Development Candidate Designation Sample Clauses

Development Candidate Designation. The Parties acknowledge and agree that, as of the Effective Date, IPI145 and IPI443 are Licensed Compounds and Development Candidates. Infinity may, in its discretion, provide to Intellikine’s in-house patent counsel a written notice of the chemical structure for any Licensed Compound following the date on which such Licensed Compound becomes a Development Candidate. Intellikine’s patent counsel may disclose such information pursuant to the last sentence of Section 12.1 solely on a need-to-know basis to Intellikine’s and its Affiliates’ employees, agents, contractors, consultants and advisers who need to know in order to respect the research exclusivity granted to Infinity pursuant to Section 2.1(d).
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Development Candidate Designation. Within [***] days following Ionis’ delivery of a Development Candidate Data Package with respect to a Collaboration Program to Biogen pursuant to Section 1.4.2(a) (and resolution of any dispute regarding omissions or deficiencies with respect to such Development Candidate Data Package in accordance with Section 1.4.2(a)), the JSC will discuss whether to designate the Compound that is recommended by Ionis’ RMC as the lead compound under such Development Candidate Data Package (or any other Compound listed in the Development Candidate Data Package as a potential backup Compound (such Compound, a “Backup Compound”)) as the Development Candidate for such Collaboration Program, taking into account the input of the JPC with respect to its intellectual property assessment of such Compound(s). Any designation of a Development Candidate for a Collaboration Program by the JSC will be documented in the written minutes of the JSC. If the JSC mutually agrees to designate such a Compound as a Development Candidate then, following the JSC’s agreement to a high level preclinical toxicology strategy for such Development Candidate in accordance with Section 1.5 below, Biogen will conduct the IND-Enabling Toxicology Studies under such strategy under Section 1.5. If the JSC cannot agree to designate the Compound that is recommended by Ionis’ RMC as the lead compound under such Development Candidate Data Package (or any Backup Compound) as a Development Candidate for a given Collaboration Program within [***] days after the JSC meets to discuss the applicable Development Candidate Data Package (such [***]-day period, the “JSC Decision Period”), then [***] will have final decision-making authority to determine whether or not to designate the Compound that is recommended by Ionis’ RMC as the lead compound under such Development Candidate Data Package (or any Backup Compound) as a Development Candidate for such Collaboration Program and will notify the JSC in writing of [***] determination within [***] days after the end of the JSC Decision Period. If the JSC (or [***] through the exercise of its final decision-making authority) does not designate such a Compound as a Development Candidate for a given Collaboration Program within [***] days after the date Biogen receives the complete Development Candidate Data Package under Section 1.4.2(a), then, unless the Parties mutually agree to amend the applicable ASO Development Candidate Identification Plan to conduct additional Developm...
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Development Candidate Designation. If the JSC determines that an Epigenomic Controller-LNP Candidate that is Developed under the R&D Plan satisfies the Development Candidate Criteria, then such Epigenomic Controller-LNP Candidate shall be the Development Candidate under this Agreement. Without limiting the foregoing, [***]. Upon designation of an Epigenomic Controller-LNP Candidate as the Development Candidate, all Collaboration Epigenomic Controllers other than the Collaboration Epigenomic Controller used in such Development Candidate (the “Program Epigenomic Controller”) shall be deemed to be Discontinued Epigenomic Controllers. For the avoidance of doubt, at any time before designation of a Development Candidate as the IND-Enabling Candidate, the Parties may replace the Development Candidate with another Epigenomic Controller-LNP Candidate that uses the Program Epigenomic Controller and, upon such replacement, such Epigenomic Controller-LNP Candidate shall be the Development Candidate for all purposes hereunder. [***] shall have final decision making authority with respect to replacement of the Development Candidate under this Section 3.2.3.
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Development Candidate Designation. (i) Within [***] days following Ionis’ delivery of a Development Candidate Data Package with respect to a Collaboration Program to Biogen pursuant to Section 1.8.3(a) (which period will begin upon resolution of any dispute regarding omissions or deficiencies with respect to such Development Candidate Data Package in accordance with Section 1.8.3(a), including the delivery of information to resolve such omissions or deficiencies, if applicable), the Neurology JDC will discuss whether to designate the Compound proposed by Ionis as the Development Candidate (or any Related Program Compounds) as the lead Development Candidate for such Collaboration Program, taking into account the input of the [***] with respect to its [***] assessment of such proposed Development Candidate and Related Program Compounds. Any designation of a Development Candidate for a Collaboration Program by the Neurology JDC will be documented in the written minutes of the Neurology JDC. If the Neurology JDC mutually agrees to designate the Compound recommended by Ionis as the lead Development Candidate or any Related Program Compound as a Development Candidate for a Collaboration Program, then the Parties will conduct the IND-Enabling Toxicology Studies for such selected Development Candidates under the applicable Toxicology Strategy that has been agreed to in accordance with Section 1.8.3(c). Confidential
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Development Candidate Designation 
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Related to Development Candidate Designation

  • Development Plan As defined in Section 3.2(a).

  • 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.

  • 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.

  • 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).

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

  • 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.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • 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.

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