Clinical Development Plans Sample Clauses

Clinical Development Plans. The JDC shall review the progress of the conduct of the Phase I Clinical Development Plan and Phase II Clinical Development Plan at each meeting of the JDC. *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission.
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Clinical Development Plans. For each Product for which BI initiates a ***, BI shall prepare a clinical development plan outlining the major clinical Development activities that BI expects to undertake, including anticipated timescales, relating to the Product up to the submission of the initial NDA for the applicable Product (each, a “Clinical Development Plan”). It is understood that each Clinical Development Plan is intended to be a fluid document and is subject to change by BI based on, among other things, changes in the market, discussions with investigators and Regulatory Authorities and the results of studies undertaken. Subject to the provisions of ARTICLE VIII, during the Term, BI shall provide MacroGenics a copy of ***. The Clinical Development Plans will be created, approved, and amended according to BI’s then-current internal standards and processes for such Clinical Development Plans. The responsibility to provide a Clinical Development Plan for a particular Product shall terminate if BI ceases further Clinical Development of such Product.
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Clinical Development Plans. The anticipated costs and timelines for activities under the Clinical Development Plans for the CNGA3 Product, the CNGB3 Product and the RPGR Product are attached hereto as parts of Exhibit 1.34. [***] with respect to the CNGA3 Product, CNGB3 Product and RPGR Product, the JDC shall develop and submit to the JSC for its review and approval, a Clinical Development Plan for each such Clinical IRD Product, and upon the JSC’s approval, each such initial Clinical Development Plan will be attached hereto and form a part of Exhibit 1.34. If Xxxxxxx elects to make the [***] Product a Clinical IRD Product in accordance with Section 2.1(b), no later than [***] following the [***] Product Opt-In Date, the JDC shall develop and submit to the JSC for its review and approval, a Clinical Development Plan for the [***] Product, and upon the JSC’s approval, such initial Clinical Development Plan shall be attached hereto and form a part of Exhibit 1.34. In the event that any Clinical Development Plan for a Clinical IRD Product conflicts with the anticipated costs and timelines set forth in Exhibit 1.34 for such Clinical IRD Product, the Clinical Development Plan shall control. Each Clinical Development Plan will set forth in reasonable detail at all times (i) all activities that are necessary or useful to be undertaken to achieve and maintain Regulatory Approval in the relevant Major Market Country for such Clinical IRD Product (the “Clinical Development Plan Activities”), (ii) an estimated timeline for completing such activities and the respective Clinical Development Plan Term, (iii) the respective deliverables for such activities and (iv) the allocation of responsibilities between the Parties for performance of each such activity. The terms of, and Clinical Development Plan Activities set forth in, each Clinical Development Plan will at all times be designed to expedite Regulatory Approval, reimbursement and Commercialization of the Clinical IRD Product that is the subject of such Clinical Development Plan, and to be in compliance with all Applicable Laws and in accordance with professional and ethical standards customary in the biopharmaceutical industry. From time to time, and at least on an annual basis, the JDC will develop, review and approve amendments or updates to each Clinical Development Plan for a Clinical IRD Product, subject to the remaining terms and conditions of this Agreement. Each such amended or updated Clinical Development Plan will automatically repla...
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Clinical Development Plans. All Development of the Licensed Products by or on behalf of either or both of the Parties after the Effective Date shall be conducted pursuant to the Global Development Plan. The Initial Global Development Plan as of the Effective Date (attached hereto as Exhibit C) includes: (a) the Work Plan for the Initial Study; (b) the Work Plan for each Ongoing Study that will continue (if any); (c) the Work Plan for each Ongoing Study that will be wound down; and (d) the Work Plan for any other clinical study of Licensed Products. The Parties acknowledge that the Initial Global Development Plan is preliminary and provides high-level Work Plans for initial Development activities. The Parties, through the JSC, shall use commercially reasonable efforts to update the Global Development Plan in due course after the Effective Date as further information develops, subject to Section 3.7.1.
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Clinical Development Plans. The Manufacturing Costs incurred by or on behalf of either Party under the Clinical Development Plans shall be deemed Clinical Development Costs and shared equally between the Parties, subject to a Party’s Opt-Out, provided, however, in each case, that the costs have been included in the respective Development Plan or have otherwise been approved by both Parties.
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Clinical Development Plans 
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Related to Clinical Development Plans

  • 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.

  • 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.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • 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.

  • Professional Development Program (a) The parties agree to continue a Professional Development Program for the maintenance and development of the faculty members' professional competence and effectiveness. It is agreed that maintenance of currency of subject knowledge, the improvement of performance of faculty duties, and the maintenance and improvement of professional competence, including instructional skills, are the primary professional development activities of faculty members.

  • 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.

  • 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 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 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).

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