Pre-Phase IIb Development and Plan Sample Clauses

Pre-Phase IIb Development and Plan. (1) If either Party’s representatives on the JDC are of the view that such Product Candidate is not ready for Phase IIb Clinical Studies, then the Parties shall not commence Phase IIb Clinical Studies for such Product Candidate at such time; and instead the JDC shall prepare a written plan setting forth: (A) the Development activities (including any additional Phase IIa Clinical Study or other Phase II Clinical Study) it believes should be conducted prior to a Phase IIb Clinical Study, or any Non-Clinical Studies to be conducted by the Parties for such Product Candidate with the goal of determining whether such Product Candidate should be further Developed in Phase IIb Clinical Studies, and related Manufacture and supply matters (such activities collectively, the “Pre-Phase IIb Development”), including the protocols for any such Clinical Studies or other such studies; (B) the allocation of the conduct of the activities under such Pre-Phase IIb Development between the Parties; (C) the timeline associated with such Pre-Phase IIb Development; and (D) the budget for such Pre-Phase IIb Development (the “Pre-Phase IIb Plan”). Any such Pre- Phase IIb Plan shall be effective upon approval of the JDC, either by the agreement of the JDC or, in the case of disagreement, as set forth in Section 5.5(a)(ii)(2) below. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission.
Sample 1
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Related to Pre-Phase IIb Development and Plan

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

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

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

  • 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.

  • 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.

  • 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.

  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

  • 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).

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Joint Project Team As soon as possible after the Effective Date, the Parties shall establish a joint project team (the “JPT”) which shall be initially responsible for the day-to-day operations of the Initial Target Program. The JPT shall also be responsible for the day-to-day operations of all other Collaboration Programs when they become ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. effective; provided, that if multiple JPTs are needed due to different Targets or disease areas, then the Parties may establish separate JPTs for different Collaboration Programs. The JPT shall be comprised of representatives from each of GSK and Adaptimmune with the appropriate scientific expertise with respect to the conduct of the Development Plans (and such representatives may vary depending on the relevant Project Phase) and shall meet on a monthly basis (or more or less frequently as agreed by the Parties) at Adaptimmune’s facilities, GSK’s facilities or via teleconference at such times as may be agreed by the Parties during the term of the applicable Collaboration Program. The JPT will report to the JSC and will be responsible for the day-to-day management of the conduct of the Development Plans including any non-material changes to the Development Plans, overseeing the conduct of experiments and reviewing data resulting from such experiments as set forth in the Development Plans, proposing amendments to the Development Plans, proposing new Development Plans to the JSC for new Collaboration Programs for JSC approval, discussing potential Lead Candidates and Development Candidates for proposal to the JSC. All decisions of the JPT on matters for which it has responsibility shall be made unanimously. In the event that the JPT is unable to reach a unanimous decision within ten (10) Business Days after it has met and attempted to reach such decision, then either Party may, by written notice to the other, have such issue submitted to the JSC for resolution in accordance with Section 4.5. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JPT, including all travel and living expenses. Each JPT shall automatically cease to exist on completion of the relevant Collaboration Programs that it supports and exercise or expiry of all Collaboration Program Options applicable to such Collaboration Programs.

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