Development Candidate Selection Sample Clauses

Development Candidate Selection. BI and Vitae shall use Diligent Efforts to select Potential Development Candidates or BI Compounds that meet the Development Candidate and backup Development Candidate selection criteria agreed upon by the Parties. If (i) Vitae recommends that BI selects a particular Potential Development Candidates, which in Vitae’s reasonable judgment satisfies the Development Candidate selection criteria agreed upon by the Parties, as a Development Candidate, and (ii) BI (a) declines to select such compound as a Development Candidate and (b) fails to select any Potential Development Candidate as a Development Candidate within twelve (12) months after Vitae’s first Development Candidate recommendation, or has not already selected any Potential Development Candidate as a Development Candidate, then any such Potential Development Candidate(s) rejected by BI as Development Candidates shall each remain a Collaboration Compound and shall no longer be considered a Potential Development Candidate, and Vitae shall have the right (but not the obligation) to pursue Development of such Collaboration Compound(s) at Vitae’s sole expense for Non-Core Indications pursuant to the procedure outlined in Section 4.6.1.
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Development Candidate Selection. On a Target-by-Target basis (i) at any time during the Research Term, or (ii) within [***] following the end of the Calendar Term, whichever is later (collectively, the “DC Selection Deadline”), Novartis will have the right, but not the obligation to select, by written notice to Licensor, up to [***] Research Compounds to take forward into further development; provided that (a) at least [***] such Research Compound will be identified by Novartis in such notice as a DC at or prior to the DC Selection Deadline and (b) any of the other such Research Compounds identified by Novartis in such notice but not selected as a DC will be each deemed a Candidate DC. If Novartis does not select any DC for such Target by the DC Selection Deadline, the Agreement will expire for such Target, unless the Parties agree to extend the Agreement for such Target. Upon selection of at least [***] DC by Novartis pursuant to this Section 2.4, the exclusive license pursuant to Section 3.1(a) will become effective, and each DC and any applicable Candidate DCs, will be each deemed a Licensed Compound.
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Development Candidate Selection. Final decision making authority with respect to the selection of a Development Candidate with the goal of developing Approved Products is as set forth in Section 4.3.
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Development Candidate Selection. With respect to each Shire Target, Shire will have the option to designate as Development Candidates one or more [***] of potential Development Candidates in any Interim Research Report or the Final Research Report (“Development Candidate Selection”) in its sole discretion. Shire may make a Development Candidate Selection for a Shire ZF Compound at any time during the Term by delivering a written notice to Sangamo indicating that it elects to designate such Shire ZF Compound as a Development Candidate. Shire will not file an IND/CTA for any [***] that Shire has not designated as a Development Candidate pursuant to this Section 3.5.
Sample 1
Development Candidate Selection. Within [***] after the date on which Alnylam has completed its responsibilities under the applicable DC Workplan for an ID Program, including delivering to Vir all data and information generated under such DC Workplan, the JSC shall select one or more of the RNAi Products identified, generated or developed in such ID Program that meets the applicable Development Candidate criteria for such ID Program to further Develop (each such product selected by the JSC, the “Development Candidate”); provided, however, that Vir shall have the right to waive the applicable Development Candidate criteria should it wish to designate such an RNAi Product as a Development Candidate despite such RNAi Product failing to meet such criteria. [***]. EXECUTION VERSION
Sample 1
Development Candidate Selection. JPI may select certain NA Therapeutics under a Joint Research Plan for further development (“Development Candidates”): (a) at a duly-convened JRC meeting; (b) by email from JPI’s JRC chairperson to Arcturus’ JRC chairperson; or (c) either during or after the Research Term by written notice to Arcturus in accordance with this Agreement. Each compound that comprises a Development Candidate is a “Licensed Compound” and each pharmaceutical product containing a Licensed Compound is a “Licensed Product”. Should JPI or its Affiliates conduct, or permit or cause to be conducted, any IND-enabling GLP study of, or any GLP manufacturing activity with respect to, any NA Therapeutics during the Research Term or any Selected NA Therapeutic after the Research Term, it shall be deemed to have designated such NA Therapeutic as a Development Candidate. Arcturus shall not be obligated to perform, or have performed, any IND-enabling GLP study of, or any GLP manufacturing activity with respect to any NA Therapeutic unless such NA Therapeutic has been designated a Development Candidate. JPI shall only select as Development Candidates those NA Therapeutics that JPI believes are potentially relevant to the treatment or diagnosis of the applicable infectious disease as set forth in the Joint Research Plan for the Research Program. ***Confidential Treatment Requested
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Development Candidate Selection. Prior to or following completion of the relevant activities in the Research Plan and the JRPT’s determination that it has identified one or more suitable potential Development Candidates, the JRPT will promptly propose to the JSC one or more Lead Candidates for the JSC’s review and selection of at least one Development Candidate. Within thirty (30) days after submission by the JRPT of the potential Development Candidate(s), the JSC (subject to [***] [***] under Section [***] ) will formally recommend one or more of such potential Development Candidate(s) to [***] for start of pre-clinical development and further development as a Product. [***] shall decide upon the selection of the proposed Development Candidate in accordance with [***] , however no later than sixty (60) days after the JSC recommendation. If the JSC does not recommend a Development Candidate to [***] for start of pre-clinical development or if [***] does not approve such start of pre-clinical development within the applicable timeframes described above, then the JSC or [***] , as applicable, will undertake one of the other decisions described in this Section 3.1.5. If at least one of the proposed Development Candidates [***] , then the JSC will be obligated to recommend, and [***] will be obligated to approve, a BiTE Antibody as the Development Candidate, such BiTE Antibody not necessarily to be the above mentioned Development Candidate [***] . If none of the proposed Development Candidates [***] , then the JSC will, within thirty (30) days after the submission of such proposed Development Candidate(s) to the JSC, either (a) formally recommend one of such proposed Development Candidates as a Development Candidate anyway to [***] for start of pre-clinical development, or (b) not approve any of the proposed Development Candidates as the Development Candidate, in which case the JSC shall, within thirty (30) days after its meeting, specify additional research and development activities for the generation or selection of more desirable BiTE Antibodies and the Parties will amend the Research Plan to reflect any such activities (thereafter, the Parties will use Commercially Reasonable Efforts to conduct such activities, subject to the terms of Section 3.3.3 below). If [***] does not approve any of the Development Candidates recommended by the JSC as the Development Candidate, then either (i) [***] will, within thirty (30) days after [***] , specify additional research and development activities f...
Sample 1
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Related to Development Candidate Selection

  • 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 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.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • 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).

  • 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.

  • 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 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.

  • 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.

  • 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.

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