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, 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.
2.2 The initial work plan for, and the initial cost estimate for ALZA’s activities under the Program is attached hereto as Exhibit B. The parties understand and agree that it is difficult to accurately predict the activities that will be necessary to develop the Product, or the cost thereof, and significant uncertainties exist in any product development effort. As a result, any such work plan and cost estimate will be diligently reviewed and revised from time to time in order that it remain a faithful best-estimate of work to be done by the parties under the Program and, with regard to ALZA’s activities, the Development Costs thereof.
2.3 In connection with the Program, BioMedicines will provide to ALZA, at no charge to ALZA, such quantities of Drug which ALZA may reasonably require to carry out its duties hereunder. BioMedicines will provide ALZA with a Material Safety Data Sheet for the Drug and will complete and return ALZA’s Safety and Environmental Evaluation Questionnaire prior to commencement of the Program. BioMedicines will also provide ALZA with all relevant information available and known to BioMedicines concerning the safety, handling, use, disposal and environmental effects of the Drug or as may be necessary to conduct the Program. ALZA will provide BioMedicines with all relevant information available and known to ALZA concerning the safety, handling, use, disposal and environmental effects on the System or as may be necessary to conduct the Program. BioMedicines will indemnify, defend and hold ALZA harmless from and against all liabilities, claims, demands, damages, losses, costs, expenses or money judgments (including reasonable attorneys’ fees) incurred by or rendered against ALZA and resulting from the use, storage or handling of the Drug under the Program, except to the extent that ALZA has not complied with written material...
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. 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. 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. 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. (a) Dendreon and Genentech hereby establish, pursuant and subject to the terms of this Agreement, a Product Development Program to develop Licensed Products, with the primary goal of obtaining Regulatory Approval in the United States of Licensed Products in Prevalent Cancers and commercially significant other indications. The Parties efforts in this Product Development Program will initially be the development of Monoclonal Products and Small Molecule Products. Each Party shall use Commercially Reasonable and Diligent Efforts to perform its respective tasks and obligations in conducting all development work ascribed to it in the Preclinical Plans and Clinical Plans for Monoclonal Products and SM Products hereunder.
(b) The Product Development Program shall consist of two principal phases: the Preclinical Program and the Clinical Program. The Preclinical and Clinical Programs are generally described in this Article 2 below and shall be more fully detailed in written Preclinical Plans and Clinical Plans. The Product Development Program shall be approved and guided by the Joint Steering Committee, as described in Article 3. The costs of the Product Development Program shall be borne by the Parties as described in this Article 2.
Product Development Program. 5.1 Conduct of Program. Apollon will devote sufficient resources and commercially reasonable efforts to the diligent conduct of a Product Development Program, the objects of which are: (i) to develop one or more Licensed Products; (ii) to conduct preclinical and clinical trials of such Licensed Products; (iii) to obtain regulatory approvals for the sale of such Licensed Products in all countries throughout the Territory where Apollon reasonably believes it is commercially prudent to offer Licensed Products for Sale; (iv) to develop markets for such Licensed Products in such countries; and (v) to sell Licensed Products in such countries. Without limiting the generality of the foregoing, Apollon shall: [ In the event Apollon does not achieve one of the foregoing milestone events within the established time period, Apollon shall extend the Option Period set forth in Section 3.1 hereof, without charge to Biogen, in an amount of time equal to the delay between the end of such established time period and actual achievement of the milestone event. Thereafter, the extension of the Option Period, and the related extension payments set forth in Section 3.2 hereof, shall continue. In the event Apollon misses one of the foregoing milestone events by more than one (1) year, Biogen shall thereafter have the right to terminate this Agreement or the license granted under Section 2 hereof.
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 [ * ] = 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.
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.
(b) All expenses incurred by IDM in connection with the Product Development Program consisting of internal research and development costs or payments to Medarex pursuant Section 4 of this Agreement (collectively, the “Anti-CTLA-4 Costs”) shall be credited to IDM’s research funding obligation pursuant to the Technology Access Agreement and performance of this Agreement by Medarex shall be deemed performance in full of Medarex’s obligations under Section 3.3 of the Technology Access Agreement. The Anti-CTLA-4 Costs shall be included as a separate line item in IDM’s periodic financial reports to Medarex.
(c) If the Product Development Program is terminated or abandoned prior to IDM’s fulfillment of its research funding obligation pursuant to the Technology Access Agreement, the parties shall negotiate and agree on the manner in which the unspent balance shall be expended for the mutual benefit of the parties. If the parties cannot reach agreement on this matter, Medarex shall receive [...***...] of the unspent balance in cash.
