[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
AMENDMENT NO. 1 TO THE EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT
This Amendment No. 1 to the Exclusive License, Supply and Distribution Agreement (the Amendment) is entered into on December 31, 2018 (Effective Date) by and between Bioventus LLC, a Delaware limited liability company, with its principal place of business at 4721 Emperor Blvd. Suite 100, Durham NC 27703 (BIOVENTUS) and IBSA Institut Biochimique SA (Switzerland), a Swiss organization, with a registered office at Via al Ponte 13, 6900 Massagno Switzerland (IBSA). BIOVENTUS and the IBSA each are referred to herein as a Party and collectively, as the Parties.
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BIOVENTUS and IBSA entered into an Exclusive License, Supply and Distribution Agreement on February 8, 2016 (Agreement); and
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BIOVENTUS desires to purchase and re-sell and IBSA desires to sell the PRODUCT, as such term is defined in the Agreement, in accordance with the terms and subject to the conditions of this Amendment.
BIOVENTUS and IBSA hereby enter into this Amendment and the Parties agree as follows.
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Definitions. Except as otherwise defined in this Amendment, all capitalized terms shall have the meaning ascribed to them in the Agreement.
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IBSA Non-Compete. Article VII.6 is hereby deleted in its entirety and replaced with the following:
IBSA will not (and will ensure that its AFFILIATES do not) develop or actively promote in the TERRITORY (or license or otherwise permit any third party to promote in the TERRITORY), either directly or indirectly, any intra-articular hyaluronan injection with any of the following characteristics (each, a Competitive Condition): (a) the same quali-quantitative formulation as the following products containing (i) [***] (ii) [***] and (iii) [***]; (b) [***]; or (c) [***].
In the event IBSA or its AFFILIATES either directly or indirectly register, market or distribute an intra-articular hyaluronan injection that does not meet any of the Competitive Conditions (each, a New Product) that is assigned the same HCPCS J code as the PRODUCT by the U.S. Center for Medicare and Medicaid Services (CMS) or other similar federal government reimbursement code within the TERRITORY: (a) IBSA shall provide BIOVENTUS written notice of such reimbursement decision within [***] days after such decision, (b) the MINIMUM PURCHASE REQUIREMENTS for the MARKETING YEAR when such determination is made and all subsequent MARKETING YEARS shall be reduced to [***], and (c) IBSA shall pay BIOVENTUS a [***] royalty equal to [***] of the net price (IBSA NET PRICE) of the New Product (determined in the same manner as the NET SELLING PRICE using IBSAs sales of New Product) for the [***] after such determination is made and all [***] (Royalty Payment). IBSA shall pay BIOVENTUS the Royalty Payment [***] within [***] days after the end of the applicable [***]. Such Royalty Payment will be made as long as the Gel-Syn Exclusive License, Supply and Distribution Agreement is in force.