Product Responsibility. (a) In furtherance of and not in limitation of the assumption of the Assumed Liabilities, following the Closing until the payment by Buyer of both Deferred Payments, Buyer shall use Commercially Reasonable Efforts to obtain and maintain, at its sole expense, in accordance with applicable Legal Requirements, all Governmental Authorizations in connection with the Product. Subject to Seller’s indemnification obligations under ARTICLE 6, from and after the Closing, Buyer shall be solely and exclusively responsible for (i) all regulatory matters with respect to the Product and the Purchased Assets, including without limitation relating to communicating and corresponding, preparing and filing reports, making adverse drug experience reports, and paying applicable fees, with and to applicable Governmental Bodies, under all applicable Legal Requirements including the FFDCA, the Prescription Drug Marketing Act of 1987, the Prescription Drug User Fee Act of 1992 and the Generic Drug User Fee Amendments of 2012; (ii) taking all actions and conducting all communication with Third Parties in respect of Product (whether sold before or after the Closing), including responding to all complaints in respect thereof and all medical information requests, including complaints related to tampering or contamination; and (iii) investigating all complaints and adverse drug experiences in respect of the Product (whether sold before or after the Closing). (b) Subject to the immediately following sentence, from and after the Closing, (a) Seller shall provide Buyer with (i) copies of all written or electronic correspondence relating to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to the Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case within twenty (20) Business Days after Buyer’s receipt, submission or production of the foregoing, as applicable. If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, revocation or variation of the Drug Authorization for the Product, the prohibition or suspension of the supply of the Product, or the initiation of any investigation, review or inquiry by such Regulatory Authority concerning the safety of the Product, then the Seller shall notify the Buyer and provide the Buyer with copies of such written or electronic correspondence as soon as practicable, but not later than five (5) Business Days after receipt of such correspondence. Unless otherwise prevented by an applicable Legal Requirement, Seller shall provide Buyer with a copy of any written response hereto in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities. (c) From and after the Closing, Buyer shall be solely and exclusively responsible for conducting, handling or processing all voluntary and involuntary recalls of units of Product, including recalls required by any Governmental Body, with respect to the Product, regardless of whether the Product was sold before or after the Closing, subject to Seller’s financial responsibility for Seller Finished Product. Buyer shall destroy, or cause to be destroyed, in either case at Buyer’s expense, all recalled Product in a manner consistent with applicable Legal Requirements. In the event that Seller Finished Product is the subject of a recall, Buyer shall notify Seller in writing as soon as practicable, but in no event more than three (3) days after Buyer becomes aware of such recall. Seller shall be financially responsible for all voluntary and involuntary recalls of Seller Finished Product; provided, however, that Seller shall not bear any financial responsibility for such recalls to the extent such recalls resulted from acts or omissions of Buyer or any of its Affiliates. Accordingly, Buyer will provide to Seller an invoice for all out-of-pocket costs actually incurred, without markup by Buyer and its Affiliates with respect to recalls of any Seller Finished Product (including amounts paid or credited by Buyer and its Affiliates for such returns according to Seller’s standard returned goods policy), and Seller will pay Buyer such amount within thirty (30) days of receipt of such invoice. Buyer shall be financially responsible for all costs and expenses related to any recalls of Product, other than the Seller Finished Product. (d) As soon as practicable following the Closing Date, Buyer shall institute appropriate procedures (including any appropriate procedures for tracking of lot number information) to ensure that the Product sold by or on behalf of Buyer can be distinguished from the Product sold by or on behalf of Seller prior to the Closing Date. (e) Following the Closing Date, other than with respect to Remaining Lot 18 Product, Buyer shall not label any Product with Seller’s NDC number without first obtaining the prior written consent of Seller. (f) Seller shall have the final authority and responsibility for final release of any Product bearing Seller’s NDC number. Buyer shall not market, sell or distribute Product bearing Seller’s NDC number prior to receipt of Seller’s written release of each quantity, batch, lot or shipment (or part thereof) of such Product. Buyer shall provide Seller, or Seller’s designee, with Product samples, completed batch records and any other documentation in accordance with the Quality Agreement for purposes of releasing the Product for commercial sale. Seller may test or cause the Product to be tested in accordance with Seller’s customary procedures. Seller shall notify Buyer in writing of Seller’s release or rejection of any quantity, batch, lot or shipment (or part thereof) of any Product within thirty (30) days after receipt of Product samples, completed batch records and other documentation by Seller or Seller’s designee. Seller’s rejection of the Product shall be based on: (a) nonconformance to Product specifications set forth in the Drug Authorization; (b) adulteration or misbranding of the Product, or (c) Product not having been prepared in compliance with an applicable Legal Requirement. For a period of one (1) year following the Closing Date, Buyer will cause Buyer’s third-party logistics provider, wholesaler or distributor (each a “Service Provider”) to provide Seller with written reports, on a biweekly basis, detailing by distribution center, NDC number, lot number, expiration date and quantity such Service Provider’s inventory of Products. (g) While Buyer remains solely responsible for regulatory compliance relating to the Product following the Closing Date, during the time that the Product bears Seller’s name or NDC Number on the Product label or the Seller’s name is included on any written, printed, or graphic materials which reference the Product, Buyer must notify Seller, in writing, within twenty-four (24) hours of any inquiry or inspection by a Governmental Body that relates to the Product. Seller shall have the right to review and comment on any response prepared by Buyer to any such inquiry or inspection, be involved in any decision making process relating to the resolution of the matter and, if Seller requests, participate in any specific meetings or conversations with any Governmental Body concerning the Product. (h) For clarity, from and after the Closing Date, Buyer shall have sole discretion over the commercialization, marketing strategy, promotion, distribution and sale of the Product and shall independently determine and set prices for the Product, provided that the foregoing shall not limit either Party’s obligations to the other Party under this Agreement (including Section 5.4(g)).
Appears in 2 contracts
Samples: Asset Purchase Agreement, Asset Purchase Agreement (Neos Therapeutics, Inc.)
Product Responsibility. (a) In furtherance of and not 8.4.1 Except as otherwise set forth in limitation of the assumption of the Assumed Liabilities, following the Closing until the payment by Buyer of both Deferred Payments, Buyer shall use Commercially Reasonable Efforts to obtain and maintain, at its sole expense, in accordance with applicable Legal Requirements, all Governmental Authorizations in connection with the Product. Subject to Seller’s indemnification obligations under ARTICLE 6this Agreement, from and after the ClosingTransition Date, Buyer Purchasers shall be solely and exclusively responsible for (i) all regulatory matters with respect to the Product and the Purchased Assets, including without limitation relating to communicating and corresponding, preparing and filing reports, making adverse drug experience reports, and paying applicable fees, with and to applicable Governmental BodiesAuthorities, under all applicable Legal Requirements legal requirements including the FFDCAAct, the Prescription Drug Marketing Act of 1987PDMA, and the Prescription Drug User Fee Act of 1992 and the Generic Drug User Fee Amendments of 20121992; (ii) taking all actions and conducting all communication with Third Parties in respect of Product (whether sold before or after the Closing), including responding to all complaints in respect thereof and all medical information requests, including complaints related to tampering or contamination; and (iii) investigating all complaints and adverse drug experiences in respect of the Product (whether sold before or after the Closing).
(b) Subject to the immediately following sentence, from and after the Closing, (a) Seller shall provide Buyer with (i) copies of all written or electronic correspondence relating to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to the Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case within twenty (20) Business Days after Buyer’s receipt, submission or production of the foregoing, as applicable. If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, revocation or variation of the Drug Authorization for the Product, the prohibition or suspension of the supply of the Product, or the initiation of any investigation, review or inquiry by such Regulatory Authority concerning the safety of the Product, then the Seller shall notify the Buyer and provide the Buyer with copies of such written or electronic correspondence as soon as practicable, but not later than five (5) Business Days after receipt of such correspondence. Unless otherwise prevented by an applicable Legal Requirement, Seller shall provide Buyer with a copy of any written response hereto in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.
(c) 8.4.2 From and after the ClosingTransition Date, Buyer Purchasers shall be solely and exclusively responsible for conducting, handling or processing all voluntary and involuntary recalls of units of Product, including recalls required by any Governmental BodyAuthority or voluntary recalls by Purchasers based on safety, efficacy or similar concerns, with respect to the Product, regardless of whether the Product was sold before or after the Closing, subject to Seller’s financial responsibility for Seller Finished Product. Buyer Purchasers shall destroy, or cause to be destroyed, in either case at Buyer’s expensecase, all recalled Product in a manner consistent with applicable Legal Requirementslegal requirements. In From and after the event Closing, Purchasers shall be financially responsible for all recalls of units of Product sold after the Closing, except to the extent indemnified under the Supply Agreement. For any recalled Product that Seller Finished Product is was sold prior to the subject of a recallClosing, Buyer Sellers shall notify Seller reimburse Purchasers for all reasonable out-of-pocket costs and expenses actually incurred in writing as connection with any and all such recalls that are required by any Governmental Authority or are voluntarily initiated by Purchasers based on safety, efficacy or similar concerns.
8.4.3 As soon as practicable, but in no event more than three (3) days after Buyer becomes aware of such recall. Seller shall be financially responsible for all voluntary and involuntary recalls of Seller Finished Product; provided, however, that Seller shall not bear any financial responsibility for such recalls to the extent such recalls resulted from acts or omissions of Buyer or any of its Affiliates. Accordingly, Buyer will provide to Seller an invoice for all out-of-pocket costs actually incurred, without markup by Buyer and its Affiliates with respect to recalls of any Seller Finished Product (including amounts paid or credited by Buyer and its Affiliates for such returns according to Seller’s standard returned goods policy), and Seller will pay Buyer such amount within thirty (30) days of receipt of such invoice. Buyer shall be financially responsible for all costs and expenses related to any recalls of Product, other later than the expiration of the Seller Finished Product.
Brand License, Purchasers will (di) As soon as practicable following establish new NDC numbers for Product and thereafter shall cause such NDC numbers to be used on the Closing Date, Buyer shall institute appropriate procedures (including any appropriate procedures labeling and packaging for tracking of lot number information) to ensure that the Product sold by or on behalf of Buyer can be distinguished from and (ii) establish new capsule imprinting for the Product sold by that does not incorporate any name or on behalf of the trademark licensed to Purchasers under the Seller prior Brand License and thereafter shall cause such new capsule imprinting to be used for the Closing Date.
(e) Following the Closing Date, other than with respect to Remaining Lot 18 Product, Buyer shall not label any Product with Seller’s NDC number without first obtaining the prior written consent of Seller.
(f) Seller shall have the final authority and responsibility for final release of any Product bearing Seller’s NDC number. Buyer shall not market, sell or distribute Product bearing Seller’s NDC number prior to receipt of Seller’s written release of each quantity, batch, lot or shipment (or part thereof) of such Product. Buyer shall provide Seller, or Seller’s designee, with Product samples, completed batch records and any other documentation in accordance with the Quality Agreement for purposes of releasing the Product for commercial sale. Seller may test or cause the Product to be tested in accordance with Seller’s customary procedures. Seller shall notify Buyer in writing of Seller’s release or rejection of any quantity, batch, lot or shipment (or part thereof) of any Product within thirty (30) days after receipt of Product samples, completed batch records and other documentation by Seller or Seller’s designee. Seller’s rejection of the Product shall be based on: (a) nonconformance to Product specifications Nothing set forth in the Drug Authorization; (b) adulteration this section shall prevent or misbranding restrict Purchasers from selling Inventory labeled with Seller Brand prior to expiration of the Product, or (c) Product not having been prepared in compliance with an applicable Legal Requirement. For a period of one (1) year following the Closing Date, Buyer will cause Buyer’s third-party logistics provider, wholesaler or distributor (each a “Service Provider”) to provide Seller with written reports, on a biweekly basis, detailing by distribution center, NDC number, lot number, expiration date and quantity such Service Provider’s inventory of ProductsBrand License.
(g) While Buyer remains solely responsible for regulatory compliance relating to the Product following the Closing Date, during the time that the Product bears Seller’s name or NDC Number on the Product label or the Seller’s name is included on any written, printed, or graphic materials which reference the Product, Buyer must notify Seller, in writing, within twenty-four (24) hours of any inquiry or inspection by a Governmental Body that relates to the Product. Seller shall have the right to review and comment on any response prepared by Buyer to any such inquiry or inspection, be involved in any decision making process relating to the resolution of the matter and, if Seller requests, participate in any specific meetings or conversations with any Governmental Body concerning the Product.
(h) For clarity, from and after the Closing Date, Buyer shall have sole discretion over the commercialization, marketing strategy, promotion, distribution and sale of the Product and shall independently determine and set prices for the Product, provided that the foregoing shall not limit either Party’s obligations to the other Party under this Agreement (including Section 5.4(g)).
Appears in 1 contract
Samples: Asset Purchase and Sale Agreement (Pernix Therapeutics Holdings, Inc.)
Product Responsibility. (a) In furtherance of and not Except as otherwise set forth in limitation of the assumption of the Assumed Liabilities, following the Closing until the payment by Buyer of both Deferred Payments, Buyer shall use Commercially Reasonable Efforts to obtain and maintain, at its sole expense, in accordance with applicable Legal Requirements, all Governmental Authorizations in connection with the Product. Subject to Seller’s indemnification obligations under ARTICLE 6this Agreement or any Ancillary Agreement, from and after the ClosingClosing Date as between Purchaser and the Transferred Entities, Buyer on the one hand, and the Sellers, on the other hand, Purchaser and the Transferred Entities shall be solely and exclusively responsible for (i) all regulatory matters with respect to the Product Transferred Products and the Purchased other Transferred Assets, including without limitation relating to communicating and corresponding, preparing and filing reports, making adverse drug experience reports, and paying applicable fees, with and to applicable Governmental BodiesEntities, under all applicable Legal Requirements including the FFDCA, the Prescription Drug Marketing Act of 1987, the Prescription Drug User Fee Act of 1992 and the Generic Drug User Fee Amendments of 2012legal requirements; (ii) taking all actions and conducting all communication with Third Parties third parties in respect of Product the Transferred Products (whether sold before or after the ClosingClosing Date), including responding to all complaints in respect thereof and all medical information requests, including complaints related to tampering or contamination; and (iii) investigating all complaints and adverse drug experiences in respect of the Product (Transferred Products, in each case, whether sold before or after the Closing)Closing Date.
(b) Subject to the immediately following sentence, from and after the Closing, (a) Seller shall provide Buyer with (i) copies of all written or electronic correspondence relating to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to the Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case within twenty (20) Business Days after Buyer’s receipt, submission or production of the foregoing, as applicable. If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, revocation or variation of the Drug Authorization for the Product, the prohibition or suspension of the supply of the Product, or the initiation of any investigation, review or inquiry by such Regulatory Authority concerning the safety of the Product, then the Seller shall notify the Buyer and provide the Buyer with copies of such written or electronic correspondence as soon as practicable, but not later than five (5) Business Days after receipt of such correspondence. Unless otherwise prevented by an applicable Legal Requirement, Seller shall provide Buyer with a copy of any written response hereto in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.
(c) From and after the ClosingClosing Date as between Purchaser and the Transferred Entities, Buyer on the one hand, and the Sellers, on the other hand, except as may be otherwise provided in this Agreement or any Ancillary Agreement, Purchaser and the Transferred Entities shall be solely and exclusively responsible for conducting, handling or processing all voluntary recalls, suspensions, withdrawals and involuntary recalls seizures of units of Productthe Transferred Products, including recalls recalls, suspensions, withdrawals and seizures required by any Governmental BodyEntities or voluntary recalls, suspensions, withdrawals and seizures by Purchaser and the Transferred Entities based on safety, efficacy or similar concerns, with respect to the ProductTransferred Products, regardless of whether the Product was Transferred Products were sold before or after the ClosingClosing Date. From and after the Closing Date as between Purchaser and the Transferred Entities, subject to Seller’s financial responsibility for Seller Finished Product. Buyer shall destroyon the one hand, or cause to be destroyedand the Sellers, in either case at Buyer’s expenseon the other hand, all recalled Product in a manner consistent with applicable Legal Requirements. In the event that Seller Finished Product is the subject of a recall, Buyer shall notify Seller in writing as soon as practicable, but in no event more than three (3) days after Buyer becomes aware of such recall. Seller Purchaser shall be financially responsible for all voluntary recalls, suspensions, withdrawals and involuntary recalls seizures of Seller Finished Product; providedunits of the Transferred Products, however, that Seller shall not bear any financial responsibility for such recalls to the extent such recalls resulted from acts whether sold before or omissions of Buyer or any of its Affiliates. Accordingly, Buyer will provide to Seller an invoice for all out-of-pocket costs actually incurred, without markup by Buyer and its Affiliates with respect to recalls of any Seller Finished Product (including amounts paid or credited by Buyer and its Affiliates for such returns according to Seller’s standard returned goods policy), and Seller will pay Buyer such amount within thirty (30) days of receipt of such invoice. Buyer shall be financially responsible for all costs and expenses related to any recalls of Product, other than the Seller Finished Product.
(d) As soon as practicable following the Closing Date, Buyer shall institute appropriate procedures (including any appropriate procedures for tracking of lot number information) to ensure that the Product sold by or on behalf of Buyer can be distinguished from the Product sold by or on behalf of Seller prior to after the Closing Date.
(ec) Following Except as may be otherwise provided in this Agreement or any Ancillary Agreement, Purchaser shall process and be financially responsible for all returns of the Closing DateTransferred Products (the “Finished Products”) under any Seller’s label or Purchaser’s label, other than with respect to Remaining Lot 18 regardless of who distributed the Finished Product, Buyer shall not label any Product with Seller’s NDC number without first obtaining the prior written consent of Seller.
(f) Seller shall have the final authority and responsibility for final release of any Product bearing Seller’s NDC number. Buyer shall not market, sell or distribute Product bearing Seller’s NDC number prior to receipt of Seller’s written release of each quantity, batch, lot or shipment (or part thereof) of such Product. Buyer shall provide Seller, or Seller’s designee, with Product samples, completed batch records and any other documentation in accordance with the Quality Agreement for purposes of releasing the Product for commercial sale. Seller may test or cause the Product to be tested in accordance with Seller’s customary procedures. Seller shall notify Buyer in writing of Seller’s release or rejection of any quantity, batch, lot or shipment (or part thereof) of any Product within thirty (30) days after receipt of Product samples, completed batch records and other documentation by Seller or Seller’s designee. Seller’s rejection of the Product shall be based on: (a) nonconformance to Product specifications set forth in the Drug Authorization; (b) adulteration or misbranding of the Product, or (c) Product not having been prepared in compliance with an applicable Legal Requirement. For a period of one (1) year following the Closing Date, Buyer will cause Buyer’s third-party logistics provider, wholesaler or distributor (each a “Service Provider”) to provide Seller with written reports, on a biweekly basis, detailing by distribution center, NDC number, lot number, expiration date and quantity such Service Provider’s inventory of Products.
(g) While Buyer remains solely responsible for regulatory compliance relating to the Product following the Closing Date, during the time that the Product bears Seller’s name or NDC Number on the Product label or the Seller’s name is included on any written, printed, or graphic materials which reference the Product, Buyer must notify Seller, in writing, within twenty-four (24) hours of any inquiry or inspection by a Governmental Body that relates to the Product. Seller shall have the right to review and comment on any response prepared by Buyer to any such inquiry or inspection, be involved in any decision making process relating to the resolution of the matter and, if Seller requests, participate in any specific meetings or conversations with any Governmental Body concerning the Product.
(h) For clarity, from and after the Closing Date. If any quantities of Finished Products are returned to any Seller, Buyer then such Seller shall notify Purchaser as soon as practicable and ship such returned Finished Products to the facility designated by Purchaser at Purchaser’s cost. The Sellers, at their option, may advise the customer that made such return that such Finished Product should have sole discretion over been returned to Purchaser. At Purchaser’s request, the commercializationSellers shall destroy such returned Finished Product in accordance with applicable Law, marketing strategyand Purchaser shall reimburse Sellers for such cost, promotionincluding the reasonable cost of destruction (except to the extent that such return relates to non-conforming product manufactured by Sellers prior to the Closing Date).
(d) Neither Purchaser, distribution on the one hand, nor any Seller, on the other hand, shall instruct, recommend or attempt to induce customers who have previously purchased any Finished Product to: (i) return such Finished Product when that would not otherwise have been the case but for such party’s instructions, recommendations or inducement; or (ii) delay the return of such Finished Product. For the avoidance of doubt, shipment of Finished Product to customers in the Ordinary Course of Business shall not be deemed to violate this Section 7.9(e).
(e) Purchaser acknowledges and sale agrees that Purchaser shall be responsible for the treatment, processing and payment of any and all Offsets due in connection with any and all sales of the Product and Transferred Products, regardless of whether such Transferred Products (i) are labelled with Purchaser’s or a Seller’s information or NDC or (ii) sold before or after the Closing Date. This Section 7.9 shall independently determine and set prices for survive after the Product, provided that the foregoing shall not limit either Party’s obligations to the other Party under this Agreement (including Section 5.4(g))Closing Date.
Appears in 1 contract
Samples: Purchase and Sale Agreement (Osmotica Pharmaceuticals PLC)
Product Responsibility. (a) In furtherance of and not 8.4.1 Except as otherwise set forth in limitation of the assumption of the Assumed Liabilities, following the Closing until the payment by Buyer of both Deferred Payments, Buyer shall use Commercially Reasonable Efforts to obtain and maintain, at its sole expense, in accordance with applicable Legal Requirements, all Governmental Authorizations in connection with the Product. Subject to Seller’s indemnification obligations under ARTICLE 6this Agreement, from and after the ClosingTransition Date, Buyer Purchasers shall be solely and exclusively responsible for (i) all regulatory matters with respect to the Product and the Purchased Assets, including without limitation relating to communicating and corresponding, preparing and filing reports, making adverse drug experience reports, and paying applicable fees, with and to applicable Governmental BodiesAuthorities, under all applicable Legal Requirements legal requirements including the FFDCAAct, the Prescription Drug Marketing Act of 1987PDMA, and the Prescription Drug User Fee Act of 1992 and the Generic Drug User Fee Amendments of 20121992; (ii) taking all actions and conducting all communication with Third Parties in respect of Product (whether sold before or after the Closing), including responding to all complaints in respect thereof and all medical information requests, including complaints related to tampering or contamination; and (iii) investigating all complaints and adverse drug experiences in respect of the Product (whether sold before or after the Closing).
(b) Subject to the immediately following sentence, from and after the Closing, (a) Seller shall provide Buyer with (i) copies of all written or electronic correspondence relating to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to the Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case within twenty (20) Business Days after Buyer’s receipt, submission or production of the foregoing, as applicable. If such written or electronic correspondence received from a Regulatory Authority relates to the withdrawal, suspension, revocation or variation of the Drug Authorization for the Product, the prohibition or suspension of the supply of the Product, or the initiation of any investigation, review or inquiry by such Regulatory Authority concerning the safety of the Product, then the Seller shall notify the Buyer and provide the Buyer with copies of such written or electronic correspondence as soon as practicable, but not later than five (5) Business Days after receipt of such correspondence. Unless otherwise prevented by an applicable Legal Requirement, Seller shall provide Buyer with a copy of any written response hereto in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.
(c) 8.4.2 From and after the ClosingTransition Date, Buyer Purchasers shall be solely and exclusively responsible for conducting, handling or processing all voluntary and involuntary recalls of units of Product, including recalls required by any Governmental BodyAuthority or voluntary recalls by Purchasers based on safety, efficacy or similar concerns, with respect to the Product, regardless of whether the Product was sold before or after the Closing, subject to Seller’s financial responsibility for Seller Finished Product. Buyer Purchasers shall destroy, or cause to be destroyed, in either case at Buyer’s expensecase, all recalled Product in a manner consistent with applicable Legal Requirementslegal requirements. In From and after the event Closing, Purchasers shall be financially responsible for all recalls of units of Product sold after the Closing, except to the extent indemnified under the Supply Agreement. For any recalled Product that Seller Finished Product is was sold prior to the subject of a recallClosing, Buyer Sellers shall notify Seller reimburse Purchasers for all reasonable out-of-pocket costs and expenses actually incurred in writing as connection with any and all such recalls that are required by any Governmental Authority or are voluntarily initiated by Purchasers based on safety, efficacy or similar concerns.
8.4.3 As soon as practicable, but in no event more than three (3) days after Buyer becomes aware of such recall. Seller shall be financially responsible for all voluntary and involuntary recalls of Seller Finished Product; provided, however, that Seller shall not bear any financial responsibility for such recalls to the extent such recalls resulted from acts or omissions of Buyer or any of its Affiliates. Accordingly, Buyer will provide to Seller an invoice for all out-of-pocket costs actually incurred, without markup by Buyer and its Affiliates with respect to recalls of any Seller Finished Product (including amounts paid or credited by Buyer and its Affiliates for such returns according to Seller’s standard returned goods policy), and Seller will pay Buyer such amount within thirty (30) days of receipt of such invoice. Buyer shall be financially responsible for all costs and expenses related to any recalls of Product, other later than the expiration of the Seller Finished Product.
Brand License, Purchasers will (di) As soon as practicable following establish new NDC numbers for Product and thereafter shall cause such NDC numbers to be used on the Closing Date, Buyer shall institute appropriate procedures (including any appropriate procedures labeling and packaging for tracking of lot number information) to ensure that the Product sold by or on behalf of Buyer can be distinguished from and (ii) establish new capsule imprinting for the Product sold by that does not incorporate any name or on behalf of the trademark licensed to Purchasers under the Seller prior Brand License and thereafter shall cause such new capsule imprinting to be used for the Closing Date.
(e) Following the Closing Date, other than with respect to Remaining Lot 18 Product, Buyer shall not label any Product with Seller’s NDC number without first obtaining the prior written consent of Seller.
(f) Seller shall have the final authority and responsibility for final release of any Product bearing Seller’s NDC number. Buyer shall not market, sell or distribute Product bearing Seller’s NDC number prior to receipt of Seller’s written release of each quantity, batch, lot or shipment (or part thereof) of such Product. Buyer shall provide Seller, or Seller’s designee, with Product samples, completed batch records and any other documentation in accordance with the Quality Agreement for purposes of releasing the Product for commercial sale. Seller may test or cause the Product to be tested in accordance with Seller’s customary procedures. Seller shall notify Buyer in writing of Seller’s release or rejection of any quantity, batch, lot or shipment (or part thereof) of any Product within thirty (30) days after receipt of Product samples, completed batch records and other documentation by Seller or Seller’s designee. Seller’s rejection of the Product shall be based on: (a) nonconformance to Product specifications Nothing set forth in the Drug Authorization; (b) adulteration this section shall prevent or misbranding restrict Purchasers from selling Inventory labeled with Seller Brand prior to expiration of the ProductSeller Brand License. 8.5 Product Returns, or (c) Product not having been prepared in compliance with an applicable Legal RequirementRebates and Chargebacks. For a period of one (1) year following 8.5.1 NDC Numbers. Following the Closing Transition Date, Buyer will cause Buyer’s third-party logistics provider, wholesaler or distributor (each a “Service Provider”) Purchasers shall obtain its own NDC numbers for Product and shall use Commercially Reasonable Efforts to provide Seller with written reports, on a biweekly basis, detailing by distribution center, NDC number, lot number, expiration date have in place as soon as reasonably practicable all artwork and quantity resources such Service Provider’s inventory that sales of Products.
(g) While Buyer remains solely responsible for regulatory compliance relating to the Product following the Closing Date, during the time that the Product bears Seller’s name or NDC Number on the Product label or the Seller’s name is included on any written, printed, or graphic materials which reference the Product, Buyer must notify Seller, in writing, within twenty-four (24) hours of any inquiry or inspection by a Governmental Body that relates to the Product. Seller shall have the right to review and comment on any response prepared by Buyer to any such inquiry or inspection, be involved in any decision making process relating to the resolution of the matter and, if Seller requests, participate in any specific meetings or conversations with any Governmental Body concerning the Product.
(h) For clarity, from and after the Closing DateDate can be accomplished under the NDC numbers of Purchasers. Purchasers shall use its new NDC numbers on all invoices, Buyer shall orders and other communications with customers and Governmental Authorities as soon as the Existing Finished Product Inventory labeled with Sellers’ NDC number have sole discretion over the commercialization, marketing strategy, promotion, distribution and sale been exhausted by Purchasers or expiration of the Product and shall independently determine and set prices for the ProductSeller Brand License, provided that the foregoing shall not limit either Party’s obligations to the other Party under this Agreement (including Section 5.4(g)).whichever is earlier. 8.5.2
Appears in 1 contract
Samples: Asset Purchase and Sale Agreement
Product Responsibility. (a) In furtherance of and not Except as otherwise set forth in limitation of this Termination Agreement or in the assumption of the Assumed LiabilitiesSupply Agreement, following the Closing until the payment by Buyer of both Deferred Payments, Buyer shall use Commercially Reasonable Efforts to obtain and maintain, at its sole expense, in accordance with applicable Legal Requirements, all Governmental Authorizations in connection with the Product. Subject to Seller’s indemnification obligations under ARTICLE 6as applicable, from and after the ClosingTransition Period End Date, Buyer XenoPort shall be solely have the sole control and exclusively responsible responsibility for (i) all regulatory matters with respect to the Product and the Purchased AssetsProduct, including without limitation relating to communicating and corresponding, preparing and filing reports, making adverse drug experience reports, and paying applicable fees, with and to applicable Governmental BodiesRegulatory Authorities, under all applicable Legal Requirements Applicable Laws, including the FFDCAUnited States Federal Food, Drug and Cosmetic Act, as amended from time to time, including all regulations promulgated thereunder, the Prescription Drug Marketing Act of 1987, and the Prescription Drug User Fee Act of 1992 and the Generic Drug User Fee Amendments of 20121992; (ii) taking all actions and conducting all communication with Third Parties in respect of Product (whether sold before or after the ClosingTransition Period End Date), including responding to all complaints in respect thereof (except for any complaints managed by GSK as set forth below in Section 5.14(b)) and all medical information requests, including complaints related to tampering or contamination; and (iii) investigating all complaints and adverse drug experiences in respect of the Product (whether sold before or after the Closingexcept for any complaints managed by GSK as set forth below in Section 5.14(b)).
(b) Subject Notwithstanding anything to the immediately following sentencecontrary contained in this Termination Agreement or in the Supply Agreement, if applicable, during the period of time from and after the ClosingTransition Period End Date, XenoPort shall have the sole right to determine whether any Product Event is required to be made, and to develop (aif applicable) Seller shall provide Buyer with (i) copies of all written or electronic appropriate correspondence relating and communications regarding such Product Event for submission to the Product received by Seller, its Affiliates, licensees, sublicensees or distributors from, or submitted by Seller, its Affiliates, licensees, sublicensees or distributors to, Regulatory Authorities and (ii) copies of all meeting minutes and other similar summaries of all meetings, conferences and discussions held by Seller with Regulatory Authorities to the extent relating to the Product, including copies of all contact reports produced by Seller and its Affiliates, licensees, sublicensees and distributors, in each case within twenty (20) Business Days after Buyer’s receipt, submission or production of the foregoing, as applicable. If such written or electronic correspondence received from a Regulatory Authority relates to Authority, and shall have the withdrawal, suspension, revocation or variation of the Drug Authorization for the Product, the prohibition or suspension of the supply of the Product, or the initiation of any investigation, review or inquiry by such Regulatory Authority concerning the safety of the Product, then the Seller shall notify the Buyer sole control and provide the Buyer with copies of such written or electronic correspondence as soon as practicable, but not later than five (5) Business Days after receipt of such correspondence. Unless otherwise prevented by an applicable Legal Requirement, Seller shall provide Buyer with a copy of any written response hereto in advance (in light of the prevailing circumstances) of submitting such response to the applicable Regulatory Authorities.
(c) From and after the Closing, Buyer shall be solely and exclusively responsible for conducting, handling or processing all such Product Events (including withdrawals or voluntary and involuntary recalls of units of Product, including recalls required by any Governmental Body, with respect to the Product, regardless of whether the such unit of Product was sold before or after the ClosingTransition Period End Date); provided, subject however, that if any such Product Event involves Product sold prior to Seller’s financial responsibility for Seller Finished Product. Buyer the Transition Period End Date, then (i) XenoPort shall notify GSK of, and if requested consult with GSK regarding, any decision (or requirement) to withdraw or recall Product sold before the Transition Period End Date, (ii) GSK shall in good faith consult with XenoPort as XenoPort may reasonably request regarding any such matters, (iii) XenoPort and GSK each agree [… * …] and (iv) XenoPort shall destroy, or cause to be destroyed, in either case at BuyerXenoPort’s expense, all recalled Product in a manner consistent with applicable Legal RequirementsApplicable Laws. In the event that Seller Finished Product is the subject of a recall[… * …] * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Buyer shall notify Seller in writing as soon as practicableMARKED BY BRACKETS, but in no event more than three (3) days after Buyer becomes aware of such recall. Seller shall be financially responsible for all voluntary and involuntary recalls of Seller Finished Product; providedIS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, however, that Seller shall not bear any financial responsibility for such recalls to the extent such recalls resulted from acts or omissions of Buyer or any of its Affiliates. Accordingly, Buyer will provide to Seller an invoice for all out-of-pocket costs actually incurred, without markup by Buyer and its Affiliates with respect to recalls of any Seller Finished Product (including amounts paid or credited by Buyer and its Affiliates for such returns according to Seller’s standard returned goods policy), and Seller will pay Buyer such amount within thirty (30) days of receipt of such invoice. Buyer shall be financially responsible for all costs and expenses related to any recalls of Product, other than the Seller Finished ProductAS AMENDED.
(dc) As soon as practicable [… * …] following the Closing Transition Period End Date, Buyer XenoPort shall use Commercially Reasonable Efforts to institute appropriate procedures (including any appropriate procedures for tracking of lot number information) to ensure that the Product sold by or on behalf of Buyer XenoPort can be distinguished from the Product sold by or on behalf of Seller prior to the Closing DateGSK.
(ed) Following the Closing Date, other than with respect [… * …] XenoPort shall use Commercially Reasonable Efforts to Remaining Lot 18 Product, Buyer establish new NDC numbers for Product and thereafter shall not label any Product with Seller’s use Commercially Reasonable Efforts to cause such NDC number without first obtaining the prior written consent of Seller.
(f) Seller shall have the final authority and responsibility for final release of any Product bearing Seller’s NDC number. Buyer shall not market, sell or distribute Product bearing Seller’s NDC number prior to receipt of Seller’s written release of each quantity, batch, lot or shipment (or part thereof) of such Product. Buyer shall provide Seller, or Seller’s designee, with Product samples, completed batch records and any other documentation in accordance with the Quality Agreement for purposes of releasing the Product for commercial sale. Seller may test or cause the Product numbers to be tested in accordance with Seller’s customary procedures. Seller shall notify Buyer in writing of Seller’s release or rejection of any quantity, batch, lot or shipment (or part thereof) of any Product within thirty (30) days after receipt of Product samples, completed batch records and other documentation by Seller or Seller’s designee. Seller’s rejection of the Product shall be based on: (a) nonconformance to Product specifications set forth in the Drug Authorization; (b) adulteration or misbranding of the Product, or (c) Product not having been prepared in compliance with an applicable Legal Requirement. For a period of one (1) year following the Closing Date, Buyer will cause Buyer’s third-party logistics provider, wholesaler or distributor (each a “Service Provider”) to provide Seller with written reports, on a biweekly basis, detailing by distribution center, NDC number, lot number, expiration date and quantity such Service Provider’s inventory of Products.
(g) While Buyer remains solely responsible for regulatory compliance relating to the Product following the Closing Date, during the time that the Product bears Seller’s name or NDC Number used on the Product label or the Seller’s name is included on any written, printed, or graphic materials which reference the Product, Buyer must notify Seller, in writing, within twenty-four (24) hours of any inquiry or inspection by a Governmental Body that relates to the Product. Seller shall have the right to review labeling and comment on any response prepared by Buyer to any such inquiry or inspection, be involved in any decision making process relating to the resolution of the matter and, if Seller requests, participate in any specific meetings or conversations with any Governmental Body concerning the packaging for Product.
(h) For clarity, from and after the Closing Date, Buyer shall have sole discretion over the commercialization, marketing strategy, promotion, distribution and sale of the Product and shall independently determine and set prices for the Product, provided that the foregoing shall not limit either Party’s obligations to the other Party under this Agreement (including Section 5.4(g)).
Appears in 1 contract
Samples: Termination and Transition Agreement (Xenoport Inc)