“Marketing Approval” means, with respect to a Combination Product, in a particular jurisdiction, the receipt of all approvals, licenses, registrations or authorizations necessary for the sale and marketing of such Combination Product in such jurisdiction, including, with respect to the United States, approval of NDA for such Combination Product by the FDA. For clarity, Marketing Approval does not include reimbursement authorization or pricing approval determinations.

Product Warranty. ​ warrants to ​ (the “Product Warranty”) that:

Product Recall. Any mandatory product recall shall be required pursuant to any order or directive of any Governmental Authority affecting the products manufactured, sold or distributed by the Borrower or any of its Subsidiaries, if the aggregate sales price of the products so recalled shall, individually or together with all other similar recalls of such products during any twelve consecutive month period, equal or exceed $50,000,000; or

Employee acknowledges and agrees that all right, title, and interest in and to all writings, works of authorship, technology, inventions, discoveries, processes, techniques, methods, ideas, concepts, research, proposals, materials, and all other work product of any nature whatsoever, that are created, prepared, produced, authored, edited, amended, conceived, or reduced to practice by Employee individually or jointly with others during the period of his employment by the Company and that relate in any way to the business or contemplated business, products, activities, research, or development of the Company or result from any work performed by Employee for the Company (in each case, regardless of when or where prepared or whose equipment or other resources is used in preparing same), all rights and claims related to the foregoing, and all printed, physical and electronic copies, and other tangible embodiments thereof (collectively, “Work Product”), as well as any and all rights in and to United States and foreign: # patents, patent disclosures and inventions (whether patentable or not); # trademarks, service marks, trade dress, trade names, logos, corporate names, and domain names, and other similar designations of source or origin, together with the goodwill symbolized by any of the foregoing; # copyrights and copyrightable works (including computer programs), mask works, and rights in data and databases; # trade secrets, know-how, and other Confidential Information; and # all other intellectual property rights, in each case whether registered or unregistered and including all registrations and applications for, and renewals and extensions of, such rights, all improvements thereto and all similar or equivalent rights or forms of protection in any part of the world (collectively, “Intellectual Property Rights”), shall be the sole and exclusive property of the Company.

Work Product. All Work Product shall be performed in strict conformity with the specifications or descriptions of the Work Product or Services set forth in the applicable SOW and shall not infringe upon the patent, copyright or other intellectual property rights of any third party.

Product Markings. To the extent permitted by applicable Law, Commercializing Party shall include on all packaging and promotional materials for each Product a designation # that the Product incorporates the Licensed Protocol and/or Kaufmann Intellectual Property Rights and # if applicable, that the Product is manufactured under license from the Licensor, which designation must comply with applicable Law and otherwise be in form and substance reasonably acceptable to Licensor. Commercializing Party shall also ensure that all sublicensees and subcontractors mark Products accordingly.

Work Product. The Executive agrees that all “Work Product”, including, for example, inventions, innovations, improvements, developments, methods, designs, analyses, drawings, reports, and all similar or related information which relate to the Company’s business, research and development or existing future products or services and which are made by the Executive while employed by the Company belong to the Company. The Executive shall perform all actions reasonably requested by the Company (whether during or after the employment period) to establish and confirm such ownership of Work Product (including, without limitation, assignments, consents, powers of attorney and other instruments) and for the application and enforcement of Letters Patent.

Product Complaints. If either TLC Hong Kong or TLC learns of any complaints/claims concerning the TLC Products, the Party learning of such complaints or claims shall advise the other Party within forty-eight (48) hours by telephone, confirmed in writing within five (5) business days thereafter.

Product Warranties. TLC hereby represents and warrants that all TLC Products delivered under this Agreement by TLC Group shall # comply with all applicable specifications (to be mutually agreed upon before TLC Products delivery); # be manufactured, packaged, labeled and delivered in compliance with all Applicable Law in the China Territory; # not be misbranded or adulterated and # not infringe any Third Party’s intellectual property right. Each delivery of TLC Products shall be accompanied by a certificate of release, in a form mutually agreed by the Parties,

Product Recall. In the event that either Party believes it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar action with respect to any Product which was sold under this Agreement (a “Recall”), AYTU and TRIS shall promptly consult with each other in good faith as to how best to proceed, it being understood and agreed that the final decision as to any Recall of any Product sold by AYTU or its Subsidiaries or its Sublicensees shall be made by AYTU, as AYTU is responsible for notifying regulatory agencies of any recall market withdrawals, etc., provided, however, that neither Party shall be prohibited hereunder from taking any action that it is required to take by Applicable Law. Each of TRIS and AYTU shall make a permanent, complete and accurate record of all costs incurred by it in connection with any Product recall.