Development Program Activities Sample Clauses

Development Program Activities. Following completion of each Discovery Program, TESARO shall be responsible, at its sole expense, for conducting the Development Program, which shall include without limitation all pre-IND activities, including cross-reactivity studies and pilot studies to enable GLP pharmacology/toxicology studies, GMP manufacturing, regulatory filings, clinical trials and commercialization activities with respect to one or more Development Antibodies under each Development Program.
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Development Program Activities. Subject to the terms and conditions set forth herein, the Parties shall perform research, conduct development, and commercialize Products pursuant to the Development Plan. Such activities shall comprise the "Development Program" and shall be conducted primarily at Integ's facility. The Parties shall use reasonable efforts to conduct the Development Program in accordance with the Development Plan set by the Development Committee, and shall use reasonable efforts to comply with all submission procedures to the appropriate regulatory authorities, to respond timely to inquires of said regulatory authorities and to maintain submissions and support new submissions. The Parties shall keep the Development Committee reasonably informed of the progress of the Development Program and shall provide the Development Committee a reasonable opportunity to review and comment on Product research and development, study designs, clinical trials, submissions, launch and other relevant factors.
Sample 1
Development Program Activities. Development and regulatory activities for Products in the Field in the Territory will be conducted as outlined in the Development Plan. For clarification, Phase IV marketing studies are not considered to be development activities. The JDC shall determine on a Calendar Quarter basis the number of FTEs of each party that will work on the Development Program during such Calendar Quarter. Any amendments or revisions to the Development Plan shall be in writing and shall require unanimous approval of the JDC. Each party, as applicable, will use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the activities set forth in the Development Plan, in each case in compliance with the terms of this Agreement and Applicable Laws. If a party proposes development activities for Products in the Field in the Territory, but the JDC does not reach agreement to include such development activities in the Development Plan, the parties will discuss and agree whether one party can proceed with such development activities at its own [ *** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Exchange Act of 1933, as amended.
Sample 1
Development Program Activities. Subject to the terms and --------------------------------- conditions set forth herein, Medarex shall (i) conduct clinical development of the Product pursuant to the Development Plan, and (ii) for a three (3) year period commencing on the Effective Date, perform research with regard to Product manufacture improvements. Such activities shall comprise the "Development Program." Medarex shall use reasonable efforts to conduct the Development Program in accordance with the Development Plan and within the time schedules contemplated therein, and shall use reasonable efforts to comply with all submission procedures to the appropriate regulatory authorities, to respond timely to inquires of said regulatory authorities and to maintain submissions and support new submissions. Medarex shall keep the Development Committee reasonably informed of the progress of the Development Program and shall provide the Development Committee a reasonable opportunity to review and comment on trial protocols, study designs, endpoints, target patient population and other relevant factors to such trials.
Sample 1
Development Program Activities. AvP shall, except as provided for in Sections 3.5.1 to 3.5.4 below, be solely responsible for the global DEVELOPMENT PROGRAM activities, directly or through third parties. In accordance with the PROGRAM Plan and Budget in effect from time to time, CRUCELL shall perform the following activities in this DEVELOPMENT PROGRAM.
Sample 1
Development Program Activities. Development and regulatory activities for Products in the Field in the Territory will be conducted as outlined in the Development Plan. For clarification, Phase IV marketing studies are not considered to be development activities. The JDC shall determine on a Calendar Quarter basis the number of FTEs of each party that will work on the Development Program during such Calendar Quarter. Any amendments or revisions to the Development Plan shall be in writing and shall require unanimous approval of the JDC. Each party, as applicable, will use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the activities set forth in the Development Plan, in each case in compliance with the terms of this Agreement and Applicable Laws. If a party proposes development activities for Products in the Field in the Territory, but the JDC does not reach agreement to include such development activities in the Development Plan, the parties will discuss and agree whether one party can proceed with such development activities at its own expense and, if so, on what terms the results of such development activities would be made available to the other party by the party that conducts such development activities.
Sample 1

Related to Development Program Activities

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

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

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • 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).

  • 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. 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.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • Research Program Funding 3.1.1 Pfizer will fund the research to be performed by Rigel, pursuant to the Agreement, according to the following schedule: COMMITMENT YEAR ANNUAL COMMITMENT 1 $2,350,000.00 2 $2,350,000.00 The funding payments of two million three hundred and fifty thousand dollars ($2,350,000.00) shall support the work of the equivalent of ten (10) full time employees ("FTEs") of Rigel.

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