Control and Ownership of Regulatory Filings Sample Clauses

Control and Ownership of Regulatory Filings. Subject to Section 6.4, Sanofi shall have sole discretion, control and responsibility to *** (collectively, “Regulatory Filings”) in the Territory with respect to any Licensed Products in the Field; provided, that IMDZ shall be the lead party for *** as set forth in Section 6.4(d); provided, further, that Sanofi shall regularly consult with and reasonably consider comments provided by IMDZ with respect to such Regulatory Filings and, with respect to any Regulatory Filings that are reasonably likely to adversely affect an IMDZ product, shall consider IMDZ’s comments with respect thereto in good faith. All such Regulatory Filings other than *** shall be in the name of, and be owned solely by, Sanofi. In addition, Sanofi shall have sole control and responsibility in the conduct of all pricing and reimbursement approval proceedings related to the Licensed Products.
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Control and Ownership of Regulatory Filings. (a) Subject to Section 11.4, [***] shall have sole discretion, control and responsibility to draft, prepare, submit and file, [***] all INDs, BLAs, the CMC filing, and other regulatory documents, dossiers and filings, (collectively, “Regulatory Filings”) in the Territory with respect to any Development Candidates or Licensed Products in the Field; provided that [***]. All such Regulatory Filings shall be in the name of, and be owned solely by, [***], other than [***], which shall be in the name of, and be owned solely by, [***]. In addition, [***] shall have sole control and responsibility in the conduct of all pricing and reimbursement approval proceedings related to the Licensed Products.
Control and Ownership of Regulatory Filings. Licensee shall have sole discretion, control and responsibility to draft, prepare, submit and file, at its own cost and expense, all Regulatory Files with respect to Licensed Products in the Field. All such Regulatory Files shall be in the name of, and be owned solely by, Licensee. In addition, Licensee shall have sole control and responsibility in the conduct of all pricing and reimbursement approval proceedings related to Licensed Products in the Field.
Control and Ownership of Regulatory Filings. Subject to Sublicensor’s, SLX’s and the SLX Licensees’ right of reference set forth in Section 3.1, Sublicensee shall have sole discretion, control and responsibility to draft, prepare, submit and file, at its own cost and expense, all Regulatory Files with respect to Licensed Program Products in the Program Field. All such Regulatory Files shall be in the name of, and be owned solely by, Sublicensee. In addition, Sublicensee shall have sole control and responsibility in the conduct of all pricing and reimbursement approval proceedings related to Licensed Program Products in the Program Field.

Related to Control and Ownership of Regulatory Filings

  • IP Ownership All Company Registered IP is owned by and registered or applied for solely in the name of a Group Company, is valid and subsisting and has not been abandoned, and all necessary registration, maintenance and renewal fees with respect thereto and currently due have been satisfied. No Group Company or any of its employees, officers or directors has taken any actions or failed to take any actions that would cause any Company Owned IP to be invalid, unenforceable or not subsisting. No funding or facilities of a Governmental Authority or a university, college, other educational institution or research center was used in the development of any material Company Owned IP. No material Company Owned IP is the subject of any Lien, license or other Contract granting rights therein to any other Person. No Group Company is or has been a member or promoter of, or contributor to, any industry standards bodies, patent pooling organizations or similar organizations that could require or obligate a Group Company to grant or offer to any Person any license or right to any material Company Owned IP. No Company Owned IP is subject to any proceeding or outstanding Governmental Order or settlement agreement or stipulation that (a) restricts in any manner the use, transfer or licensing thereof, or the making, using, sale, or offering for sale of any Group Company’s products or services, by any Group Company, or (b) may affect the validity, use or enforceability of such Company Owned IP. Each Principal has assigned and transferred to a Group Company any and all of his/her Intellectual Property related to the Business. No Group Company has (a) transferred or assigned any Company IP; (b) authorized the joint ownership of, any Company IP; or (c) permitted the rights of any Group Company in any Company IP to lapse or enter the public domain.

  • 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.

  • Healthcare Regulatory Matters (a) Each Company Group Member is currently in material compliance with and, since January 1, 2019, each Company Group Member has complied in all material respects, with all Applicable Healthcare Industry Laws. Since January 1, 2019, each Company Group Member has maintained and complied in all material respects with a corporate compliance program that includes the implementation of policies, procedures, and training programs, and other compliance activities designed for its employees and agents to comply with all Applicable Healthcare Industry Laws.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Ownership Information The Participant hereby covenants that so long as the Participant holds any LTIP Units, at the request of the Partnership, the Participant shall disclose to the Partnership in writing such information relating to the Participant’s ownership of the LTIP Units as the Partnership reasonably believes to be necessary or desirable to ascertain in order to comply with the Code or the requirements of any other appropriate taxing authority.

  • Ownership Rights Nothing contained in this Agreement shall be construed as (a) establishing or granting to Registry Operator any property ownership rights or interests of Registry Operator in the TLD or the letters, words, symbols or other characters making up the TLD string, or (b) affecting any existing intellectual property or ownership rights of Registry Operator.

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