Manufacturing Approvals. GS shall be promptly notified of any proposed change in the process for the manufacture of Product pursuant to this Article 5 which potentially impacts the Marketing Authorization Applications or Regulatory Approval in the Territory including, without limitation, any proposed change as to the site at which such manufacture is to occur. No Product incorporating any such proposed change and no Product manufactured at any proposed new facility shall be supplied by LGLS to GS hereunder without such changes having first been approved by the appropriate Regulatory Authorities or by mutual agreement by the Parties, which regulatory approvals the Parties agree to pursue diligently following notice from LGLS of such proposed changes.
Manufacturing Approvals. Pacira shall maintain and shall require any Third Party Manufacturer to maintain in good order all Manufacturing Approvals and permits relating to the Approved Facilities, the Backup Facility, if applicable and the Manufacturing Services, as granted by any Relevant Authority, for so long and insofar as is necessary to permit Pacira to provide the Manufacturing Services as contemplated hereunder. Pacira shall, and will require any Third Party Manufacturer to, make copies of such Manufacturing Approvals and all related documents available to Company and its designees for inspection, upon reasonable request from Company.
Manufacturing Approvals. Prothena shall be responsible for obtaining Regulatory Approval for the manufacture of the Lead Product until the transfer of the IND as agreed by the JSC under Section 6.1(a). Thereafter, Roche shall be responsible for obtaining Regulatory Approval for the manufacture of Licensed Products as part of the Regulatory Filings [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. for such Licensed Products. Such filings shall include the filing and maintenance of a Drug Master File with the FDA and the equivalent thereof in the other countries in the Territory.
Manufacturing Approvals. NanoTx shall remain responsible for the drug master files until the completion of the Manufacturing Tech Transfer Plan. Thereafter, PLUS shall be responsible for the filing and maintenance of the drug master files with the FDA and the equivalent thereof in the other countries in the Territory as part of obtaining Regulatory Approval for the Manufacture of the Licensed Products.
Manufacturing Approvals. Medarex shall be responsible for any filings, permits and approvals necessary for the manufacture of the Antibody pursuant to the Medarex Development Programs. Medarex shall be responsible for the costs and expenses incurred by it in connection with the filings, permits and approvals made or obtained pursuant to this subsection 2.6(a). If Medarex discontinues all Medarex Development Programs and if IDM decides to fund the process development for the Antibody, then IDM shall bear the costs and expenses incurred by Medarex following such discontinuance in connection with such filings, permits and approvals.
Manufacturing Approvals. Notwithstanding Sections 2.5 and 2.6, above, Scios will use diligent efforts to make necessary filings to obtain, or to cause a Third Party manufacturer of API to obtain, the necessary regulatory approvals for the manufacture of API as contemplated herein. GSK shall be promptly notified of any proposed change in the process for the manufacture of API which impacts the Marketing Authorization Applications and Regulatory Approval in the Territory as well as any proposed change as to the site at which such manufacture is to occur. Thereafter, the Parties shall in good faith consult as to the best way of ensuring sufficient supply of API to GSK; provided, however, that Scios shall in any event ensure a sufficient source of supply of API (as approved by the relevant Regulatory Authorities) to GSK pending regulatory approval, if required, to such proposed process changes or site change, and provided that such supply is consistent with Sections 5.6 and 5.7, below. Except as required of Scios by law, no API incorporating any such proposed change and no API manufactured at any proposed new facility shall be supplied by Scios to GSK hereunder without such changes having first been approved by the appropriate Regulatory Authorities in the Major Markets or other mutual agreement by the Parties, which regulatory approvals the Parties agree to pursue diligently following notice from Scios of such proposed changes.
Manufacturing Approvals. Editas shall be responsible for obtaining Regulatory Approval for the Manufacture of the Initial Co-Co Product until the IND Transfer. Thereafter, Allergan shall be responsible for obtaining Regulatory Approval for the Manufacture of Co-Co Products as part of the Regulatory Filings for such Co-Co Products. Such filings shall include the filing and maintenance of a drug master file with the FDA and the equivalent thereof in the other countries in the Territory.
Manufacturing Approvals. Tevard shall be responsible for obtaining and maintaining Regulatory Approval for the Manufacture of Products until the date of the Manufacturing Technology Transfer. Thereafter, Zogenix or its designee shall be responsible for obtaining and maintaining such Regulatory Approvals.
Manufacturing Approvals. It shall be Ligand's responsibility, without any additional cost to Elan, to maintain all necessary governmental approvals and permissions which may be required for Ligand to manufacture (or have manufactured) the Products for distribution in the Territory.
Manufacturing Approvals. The Lead Development Party shall use Diligent Efforts to make necessary filings to obtain, or to cause the then current Third Party manufacturer of Collaboration Products to make necessary filings to obtain, Regulatory Approval for the manufacture of Collaboration Compounds and Collaboration Products as part of the approval of an Approval Application for each Collaboration Product. Such filings shall include the filing and maintenance of a DMF or CMC in the United States and the equivalent thereof in the other countries of the world in which the parties seek Regulatory Approval of Collaboration Products.
