Pediatric Exclusivity definition

Pediatric Exclusivity means exclusivity obtained in accordance with the requirements of Section 505(a) of the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(a)).

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Pediatric Exclusivity means exclusivity obtained in accordance with the requirements of Federal Food, Drug, and Cosmetic Act § 505a, 21 U.S.C. 355a.

Pediatric Exclusivity means a Market Approval issued by FDA in application of 21 C.F.R. § 355a or its successor regulation.

Examples of Pediatric Exclusivity in a sentence

Cephalon shall reasonably cooperate with ▇▇▇▇ in notifying the FDA that Cephalon has waived Pediatric Exclusivity with respect to ▇▇▇▇, including, but not limited to, by filing with the FDA a dated and executed copy of the letter attached hereto as Exhibit H.
Immediately upon the ACTIQ SF Patent Rights License Effective Date for the ACTIQ SF Patent Rights License granted pursuant to Section 2.2(a)(i) and (iii) as determined under Section 2.2(b), Cephalon shall grant a license to ▇▇▇▇ with respect to any Pediatric Exclusivity that may then exist or thereafter arise solely with respect to ACTIQ SF.
If, and only if, the Existing License Effective Date has not occurred on or prior to December 6, 2006, then, during the Exclusivity Period, Cephalon shall grant a license to ▇▇▇▇ with respect to any such Pediatric Exclusivity that may exist during such period with respect to ACTIQ or ACTIQ SF.
Subject to Sections 2.2 and 2.3 below, Cephalon grants to ▇▇▇▇ a royalty-bearing, non-exclusive license, without a right to sublicense, under the Listed Patents and any regulatory exclusivities, including Pediatric Exclusivity, to use, offer for sale, sell, distribute and have distributed, promote, market and advertise, import and have imported, the ▇▇▇▇ Generic Modafinil Product, and to make and have made the ▇▇▇▇ ▇▇▇▇ Modafinil Product, in the United States.
Cephalon shall reasonably cooperate with ▇▇▇▇ in notifying the FDA that Cephalon has waived Pediatric Exclusivity with respect to ▇▇▇▇, including, but not limited to, by filing with the FDA a dated and executed copy of the letter attached as Exhibit H to the Existing License and Supply Agreement.
Cadence agrees to notify the Sandoz ANDA Holder within [***] of its receipt of notice regarding the grant or denial of Pediatric Exclusivity with respect to the Cadence Product.
ENDO will pay for a Pediatric Exclusivity Study if it receives confirmation in the form of a written FDA communication which identifies a pediatric study which can reasonably be conducted and submitted in sufficient time to obtain regulatory exclusivity for the Licensed Product.
Cadence agrees to notify Paddock within [***] of its receipt of notice regarding the grant or denial of Pediatric Exclusivity with respect to the Cadence Product.
Lilly waives, as to the Eagle NDA only, any Regulatory Exclusivity awarded to Lilly relating to pemetrexed, whether existing now or in the future, including any Pediatric Exclusivity in effect for the Lilly NDA.
Immediately upon the ACTIQ Patent Rights License Effective Date for the ACTIQ Patent Rights License granted pursuant to Section 2.1(a)(i),(ii) and (iv) as determined under Section 2.1(b), Cephalon shall grant a license to ▇▇▇▇ with respect to any Pediatric Exclusivity that may then exist or thereafter arise with respect to ACTIQ (except for any Pediatric Exclusivity that may exist solely with respect to ACTIQ SF).

More Definitions of Pediatric Exclusivity

Pediatric Exclusivity means the period of Regulatory Exclusivity awarded to a drug product during which FDA may not approve another drug product pursuant to 21 U.S.C. 355a(b)-(c).

Pediatric Exclusivity means and refer to any exclusivity granted by the FDA for pediatric studies pursuant to § 505A of the FDC Act or any equivalent exclusivity granted by the applicable government agencies authorized to grant Market Exclusivity in a country or territory.

Pediatric Exclusivity means the period of exclusivity provided by 21 U.S.C. § 355a(b)(1)(B) (as amended or replaced) and/or 21 U.S.C. § 355a(c)(1)(B) (as amended or replaced).

Pediatric Exclusivity means the additional six (6) months of exclusivity extension provided under the Food and Drug Administration Modernization Act of 1997, section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(a)), or any replacement thereto. For purposes of clarification, however, Lilly, in its sole discretion, shall have the right to seek any government-conferred exclusivity available with respect to products containing the Compound, whether or not such exclusivity is based on PAH.

Pediatric Exclusivity means the period of exclusivity provided by 21 U.S.C. § 355a(b)(1)(B) (as amended or replaced) and/or 21 U.S.C. § 355a(c)(1)(B) (as amended or replaced). “Pending Litigation” means Cadence Pharmaceuticals, Inc. and *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.