Additional Studies. If a Party (including its Affiliates or Sublicensees) wishes to conduct one or more additional Clinical Studies or Development activities for a CoDev Product (beyond the Pivotal Clinical Study or other Clinical Studies included in the then-current CoDev Product Plan), such Party (the “Proposing Party”) shall notify the other Party (the “Non-Proposing Party”) of such proposed studies (the “Proposed Study(ies)”) and provide the Non-Proposing Party with any Data or publications supporting any such proposal. In such event, the JDC shall consider such proposal and evaluate the supporting Data and information in good faith. If the Parties both wish to collaborate in the conduct of such Proposed Study(ies), the Proposing Party shall prepare an amendment to a CoDev Product Plan and Joint Development Budget to include the Proposed Study(ies) for review and approval by the JDC, and subsequently the JSC. If, after consideration in good faith by the JDC and the JSC, as applicable, the Parties do not, within [***] days of the first applicable JSC meeting, mutually agree to include the Proposed Study(ies) in a CoDev Product Plan, the Proposing Party may elect to conduct such rejected Proposed Study(ies) (such study(ies), in such event, “Unsponsored Work”), rather than escalate further as described in Section 3.6.2.
1. Notwithstanding the foregoing, the Non-Proposing Party may, within [***] days following the failure of the JDC to mutually agreed to include the Proposed Study(ies) in a CoDev Product Plan (the “Objection Period”), provide reasonable written objection to such Unsponsored Work on the basis of likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product. If the Non-Proposing Party makes such an objection, the Proposing Party shall not be permitted to proceed with such Unsponsored Work, provided that if the Proposing Party disputes the stated likely potential Material Adverse Effect upon the procurement or maintenance of Marketing Approval or Commercialization of a CoDev Product by the Unsponsored Work, then such dispute shall be subject to Accelerated Arbitration. The
Additional Studies. 5.6.1 The Parties recognize that AstraZeneca or its Affiliates are currently in the process of negotiating or have recently executed certain Additional Studies with potential Third Party partners in relation to the Compounds. Following the Effective Date, AstraZeneca shall keep Mereo informed as to the negotiation status of such Additional Studies, if applicable, and shall [***], including by [***] Following the conclusion of such negotiations, if applicable, AstraZeneca or its Affiliates or Mereo, as agreed between the Parties, shall enter into agreements governing the conduct of such Additional Studies, provided that [***]
5.6.2 Following the later of (a) the Effective Date or (b) the date of execution of the agreement governing an Additional Study, AstraZeneca shall promptly provide Mereo with fully executed copies of the relevant agreements and provide such information as Mereo reasonably requires relating thereto.
5.6.3 Following the execution of any agreements described in Section 5.6 governing Additional Studies, such agreements shall be promptly assigned by AstraZeneca to Mereo by way of an assignment and assumption agreement to be agreed between the Parties acting reasonably and Mereo, following such assignment, shall assume AstraZeneca’s rights, obligations and liabilities thereunder occurring from and after the assignment date.
5.6.4 Following any such assignment:
(a) Mereo shall be the sponsor for the applicable clinical trials and studies under such Additional Studies;
(b) AstraZeneca shall agree in writing to provide directly to Mereo available compound and drug product for such Additional Studies, to the extent the same are in AstraZeneca’s possession as of the date of execution of agreements governing the conduct of the Additional Studies described in Section 5.6. Except as provided in the immediately preceding sentence, AstraZeneca shall have no further obligation to manufacture or procure the manufacture of relevant compound or drug product thereafter and any such obligations under the Applicable Studies shall pass to Mereo;
(c) Any funding obligations under the Additional Studies shall, as between the Parties, be assumed by and be the responsibility of [***]; and
(d) AstraZeneca shall have no rights relating to such Additional Studies, including any rights to any resulting clinical data or intellectual property rights.
Additional Studies. During the Term and continuing [***], Corvus agrees to negotiate exclusively with Genentech for a period of [***] prior to entering into any clinical study or clinical development agreement with a Third Party involving the combination of Corvus Molecule and any PD-L1 Antagonist or PD-1 Antagonist. During such [***], the Parties shall discuss in good faith the terms and conditions for collaborating with each other to conduct further clinical studies of the Combination, including terms [***].
Additional Studies. After completion of the Combined Therapy Trials, the Parties agree to discuss in good faith additional clinical trials (other than clinical trials contemplated by Section 2.1(a)) of the Combined Therapy. If the Parties jointly agree to conduct any such further clinical trials, such further clinical trials will be conducted in accordance with a separate agreement between the Parties. For clarity, no Party shall be obligated to collaborate with the other Party or agree on terms with the other Party with respect to such additional clinical trials.
Additional Studies. If a Party would like to conduct additional clinical studies using the Combination, at the request of such Party, the Parties shall discuss in good faith the possibility of, and the terms and conditions for, conducting such clinical studies, including cost sharing, decision making and the supply of Compounds. This Section shall survive the expiration of this Agreement for a period of ***.
Additional Studies. NEOTHERAPEUTICS reserves the right, subject to the approval and oversight of the Joint Development Committee, which approval will not be unreasonably withheld, to propose additional studies of Satraplatin at its own expense.
Additional Studies. The Parties agree to discuss in good faith additional studies of PRT064445 as it relates to Apixaban, and upon mutual agreement, the Parties may continue the collaboration with additional preclinical studies or clinical trials. If the Parties jointly agree to conduct any such further studies, such further studies will be conducted in accordance with a separate agreement between the Parties. For clarity, no Party shall be obligated to collaborate with respect to such additional studies, and no Party shall obtain any right under this Agreement to commercialize any proprietary product of any other Party.
Additional Studies. All of the restoration opportunities mentioned in this report will require further investigation and analysis to fully assess feasibility and determine actual benefits and costs. In some cases, restoration actions are recommended that may involve private properties. This plan makes no claims as to the ownership or availability of any parcel of land for restoration purposes and does not recommend takings of any private land. Restoration activities described here would be undertaken on a voluntary basis with the express permission of private property owners. Additional study, collaboration, and project planning and design would be required to ensure consensus on the restoration priorities; acquire permission or easements; and develop detailed implementation plans, budgets, schedules, and monitoring programs.
1.3.1 Data Gaps Due to data limitations many important ecological processes, features, and conditions could not be fully described in this plan. No single comprehensive restoration assessment has been conducted for all of the shores of Hood Canal or Southern Puget Sound. Additional data gaps include a County-wide wetland inventory; restoration opportunities for many freshwater lakes, and comprehensive mapping of abandoned and derelict overwater structures.
Additional Studies. At least [***] prior to the end of the BSP Option Period for a Biologic Collaboration Compound Class, BSP shall notify the JSC as to its determination as to whether the data resulting from the Phase Ib Trial for the first Collaboration Compound in such Class is reasonably sufficient for BSP to determine whether to exercise the BSP Option for such Class, or whether additional preclinical studies or Phase I Trials should be performed to provide data reasonably sufficient for BSP to determine whether to exercise its BSP Option for such Class. If the JSC determines that additional preclinical studies or Phase I Trials should be performed, OncoMed (reasonably considering any guidance and comments from BSP with respect to such additional preclinical studies or Phase I Trials), or at OncoMed’s discretion BSP, shall conduct such additional preclinical studies or Phase I Trials, at BSP’s expense, pursuant to an updated Biologic Development Plan for such activities, which shall include a timeline for completion of such activities. If the JSC determines to conduct such additional preclinical studies or Phase I Trials, the BSP Option Period for such Class will be extended until the date that is [***] after such additional preclinical activities have been completed or such additional Phase I Trials have been Completed, whichever is later. If the JSC cannot agree whether additional preclinical studies or Phase I Trials should be conducted, [***]. Notwithstanding anything to the contrary, BSP can request such additional studies to be conducted under this Section 3.1.3 [***].
Additional Studies. If required or requested for the purpose of registering and/or commercializing the Product in any particular country in the Territory, Ipsen shall be authorized to conduct the required or requested pre-clinical, clinical or other studies, including Phase IV studies (collectively “Additional Studies”), relating to the Product, subject to prior written notification to Auxilium and subject to Sections 4.5.1 and 4.5.2 below. ** 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.
4.5.1. Ipsen shall provide Auxilium with the study plans and/or protocols relating to such Additional Studies before such Additional Studies are started and Auxilium shall have the right to review and comment on such study Plans and/or protocols.
