Ongoing Studies Sample Clauses
Ongoing Studies. 5.3.1 ARIAD US shall be responsible for the conduct of the Ongoing Studies. For clarity, if the Ongoing Studies are Global Studies they are not subject to Section 5.7. ARIAD SWISSCO shall reimburse ARIAD US for ongoing Third Party Development Costs incurred by ARIAD US in the Ongoing Studies, subject to a maximum aggregate amount of US$7,000,000 for the period from the Effective Date until December 31, 2016 and US$7,000,000 for the calendar year 2017 (together, the “Ongoing Studies Budget”). ARIAD SWISSCO shall reimburse the actual, undisputed Third Party Development Costs quarterly within [**] of receipt of ARIAD US’s quarterly invoice and supporting evidence of the Third Party Development Costs having been incurred. Payment shall be made into such bank account as ARIAD US shall specify from time to time. For the period ending [**], no invoice shall be in excess of [**] (provided that for [**] in which the Effective Date occurs the invoice shall be for a pro-rated amount) and no invoice shall be delivered before [**]. For clarity if a [**] invoice during the calendar year ending [**] does not include the maximum of [**] any excess may be included in a subsequent invoice for calendar year [**], provided however that no excess at the end of the calendar year [**] may be rolled over to the calendar year [**]. If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is terminated prior to [**], then the maximum aggregate amount owed by ARIAD SWISSCO with effect from the date of termination of the relevant Ongoing Study, shall be [**] of the remaining Ongoing Studies Budget. If both the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial are terminated prior to [**], then no further amounts will be payable by ARIAD SWISSCO after the date of termination of the last of the OPTIC Clinical Trial and the OPTIC 2L Clinical Trial. In addition to the Ongoing Studies Budget, ARIAD SWISSCO shall pay ARIAD US (i) [**] and (ii) [**] upon either (a) [**]; or (b) [**]. For clarity, [**] will not be [**] in the event of [**]. For clarity, [**] will not be [**]. For clarity, ARIAD US shall continue to control the conduct of the Ongoing Studies and shall continue to be listed as the sponsor until completion. ARIAD US will be responsible for collection and reporting of all serious adverse events from these trials to the regulatory agencies in which the trials are being conducted. No amounts will be due under this Section 5.3.1 and payable by ARIAD SWISSCO if the Buy-B...
Ongoing Studies. Salix will cooperate with Progenics to transfer any on-going clinical studies for which it has responsibility hereunder in which patient dosing has commenced or, if reasonably practicable and requested by Progenics, allow Progenics to complete such trials (and then assign all related Regulatory Documentation and investigator and other agreements relating to such studies), all at Salix’s expense.
Ongoing Studies a) Ongoing Studies under the Development Plan Notwithstanding Section 5.3, if, at Closing Date, EVOTEC conducts any non-clinical or clinical studies under the agreed Development Plan (as defined in the License Agreement), then (i) EVOTEC shall use Commercially Reasonable Efforts (as defined for EVOTEC in the License Agreement) to complete such studies, (ii) EVOTEC shall use Commercially Reasonable Efforts (as defined for EVOTEC in the License Agreement) to finalize all study reports in a format ready for submission to Regulatory Authorities, e.g. including all appendices and listings and quality controlled and (iii) ROCHE shall assume the cost for such studies under an agreement to be negotiated between the Parties in good faith.
b) Ongoing Studies outside the Development Plan Notwithstanding Section 5.3, if, at Closing Date, EVOTEC conducts and non-clinical or clinical studies outside the agreed Development Plan (as defined in the License Agreement), then ROCHE has the right but not the obligation to (I) request the transfer of such studies to ROCHE or to (II) ask EVOTEC to continue the studies at ROCHE’s future costs or (III) to decline interest in (I) and (II).
(I) If ROCHE requests the transfer of such studies to ROCHE, then the Parties will discuss in good faith the modalities of such transfer and execute a Pharmacovigilance Agreement, if necessary.
(II) If ROCHE asks EVOTEC to continue the studies, then (i) EVOTEC shall use Commercially Reasonable Efforts (as defined for EVOTEC in the License Agreement) to complete such studies, (ii) EVOTEC shall use Commercially Reasonable Efforts (as defined for EVOTEC in the License Agreement) to finalize all study reports in a format ready for submission to Regulatory Authorities, e.g. including all appendices and listings and quality controlled and (iii) ROCHE shall assume the future cost for such studies under an agreement to be negotiated between the Parties in good faith.
(III) If ROCHE declines (I) and (II) within thirty (30) days after Closing, then, except for any activities conducted under the Development Plan, EVOTEC shall have the right but not the obligation to continue, at EVOTEC’s costs, non-clinical development activities and clinical, including preparatory activities, ongoing as of the Closing Date. Notwithstanding the foregoing, EVOTEC shall not initiate any new activities relating to Compounds and Products after the Closing Date.
Ongoing Studies. With respect to a Unilateral Development Compound that was previously a Joint Development Compound, upon designation of such compound as a Unilateral Development Compound:
Ongoing Studies. The Parties have agreed either to wind-down and terminate each Ongoing Study or at ▇▇▇▇▇▇▇’▇ election to continue it, in each case as part of the Initial Global Development Plan as set forth on Exhibit K. Achillion shall bear all costs incurred for Ongoing Studies, except that ▇▇▇▇▇▇▇ shall bear all Development Costs incurred in connection with the continuation of the applicable Ongoing Studies to the extent it elects to continue them and such costs are for periods after the Effective Date and incurred pursuant to a Development Budget to be agreed by the Parties within [**] days after the Execution Date (and shall reimburse Achillion for any such budgeted Development Costs incurred by Achillion).
Ongoing Studies. Salix will cooperate with Photocure to transfer any on-going clinical studies or Post Approval Studies for which it has responsibility hereunder in which patient dosing has commenced or, if reasonably practicable and requested by Photocure, allow Photocure to complete such trials (and then assign all related Regulatory Documentation and investigator and other agreements relating to such studies).
Ongoing Studies. RXP114025: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in the Treatment of Subjects With Moderate-to-Severe Primary Restless Legs Syndrome (RLS) * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Commercial Product: Those product specifications listed in NDA 022399 for drug substance and for finished product. Clinical/R&D Product: Those product specifications for material used in clinical studies listed in IND 71352 and/or IND 68341 * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. • US IND 071352 for the treatment of restless legs syndrome, includ...
Ongoing Studies. With respect to a Unilateral DDC that was previously a Joint DDC, upon designation of such compound as a Unilateral DDC, the Parties shall transition any ongoing pre-clinical and clinical studies in order to preserve, to the maximum extent practicable, the results, clinical site participation and validity of such studies. Without limiting the generality of the foregoing, the non-Developing Party shall, at the request of the Developing Party, continue any such ongoing pre-clinical and clinical studies, at the expense of the Developing Party, until such studies can be effectively transitioned to the Developing Party.
Ongoing Studies. KuDOS shall conduct and use reasonable endeavours to complete, for the benefit of Novacea, and subject to reasonable input by Novacea, the ongoing studies listed in Schedule 4 (the “Ongoing Studies”). KuDOS will also use reasonable endeavours to deliver to Novacea, the activities and deliverables listed in Schedule 4.
Ongoing Studies. If there are any ongoing clinical studies with respect to the Product being conducted by or on behalf of Collaborator (or its Affiliate) at the time of notice of termination, Collaborator agrees to (a) promptly transition to MSB or its designee some or all of such clinical studies and the activities related to or supporting such studies or (b) terminate such clinical studies, in each case as requested by MSB. In addition, if this Agreement is terminated by MSB pursuant to Section 12.3, 12.4, 12.5 or 12.6 or by Collaborator pursuant to Section 12.2.1, Collaborator shall if requested by MSB, continue to conduct such clinical studies for a period requested by MSB up to a maximum of six (6) months after the effective date of such termination. If this Agreement is terminated by MSB pursuant to Section 12.3, 12.4, 12.5 or 12.6 or by Collaborator pursuant to Section 12.2.1, Collaborator shall be responsible for the costs of such transition and any ongoing activities; in all other events, MSB shall be responsible for the costs of such transition and any ongoing activities. If MSB terminates this Agreement pursuant to Section 12.3, 12.4 or 12.5 and there are any ongoing clinical studies with respect to the Product for the Territory being conducted by or on behalf of MSB (or its Affiliate), Collaborator shall continue to be obligated to fund the conduct of such studies pursuant to Section 4.6 for six (6) months after MSB provides Collaborator notice of such termination.