Examples of CNS Product in a sentence
The Parties shall use commercially reasonable efforts to Develop each of the Cardiovascular Product, Expanded HPCs and CNS Product for the Territory in a manner compatible with such goals, principles and timelines.
Each Development Plan shall contain a description of the activities to be carried out for the Cardiovascular Product, Expanded HPCs and CNS Product for the Field in the Territory with timelines for the completion of such activities and in a level of detail consistent with practice in the biopharmaceutical industry.
Strong PipelineStrong Pipeline PRODUCT/ PROGRAM Pre-Clinical Phase 1 Phase 2 Phase 3 NDA Commercial Status ZOHYDRO® ER ER Hydrocodone Capsules For Chronic Pain 2 AD Formulations RELDAY TM Monthly SQ Risperidone for Schizophrenia Undisclosed DosePro CNS Product Candidate(s) Undisclosed N/A N/A Approved October 25 2013 Launched March 3rd 2014 • Targeting Late 2016 • MD PK Study in 2H 2014 Pre-IND Mtg Nov.
Without limiting the foregoing, the right of Angioblast to terminate the Agreement pursuant to this Section 13.3(b) shall expire upon the earlier to occur of (I) the [***] Clinical Trial for the CNS Product for use in the CNS Field pursuant to Section 4.3(a)(i) above is unsuccessful as determined by the JSC or (B) Initiation of a [***] Clinical Trial or [***] Clinical Trial as described in clause (ii) of this Section 13.3(b).
For the sake of clarity, all Development Costs incurred thereafter by the Parties in performing such Additional CNS Development Activities shall be treated as Shared Development Costs unless and until the Co‑Funding End Date occurs with respect to such CNS Product that is the subject of such Additional CNS Development Activities.
Reasonably in advance of the Initiation of Sanofi CNS Development Activities for a particular CNS Product, the JDC will prepare a Transition Plan to be approved by the Parties for the transfer of the Development Lead with respect to such CNS Product from Denali to Sanofi.
For any CNS Product that is the subject of Cost Profit Sharing in a Cost Profit Sharing Country, Sanofi shall prepare, in consultation with Denali and for discussion, review and approval by the JCC (or if such CNS Products are not also Co-Commercialization Products, by the JSC), a detailed Co‑Commercialization Plan for the Commercialization of such CNS Products in such country.
Strong Pipeline PRODUCT/ PROGRAM Pre-Clinical Phase 1 1 Phase 2 Phase 3 NDA Commercial Status Zohydro ER ER Hydrocodone Capsules For Chronic Pain Approved October 25 2013 Launched March 3rd 2014 2 AD Formulations N/A N/A • Targeting Late 2016 RELDAY Monthly SQ Risperidone for Schizophrenia • MD PK Study in 2H 2014 Undisclosed DosePro CNS Product Candidate(s) Undisclosed Pre-IND Mtg Nov.
On a country-by-country basis and CNS Product-by-CNS Product basis, the royalties otherwise payable to Denali under this Section 7.5 (Royalties) with respect to a CNS Product would be subject to an offset by [***] of the royalties paid by Sanofi with respect to New CNS Program Technology that is [***].
Without limiting the foregoing, the right of Angioblast to terminate the Agreement pursuant to this Section 13.3(b) shall expire upon the earlier to occur of (I) the [**] Clinical Trial for the CNS Product for use in the CNS Field pursuant to Section 4.3(a)(i) above is unsuccessful as determined by the JSC or (B) Initiation of a [**] Clinical Trial or [**] Clinical Trial as described in clause (ii) of this Section 13.3(b).