Development Program. RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following:
(i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and
(ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT.
(iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION;
(iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, da...
Development Program. A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)
B. Estimated total development time
Development Program. The Project Manager shall produce a program of activities for the development of the Project, which shall set forth the activities to be carried out during the Development Process, the date by which, or the period of time during which, each
Development Program. During the life of this Agreement, it is anticipated that the Parties will meet from time to time to explore opportunities to collaborate with each other under a Development Program to develop new products and/or technology that could potentially benefit the Parties. If, as a result of these meetings, the Parties mutually agree to pursue a Development Program, the Parties will work in cooperation, through the Steering Committee or as otherwise agreed by the Parties, to define goals and objectives of such Program and, thereafter, the scope of work, milestones and timelines of the Development Program. The Parties shall also define the roles and responsibilities of each Party, and nominate program leaders from each of their respective organizations, as further described in Section 6, who will work with each other to oversee and manage the establishment and implementation of the Development Program and jointly develop protocols for the exchange of experimental plans, technical program data and reporting periodic progress reviews. All of the foregoing activities, etc. will be described in a separate written Development Program Form, substantially in the form attached hereto as Exhibit A (Development Program Form). Each Development Program Form shall be signed by a duly authorized representative of each Party and maintained by the Parties in a separate database and/or in the file where this Agreement is maintained. Each Party agrees to regularly share data and information generated as a result of each Development Program undertaken hereunder, and to promptly notify the other Party of any new Development Program Technology, including without limit, any Invention conceived or reduced to practice in the course of a Development Program. For the purpose of clarity, in the event that any joint development activity or initiative is carried out by the Parties and, in so doing, the Parties fail to complete and execute a Development Program Form, such activity will nevertheless be subject to all of the terms and conditions of this Agreement and such failure will not relieve a Party or the Parties from complying with this Agreement.
Development Program. The term “
Development Program. 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be carried out generally in accordance with Appendix B.
1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be Martynn Sheehan. Xxxx xxxxx xxx change the designated Program Manager upon written notice to the other party of such change.
1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program.
1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program.
1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obt...
Development Program. Novo Nordisk shall conduct the Development Program in its sole discretion and at its own expense.
Development Program. The Parties have agreed upon, and set forth in Attachment A, requirements and objectives for a program to develop and produce for clinical trials Products suitable for Regulatory Approval and commercialization (as the same may be amended in accordance with the terms of this Agreement, the “Development Program”).
Development Program. Coronado shall use its Commercially Reasonable Efforts to carry out all of the Product Development with the overall objective of obtaining all Regulatory Approvals necessary for the Commercialization of Product(s); including, but not limited to, all clinical development, the filing with the FDA of an NDA for a Product and seeking to obtain the FDA’s Regulatory Approval to market such Product in accordance with its terms and in compliance with all Applicable Laws. Without limiting the foregoing, Coronado and/or its Affiliates shall perform all Development activities in compliance with all cGMP, good laboratory practices, standard industry practices and Applicable Laws.
Development Program. (a) VIA shall, at its expense, conduct a clinical and commercial development program relating to the use of a Licensed Product using commercially reasonable efforts (“Development Program”) consistent with a Development Plan that is to be provided to Roche as soon as practicable after creation by VIA. VIA shall provide on a once yearly basis written reports to the Global Liaison on the progress of the Development Program, and annually shall provide to the Global Liaison a written overview of material Development Program activities.
(b) VIA shall maintain a clinical trials database in accordance with the standards of Regulatory Agencies.
(c) The Development Plan may be reasonably modified and updated at any time as is deemed necessary at the discretion of VIA.
(d) Upon completion of a Phase I clinical trial for each Licensed Product, VIA shall present to Roche (i) a summary presentation of the data generated by such Phase I clinical trial, and (ii) a Development Plan for Phase II.
(e) Notwithstanding anything to the contrary hereunder (including without limitation under Section 6.1 and this Section 6.2), VIA’s sole and exclusive liability and Roche’s sole and exclusive remedy for any failure by VIA to exercise any required level of efforts to research, develop, obtain Registrations or commercialize the Licensed Products shall be for Roche to exercise any termination right that Roche might have pursuant to Section 12.3 on account of such failure.
