MA Holder definition
Examples of MA Holder in a sentence
In the case of a Product approved in the United States under the PHS Act (or, in the case of a country in the Territory other than the United States, any similar Law), to the extent permitted by applicable Law, the MA Holder, as the sponsor of the application for the Product, will be the “reference product sponsor” under the PHS Act.
The MA Holder will give written notice to the other Party of receipt of a Biosimilar Notice received by MA Holder with respect to a Product, and MA Holder will consult with the other Party with respect to the selection of any Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder will have final say on such selection of Patent Rights.
It defines the individual responsibilities of the MA Holder, the Contract Giver and the Contract Acceptor, and in particular defines who is responsible for the GMP aspects of manufacturing and specifies the way in which the Qualified Person releases product batches for the market in agreement with the FDA Marketing Authorization.
In connection with any action brought by such other Party under this Section 10.4.6, such other Party, upon the MA Holder’s request, will reasonably cooperate and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to reasonably cooperate with MA Holder in any such action, including timely commencing or joining in any action brought by MA Holder under this Section 10.4.6.
With respect to any ▇▇▇▇▇▇▇ Country for which Gilead (or its Affiliate, Sublicensee or Third Party Distributor) is the MA Holder for a Territory Combination Product, ▇▇▇▇▇▇▇ shall not use any adaptation of the Core SRDs (regardless of whether or not such adaptation reflects a change in the content of the Core SRDs) in responding to medical inquiries about such Territory Combination Product in such ▇▇▇▇▇▇▇ Country unless and until Gilead has approved such adaptation in writing.
The Current MA Holder shall, at its sole cost and expense, provide all assistance to the New MA Holder to effectuate such transfer, including executing and delivering to the New MA Holder all necessary documents as may be reasonably requested by the New MA Holder for the United States in connection with such transfers.
The MA Holder for the United States shall use [****] to obtain and maintain Regulatory Approval of the Initial Licensed Product in the United States; provided that, [****].
In relation to Section 3.3, it is acknowledged and agreed for the avoidance of doubt that ▇▇▇▇▇▇ shall at all times have the responsibilities of the MA Holder of the EU Marketing Authorisation under this Section 3.5 save in the event of an MA Transfer in which case ▇▇▇▇▇▇’▇ responsibilities as the MA Holder of the EU Marketing Authorisation under this Section 3.5 shall cease on the date of the MA Transfer.
Without limitation to the foregoing, the MA Holder shall immediately inform the Non-MA Holder in the event that the MA Holder receives any notice from a Regulatory Authority relating to any finding of deficiency, finding of non-compliance, investigation, penalty for corrective or remedial action or of any other compliance or enforcement action related to a Product or any New Presentation.
For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 5.1.4(b), the MA Holder shall be solely responsible for the execution thereof, and the Non-MA Holder Party shall [****] cooperate in all such efforts.