(each of [(a) through (c)] are referred to as a “Failure to Supply”), then immediately following such Failure to Supply and through and until such time as Alba fully resumes its supply obligations pursuant to this Agreement,

“Supply Failure” means # with respect to Product manufactured by Verrica or its Affiliate, a material or repeated failure to meet a firm order for Product or a material or repeated failure to manufacture Product in accordance with GMP (as such term will be defined in the Supply Agreements) or the applicable specifications for such Product; provided, that failure to meet ​, shall be deemed to be a Supply Failure, or # with respect to Product or components thereof that are manufactured by a CMO engaged by Verrica or its Affiliate, # that a breach of supply obligation (or corresponding term) under the applicable CMO agreement has occurred, or # Verrica’s material or repeated failure to make necessary arrangements with a CMO for manufacturing and supplying the Product in accordance with its obligations under the Clinical Supply Agreement or Commercial Supply Agreement.

“Failure” means sales by or on behalf of AcelRx are less than ​ of the Minimum Sales Obligations for such MY, and such failure is not justified or due to Aguettant’s failure in any of its contractual obligations (e.g., failure to supply, delay in supply, etc.).

In the event of a Supply Failure, Verrica shall promptly investigate the cause of the Supply Failure and the Parties shall discuss in good faith potential remedies or failure mitigation strategies, including potentially qualifying a second source of supply. Verrica shall use Commercially Reasonable Efforts to remedy such Supply Failure. In the case where Licensee is entitled to select or designate a new Third Party CMO pursuant to this [Section 7.8], promptly upon Licensee’s request, Verrica shall use Commercially Reasonable Efforts to introduce to Licensee one or more other Third Party CMOs that are, in the reasonable opinion of Verrica, suitable to manufacture the Product or component that was the subject of the applicable Supply Failure.

Article # FAILURE TO SUPPLY

The failure of INCY to supply the required Licensed Product(s) to Zai Lab for use in Clinical Trials in accordance with timelines provided in the Clinical Supply Agreement and such failure results in a Zai Lab delay;

“Supply Failure” means, for a given ​, that Lyra has failed to supply or cause to be supplied to Lian those quantities of Licensed Product ordered in accordance with the terms of the applicable Supply Agreement, and ​.

by Customer pursuant to Clause 7.5.2 (Uncured Supply Failure);

. Promptly after [[Durect:Organization]]’s receipt of the Manufacturing Notice, the Parties shall negotiate in good faith and enter into a supply agreement, together with a quality assurance agreement, pursuant to which [[Durect:Organization]] shall, itself or through one (1) or more Contractor(s), supply to Gilead, its Affiliates or its Sublicensees ​ quantities of [[Durect:Organization]] Excipients (including ​) for incorporation in Products for the Field in the Territory, and Gilead, its Affiliates or its Sublicensees shall purchase ​of [[Durect:Organization]] Excipients ​from [[Durect:Organization]] (subject to exceptions in the supply agreement in the case of [[Durect:Organization]]’s material breach, supply failure or interruption or failure to maintain safety stock). Such supply agreement shall contain customary terms for the supply of a pharmaceutical ingredient to address the forecasting, order, delivery, and other customary provisions applicable to the supply of pharmaceuticals, will include provisions and exceptions for supply failure or interruption and for maintenance by [[Durect:Organization]] of safety stock, ​ quantities of ​; provided that such ​; and provided further that, in no event shall ​.

Request to Supply. If ITEOS requests supply of Licensed Product from GSK for Development activities (including Additional Development Activities) conducted hereunder, then prior to any such supply, the Parties will enter into a clinical supply agreement and quality agreement under which GSK will, subject to [Section 5.3] (Prioritization of Supply), supply Licensed Product to ITEOS at a supply price equal to ​. Any requests for supply of Licensed Product by ITEOS from GSK will be ordered under such clinical supply agreement pursuant to the terms thereof and the Parties will not be obligated to enter into any additional supply agreements. The clinical supply agreement shall include terms for the required lead time from the date GSK receives the purchase order from ITEOS and the requested delivery date in the purchase order and will be on terms customary for supply agreements between collaboration partners with respect to Development of products.