Licensed Brands. The definition of “Licensed Brands” in [Section 1.01(a)] of the Purchase Agreement is hereby amended and restated in its entirety to read as follows:

Manufacturing Responsibility. Licensee will be responsible for the manufacturing of the Licensed Compound and Licensed Product for use by Licensee, its Affiliates, and its sublicensees in the Field in the Territory.

Licensee or its Affiliates shall hold all Marketing Authorizations for Licensed Product in the Territory in the Field.

Generally. Licensee shall use Diligent Efforts to Develop and Commercialize the Licensed Product in the Field in the Territory.

Licensee shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA and other regulatory authorities in the Field in the Territory with respect to Licensed Product.

Licensee shall provide, disclose and transfer to Axsome all data obtained or collected solely to the extent such data or information relates to the Development or Commercialization of Licensed Products and is necessary to permit Axsome or Axsome’s designee to continue to Develop and Commercialize Licensed Products in the Field in the Territory;

Licensee shall transfer and assign to Axsome all Regulatory Approvals and other regulatory filings relating to any Licensed Product and to the extent that any such Regulatory Approval or other regulatory filing is necessary to permit Axsome to continue to Develop or Commercialize such Licensed Product in the Field in the Territory;

“DRL Licensed IP” means the IP and Know-How that DRL Controls on the Effective Date or during the Term that is necessary or reasonably useful to Develop, Commercialize, manufacture and otherwise exploit the Product and the Final Product in the Field. For clarity, the DRL Licensed IP shall include the Technical Package.

“Field” shall mean the use of the Licensed Compound or the Licensed Product to treat or prevent any disease, disorder or condition in humans only; except that it shall not include research, development, manufacture, import, marketing, distribution or sale of the Licensed Compound or Licensed Product for the acceleration or promotion of healing of wounds (including chronic wounds), the prevention or reduction of scarring, or the treatment or prevention of fibrotic disorders; at any body sites.

Overview. As of the Effective Date, Licensee shall be solely responsible for the Development and Commercialization, including all costs thereof, of the Licensed Product in the Field in the Territory. Licensee shall perform all of its Development activities in accordance with any IND for the Licensed Product and with all applicable laws, rules and regulations.