Ongoing Development Activities Clause Samples
Ongoing Development Activities. Except as set forth below, ▇▇▇▇▇▇▇ shall have no further obligation to conduct Development activities with respect to a Compound or Product after the date of notice of termination. After the Opt-In Date, if ▇▇▇▇▇▇▇ is conducting any Development activity with respect to a Compound or Product on the date of notice of termination, then Theravance shall notify ▇▇▇▇▇▇▇ within [***] after the notice of termination: (i) with regard to any Clinical Trial, whether Theravance elects to have ▇▇▇▇▇▇▇ (A) complete such Clinical Trial on behalf of Theravance (unless ▇▇▇▇▇▇▇ reasonably believes there is a Material Safety Issue that should prevent the continuation of such Clinical Trial), (B) wind down such Clinical Trial as soon as practicable, subject to compliance with ethical and legal requirements or (C) transfer such Clinical Trial to Theravance as soon as practicable; and (ii) with regard to any other Development activity, whether Theravance elects to have ▇▇▇▇▇▇▇ wind down or transfer such activity to Theravance. Notwithstanding the foregoing, if ▇▇▇▇▇▇▇ terminates this Agreement pursuant to Section 11.3, 11.4 or 11.5, then this Section 11.6(b) shall not apply and ▇▇▇▇▇▇▇ shall wind down any ongoing Development activities as soon as practicable after the date of notice of termination, subject to compliance with ethical and legal requirements; and each Party shall bear its own expenses incurred pursuant to such wind down. After the Opt-In Date:
(i) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ complete a Clinical Trial on behalf of Theravance, ▇▇▇▇▇▇▇ and Theravance will, as necessary, negotiate in good faith a separate agreement pursuant to which ▇▇▇▇▇▇▇ would complete such Clinical Trial. If the Parties fail to reach agreement within [***] after Theravance makes such election, ▇▇▇▇▇▇▇ may wind down such Clinical Trial, subject to compliance with ethical and legal requirements or, if requested by Theravance, transfer such Clinical Trial to Theravance.
(ii) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ wind down such Clinical Trial or other Development activity (or fails to provide notice within such [***] period), then ▇▇▇▇▇▇▇ shall wind-down such Clinical Trial or Development activity as soon as practicable, subject to compliance with ethical and legal requirements.
(iii) If Theravance notifies ▇▇▇▇▇▇▇ of its election to have ▇▇▇▇▇▇▇ transfer such Clinical Trial or other Development activity to Theravance, then ▇▇▇▇▇▇▇ shall use ...
Ongoing Development Activities. Notwithstanding anything in this Agreement to the contrary, including Section 2.8 and this Section 4.1, (i) G1 shall continue until completion, as the Clinical Trial sponsor, the Clinical Trials [***], and (ii) G1 shall use [***] to wind down any pre-clinical studies in respect of the Licensed Compound or Licensed Product that are ongoing as of the Effective Date, [***] in each case ((i) and (ii)) which activities shall not be deemed to be a breach of G1’s obligations under Section 2.8. At Licensee’s request, G1 shall permit [***] representative of Licensee to join as an observer at any of G1’s or its Affiliate’s external meetings, teleconference calls or other material activities directly related to such Clinical Trials, including all meetings or teleconference calls with Regulatory Authorities directly related to such Clinical Trials, in all cases subject to the terms and conditions of all applicable agreements with the applicable Clinical Trial sites (including confidentiality obligations therein). Further, on a [***] basis (or such other frequency as the Parties may mutually agree) until the completion of such Clinical Trials, such Licensee representative shall meet with members of G1’s clinical operations team to discuss the progress of such Clinical Trials. [***] in connection with the Clinical Trials described in clause (i) above. Within [***] after the end of each [***] during which such Clinical Trials are ongoing, G1 will provide an invoice to Licensee setting forth in reasonable detail the Out-of-Pocket Costs incurred in connection with such Clinical Trials during such [***]. Such [***] invoices will be accompanied by available supporting documentation, receipts or related information to the extent necessary to verify such incurred Out-of-Pocket Costs for a particular [***]. Within [***] after its receipt of such [***] invoice, [***] the undisputed amounts set forth in such [***] invoice. For purposes of this Section 4.1(b), “Out-of-Pocket Costs” means, with respect to activities performed by or on behalf of G1 after the Effective Date in connection with the Clinical Trials described in clause (i) above, specifically identifiable direct expenses paid or payable by G1 or its Affiliates to Third Parties and incurred to conduct such activities, including payments to contract personnel (including contractors, consultants and subcontractors).