Ownership of Data and Regulatory Approvals Sample Clauses

Ownership of Data and Regulatory Approvals. Except as otherwise set forth in this Agreement, all data and information generated by any Development Activities pursuant to this Section 3.1 shall be owned by Rosemont and/or its Affiliates and shall be deemed Licensed Know-How. Rosemont and/or its Affiliates shall hold and own all Regulatory Approvals. Rosemont grants to Oncogenerix the sole and exclusive right to market the Licensed Product under Rosemont’s and/or its Affiliates’ Regulatory Approvals in the Field in the Territory. Oncogenerix shall hold and own all Prescriber Data, marketing, sales, distribution and other commercialization data and other marketing, sales, distribution and commercialization information resulting from the Activities regarding the Licensed Product undertaken by Oncogenerix (and/or its Affiliates and sublicensees) in the Field in the Territory following the Effective Date (together referred to as “Oncogenerix Data”). Upon request, Oncogenerix shall make available to Rosemont any and all Oncogenerix Data within Oncogenerix’s (or Oncogenerix’s Affiliates’ and/or sublicensees’) possession or control that Rosemont may need to comply with FDA reporting requirements and other regulations; Oncogenerix shall provide copies of any documents, in electronic or paper form as requested by Rosemont, within five (5) business days of Rosemont’s request.
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Ownership of Data and Regulatory Approvals. LICENSOR and LICENSEE will fully cooperate in the activities referenced in Section 8.02 ("LICENSOR Responsibilities") and Section 8.03 ("LICENSEE Responsibilities"), including sharing all data obtained in connection with such activities. LICENSEE will own the clinical study data and regulatory approvals; provided, however, that LICENSOR shall have access and rights of reference to such information for (i) purposes of use in products other than the LICENSED PRODUCTS; and (ii) for all internal research purposes. In the event of any early termination of this Agreement for reasons other than an uncured material breach by LICENSOR, rights to regulatory filings, data and approvals for the LICENSED PRODUCTS will automatically be assigned to and vested in LICENSOR, and LICENSEE shall execute and deliver any and all appropriate documents to evidence and perfect such rights in LICENSOR. LICENSEE shall regularly disclose to LICENSOR all data and information relating to the clinical study data, regulatory filings and regulatory approvals relating to LICENSED PRODUCTS.
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Ownership of Data and Regulatory Approvals. ATS and IMDC will ------------------------------------------ fully cooperate in the activities referenced in Section 3.2 ("ATS Responsibilities") and Section 3.3 ("IMDC Responsibilities"), including sharing all data obtained in connection with such activities. [**] will own the clinical study data and regulatory approvals; provided, however, that [**] shall have access to such information for (i) purposes of [**
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Ownership of Data and Regulatory Approvals. Except as otherwise ------------------------------------------- set forth in this Agreement, all data and information generated by Savient development activities pursuant to this Section 3.1 shall be owned by Savient and/or its Affiliates and shall be deemed Licensed Know-How. Savient and/or its Affiliates shall own all Regulatory Approvals. Savient shall grant to Cytogen the sole and exclusive right to market the Licensed Product under Savient's and/or its Affiliates' Regulatory Approvals in the Field in the Territory. Cytogen shall own all Prescriber Data, marketing (including the Promotion Plan), sales, distribution and other commercialization data and other marketing, sales, distribution and commercialization information resulting from the distribution of the Licensed Product by Cytogen following the Effective Date. Upon request, Cytogen shall make available to Savient any data or information within Cytogen's (or Cytogen's Affiliates') possession or control that Savient may need to comply with FDA reporting requirements and other regulations; Cytogen shall provide copies of any documents, in electronic or paper form as requested by Savient, within three (3) business days of Savient's request. Upon termination or expiration of this Agreement for any reason other than Savient's breach, Cytogen shall (to the extent that Cytogen has a right to do so) transfer ownership to Savient of all then-current Prescriber Data, marketing (including the Promotion Plan), sales, distribution and other commercialization data and other marketing, sales, distribution and commercialization information resulting from the distribution of the Licensed Product by Cytogen. If the Agreement is terminated because of Savient's breach, then Savient shall pay Cytogen fair and reasonable compensation to be negotiated in good faith by the parties (but not to exceed Cytogen's reasonable out-of-pocket expenses incurred in transferring such data and information) to compensate Cytogen for its efforts to transfer to Savient the above-described data and information.
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Ownership of Data and Regulatory Approvals. ATS and IMDC will fully cooperate in the activities referenced in Section 3.2 (“ATS Responsibilities”) and Section 3.3 (“IMDC Responsibilities”), including sharing all data obtained in connection with such activities. IMDC will own the clinical study data and regulatory approvals; provided, however, that ATS shall have access to such information for (i) purposes of marketing the ATS Intellectual Property rights to other parties for use in products other than the Subject Products; and (ii) for internal research purposes. In the event of any early termination of this Agreement for reasons other than a breach by ATS, rights to regulatory filings, data and approvals for the Product Portfolio will automatically be granted to and vested in ATS, and IMDC shall execute and deliver any and all appropriate documents to evidence and implement such rights.
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Related to Ownership of Data and Regulatory Approvals

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • Governmental and Regulatory Approvals Other than the filing of the Articles of Merger provided for under Section 1.3, all consents, approvals and actions of, filings with and notices to any Governmental Entity required by the Company, Parent or any of their subsidiaries under applicable law or regulation to consummate the Merger and the transactions contemplated by this Agreement, the failure of which to be obtained or made would result in a material adverse effect on Parent’s ability to conduct the business of the Company in substantially the same manner as presently conducted, shall have been obtained or made (all such approvals and the expiration of all such waiting periods, the “Requisite Regulatory Approvals”).

  • 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.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Other Regulatory Approvals Each party hereto shall cooperate and use its reasonable best efforts to promptly prepare and file all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and use all reasonable efforts to obtain (and will cooperate with each other in obtaining) any consent, acquiescence, authorization, order or approval of, or any exemption or nonopposition by, any Governmental Entity required to be obtained or made by Parent or the Company or any of their respective Subsidiaries in connection with the Offer and the Merger or the taking of any other action contemplated by this Agreement.

  • Regulatory Approvals; Efforts (a) Prior to the Closing, Parent, Merger Sub and the Company shall use their respective reasonable best efforts to take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary, proper or advisable under any applicable Laws to consummate and make effective the Merger including (i) the preparation and filing of all forms, registrations and notices required to be filed to consummate the Merger, (ii) the satisfaction of the conditions to consummating the Merger, (iii) taking all reasonable actions necessary to obtain (and cooperating with each other in obtaining) any consent, authorization, Order or approval of, or any exemption by, any third party, including any Governmental Entity (which actions shall include furnishing all information and documentary material required under the HSR Act) required to be obtained or made by Parent, Merger Sub, the Company or any of their respective Subsidiaries in connection with the Merger or the taking of any action contemplated by this Agreement, and (iv) the execution and delivery of any additional instruments necessary to consummate the Merger and to fully carry out the purposes of this Agreement. Additionally, each of Parent, Merger Sub and the Company shall use reasonable best efforts to fulfill all conditions precedent to the Merger and shall not take any action after the date of this Agreement that would reasonably be expected to materially delay the obtaining of, or result in not obtaining, any permission, approval or consent from any such Governmental Entity necessary to be obtained prior to Closing. To the extent that transfers of any permits issued by any Governmental Entity are required as a result of the execution of this Agreement or the consummation of the Merger, the parties hereto shall use reasonable best efforts to effect such transfers.

  • 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 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.

  • Regulatory Approvals; No Defaults (a) No consents or approvals of, or waivers by, or filings or registrations with, any Governmental Authority are required to be made or obtained by HCBF or any of its Subsidiaries in connection with the execution, delivery or performance by HCBF of this Agreement or to consummate the transactions contemplated by this Agreement, except as may be required for (i) filings of applications and notices with, and receipt of consents, authorizations, approvals, exemptions or nonobjections from, the SEC, NASDAQ, state securities authorities, the Financial Industry Regulatory Authority, Inc., applicable securities, commodities and futures exchanges, and other industry self-regulatory organizations (each, an “SRO”), (ii) filings of applications or notices with, and consents, approvals or waivers by the FRB, the FDIC and applicable state banking agencies, the Office of the Comptroller of the Currency (the “OCC”), the Florida Office of Financial Regulation (the “FOFR”) and other banking, regulatory, self-regulatory or enforcement authorities or any courts, administrative agencies or commissions or other Governmental Authorities and approval of or non-objection to such applications, filings and notices (taken together with the items listed in clause (i), the “Regulatory Approvals”), (iii) the filing with the SEC of the Proxy Statement-Prospectus and the Registration Statement and declaration of effectiveness of the Registration Statement, (iv) the filing of the Articles of Merger and the filing of documents with the OCC, applicable Governmental Authorities, and the Secretary of State of the State of Florida to cause the Bank Merger to become effective and (v) such filings and approvals as are required to be made or obtained under the securities or “Blue Sky” laws of various states in connection with the issuance of the shares of CenterState Common Stock pursuant to this Agreement and approval of listing of such CenterState Common Stock on the NASDAQ. Subject to the receipt of the approvals referred to in the preceding sentence and the Requisite HCBF Shareholder Approval, the execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby by HCBF do not and will not (1) constitute a breach or violation of, or a default under, the articles of incorporation, bylaws or similar governing documents of HCBF or any of its respective Subsidiaries, (2) violate any statute, code, ordinance, rule, regulation, judgment, order, writ, decree or injunction applicable to HCBF or any of its Subsidiaries, or any of their respective properties or assets, (3) conflict with, result in a breach or violation of any provision of, or the loss of any benefit under, or a default (or an event which, with or without notice or lapse of time, or both, would constitute a default) under, result in the creation of any Lien under, result in a right of termination or the acceleration of any right or obligation under any permit, license, credit agreement, indenture, loan, note, bond, mortgage, reciprocal easement agreement, lease, instrument, concession, contract, franchise, agreement or other instrument or obligation of HCBF or any of its Subsidiaries or to which HCBF or any of its Subsidiaries, or their respective properties or assets is subject or bound, or (4) require the consent or approval of any third party or Governmental Authority under any such Law, rule or regulation or any judgment, decree, order, permit, license, credit agreement, indenture, loan, note, bond, mortgage, reciprocal easement agreement, lease, instrument, concession, contract, franchise, agreement or other instrument or obligation.

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