Lead Compound Sample Clauses

Lead Compound. Subject to the terms and conditions of this Agreement (including the rest of this Section 8.2), Biogen Idec shall pay to Portola the milestone payments set forth below upon (i) [*][*] or [*][*]; or (ii) with respect to [*][*], [*][*] or [*][*]: Milestone Milestone Payment Development Milestones [*] $[*] [*] [*] [*] $[*] [*] [*] $[*]; [*] $[*]; [*] $[*]; and [*] $[*]. [*] [*] [*] [*] = 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 Act of 1933, as amended. Milestone Milestone Payment Milestone Milestone Payment [*] $[*] [*] $[*] [*] $[*] [*] $[*] [*] Milestone Milestone Payment [*] $[*] [*] $[*] [*] $[*] [*] $[*] [*] $[*] [*] $[*]
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Lead Compound. The term “
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Lead Compound. As used herein "Lead Compound" shall mean a compound identified among the Hits as a compound suitable for Lead Optimization, with the aim to identify Potential CDs (as defined below) meeting the CD Nomination Criteria.
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Lead Compound. Solvay will notify ArQule of the designation of any Licensed Compound or Derivative Compounds thereof as a lead compound that fulfills Solvay's primary criteria in a particular project (e.g., potency, selectivity, and bioavailability). Within 60 days of such designation, Solvay will provide ArQule with a copy of a revised time line of its research activities for that lead compound and will keep ArQule periodically informed of its progress under such schedule.
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Lead Compound. A "Lead Compound" shall be deemed to have been -------------------- identified at such time as SPL, its Affiliates or Sublicensees initiates a program of medicinal chemistry optimization with respect to an Agreement Compound. Within thirty (30) days after the initiation of such a program, SPL shall notify Pharmacopeia thereof, which notification will include identification __________________ * CONFIDENTIAL TREATMENT REQUESTED of the applicable Target(s) (in coded form only) and the general therapeutic area relevant to such Target.
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Lead Compound. A "Lead Compound" shall be deemed to have been -------------------- identified at such time as Schering, its Affiliates or Sublicensees initiates a program of medicinal chemistry optimization with respect to an Agreement Compound. Within thirty (30) days after the initiation of such a program, Schering shall notify Pharmacopeia thereof, which notification will include identification of the applicable Target(s) (in coded form only) and the general therapeutic area relevant to such Target.
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Lead Compound. Solvay Duphar will notify ArQule of the designation of any Active ArQule Compound or Derivatives thereof as a Lead Compound. Within 60 days of such designation, Solvay Duphar will provide ArQule with a copy of a revised time line of its research activities for that Lead Compound and will keep ArQule periodically informed of its progress under such schedule.
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Lead Compound. The Parties acknowledge and agree that CVT 3146 is the lead development candidate ("Lead Compound"). CVT may replace the Lead Compound with [ * ] at any time during the Term by providing FHI with forty five (45) days written notice thereof, which notice shall include the reason(s) for making any such replacement. Upon FHI's receipt of such notice, FHI shall have forty five (45) days in which to notify CVT that: (a) CVT should proceed with the development of [ * ] as the Lead Compound under the terms and conditions of this Agreement; or (b) FHI will terminate this Agreement under Section 12.2 below; provided, however, that if FHI has not provided any written notice by the end of such forty five (45)-day period, FHI automatically shall be deemed to have elected clause (a). If such notice from FHI to CVT indicates that FHI desires for CVT to proceed with the development of [ * ] as the Lead Compound, the Management Committee will then promptly and expeditiously prepare a Development Program and Annual Plan and Budget for [ * ]. FHI shall not be responsible for any Development Costs other than for pre-clinical studies after the Effective Date in connection with [ * ], until the date that FHI notifies CVT that it accepts (or, as set forth above, is deemed to have accepted) development of [ * ] as the new Lead Compound. The Parties acknowledge and agree that while CVT 3146 is the Lead Compound, CVT shall have no responsibility to conduct in parallel development activities with respect to [ * ] other than pre-clinical studies after the Effective Date, unless the parties otherwise mutually agree. Once CVT has replaced CVT 3146 with [ * ] as the Lead Compound, FHI shall be free to develop CVT 3146 in the FHI Field at FHI's sole cost and expense.
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Lead Compound. Subject to the terms and conditions of this Agreement (including the rest of this Section 8.2), Biogen Idec shall pay to Portola the milestone payments set forth below upon (i) [*][*] or [*][*]; or (ii) with respect to [*][*], [*][*] or [*][*]: Milestone Milestone Payment Development Milestones
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Related to Lead Compound

  • 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.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

  • Research Collaboration (a) GSK hereby grants to Anacor a non-exclusive, non-royalty bearing license under the GSK IP, solely as and to the extent necessary or important to conduct activities for which Anacor is responsible under the Research Plans during the Research Collaboration Term.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • 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:

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • 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.

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