No Litigation; Consents. (a) (i) There is no Litigation pending or, to Sellers’ Knowledge, threatened in writing against either Seller or any of its Affiliates before any Governmental Authority in respect of the Product Business or the Purchased Assets, (ii) there is no Order to which a Seller or any of its Affiliates is subject in respect of the Product Business or the Purchased Assets, or (iii) Litigation that in any manner challenges or seeks to prevent, enjoin, alter, or materially delay the transactions contemplated by this Agreement and the Ancillary Agreements.
(b) Except for (i) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to be material to the Product Business or the Purchased Assets, (ii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Buyer or its Affiliates, and (iii) the Sellers FDA Transfer Letters, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Authority is required for Sellers to consummate the transactions contemplated hereby or by the Ancillary Agreements.
No Litigation; Consents. 3.5.1 Except as set forth on Section 3.5.1 of the Seller Disclosure Schedule, there is no Litigation (other than any investigation, inquiry, audit, examination or finding of deficiency or noncompliance) pending or, to Seller’s Knowledge, threatened against Seller or any of its Affiliates before any Governmental Authority or private dispute resolution body, that (i) involves or otherwise relates to the Product Business, the Purchased Assets, or the Assumed Liabilities; or (ii) challenges or, if resolved against Seller, would prevent, delay or make illegal any of the Transactions; or (iii) would reasonably be expected to impose any material limitation on the ability of Purchaser or any of its Affiliates to operate the Product Business as of the Closing.
3.5.2 Except as set forth on Section 3.5.2 of the Seller Disclosure Schedule, there is no order or judgment of a Governmental Authority to which Seller or any of its Affiliates is subject that involves or otherwise relates to the Product Business, the Purchased Assets or the Assumed Liabilities that would reasonably be expected to impose any Liability on Purchaser or the Product Business, or imposes any limitation on the ability of Seller to sell the Purchased Product Inventory or operate the Product Business or the Purchased Assets as currently conducted or planned to be conducted as of the date hereof by Seller and, to Seller’s Knowledge, there are no facts which would form a basis for such order or judgment.
3.5.3 Since May 1, 2012, Seller has not received any written notice, claim or complaint from any other Person alleging (a) a violation of, or failure to comply with, or any Liability under, any Laws relating to the Product Business, the Purchased Assets or the Assumed Liabilities as a result of Seller’s and its Affiliates’ operation of the Product Business, except for any such notice relating to a failure to comply that has since been cured; or (b) any material defects in the Product or alleging any failure of the Product to meet Specifications.
3.5.4 Except for (i) if required, the filings under the HSR Act and the expiration or termination of the waiting periods thereunder; (ii) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to materially affect the Product Business, the Purchased Assets or the Assumed Liabilities; (iii) consents, permits, authorizations, declarations, filings or registrations that...
No Litigation; Consents. (a) As of the Execution Date, (i) there is no Litigation pending or, to the knowledge of Buyer, threatened in writing against Buyer or any of its Affiliates before any Governmental Authority, and (ii) there is no order or judgment of a Governmental Authority to which Buyer or any of its Affiliates is subject, except, in each case ((i) and (ii) immediately above) for such Litigation, orders and judgments that would not reasonably be expected to constitute a Buyer Material Adverse Effect.
(b) Except for (i) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to constitute a Buyer Material Adverse Effect, and (ii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Seller or its Affiliate, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Authority or other Person is required for Buyer to consummate the transactions contemplated hereby or by the Ancillary Agreements.
No Litigation; Consents. (a) (i) To the knowledge of Buyer, there is no material Litigation pending or threatened against Buyer or any of its Affiliates before any Governmental Authority, and (ii) there is no material Order to which Buyer or any of its Affiliates is subject.
(b) Except for (i) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to be material to the Product Business or the Purchased Assets, and (ii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Sellers or their respective Affiliates, no notice to, filing with, permit of, authorization of, exemption by, or consent of, Governmental Authority or other Person is required for Buyer to consummate the transactions contemplated hereby or by the Ancillary Agreements.
No Litigation; Consents. (a) As of the Execution Date, (i) there is no Litigation pending or, to Seller’s Knowledge, threatened in writing against Seller or any of its Affiliates before any Governmental Authority in the Territory in respect of the Product Business, the Purchased Assets or the Licensed Intellectual Property, and (ii) there is no order or judgment of a Governmental Authority in the Territory to which Seller or any of its Affiliates is subject in respect of the Product Business, the Purchased Assets or Licensed Intellectual Property, except, in each case ((i) and (ii)), for such Litigation, orders and judgments that would not reasonably be expected to constitute a Material Adverse Effect.
(b) Except for (i) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to constitute a Material Adverse Effect, (ii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Buyer or its Affiliates and (iii) items disclosed in Schedule 3.1.7(b) of the Disclosure Schedules, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Authority or other Person is required for Seller to consummate the transactions contemplated hereby or by the Ancillary Agreements.
No Litigation; Consents. (a) There is no Litigation (other than any investigation or finding of deficiency or noncompliance, which are addressed in clause (b) below) pending or to AstraZeneca’s Knowledge, threatened, against AstraZeneca or any of its Affiliates before any Governmental Authority relating to the Product Business, the Purchased Assets, the APA Licensed Intellectual Property or the Licensed Regulatory Documentation or for which the Product Business, the Purchased Assets, the APA Licensed Intellectual Property or the Licensed Regulatory Documentation is subject.
(b) To AstraZeneca’s Knowledge there is no investigation or finding of deficiency or noncompliance pending or threatened against AstraZeneca or any of its Affiliates before any Governmental Authority relating to the Product Business, the Purchased Assets, the APA Licensed Intellectual Property or the Licensed Regulatory Documentation or for which the Product Business, the Purchased Assets, the APA Licensed Intellectual Property or the Licensed Regulatory Documentation is subject.
(c) There is no order or judgment of a Governmental Authority to which AstraZeneca or any of its Affiliates is subject relating to the Product Business, the Purchased Assets, the APA Licensed Intellectual Property or the Licensed Regulatory Documentation.
(d) Except for (i) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Horizon or its Affiliates and (ii) items disclosed in Section 3.1.5(d) of the Disclosure Schedules, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Authority or other Person is required for AstraZeneca to consummate the transactions contemplated hereby or by the Ancillary Agreements.
No Litigation; Consents. (a) No action or proceeding before a court or any other governmental agency or body shall have been instituted or threatened by any Person not a party to this Agreement to restrain or prohibit the consummation of the transactions contemplated by this Agreement and the other Transaction Documents.
(b) All consents, waivers, authorizations and approvals of any governmental agency or body and of any other Person required in connection with the execution, delivery and performance of this Agreement shall have been duly obtained and shall be in full force and effect on the Closing Date.
No Litigation; Consents. (a) (i) There is no Litigation (other than investigations or inquiries) pending or, to Seller’s Knowledge, pending investigation or inquiry, or threatened Litigation of any nature whatsoever, against Seller relating primarily to the Product, the Product Business or the Purchased Assets, and (ii) there is no order or judgment of a Governmental Authority in the Buyer Territory to which Seller is subject relating to the Product, the Product conduct of the Product Business as it is currently conducted, except where the failure to possess or comply with any such Authorization would not reasonably be expected to materially affect the Product Business, the Purchased Assets or the Assumed Liabilities (or any material portion of the Product Business, the Purchased Assets or the Assumed Liabilities).
No Litigation; Consents. (a) (i) There is no Litigation pending or, to Seller’s Knowledge, threatened against Seller before any Governmental Authority relating to the Transferred Products or the Purchased Assets, and (ii) there is no order or judgment of a Governmental Authority to which Seller is subject relating to the Transferred Products or the Purchased Assets. This Section
No Litigation; Consents. (a) As of the Execution Date, there is no Litigation (other than any investigation, inquiry, audit, examination or finding of deficiency or noncompliance) pending or, to Seller’s Knowledge, threatened against Seller or any of its Affiliates before any Governmental Authority, and to Seller’s Knowledge, there are no investigations, inquiries, audits, examinations or findings of deficiency or noncompliance pending or threatened by or before any Governmental Authority, in each case, that (i) involves or otherwise relates to the Product Business, the Purchased Assets, or the Licensed Intellectual Property, or (ii) challenges or, if resolved against Seller, would prevent, delay or make illegal any of the Transactions. There is no order or judgment of a Governmental Authority to which Seller or any of its Affiliates is subject that involves or otherwise relates to the Product Business, the Purchased Assets or the Licensed Intellectual Property or that prevents, delays or makes illegal any of the Transactions.
(b) Seller has not, in the [***] years prior to the Execution Date, received any written notice, claim or complaint from any other Person alleging a violation of, or failure to comply with, or any liability under, any Laws relating to the Product Business, the Purchased Assets or the Licensed Intellectual Property as a result of Seller’s and its Affiliates’ operation of the Product Business, except for any such notice relating to a failure to comply that has since been cured.
(c) Except for (i) if required, the filings under the HSR Act and the expiration or termination of the waiting periods thereunder, (ii) consents, permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to materially affect the Product Business, the Purchased Assets or the Licensed Intellectual Property (iii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Buyer or its Affiliates and (iv) items disclosed in Section 3.1.5(c) of the Disclosure Schedules, no notice to, filing with or Authorization of, any Governmental Authority or other Person is required for Seller or any of its Affiliates to consummate the Transactions.
(d) As of the Execution Date, neither Seller nor any Affiliate of Seller has received or been notified in writing of any Paragraph IV certification notice in accordance with 21 U....
