Product Supply. The Parties shall reasonably cooperate and assist each other in transferring ownership of Product drug product and/or Product drug substance (such material, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. collectively, the “Product Lots”) set forth in Exhibit A attached hereto as promptly as reasonably practicable following the Effective Date; provided, however, that neither Party shall be required to pay money to any Third Party, commence any litigation with, or offer or grant any accommodation (financial or otherwise) to any Third Party. Such Product Lots shall be delivered EXW (Ex Works) (Incoterms 2010) AMGEN, Thousand Oaks, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxes). Subject to the terms of this Section 5.4 and Section 6.2 (Additional AMGEN Warranties), AMGEN transfers the Product Lots to AKERO “as is”, and makes no other representation to AKERO in connection therewith. The Parties have entered into a Quality Agreement substantially in the form attached hereto as Exhibit F, dated as of the date hereof, governing the quality of the Product Lots to be supplied pursuant to this Section 5.4. For the avoidance of doubt, Product Lots consisting of drug product as set forth in Exhibit A supplied pursuant to this Section 5.4 shall be labeled for their intended clinical use as set forth in Exhibit A and the labeling of any Product drug product manufactured after the Effective Date shall be the responsibility of AKERO. Except for the Licensed Materials and such Product Lots to be transferred to AKERO, AKERO shall be responsible for, and shall bear the cost of, obtaining (whether by manufacturing or causing to be manufactured) research, clinical and commercial supplies of the Product. From and after the Effective Date, AKERO shall be responsible for all costs and expenses in connection with the storage of, and any stability studies performed on, the Product Lots.
Product Supply. XOMA shall supply exclusively (subject to Section 5.1) all of Alexion's requirements of Product in accordance with this Section 5.3. XOMA's supply obligations shall be limited to the reasonable capacity (one shift/day) of [*]. When [*] indicate that demand will exceed capacity of [*], the Parties will use commercially reasonable efforts to determine an appropriate means of expanding capacity.
Product Supply. 10.1 Northlands is not responsible for loss of, or damage howsoever caused to or by, the Licensee’s products, including, but not limited to, loss or damage as a result of the delivery of the Licensee’s products.
Product Supply. 5.2.1 HEMISPHERX undertakes and agrees to supply to IMPATIENTS on an exclusive basis, IMPATIENTS’ requirements of Product ordered in accordance with the terms of this Agreement, for distribution and sale in the Territory, limited to EAP use of Product in accordance with Early Access Approvals.
Product Supply. Ascentage shall supply Unity, its Affiliates and Sublicensees with such quantities of Clinical Materials and Licensed Compound as Unity, its Affiliates and Sublicensees may order from time-to-time during the term of the Agreement.
Product Supply. 5.1 In the event that Eisai notifies Radius of its desire to purchase bulk substance of Compound from Radius, Radius shall supply Eisai with all amount of such bulk substance of Compound, which meets specifications for the Product determined by Radius in the course of its Development activities pursuant to this Agreement, required by Eisai for commercial sales of Product in Japan With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai the bulk substance of Compound for * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of the bulk substance of Compound required for clinical trials in Japan. Radius shall charge Supply Price for applicable bulk substance of Compound. Radius shall ship such bulk substance of Compound, FOB point of manufacturing.
Product Supply. 9.1. BioCancell will, at its own expense, supply to the Fund all necessary quantities of the drugs to be used in the Trial, and only for the purposes as described in the Protocol. Any surplus shall be returned to BioCancell without delay, upon completion of the Trial or termination of this agreement for any reason whichever is the earlier.
Product Supply. 2.1 All FUJIFILM Products will be supplied by FUJIFILM to Customer in accordance with the terms and conditions of this Agreement.
Product Supply. During the Term, Cyclomedical shall supply multi-dose vials and/or individual unit doses of the Product (“Product Units”) to Customer as follows:
Product Supply. 4.1. [*] Supply. Subject to the terms and conditions of this Agreement, Salix agrees to supply, or cause its Affiliate or a Third Party to supply, to Xxxxxx during the Term, and Xxxxxx agrees to purchase from Salix, Salix’s Affiliate or such Third Party, as the case may be, [*] of Xxxxxx’x requirements of the Generic Product. Salix, in its sole discretion, shall determine whether to Manufacture the Generic Product or to have an Affiliate of Salix or Third Party Manufacture Generic Product.
