Regulatory Audits BNY Mellon shall, upon reasonable prior notice when possible, make all books and records available to the applicable Voya or Voya Fund regulators and state government representatives or their designees to audit, evaluate and inspect BNY Mellon’s books and records for Voya and such Voya Fund. BNY Mellon agrees to reasonably cooperate with and assist Voya in meeting any regulatory requirements related to audits or inspections imposed upon Voya to the extent that Voya notifies BNY Mellon of such requirements.
Regulatory Examinations The Sub-Advisor will cooperate promptly and fully with the Advisor and/or the Trust in responding to any regulatory or compliance examinations or inspections (including information requests) relating to the Trust, the Fund or the Advisor brought by any governmental or regulatory authorities having appropriate jurisdiction (including, but not limited to, the SEC).
Regulatory Affairs Each Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any country of the Territory.
Corporate Examinations and Investigations Prior to the Closing Date, the parties acknowledge that they have been entitled, through their employees and representatives, to make such investigation of the assets, properties, business and operations, books, records and financial condition of the other as they each may reasonably require. No investigations, by a party hereto shall, however, diminish or waive any of the representations, warranties, covenants or agreements of the party under this Agreement.
Authority of the Representatives Any action by the Underwriters hereunder may be taken by the Representatives on behalf of the Underwriters, and any such action taken by the Representatives shall be binding upon the Underwriters.
Sellers’ Representative By execution of this Agreement, the Sellers hereby irrevocably and unconditionally appoint Nephron Pharmaceuticals Corporation as the Sellers’ Representative of all Sellers, as the attorney-in-fact for and on behalf of each such Seller, and irrevocably agree that the taking by the Sellers’ Representative of any and all actions and the making of any decisions required or permitted to be taken by it or by a Seller under this Agreement or any Transaction Documents to which the Sellers are a party are hereby authorized and approved in all respects, including without limitation the exercise of the power to (i) receive from Buyer and disburse to Sellers any payments constituting any part of the Purchase Price and receive and disburse from and to any Party or any Third Party which may be contemplated to be made under the Transaction Documents, (ii) agree to, negotiate, enter into settlements and compromises of and comply with orders of courts with respect to any indemnification claims or disputes, (iii) resolve any indemnification claims or disputes, and (iv) take all actions necessary in the judgment of the Sellers’ Representative for the accomplishment of the other terms, conditions and limitations of this Agreement and the Transaction Documents. The Sellers’ Representative has authority and power to act on behalf of the Sellers with respect to this Agreement and the other Transaction Documents and the disposition, settlement or other handling of all indemnification claims, rights or obligations arising from and taken pursuant to this Agreement and the other Transaction Documents. The Sellers irrevocably agree to be bound by all and any such actions taken by the Sellers’ Representative in connection with this Agreement and the other Transaction Documents to which the Sellers are a party, and Sellers and Buyer shall only be required to acknowledge or act upon written communication signed by the Sellers’ Representative. Each Seller agrees that he, she or it has not, and will not, threaten or commence or join any legal action, which term includes, without limitation, any demand for arbitration proceedings and any complaint to any foreign, federal, state or local agency, court or other tribunal, to assert any claim against the Sellers’ Representative or its advisors for acting in such capacity with respect to this Agreement or the other Transaction Documents. If any Seller commences or joins any such prohibited legal action against the Sellers’ Representative, such Seller agrees to promptly indemnify Sellers’ Representative and advisers of Sellers’ THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Representative for all losses, liabilities, reasonable costs or expenses, including without limitation all reasonable fees, disbursements and other charges of attorneys incurred by Sellers’ Representative and/or its advisers in defending such action as well as any monetary judgment obtained against the Sellers’ Representative in such action. The Sellers’ Representative may resign at any time upon 30 days written notice to the Sellers. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Regulatory Submissions From and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than Jointly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc. respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.
Due Diligence Cooperation The Company will cooperate with any reasonable due diligence review conducted by the Agent or its representatives in connection with the transactions contemplated hereby, including, without limitation, providing information and making available documents and senior corporate officers, during regular business hours and at the Company’s principal offices, as the Agent may reasonably request.
Due Diligence Investigation Pubco shall be reasonably satisfied with the results of its due diligence investigation of the Company in its sole and absolute discretion.
Buyers’ representatives After this Agreement has been signed by the Parties and the Deposit has been lodged, the Buyers have the right to place two (2) representatives on board the Vessel at their sole risk and expense. These representatives are on board for the purpose of familiarisation and in the capacity of observers only, and they shall not interfere in any respect with the operation of the Vessel. The Buyers and the Buyers’ representatives shall sign the Sellers’ P&I Club’s standard letter of indemnity prior to their embarkation.
