IPI-145 Product definition
Examples of IPI-145 Product in a sentence
Licensee may publish the scientific results of activities undertaken by either Party, any of its Affiliates or any Sublicensee (or, with respect to INFI, any licensee or sublicensee) with respect to the Research, Development, Manufacture and Commercialization of the IPI-145 Compound or IPI-145 Product.
In Commercializing the IPI-145 Product under this Agreement, Licensee shall, and shall ensure that its Affiliates and the Sublicensees, comply in all respects with the INFI Third Party Agreements and with all applicable Laws and applicable guidelines, including those concerning the advertising, sales and marketing of prescription drug products, the Foreign Corrupt Practices Act of 1977, as amended, and any applicable local anti-bribery Laws.
As between the Parties, and subject to the terms and conditions of this Agreement, Licensee shall control, and bear all responsibility, costs and expenses associated with, the Commercialization of the IPI-145 Product in the Field in the Territory.
Licensee shall have the sole right, but not the obligation, to select and submit to all applicable Governmental Authorities patent information pertaining to each IPI-145 Product pursuant to 21 U.S.C. § 355(b)(1)(G) (or any amendment or successor statute thereto), or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction.
In addition, except for submissions which are required to meet the “Sponsor” obligations under 21 C.F.R. 312 and analogous regulations in non-U.S. jurisdictions, during such period INFI will be responsible for all communications and other dealings with Regulatory Authorities in the Territory with respect to the IPI-145 Compound and the IPI-145 Product, provided, however, that INFI will only communicate with the Regulatory Authorities as instructed by Licensee.
Instead, Licensee will be required to pay MICL an amount equal to one percent (1%) of Net Sales of IPI-145 Product in the United States (the “MICL Trailing Royalty Payment”).
Licensee shall only be obligated to make the MICL Royalty Payment on Net Sales of IPI-145 Product until such time as MICL has received an aggregate amount equal to $244,547,850 (the “MICL Repayment Amount”) from the combination of MICL Royalty Payments made by Licensee with respect to IPI-145 Product and other royalties paid by INFI or its Affiliates or licensees or sublicensees with respect to any other Products subject to the royalty payments under the MICL Agreement with MICL.
Such reports shall be submitted, with respect to activities for the United States, until first Commercial Sale of the IPI-145 Product in the United States, and with respect to activities for countries or regions outside the United States, until first Commercial Sale of the IPI-145 Product in any country outside the United States.
Licensee shall only be obligated to make the Purdue Royalty Payment on Net Sales of IPI-145 Product until such time as Purdue has received an aggregate amount equal to $15,908,706 (the “Purdue Repayment Amount”) from the combination of Purdue Royalty Payments made by Licensee with respect to IPI-145 Product and other royalties paid by INFI or its Affiliates or licensees or sublicensees with respect to any other Products subject to the royalty payments under the MICL Agreement with Purdue.
The financial information described in this Section 6.7 will be prepared in accordance with (X) the books and records of the business related to the IPI-145 Product and (Y) U.S. GAAP; provided, however, that all such information is unaudited and may be subject to change.