Example ContractsClausesRegulatory Permits
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Regulatory Permits. The Company and the Subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the SEC Reports, except where the failure to possess such permits would not reasonably be expected to result in a Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any Material Permit.

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Regulatory Permits. Seller possesses all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct the Wound Care Business, except where the failure to possess such permits could not reasonably be expected to result in a material adverse effect (“Material Permits”), and Seller has not received any notice of proceedings relating to the revocation or modification of any Material Permit.

Permits. (i) The Permal Entities have in full force and effect all Permits of or with all Governmental Authorities necessary for them to own, lease or operate their properties and other assets and to carry on their business, # there are no Actions pending or, to the Knowledge of the Permal Contributor, threatened to terminate or otherwise limit rights under any such Permits (including as a result of the Transactions) other than expirations in accordance with the terms thereof, which terms do not expire as a result of the consummation of the Transactions and # in the past three (3) years, there has occurred no material default under, or violation of, any Permit held by any Permal Entity. All of such Permits are in full force and effect and will remain in full force and effect and will be available for use by the applicable Permal Entity immediately after the Closing. Except for any Permits relating solely to the use or occupancy of real property, [Section 5.12(b)] of the Permal Disclosure Schedule sets forth a true, complete and correct list of each material Permit held by the Permal Entities, indicating # the name of the Permit, # the holder thereof, # the Governmental Authority that is the issuer thereof and # the expiration date, if any, thereof. Copies of such Permits were made available to the EnTrust Contributor prior to the date hereof. Except as indicated on [Section 5.12(b)] of the Permal Disclosure Schedule, none of the Permal Entities is required to be authorized, registered or licensed under applicable Laws in any non-U.S. jurisdiction.

Permits. All material governmental licenses, approvals, authorizations, registrations, consents, orders, certificates, decrees, franchises and permits (collectively, “Permits”) of , are set forth on [Section 3.16] of the Disclosure Schedule. Such Permits are all of the material Permits necessary for the services provided by and the conduct and operation of its business. All such Permits are in full force and effect; and no proceeding is pending or, to ’s Knowledge, threatened, seeking the revocation or limitation of any such Permit. To ’s Knowledge, there exists no state of facts which could cause any Governmental Entity to limit, revoke or fail to renew any Permit related to or in connection with any business as currently conducted or operated by .

Licenses and Permits. WuXi ATU will be responsible for obtaining and maintaining, at its expense, any Facility or other regulatory licenses, permits, or approvals required for the performance of Services by WuXi ATU under this Agreement. At Graphite's written request, WuXi ATU will provide Graphite with copies of such licenses, permits and approvals. Graphite may use such provided regulatory licenses, permits, and approval in connection with Graphite’s regulatory submissions and/or commercial development of the Product.

Permits; Compliance. The Company and each of its Subsidiaries is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exemptions, consents, certificates, approvals and orders necessary to own, lease and operate its properties and to carry on its business as it is now being conducted (collectively, the “Company Permits”), and there is no action pending or, to the knowledge of the Company, threatened regarding suspension or cancellation of any of the Company Permits. Neither the Company nor any of its Subsidiaries is in conflict with, or in default or violation of, any of the Company Permits, except for any such conflicts, defaults or violations which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. Since , neither the Company nor any of its Subsidiaries has received any notification with respect to possible conflicts, defaults or violations of applicable laws, except for notices relating to possible conflicts, defaults or violations, which conflicts, defaults or violations would not have a Material Adverse Effect.

Regulatory Inspections. WuXi ATU will allow representatives of any Regulatory Agency to inspect the relevant parts of the Facility where the Manufacture of the Product is carried out and to inspect the master production record and Batch Records to verify compliance with cGMP and other practices or regulations and will promptly notify Graphite of the scheduling of any such inspection relating to the Manufacture of Product. The Parties shall cooperate in good faith with respect to the conduct of any such inspections. WuXi ATU shall permit the attendance of Graphite at any such regulatory inspections in accordance with the Parties' Quality Agreement. WuXi ATU will promptly send to Graphite a copy of any reports, citations, or warning letters or other written communication received from such Regulatory Authority in connection with such visit or inspection, and any written communication received from any Regulatory Authority relating to any Product, the Facility (if it specifically relates to or adversely affects the Development and/or Manufacture of any Product) or the Graphite Process, within ​ Business

Regulatory Filings. Graphite may request WuXi ATU to assist with authoring manufacturing and cGMP related sections of the regulatory filings. If such work is needed it will be included as a part of a Work Order. If the Services relate to any cGMP Manufacturing of Product, then prior to filing with the Regulatory Authority any clinical trial application, including any U.S. Investigational New Drug Application, amendments thereto, or EU Investigational Medicinal Product Dossier or Quality Module of the Common Technical Document (the “CTD”), Graphite will provide to WuXi ATU a copy of any documentation that is equivalent to these applications that relates to the application. This disclosure will permit WuXi ATU to review and verify, at Graphite’s reasonable cost, that the application accurately describes the Services that WuXi ATU has performed and the Manufacturing and testing processes that WuXi ATU will perform under a Work Order.

Regulatory Events. Borrowers shall notify the Agent within three (3) Business Days (or such longer period as Agent shall agree) after # any material enforcement action (it being agreed, for the avoidance of doubt, that any remediation required by any Governmental Authority in connection with state contract audits in the ordinary course of business does not constitute a material enforcement action), material inquiry (other than ordinary course information requests), or material investigation instituted or, to Borrower’s or any Subsidiary’s knowledge, threatened, against Borrower or any of its Subsidiaries, servicer of the Borrowers’ portfolios of Contracts, or Borrowers’ or servicers’ respective Affiliates by any Governmental Authority, including without limitation any proceeding or action to be commenced by the filing of a stipulation and consent, # receipt by Borrower or any of its Subsidiaries, servicer of the Borrowers’ portfolios of Contracts, or Borrowers’ or servicers’ respective Affiliates of an “Early Warning Notice,” “Notice and Opportunity to Respond and Advise”, “Civil Investigative Demand”, or request for information from the Consumer Financial Protection Bureau or similar notice or request from any other Governmental Authority and # without duplication, the occurrence of any Regulatory Event.

Regulatory Event. The occurrence of a Level Two Regulatory Event which # remains unvacated, undischarged, unbounded or unstayed by appeal or otherwise for a period of 60 days from the date of its entry and # is reasonably likely to have a Material Adverse Effect; or

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