Funding of DURECT Activities, Development Plan and Post-Registration Plan Sample Clauses

Funding of DURECT Activities, Development Plan and Post-Registration Plan. (a) From and after the Effective Date, each of DURECT and Endo shall be responsible for the Development Costs and DURECT Activities Costs listed below its name in the following table: DURECT Endo ***Material has been omitted pursuant to a request for confidential treatment and such material has been filed separately with the SEC. 100% of the DURECT Activities Costs, if any, prior to June 30, 2004 0% of the DURECT Activities Costs, if any, prior to June 30, 2004 50% of the DURECT Activities Costs, if any, after June 30, 2004 50% of the DURECT Activities Costs, if any, after June 30, 2004 50% of the Development Costs under the Development Plan for the Product (and any development plan for any line extensions of the Product and Related Products pursuant to Section 2.2(b)(xi) and (xii)) 50% of the Development Costs under the Development Plan for the Product (and any development plan for any line extensions of the Product and Related Products pursuant to Section 2.2(b)(xi) and (xii)) [* * *] % of the Development Costs under the Post-Registration Plan for the Product that are NOT intended for supplemental NDA submissions, as determined by the JCC [* * *] % of the Development Costs under the Post-Registration Plan for the Product that are NOT intended for supplemental NDA submissions, as determined by the JCC .[* * *] % of the Development Costs for the development activities that ARE intended for supplemental NDA submissions, as determined by the PDC [* * *] % of the Development Costs for the development activities that ARE intended for supplemental NDA submissions, as determined by the PDC
Sample 1
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Funding of DURECT Activities, Development Plan and Post-Registration Plan. (a) From and after the Effective Date, each of DURECT and Endo shall be responsible for the Development Costs and DURECT Activities Costs listed below its name in the following table: ---------------------------------------------------- ------------------------------------------------- DURECT Endo ---------------------------------------------------- ------------------------------------------------- 100% of the DURECT Activities Costs, if any, prior 0% of the DURECT Activities Costs, if any, to June 30, 2004 prior to June 30, 2004 ---------------------------------------------------- ------------------------------------------------- 50% of the DURECT Activities Costs, if any, after 50% of the DURECT Activities Costs, if any, June 30, 2004 after June 30, 2004 ---------------------------------------------------- ------------------------------------------------- 50% of the Development Costs under the Development 50% of the Development Costs under the Plan for the Product (and any development plan for Development Plan for the Product (and any any line extensions of the Product and Related development plan for any line extensions of the Products pursuant to Section 2.2(b)(xi) and (xii)) Product and Related Products pursuant to Section 2.2(b)(xi) and (xii)) ---------------------------------------------------- ------------------------------------------------- ***% of the Development Costs under the ***% of the Development Costs under the Post-Registration Plan for the Product that are Post-Registration Plan for the Product that are NOT intended for supplemental NDA submissions, as NOT intended for supplemental NDA submissions, determined by the JCC as determined by the JCC ---------------------------------------------------- ------------------------------------------------- ***% of the Development Costs for the development ***% of the Development Costs for the activities that ARE intended for supplemental NDA development activities that ARE intended for submissions, as determined by the PDC supplemental NDA submissions, as determined by the PDC ---------------------------------------------------- -------------------------------------------------
Sample 1

Related to Funding of DURECT Activities, Development Plan and Post-Registration Plan

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • 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.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

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

  • 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.

  • 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.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • 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:

  • Regulatory Compliance Program of the Sub-Adviser The Sub-Adviser hereby represents and warrants that:

  • 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.

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