Responsibility for Regulatory Applications in the Territory Clause Samples

Responsibility for Regulatory Applications in the Territory. Save in respect of the Ongoing Clinical Studies [**], Licensee shall be responsible, at its own cost, for filing and maintaining, in Licensee’s name, the INDs, BLAs and other regulatory applications necessary to obtain and maintain Marketing Authorization for each Licensed Product in all countries and jurisdictions in the Territory. Licensee shall allow Oncolytics to review and comment on all INDs, BLAs and other similar regulatory applications for each Licensed Product prior to submission to any Regulatory Authority in the Territory, as well as confer with Oncolytics regarding the preparation of such filings and communications and the registration process and any revisions to any filings or communications with the Regulatory Authorities. Licensee shall keep Oncolytics informed as to the status of its draft regulatory applications for each Licensed Product and shall provide copies of all communications with Regulatory Authorities on reasonable request by Oncolytics. If recording of this Agreement or any part of it by a Regulatory Authority is necessary for Licensee or Oncolytics to fully enjoy the rights, privileges and benefits of this Agreement, Licensee shall at its own expense record this Agreement or all such parts of this Agreement and information concerning the license granted hereunder with each such appropriate Regulatory Authority. Licensee shall (a) provide to Oncolytics for Oncolytics’ review and approval all documents or information it proposes to record complete at least ten (10) Business Days prior to the submission thereof, except submission required immediately, and (b) promptly notify Oncolytics with verification of Licensee’s recordation or any related agency decision. In making any such disclosures, Licensee shall maintain, to the fullest extent permitted by Law, the confidentiality of this Agreement, the terms and conditions of this Agreement and any other Confidential Information. Any specific disclosure made in accordance with this Clause 6.2 and not objected to by Oncolytics shall not constitute a breach of the Licensee’s obligations under Clause 17.
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Responsibility for Regulatory Applications in the Territory. ▇▇▇ shall be responsible, at its own cost, for the diligent filing and maintaining, in ▇▇▇’ name, the IDEs, PMAs and other regulatory applications necessary to obtain and maintain Regulatory Approval for each Licensed Product in the Field in the Territory, in a manner that is consistent with each applicable Development Plan. If requested by ▇▇▇, KTI shall review and comment in a timely manner on all IDEs, PMAs and other similar regulatory applications for each Licensed Product prior to submission to any Regulatory Authority in the Territory; and ▇▇▇ may as well confer with KTI regarding the preparation of such filings and communications and the registration process and any revisions to any filings or communications with the Regulatory Authorities provided, however, that the first filing for a Licensed Product or a new indication within the Field in a Major Market must be timely submitted to KTI for review and comment. It is the responsibility of ▇▇▇ to decide who shall attend regulatory meetings with Regulatory Authorities (e.g. scientific advice meeting prior to submission or meetings/advisory panel discussions under the approval process) and if requested by ▇▇▇, KTI shall, at the expense of ▇▇▇, attend such meetings. Any Regulatory Approval and Notification obtained by ▇▇▇ for any Licensed Product shall be exclusively owned by ▇▇▇.
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Related to Responsibility for Regulatory Applications in the Territory

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • APPROVAL OF GENERAL COMMUNICATIONS Competitive Supplier shall cooperate with the Town in the drafting and sending of messages and information to Eligible Consumers concerning the Program or any matter arising under or related to this ESA. Prior to sending any direct mail, advertising, solicitation, bill insert, electronic mail, or other similar written or electronic communication (collectively, “General Communications”) to Participating Consumers (but excluding individually drafted or tailored communications responding to the specific complaint or circumstance of an individual consumer), Competitive Supplier shall provide a copy of such General Communication to the Town for its review to determine whether it is consistent with the purposes and goals of the Town. The Town shall have the right to disapprove such General Communications and suggest revisions if it finds the communication inconsistent with the purposes and goals of the Town, factually inaccurate or likely to mislead; provided, however: (i) that the communication shall be deemed approved if the Town fails to respond within seven (7) business days; and (ii) that no approval shall be necessary for any communication (a) regarding any emergency situation involving any risk to the public health, safety or welfare; (b) which has been approved by or is required by the Department, the DOER, or any other Governmental Authority; or (c) in the nature of routine monthly or periodic bills, or collection notices, except that any bill insert or message included at the bottom of such bill not within the scope of (a) or (b) above shall require approval. If the Town objects to any General Communication on the grounds it is inconsistent with the purposes and goals of the Town, the Competitive Supplier, after consultation as provided in this Article 5.6, may nevertheless elect to send such General Communication provided that it: (i) clearly indicates on such mailing that it has not been endorsed by the Town, (ii) has previously provided all Participating Consumers a meaningful chance to opt not to receive such General Communications, (iii) has stated in connection with such chance to opt not to receive such communications that “the Town wants to protect Eligible Consumers from receiving marketing materials if you do not wish to do so,” and

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).