Additional Compounds Clause Samples
The "Additional Compounds" clause defines the terms under which substances or chemical compounds not originally specified in the agreement may be included or addressed. Typically, this clause outlines the process for identifying, approving, and incorporating such additional compounds, often requiring mutual consent or specific notification procedures between the parties. Its core practical function is to provide flexibility for the parties to expand the scope of their collaboration or agreement to cover new compounds as they are discovered or become relevant, thereby ensuring the contract remains adaptable to evolving needs or opportunities.
Additional Compounds. If, at any time during the Term, Paratek reasonably determines in good faith that a Paratek Compound is potentially more suitable for Development and Commercialization than the then specified Lead Candidates (such compound, an “Additional Compound”), Paratek shall promptly inform WCCI (the “Additional Compound Notification”) of such determination and WCCI shall have the right to designate such Additional Compound as a Lead Candidate hereunder (which shall be reflected in an amendment to Schedule 1 hereto), it being understood that WCCI must notify Paratek in writing of such designation within forty-five (45) days of receipt of the Additional Compound Notification in order to exercise its rights under this Section 3.6.2. For the avoidance of doubt, Paratek shall have no obligation under this Section 3.6.2 to engage in research activities it would not otherwise conduct in the ordinary course of its research and development with respect to Paratek Compounds.
Additional Compounds. (i) If (A) MyoKardia has Initiated a clinical trial of a Compound under a POC Development Plan and has not terminated Development thereof, (B) another Compound is designated as a Development Candidate for the same Program, and (C) either Party desires to conduct IND-enabling studies and clinical trials of such second Compound, such Party shall notify the other Party in writing. If both Parties desire to initiate such further Development activities, then the Parties shall revise the POC Development Plan and budget therein for such Program accordingly to include the Development of such second Compound, and Sanofi shall reimburse all such Pre-POC Development Costs on a Calendar Quarterly basis in accordance with Section 9.5(a), mutatis mutandis, and such additional costs (if incurred after 2018) will not count toward the Post-2018 POC Cost Cap. The estimated amount to be so reimbursed shall be provided by MyoKardia in advance of the decision whether to so initiate further Development thereof. If instead Sanofi does not elect to bear such costs, then MyoKardia shall have the right, but not obligation, to conduct such Development of such additional Compound under the POC Development Plan for such Program at its sole discretion and expense, provided that upon the earlier of (y) discontinuation of Development of the first Compound for the same Program or (z) completion of the final study report for a Phase 2a Clinical Trial of such second Compound and delivery of the results and an accounting of amounts required to be reimbursed, Sanofi shall reimburse all Pre-POC Development Costs then incurred by MyoKardia in the conduct of the Development of such second Compound after its designation as a Development Candidate, and thereafter Sanofi shall reimburse all Pre-POC Development Costs for such Compound subsequently incurred by MyoKardia on a Calendar Quarterly basis in accordance with Section 9.5(a), mutatis mutandis. For clarity, the requirement of reimbursement under this provision applies only with respect to one additional Compound per Program. In no event shall reimbursement be due to MyoKardia under this Section 5.4(b)(i) in the case in which Sanofi has delivered a notice of termination with respect to this Agreement in its entirety or with respect to the applicable Program prior to the delivery to Sanofi of such final study report.
(ii) If instead MyoKardia does not elect to bear such costs with respect to a DCM1 Compound, then Sanofi shall have the right, but...
Additional Compounds. [***], Theravance may propose that such Additional Compound be included in this Agreement by providing ▇▇▇▇▇▇▇ with written notice of such Additional Compound (each, an "Additional Compound Notice"), which notice shall include any Data that has been generated by or on behalf of Theravance or its Affiliates that is reasonably necessary for ▇▇▇▇▇▇▇ to assess whether to include such Additional Compound under this Agreement. Upon receipt of an Additional Compound Notice, ▇▇▇▇▇▇▇ shall have a period of [***] (the "Assessment Period") to assess whether it desires to include such Additional Compound within the Compounds and provide notice to Theravance of such determination. Such Assessment Period can be mutually extended by the Parties. [***].
Additional Compounds. Under Section 3.1.2 of the BI License, BI has an exclusive worldwide license to any Additional Compounds selected by BI for use in the BI Field, the terms of which license are subject to an agreement to be negotiated in good faith.
Additional Compounds. (i) In the event that, after Signal exercises the Option, Axys desires to engage in any additional research or clinical development with respect to any additional Collaboration Compound (such as a Back-Up Compound or a second generation compound), Axys will prepare and present to the JDC (and the JRC to the extent additional research is contemplated) an initial Product Development Plan for such additional Collaboration Compound. The JDC (and, if applicable, the JRC) will review, revise and approve such Product Development Plan or additional research (as the case may be) for such additional Collaboration Compound in good faith. Any disagreements with respect to approval of such proposed Product Development Plan will be resolved in the manner that disagreements over Major Changes are resolved under Section 4.2(f). Following approval of such Product Development Plan, updates, revisions and modifications will be governed by Sections 4.2(e), (f) and (g).
(ii) The Parties agree that fundraising constraints should not affect their decision-making regarding the development of additional Collaboration Compounds. Accordingly, in the event that a Party has a good faith concern about its fundraising ability for a second Collaboration Compound, the Parties will meet in good faith to achieve a mutually satisfactory resolution for continued research and development and achieving the risk-return objectives contemplated herein. Towards that end, and subject to Axys' financial ability to do so, the following will be offered by Axys: In the event that, prior to commercialization of the first Licensed Product, Signal indicates its inability to fund its share of the research and ***CONFIDENTIAL TREATMENT REQUESTED 18 23 development of a second Collaboration Compound as contemplated in the Product Development Plan, then Axys would fund [***] of the research and development costs of such second Collaboration Compound, provided that [***] of such research and development costs (plus interest at the reference rate for the Bank of America or any successor rate thereto) would be fully credited against amounts due Signal hereunder with respect to the commercialization of the first Licensed Product. In the event that the first Collaboration Compound does not receive Regulatory Approval or ceases to be marketed before Axys has been repaid in full by Signal, Signal would have the option to either (A) repay all amounts due to Axys (plus interest) within a reasonable period of time (not t...
Additional Compounds. During the term of the Collaboration, the Parties may discuss additional obesity compounds (including but not limited to, current or future compounds in ProGen’s pipeline or discovery programs) for inclusion in the Collaboration on the same terms as set forth in this Agreement. If Rani selects any such compound(s), ProGen shall not unreasonably withhold its consent from including such compound(s) in the Collaboration on the same terms as set forth in this Agreement, provided that the compound(s) is/are otherwise unencumbered when selected and Rani is not developing at such time a compound with the same primary mechanism of action for therapeutic effect as the selected compound (e.g., [*]).
Additional Compounds. (a) Ardent may develop one or more Delta/Mu Opioid Receptor Agonist compounds (other than the Compound) outside of the Program that have potential antinociceptive activity and safety as specified below ("New Compound"). Unless and until ALZA enters into any Additional Compound License, ALZA will have no rights with respect to such New Compound or any know-how or information disclosed by Ardent with respect thereto except as expressly provided in this Article X (including without limitation Section
Additional Compounds. The Additional Compounds shall be treated as Compounds for the purposes of the Collaboration Agreement except, in addition to the terms and conditions of the Collaboration Agreement, COR shall pay to Kyowa Hakko [*] royalty on Net Sales of any Additional Products, to be [*] . Upon request by either party, the parties shall negotiate in good faith [*] for the applicable Additional Product. Such royalty shall be payable as follows:
(a) For sales of Additional Products in the United States, such royalty shall be paid in U.S. Dollars quarterly within 60 days after the end of each calendar quarter. Each royalty payment shall be accompanied by a statement of such royalties showing the Net Sales of each Additional Product during such quarter, the calculation of the royalties due, and showing evidence of payment as to any taxes paid on Kyowa Hakko's behalf.
(b) For sales of Additional Products in the JV Territory, such royalty shall be deemed to be an [*] of Kyowa Hakko, and shall be [*] basis from Net Sales for purposes of determining Marketing Profits, as provided in Article 7 of the Collaboration Agreement.
(c) Such royalties shall terminate as to each Additional Product and as to each country in the JV Territory and the United States upon the later to occur of (i) the last to expire of a patent for an Additional Product in such country or (ii) 10 years after the first commercial sale of such Additional Product in such country.
Additional Compounds