Examples of Global Medical Affairs Strategy in a sentence
No less than [***] prior to the reasonably anticipated date for a First Commercial Sale of a Product in its respective Territory, each Party shall prepare and present at a JSC meeting a plan containing the strategy, activities and timeline with respect to the Medical Affairs Activities in support of the Products in the Field in its respective Territory (each, “Medical Affairs Plan”) that shall, to the extent reasonably practicable, be aligned with the Global Medical Affairs Strategy.
Hutchmed shall ensure that the Medical Affairs strategy that each applicable Hutchmed Entity pursues for the Licensed Products in the Territory has taken into consideration in good faith the Global Medical Affairs Strategy.
The Parties shall ensure at all times that the Commercialization Plan is consistent with the terms and conditions of this Agreement, and Hutchmed shall consider in good faith the Global Brand Strategy and the Global Medical Affairs Strategy.
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.
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.
If from time to time ADCT wishes to amend the Global Medical Affairs Strategy, ADCT shall prepare and present the revised strategy at a JSC meeting for review and discussion.
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”).
Licensee shall ensure that the Medical Affairs strategy that each applicable Licensee Entity pursues for the Licensed Products in the Territory is in line with the Global Medical Affairs Strategy and that all Licensed Products Commercialized by Licensee Entities conform to the specifications and quality standards therefor provided by Agios.
Ionis, through the Europe JSC, will update the Global Medical Affairs Strategy and the American Commercialization Operating Plan on [***] basis.
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 [***].