AYTU Indemnification. AYTU agrees to indemnify and hold forever harmless TRIS and its Affiliates and each of their agents, directors, officers and employees (each such person, a “TRIS Indemnified Party”) from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees) (“Losses”) in connection with any and all suits, investigations, claims or demands of Third Parties (“Claims”) to the extent arising from or in connection with # the Marketing, use, the offer for sale, sale or distribution of the Product or any Competing Product by AYTU or its Subsidiaries or Sublicensees in the Territory; # infringement or misappropriation of any copyright or Trademark (other than TRIS Marks) arising out of the Marketing of a Product or any Competing Product in the Territory; # the breach or inaccuracy of any representations, warranties or covenants made by AYTU in this Agreement; # a Recall described in Section 5.5(b); and # the gross negligence or willful misconduct of AYTU or its Subsidiaries or Sublicensees or any of their agents, directors, officers or employees; provided, however, that AYTU shall not be obligated to indemnify any TRIS Indemnified Party pursuant to this Section 13.1(a) for any Losses to the extent TRIS is obligated to indemnify an AYTU Indemnified Party for such Losses pursuant to Section 13.1(b).

Infringement Actions by TRIS or AYTU. In the event that any Party becomes aware during the Term of any Person infringing or potentially infringing the Product Technology, whether by direct or indirect infringement, or by misappropriation of Product Technology, or that a Person has filed a certification under 21 USC 355(b)(2)(A)(iv) or [Section 355(j)(2)(A)(vii)(IV)] (or successor provisions) of the Hatch-Waxman Act relating to a Product (a “Hatch-Waxman Certification”), it shall promptly notify the other Party and in the case of a Hatch Waxman Notification shall provide a copy to the other Party within two Business Days of receipt thereof. TRIS in its sole discretion shall determine whether an action should be commenced relating to such infringement, potential infringement or certification, TRIS shall control and manage any such action (including without limitation, control over the settlement of such action, subject to AYTU’s consent for such settlement as provided below), and AYTU shall cooperate with TRIS and join the action as reasonably requested. Each Party shall be responsible for fifty percent (50%) of the ongoing costs and expenses (including attorney’s fees) and any damages, settlements, or judgements related to any such action. AYTU shall reimburse TRIS for AYTU’s share of such costs and expenses within thirty (30) days after the date of TRIS’ invoice for same. Any and all amounts recovered with respect to such an action shall be applied first to reimburse the Parties for their reasonable and documented out-of-pocket expenses (including reasonable attorney’s fees) in prosecuting such infringement or misappropriation and the remainder shall be shared equally. TRIS shall have the right to settle such action only with the consent of AYTU, not to be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, AYTU shall not have the right to settle such action.

AYTU represents, warrants and covenants to TRIS that the following are true and correct as of the date stated therein, or if none is specified then as of the date hereof:

by TRIS upon written notice to AYTU if AYTU or its Subsidiaries directly, or indirectly by controlling, providing assistance or direction to a Third Party, # file an action seeking to invalidate or challenge the validity or enforceability of, # oppose any extension of, or # commence any interference or opposition proceeding with respect to, any Patent included in TRIS Intellectual Property Rights (“TRIS Patent Rights“) and listed in the FDA Orange Book with respect to the Products (each such action, a “AYTU Patent Challenge”). AYTU will include provisions in any agreement entered into with a Sublicensee providing that if the Sublicensee or its Affiliates undertake or threaten an AYTU Patent Challenge with respect to any TRIS Patent Rights under which the Sublicensee is granted the right to Market a Product, AYTU will be permitted to terminate such sub-licensed rights. If such a Sublicensee of AYTU (or an Affiliate of such Sublicensee) undertakes an AYTU Patent Challenge of any such TRIS Patent Right relating to a Product, then AYTU upon receipt of notice from TRIS of such AYTU Patent Challenge will terminate the applicable sublicense agreement. In connection with such sublicense termination, AYTU shall cooperate with TRIS’ reasonable requests to cause such a terminated Sublicensee to discontinue activities with respect to such Product;

AYTU shall register and sell the Products only using National Drug Codes that reflect AYTU as the distributor.

As between AYTU and TRIS, AYTU hereby acknowledges the exclusive ownership of TRIS of the TRIS Marks furnished by TRIS (or its Affiliates) for use in connection with the Products. AYTU shall not, during the Term or thereafter, register, use, or attempt to obtain any right in and to any TRIS Marks or in and to any name, logo or trademark confusingly similar thereto, including, without limitation, by adding to or supplementing the TRIS Marks with additional words or phrases. As between AYTU and TRIS, TRIS hereby acknowledges AYTU’s exclusive ownership rights in the AYTU Marks, and accordingly agrees that, subject to Section 4.10(b) and Section 9.3(a)(ix) solely with respect to an AYTU Product Trademark upon termination of this Agreement, at no time during or after the Term of this Agreement to challenge or assist others to challenge the AYTU Marks or the registration thereof or attempt to register any Trademarks, trade names or logo confusingly similar to such AYTU Marks, including without limitation, by adding to or supplementing the AYTU Marks with additional words or phrases.

“AYTU Regulatory Documentation” means, with respect to a Product, the Regulatory Documentation prepared for such Product by or on behalf of AYTU.

As soon as it becomes apparent to TRIS that circumstances resulting in any failure or delay in delivery of the Product will continue for more than thirty (30) days, it shall promptly notify AYTU in writing and as soon as possible thereafter confer with AYTU to discuss the alternatives, and cooperate with AYTU as AYTU may reasonably request for AYTU to obtain a source of supply of the Product during the continuance of such circumstances, provided however, that in no event shall TRIS be required to transfer manufacturing to another manufacturer or facility or cooperate with respect thereto.

General. AYTU will Market the Products in the Territory, subject to Section 4.10 and Section 7.4(c)(i), under the AYTU Marks and the TRIS Trademarks.

On or promptly following the Effective Date, as consideration for the Upfront Cash Payment and Upfront Stock Issuance, TRIS shall transfer the Tuzistra XR Product NDA to AYTU and shall # send to the FDA (with a copy to AYTU) any required properly executed forms (i.e., FDA Forms 356h and 1571, if applicable) and a letter transferring the NDA for such Product to AYTU and # provide the TRIS Regulatory Documentation related to such Product, excluding any DMFs or the contents thereof, to AYTU.