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. At a mutually agreed upon time after the Closing, Seller shall provide Purchaser with information relating to the investigation and reporting of all adverse experiences regarding the Product prior to the Closing and all other information which is materially relevant to the safe use of the Product in Seller’s possession as of the Closing. After the Closing, Seller shall promptly submit to Purchaser all adverse drug experience information or customer complaints brought to the attention of Seller in respect of the Product, as well as any material events and matters concerning or affecting the safety or efficacy of the Product. After the Closing and after the time the appropriate Governmental Authorities are notified of the transfer of the applicable Regulatory Approvals, Purchaser shall have all responsibility for required reporting of adverse experiences for the Product.
Adverse Experience Reports. From and after the transfer of the Evamist FDA Submissions, the Acquiror shall be responsible for the investigation, analysis and reporting to the FDA of any adverse experience report or complaint in connection with the Product received by either the Acquiror or the Seller from and after the Closing from any source (including any patient, health care professional or other customer of the Evamist Business), regardless of whether the Product involved in any such adverse experience report or complaint was manufactured, tested, used or distributed by the Seller or Acquiror. Any adverse experience report or complaint received by the Seller relating to the Product after the Closing shall be reported by the Seller to Acquiror, within a sufficient time period to allow the Acquiror to comply with its obligations to the FDA, after receipt of such adverse experience report or complaint by the Seller. The Seller shall cooperate with the Acquiror in connection with the investigation and analysis of all adverse experience reports or complaints that relate to the period before the date of the assignment of the Evamist FDA Submissions. It is understood and agreed that the Seller shall be responsible for all foregoing obligations listed in this Section 8.5(e) prior to the transfer of the Evamist FDA Submissions and shall use commercially reasonable efforts to timely and appropriately fulfill such obligations.
Adverse Experience Reports. Within three Business Days after the Closing, Seller shall provide Purchaser with copies of all adverse experiences in its or its Affiliates possession or control regarding the Product, since the date of Seller’s first commercial sale of any Product in the United States. After the Closing, Seller shall submit to Purchaser all adverse drug experience information brought to the attention of Seller or its Affiliates in respect of the Product, as well as any material events and matters concerning or affecting the safety of the Product. Additionally, after the Closing, Seller shall assist Purchaser with the provision of data relating to adverse experiences for the Product, for Purchaser’s preparation of its first Periodic Adverse Drug Experience Report after the Closing. After the Closing, Purchaser shall have all responsibility for investigating and reporting adverse experiences for the Products, and addressing any FDA or other Governmental or Regulatory Authority inquiries relating to the safety of the Product. Purchaser shall reimburse Seller for any and all out-of-pocket expenses incurred by Seller in connection with its assistance of Purchaser as provided in this Section 9.09.
Adverse Experience Reports. After the Closing, Seller shall promptly submit to Buyer all adverse drug experience information brought to the attention of Seller in respect of the Compound or the Product, as well as any material events and matters concerning or affecting the safety or efficacy of the Compound or the Product, each as they relate to activities of Seller prior to the Closing. After the Closing, Buyer shall have all responsibility for required reporting of adverse experiences for the Compound and the Product, but such reporting shall not limit Seller’s obligation for any actions necessary with respect to Products distributed prior to the Closing based upon the facts and circumstances contained in such adverse drug experience information.
Adverse Experience Reports. On or prior to the Closing Date, Access shall provide ULURU with all information relating to the investigation and reporting of Adverse Experiences regarding the Products since three (3) years prior to the Closing Date and all information which is relevant to the safe use of the Products as of the Closing Date, in each case to the extent received by, or in the possession of, Access, and will confer with ULURU on Adverse Experience history related to the Products. After the Closing Date, Access and its Affiliates shall promptly submit to ULURU all such Adverse Experience information or customer complaints brought to the attention of Access or its Affiliates in respect of the Products, as well as any material events and matters concerning or affecting the safety or efficacy of the Products. Such information or customer complaints shall be forwarded to ULURU, Attention: Xxxxx X. Xxxx. Beginning on the Closing Date, ULURU shall have all responsibility for required reporting of Adverse Experiences for the Products.
Adverse Experience Reports. On or prior to the Closing Date, the Seller shall provide the Buyer with all adverse drug experience reports of the Products in the Territory, covering the seven (7) year period ending on the Closing Date. After the Closing Date, the Buyer will have all responsibility for investigating and reporting adverse experiences for the Product in the Territory arising after the Closing Date to any Governmental Entities and addressing any such Governmental Entities' inquiries related to the safety of the Products; provided, that after the Closing, the Seller shall assist the Buyer in the investigation of adverse experiences and product complaints reported after the Closing for Products manufactured or distributed by or for the Seller. After the Closing, the Seller shall within a reasonable time forward to the Buyer all adverse experience reports and product complaints for the Product received after the Closing by the Seller, or its agents, contractors or licensees that arose in the Territory.
Adverse Experience Reports. Each Party agrees and covenants to provide to the other, within twenty-four hours of the initial receipt, any report of any serious adverse experience with respect to the System. Serious adverse experience means any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, is permanently disabling, or requires or prolongs inpatient hospitalization.
Adverse Experience Reports. At a mutually agreed upon time after the Closing, Seller shall provide Buyer with information relating to the investigation and reporting of adverse experiences regarding the Product since the Product launch and all information which is materially relevant to the safe use of the Product in Seller's possession as of the Closing. After the Closing, Seller shall promptly submit to Buyer all adverse drug experience information or customer complaints brought to the attention of Seller in respect of the Product, as well as any material events and matters concerning or affecting the safety or efficacy of the Product. After the Closing, Buyer shall have all responsibility for required reporting of adverse experiences for the Product.
Adverse Experience Reports. 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 Seller shall negotiate in good faith and agree on a process and procedure for sharing adverse event information for the Products in which 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, Seller shall at all times provide to Buyer all adverse drug experience information brought to the attention of Seller in respect of the Products manufactured by Seller or its Affiliates, as well as any material events and matters concerning or affecting safety of the Products manufactured by Seller or its Affiliates. At and after the Closing, 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. 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 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 Seller will be forwarded to Buyer, together with any source documents.
