Preparation of Regulatory Submissions Sample Clauses

Preparation of Regulatory Submissions. Subject to the terms of this Agreement, and except as expressly set forth in Section 3.2 (Preparation of the Initial U.S. MAA and the Initial E.U. MAA), the Regulatory Responsible Party will be responsible for the preparation and submission of all Regulatory Submissions for the Licensed Products in the Field in the Territory. If uniQure is the Regulatory Responsible Party, then uniQure: (a) will be subject to Partner’s direction, oversight, review, and approval of all Regulatory Submissions and uniQure shall act in accordance with Partner’s reasonable direction; (b) will provide Partner with an opportunity to ​ ​
Sample 1
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Preparation of Regulatory Submissions. Under the oversight of the SC, Yakult shall, at its sole cost and expense, prepare, obtain and maintain, Regulatory Approvals for the Licensed Product in Japan; provided, however, that if Applicable Law in Japan requires that GPC Biotech (or its Third Party supplier under the Supply Agreement) obtain and maintain a foreign manufacturer registration, Yakult shall, at GPC Biotech’s reasonable cost and expense, provide GPC Biotech (or such Third Party supplier) such assistance as GPC Biotech reasonably may request. Ownership of Regulatory Approvals and related submissions within Japan relating to the Licensed Product shall be governed by Section 7.1.4.
Sample 1
Preparation of Regulatory Submissions. The JDC shall have the right to review the content and subject matter of, and strategy for, each MAA and other material filing for Regulatory Approval, all material correspondence submitted to the Regulatory Authorities related to the design of Regulatory Clinical Trials, and all proposed Product Labeling for the Product and related material communications and material decisions with the Regulatory Authorities (including the final approved Product Labeling for the Product and any changes thereto), in each case to the extent relating to the Territory. Notwithstanding the foregoing, Lundbeck shall not be required to delay a regulatory submission in a manner that affects Lundbeck’s ability to comply with Applicable Law. Myriad shall be responsible for preparing and delivering to Lundbeck a complete CMC package and a complete initial draft of any CMC non-clinical and clinical section (and any similar sections) of any Marketing Authorisation Application or other Regulatory Documentation for Lundbeck’s review, amendment and use in connection with any XXXx or other Regulatory Documentation or correspondence with respect to the Product in the Territory. Such CMC section and CMC package shall be delivered to Lundbeck in e-CTD format (or such other format as may be reasonably requested by Lundbeck).
Sample 1
Preparation of Regulatory Submissions. The JSC shall have the right to review the content and subject matter of the MAA submitted to the EMA and other material filing for Regulatory Approval and material correspondence submitted to EMA related to the design of Regulatory Clinical Trials, and to the proposed and final Product Labeling for the Product and any changes thereto. Notwithstanding the foregoing, Recordati shall not be required to delay a regulatory submission in a manner that affects Recordati’s ability to comply with Applicable Law nor to submit the above materials, correspondence, communications to the JSC or request related decisions of the JSC in advance of Recordati’s submissions or decisions. Nymox shall be responsible for preparing and delivering to Recordati in a timely manner a complete CMC package and a complete initial draft of any CMC non-clinical and clinical section (and any similar sections) of any Marketing Authorisation Application or other Regulatory Documentation for Recordati’s review, amendment and use in connection with any XXXx or other Regulatory Documentation or correspondence with respect to the Product in the Territory. Such CMC section and CMC package shall be delivered to Recordati in e-CTD format (or such other format as may be reasonably requested by Recordati).
Sample 1
Preparation of Regulatory Submissions. Through their members on the JDC, Medarex and BMS shall cooperate in the drafting and review of all submissions (including any supplements or modifications thereto, but excluding routine adverse event filings (i.e., not relating to serious adverse events as defined by Applicable Law)) to the FDA (including the preparation of an electronic submission of a BLA to the FDA, with the applicable Lead Regulatory Party having primary responsibility for preparing the electronic dossier for each Indication). Each Party shall promptly provide the other with copies of all written or electronic communications received by it from, or sent by it to, the FDA with respect to obtaining and maintaining, Approvals for an Indication for a Product in the United States (it being understood that routine adverse event filings (i.e., not relating to serious adverse events as defined by Applicable Law)) shall not fall within the meaning of maintenance) and copies of all contact reports produced by such Party.
Sample 1
Preparation of Regulatory Submissions. The Lead Regulatory Party in a country shall prepare and draft all submissions (including any supplements or modifications thereto and including the preparation of any electronic submission of a Drug Approval Application) to Regulatory Authorities in such country. Through the Parties’ members on the JDC, the Lead Regulatory Party shall keep the other Party informed with respect to, and shall promptly provide to such other Party copies of, all material written or electronic communications received by it from, or sent by it to, (a) a Regulatory Authority in a Major Market Country or for the EU, and (b) a Regulatory Authority outside the Major Market Countries to the extent that the substance of such communications (i) vary materially from what the Lead Regulatory Party has already disclosed to such other Party with respect to a Major Market Country under this Section 3.5.2 and (ii) are material to the Collaboration.
Sample 1

Related to Preparation of Regulatory Submissions

  • Preparation and Submission The Recipient will:

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • 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).

  • Application Submission Submissions of a rental application does not guarantee approval or acceptance. It does not bind us to accept the application or to sign a Lease contact. APPLICANT SCREENING CRITERIA Fair Housing Statement. Xxxxx Management is an equal housing opportunity & fair housing provider. We do not discriminate against persons on the basis of race, color, religion, national origin, sex, familial status, disability, creed, marital status, public assistance, ancestry, and sexual or affectional orientation. Identification and Application Process. Every person over 18 must give consent to be screened and provide a government issued photo ID. Social Security Number verification may be required for specific housing programs. Application Requirements. Applications must be filled out completely and accurately. Any misstatements or omissions made on your application, whether or not discovered before you move into the building, is grounds for denial of an application or termination of an existing lease. Information must be legible and verifiable. If information given on the application cannot be verified, this is a reason for rejection. Omission of information, such as an address or employer, may be grounds for rejection. Occupancy. The initial maximum number of residents in a unit is equal to two persons per bedroom unless otherwise stated in the property’s Resident Selection Plan, where applicable. Each unit is limited to no more than two (2) unrelated or four (4) related adult persons per unit. Xxxxx Management defines a related adult person as either a child, dependent, or parent of the head of household. General occupancy standards and any federal, state, or local housing ordinances will supersede this policy. Housing History. We require the name and last known telephone number of each landlord/property manager for each address you have had for the last three years. Roommate references are not acceptable. The refusal of a prior landlord to give a reference, or a negative reference, may be grounds for rejection. In the case of first-time renters, or applicants without prior rental history, this requirement may be varied subject to additional requirements of management. Eviction Filings. Unlawful detainers or evictions within the past five (5) years is a basis for denial of an application.

  • REPORT SUBMISSION 1. Copies of reporting packages for audits conducted in accordance with 2 CFR Part 200, Subpart F-Audit Requirements, and required by PART I of this form shall be submitted, when required by 2 CFR 200.512, by or on behalf of the recipient directly to the Federal Audit Clearinghouse (FAC) as provided in 2 CFR 200.36 and 200.512

  • SUBMISSIONS You acknowledge and agree that any questions, comments, suggestions, ideas, feedback, or other information regarding the Site ("Submissions") provided by you to us are non-confidential and shall become our sole property. We shall own exclusive rights, including all intellectual property rights, and shall be entitled to the unrestricted use and dissemination of these Submissions for any lawful purpose, commercial or otherwise, without acknowledgment or compensation to you. You hereby waive all moral rights to any such Submissions, and you hereby warrant that any such Submissions are original with you or that you have the right to submit such Submissions. You agree there shall be no recourse against us for any alleged or actual infringement or misappropriation of any proprietary right in your Submissions.

  • COPIES OF REGULATORY REPORTS AND FILINGS Upon reasonable request, Competitive Supplier shall provide to the Town a copy of each public periodic or incident-related report or record relating to this ESA which it files with any Massachusetts or federal agency regulating rates, service, compliance with environmental laws, or compliance with affirmative action and equal opportunity requirements, unless the Competitive Supplier is required by law or regulation to keep such reports confidential. The Town shall treat any reports and/or filings received from Competitive Supplier as confidential information subject to the terms of Article 16. Competitive Supplier shall be reimbursed its reasonable costs of providing such copies.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

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