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, ...
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
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.