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 [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 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 e...
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. 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. 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. 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. 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. For any pre-clinical or clinical study initiated prior to the Execution Date and set forth on Schedule 4.5, all costs of such study incurred after the Execution Date shall be shared by Pharmacia less the amount paid by Pharmacia to Celltech pursuant to Section 8.2(b), and Celltech as set forth on Schedule 4.5, and Pharmacia’s portion of such costs (including the amount paid by Pharmacia to Celltech pursuant to Section 8.2(b)) shall be considered Development Costs related to the RA Indication and *. For any additional costs incurred as a result of changes to the design or nature of such studies following the Execution Date, such additional costs shall be considered Development Costs under this Agreement. For any pre-clinical or clinical study initiated prior to the Execution Date which is not set forth on Schedule 4.5, all costs of such study shall be the sole responsibility of Celltech.
Ongoing Studies. At Tularik’s option and expense, Amgen shall complete all clinical studies of Amgen Development Compounds and AD Products that have reverted to Tularik under Section 3.3 or Section 3.4.2 that were initiated prior to Tularik’s receipt of a Notice of Discontinuance, the occurrence of a Development Failure or the date on which a Program Target became a Tularik Target, as the case may be; provided however, that [**].
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. Any proposed modification to the Work Plan or Development Budget for any Ongoing Study shall be subject to the approval of the JSC and the decision-making authority set forth in Section 3.6, provided, however, that Xxxxxxx shall not have the deciding vote thereon, and further that Achillion shall not unreasonably withhold its consent to any modifications reasonably proposed by Xxxxxxx in good faith to any Work Plan with respect to an Ongoing Study.
