Common use of Adverse Experience Reports Clause in Contracts

Adverse Experience Reports. Sellers shall continue to be responsible for adverse experience reporting to the FDA until the Closing Date. Buyer and Sellers shall negotiate in good faith and agree on a process and procedure for sharing adverse event information for the Products in which Sellers will manufacture and supply Buyer from a retained ANDA, which shall be documented in a pharmacovigilance agreement to be entered into by the parties pursuant to the Supply Agreement. For all other Products, Sellers shall at all times provide to Buyer all adverse drug experience information brought to the attention of Sellers in respect of the Products manufactured by Sellers, as well as any material events and matters concerning or affecting safety of the Products manufactured by Sellers. At and after the Closing, Sellers shall cooperate with Buyer’s requests regarding adverse experience information in respect of the Products to ensure that all adverse experience data is transferred to Buyer, including data migration and transition reporting services as requested by Buyer consistent with Schedule 9.2. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken pursuant to Schedule 9.2. After the Closing Date, subject to this Agreement, the Supply Agreement, the Quality Agreement and any other agreement executed between the parties and/or their Affiliates with respect to any Product, Sellers will submit to Buyer all adverse drug experience information brought to the attention of Sellers in respect of the Products, as well as any material events and matters concerning or affecting safety of the Products. After the Closing Date, any new adverse experience reports or any follow-up adverse experience reports received by Sellers will be forwarded to Buyer, together with any source documents. Unless notified otherwise in writing by Buyer, Sellers shall forward such reports to: Impax Laboratories, Inc. 00000 Xxxxxxx Xxxx Xxxxxxx, XX 00000 Attention: Xxxxxx X. Xxxxxxx Senior Director, Corporate Drug Safety Operations Facsimile: (000) 000-0000.

Adverse Experience Reports. Sellers Seller shall continue to be responsible for adverse experience reporting to the FDA until the Closing Date. Buyer and Sellers Seller shall negotiate in good faith and agree on a process and procedure for sharing adverse event information for the Products in which Sellers Seller will manufacture and supply Buyer from a retained ANDA, which shall be documented in a pharmacovigilance agreement to be entered into by the parties pursuant to the Supply Agreement. For all other Products, Sellers Seller shall at all times provide to Buyer all adverse drug experience information brought to the attention of Sellers Seller in respect of the Products manufactured by SellersSeller, as well as any material events and matters concerning or affecting safety of the Products manufactured by SellersSeller. At and after the Closing, Sellers Seller shall cooperate with Buyer’s requests regarding adverse experience information in respect of the Products to ensure that all adverse experience data is transferred to Buyer, including data migration and transition reporting services as requested by Buyer consistent with Schedule 9.2 Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken pursuant to Schedule 9.2. After the Closing Date, subject to this Agreement, the Supply Agreement, the Quality Agreement and any other agreement executed between the parties and/or their Affiliates with respect to any Product, Seller will submit to Buyer all adverse drug experience information brought to the attention of Seller in respect of the Products, as well as any material events - 28– [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken pursuant to Schedule 9.2. After the Closing Date, subject to this Agreement, the Supply Agreement, the Quality Agreement and any other agreement executed between the parties and/or their Affiliates with respect to any Product, Sellers will submit to Buyer all adverse drug experience information brought to the attention of Sellers in respect of the Products, as well as any material events and matters concerning or affecting safety of the Products. After the Closing Date, any new adverse experience reports or any follow-up adverse experience reports received by Sellers Seller will be forwarded to Buyer, together with any source documents. Unless notified otherwise in writing by Buyer, Sellers Seller shall forward such reports to: Impax Laboratories, Inc. 00000 Xxxxxxx Xxxx Xxxxxxx, XX 00000 Attention: Xxxxxx X. Xxxxxxx Senior Director, Corporate Drug Safety Operations Facsimile: (000) 000-0000.

Adverse Experience Reports. Sellers (a) The definitions “adverse drug experiences” and “serious” shall continue comply with the guidelines set forth by the FDA in the Code of Federal Regulations, Title 21 CFR 314.80(a) “Post marketing reporting of adverse drug experiences.” In order to properly execute the duty of care, the following categories of reports shall also be responsible for treated as adverse experience reporting events, even if they do not involve adverse symptomatology: overdose, drug abuse/misuse/maladministration, interactions, lack of efficacy, and exposure during pregnancy. “Working Days” are defined as Monday through Friday exclusive of United States federal holidays. (b) On or prior to the FDA until Closing Date, Sellers will provide Buyer with adverse experiences report for Migranal and DHE since one year prior to the Closing Date. After the Closing Date, Sellers will submit to Buyer and Sellers shall negotiate in good faith and agree on a process and procedure for sharing any or all historical adverse event information for drug experience reports with the Products in which Sellers will manufacture and supply Buyer from a retained ANDA, which shall be documented in a pharmacovigilance agreement to be entered into as requested by the parties pursuant Buyer. (c) After the Closing Date, Buyer will submit to the Supply Agreement. For all other Products, Sellers shall at all times provide to Buyer NPC all adverse drug experience information reports for Migranal or DHE brought to the attention of Sellers in respect of the Products manufactured by SellersBuyer, as well as any material events and matters concerning or affecting the safety of Migranal or DHE. To allow Sellers to comply with health authority regulations outside the Products manufactured by Sellers. At and after the ClosingTerritory, Sellers shall cooperate with Buyer’s requests regarding adverse experience information in respect Buyer agrees to forward copies of the Products to ensure that all adverse experience data is transferred reports to NPC within seven calendar days of receipt thereof by Buyer, including data migration and transition reporting services as requested by Buyer consistent with Schedule 9.2. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken pursuant to Schedule 9.2. After the Closing Date, subject Buyer will have all responsibility for investigating and reporting adverse experiences for Migranal and DHE to this Agreementthe FDA and addressing any FDA inquiries related to the safety of Migranal or DHE. (d) After the Closing Date, in order to allow the Supply Agreement, the Quality Agreement and any other agreement executed between the parties and/or their Affiliates Buyer to comply with respect to any ProductFDA regulations, Sellers agree to forward copies of all serious adverse experience reports outside the Territory to Buyer within two working days of receipt thereof by AG. Sellers also will submit to Buyer all adverse drug experience information brought to the attention of Sellers in respect of the Products, as well as any material events and matters concerning or affecting the safety of Migranal or DHE. Additionally, after the Products. Closing Date, Sellers will assist Buyer with the provision of data relating to adverse experiences for Migranal and DHE for the Buyer’s preparation of its first Periodic Safety Report for each Product. (e) After the Closing Date, any new adverse experience reports or any follow-up adverse experience reports received by Sellers and Buyer will be forwarded to Buyer, together responsible for health authority safety inquiries in their respective territory(ies). The parties will provide each other with any source documents. Unless notified otherwise information needed to respond to health authority safety requests in writing by Buyer, Sellers shall forward such reports to: Impax Laboratories, Inc. 00000 Xxxxxxx Xxxx Xxxxxxx, XX 00000 Attention: Xxxxxx X. Xxxxxxx Senior Director, Corporate Drug Safety Operations Facsimile: (000) 000-0000a complete and accurate manner.

Adverse Experience Reports. Sellers Seller shall continue to be responsible for adverse experience reporting to the FDA until the Closing Date. On and after the Closing Date, Buyer and Sellers shall negotiate in good faith and agree on a process and procedure for sharing adverse event information for the Products in which Sellers will manufacture and supply Buyer from a retained ANDA, which shall be documented in a pharmacovigilance agreement to be entered into by the parties pursuant responsible for adverse experience reporting to the Supply AgreementFDA in respect of the Products. For all other Products, Sellers Seller shall at all times provide to Buyer all adverse drug experience information brought to the attention of Sellers Seller in respect of the Products manufactured by SellersSeller or its Affiliates, as well as any material events and matters concerning or affecting safety of the Products manufactured by SellersSeller or its Affiliates. At and after the Closing, Sellers Seller shall cooperate with Buyer’s requests regarding adverse experience information in respect of the Products to ensure that all adverse experience data is transferred to Buyer, including data migration and transition reporting services as requested by Buyer consistent with Schedule 9.2. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Each party will bear the Direct Costs incurred by it and its Affiliates in connection with its activities undertaken pursuant to Schedule 9.2. After the Closing Date, subject to this Agreement, the Supply Agreement, the Quality Agreement and any other agreement executed between the parties and/or their Affiliates with respect to any Product, Sellers Seller will promptly submit to Buyer all adverse drug experience information brought to the attention of Sellers Seller or its Affiliates or their respective agents in respect of the Products, as well as any material events and matters concerning or affecting safety of the Products. After the Closing Date, any new adverse experience reports or any follow-up adverse experience reports received by Sellers Seller will be forwarded to Buyer, together with any source documents, as promptly as reasonably practicable and in any event within three (3) Business Days after receipt by Seller. Unless notified otherwise in writing by Buyer, Sellers Seller shall forward such reports to: Impax LaboratoriesHead of Pharmacovigilance, Inc. 00000 Xxxxxxx Xxxx XxxxxxxXx. Xxxxx’x Laboratories S.A., XX 00000 Attention: Xxxxxx X. Xxxxxxx Senior DirectorXxxxxxxxxxxxxxxxx 00, Corporate Drug Safety Operations Facsimile: (000) 000-00000000 Xxxxx, Xxxxxxxxxxx.

Adverse Experience Reports. Sellers Parent, the Acquired Companies or the Business Subsidiaries, as the case may be, shall continue to be responsible for adverse experience reporting to the FDA all applicable Regulatory Authorities until the Closing Dateand, prior to the Closing, shall provide Buyer with copies of all adverse experience reports contemporaneously with submittal to the FDA or any other Regulatory Authority. On and after the Closing and, with respect to the Recothrom Products, the subsequent transfer of the Regulatory Approvals (as provided in Section 10.5), Buyer and Sellers shall negotiate in good faith and agree on a process and procedure for sharing adverse event information for the Products in which Sellers will manufacture and supply Buyer from a retained ANDA, which shall be documented in a pharmacovigilance agreement to be entered into by the parties pursuant responsible for adverse experience reporting to the Supply AgreementFDA and any other Regulatory Authority in respect of the Products. For all other Products, Sellers Parent shall at all times until the second (2nd) anniversary of the Closing Date provide to Buyer all adverse drug experience information and customer complaints brought to the attention of Sellers Parent in respect of the Products manufactured by Sellersor for Parent or any of the Acquired Companies or Business Subsidiaries, as well as any material events and matters concerning or affecting safety of the Products manufactured by Sellersor for Parent or any of the Acquired Companies or Business Subsidiaries. At and after the Closing until the second (2nd) anniversary of the Closing, Sellers Parent shall promptly cooperate with Buyer’s reasonable requests regarding adverse experience information in respect of the Products to ensure that all adverse experience data is transferred to Buyer, including data migration and transition reporting services as requested by Buyer consistent with Schedule 9.2. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Each party will bear the Direct Costs incurred by it and or its Affiliates in connection with its activities undertaken pursuant to Schedule 9.2designated Affiliate. After the Closing Dateuntil the second (2nd) anniversary of the Closing, subject to this Agreement, the Supply Agreement, the Quality Agreement and any other agreement executed between the parties and/or their Affiliates with respect to any Product, Sellers Parent will submit to Buyer all adverse drug experience information and customer complaints brought to the attention of Sellers Parent in respect of any of the Products, as well as any material events and matters concerning or affecting safety of any of the Products. After the Closing Dateuntil the second (2nd) anniversary of the Closing, any new adverse experience reports or information, customer complaints, or any follow-up adverse experience reports or information received by Sellers Parent relating to any Product will be forwarded to Buyer, together with any source documents, within five (5) calendar days after receipt by Parent. Unless notified otherwise in writing by Buyer, Sellers Parent shall forward such reports to: Impax Laboratories, Inc. 00000 Xxxxxxx Xxxx Xxxxxxx, XX 00000 Attention: Xxxxxx X. Xxxxxxx Senior Director, Corporate Drug Safety Operations Facsimile: (000) 000-0000to such address as Buyer may specify by written notice to Parent.