Marketing Authorization Holder. Without limiting its obligations under Section 3.2, Licensee or its Affiliates or nominees shall be the Marketing Authorization Holder (“MAH”) for the Licensed Products in the Territory and shall be responsible for preparing, seeking, submitting and maintaining all regulatory filings and Regulatory Approvals for all Licensed Products in the Territory.

Marketing. As of the Effective Date of this Agreement, Landlord shall be entitled to enter any portion of the Demised Premises at all reasonable times and from time to time for the purpose of showing the same to prospective lessees or purchasers, and Landlord shall be entitled to market the Demised Premises for sale or lease including placing “For Sale” or “For Lease” signs on the Property within the vicinity of or on the Demised Premises.

Marketing. Promotion and Sublicense of BBTR System. Throughout the Term, BBTR shall use its commercially reasonable best efforts to market, promote and sublicense the BBTR System and use thereof by Customers. The BBTR System shall be sublicensed only pursuant to a BBTR Sublicense agreement in a form approved by Blackbox in advance and in writing.

Marketing Plan. AYTU will be responsible for assessing the market opportunities for the Product in the Territory and preparing and providing to TRIS, for TRIS’ review and comment, within thirty (30) days of the execution of this Agreement, a marketing plan for the Tuzistra XR Product and sixty (60) days after NDA Approval of CCP-08, a marketing plan for the CCP-08 Product (each such marketing plan for Tuzistra XR and CCP-08, a “Marketing Plan”), which Marketing Plan, and each subsequent Marketing Plan delivered in accordance with this Section 4.2, shall set forth AYTU’s plan, strategy and proposed activities, to Market such Product in the Territory. Each Marketing Plan will include as appropriate, without limitation, the following elements:

Marketing Restrictions. Unless specified in the applicable customization Schedule or otherwise agreed, all Customizations shall be deemed [[Bank of America:Organization]] Customizations. [[Bank of America:Organization]] shall own all right, title, and interest in and to the [[Bank of America:Organization]] Customizations as Work Product in accordance with [Section 39.0]. [[Organization A:Organization]] shall not provide a [[Bank of America:Organization]] Customization to any third party. In the event that any [[Bank of America:Organization]] Customization is furnished or plan, design or specification for producing the same has been specifically designed, developed or modified for or by [[Bank of America:Organization]], then no such [[Bank of America:Organization]] Customization, plan, design or specification shall be duplicated or furnished to others by [[Organization A:Organization]] without the prior written consent of [[Bank of America:Organization]].

“NDA” shall mean a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Application Authorization, filing pursuant to Section 510(k) of the Act, or similar application or submission for Marketing Authorization of a Product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.

“Biosimilar Product” means, on a country-by-country basis, a biologic product # whose licensing, approval, or marketing authorization relies in whole or in part on a prior approval, licensing or marketing authorization granted any Product, # whose licensing, approval, or marketing authorization relies in whole or in part on any data generated in support of a prior approval, licensing, or marketing authorization granted any Product, or # is determined by the FDA to be interchangeable with a Product, as set forth at 42 USC 262(k)(4). Any product or component thereof (including any Product or component thereof) licensed, marketed, sold, manufactured, or produced by a Party, its Affiliates or (sub)licensees will not constitute a Biosimilar Product.

“Marketing Authorization Holder” or “MAH” has the meaning set forth in [Section 3.4.1].

“Centralized Approval Procedure” means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union.

Subject to [Section 2.8, GSK or GSK]K]K] Designated Party shall be the sole holder of the Marketing Authorization of the Product in China.