Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds, and each Party may propose a Subsequent Study (as defined below) in connection therewith in accordance with Section 3.14.
Regulatory Submission. 3.1.1 Eyemax shall own any Registrations for Product and hereby grants to Eton exclusive rights under all such Registrations.
Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds. In such event, the Parties will enter into good faith negotiations to determine a regulatory submission strategy for the Compounds [*].
Regulatory Submission. To the extent required by Law, and within 30 days after the Effective Date of this Agreement, Supplier, its Subcontractors and/or any Managed Third Party Telecom Transport Provider shall file any applicable tariff, tariff option or other regulatory submission required to implement the Agreement. Such filing shall be consistent in all material respects with all applicable provisions of this Agreement and shall not be less favorable to Kraft and the Eligible Recipients than the rates and other terms and conditions of this Agreement. Supplier shall make a copy of any applicable filings available to Kraft for Kraft’s review and inspection and shall provide Kraft with a copy of all amendments to such tariffs or other filings having a bearing on the Agreement when such amendments are filed with the appropriate governmental agencies. In addition, Supplier shall provide a draft of any revisions that may substantively affect Kraft’s rights and obligations under this Agreement at least 10 days before such revisions are filed with and Applicable Regulatory Authority, where feasible. If Supplier, its Subcontractors and/or any Managed Third Party Telecom Transport Provider makes revisions to a tariff, tariff option or other submission that materially and adversely affect Kraft’s rights hereunder without obtaining Kraft’s prior written consent, Kraft shall have the right to terminate any affected portions of this Agreement without payment of Termination Charges or other liability.
Regulatory Submission. Aptalis shall be responsible for fulfilling Spontaneous AE reporting obligations to the Competent Authorities or Regulatory Agency in the Territory and Strakan shall be responsible for fulfilling Spontaneous AE reporting obligations to the Competent Authorities or Regulatory Agency outside the Territory. Strakan and Aptalis will make every effort to ensure that their respective partners are accountable for the regulatory submission where neither Party is the MA holder for the Subject Product.
Regulatory Submission. It is understood and acknowledged by the Parties that positive Clinical Data may be used to[***].
Regulatory Submission. At the appropriate time, Scopus Biopharma plans to file a pre-IND meeting request with FDA to confirm that the planned CMC and non-clinical tasks will support the initiation of the proposed Phase 1 clinical trials. In this way, course corrections in the development plan can be made early on, expediting development and avoiding waste of resources. Following the completion of the Phase 1 clinical studies, Scopus Biopharma intends to request an end of phase 1 (EOP) meeting. At the completion of the Phase 2 study, we expect to file for an EOP2 meeting. Following the completion of the Phase 3 pivotal trials, a pre-NDA meeting will be requested and a NDA 505(b)2 will be filed. Development Event Anticipated Timeline Complete IND enabling pre-clinical studies [ ] Phase 1 clinical studies start [ ] Phase 2 clinical study start [ ] Phase 3 clinical studies start [ ] NDA [ ] NB: This development plan is subject to change based on circumstance and regulatory requirements.
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.
Regulatory Submission. PDTI shall be responsible for preparing and filing in its own name any IDE or IND which may be necessary for conducting Clinical Tests of SnET2 Light Devices. PDTI shall be responsible for preparing and submitting PMAs or other regulatory submissions for SnET2 Light Devices;, except in those countries where PMAs are not independent from an NDA for SnET2, in which case P&U shall have primary responsibility for the submission. All regulatory submissions for SnET2 Light Devices shall be filed in the name of, and shall remain the sole and exclusive property of PDTI, except in such countries which require that regulatory approvals be held by the distributor in such country. Each party shall provide the other with copies of all regulatory submissions. If any information is submitted to the FDA directly by the Light Device Provider or other third party, P&U shall be granted rights of reference or other rights to such submissions adequate for it to comply with all regulatory requirements. P&U shall be responsible for, and PDTI shall cooperate with, securing government or private price approvals and reimbursement qualifications in preparation for product launch of SnET2 Light Devices (other than SnET2 Light Sources).
Regulatory Submission. No revisions to the Specifications that would affect the Processing and/or Packaging of a specific Product shall be submitted to any Regulatory Authorities unless approved by both Parties in writing. It is understood by both Parties that changes mandated by Regulatory Authorities shall be acted upon with due diligence.
