Common use of Development and Commercialization of Licensed Product Clause in Contracts

Development and Commercialization of Licensed Product. Within [* * *] days of the Effective Date, Company shall present to Novavax for its written approval Development plans for the Licensed Product which shall specify preclinical studies (including a toxicology program and other preclinical testing), human clinical trials, manufacturing scale up, Regulatory Approval strategy and any other significant Development activities, that Company plans to perform to obtain Regulatory Approval of such Licensed Product in the Territory (the “Development Plans”). Novavax may reasonably request adjustments to activities described in such Development plans as a condition to granting its approval. In no event shall Company materially alter a Development Plan without Novavax’s prior written consent. Company shall conduct Development of such Licensed Product in a manner that is materially consistent with the Development Plans. All clinical trial protocols for Licensed Product conducted by Company shall require the prior written approval of Novavax. At least [* * *] prior to anticipated commercial launch, Company shall present to Novavax for its written approval a plan to Commercialize the Licensed Product which shall specify a multi-year marketing and public relations strategy, operational plans to implement such strategies and any other significant Commercialization activities (the “Commercialization Plan”). Novavax may reasonably request adjustments to the Commercialization plan as a condition to granting its approval. In no event shall Company materially alter the Commercialization Plan without Novavax’s prior written consent. Company shall conduct Commercialization of such Licensed Product in a manner that is materially consistent with the Commercialization Plan. Novavax acknowledges that the Licensed Product is being contributed by Novavax to the Company in accordance with the Joint Venture Agreement and that if the Company cannot Develop and Commercialize such Licensed Product it will not obtain the value of such contribution. Company acknowledges that Novavax (or its affiliates or licensees) are Developing and Commercializing Licensed Product outside the Territory and Company’s activities could raise safety concerns and have an impact on Novavax’s activities including the Regulatory Approval and regulatory profile of an approved product outside the Territory. Accordingly, taking into account Novavax’s and Company’s respective interests including, without limitation, as provided in the two preceding sentences, Novavax shall not unreasonably withhold, delay or condition any of its consents or approvals hereunder.