Screenie program trial#
Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. The Development Plan may be revised from time to time by the JDC. As of the Execution Date, the Parties have agreed upon a Development Plan for the Development of Product(s), attached to this Agreement as Exhibit A. The non-enforcing Party shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the enforcing Party.ĭevelopment Plan The Parties’ respective responsibilities for the Development of the Collaboration Compounds and the Products are set forth in this Article 4.
The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts, including determination of litigation strategy and filing of material papers to the competent court. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.Ĭollaboration Each Party shall provide to the enforcing Party reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including to be named in such action if required by Applicable Laws to pursue such action. Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP) (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell) (c) and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The Research Program will be under the direction of _ (“Principal Investigator”), or his or her successor as mutually agreed to by the Parties and will be conducted by the Principal Investigator at the University.ĭevelopment and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products.
Screenie program full#
Research Program 2.1 University will use reasonable efforts to conduct the Research Program described in Attachment A which is hereby incorporated in full by reference (“Research Program”), and will furnish the facilities necessary to carry out said Research Program. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)
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