Regulatory Submission. a submission to the appropriate regulatory agency in any one of the United States or the European Union of a properly completed application (together with all required supplementary materials and supporting data) meeting all applicable requirements for approval that, if approved by the agency, would permit commercialization of the plant product without filing any additional applications or submitting any additional supporting data or other supplemental materials. If the submission meets the requirements set forth above, then whether or not the agency approves of the plant product is not relevant in determining whether Regulatory Submission has been achieved. If no Regulatory Submission is required, then the plant product shall be deemed to have achieved Regulatory Submission if it has been commercially sold.
Appears in 2 contracts
Sources: Enabling Technology License Agreement (Ceres, Inc.), Enabling Technology License Agreement (Ceres, Inc.)