Commercial Sale Testing and Reporting. Notwithstanding the generality of Section 9.02 above, if, after the date of First Commercial Sale in any Jurisdiction, a Competent Authority in the Territory requires additional testing, modification or communication related to approved indications of the Product, then the Parties shall design and Nycomed shall implement any such testing, modification or communication as shall be mutually agreed upon by the Parties, provided that Nycomed shall be solely responsible for all costs associated with such testing, modification or communication.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale, a Competent Authority in the Territory requires additional testing, modification or communication related to approved indications of the Fentanyl Product, then Arius, in consultation with Arius Two, shall design and implement any such testing, modification or communication at its own cost.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale in any country in the Territory, a Governmental Authority requires (a) additional testing, modification or communication related to approved indications of the Product or (b) CYTOB to conduct a Phase IV study as a condition to receiving a Marketing Authorization, then CYTOB shall design and implement any such testing, modification or communication and the costs shall be paid by CYTOB.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale, a Competent Authority requires additional testing, modification or communication related to approved indications of any Licensed Product, then the Development Committee shall design any such testing, modification, or communication. BDSI shall be responsible for any additional formulation or CMC work as required, at Meda’s cost, while Meda shall be responsible for an additional pre-clinical and clinical testing and any other items required by such Competent Authority, at its cost.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale in any country in the Territory, a Governmental Authority requires (a) additional testing, modification or communication related to approved indications of the Product or (b) GKI to conduct a Phase IV study as a condition to receiving a Marketing Authorization, then GKI shall design and implement any such testing, modification or communication and the costs shall be paid by GKI.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale in any country in the Territory, a Governmental Authority requires (a) additional testing, modification or communication related to approved indications of the Product or (b) IPL to conduct a Phase IV study as a condition to receiving a Marketing Authorization, then IPL shall design and implement any such testing, modification or communication and the costs shall be paid by IPL.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale in any country in the Territory, a Governmental Authority requires (a) additional testing, modification or communication related to approved indications of the Product or (b) Atrix to conduct a Phase IV study as a condition to receiving a Marketing Authorization, then Atrix shall design and implement any such testing, modification or communication and the costs shall be paid by Atrix.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale, a Competent Authority requires additional testing, modification or communication related to approved indications of the Licensed Product, then Meda, subject to prior review and approval by BDSI, shall design and implement any such testing, modification, or communication at its own cost.
Commercial Sale Testing and Reporting. 27 Section 9.04. Assistance.............................................27 Section 9.05. Compliance.............................................28 ARTICLE X: REPRESENTATIONS, WARRANTIES AND COVENANTS........................28 Section 10.01. Corporate Power........................................28 Section 10.02. Due Authorization......................................28 Section 10.03. Binding Obligation.....................................28 Section 10.04. Ownership of ABI Rights................................28 Section 10.05.
Commercial Sale Testing and Reporting. If, after the date of First Commercial Sale in any country in the Territory, a Governmental Authority requires (a) additional testing, modification or communication related to approved indications of the Product or (b) BME to conduct a Phase IV study as a condition to receiving a Marketing Authorization, then BME shall design and implement any such testing, modification or communication and the costs shall be paid by BME.
