATTLE GENETICS in obtaining approvals from other government or regulatory agencies which may be required for the conduct of clinical trials of the Product in other country(ies). Gensia Sicor specifically agrees to cooperate with the FDA or other regulatory agencies, including but not limited to any inspection prior to approval of any IND or NDA.

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. (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. (b) Patheon agrees to cooperate with any inspection by the FDA or other Regulatory Authority. Patheon specifically agrees to meet and confer with Gilead representatives in advance of the pre-approval inspections for any Drug Product and, at Gilead’s request, any other inspection of the Facility concerning any Drug Product, provided that Patheon receives advance notice of such inspection, and will provide Gilead with all necessary support in connection with each such inspection as may be reasonably required. (c) Each Party shall notify the other Party immediately in writing in the event a Party learns of any action that has been or will be taken by the FDA or other Regulatory Authority which relates to the Facility and the Processing of any Drug Product, or which may delay or impair the ability to Process any Drug Product in accordance with this Agreement.

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) 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. (b) In the event that Manufacturer is audited or inspected for the Bulk Drug Substance by any government or regulatory agency, Manufacturer will provide Customer with written notice of such audit or inspection no later than [****] days before the date of such proposed audit or inspection or if Manufacturer is not notified of such audit or inspection within such time frame, within [****] of time Manufacturer receives notice of such audit or inspection. Manufacturer will also provide Customer with copies of any correspondence or reports to the extent permitted by law, relating to such audit or inspection within five (5) days of receipt.