Referral to Independent Laboratory. In the event of a dispute between the Parties as to any defect in a Drug Substance or Drug Product, including whether a defect was a Detectable Defect or whether such defect existed at the time of delivery, that cannot be resolved within [***] days of a claim being made to Takeda pursuant to Section 8.1 or Section 8.2, the matter shall promptly (but in no case later than [***] Business Days after the expiration of such [***] day period) be submitted to an independent laboratory to be mutually agreed between the Parties. The independent laboratory will examine the Drug Substance or Drug Product at issue and determine the existence and, if relevant, the timing of any defect in the Drug Product. The decision of the independent laboratory shall be binding on the Parties, except in the case of fraud. Myovant shall bear the costs of the independent laboratory if the independent laboratory finds that the Drug Product or Drug Substance was not defective or that such defect did not exist at the time of delivery. Takeda shall bear the costs of the independent laboratory if the independent laboratory finds that the Drug Product or Drug Substance was defective at the time of delivery.
Appears in 3 contracts
Samples: Manufacturing Agreement (Myovant Sciences Ltd.), Manufacturing Agreement (Myovant Sciences Ltd.), Manufacturing Agreement (Myovant Sciences Ltd.)
Referral to Independent Laboratory. In the event of a dispute between the Parties as to any defect in a Drug Substance or Drug ProductSubstance, including whether a defect was a Detectable Defect or whether such defect existed at the time of deliverydelivery hereunder, that cannot be resolved within [***] days of a claim being made to Takeda pursuant to Section 8.1 9.1 or Section 8.29.2 hereof, the matter shall promptly (but in no case later than [***] Business Days after the expiration of such [***] day period) be submitted to an independent independent, qualified laboratory to be mutually agreed between the Parties. The Such independent laboratory will examine the Drug Substance or Drug Product at issue and determine the existence and, if relevant, the timing of any defect in the Drug ProductSubstance. The decision of the such independent laboratory shall be binding on the Parties, except in the case of fraud. Myovant shall bear the costs of the such independent laboratory if the such independent laboratory finds that the Drug Product or Drug Substance was not defective or that such defect did not exist at the time of deliverydelivery hereunder. Takeda shall bear the costs of the such independent laboratory if the such independent laboratory finds that the Drug Product or Drug Substance was defective at the time of deliverydelivery hereunder.
Appears in 2 contracts
Samples: Commercial Manufacturing & Supply Agreement (Myovant Sciences Ltd.), Commercial Manufacturing & Supply Agreement (Myovant Sciences Ltd.)