Common use of No Litigation; Consents Clause in Contracts

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 have become applicable solely as a result of the specific regulatory status of Purchaser or its Affiliates; and (iv) Seller Third Party Consents, 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. 3.5.5 Except as set forth on Section 3.5.5 of the Seller Disclosure Schedule, as of the Execution Date, neither Seller nor any Affiliate of Seller has received or been notified in writing of any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA that relies on the FDA’s prior finding of safety and effectiveness for the Product. 3.5.6 Since May 1, 2012, no product liability claims by any Third Party or any notice of investigation from a Governmental or Regulatory Authority have been received by Seller or any of its Affiliates and, to Seller’s Knowledge, no such product liability claims or investigations have been threatened against Seller or any of its Affiliates relating to marketing and sale of the Product, and to Seller’s Knowledge, there are no facts or circumstances that would reasonably give rise to any Litigation for product liability. There is no order outstanding against Seller relating to Product liability claims or Governmental or Regulatory Authority investigations relating to the marketing and sale of the Product.

No Litigation; Consents. 3.5.1 Except as set forth on Section 3.5.1 (a) (i) As of the Seller Disclosure ScheduleExecution 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 in writing, against Seller or any of its Affiliates before any Governmental Authority or private dispute resolution body, that (i) involves or otherwise relates to in respect of the Product Business, Business or the Purchased Assets, Assets or the Assumed Liabilities; or transactions contemplated by this Agreement and the Ancillary Agreements, and (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 Order 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 in respect of Seller to sell the Purchased Product Inventory or operate the Product Business or the Purchased Assets as currently conducted or planned the transactions contemplated by this Agreement and the Ancillary Agreements, except, in each case ((i) and (ii) immediately above), for such Litigation and Orders that would not reasonably be expected 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 material to the Product Business, Business or 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 Assets. (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 any comparable filing under applicable Foreign Competition Law, and the expiration or termination of the any applicable waiting periods thereunder; , (ii) consents, permits Permits or authorizations that if not received, or declarations, filings or registrations that if not made, would not reasonably be expected to materially affect and adversely impact the Product Business, Business or the Purchased Assets or the Assumed Liabilities; Assets, (iii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Purchaser Buyer or its Affiliates; Affiliates and (iv) items disclosed in Section 3.1.5(b) of the Seller Third Party ConsentsDisclosure Schedules, no notice to, filing with with, permit of, authorization of, exemption by, or Authorization consent of, any Governmental Authority or other Person is required for Seller or any of its Affiliates to consummate the Transactionstransactions contemplated hereby or by the Ancillary Agreements. 3.5.5 Except as set forth on Section 3.5.5 of the Seller Disclosure Schedule, as of the Execution Date, neither Seller nor any Affiliate of Seller has received or been notified in writing of any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA that relies on the FDA’s prior finding of safety and effectiveness for the Product. 3.5.6 Since May 1, 2012, no product liability claims by any Third Party or any notice of investigation from a Governmental or Regulatory Authority have been received by Seller or any of its Affiliates and, to Seller’s Knowledge, no such product liability claims or investigations have been threatened against Seller or any of its Affiliates relating to marketing and sale of the Product, and to Seller’s Knowledge, there are no facts or circumstances that would reasonably give rise to any Litigation for product liability. There is no order outstanding against Seller relating to Product liability claims or Governmental or Regulatory Authority investigations relating to the marketing and sale of the Product.

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 by any Person (including, without limitation, by any Shareholder of Seller) against the Seller Parties or Purchaser or any of its their 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 Sellerthe Seller Parties, 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 the Seller Parties or any of its their 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 the Seller Parties 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 Execution Date by the Seller Parties and, to Seller’s Knowledge, there are no facts which would form a basis for such order or judgment. 3.5.3 Since May Except as set forth on Section 3.5.3 of the Seller Disclosure Schedule, since January 1, 20122014, the Seller has Parties have 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 Seller Parties’ and its their 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 Seller Product or alleging any failure of the Seller Product to meet Specifications. 3.5.4 Except as set forth on Section 3.5.4 of the Seller Disclosure Schedule and 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; (iiiii) consents, permits, authorizations, declarations, filings or registrations that have become applicable solely as a result of the specific regulatory status of Purchaser or its Affiliates; and (iviii) Seller Third Party Consentsconsents, approval, authorization, filing or notification required under the Exchange Act or the rules and regulations of The NASDAQ Global Market, no notice to, filing with or Authorization of, any Governmental Authority or other Person is required for Seller Parties or any of its their Affiliates to consummate the Transactions. 3.5.5 Except as set forth on Section 3.5.5 of the Seller Disclosure Schedule, as of the Execution Date, neither Seller nor any Affiliate of Seller has received or been notified in writing of any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA that relies on the FDA’s prior finding of safety and effectiveness for the Product. 3.5.6 Since May January 1, 20122014, no product liability claims by any Third Party or any notice of investigation from a Governmental or Regulatory Authority have been received by the Seller Parties or any of its their Affiliates and, to Seller’s Knowledge, no such product liability claims or investigations have been threatened against Seller Parties or any of its their Affiliates relating to marketing and sale of the Seller Product, and to Seller’s Knowledge, there are no facts or circumstances that would reasonably give rise to any Litigation for product liability. There is no order outstanding against the Seller Parties relating to Product liability claims or Governmental or Regulatory Authority investigations relating to the marketing and sale of the ProductSeller Products.