Examples of BID Product in a sentence
Kadmon shall cooperate with AbbVie in giving full effect to any investigation and/or recall as it relates to the BID Product component of an Exclusive Product.
Notwithstanding the foregoing or anything to the contrary herein, (a) no Royalty Payment will be due and owing for the BID Product or Co-Packaged Product (but only with respect to product co- CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
With respect to the BID Product, AbbVie shall coordinate with Kadmon and provide any Marketing Materials in advance to Kadmon for review.
AbbVie shall, with support from Kadmon (including Kadmon’s submission of appropriate documentation to enable AbbVie to), obtain all necessary advanced regulatory review and approval of Marketing Materials developed after the Effective Date by AbbVie for the BID Product, including submitting such Marketing Materials to the Office of Prescription Drug Promotion, and shall provide copies of the Marketing Materials so submitted to Kadmon for its records.
At all such meetings and conferences AbbVie shall have the right to attend as an observer to the extent permitted by Governmental Authorities; provided that AbbVie shall be permitted to contribute and participate in interactions during such meetings as they pertain to BID Product Commercialized by AbbVie hereunder.
Kadmon shall forward to AbbVie all regulatory documents intended for submission with the applicable Governmental Authority and directed specifically to BID Product fifteen (15) Business Days prior to such submission.
Subject to the terms of this Agreement, for calendar years 2015 and 2016 only (the “Initial Royalty Term”), AbbVie will pay Kadmon a royalty based on the number of prescriptions of High Dose BID Product dispensed for use with any other approved product sold by AbbVie for the treatment of Hepatitis C virus during each such calendar year in the Territory (the “High Dose BID Royalty”), as evidenced by the Prescription Data (as defined below) and calculated pursuant to the Royalty Formula (as defined below).
Notwithstanding the foregoing, with respect to BID Product Commercialized by AbbVie hereunder, Kadmon is obligated to submit such materials to Governmental Authorities as AbbVie may provide from time-to-time to enable AbbVie’s Commercialization of BID Product, and Kadmon shall take all such actions as are necessary to enable AbbVie to communicate with Governmental Authorities with respect to such BID Product and related materials.
However, should such communication relate to the safety of BID Product, Kadmon shall forward such communication to AbbVie within twenty-four (24) CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
Lilly shall be solely responsible for 100% of BID Product Commercialization Costs relating to the Commercialization of BID Products outside of the U.S. (including without limitation OUS BID Commercialization Trial Costs), and regardless of whether such Commercialization Costs were incurred before or after the Amendment Date.