IR Product definition
Examples of IR Product in a sentence
As between Teva and Wyeth, Teva shall be solely responsible for all product liability claims filed by any Third Party to the extent that they claim injury from the IR Product or the XR Product manufactured, sold or distributed by Teva or its Affiliates.
Unless and until DSP exercises the MR Option pursuant to Section 3.2, DSP shall use such MR Program Data for the sole purpose of obtaining and maintaining the Regulatory Approval for the IR Product in the Territory.
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 [**].
Teva shall not sell or distribute IR Product before the IR Entry Date.
For the sake of clarity and without limiting the foregoing, any IR Product tablet shall be of a different shape than is any tablet of the IR Reference Product as of the Signing Date, and such IR Product tablets and any XR Product capsules and the packaging therefor shall not bear any markings, trademarks, trade names or other trade dress that are confusingly similar to that used by Wyeth or any of its Affiliates for the IR Reference Product or the XR Reference Product.
Wyeth shall have no obligation to obtain, maintain or assist Teva in obtaining or maintaining any (except to the extent expressly provided in Section 4.1) regulatory and governmental permits, licenses and approvals for any IR Product or any XR Product.
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.
Teva shall be solely responsible for manufacturing IR Product and XR Product in order to supply its demand therefor in the Territory in connection with its exercise of the rights and licenses granted to it hereunder.
Teva will not use, any of Wyeth’s trademarks, trade names or trade dress or any trademarks, trade names or trade dress which are confusingly similar to any of Wyeth’s trademarks, trade names or trade dress, in connection with its sale, distribution or promotion of any IR Product or XR Product.
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.