Product Development Program. The term “
Product Development Program. 4.1 Section 4.1 of the Agreement is hereby amended and restated in its entirety as follows:
Product Development Program. 2.1 Promptly after execution of this Agreement and approval of a work plan as described in Section 2.2, ALZA will commence the Program activities necessary to continue development of the New Models. In connection with the Program, both parties will make available appropriate scientific, engineering and other *Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. 10 personnel to perform tasks under the Program. The parties will use reasonable commercial efforts to carry out the Program, will participate in periodic conferences to review its status and will cooperate in the prompt preparation and review of, and discussion concerning, work plans and cost estimates and revisions thereto described in Section 2.2.
Product Development Program. After the Effective Date, Zai Lab will, either by itself or through its Affiliates, licensees and/or sublicensees, be solely responsible for designing and performing all aspects of the Development Program in accordance with the Development Plan, provided that Zai Lab may undertake changes to its development plans from time to time as long as it continues to satisfy its diligence obligations under this Agreement. Zai Lab will have sole responsibility and control for the managing and the financing of the Development Plan and all Development Costs. The primary focus of the Development Program will be to Develop and obtain Regulatory Approvals for one or more Products.
Product Development Program. (a) IDM shall use commercially reasonable efforts to conduct the Product Development Program in accordance with the Product Development Plan. IDM shall be the Sponsor of any clinical trial based upon the Cell-based Vaccine or the Product.
Product Development Program. (a) Subject to the terms and conditions set forth in this Option Agreement, Cell Genesys shall diligently engage in pre-clinical product development of the Development Products (including any derivatives or back-ups thereof as a Substitute Product as provided under Section 2.4) into Product Candidates. No later than one hundred and twenty (120) Days from the Effective Date, Cell Genesys shall submit to Novartis the product development plan for each Development Product ("PDP") detailing Cell Genesys' proposed Research Program, together with a budget proposal and plans to meet the Development Information criteria in connection therewith. Cell Genesys will entertain, in good faith, any comments and suggestions Novartis may have regarding the PDP. Consistent with the foregoing, Cell Genesys shall be solely responsible for the details (and implementation) of the finalized PDP. The PDP shall be attached hereto and made part hereof as Exhibit I. Subject to Section 2.4, Cell Genesys shall use diligent and commercially reasonable efforts consistent with sound and reasonable business practices and judgment to develop the Development Products into Product Candidates as soon as reasonably practicable, devoting not less than the same degree of attention and diligence to such efforts that it devotes to such activities for other of its products of comparable market potential. In determining whether Cell Genesys is in compliance with the foregoing provisions, there shall be taken into account the normal course of drug development programs in the pharmaceutical industry conducted with sound and reasonable business practices and judgment for compounds with a comparable market potential. [*] 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.
Product Development Program. Lilly shall have principal responsibility for the Product Development Program including the development of the process to produce the Drug Product from Bulk Drug Substance, provision of analytical methods, environmental testing, in-process testing, and release testing of the Drug Product, generation of appropriate procedures and controls in order to ensure compliance with GLP and GMP regulations, and the procurement of necessary manufacturing facilities for production of the Drug Product from Bulk Drug Substance for the supply of clinical studies. Vertex shall provide advice with respect to the Product Development Program, and the Project Team shall review and approve procedures and practices required to ensure compliance with GLP, GMP, environmental and other regulatory requirements.
Product Development Program. The fourth sentence of Section 2.3(b) and Section 2.6 in its entirety of the Original Agreement are hereby deleted.
Product Development Program. 2.1 Product Candidate Identification Process. Within 30 days ---------------------------------------- after the date of the Distribution and at least annually thereafter, ALZA shall provide Crescendo with a proposed Work Plan covering activities to be undertaken by ALZA to search for and identify Product Candidates for consideration by Crescendo under Section 2.2 and to identify potential Technical Evaluations for consideration by Crescendo under Section 2.4. Promptly after ALZA provides Crescendo with such proposed Work Plan, Crescendo shall notify ALZA of its acceptance or rejection of such proposed Work Plan.
Product Development Program. 2.1 Promptly after execution of this Agreement and receipt from BioMedicines of Drug and the materials described in Section 2.3, the parties will commence the Program. In connection with the Program, the parties will make available appropriate scientific, [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED. engineering and other personnel to perform tasks under the Program. The parties will use diligent efforts to carry out the Program, will participate in periodic conferences to review its status and will cooperate in the prompt preparation and review of, and discussion concerning, work plans and cost estimates and revisions thereto as further described in Section 2.2.
