Common use of Disputes Over Non-Conforming Licensed Product Clause in Contracts

Disputes Over Non-Conforming Licensed Product. In the event that KHK disagrees with UGNX’s rejection because the Licensed Products are in fact conforming, the Parties shall cooperate to have both UGNX’s returned samples and KHK’s retained samples from the same production batch of the Licensed Products in dispute analyzed by a mutually acceptable independent testing laboratory of recognized reputation in the pharmaceutical industry, using the analytical methods, tests and criteria for conformance set forth in the Specifications. The out-of-pocket external costs of such arrangement shall be shared [***] by the Parties, unless and until an alternative determination is made as provided below. The results of such laboratory testing shall be conclusive and binding on the Parties on the issue of compliance of such units of Licensed Product with the Specifications at the time of Delivery. If such independent testing laboratory determines that UGNX’s returned samples of such Licensed Product conform to the Specifications, then (i) the applicable Licensed Product shall be deemed to have been improperly rejected by UGNX, and (ii) UGNX shall bear the cost of the independent laboratory testing and all out-of-pocket external costs and expenses of returning the improperly rejected Licensed Product to UGNX. If such independent testing laboratory determines that UGNX’s returned samples of such Licensed Product did not conform to the Specifications and that such returned samples conform to the samples for such batch retained by KHK, then KHK shall bear the cost of the laboratory testing, as well as the costs associated with properly-rejected Licensed Product described in Section 8.2.7(b), and KHK shall promptly supply to UGNX conforming Licensed Products in accordance with Section 8.2.7(b).

Disputes Over Non-Conforming Licensed Product. In the event that KHK Reata disagrees with UGNXKyowa Kirin’s rejection because the Licensed Products are in fact conforming, the Parties shall cooperate to have both UGNXKyowa Kirin’s returned samples and KHKReata’s retained samples from the same production batch of the Licensed Products in dispute analyzed by a mutually acceptable independent testing laboratory of recognized reputation in the pharmaceutical industry, using the analytical methods, tests and criteria for conformance set forth in the Specifications. The out-of-pocket external costs of such arrangement shall be shared [***] equally by the Parties, unless and until an alternative determination is made as provided below. The results of such laboratory testing shall be conclusive and binding on the Parties on the issue of compliance of such units of Licensed Product with the Specifications at the time of Delivery. If such independent testing laboratory determines that UGNXKyowa Kirin’s returned samples of such Licensed Product conform to the Specifications, then (i) the applicable Licensed Product shall be deemed to have been improperly rejected by UGNXKyowa Kirin, and (ii) UGNX Kyowa Kirin shall bear the cost of the independent laboratory testing and and, solely if Kyowa Kirin so requests the return shipment thereof, all out-of-pocket external costs and expenses of returning the improperly rejected Licensed Product to UGNXKyowa Kirin. If such independent testing laboratory determines that UGNXKyowa Kirin’s returned samples of such Licensed Product did not conform to the Specifications and that such returned samples conform to the samples for such batch retained by KHKReata, then KHK Reata shall bear the cost of the laboratory testing, as well as the costs associated with properly-rejected Licensed Product described in Section subsection 8.2.7(b)) above. If such independent testing laboratory determines that Kyowa Kirin’s returned samples do not meet the Specifications but are different than the Reata retained samples, and KHK then additional samples shall promptly supply be tested, or the Parties will mutually establish alternative tests to UGNX determine if the Licensed Product delivered to Kyowa Kirin was conforming Licensed Products in accordance with Section 8.2.7(b)or not.

Disputes Over Non-Conforming Licensed Product. In the event that KHK Reata disagrees with UGNXKyowa Kirin’s rejection because the Licensed Products are in fact conforming, the Parties shall cooperate to have both UGNXKyowa Xxxxx’s returned samples and KHKReata’s retained samples from the same production batch of the Licensed Products in dispute analyzed by a mutually acceptable independent testing laboratory of recognized reputation in the pharmaceutical industry, using the analytical methods, tests and criteria for conformance set forth in the Specifications. The out-of-pocket external costs of such arrangement shall be shared [***] equally by the Parties, unless and until an alternative determination is made as provided below. The results of such laboratory testing shall be conclusive and binding on the Parties on the issue of compliance of such units of Licensed Product with the Specifications at the time of Delivery. If such independent testing laboratory determines that UGNXKyowa Xxxxx’s returned samples of such Licensed Product conform to the Specifications, then (i) the applicable Licensed Product shall be deemed to have been improperly rejected by UGNXKyowa Kirin, and (ii) UGNX Kyowa Kirin shall bear the cost of the independent laboratory testing and and, solely if Kyowa Kirin so requests the return shipment thereof, all out-of-pocket external costs and expenses of returning the improperly rejected Licensed Product to UGNXKyowa Kirin. If such independent testing laboratory determines that UGNXKyowa Xxxxx’s returned samples of such Licensed Product did not conform to the Specifications and that such returned samples conform to the samples for such batch retained by KHKReata, then KHK Reata shall bear the cost of the laboratory testing, as well as the costs associated with properly-rejected Licensed Product described in Section subsection 8.2.7(b)) above. If such independent testing laboratory determines that Kyowa Xxxxx’s returned samples do not meet the Specifications but are different than the Reata retained samples, then additional samples shall be tested, or the Parties will mutually establish alternative tests to determine if the Licensed Product delivered to Kyowa Kirin was conforming or not. Specific terms in this Exhibit have been redacted because such terms are both not material and KHK shall promptly supply to UGNX conforming Licensed Products are of the type that the Company treats as private or confidential. These redacted terms have been marked in accordance this Exhibit with Section 8.2.7(b)three asterisks [***].