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. 2.8.2 Subject to Section 2.3.6, EPIZYME shall keep CELGENE reasonably informed of its performance of the Research Plan by updating the JRC on a [**] basis with the results of its activities under the Research Plan, including all Compounds, Collaboration IP and Regulatory Materials, for each Available Target during the Option Term. 2.8.3 Within [**] days after the completion of all IND-enabling studies for a Development Candidate directed to an Available Target, EPIZYME shall provide to CELGENE, or a Third Party advisor designated by CELGENE, the IND Data Package for such Development Candidate; provided that, as to [**], during any period when CELGENE is engaged in a [**], CELGENE may only elect to have EPIZYME provide such IND Data Package to a Third Party advisor. If CELGENE designates a Third Party advisor to receive the IND Data Package, such Third Party advisor shall agree to be bound by confidentiality obligations consistent with those set forth in Article 9 and shall only provide to CELGENE a written report summarizing its conclusions regarding the suitability of such Development Candidate for further Development and Commercialization and shall not provide to CELGENE the IND Data Package. Upon receipt of the IND Data Package, CELGENE (or its designee) shall have [**] days t...
Sample 1
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Related to IND and Phase 1 Development

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Design Development Phase INDICATE IN STATEMENT OF WORK “NOT APPLICABLE” IF SECTION IS NOT APPLICABLE 1.1.6.1. The ARCHITECT/ENGINEER shall prepare from the approved Schematic Design Studies, the Design Development Documents consisting of drawings (including at least architectural, landscaping, civil, structural, mechanical and electrical plans, building sections; and finish schedule), outline specifications following the Construction Specification Institute "CSI" Format and other necessary documents to fix and describe the size and character of the entire Project as to its site, structural, mechanical, and electrical systems, materials and other such essentials as may be appropriate, for and until approved by the State. 1.1.6.2. The ARCHITECT/ENGINEER shall conduct meetings with the State, Efficiency Vermont, and relevant members of the design team, to review the Design Development Documents for the purposes of furthering the energy efficiency objectives of the Project. 1.1.6.3. The ARCHITECT/ENGINEER shall prepare for the State a revised accounting of how the Project is responding to LEED criteria. 1.1.6.4. The ARCHITECT/ENGINEER shall submit to the State a revised Statement of Probable Construction Cost based thereon for and until approved by the State.

  • Project Development a. Collaborate with COUNTY and project clients to identify requirements and develop a project Scope Statement. a. Develop a Work Breakdown Structure (WBS) for each project. b. Evaluate Scope Statement to develop a preliminary cost estimate and determinate whether project be vendor bid or be executed under a Job Order Contract (JOC).

  • Commencement of Development 5.3.1 In the event that development on the Lands has not commenced within five (5) years from the date of registration of this Agreement at the Registry of Deeds or Land Registry Office, as indicated herein, the Agreement shall have no further force or effect and henceforth the development of the Lands shall conform with the provisions of the Land Use By-law. For the purpose of this section, commencement of development shall mean issuance of a Mobile Home Park Construction Permit. 5.3.2 For the purpose of this section, Council may consider granting an extension of the commencement of development time period through a resolution under Section 4.1 of this Agreement, if the Municipality receives a written request from the Developer at least sixty (60) calendar days prior to the expiry of the commencement of development time period.

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • Joint Development If joint development is involved, the Recipient agrees to follow the latest edition of FTA Circular 7050.1, “Federal Transit Administration Guidance on Joint Development.”

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • Design Development An interim step in the design process. Design Development documents consist of plans, elevations, and other drawings and outline specifications. These documents will fix and illustrate the size and character of the entire project in its essentials as to kinds of materials, type of structure, grade elevations, sidewalks, utilities, roads, parking areas, mechanical and electrical systems, and such other work as may be required.

  • Completion of Development 7.4.1 Upon the completion of the whole development or complete phases of the development, Council may review this Agreement, in whole or in part, and may: (a) retain the Agreement in its present form; (b) negotiate a new Agreement; (c) discharge this Agreement; or (d) for those portions of the development which are completed, discharge this Agreement and apply appropriate zoning pursuant to the Municipal Planning Strategy and Land Use By-law for Halifax Peninsula as may be amended from time to time.

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