any and all normal and customary trade, prompt payment, cash and quantity discounts, customary allowances actually granted to purchasers of a Product for returns and recalled Product (including in connection with Product withdrawals, expired Product and Product recalls), chargeback and reporting fees paid to wholesalers and other distributors, allowances to end users participating in incentive programs, rebates and other credit adjustments based upon shipping discrepancies and order errors;

Withdrawal or Recall of Products. If ​ or any governmental authority determines that any Product sold to ​ is materially defective and a recall campaign is necessary, ​ will have the right to implement such recall campaign and will coordinate the return of defective Product by ​ to ​ or order ​ to destroy such recalled Product, as determined by ​ in its reasonable discretion, at ​’s sole cost and risk.

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

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.

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.

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.

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.

Work Product. In the event that the Director participates in any of the Company's research and development activities ("Company Practice"), or pursues research and development activities that are premised on, or extensions of, in whole or in part, research or development activities carried on by the Company ("Derivative Practice"), then the Company shall own all right, title and interest relating to all inventions, improvements, discoveries, methods, developments, software, and works of authorship, whether patentable or not, which are created, made, conceived or reduced to practice by the Director or jointly with others and are either materially derivative from Company Practice or Derivative Practice or involved Director's use of Company IP (collectively, “Developments”). The Director agrees to make full and prompt disclosure to the Company of all Developments and provide all Developments and all materials and concepts relating to Developments to the Company. Director hereby assigns to the Company or its designee all of the Director's right, title and interest in and to any and all Developments. The Director agrees to cooperate fully with the Company, both during and after the term of this Agreement, with respect to the procurement, maintenance and enforcement of intellectual property rights (both in the United States and foreign countries) relating to any Developments. The Director shall sign all documents which may be necessary or desirable in order to protect the Company's rights in and to any Developments, and the Director hereby irrevocably designates and appoints each officer of the Company as the Director's agent and attorney-in-fact to execute any such documents on the Director's behalf, and to take any and all actions as the Company may deem necessary or desirable in order to protect its rights and interests in any Developments. Notwithstanding anything to the contrary above, this Section 7 does not apply to an invention for which no equipment, supplies, facility of the Company or Company IP was used, unless the invention relates to the business of the Company or to the Company's actual or demonstrably anticipated research or development, or the invention results from any work performed by the Director for the Company.

Product Recalls. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, in the event that a governmental entity issues a request, directive, or order, or ​ determines, in its sole discretion, to recall or retrieve some or all of the Lead Compound by way of a recall, market withdrawal or other corrective action (“Recall”), ​ shall, in cooperation with [[Organization A:Organization]], as reasonably requested by [[Organization A:Organization]], conduct such Recall (and any subsequent investigation by ​ into the cause of the Recall). ​ shall make every reasonable effort to notify [[Organization A:Organization]] promptly following its determination that any event, incident, or circumstance has occurred that may result in a need for a Recall. ​ shall have the sole right to determine whether to conduct and control a Recall; provided, that to the extent practicable, ​ shall consult with [[Organization A:Organization]], through a special meeting of the JDC, prior to any implementation of any such Recall. If a Recall is mandated by a Regulatory Authority, ​ shall initiate such a Recall in compliance with Applicable Law. […​…].

Product Trademarks. Subject to Section 4.6, [[Organization A:Organization]] shall have the sole right to determine and own the Product Trademarks to be used with respect to the Exploitation of the Licensed Products on a worldwide basis. ​ shall not, and shall not permit its Affiliates to, # use in their respective businesses, any Trademark that is confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any part) of the Product Trademarks, and # do any act which endangers, destroys, or similarly affects the value of the goodwill pertaining to the Product Trademarks. ​ agrees, and shall cause its Affiliates, to conform # to the customary industry standards for the protection of Product Trademarks for products and such guidelines of [[Organization A:Organization]] with respect to manner of use (as provided in writing by [[Organization A:Organization]]) of the Product Trademarks, and # to maintain the quality standards of [[Organization A:Organization]] with respect to the goods sold and services provided in connection with such Product Trademarks. ​ shall not do any act which endangers, destroys, or similarly affects the value of the goodwill pertaining to the Product Trademarks. ​ shall not, and shall not permit its Affiliates to, attack, dispute, or contest the validity of or ownership of such Product Trademark anywhere in the Territory or any registrations issued or issuing with respect thereto.