Product Development Program Clause Samples

Product Development Program. The term “

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. 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. 2.2 ALZA and DURECT agree to cooperate to devise mutually acceptable work plans and cost estimates for the development of the New Models. The parties understand and agree that it is difficult to accurately predict the activities that will be necessary to develop the New Models, 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 DURECT will pay to ALZA, on a monthly basis, [* * *]. ALZA will invoice DURECT on or before the fifteenth day of each month for the preceding month's Development Costs. All payments will be made within 30 days after the date of the invoice. Notwithstanding the foregoing, [* * *] -

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. Product Development Program shall mean the Initial Product Development Program and any Additional Product Development Program(s).

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.

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. (b) Cell Genesys shall commence and conduct the Research Program with respect to the Development Products in accordance with the PDP. Cell Genesys shall ensure that it submits an IND for each of the Development Products (other than for Terminated Development Products) and Substitute Products (if applicable) to applicable Regulatory Authorities. Cell Genesys shall promptly notify Novartis of any acceptance or any objection or rejection of the submitted IND by the applicable Regulatory Authorities. Cell Genesys shall use commercially reasonable efforts to overcome any such objection or rejection until final acceptance of...

Product Development Program. 2.1 Subject to the terms of this Agreement, Kodak hereby agrees to diligently undertake the Development Program for Medis according to the Statements of Work, using Eastman Kodak Company standards of engineering and technical ▇▇▇▇▇▇▇nce to conduct the development work. Medis hereby authorizes Kodak to proceed with tasks of the agreed to Statements of Work as provided in Article 2.2