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.
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 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.
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).
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.
For the avoidance of doubt, notwithstanding the initiation of Sanofi CNS Development Activities for a particular CNS Product, Denali will continue to be Development Lead for any additional Denali CNS Development Activities with respect to [***], unless otherwise agreed between the Parties.
Denali and Sanofi shall each ensure that its sales representatives do not make any representation, statement, warranty or guaranty with respect to a CNS Product that is not consistent with the applicable, current package insert of prescribing information or other documentation accompanying or describing such CNS Product, including mutually approved limited warranty and disclaimers, if any.
If Denali provides Sanofi with a timely [***], then Denali shall pay to Sanofi the applicable [***] within [***] after Regulatory Approval of the subject CNS Product is obtained.