Examples of regulated product in a sentence
The Company has not been informed by any Regulatory Authority that such Regulatory Authority will prohibit the marketing, sale, license or use in the relevant territory of any Regulated Product proposed to be developed, produced or marketed by the Company nor has such Regulatory Authority expressed any concern as to approving or clearing for marketing any Regulated Product being developed or proposed to be developed by the Company.
Parent has not received any material notice or other material communication from the FDA or any other Governmental Entity (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of Parent or any of its Subsidiaries or (ii) otherwise alleging any violation applicable to any Regulated Product of Parent or any of its Subsidiaries by Parent or any of its Subsidiaries, Affiliates or agents of any Law.
In the event that during the Term of the License (as defined in Section 4 above), there is any Generic Competition (as defined below) with respect to a particular Regulated Product in a particular country in which such Regulated Product is being sold, and for so long as such Generic Competition persists, the royalty amount payable to Yissum for sales of such Regulated Product (only) in such country shall be reduced by ..
The Company has not received any material notice or other material communication from the FDA or any other Governmental Entity (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Company or any of its Subsidiaries or (ii) otherwise alleging any violation applicable to any Regulated Product by the Company or any of its Subsidiaries, Affiliates or agents of any Law.
Each Regulated Product is being manufactured, tested, distributed and marketed in material compliance with all Legal Requirements, including but not limited to those relating to investigational use, premarket clearance, good manufacturing practices, good laboratory practices, labeling, advertising, record keeping, filing of reports and security.