IR Product Sample Clauses
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IR Product. Teva may advise the FDA in connection with the IR ANDA (as the same may be converted from a Paragraph III ANDA to a Paragraph IV ANDA as provided in Section 2.E. of the Settlement Agreement) filed by it for the IR Product that the IR ANDA is approvable as a result of the license granted by Wyeth to Teva under Section 2.1, provided, however, that in the event that [**] the IR ANDA [**]. As Teva may reasonably request, Wyeth shall submit appropriate and reasonable documentation to the FDA evidencing the licenses, covenants not to ▇▇▇ and waivers granted to it under this Agreement and the Settlement Agreement for the IR Product. Without limiting the generality of the foregoing, no later than the earlier of (i) June 15, 2006 [**] Wyeth and Teva each shall send a letter to the FDA advising the FDA that Wyeth has granted a license to Teva for the IR Product and, as such, that the FDA may make approval of ANDA No. 76-690 effective on or after the IR Entry Date, assuming such ANDA is otherwise approvable, in order to authorize Teva to market and distribute IR Product in the Territory on and after the IR Entry Date.
IR Product. In consideration of Wyeth entering into this Agreement, Teva shall pay to Wyeth [**] percent ([**]%) of all Profits obtained by Teva or its Affiliates from the sale of IR Products for use in the Territory. In addition to [**] the Settlement Agreement [**]. The consideration to be paid by Teva under this Section 3.1.1 will be payable for all IR Product sold prior to the Compound Patent Termination Date, but not thereafter. Notwithstanding the foregoing, during such period that [**] in the Territory, [**] under this Section 3.1.1 [**].
IR Product. 7.2.1.1 File an IND with [*] for an IR Product within [*]
7.2.1.2 commence a clinical trial of the Current IR Product [*] for such trial ([*] to [*]); and
7.2.1.3 if warranted by the results of the clinical program, submit an NDA to the FDA to request Regulatory Approval to market the Current IR Product, [*] after [*] of such Licensed Product data from which trial will be incorporated in the NDA [*] of such Product data from which trial will be incorporated in the NDA [*]
IR Product. The quantity necessary to satisfy the next (at the time) [*] of Avigen’s requirements for IR Product based upon Avigen’s forecasts and orders placed in accordance with Supply Terms Section 2.3.
IR Product. [**] If Teva or any of its Affiliates intends to sell or distribute IR Product in the Territory hereunder [**], Teva shall provide written notice (the “IR Sale Notice”) to Wyeth between [**] before the first such sale or distribution. Teva shall indicate in the IR Sale Notice [**] and Teva’s [**], and Teva shall send the IR 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 an IR Sale Notice, Wyeth shall notify Teva in writing (the “IR Response Notice”), by facsimile, email or personal delivery as provided in Section 13.6 within [**] of Wyeth’s receipt of the IR Sale Notice, whether or not [**]. If Wyeth [**], the IR Response Notice shall describe [**]. If Wyeth does not indicate in the IR Response Notice that Wyeth [**] or if Teva fails to receive the IR Response Notice within [**] then the remainder of this Section 13.1.3 shall have no force or effect. Alternatively, upon receiving an IR Response Notice [**] in which Wyeth indicates that Wyeth [**] Teva shall [**] and shall cause its Affiliates to [**] after Teva’s receipt of such an IR 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 2.1.4 before the expiration or [**] termination of [**] treating for these purposes the end [**] as the “IR Entry Date” in that Section.