has all requisite governmental licenses, authorizations, consents and approvals to operate its business as currently conducted;

“Regulatory Approval” means, with respect to a country or extra-national territory, any and all required approvals, licenses, registrations, or authorizations of any Regulatory Authority necessary in order to commercially distribute, sell or market a product in such country or some or all of such extra-national territory, including emergency use authorizations in any country or extra-national territory.

Government Licenses, Permits, Authorizations. BUTTE has all governmental licenses, permits, authorizations and approvals necessary for the conduct of its business as currently conducted (“Licenses and Permits”). All such Licenses and Permits are in full force and effect, and no proceedings for the suspension or cancellation of any thereof is pending or, to the knowledge of BUTTE, threatened.

If the transaction contemplated hereby shall require authorization or approval of any governmental agency having jurisdiction, all such authorizations and approvals shall have been obtained and shall be in full force and effect on and as of the Closing Date. If such authorizations and approvals shall not have been obtained on or prior to the last day for Closing hereinabove provided, the Closing Date may be deferred, at the election of either party, for an additional period of time, not to exceed thirty (30) days, as shall be necessary to obtain any authorizations or approvals not then obtained.

The Target Group is in material compliance with all applicable Laws and Regulations. No notice has been issued and no proceeding is pending or, to the actual knowledge of Seller, threatened against the Target Group with respect to any alleged violation of any legal requirement applicable to the Target Group. The Target Group has all material governmental authorizations required by all legal requirements applicable to the operation of the business. The material governmental authorizations issued to the Target Group are in full force and effect and the Target Group is in compliance in all material respects with such applicable governmental authorizations.

Compliance with Legal Requirements; Governmental Authorizations. The Company is in material compliance with all applicable Legal Requirements. No notice has been issued and no Proceeding is pending or, to the Knowledge of the Seller, threatened against the Company with respect to any alleged violation of any Legal Requirement applicable to the Company. The Company has all material Governmental Authorizations required by all Legal Requirements applicable to the operation of the Business. The material Governmental Authorizations issued to the Company are in full force and effect and the Company is in compliance in all material respects with such applicable Governmental Authorizations. [Schedule 4.1.19] contains a complete and accurate list of each Governmental Authorization that is held by the Company. Unless by its terms it is non-transferable, each such Governmental Authorization shall remain in full force and effect immediately following the Closing.

Licensee or its Affiliates shall hold all Marketing Authorizations for Licensed Product in the Territory in the Field.

“Permit” means all approvals, authorizations, registrations, certificates, filings, franchises, licenses, notices and permits issued by any Governmental Authority.

Environmental Permit. “Environmental Permit” means all licenses, permits, authorizations, approvals, franchises and rights required under any applicable Environmental Law or Order.

“Governmental Approvals” means all authorizations, consents, approvals, permits, licenses and exemptions of, registrations and filings with, and reports to, Governmental Authorities.