XR Product Clause Samples
XR Product. Teva may advise the FDA in connection with the XR ANDA filed by it for the XR Product that the XR ANDA is approvable as a result of the license granted by Wyeth to Teva under Section 2.2, provided, however, that in the event that [**] the XR ANDA [**]. As Teva may reasonably request, Wyeth shall submit appropriate and reasonable documentation to the FDA evidencing the licenses and waivers granted to it under this Agreement for the XR Product. Without limiting the generality of the foregoing, no later than the earlier of (i) June 1, 2010 [**], Wyeth and Teva each shall send a letter to the FDA advising the FDA that Wyeth has granted a license to Teva for the XR Product and, as such, that the FDA may make approval of ANDA No. 76-565 effective on or after the XR Entry Date, assuming such ANDA is otherwise approvable, in order to authorize Teva to market and distribute XR Product in the Territory on and after the XR Entry Date.
XR Product. In consideration of Wyeth entering into this Agreement, Teva will pay to Wyeth consideration at the rates set forth below on all Profits obtained by Teva or its Affiliates from the sale of XR Products for use in the Territory, for all XR Product sold prior to (but not after) the XR Patent Termination Date: [**] [**] [**] [**]% [**] [**]% [**].
XR Product. Wyeth shall be solely responsible for all pharmacovigilance activities for the XR Reference Product and all Authorized Generic Products regarding XR Reference Product, including: AE/ADR reporting including literature review and associated reporting; AE/ADR follow-up reporting; preparation and submission of all safety reports to the regulatory authorities as required by local laws and/or regulations in the Territory; maintaining the local safety database; all interactions with health authorities regarding safety; periodic submissions; labeling modifications; safety monitoring and detection; and safety measures (e.g, Dear Doctor Letters, restriction on distribution). Teva shall be solely responsible for all pharmacovigilance activities for the XR Product, including: AE/ADR reporting including literature review and associated reporting; AE/ADR follow-up reporting; preparation and submission of all safety reports to the regulatory authorities as required by local laws and/or regulations in the Territory; maintaining the local safety database; all interactions with health authorities regarding safety; periodic submissions; labeling modifications; safety monitoring and detection; and safety measures (e.g, Dear Doctor Letters, restriction on distribution).
XR Product. In consideration of Wyeth entering into this Agreement, Teva will pay to Wyeth consideration at the rates set forth below on all
XR Product. [**] If Teva or any of its Affiliates intends to sell or distribute XR Product in the Territory hereunder [**] Teva shall provide written notice (the “XR Sale Notice”) to Wyeth between [**] before the first such sale or distribution. Teva shall indicate in the XR Sale Notice [**] and Teva’s [**] and Teva shall send the XR Sale Notice by facsimile and email as provided in Section 13.6 [**] with additional copies provided to up to three (3) additional Wyeth personnel as Wyeth may indicate to Teva from time to time in writing. Upon receiving a XR Sale Notice, Wyeth shall notify Teva in writing (the “XR Response Notice”), by facsimile, email or personal delivery as provided in Section 13.6 within [**] of Wyeth’s receipt of the XR Sale Notice, whether or not [**] If Wyeth [**] the XR Response Notice shall describe [**]. If Wyeth does not indicate in the XR Response Notice that Wyeth [**] or if Teva fails to receive the XR Response Notice within [**], then the remainder of this Section 13.1.3 shall have no force or effect. Alternatively, upon receiving a XR Response Notice [**] in which Wyeth indicates that Wyeth [**] Teva shall [**] and shall cause its Affiliates to [**] after Teva’s receipt of such a XR Response Notice or [**] unless earlier terminated as provided below [**] For the sake of clarity, upon the initiation of [**], Teva and its Affiliates may exercise the rights granted in the first sentence of Section 2.2.6 before the expiration or [**] termination of [**] treating for these purposes the end [**] as the “XR Entry Date” in that Section.