Clinical Study(ies) definition
Examples of Clinical Study(ies) in a sentence
Pursuant to Section 4.4(a), the Working Group designated by JDRC shall in good faith discuss and prepare the Joint Development Plan covering Approved Clinical Study(ies) for review by JDRC.
MD ▇▇▇▇▇▇▇▇ and/or Principal Investigator shall have the right to independently publish or publicly disclose, either in writing or orally, the Data and results of the Clinical Study/ies after the earlier of the (i) first publication (including any multi-site publication) of such Data and/or results; (ii) twelve (12) months after completion of any multi-site study encompassing any Study or if none, six (6) months after completion of Study.
For each Unilateral Product in each applicable Royalty Region, the Participating Phase III Party shall conduct the Phase III Clinical Study(ies), as well as other Development activities required for Regulatory Approval, all in accordance with the Unilateral Phase III Plan, and such Phase III Development shall be deemed “Unilateral Phase III Development”.
Unless otherwise agreed by the Parties, if such Approved Clinical Study(ies) are Global Registration Studies, then the cost of such Approved Clinical Study(ies) (including out-of-pocket costs incurred by the Parties together with FTE-costs associated with the Parties’ personnel managing such Approved Clinical Study) shall be allocated eighty eight percent (88%) to Array and twelve percent (12%) to Ono.
Repare shall have the right to authorize the protocol for each Investigator Sponsored Clinical Study in the Repare Territory and support such Clinical Study at Repare’s own discretion, provided, however, Repare agrees to inform Ono of all such Investigator Sponsored Clinical Study(ies) in a timely manner and each proposal shall be subject to review and comment by the JSC.
Ono shall have the right to authorize the protocol for each Investigator Sponsored Clinical Study in the Ono Territory and support such Investigator Sponsored Clinical Study at Ono’s own discretion, provided, however, Ono agrees to inform Repare of all such Investigator Sponsored Clinical Study(ies) in a timely manner and each proposal shall be subject to review and comment by the JSC.
If any Clinical Studies that were Initiated by or on behalf of Mallinckrodt prior to the termination of this Agreement (whether terminated in its entirety or with respect to a Target) are on-going as of the effective date of such termination, Mallinckrodt shall cooperate with Silence to wind-down such Clinical Study(ies) in an orderly fashion; provided, however, that [***] to transition the sponsorship of any such ongoing Clinical Study(ies) to Silence.
These Development Costs may be borne by a Party in accordance with its respective obligations under the then current Joint Development Plan and/or subject to the Section 8.6 profit and loss share election, as the case may be, should Magainin elect to share in U.S. profits and losses by co-funding the Collaboration Program from Phase III Clinical Study(ies) through and including all Regulatory Approvals.
At Magainin's option, Magainin will have the right but not the obligation to fund its [**] share of Phase III Clinical Study(ies), NDA/BLA filing, Regulatory Approval expenses and [**] of launch year losses ("Cumulative Investment") with funds generated from Genentech's quarterly purchases of Series A preferred stock or debt, pursuant to the Stock Purchase Agreement of even date herewith.
Ono shall have the right to authorize the protocol for each Investigator Sponsored Clinical Study in the Ono Territory and support such Investigator Sponsored Clinical Study at Ono’s own discretion, provided, however, Ono agrees to inform Karyopharm of all such Investigator Sponsored Clinical Study(ies) in a timely manner and each proposal shall be subject to review and comment by a Working Group designated by the JOC.