The term “Generic Product” shall mean a product that is not produced, licensed or owned by the Roche Group that # contains a pharmaceutically active ingredient that is the same as the Compound in the Product which is approved through in reliance, in whole or in part, on the prior Regulatory Approval (or on safety or efficacy data submitted in support of the prior Regulatory Approval) of such Product, pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)), or for countries outside the US, any international equivalent laws, and # has the same or substantially the same labelling as the applicable Product for at least one indication of such Product.

The term “Patent Product” shall mean any Product containing a Compound that is Covered by a Composition of Matter Claim.

If Roche or its Affiliates intend to sell a Combination Product, then the Parties shall meet approximately ​ prior to the anticipated First Commercial Sale of such Combination Product in the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative commercial value contributed by the components of the Combination Product (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed ​ days, the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the executive officers of the Parties in accordance with Section 21.2.

Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Collaborative Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred impacting product

Product Recalls. If any Regulatory Authority having jurisdiction in the Territory requires or reasonably requests to recall a Licensed Product due to a defect in the manufacture, processing, packaging or labeling of such Licensed Product or for any other reason whatsoever, XPH shall immediately notify Kinex. XPH shall have the sole right and responsibility, at its expense, to initiate all recall procedures required or requested by any such Regulatory Agency. XPH shall have be responsible, at its expense, for carrying out any such recall as expeditiously as possible and in such a way as to cause the least disruption to the sales of the Licensed Product and to preserve the goodwill and reputation attached to the Licensed Product and to the names of XPH and Kinex. XPH agrees to maintain the appropriate record and procedures to permit the recall of the Licensed Product.

Product Abandonment. With respect to each Product for which the “Dosing of first patient in a Phase I study” Milestone Event has been achieved, this License Agreement shall terminate in the event that iTeos ceases significant development and/or commercialization activities (either itself or through a Licensee) of such Product for a period of at least ​, where “significant development and/or commercialization activities” means devoting at least one FTE, in the aggregate, to such activities.

Combination Product. Licensee shall not develop a Combination Product, except as is permitted pursuant to this [Section 4.6]. If Licensee desires to develop a Combination Product, then Licensee shall submit to Verrica a reasonably detailed plan for such Combination Product (the “Combination Product Plan”). Through the JSC, Verrica and Licensee shall review and discuss in good faith the Combination Product and the Combination Product Plan for such clinical development and commercialization prior to the occurrence of any of the foregoing. If Verrica approves the Combination Product Plan, then Licensee may conduct the development activities described in the Combination Product Plan or request Verrica to conduct such development activities. Upon such Licensee’s request, Verrica shall conduct such development activities in accordance with the approved Combination Product Plan and Licensee shall reimburse Verrica for reasonable costs and expenses incurred by Verrica to conduct such development activities to the extent such costs and expenses are incurred solely for the development of the Combination Product in the Field in the Territory. Licensee may, from time to time, provide updates or amendments to the Combination Product Plan to Verrica for approval. For the avoidance of doubt, Net Sales for a Combination Product in the Territory shall be determined in accordance with [Section 1.97] and Licensee shall be under no obligation to make payment to Verrica with respect to the development and commercialization of a Combination Product except for the costs and expenses for such development activities pursuant to this [Section 4.6(a)] and the applicable transfer price required on the Net Sales for such Combination Product.

Product Tracing. Licensee shall, and shall ensure that its Affiliates and Sublicensees will, maintain adequate records to permit the Parties to trace the distribution of Products in the Territory. Each Party shall provide the other Party, at the other Party’s expense, with such assistance in connection with a Remedial Action as may be reasonably requested by such other Party.

Product Marks. GSK shall select, obtain and maintain any Product Marks for Licensed Products. Prior to selecting any Product Marks for Licensed Products, GSK will present the trademarks that it is considering for selection along with any relevant related reports or information to the JCC for review and discussion at a regularly scheduled meeting of the JCC. In addition, upon reasonable request of GSK, ITEOS shall provide reasonable assistance in the selection of Product Marks for a Licensed Product. As between the Parties, GSK shall be the owner of the Product Marks for any Licensed Product. GSK will and hereby does grant ITEOS the right to use such Product Marks, and the Marketing Materials (including Promotional Materials), to perform Medical Affairs activities and to Commercialize the Licensed Products in the Profit-Sharing Territory in accordance with this Agreement and as set forth in the Joint Commercialization Plan.

“Combination Product”. Combination Product means # any pharmaceutical product that is a single formulation consisting of a Licensed Product and one or more other active compounds or active ingredients or # any combination of a Licensed Product sold together with other separately formulated active compounds or active ingredients for a single invoiced price.