NDC Numbers. (a) Purchaser shall fully reimburse Sellers for any increased cost or Liability (including any returns, Rebates or Chargeback Claims) associated with any changes in pricing, including any changes in wholesale acquisition cost, made by Purchaser or any of its Affiliates to any Product that bears an NDC Number of Sellers or CPI. Purchaser shall notify Sellers immediately of any such changes in pricing to a Product that bears an NDC Number of Sellers or CPI. (b) Purchaser shall fully cooperate with Sellers and CPI by providing whatever assistance, product sales and other information and access as may be required by Sellers or CPI to comply with any reporting obligations that arise as a result of the sale by Purchaser of Product bearing an NDC Number of Sellers or CPI, and to audit the Books and Records of Purchaser and its Affiliates with respect to any such sales (provided that such audit takes place upon reasonable advance written notice to Purchaser, during normal business hours of Purchaser and does not materially interfere with Purchaser’s business). Purchaser represents and warrants that all Product sales and other information provided to Sellers in connection with the foregoing shall be accurate and complete in all material respects, and shall be calculated in accordance with applicable Laws and regulatory guidance. (c) Subject to appropriate confidentiality protection, after the Closing Date and for a period of ten (10) years thereafter (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue as long as there is potential for a claim), Purchaser and its Affiliates shall cooperate with Sellers and their Representatives, subject to confidentiality protections reasonably satisfactory to Purchaser, during normal business hours and upon reasonable advance notice, to provide reasonable access to records maintained by Purchaser and its Affiliates relating to Purchaser and its Affiliates’ distribution of Seller-Labeled Products or related regulatory filing and reporting requirements and activities with respect to Seller-Labeled Products, including, without limitation, government price reporting (“Distribution Activities”), to provide reports reasonably requested by Sellers regarding such records and information, and to permit copying at the expense of Sellers or, where reasonably necessary, to loan original documents relating to the same for the purposes of (i) any financial reporting or Tax matters relating to Distribution Activities, (ii) any claims or litigation involving Distribution Activities or (iii) any investigation being conducted by any federal, state or local Governmental Authority relating to Distribution Activities.
Appears in 1 contract
Samples: Asset Purchase Agreement (Concordia Healthcare Corp.)
NDC Numbers.
(a) As soon as reasonably possible, but in any event no later than nine (9) months after the Closing Date, Purchaser shall obtain a new NDC Number and labeler code for the Product. Purchaser, at its own expense, shall prepare and file with the FDA any and all reports, documents and materials, and take such other actions, as are necessary to undertake the foregoing.
(b) Purchaser shall fully reimburse Sellers Seller and its Affiliates and distributors for any increased cost or Liability (including any returns, Rebates rebates or Chargeback Claimschargeback claims) incurred by them and associated with any changes in pricing, including any changes in wholesale acquisition cost, made by Purchaser or any of its Affiliates to any Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates. Purchaser shall pay any such reimbursement within thirty (30) days of receiving a written request for such reimbursement from Seller, which shall be accompanied by supporting documentation that reasonably evidences the increased cost or Liability to be reimbursed. Purchaser shall notify Sellers immediately Seller promptly of any such changes in pricing to a Product that bears an NDC Number of Sellers Seller or CPI.any of its Affiliates or distributors.
(bc) Purchaser shall fully cooperate with Sellers Seller and CPI its Affiliates and distributors by providing whatever assistance, product sales and other information and access as may be required by Sellers Seller or CPI any of its Affiliates or distributors to comply with any reporting obligations that arise as a result of the sale by Purchaser of Product bearing an NDC Number of Sellers Seller or CPIany of its Affiliates, and to enable Seller and its Affiliates, one time within the period of 12 months from and after the date of last commercial sale to an end customer of Product bearing an NDC Number of Seller or any Affiliate thereof, to audit the Books books and Records records of Purchaser and its Affiliates with respect to any such sales (provided provided, that such audit takes place upon reasonable advance written notice to Purchaser, during normal business hours of Purchaser and does not materially interfere with Purchaser’s business). Purchaser represents and warrants that all Product sales and other information provided to Sellers Seller or any of its Affiliates or distributors in connection with the foregoing shall be accurate and complete in all material respects, and shall be calculated in accordance with applicable Laws and regulatory guidance..
(cd) Subject to appropriate confidentiality protection, after the Closing Date and for a period of ten (10) [***] years thereafter (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue as long as there is potential for a claim), Purchaser and its Affiliates shall reasonably cooperate (at Seller’s expense) with Sellers Seller and their its Affiliates, distributors and Representatives, subject to confidentiality protections reasonably satisfactory to Purchaser, during normal business hours and upon reasonable advance notice, to provide reasonable access to records maintained by Purchaser and its Affiliates relating to Purchaser and its Affiliates’ distribution of Seller’s Seller-Labeled Products Product or related regulatory filing and reporting requirements and activities with respect to Seller’s Seller-Labeled ProductsProduct, including, without limitation, government price reporting (“Distribution Activities”), to provide reports reasonably requested by Sellers Seller or its Affiliates or distributors regarding such records and information, and to permit copying at the expense of Sellers Seller or, where reasonably necessary, to loan original documents relating to the same for the purposes of (i) any financial reporting or Tax matters relating to Distribution Activities, (ii) any claims or litigation involving Distribution Activities or (iii) any investigation being conducted by any federal, state or local Governmental Authority relating to Distribution Activities..
Appears in 1 contract
NDC Numbers. (a) As soon as reasonably possible, but in any event no later than nine (9) months after the Closing Date, Purchaser shall obtain a new NDC Number and labeler code for such Product. Purchaser, at its own expense, shall prepare and file with the FDA any and all reports, documents and materials, and take such other actions, as are necessary to undertake the foregoing.
(b) Purchaser shall fully reimburse Sellers Seller and its Affiliates and distributors for any increased cost or Liability (including any returns, Rebates rebates or Chargeback Claimschargeback claims) associated with any changes in pricing, including any changes in wholesale acquisition cost, made by Purchaser or any of its Affiliates to any Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates. Purchaser shall pay any such reimbursement within thirty (30) days of receiving a written request for such reimbursement from Seller, which shall be accompanied by supporting documentation that reasonably evidences the increased cost or Liability to be reimbursed. Purchaser shall notify Sellers immediately Seller promptly of any such changes in pricing to a Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates or distributors.
(bc) Purchaser shall fully cooperate with Sellers Seller and CPI its Affiliates and distributors by providing whatever assistance, product sales and other information and access as may be required by Sellers Seller or CPI any of its Affiliates or distributors to comply with any reporting obligations that arise as a result of the sale by Purchaser of Product bearing an NDC Number of Sellers Seller or CPIany of its Affiliates, and to enable Seller and its Affiliates, one time within the period of 12 months from and after the date of last commercial sale to an end customer of Product bearing an NDC Number of Seller or any Affiliate thereof, to audit the Books books and Records records of Purchaser and its Affiliates with respect to any such sales (provided provided, that such audit takes place upon reasonable advance written notice to Purchaser, during normal business hours of Purchaser and does not materially interfere with Purchaser’s business). Purchaser represents and warrants that all Product sales and other information provided to Sellers Seller or any of its Affiliates or distributors in connection with the foregoing shall be accurate and complete in all material respects, and shall be calculated in accordance with applicable Laws and regulatory guidance.
(cd) Subject to appropriate confidentiality protection, after the Closing Date and for a period of ten (10) [***] years thereafter (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue as long as there is potential for a claim), Purchaser and its Affiliates shall reasonably cooperate (at Seller’s expense) with Sellers Seller and their its Affiliates, distributors and Representatives, subject to confidentiality protections reasonably satisfactory to Purchaser, during normal business hours and upon reasonable advance notice, to provide reasonable access to records maintained by Purchaser and its Affiliates relating to Purchaser and its Affiliates’ distribution of Seller’s Seller-Labeled Products or related regulatory filing and reporting requirements and activities with respect to Seller’s Seller-Labeled Products, including, without limitation, government price reporting (“Distribution Activities”), to provide reports reasonably requested by Sellers Seller or its Affiliates or distributors regarding such records and information, and to permit copying at the expense of Sellers Seller or, where reasonably necessary, to loan original documents relating to the same for the purposes of (i) any financial reporting or Tax matters relating to Distribution Activities, (ii) any claims or litigation involving Distribution Activities or (iii) any investigation being conducted by any federal, state or local Governmental Authority relating to Distribution Activities.
Appears in 1 contract
NDC Numbers. (a) As soon as reasonably possible, but in any event no later than nine (9) months after the Closing Date, Purchaser shall obtain a new NDC Number and labeler code for the Product. Purchaser, at its own expense, shall prepare and file with the FDA any and all reports, documents and materials, and take such other actions, as are necessary to undertake the foregoing.
(b) Purchaser shall fully reimburse Sellers Seller and its Affiliates and distributors for any increased cost or Liability (including any returns, Rebates rebates or Chargeback Claimschargeback claims) incurred by them and associated with any changes in pricing, including any changes in wholesale acquisition cost, made by Purchaser or any of its Affiliates to any Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates. Purchaser shall pay any such reimbursement within thirty (30) days of receiving a written request for such reimbursement from Seller, which shall be accompanied by supporting documentation that reasonably evidences the increased cost or Liability to be reimbursed. Purchaser shall notify Sellers immediately Seller promptly of any such changes in pricing to a Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates or distributors.
(bc) Purchaser shall fully cooperate with Sellers Seller and CPI its Affiliates and distributors by providing whatever assistance, product sales and other information and access as may be required by Sellers Seller or CPI any of its Affiliates or distributors to comply with any reporting obligations that arise as a result of the sale by Purchaser of Product bearing an NDC Number of Sellers Seller or CPIany of its Affiliates, and to enable Seller and its Affiliates, one time within the period of 12 months from and after the date of last commercial sale to an end customer of Product bearing an NDC Number of Seller or any Affiliate thereof, to audit the Books books and Records records of Purchaser and its Affiliates with respect to any such sales (provided provided, that such audit takes place upon reasonable advance written notice to Purchaser, during normal business hours of Purchaser and does not materially interfere with Purchaser’s business). Purchaser represents and warrants that all Product sales and other information provided to Sellers Seller or any of its Affiliates or distributors in connection with the foregoing shall be accurate and complete in all material respects, and shall be calculated in accordance with applicable Laws and regulatory guidance.
(cd) Subject to appropriate confidentiality protection, after the Closing Date and for a period of ten (10) [***] years thereafter (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue as long as there is potential for a claim), Purchaser and its Affiliates shall reasonably cooperate (at Seller’s expense) with Sellers Seller and their its Affiliates, distributors and Representatives, subject to confidentiality protections reasonably satisfactory to Purchaser, during normal business hours and upon reasonable advance notice, to provide reasonable access to records maintained by Purchaser and its Affiliates relating to Purchaser and its Affiliates’ distribution of Seller’s Seller-Labeled Products Product or related regulatory filing and reporting requirements and activities with respect to Seller’s Seller-Labeled ProductsProduct, including, without limitation, government price reporting (“Distribution Activities”), to provide reports reasonably requested by Sellers Seller or its Affiliates or distributors regarding such records and information, and to permit copying at the expense of Sellers Seller or, where reasonably necessary, to loan original documents relating to the same for the purposes of (i) any financial reporting or Tax matters relating to Distribution Activities, (ii) any claims or litigation involving Distribution Activities or (iii) any investigation being conducted by any federal, state or local Governmental Authority relating to Distribution Activities.
(e) Seller will maintain Seller’s NDC numbers for the Product at all times after the Closing Date until the shelf life of all Purchased Inventory has expired based on the respective expiration dates set forth on the labels for the Product included in the Purchased Inventory and thereafter remove (or delist) the Product from the DailyMed website as soon as reasonably practicable. Seller will work with the Purchaser to update the prescribing information, or other required update, in the drug listing files to maintain regulatory compliance when necessary prior to the delisting.
Appears in 1 contract
NDC Numbers. (a) As soon as reasonably possible, but in any event no later than nine (9) months after the Closing Date, Purchaser shall obtain a new NDC Number and labeler code for the Product. Purchaser, at its own expense, shall prepare and file with the FDA any and all reports, documents and materials, and take such other actions, as are necessary to undertake the foregoing.
(b) Purchaser shall fully reimburse Sellers Seller and its Affiliates and distributors for any increased cost or Liability (including any returns, Rebates rebates or Chargeback Claimschargeback claims) incurred by them and associated with any changes in pricing, including any changes in wholesale acquisition cost, made by Purchaser or any of its Affiliates to any Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates. Purchaser shall pay any such reimbursement within thirty (30) days of receiving a written request for such reimbursement from Seller, which shall be accompanied by supporting documentation that reasonably evidences the increased cost or Liability to be reimbursed. Purchaser shall notify Sellers immediately Seller promptly of any such changes in pricing to a Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates or distributors.
(bc) Purchaser shall fully cooperate with Sellers Seller and CPI its Affiliates and distributors by providing whatever assistance, product sales and other information and access as may be required by Sellers Seller or CPI any of its Affiliates or distributors to comply with any reporting obligations that arise as a result of the sale by Purchaser of Product bearing an NDC Number of Sellers Seller or CPIany of its Affiliates, and to enable Seller and its Affiliates, one time within the period of 12 months from and after the date of last commercial sale to an end customer of Product bearing an NDC Number of Seller or any Affiliate thereof, to audit the Books books and Records records of Purchaser and its Affiliates with respect to any such sales (provided provided, that such audit takes place upon reasonable advance written notice to Purchaser, during normal business hours of Purchaser and does not materially interfere with Purchaser’s business). Purchaser represents and warrants that all Product sales and other information provided to Sellers Seller or any of its Affiliates or distributors in connection with the foregoing shall be accurate and complete in all material respects, and shall be calculated in accordance with applicable Laws and regulatory guidance.
(cd) Subject to appropriate confidentiality protection, after the Closing Date and for a period of ten (10) [***] years thereafter (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue as long as there is potential for a claim), Purchaser and its Affiliates shall reasonably cooperate (at Seller’s expense) with Sellers Seller and their its Affiliates, distributors and Representatives, subject to confidentiality protections reasonably satisfactory to Purchaser, during normal business hours and upon reasonable advance notice, to provide reasonable access to records maintained by Purchaser and its Affiliates relating to Purchaser and its Affiliates’ distribution of Seller’s Seller-Labeled Products Product or related regulatory filing and reporting requirements and activities with respect to Seller’s Seller-Labeled ProductsProduct, including, without limitation, government price reporting (“Distribution Activities”), to provide reports reasonably requested by Sellers Seller or its Affiliates or distributors regarding such records and information, and to permit copying at the expense of Sellers Seller or, where reasonably necessary, to loan original documents relating to the same for the purposes of (i) any financial reporting or Tax matters relating to Distribution Activities, (ii) any claims or litigation involving Distribution Activities or (iii) any investigation being conducted by any federal, state or local Governmental Authority relating to Distribution Activities.
Appears in 1 contract
NDC Numbers.
(a) As soon as reasonably possible, but in any event no later than nine (9) months after the Closing Date, Purchaser shall obtain a new NDC Number and labeler code for the Product. Purchaser, at its own expense, shall prepare and file with the FDA any and all reports, documents and materials, and take such other actions, as are necessary to undertake the foregoing.
(b) Purchaser shall fully reimburse Sellers Seller and its Affiliates and distributors for any increased cost or Liability (including any returns, Rebates rebates or Chargeback Claimschargeback claims) incurred by them and associated with any changes in pricing, including any changes in wholesale acquisition cost, made by Purchaser or any of its Affiliates to any Product that bears an NDC Number of Sellers Seller or CPIany of its Affiliates. Purchaser shall pay any such reimbursement within thirty (30) days of receiving a written request for such reimbursement from Seller, which shall be accompanied by supporting documentation that reasonably evidences the increased cost or Liability to be reimbursed. Purchaser shall notify Sellers immediately Seller promptly of any such changes in pricing to a Product that bears an NDC Number of Sellers Seller or CPI.any of its Affiliates or distributors.
(bc) Purchaser shall fully cooperate with Sellers Seller and CPI its Affiliates and distributors by providing whatever assistance, product sales and other information and access as may be required by Sellers Seller or CPI any of its Affiliates or distributors to comply with any reporting obligations that arise as a result of the sale by Purchaser of Product bearing an NDC Number of Sellers Seller or CPIany of its Affiliates, and to enable Seller and its Affiliates, one time within the period of 12 months from and after the date of last commercial sale to an end customer of Product bearing an NDC Number of Seller or any Affiliate thereof, to audit the Books books and Records records of Purchaser and its Affiliates with respect to any such sales (provided provided, that such audit takes place upon reasonable advance written notice to Purchaser, during normal business hours of Purchaser and does not materially interfere with Purchaser’s business). Purchaser represents and warrants that all Product sales and other information provided to Sellers Seller or any of its Affiliates or distributors in connection with the foregoing shall be accurate and complete in all material respects, and shall be calculated in accordance with applicable Laws and regulatory guidance..
(cd) Subject to appropriate confidentiality protection, after the Closing Date and for a period of ten (10) [***] years thereafter (except with respect to government claims not subject to a statute of limitations, such as Medicaid rebate claims, which shall continue as long as there is potential for a claim), Purchaser and its Affiliates shall reasonably cooperate (at Seller’s expense) with Sellers Seller and their its Affiliates, distributors and Representatives, subject to confidentiality protections reasonably satisfactory to Purchaser, during normal business hours and upon reasonable advance notice, to provide reasonable access to records maintained by Purchaser and its Affiliates relating to Purchaser and its Affiliates’ distribution of Seller’s Seller-Labeled Products Product or related regulatory filing and reporting requirements and activities with respect to Seller’s Seller-Labeled ProductsProduct, including, without limitation, government price reporting (“Distribution Activities”), to provide reports reasonably requested by Sellers Seller or its Affiliates or distributors regarding such records and information, and to permit copying at the expense of Sellers Seller or, where reasonably necessary, to loan original documents relating to the same for the purposes of (i) any financial reporting or Tax matters relating to Distribution Activities, (ii) any claims or litigation involving Distribution Activities or (iii) any investigation being conducted by any federal, state or local Governmental Authority relating to Distribution Activities..
(e) Seller will maintain Seller’s NDC numbers for the Product at all times after the Closing Date until the shelf life of all Purchased Inventory has expired based on the respective expiration dates set forth on the labels for the Product included in the Purchased Inventory and thereafter remove (or delist) the Product from the DailyMed website as soon as reasonably practicable. Seller will work with the Purchaser to update the prescribing information, or other required update, in the drug listing files to maintain regulatory compliance when necessary prior to the delisting.
Appears in 1 contract
