OTC Field definition
Examples of OTC Field in a sentence
Except for ANDA No. 76-050 and ANDA No. 75-989, WCH shall file, own and maintain all other submissions for Regulatory Approval and Pricing Approval of Products for the OTC Field in the Exclusive Territory.
WCH shall be responsible for all communications with the FDA and other Regulatory Authorities regarding applications for Regulatory Approval submitted by WCH and post-Regulatory Approval regulatory requirements for Product marketed by WCH for the OTC Field in the Territory, including pharmacovigilance and Adverse Drug Experience reporting, unless otherwise agreed in advance in writing by the Parties.
During the Term, neither WCH nor its Affiliates shall market, promote, use, distribute, sell, have sold, import, export, make or have made a Competing Product for the OTC Field in the Territory.
During the Term, IMPAX and its Affiliates shall only sell Product for the OTC Field in the Exclusive Territory to WCH and shall not market, promote, use, distribute, sell, have sold, import, export, make or have made either a twelve-hour or twenty-four hour, extended release Loratadine and Pseudoephedrine combination product (other than the Products) which is, in dosage strength, identical to either Product (a "Competing Product") to a Third Party for the OTC Field in the Exclusive Territory.
During the Term, IMPAX and its Affiliates shall only sell Product for the OTC Field in the Exclusive Territory to WCH and shall not market, promote, use, distribute, sell, have sold, import, export, make or have made either a twelve-hour or twenty-four hour, extended release Loratadine and Pseudoephedrine combination product (other than the Products) which is, in dosage strength, identical to either Product (a “Competing Product”) to a Third Party for the OTC Field in the Exclusive Territory.
CIMA and WCH wish to amend the Original Supply Agreement to remove the OTC Field (as defined herein) and to enter into this Supply Agreement which relates only to the OTC Field, all on the terms and subject to the conditions set forth herein.
In addition to the foregoing, WCH shall have an exclusive license under the CIMA Patents and Technical Information, and CIMA's interest in the Joint Patent Rights, to make (and to have made) Product for the OTC Field in the Territory subject to, and in accordance with, the provisions of Section 11.3(b) and the applicable provisions of the Supply Agreement.
Subject to Section 2.9, WCH shall exclusively purchase all of WCH's requirements of Product for the OTC Field in the Territory from CIMA and CIMA shall exclusively supply Product for the OTC Field to WCH in the Territory.
In addition, WCH shall provide CIMA with a non-binding estimate of its annual Net Sales of Product by quarter ninety (90) days prior to the Launch Date of Product in the OTC Field.
WCH shall be responsible for and shall file, own and maintain all submissions for Regulatory Approval and Regulatory Approvals of Product for the OTC Field in the United States.