Common use of Adverse Experience Reporting Clause in Contracts

Adverse Experience Reporting. (a) Until the Registrations are transferred to Buyer, Seller shall be responsible for the adverse experience and safety reporting for the CV Products in compliance with the requirements of the FD&C Act and the regulations promulgated thereunder. After the Registrations are transferred to Buyer, Buyer shall assume such responsibility. Buyer and Seller agree to meet promptly after the Closing Date to determine mutually agreeable reporting procedures to communicate the information as required under this Section 10.4. (b) On or before the Closing Date, Seller shall provide Buyer with a summary of the information relating to the investigation and reporting of adverse experiences regarding the CV Products and all appropriate information that is relevant to the safe use of the CV Products as of the Closing Date. (c) After the Closing Date and until the Registrations are transferred to Buyer, Buyer agrees to promptly submit to Seller all adverse drug experience information and customer complaints brought to the attention of Buyer with respect to the CV Products, as well as any material events and matters concerning or affecting the safety or efficacy of the CV Products. Such information or customer complaints shall be forwarded to Seller to the attention of: Name: [****]* Title: Medical Director, Drug Safety Address: 0000 Xxxxxxx Xxxx Xxxxxxx Xxxx, XX 00000 Facsimile: 000-000-0000 Drug safety mailbox: xxxxxxxxxx@xxx.xxx (d) After the Registrations have been transferred to Buyer, Seller shall assist Buyer with the provision of data relating to adverse experiences for the CV Products after such transfer to Buyer. Additionally, after the transfer of the Registrations to Buyer, Seller shall provide Buyer with all adverse drug experience information and customer complaints brought to the attention of Seller with respect to the CV Products, as well as any material events and matters concerning or affecting the safety or efficacy of the CV Products, via facsimile to the attention of: Name: [****]* Title: Director of Regulatory Affairs Address: 0 Xxxx Xxxxxxxxx Xxxxx Cedar Knolls, NJ 07927 E-mail: [****]*

Adverse Experience Reporting. (a) Until the Registrations are transferred to Buyer, Seller shall be responsible for the adverse experience and safety reporting for the CV Products Product in compliance with the requirements of the FD&C Act and the regulations promulgated thereunder. After the Registrations are transferred to Buyer, Buyer shall assume such responsibility. Buyer and Seller agree to meet promptly after the Closing Date to determine mutually agreeable reporting procedures to communicate the information as required under this Section 10.410.5. (b) On or before the Closing Date, Seller shall provide Buyer with a summary of the information relating to the investigation and reporting of adverse experiences regarding the CV Products Product and all appropriate information that is relevant to the safe use of the CV Products Product as of the Closing Date. (c) After the Closing Date and until the Registrations are transferred to Buyer, Buyer agrees to promptly submit to Seller all adverse drug experience information and customer complaints brought to the attention of Buyer with respect to the CV ProductsProduct, as well as any material events and matters concerning or affecting the safety or efficacy of the CV ProductsProduct. Such information or customer complaints shall be forwarded to Seller to the attention of: PDL BioPharma, Inc. Name: [****]* ] Title: Medical Director, Drug Safety Address: 0000 Xxxxxxx Xxxx Xxxxxxx Xxxx, XX 00000 Facsimile: 000-000-0000 Drug safety mailbox: xxxxxxxxxx@xxx.xxx (d) After the Registrations have been transferred to Buyer, Seller shall assist Buyer with the provision of data relating to adverse experiences for the CV Products Product after such transfer to Buyer. Additionally, after the transfer of the Registrations to Buyer, Seller shall promptly provide Buyer with all adverse drug experience information and customer complaints brought to the attention of Seller with respect to the CV ProductsProduct, as well as any material materials events and matters concerning or affecting the safety or efficacy of the CV ProductsProduct, via facsimile to the attention of: Otsuka Pharmaceutical Co., Ltd. Name: [****]* ] Title: Director of Regulatory Affairs Director, Global Pharmacovigilance Address: Otsuka Pharmaceutical Co., Ltd. 9F Kitahama TNK Bldg, 0-0-0 Xxxx Xxxxxxxxx Xxxxx-xxxxx, Xxxx-xx, Xxxxx Cedar Knolls000-0000, NJ 07927 EXXXXX Facsimile: +00-mail: [****]*0-0000-0000

Adverse Experience Reporting. (a) Until the Registrations are transferred to BuyerBUYER, Seller SELLER shall be responsible for the adverse experience and safety reporting for the CV Products Product in compliance with the requirements of the FD&C Act U.S. Food, Drug and Cosmetic Act, 21 USC § 321 et seq. and the regulations promulgated thereunder. After the Registrations are transferred to BuyerBUYER, Buyer BUYER shall assume such responsibility. Buyer BUYER and Seller SELLER agree to meet promptly after the Closing Date to determine mutually agreeable reporting procedures to communicate the information as required under this Section 10.47.5. (b) On or before the Closing Date, Seller SELLER shall provide Buyer BUYER with a summary of the information relating to the investigation and reporting of adverse experiences regarding the CV Products Product and all appropriate information that is relevant to the safe use of the CV Products Product as of the Closing Date. (c) After the Closing Date and until the Registrations are transferred to BuyerBUYER, Buyer BUYER agrees to promptly submit to Seller SELLER all adverse drug experience information and customer complaints brought to the attention of Buyer BUYER or its Affiliates with respect to the CV ProductsProduct, as well as any material events and matters concerning or affecting the safety or efficacy of the CV ProductsProduct. Such information or customer complaints shall be forwarded to Seller SELLER to the attention of: NameXxxxxxxx Xxxxxx Benefit Risk Management JJPRD, LLC. 000 Xxxxxxxxxx Xxxxx Xxxxxxxx: [****]* Title: Medical Director, Drug Safety Address: 0000 Xxxxxxx Xxxx Xxxxxxx XxxxX-XX Xxxxxxx, XX 00000 FacsimileHorsham Adverse Event Fax Number: 000-000-0000 Drug safety mailboxTelephone: xxxxxxxxxx@xxx.xxx000 000-0000 Xxxx Xxxxxxx Centocor, Inc. 000 Xxxxx Xxxxxx Xxxxxxx Xxxxxxx. XX 1 Facsimile 000 000-0000 Telephone: (000) 000-0000. (d) After the Registrations have been transferred to BuyerBUYER, Seller SELLER shall assist Buyer BUYER with the provision of data relating to adverse experiences for the CV Products Product for BUYER’s preparation of its first Periodic Safety Update Report after such transfer to BuyerBUYER. Additionally, after the transfer of the Registrations to BuyerBUYER, Seller SELLER shall provide Buyer BUYER with all adverse drug experience information and customer complaints brought to the attention of Seller SELLER or its Affiliates with respect to the CV ProductsProduct, as well as any material materials events and matters concerning or affecting the safety or efficacy of the CV ProductsProduct, via facsimile to the attention of: Name: [****]* Title: Director of Regulatory Affairs Address: 0 Xxxx Xxxxxxxxx Xxxxx Cedar Knolls, NJ 07927 E-mail: [****]*:

Adverse Experience Reporting. (a) Until the Registrations Regulatory Materials are transferred to Buyer, Seller shall be responsible for the adverse experience and safety reporting for the CV Products Product in compliance with the requirements of the FD&C Act and the regulations promulgated thereunderapplicable Law (including Healthcare Laws). After the Registrations Regulatory Materials are transferred to Buyer, Buyer shall assume such responsibility. Buyer and Seller agree to meet promptly after the Closing Date to determine mutually agreeable reporting procedures to communicate the information as required under this Section 10.45.15. (b) Until the Regulatory Materials are transferred to Buyer, Seller shall be responsible for (i) maintaining the global safety database for the Seller Compounds, (ii) monitoring of all clinical experiences for the Seller Compounds and (iii) safety monitoring, pharmacovigilance surveillance, compliance and filing of all required safety reports to Regulatory Authorities, including without limitation annual safety reports, as and to the extent required by applicable Law (including Healthcare Laws) for any study conducted by or for Seller with respect to the Seller Compounds. On or before the Closing Date, Seller shall provide Buyer with a summary of the information relating to the investigation and reporting of adverse experiences regarding the CV Products Seller Compounds and all appropriate information that is relevant any existing material safety data sheets with respect to the safe use of the CV Products Seller Compounds as of the Closing Date. (c) . After the Closing Date and until the Registrations Regulatory Materials are transferred to Buyer, Buyer agrees to promptly submit to Seller all adverse drug experience information and customer complaints brought to the attention of Buyer with respect to the CV ProductsSeller Compounds, as well as any material events and matters concerning or affecting the safety or efficacy of the CV Products. Such information or customer complaints shall be forwarded to Seller Compounds brought to the attention of: Name: [****]* Title: Medical Directorof Buyer, Drug Safety Address: 0000 Xxxxxxx Xxxx Xxxxxxx Xxxx, XX 00000 Facsimile: 000-000-0000 Drug safety mailbox: xxxxxxxxxx@xxx.xxx (d) via facsimile to the attention of Seller. After the Registrations Regulatory Materials have been transferred to Buyer, Seller shall assist Buyer with the provision of data relating to adverse experiences for the CV Products Seller Compounds after such transfer to Buyer. Additionally, after the transfer of the Registrations Regulatory Materials to Buyer, Seller shall provide Buyer with all adverse drug experience information and customer complaints brought to the attention of Seller with respect to the CV ProductsSeller Compounds, as well as any material materials events and matters concerning or affecting the safety or efficacy of the CV ProductsSeller Compounds brought to the attention of Seller, via facsimile to the attention of: Name: [****]* Title: Director of Regulatory Affairs Address: 0 Xxxx Xxxxxxxxx Xxxxx Cedar Knolls, NJ 07927 E-mail: [****]*Buyer.

Adverse Experience Reporting. (a) Until the Registrations are transferred to Buyer, Seller shall be responsible for the adverse experience and safety reporting for the CV Products in compliance with the requirements of the FD&C Act and the regulations promulgated thereunder. After the Registrations are transferred to Buyer, Buyer shall assume such responsibility. Buyer and Seller agree to meet promptly after the Closing Date to determine mutually agreeable reporting procedures to communicate the information as required under this Section 10.4. (b) On or before the Closing Date, Seller shall provide Buyer with a summary of the information relating to the investigation and reporting of adverse experiences regarding the CV Products and all appropriate information that is relevant to the safe use of the CV Products as of the Closing Date. (c) After the Closing Date and until the Registrations are transferred to Buyer, Buyer agrees to promptly submit to Seller all adverse drug experience information and customer complaints brought to the attention of Buyer with respect to the CV Products, as well as any material events and matters concerning or affecting the safety or efficacy of the CV Products. Such information or customer complaints shall be forwarded to Seller to the attention of: Name: [****]* Title: Medical Director, Drug Safety Address: 0000 Xxxxxxx Xxxx Xxxxxxx Xxxx, XX 00000 Facsimile: 000-000-0000 Drug safety mailbox: xxxxxxxxxx@xxx.xxx (d) After the Registrations have been transferred to Buyer, Seller shall assist Buyer with the provision of data relating to adverse experiences for the CV Products after such transfer to Buyer. Additionally, after the transfer of the Registrations to Buyer, Seller shall * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions. provide Buyer with all adverse drug experience information and customer complaints brought to the attention of Seller with respect to the CV Products, as well as any material events and matters concerning or affecting the safety or efficacy of the CV Products, via facsimile to the attention of: Name: [****]* Title: Director of Regulatory Affairs Address: 0 Xxxx Xxxxxxxxx Xxxxx Cedar Knolls, NJ 07927 E-mail: [****]*