Examples of Global Medical Affairs Strategy in a sentence
Subject to the last sentence of Section 6.4.1 (Global Brand Strategy and American Commercialization Operating Plan) and the last sentence of Section 6.6.1 (Global Medical Affairs Strategy and American Medical Affairs Operating Plan), and without limiting Ionis’ obligations under this Article 6 (Commercialization and Medical Affairs), Ionis and its Affiliates will have [***] with respect to the Commercialization of the Licensed Products in the Ionis Territory, including, if applicable, [***].
In addition, between [***] updates, either Party may propose material updates or modifications to the Global Medical Affairs Strategy and Ionis may propose material updates or modifications to the American Medical Affairs Operating Plan [***].
The Global Medical Affairs Strategy and the American Medical Affairs Operating Plan shall at all times conform to applicable Professional Requirements and Applicable Law (including compliance requirements) with adjustments with respect to the Global Medical Affairs Strategy as necessary to comply with local Applicable Law and Professional Requirements in the Otsuka Territory.
Within [***] after the date [***] approves the initial Global Medical Affairs Strategy and the initial American Medical Affairs Operating Plan, Otsuka will prepare and submit to [***] a plan for the Medical Affairs activities for the Licensed Products in the Europe Territory (such plan, the “Europe Territory Medical Affairs Plan”).
No update or modification to the Global Medical Affairs Strategy or the American Medical Affairs Operating Plan will be effective unless and until approved by [***].
Each Otsuka Territory Medical Affairs Plan will, at all times during the Term, be consistent with the then-current Global Medical Affairs Strategy, except to the extent such inconsistency is (i) necessary to conform with any written requirement from any Regulatory Authority or with any Applicable Law or Professional Requirements in the Europe Territory or the Asia Territory, as applicable, or (ii) approved by the applicable JSC or Executive Committee (by unanimous Party Vote).
Ionis, through the Europe JSC, will update the Global Medical Affairs Strategy and the American Commercialization Operating Plan on [***] basis.
Once approved by [***], such updated version of the Global Medical Affairs Strategy or the American Medical Affairs Operating Plan will become effective and replace the then-prior version of the Global Medical Affairs Strategy or American Medical Affairs Operating Plan.