New Development Activities Clause Samples

New Development Activities. (i) If, at any time, ▇▇▇▇▇▇▇ desires to Develop a Product containing or comprised of a Compound, alone or in combination with one or more other APIs, for a New Indication or to Develop a New Formulation of such a Product, ▇▇▇▇▇▇▇ shall submit to ▇▇▇▇▇▇▇ a proposal for ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ to jointly Develop such New Indication or New Formulation under the terms and conditions of this Agreement. Such proposal shall contain, at a minimum, information supporting the rationale for Developing such New Indication or New Formulation from a scientific, regulatory and commercial standpoint, as well as an estimated developmental critical path and an estimate of the timeframe for and cost of such Development, including: (A) all major Development tasks to be accomplished prior to submission of filings for Regulatory Approvals for such New Indication or New Formulation; (B) key Development objectives, expected associated resources, risk factors, timelines, Go/No Go decision points and relevant decision criteria and, where appropriate, decision trees; (C) how resources are expected to be provided by ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ to support the Development for such New Indication or New Formulation; and (D) a reasonably detailed description and budget for the Development activities that are expected to be performed by ▇▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ for such New Indication or New Formulation. (ii) If ▇▇▇▇▇▇▇ proposes the Development of a New Indication or New Formulation to ▇▇▇▇▇▇▇, then ▇▇▇▇▇▇▇ shall, within [*] days following receipt of such proposal, give ▇▇▇▇▇▇▇ written notice of whether it elects to: (A) participate in the joint Development of such New Indication or New Formulation, in which case: (1) such New Indication or New Formulation, as the case may be, shall be deemed included within the scope of the licenses granted to ▇▇▇▇▇▇▇ pursuant to Sections 2.1, 2.2, 2.3 and 2.4; (2) the Parties shall promptly amend the Development Plan and the Development Budget pursuant to Section 3.10(c) in order provide for the joint Development of such New Indication or New Formulation, as the case may be; and (3) the Development Costs incurred in connection with the Development of such New Indication or New Formulation, as the case may be, pursuant to the Development Plan (as so amended) shall be shared by the Parties pursuant to Section 3.10(f)(i) and shall not be subject to the Initial Stage Cap or the Second Stage Cap; or (B) opt out of joint Development of such New Indication or New Formulation, ...
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New Development Activities. From time to time during the Term, in accordance with the timelines set forth in Section 3.4, either Party may submit to the JDC an expansion of the Development Plan to cover new Development Activities (including proposals to make any Non-NDA Study a Joint Development Activity) that are not amending ongoing Joint Development Activity (e.g. a new Trial) and that are not yet included in the Development Plan with respect to the Product in the Territory in the Field for the JDC’s review and referral for decision to the
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New Development Activities. If either Party proposes to Develop in the Territory, (a) a new formulation of any DT Co-Co Product or (b) any DT Co-Co Product for a new Indication (including any different patient population or line of therapy, which shall be deemed to be a different Indication for purposes of this Section 6.4.7 (New Development)), in each case ((a) and (b)), other than the formulations and Indications set forth in the applicable Development Plan for such DT Co-Co Product ((a) and (b), “New Development”), then the proposing Party shall present to the JDC, to review and discuss, a proposal to add such New Development to the Development Plan, for the applicable DT Co-Co Product, including the countries in which such activities would be conducted and the allocation of performance of such activities between the Parties (a “New Development Proposal”). Each New Development Proposal shall describe in reasonable detail the applicable non-clinical studies, pre-clinical studies, and Clinical Trials, in each case, that the proposing Party desires to conduct as part of such New Development, including a synopsis of the trial or activities, the proposed enrollment criteria, the number of patients to be included, the endpoints to be measured, and the statistical design and powering (the “New Development Activities”), as well as a proposed timeline and budget and an analysis of the business opportunity and revenue potential for such New Development Activities.
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Related to New Development Activities

  • 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 ▇▇▇▇▇; 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.

  • Collaboration activities 4.1 The Collaboration Suppliers will perform the Collaboration Activities and all other obligations of this Agreement in accordance with the Detailed Collaboration Plan. 4.2 The Collaboration Suppliers will provide all additional cooperation and assistance as is reasonably required by the Buyer to ensure the continuous delivery of the services under the Call-Off Contract. 4.3 The Collaboration Suppliers will ensure that their respective subcontractors provide all cooperation and assistance as set out in the Detailed Collaboration Plan.

  • 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 Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • 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.