IND and Phase 1 Development Sample Clauses

IND and Phase 1 Development. 2.8.1 Subject to Section 2.4, during the applicable Selection Term for an Available Target, (a) subject to Section 2.8.3, EPIZYME shall use Commercially Reasonable Efforts to prepare, file and obtain the effectiveness of an IND in the United States or a Major EU Country for at least one (1) Development Candidate for such Available Target; and (b) if CELGENE has exercised the IND Option with respect to an Available Target, EPIZYME may initiate, conduct and complete, in its sole discretion, a Phase 1 Clinical Trial for Development Candidate(s) Directed to each such Available Target, subject to Section 2.3.5; in each case ((a) and (b)), at EPIZYME’s sole cost and expense and in accordance with the Research Plan. If EPIZYME so elects to not initiate, conduct and complete a Phase 1 Clinical Trial, EPIZYME shall provide written notice thereof to CELGENE prior to the filing of the IND for the applicable Development Candidate. For clarity, if EPIZYME elects not to conduct a Phase 1 Clinical Trial for the applicable Development Candidate Directed to an Available Target, EPIZYME shall be deemed to have exercised an EPIZYME Pre-IND Opt-Out as to such Available Target pursuant to Section 2.4.
Sample 1
AutoNDA by SimpleDocs

Related to IND and Phase 1 Development

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Joint Development All inventions, know-how, trade secrets, data or information which result from joint development by the Parties hereto shall be jointly owned by the Parties. The Parties hereby agree to cooperate in good faith in the filing of any and all patent applications in all jurisdictions.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Development 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. 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 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).

  • Development 3.1.1 Licensee agrees to and warrants that:

  • Product Development SB shall have responsibility for, and control of, the development and commercialization of each Product arising from this Agreement, including process development, delivery system and formulation development, preclinical studies, clinical studies, sales and marketing.

  • Development Agreement That certain Development Agreement dated of even date herewith by and between the Company and Developer providing for the development of the Project on the Property, a copy of which is attached hereto as Exhibit C and incorporated herein by reference. Development Fee. As described in Section 6.8.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

Time is Money Join Law Insider Premium to draft better contracts faster.