Manufacturing Information. Accurate and complete copies of Seller's Manufacturing Worksheets and copies of Seller's Manufacturing Quality Assurance Notebooks to the extent available, as well as relevant packaging information.
Manufacturing Information. Gilead represents and warrants that, it has delivered or shall by the Delivery Date deliver to EyeTech all of the Transferred Assets and the Manufacturing Information.
Manufacturing Information. Accurate and complete copies of the current Manufacturing Worksheets and copies of the Manufacturing Quality Assurance Notebooks with respect to the Products currently available, including batch records, development reports (if existing), and other documents and records embodying manufacturing information.
Manufacturing Information. EPRO shall disclose all information it owns, or has the right to disclose to Spectrum to enable Spectrum to manufacture and use Licensed Products. This information shall include complete details of the manufacturing process to produce Licensed Product in finished form.
Manufacturing Information. As reasonably requested by ZENECA, ISIS will provide ZENECA all information in ISIS control relating to Development Candidates and Collaboration Products being developed by ZENECA including without limitation information regarding process, in process control methods, final product characterization/analysis methods, scale, cost and alternative manufacturing sites.
Manufacturing Information. Lilly represents and warrants that it is ------------------------- transferring to Tularik as part of the Transferred Assets all of the Manufacturing Information in Lilly's tangible possession as of the Effective Date that is necessary for development and commercialization of the Product by Tularik.
Manufacturing Information. On United Therapeutics request, MannKind shall deliver to United Therapeutics, at no additional cost or expense to United Therapeutics, all Manufacturing Information that exists as of the Effective Date. Upon United Therapeutics’ request at any time, MannKind shall also deliver to United Therapeutics, at no additional cost or expense to United Therapeutics, all Manufacturing Information that has not previously been provided under this Agreement, promptly upon such Manufacturing Information being obtained or generated by MannKind. The Manufacturing Information will be of sufficient detail to enable a reasonably experienced manufacturer to manufacture, assemble, test, operate, and service the Initial Product.
Manufacturing Information. Immunotech represents and warrants that, it will deliver all Manufacturing Information by the Delivery Date (subject to the consummation of Steps in Section 2.1).
Manufacturing Information. Cubist acknowledges and agrees that certain Cubist Know-How and other Information pertaining to the manufacture of the Licensed Products (the “Manufacturing Information”) will be required to be provided or made available to Chiron so as to permit Chiron to obtain Regulatory Approval in the Territory, conduct quality assurance testing and release of Licensed Products for use in the Territory and otherwise comply with the requirements of the Regulatory Authorities in the Territory. The right of Chiron to * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION receive and use Manufacturing Information shall be as set forth in this Section 5.3(d) and the Supply Agreement. To the extent that Chiron needs to submit and make available any Manufacturing Information in connection with obtaining Regulatory Approval in the Territory, the Parties agree that, to the fullest extent permissible under applicable law, rules and regulations, such Manufacturing Information shall be made available to the applicable Regulatory Authorities in the Territory via a Drug Master File appropriately formatted for the country in which such DMF is filed and [*] (i.e. upon Chiron’s [*] under the Supply Agreement to manufacture or have manufactured Licensed Products). Drug Master Files will be maintained and kept up to date by Cubist or the Cubist Suppliers. Chiron will be notified of changes proposed to the DMF [*] in accordance with change control procedures set forth in Section 3.2 of the Supply Agreement. Chiron shall be responsible for notifying the Regulatory Authorities in the Territory, as required by applicable laws, of the updating of the DMF by Cubist or the Cubist Suppliers. Notwithstanding the foregoing, the applicable Regulatory Authorities in the Territory shall have full access to all of the Manufacturing Information in such DMF [*], to the extent considered necessary by such applicable Regulatory Authorities to consider and act upon any applications for Regulatory Approvals in the Territory that are submitted by Chiron, and [*] to allow such Regulatory Authorities to refer to all of the Manufacturing Information in such DMF to the extent necessary to assess applications for Regulatory Approvals of Licensed Products in the Territory and to obtain such Regulatory Approvals. If and to the extent that Chiron needs to submit and make available any Manufacturing Information in connection with any submission by Chiron of any application for Re...
Manufacturing Information. Upon Licensee’s reasonable request, AstraZeneca shall provide Licensee one or more letters permitting Licensee to reference the CMC Data for the Licensed Compound solely to the extent necessary for Licensee to prepare, submit, obtain or maintain an IND, Drug Approval Application, or other Regulatory Approval for a Licensed Product in the Field in the Territory.
