Rx Product definition
Examples of Rx Product in a sentence
The foregoing requirements shall be referred to as the "Generic Purchase Requirements." To support Buyer's achievement of the Generic Purchase Requirements, Cardinal will use commercially reasonable efforts to make generic Rx Products available to Buyer at prices that are equal to or better than those prices that Buyer can obtain directly from the generic Rx Product manufacturers.
Such notice shall be provided in English within five (5) days after such party becomes aware of such information where such potential Adverse Event is Serious and associated with the clinical uses, studies, investigations, tests or marketing of a Consumer Care Product or an Rx Product.
The Rx Product Marketing Authorizations include all material Drug Approval Applications required to be obtained from any Governmental Authority to sell, market, distribute, store or manufacture all products currently being sold, offered for sale, marketed, distributed, stored or manufactured, as applicable, by the Rx Product Business.
Subject to the terms and conditions of this Agreement, the NOVARTIS Parties hereby grant to ENDO the exclusive right and license to Develop (solely to the extent expressly permitted in Section 8) and Commercialize the Licensed Product as an Rx Product under the NOVARTIS AG Technology and the NOVARTIS Technology and the Product Trademark in the Field in the Territory in accordance with this Agreement.
Except as set forth in Section 3.8(b)(ii) of the Seller Disclosure Schedule, as of the date hereof, each item of Registered Transferred Owned Rx IP that is an issued patent or is a Trademark registration, in each case that is material to the operation of the Specified Rx Product Business as currently conducted, has not been adjudged by any Governmental Authority, without further appeal possible, to be invalid or unenforceable.
Section 3.6(a)(iii) of the Seller Disclosure Schedule sets forth the net sales of the Rx Product Business, which has been properly extracted from the books and records of Seller, which have been prepared in accordance with GAAP.
In the EEA, Seller or one of its Affiliates will report to EudraVigilance for the Polaramine Rx Products for as long as Seller or one of its Affiliates has a Drug Approval Application for a Polaramine Rx Product in Spain or France and each party hereto is responsible for reporting to its respective - 66 - Governmental Authorities if required.
Notwithstanding the foregoing, NOVARTIS shall not Launch an OTC Equivalent Product prior to April 1, 2014, and NOVARTIS shall not take any action that results in the loss of Rx Product status for the Licensed Product prior to such time.
Subject to the final sentence of this Section 9.1, NOVARTIS and/or its Affiliates shall have the exclusive right, at its sole discretion, to effect a switch of the Licensed Product from an Rx Product to an OTC Product in the Territory (an “OTC Switch”) by filing an amendment or supplement to the Licensed Product NDA or taking any other action necessary or advisable in connection therewith to effect the OTC Switch, and thereafter to Commercialize such OTC Product.
Outside the EEA territories, for each Consumer Care Product and Rx Product, the party who owns the applicable Drug Approval Application is responsible for reporting to its respective Governmental Authorities if required.