2.5 mg Dosage Strength definition
Examples of 2.5 mg Dosage Strength in a sentence
Neither Seller nor its Affiliates is in violation of the terms of any Regulatory Approval related to the Product, the 2.5 mg Dosage Strength or [***] Product.
In addition, any orders for excess amounts of Product or 2.5 mg Dosage Strength, as applicable, submitted under Section 3.3(b) shall, subject to Section 3.3(b), be binding on Seller to the extent Seller accepts such orders.
Seller has not received any written notice, charge, subpoena or other request for information, which has not been complied with or withdrawn, by a Governmental Authority asserting any material breach of the conditions for approval of any ongoing clinical trials for the Product or the 2.5 mg Dosage Strength in the Buyer Territory.
For the 2.5 mg Dosage Strength, Seller will manufacture [***] validation batches as described above.
To Seller’s Knowledge, other than the Licensed Intellectual Property, Seller and its Affiliates do not own or have license rights to any Intellectual Property Rights in the Buyer Territory that would be infringed, violated or misappropriated by use, offer for sale or sale (by an unauthorized Third Party) of Product the 2.5 mg Dosage Strength or the [***] Product in the Buyer Territory, as the Product Business is currently being conducted.
Seller and its Affiliates have made all necessary material filings and received all necessary material approvals and consents for the conduct of such Phase IV clinical trials and 2.5 mg Clinical Trials from the necessary Governmental Authorities and, to Seller’s Knowledge, there is no Litigation pending or threatened by such Governmental Authorities to suspend or terminate any ongoing clinical trials for the Product or the 2.5 mg Dosage Strength in the Buyer Territory.
Seller has not voluntarily or involuntarily surrendered, terminated or permitted to lapse or expire any Regulatory Approval used or maintained by Seller in the conduct of the Product Business or the development of the 2.5 mg Dosage Strength or [***] Product in the Buyer Territory, except where any such Regulatory Approval has been not renewed in the ordinary course of business.
For any future orders of the 2.5 mg Dosage Strength, purchase orders will be placed with at least [***] lead time for initial orders.
Parties shall negotiate in good faith and agree on a reasonable forecasting process for 2.5 mg Dosage Strength Product a reasonable time prior to approval of such Product.
For clarity, Buyer shall pay to Seller (x) the Floor Price for validation batches of 2.5 mg Dosage Strength Manufactured in connection with the activities described in this Section 2.7, and (y) the Supply Price for 2.5 mg Dosage Strength validation batch product supply that is sold commercially in the Buyer Territory.