Examples of Post-POC Principal Party in a sentence
The Post-POC Other Party shall also provide to the Post-POC Principal Party any drug safety data from such additional clinical trials in accordance with Section 7.4. Separate from the determination of whether to include such clinical trial(s) in the relevant Development Plan, the Post-POC Principal Party may disapprove the conduct of an Additional Trial outside the relevant Development Plan, or any such protocols or clinical trial designs, or any amendments thereto, for [***].
With respect to each IO Licensed Product, the Post-POC Principal Party for such IO Licensed Product shall be the Lead Commercialization Party for such IO Licensed Product in the U.S. Regeneron shall be the Lead Commercialization Party for all PD-1 Licensed Products in the U.S., subject to the last sentence of this Section 6.1(a).
In the event that either Party proposes a Combination Therapy of an IO Licensed Product with another IO Licensed Product (including any PD-1 Licensed Products), the [***] shall be the Post-POC Principal Party with respect to the Development of such Combination Therapy.
Sanofi shall be responsible for paying one hundred percent (100%) of the total Development Costs for IO Licensed Products for which Sanofi is the Post-POC Principal Party, whether incurred by or on behalf of Sanofi, Regeneron or their respective Affiliates (provided that such Development Costs are incurred in accordance with the applicable Global Development Budget), and fifty percent (50%) of such expenses shall count as IO Development Balance Costs and be included in the IO Development Balance.
The Post-POC Principal Party with respect to an IO Licensed Product shall have principal responsibility for formulating and carrying out the Development activities for such IO Licensed Product under the applicable Development Plan(s).