Common use of New Development Activities Clause in Contracts

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, in which case ▇▇▇▇▇▇▇ shall have the right to Develop such New Indication or New Formulation, as the case may be, subject to the provisions of this Section 3.10(h)(ii)(B). If ▇▇▇▇▇▇▇ reasonably believes that Development of such New Indication or New Formulation, as the case may be, would be likely to (1) have a material negative impact on Minerva’s business interest in a Licensed Product in the ▇▇▇▇▇▇▇ Territory or (2) raise material toxicity or drug safety concerns, ▇▇▇▇▇▇▇ may provide ▇▇▇▇▇▇▇ with a reasonably detailed written explanation of the basis for its view. In the event that ▇▇▇▇▇▇▇ disagrees with Minerva’s view, such dispute shall be referred to the JSC for resolution. In the event that the JSC agrees with Minerva’s view, then ▇▇▇▇▇▇▇ shall not proceed with such Development activities. If the JSC does not agree with Minerva’s view, then ▇▇▇▇▇▇▇ shall be entitled to proceed with Development of such New Indication or New Formulation, as the case may be, and such activities shall be outside of the Development Plan and ▇▇▇▇▇▇▇ shall be responsible for all costs and expenses for the Development of such New Indication or New Formulation, subject to Minerva’s buy-in rights pursuant to Section 3.10(h)(iii). For the avoidance of doubt, unless ▇▇▇▇▇▇▇ exercises its buy-in rights pursuant to Section 3.10(h)(iii), such New Indication or New Formulation for which ▇▇▇▇▇▇▇ did not share in the Development Costs shall not be included in ▇▇▇▇▇▇▇’▇ Net Sales for purposes of calculating the royalties due from ▇▇▇▇▇▇▇ to ▇▇▇▇▇▇▇ pursuant to Section 6.3 and shall not be included within the scope of the licenses granted to ▇▇▇▇▇▇▇ pursuant to Sections 2.1, 2.2, 2.3 and 2.4. (iii) If ▇▇▇▇▇▇▇ wishes to Commercialize a New Indication or New Formulation in the ▇▇▇▇▇▇▇ Territory with respect to which ▇▇▇▇▇▇▇ elected to opt out of joint Development pursuant to Section 3.10(h)(ii)(B), then, within thirty (30) days following database lock with respect to the first Phase IIb Trial for such New Indication or New Formulation, as the case may be, ▇▇▇▇▇▇▇ may request an itemized invoice of the Development Costs incurred by or on behalf of ▇▇▇▇▇▇▇ in connection with the Development of such New Indication or New Formulation, as the case may be (which invoice ▇▇▇▇▇▇▇ shall provide within [*] days following such request), and ▇▇▇▇▇▇▇ shall have the right to Commercialize such New Indication or New Formulation, as the case may be, in the ▇▇▇▇▇▇▇ Territory in accordance with the terms and conditions of this Agreement effective upon payment to ▇▇▇▇▇▇▇ of the amount equal to [*] of such Development Costs within ninety (90) days following [*], in which case: (A) 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; (B) the Development Costs incurred in connection with the further Development of such New Indication or New Formulation, as the case may be, 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; and (C) such New Indication or New Formulation, as the case may be, shall be included in ▇▇▇▇▇▇▇’▇ Net Sales for purposes of calculating the royalties due from ▇▇▇▇▇▇▇ to ▇▇▇▇▇▇▇ pursuant to Section 6.3.