Clinical Development and Phase IV Development Sample Clauses

Clinical Development and Phase IV Development. Sepracor shall, without undue delay, coordinate with Nycomed, to the extent relevant and still applicable at that time, the continuation or cancellation by Nycomed or Nycomed's designee, as the case may be, of all clinical studies related Clinical Development or Phase IV Development that are ongoing at the effective date of Termination or expiry, or that were scheduled to be initiated within six (6) months from such date, under the sponsorship of Sepracor (the "Further Clinical Trials"). The final decision whether or not any such Further Clinical Trial shall be continued or terminated shall be with Nycomed. In the event that any such Further Clinical Trial is continued, Sepracor shall fully and reasonably co-operate with Nycomed in order to ensure an orderly transfer to Nycomed or Nycomed's designee of any such Further Clinical Trial. In order to achieve such purpose, Sepracor undertakes to continue conducting any such Further Clinical Trial for a reasonable period of time following the date of termination of this Agreement in close coordination with Nycomed. The costs and expenses incurred by Sepracor in carrying out its obligations under this Section 19.1.3 shall be (i) [**] if this Agreement has been terminated primarily due to the fault of Nycomed, (ii) borne by [**] if this Agreement has been terminated primarily due to the fault of Sepracor, and (iii) [**] if this Agreement has been terminated without either Party being primarily at fault.
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Clinical Development and Phase IV Development. Partner shall, without undue delay, coordinate with Nycomed, to the extent relevant and applicable at that time, the continuation or cancellation by Nycomed or Nycomed’s designee, as the case may be, of all clinical studies related to Clinical Development or Phase IV Development that are ongoing at the effective date of termination, [***] (the “Further Clinical Trials”). The final decision whether or not any such Further Clinical Trial shall be continued or terminated shall be with Nycomed. In the event that any such Further Clinical Trial is continued, Partner shall fully and reasonably co-operate with Nycomed in order to ensure an orderly transfer to Nycomed or Nycomed’s designee of any such Further Clinical Trial. In order to achieve such purpose, Partner undertakes to continue conducting any such Further Clinical Trial for a reasonable period of time following the date of termination of this Agreement in close coordination with Nycomed. The costs and expenses incurred by Partner in carrying out its obligations under this Section 19.1.3 shall be (i) borne by Partner if this Agreement has been terminated by Nycomed pursuant to Sections 18.2.1, 18.2.2, 18.3.1.1 or 18.3.2, (ii) reimbursed to Partner by Nycomed if this Agreement has been terminated by Partner pursuant to Sections 18.2.1 or 18.2.2, and (iii) shared equally by the Parties if this Agreement has been terminated by either Party pursuant to Sections 18.2.3 or 18.2.4 or by Partner pursuant to Section 18.4.

Related to Clinical Development and Phase IV 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.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.”

  • 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).

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members. (b) Information collected as part of this program shall be the sole property of the faculty member. This information or any judgments arising from this program shall not be used to determine non-renewal or termination of a faculty member's contract, suspension or dismissal of a faculty member, denial of advancement on the salary scale, nor affect any other administrative decisions pertaining to the promotion or employment status of the faculty member. (c) A joint advisory committee consisting of three regular faculty members who shall be elected by and are P.D. Committee Chairpersons and three administrators shall make recommendations for the operation, financing and management of the Professional Development Program.

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