Responsibility for Regulatory Matters Sample Clauses

Responsibility for Regulatory Matters. Unless otherwise agreed by the Parties in writing, Galapagos shall be solely responsible for all regulatory matters relating to any Pre-Program Activities or Galapagos Product.
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Responsibility for Regulatory Matters. All regulatory matters regarding obtaining and maintaining any necessary clearance or other permit, permission, consent or approval, or promotion or labeling, or otherwise complying or assuring compliance with applicable law for or relating to the importation, sale and use of Celera Products, if any such requirements exist, from the FDA, or under the European IVD Directive or any other body or agency, will remain under the exclusive control of Celera and will be solely Celera’s responsibility. AB will provide Celera access to documentation under AB’s control reasonably required for Celera Product regulatory registration (subject to AB’s reasonable confidentiality requirements), provided that any such registration will not impose any duties or requirements on AB or require AB to take any action except to permit regulatory inspections as and to the extent expressly set forth in Section 11.3 of this Agreement. 12 Defects and Returns
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Responsibility for Regulatory Matters. Following the Regulatory Transition Date, Gilead will be solely responsible for all regulatory matters relating to any Licensed Product or Gilead Combination Product in the Territory, and shall use Commercially Reasonable Efforts with respect to such regulatory matters for the first Licensed Product in each Major Market in each Target Indication, and Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with such regulatory matters. Notwithstanding anything to the contrary in this Agreement, the immediately foregoing obligation with respect to Commercially Reasonable Efforts in the Major Markets and the Target Indications shall be Gilead’s sole diligence obligation with respect to regulatory matters for Licensed Products and Gilead Combination Products, and Gilead shall have the sole right, but not any obligation, with respect to regulatory matters for other Licensed Products and Gilead Combination Products in other countries or for other indications and no diligence obligation of Gilead shall arise under this Agreement with respect to seeking or obtaining Regulatory Approvals for Gilead Combination Products. Gilead’s sole responsibility shall include (i) overseeing, monitoring and coordinating regulatory actions, communications and filings with, and submissions to, Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Products; (ii) interfacing, corresponding and meeting with Regulatory Authorities in the Territory with respect to Licensed Products and Gilead Combination Products; (iii) seeking and maintaining regulatory filings in the Territory with respect to Licensed Products and Gilead Combination Products; and (iv) maintaining and submitting records required to be maintained or required to be submitted to any Regulatory Authority in the Territory with respect to Licensed Products and Gilead Combination Products.
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Responsibility for Regulatory Matters. 9 3.5 Abandonment by BMS................................. 11 3.6 Development and Marketing Obligations of BMS....... 12 3.7
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Responsibility for Regulatory Matters. Under the auspices of, and subject to review and approval by, the Joint Development Committee, the Parties shall have the following responsibilities relating to regulatory matters with respect to the Product in the Territory:
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Responsibility for Regulatory Matters. 3.1.1 Subject to the terms and conditions of this Agreement, including oversight by the JCC, except as set forth herein, DS shall be solely responsible, [***], for all regulatory matters relating to each Licensed Product in the DS Territory, including (a) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, the applicable Regulatory Authority with respect to Licensed Products; (b) interfacing, corresponding and meeting with the applicable Regulatory Authority with respect to Licensed Products; (c) seeking and maintaining all Regulatory Approvals with respect to Licensed Products, including any amendments, supplements or modifications to Regulatory Approvals; and (d) maintaining and submitting all records required to be maintained or required to be submitted to the applicable Regulatory Authority with respect to Licensed Products, in each case in the DS Territory. Notwithstanding anything to the contrary in this Agreement, Esperion shall be responsible, [***], for (i) preparing and maintaining the drug master file(s) for the API(s) containing data and information related to the Manufacture of the API(s) for the Licensed Products (the “DMF”), including any amendments (ii) providing the DMF directly to the applicable Regulatory Authority in the DS Territory, and (iii) communicating with Regulatory Authorities in the DS Territory regarding the DMF. DS shall be entitled to reference the DMF in Regulatory Documentation, including in applications for Regulatory Approval, for the Licensed Product in the DS Territory. Esperion shall provide all assistance reasonably requested by DS in connection with such preparation and filing of Regulatory Documentation and communications with Regulatory Authorities, including but not limited to responding to any queries related to the Licensed Products received from such Regulatory Authority; provided, however, that Esperion shall not be required to [***] in connections therewith unless [***], and, at the request of DS and at [***], Esperion shall send representative(s) of Esperion to attend in-person meetings with Regulatory Authorities in the DS Territory relating to the Manufacture of API(s) or Bulk Tablets.[***]
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Responsibility for Regulatory Matters. Atrix shall be solely responsible for making all necessary or desirable declarations, filings (including, without limitation, the NDA and all supplements thereto and reports thereunder) and registrations with, and obtaining all necessary or desirable Governmental Approvals (including, without limitation, the FDA) relating to the Product and the Units; provided, however, that Block shall have the right to attend all meetings with the FDA or other similar Governmental Authority as a silent observer and Atrix shall immediately provide to Block copies of all correspondence and other documentation reflecting communications between Atrix and the FDA or other similar Governmental Authority.
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Responsibility for Regulatory Matters. In accordance with the Development Plan and any Development Amendment, at its sole expense, under the oversight of the JDC, Licensor shall retain control and responsibility for all regulatory submissions for the Existing Licensed Product in the Field in the Territory with respect to obtaining the Initial Approval. As promptly as practicable after the grant of the Initial Approval, Licensor shall transfer the NDA for the Existing Licensed Product in the Field in the Territory as set forth Section 9.1.2 (such transfer, the "REGULATORY APPROVAL TRANSFER"), and such NDA and related submissions in the Territory related to such Existing Licensed Product in the Field shall be, subject to the terms of this Agreement, the property of Licensee and held in the name of Licensee. Thereafter, at Licensee's sole expense, Licensee shall, subject to Section 5.3, 5.4, 5.5, 5.6 and ARTICLE 14, assume control of and responsibility for all regulatory submissions with respect to all Regulatory Approvals for Licensed Products in the Field in the Territory; PROVIDED, HOWEVER, that, notwithstanding anything in this ARTICLE 5, as between Licensee and Licensor, Licensor shall retain responsibility for any IND owned or Controlled by Licensor or any of its Affiliates and any Drug Master Files of Licensor, its Affiliates or any of their respective contract manufacturers.
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Responsibility for Regulatory Matters 
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Related to Responsibility for Regulatory Matters

  • Responsibility for Filing Tax Returns Buyer shall prepare or cause to be prepared and file or cause to be filed all Tax Returns for the Company that are filed after the Closing Date. Buyer shall permit the Interest Owners to review and comment on each such Tax Return described in the preceding sentence prior to filing.

  • Responsibility for Recitals, Etc The recitals herein and in the Notes (except in the Trustee's certificate of authentication) shall be taken as the statements of the Company, and the Trustee assumes no responsibility for the correctness thereof. The Trustee makes no representations as to the validity or sufficiency of this Eighth Supplemental Indenture or of the Notes. The Trustee shall not be accountable for the use or application by the Company of the Notes or of the proceeds thereof.

  • Responsibility of PFPC (a) PFPC shall be under no duty to take any action on behalf of the Fund except as specifically set forth herein or as may be specifically agreed to by PFPC in writing. PFPC shall be obligated to exercise care and diligence in the performance of its duties hereunder, to act in good faith and to use its best efforts in performing services provided for under this Agreement. PFPC shall be liable for any damages arising out of PFPC's failure to perform its duties under this Agreement to the extent such damages arise out of PFPC's willful misfeasance, bad faith, negligence or reckless disregard of such duties.

  • Responsibility for Contract Administration The Servicer will have the sole obligation to manage, administer, service and make collections on the Contracts and perform or cause to be performed all contractual and customary undertakings of the holder of the Contracts to the Obligor. The Owner Trustee, at the written request of a Servicing Officer, shall furnish the Servicer with any powers of attorney or other documents necessary or appropriate in the opinion of the Owner Trustee to enable the Servicer to carry out its servicing and administrative duties hereunder. The Servicer is hereby appointed the servicer hereunder until such time as any Service Transfer may be effected under Article VIII.

  • Responsibility for documentation Neither the Agent nor the Arranger:

  • Responsibility for Taxes Regardless of any action the Company or, if different, the Participant’s employer (the “Employer”) takes with respect to any or all income tax, social insurance, payroll tax, fringe benefit tax, payment on account or other tax-related items related to the Participant’s participation in the Plan and legally applicable to the Participant (“Tax-Related Items”), the Participant acknowledges that the ultimate liability for all Tax-Related Items is and remains the Participant’s responsibility and may exceed the amount, if any, actually withheld by the Company or the Employer. The Participant further acknowledges that the Company and/or the Employer (i) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the Restricted Stock Units, including, but not limited to the grant of the Restricted Stock Units, the vesting or settlement of the Restricted Stock Units, the issuance of Shares in settlement of the Restricted Stock Units, the subsequent sale of Shares acquired at vesting and the receipt of any dividends and/or any dividend equivalents; and (ii) do not commit to and are under no obligation to structure the terms of the Award or any aspect of the Restricted Stock Units to reduce or eliminate the Participant’s liability for Tax-Related Items or achieve any particular tax result. Furthermore, if the Participant is subject to tax in more than one jurisdiction, the Participant acknowledges that the Company and/or the Employer (or former employer, as applicable) may be required to withhold or account for Tax-Related Items in more than one jurisdiction. Prior to any relevant taxable or tax withholding event, as applicable, the Participant must pay or make adequate arrangements satisfactory to the Company and/or the Employer to satisfy all Tax-Related Items. In this regard, the Participant hereby authorizes the Company and/or the Employer, or their respective agents, in their sole discretion and without any notice to or additional authorization by the Participant, to satisfy their withholding obligations with regard to all Tax-Related Items, if any, by one or a combination of the following:

  • Regulatory Responsibility (a) Licensee, its Affiliates, and Sublicensees shall be the legal and beneficial owner of all Regulatory Approvals and Regulatory Materials for Licensed Product in the Territory, and Regulatory Materials relating to such Regulatory Approvals in the Territory shall be submitted by, and in the name of, Licensee (or its Affiliates or Sublicensees, as the case may be). All INDs and CTAs for the Existing Study shall be transferred to Licensee within *** days following the completion of the Existing Study, and thereafter the Licensee will be the sponsor under all INDs and CTAs relating to the Licensed Product. As such, Licensee shall be responsible for reporting all adverse drug reactions related to Licensed Products to the appropriate Regulatory Authorities in the relevant countries in the Territory, in accordance with Applicable Law of such countries. Licensee shall also be responsible for all meetings with Regulatory Authorities and all post-Regulatory Approval commitments to Regulatory Authorities.

  • Responsibility for Costs The Servicer is responsible for collection from such Borrower of any recording or similar costs or expenses incidental to the granting of relief with respect to a delinquent Mortgage Loan.

  • No Responsibility for Certain Matters No Agent shall be responsible to any Lender for the execution, effectiveness, genuineness, validity, enforceability, collectibility or sufficiency of this Agreement or any other Loan Document or for any representations, warranties, recitals or statements made herein or therein or made in any written or oral statements or in any financial or other statements, instruments, reports or certificates or any other documents furnished or made by such Agent to Lenders or by or on behalf of Company to such Agent or any Lender in connection with the Loan Documents and the transactions contemplated thereby or for the financial condition or business affairs of Company or any other Person liable for the payment of any Obligations, nor shall such Agent be required to ascertain or inquire as to the performance or observance of any of the terms, conditions, provisions, covenants or agreements contained in any of the Loan Documents or as to the use of the proceeds of the Loans or the use of the Letters of Credit or as to the existence or possible existence of any Event of Default or Potential Event of Default. Anything contained in this Agreement to the contrary notwithstanding, Administrative Agent shall not have any liability arising from confirmations of the amount of outstanding Loans or the Letter of Credit Usage or the component amounts thereof.

  • RESPONSIBILITY OF PFPC TRUST (a) PFPC Trust shall be under no duty to take any action hereunder on behalf of the Fund or any Portfolio except as specifically set forth herein or as may be specifically agreed to by PFPC Trust and the Fund in a written amendment hereto. PFPC Trust shall be obligated to exercise care and diligence in the performance of its duties hereunder and to act in good faith in performing services provided for under this Agreement. PFPC Trust shall be liable only for any damages arising out of PFPC Trust's failure to perform its duties under this Agreement to the extent such damages arise out of PFPC Trust's willful misfeasance, bad faith, gross negligence or reckless disregard of its duties under this Agreement.

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