Transfer of INDs; Regulatory Matters Sample Clauses

Transfer of INDs; Regulatory Matters. On or before June 15, 2015, MSK will transfer (or cause the transfer) of MSK [ * ] to Licensee and grant Licensee the right to reference any other INDs held by MSK for Licensed Product as of the Effective Date. Upon the written request of Licensee from time to time after the Effective Date, MSK will also transfer (or cause the transfer) to Licensee of each other IND held by MSK (or foreign equivalents) for any Licensed Product as of the Effective Date in any country. MSK shall execute and deliver all documents and instruments, and take all such actions, as needed to effect each of the transfers described above, including appropriate communications with the FDA and other regulatory authorities, including as requested by Licensee. Further, MSK shall provide to Licensee, at its request, all reasonable regulatory assistance with respect to such transferred INDs (and equivalents) and the regulatory activities of Licensee relating to development of Licensed Products. Upon Licensee’s request, MSK will provide Licensee and/or its designee with copies of all regulatory documentation and correspondence relating to the [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Licensed Products and will cooperate with Licensee and its designees, and take all such actions that are reasonably requested to remove PHI from such regulatory documentation and correspondence. Licensee covenants and agrees that if this Agreement is terminated early pursuant to Article 17, Licensee shall transfer back to MSK the INDs (and foreign equivalents) held by MSK that were transferred by MSK to Licensee pursuant to the above provisions of this Section 2.9(a) promptly after the effective date of termination, and Licensee shall have the same obligations of cooperation and assistance as set forth above with respect to the initial transfer from MSK to Licensee.
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Related to Transfer of INDs; Regulatory Matters

  • Certain Regulatory Matters Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member of the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

  • Reports; Regulatory Matters (a) Each of the Companies and their Subsidiaries have timely filed or furnished, as applicable, all reports, registrations, statements and certifications, together with any amendments required to be made with respect thereto, that they were required to file or furnish, as applicable, since January 1, 2006 with (i) any state regulatory authority, (ii) the SEC, (iii) any foreign regulatory authority, and (iv) any self-regulatory authority, (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed or furnished by them since January 1, 2006, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or other Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except as set forth in Section 3.5 of the Company Disclosure Schedule, no Regulatory Agency or other Governmental Entity has initiated since January 1, 2006 or has pending any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. Since January 1, 2006, no Regulatory Agency or other Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. There is no unresolved, or, to Seller’s knowledge, threatened criticism, comment, exception or stop order by any Regulatory Agency or other Governmental Entity with respect to any report or statement relating to any examinations or inspections of any of the Companies or any of its Subsidiaries. Since January 1, 2006, there have been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or other Governmental Entity with respect to the business, operations, policies or procedures of any of the Companies or any of its Subsidiaries (other than normal inquiries made by a Regulatory Agency or other Governmental Entity in the Companies’ ordinary course of business). (b) No Company nor any of its Subsidiaries is subject to any cease-and-desist or other order or enforcement action issued by, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or has been ordered to pay any civil money penalty by, or has been since January 1, 2006 a recipient of any supervisory letter from, or since January 1, 2006 has adopted any policies, procedures or board resolutions at the request or suggestion of, any Regulatory Agency or other Governmental Entity that currently restricts or affects in any material respect the conduct of its business (or to Seller’s knowledge that, upon consummation of the transactions contemplated hereby, would restrict in any material respect the conduct of the business of either Buyer or any of its Subsidiaries), or that in any material manner relates to its capital adequacy, its ability to pay dividends, its credit, risk management or compliance policies, its internal controls, its management or its business, other than those of general application that apply to similarly situated companies or their Subsidiaries (each item in this sentence, a “Company Regulatory Agreement”), nor has any of the Companies or any of their Subsidiaries been advised since January 1, 2006 by any Regulatory Agency or other Governmental Entity that it is considering issuing, initiating, ordering, or requesting any such Company Regulatory Agreement. (c) Seller has previously made available to Buyers an accurate and complete copy of each (i) final registration statement, prospectus, report, schedule and definitive proxy statement filed with the SEC by Seller pursuant to the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”) since January 1, 2006 (the “Seller SEC Reports”) and prior to the date of this Agreement and (ii) communication mailed by Seller to its shareholders since January 1, 2006 and prior to the date of this Agreement. No such Seller SEC Report or communication, at the time filed or communicated (or, if amended prior to the date hereof, as of the date of such amendment), with respect to the Companies and their Subsidiaries only, contained any untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances in which they were made, not misleading. To the knowledge of Seller, other than as set forth in Section 3.5 of the Company Disclosure Schedule, none of the Seller SEC Reports is the subject of any ongoing review or investigation by the SEC or any other Governmental Entity and there are no unresolved SEC comments with respect to any of such documents.

  • Regulatory Matters (a) VFL and Purchaser shall cooperate and use commercially reasonable efforts to obtain all consents, approvals and agreements of, and to give and make all notices and filings with, any Governmental Entity necessary to authorize, approve or permit the consummation of the transactions contemplated by this Agreement, the Related Agreements and any other agreements contemplated hereby or thereby, including, without limitation, as set forth on Schedule 3.04 and Schedule 4.04. Purchaser and VFL will provide each other and their counsel the opportunity to review in advance and comment on all such filings with any Governmental Entity. Purchaser and VFL will keep each other informed of the status of matters relating to obtaining the regulatory approvals specified in Schedule 3.04 and Schedule 4.04. It is expressly understood by the parties hereto that each party hereto shall use commercially reasonable efforts to ensure that representatives of both Purchaser and VFL shall have the right to attend and participate in any hearing, proceeding, meeting, conference or similar event before or with a Governmental Entity or other organization relating to this Agreement or a Related Agreement. In furtherance of the foregoing, Purchaser and VFL shall provide each other reasonable advance notice of any such hearing, proceeding, meeting, conference or similar event. The notice required to be given under this Section 5.04 shall be given to representatives of VFL or Purchaser entitled to receive notices hereunder. (b) VFL and Purchaser shall cooperate and use commercially reasonable efforts to obtain all other approvals and consents to the transactions contemplated by this Agreement and the Related Agreements, including the consents of third parties under Assigned Contracts. In the event and to the extent that VFL is unable to obtain any required approval or consent of non-governmental authorities to any agreement to be assigned to Purchaser hereunder, (i) VFL shall use commercially reasonable efforts in cooperation with Purchaser to (A) provide or cause to be provided to Purchaser the benefits of any such agreement, (B) cooperate in any arrangement, reasonable and lawful as to VFL and Purchaser, designed to provide such benefits to Purchaser and (C) enforce for the account of Purchaser any rights of VFL arising from such agreements, including the right to elect to terminate in accordance with the terms thereof on the advice of Purchaser and (ii) Purchaser shall use commercially reasonable efforts to perform the obligations of VFL arising under such agreements and licenses, to the extent that, by reason of the transactions consummated pursuant to this Agreement or otherwise, Purchaser has control over the resources necessary to perform such obligations. If and when any such approval or consent shall be obtained or such agreement or license shall otherwise become assignable, VFL shall promptly assign all of its rights and obligations thereunder to Purchaser without the payment of further consideration and Purchaser shall, without the payment of any further consideration therefor, assume such rights and obligations and VFL shall be relieved of any and all obligation or liability hereunder.

  • Tax and Regulatory Matters No Buyer Entity or, to the Knowledge of Buyer, any Affiliate thereof has taken or agreed to take any action, and Buyer does not have any Knowledge of any agreement, plan or other circumstance, that is reasonably likely to (i) prevent the Merger from qualifying as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code, or (ii) materially impede or delay receipt of any of the Requisite Regulatory Approvals.

  • Accounting, Tax and Regulatory Matters Each Owner and the Company, -------------------------------------- jointly and severally, represents and warrants to Premiere that neither the Company, any Owner nor any Affiliate thereof has taken or agreed to take any action or has any knowledge of any fact or circumstance that is reasonably likely to (i) prevent the Merger from qualifying for pooling-of-interests accounting treatment or as a reorganization within the meaning of Section 368(a) of the Code, or (ii) materially impede or delay receipt of any consents referred to in Section 5.6 of the Uniform Terms or result in the imposition of a condition or restriction of the type referred to in the last sentence of such Section.

  • Regulatory Matters and Approvals Each of the Parties will give any notices to, make any filings with, and use its reasonable best efforts to obtain any necessary authorizations, consents, and approvals of governments and governmental agencies in connection with the transactions contemplated by this Agreement. Without limiting the generality of the foregoing:

  • Governing Law, Regulatory Authority, and Rules The validity, interpretation and enforcement of this Agreement and each of its provisions shall be governed by the laws of the state of New York, without regard to its conflicts of law principles. This Agreement is subject to all Applicable Laws and Regulations. Each Party expressly reserves the right to seek changes in, appeal, or otherwise contest any laws, orders, or regulations of a Governmental Authority.

  • Compliance Matters (a) The Sub-Adviser understands and agrees that it is a “service provider” to the Trust as contemplated by Rule 38a-1 under the 1940 Act. As such, the Sub-Adviser agrees to cooperate fully with the Adviser and the Trust and its Trustees and officers, including the Fund’s CCO, with respect to (i) any and all compliance-related matters, and (ii) the Trust’s efforts to assure that each of its service providers adopts and maintains policies and procedures that are reasonably designed to prevent violation of the “federal securities laws” (as that term is defined by Rule 38a-1) by the Trust, the Adviser and the Sub-Adviser. In this regard, the Sub-Adviser shall: (1) submit to the Board for its consideration and approval, prior to the effective date of this Agreement, the Sub-Adviser’s compliance program, it being understood that the Sub-Adviser’s obligation under Section 2(e) of this Agreement to vote all proxies solicited by or with respect to the issuers of securities in which the assets of the Portfolio may be invested shall be subject to the fulfillment of the condition that the Board approve the Sub-Adviser’s proxy voting policies and procedures; (2) submit annually (and at such other times as the Trust may reasonably request) to the Fund’s CCO and the Adviser for consideration by the Board, a report discussing the adequacy and effectiveness of the Sub-Adviser’s compliance program, and fully describing any material amendments to such compliance program since the most recent such report; (3) provide periodic reports, certifications and information concerning the Sub-Adviser’s compliance program including, but not limited to, the following; (i) Quarterly Compliance Certifications, including any required attachments, no later than the tenth (10th) business day after each calendar quarter; and (ii) Annual Report on Code of Ethics Matters, including any required attachments, no later than the fifteenth (15th) business day of October each year. (4) provide the Adviser and the Trust and its Trustees and officers with reasonable access to information regarding the Sub-Adviser’s compliance program, which access shall include on-site visits with the Sub-Adviser as may be reasonably requested from time to time; (5) permit the Adviser and the Trust and its Trustees and officers to maintain an active working relationship with the Sub-Adviser’s compliance personnel by, among other things, providing the Adviser and the Fund’s CCO and other officers with a specified individual within the Sub-Adviser’s organization to discuss and address compliance-related matters; (6) provide the Adviser and its chief compliance officer and the Trust and its Trustees and officers, including the Fund’s CCO, with such certifications as may be reasonably requested; and (7) reasonably cooperate with any independent registered public accounting firm engaged by the Trust, ensure that all reasonably necessary information and the appropriate personnel are made available to such independent registered public accounting firm, to support the expression of the independent registered public accounting firm’s opinion, and each year provide the Adviser and such independent registered public accounting firm with a copy of the most recent SSAE 16 Report prepared by the Sub-Adviser’s independent auditors regarding the Sub-Adviser’s internal controls. (b) The Sub-Adviser represents, warrants and covenants that it has implemented and shall maintain a compliance program in accordance with the requirements of Rule 206(4)-7 under the Advisers Act.

  • Compliance with U.S. Securities Laws; Regulatory Compliance Notwithstanding any provisions in this Receipt or the Deposit Agreement to the contrary, the withdrawal or delivery of Deposited Securities will not be suspended by the Company or the Depositary except as would be permitted by Instruction I.A.(1) of the General Instructions to the Form F-6 Registration Statement, as amended from time to time, under the Securities Act.

  • Transitional Matters (a) Each of the parties acknowledges and agrees that the transition of the Business from the Selling Companies to Buyer will require that certain transactions and relationships will need to be entered into, restructured and reorganized in connection with the transition of the Business from the Selling Companies to Buyer. The parties agree that prior to the Closing Date, the parties shall cooperate with each other to identify all such transactions and relationships and negotiate in good faith to enter into a mutually acceptable Transitional Agreement effective as of the Closing Date, which agreement shall provide for all such transactions and relationships as are reasonably necessary to provide, (i) for (A) the operation of the Business and use of the Purchased Assets by Buyer, (B) the operation and use of the Excluded Assets by Sellers and the Selling Subsidiaries and (C) the separation of the Business, the Purchased Assets and the Assumed Liabilities from Parent and its Affiliates (including the Selling Companies), in each case during the period commencing on and after the Closing Date and ending no later than the one year anniversary of the Closing Date or such longer period as the parties may agree, including the following: (1) the transitioning of the financial systems, assets and hedging valuation systems, asset management systems, payroll and employee benefits systems and any other applicable business operating systems; (2) the provision of rights of access (provided that access to the ALSS Platform shall be governed and limited by the Intellectual Property Rights Agreement and the Services Agreement) to the Parent and its Affiliates to Intellectual Property currently owned (or licensed) by the Selling Companies (and included in the Purchased Assets) and used by Parent or the Selling Companies in the ordinary course of their business, or required by the Selling Companies for the operation and use of the Excluded Assets or Excluded Liabilities; provided, that access to the ALSS Platform and other Software shall be governed solely by the Intellectual Property Rights Agreement and the Services Agreement and, provided further, anything foregoing to the contrary notwithstanding, Buyer shall not be required to disclose or deliver trade secret or confidential information regarding the ALSS Platform, Software or Acquired Intellectual Property unless required by the Intellectual Property Rights Agreement, the Services Agreement or required by law or legal proceedings and under the type of protective provisions in the Intellectual Property Rights Agreement. (3) the provision of rights of access (to the extent not covered by the Intellectual Property Rights Agreement) to Buyer to Intellectual Property currently owned (or licensed) by Parent (or the Selling Companies) and used by the Selling Companies in connection with the Purchased Assets or Assumed Liabilities; (4) moving corporate records related to the Selling Companies; and (5) the provision of office space, computer equipment and supplies sufficient to enable the Selling Companies to complete any transition services; and (ii) for such services and facilities as Sellers and Selling Subsidiaries may require to monitor compliance with, and implementation of the Subservicing Agreement, during its term, including the provision of office space, computer equipment and supplies sufficient to enable Sellers to monitor compliance with the Retained Portfolio Subservicing Agreement throughout its term. (b) In addition to the matters to be identified pursuant to paragraph (a) of this Section 5.12, the Transition Agreement shall specifically provide for the transactions and matters outlined in Section 5.12 of Sellers' Disclosure Schedule. (c) For the purpose of facilitating the transition of the financial system, on or prior to the 15th day prior to the Closing Date, the Selling Companies shall create on their general ledger, a separate general ledger company ("GL Company"), as well as accounts for such GL Company ("Buyer GL Accounts"), which accounts shall be duplicative of the Selling Companies' own accounts ("Seller GL Accounts") and are intended to be used by the Buyer in the operation of the Business, the Purchased Assets and the Assumed Liabilities from and after the Closing Date. From and after the creation of the Buyer GL Accounts, until Closing, the Selling Companies shall maintain such accounts (as duplicate entries on the books of the Selling Companies in the name of the GL Company). From and after Closing until the completion of the transition of the financial system of the Selling Companies, the Buyer shall operate the Business by recording entries using the Buyer GL Accounts, and shall maintain on behalf of the Selling Companies, the Seller GL Accounts on its general ledger. (d) The party receiving service under the Transitional Agreement shall pay to the party providing service the costs incurred by such providing party. Services provided under the Transitional Agreement shall be performed at the same standard as the providing party performs such service for its own account.

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