“Commercialisation”, “Commercialising”, or “Commercialise” - all activities relating to manufacturing, importing, exporting, advertising, promoting and other marketing, pricing and reimbursement, detailing, distributing, storing, handling, packaging, offering for sale and selling, customer service and support, post-marketing authorisation Clinical Studies, and regulatory activities of a Product.

Incumbent Board will constitute at least a majority of the members of the board of directors of the corporation resulting from such Business Combination; or

“Combination Product” shall mean a Licensed Product which includes one or more active ingredients, other than Licensed Compound, in combination with Licensed Compound. All references to Licensed Product in this Agreement shall be deemed to include Combination Product.

Business Combination Vote. It is acknowledged and agreed that the Company shall not enter into a definitive agreement regarding a proposed initial Business Combination without the prior consent of the Sponsor. The Sponsor and each Insider, with respect to itself or herself or himself, agrees that if the Company seeks shareholder approval of a proposed initial Business Combination, then in connection with such proposed initial Business Combination, it, she or he, as applicable, shall vote all Founder Shares, Private Placement Shares and any Public Shares held by it, her or him, as applicable, in favor of such proposed initial Business Combination (including any proposals recommended by the Board in connection with such proposed initial Business Combination) and not redeem any Public Shares held by it, her or him, as applicable, in connection with such shareholder approval.

Neither the Company, any Subsidiary, nor, to the Company’s knowledge, any of its or their licensees, partners, collaborators or joint venturers has developed, manufactured, commercialized, produced, formulated, propagated, modified, customized, processed, distributed or sold any Company Product that did not comply with any express or implied warranty regarding such Company Product or that contained any unintended Hazardous Substance or that was otherwise adulterated, contaminated, mislabeled, defective, off-specification or improperly packaged or transported.

“Other Product” means, with respect to a Combination Product, any active pharmaceutical ingredient other than a particular Antibody within such Combination Product. It is understood that an Other Product may be another antibody.

Notwithstanding the foregoing, in the event a Product is sold in a country in the Territory as Combination Product, Net Sales of the Combination Product will be calculated as follows:

If, on a country-by-country basis, a Licensed Product is sold in the form of a Combination Product, the Net Sales for such Licensed Product in the Combination Product under this Agreement will be calculated by ​.

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

If, on a country-by-country basis, a Licensed Product is sold in the form of a Combination Product, the Net Sales for such Licensed Product in the Combination Product under this Agreement will be calculated by ​.

In the event that, with respect to any Primary Combination Product sold in a particular country, the weighted average sale price(s) in such country of neither the Primary Basic Product nor the Primary Other Product(s) in the Primary Combination Product can be determined, the Primary Net Sales of the Primary Combination Product shall, for the purposes of determining royalty payments with respect to such Primary Combination Product, be commercially reasonable and determined by good faith negotiation between Primary and Legacy consistent with the ratios and related principles referenced above and based on the relative value of the CDC(s) and the other active pharmaceutical ingredient(s) to such Primary Combination Product.

“Combination Product” means a product that is a combination of a Licensed Product sold together with another biologically active compound(s) or another biologically active ingredient(s) (such other compound or ingredient, the “Other Product”) for a single invoiced price.

Net Sales for any Combination Product will be calculated on a country-by-country basis by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B), where A is the average price paid for the Licensed Product contained in such Combination Product sold separately in finished form in such country, and B is the average invoice price paid for the other active ingredients contained in such Combination Product sold separately in finished form in such country, if such Licensed Product and such other active ingredients are each sold separately in such country.

“Y” is the sum of the average sales price as a single entity during the applicable reporting period achieved in that country (as applicable) of each product included in the Combination Product when such product is sold as a separate product and not as part of a Combination Product; and

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.

Selling Product. You agree to make no representations or claims about any products beyond those shown on product labels and/or in official NewYou literature. Claims (which include personal testimonials) as to therapeutic, curative or beneficial properties of any NewYou products may not be made except those contained in official NewYou materials. You may not make any claim that Company products are useful in the cure, treatment, diagnosis, mitigation or prevention of any diseases. Such statements can be perceived as medical or drug claims. Not only do such claims violate this Agreement, but also potentially violates federal and state laws and regulations, including the federal Food, Drug, and Cosmetic Act and Federal Trade Commission Act.

Product Testing. TRIS shall conduct, or cause to be conducted, all physical parameters and in-process testing with respect to each batch of a Product to be supplied pursuant hereto prior to delivery thereof to AYTU. Prior to release to AYTU, TRIS shall perform quality control testing at its own expense on representative samples of each batch of Product to determine/verify it meets Product Specifications. TRIS will provide AYTU with each shipment of Product, a Certificate of Analysis certifying the Product has met Product Specifications. TRIS shall retain a sample of each batch tested for at least the shelf life of such batch, or such longer period as may be required by cGMP.

Except as otherwise provided in written agreement between Executive and the Company, Executive shall retain all right, title and interest in and to all inventions, developments, ideas, methods, processes, designs, analyses, reports and all similar or related information (in each case whether or not patentable), all copyrightable works, all trade secrets, confidential information and know-how, and all other intellectual property rights that were conceived, reduced to practice, developed or made by Executive prior to his Employment with the Company (“Executive’s Inventions”).

Product Specifications. [[Organization A:Organization]] shall supply all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by [[Organization B:Organization]] in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. "Specifications" means, with respect to any Product, the design, composition, dimensions, other physical characteristics, chemical characteristics, packaging, unit count and trade dress of such Product. The Specifications hereby incorporate the Laws and all rules and regulations promulgated thereunder by any governmental authority, including but not limited to the Oregon Department of Agriculture and the U.S Agricultural Improvement Act of 2018. The Products shall not contain any substance or chemical prohibited by such Laws, rules and regulations.