CELGENE's Discretion Sample Clauses

CELGENE's Discretion. ENTREMED agrees that, subject to Section 3.6 of this Agreement, (i) the decision regarding which uses to pursue regulatory approval of PRODUCTS for, and/or to fund and conduct clinical trials of PRODUCTS for, pursuant to Section 3.2(a) of this Agreement, shall be made by and in the sole discretion of CELGENE; and (ii) with respect to the manner in which regulatory approval is sought and/or clinical trials are funded and conducted, CELGENE shall have sole discretion, including, without limitation, complete control over all regulatory submissions of PRODUCTS to the appropriate regulatory agencies worldwide, including whether, when, and how to file, maintain, withdraw, or abandon an application for regulatory approval of PRODUCTS.
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CELGENE's Discretion. CMCC agrees that (i) the decision regarding which uses to pursue regulatory approval of PRODUCTS for, and/or to fund and conduct clinical trials of PRODUCTS for, pursuant to Sections 3.1, 3.2, 3.3 and 3.4 of this Agreement, shall be made by and in the sole discretion of CELGENE; and (ii) with respect to the manner in which regulatory approval is sought and/or clinical trials are funded and conducted, CELGENE shall have sole discretion, including, without limitation, complete control over all regulatory submissions of PRODUCTS to the appropriate regulatory agencies worldwide, including whether, when, and how to file, maintain, withdraw, or abandon an application for regulatory approval of PRODUCTS.
Sample 1
CELGENE's Discretion. CMCC agrees that (i) the decision regarding which Licensed Product to pursue regulatory approval of, and/or to fund and conduct clinical trials of, shall be made by and in the sole discretion of Celgene; and (ii) with respect to the manner in which any regulatory approval is sought and/or clinical trials are funded and conducted, Celgene shall have sole discretion, including, without limitation, complete control over any regulatory submissions for such Licensed Product to the appropriate regulatory agencies worldwide, including whether, when, and how to file, maintain, withdraw, or abandon an application for regulatory approval of same. In the event that Celgene determines, in the exercise of reasonable business judgment and consistent with then-prevailing scientific standards in the pharmaceutical industry, that the continued development of, and pursuit of regulatory approval for, Celgene's Licensed Product is not warranted or advisable, Celgene may, in its sole discretion, discontinue same, and Celgene's diligence obligations hereunder shall be deemed to be satisfied with respect to that Licensed Product.
Sample 1

Related to CELGENE's Discretion

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of at least one (1) and up to two (2) representatives of Omega and at least one (1) and up to two (2) representatives of Acuitas (the “JDC”). One such representative from each Party will be such Party’s Workplan Leader. Each Party may replace its Workplan Leader and other JDC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts to ensure continuity on the JDC. With the consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), each Party may invite non-voting employees and consultants to attend JDC meetings as necessary, subject to consultant’s agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

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

  • 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.

  • 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.

  • 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. 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.

  • Steering Committee The Project Manager shall set up a Steering Committee for the Project, consisting of representatives from the Department, the Contractor, and any other key organisations whom the project will impact on, to be agreed between the parties. The function of the Steering Committee shall be to review the scope and direction of the Project against its aims and objectives, monitor progress and efficiency, and assess, manage and review expected impact and use of the findings from the Project. The Committee shall meet at times and dates agreed by the parties, or in the absence of agreement, specified by the Department. The Contractor’s representatives on the Steering Committee shall report their views on the progress of the Project to the Steering Committee in writing if requested by the Department. The Contractor’s representatives on the Steering Committee shall attend all meetings of the Steering Committee unless otherwise agreed by the Department.

  • Research Term The Research Program will be carried out during the two (2) year period following the Effective Date, unless this Agreement is terminated in accordance with Article 13 (such period, as may be extended pursuant to this Section 3.2, being the “Research Term”). BMS shall have the option to extend the Research Term for three (3) additional one (1) year periods on a year-by-year basis after the initial two (2) year period. At least one hundred eighty (180) days prior to the scheduled expiration of the Research Term (i.e., the applicable anniversary of the Effective Date) BMS will provide Ambrx with a nonbinding, good faith indication of whether or not BMS intends to extend the Research Term. In order to exercise its option to extend the Research Term, BMS must provide Ambrx a written notice exercising BMS’ option to extend the Research Term at least ninety (90) days prior to the scheduled expiration of the Research Term (i.e., the applicable anniversary of the Effective Date). If BMS does not provide such written notice, the Research Term will end when scheduled (i.e., on the applicable anniversary of the Effective Date). For each extension of the Research Term, subject to Section 3.4, the JRC will prepare an update to the Research Plan which will include an updated Budget for the BMS-funded Ambrx FTEs to perform the work required under such Research Plan and the projected Third Party Costs.

  • Research Committee 2.2.1 Establishment and Functions of RC. ---------------------------------

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