Pharmacovigilance Agreement; Global Safety Database. The Parties shall enter into a pharmacovigilance agreement at least ​ days prior to the initiation of Phase 1 Clinical Trial by Everest in the Territory providing for the terms pursuant to which # NPLH shall establish, hold and maintain (at NPLH’s sole cost and expense) the global safety database for Licensed Products and # Everest shall timely provide NPLH with information in the possession and Control of Everest as necessary for NPLH to comply with its pharmacovigilance responsibilities outside the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. [sections 312.32 or 314.80]0] or to foreign Regulatory Authorities under corresponding Applicable Laws outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product, in each case, in English, in the form reasonably requested by NPLH and at Everest’s sole cost and expense.

Global Safety Database. Licensee shall establish, hold and maintain (at Licensee’s sole cost and expense) the global safety database for Licensed Products following transition of such database to Licensee in accordance with the Transition Plan. Within ​, the Parties shall enter into a written pharmacovigilance agreement governing each Party’s respective obligations with respect to allocation of responsibilities for reporting to the other Party and appropriate Regulatory Authorities adverse events, complaints, and other safety-related matters with respect to the Licensed Compounds and Licensed Products (the “Pharmacovigilance Agreement”).

Global Database. Following the earliest to occur of # initiation of Clinical Trials regarding the Licensed Product by Licensee or its Affiliates in the Territory, # as applicable, the transfer of the MAA (or the application therefor) from Acorda to Licensee or the filing of the MAA (or application therefore) by Licensee, or # First Commercial Sale of Licensed Product in the Territory, Acorda shall, itself or through its Affiliate or a mutually agreeable Third Party (or, upon mutual written agreement of the Parties, through Licensee or its Affiliates), establish and maintain a worldwide safety database for the Licensed Product. Such database shall comply with all Laws applicable to pharmacovigilance anywhere where the Licensed Product is being or has been Developed or Commercialized. The Parties shall equally share in the Out-of-Pocket Costs associated with establishing and maintaining such database; provided, that Licensee shall reimburse Acorda any FTE Costs incurred by Acorda with respect to the establishment and maintenance of such database to the extent solely attributable to the Territory. After the transfer to or filing by Licensee or its Affiliate of an NDA covering the Licensed Product in the Territory, Acorda shall continue to be responsible for maintaining such a worldwide safety database, but the Party with obligations under Law to maintain the safety database with respect to a given country in the Territory shall have primary responsibility for the safety database for such country in the Territory. Each Party shall, and shall ensure that its Affiliates and in the case of Acorda, its licensees (other than Licensee), and in the case of Licensee, its Third Party Distributors, provide information for the worldwide safety database on a prompt basis and as required by the most stringent Law in any jurisdiction where the Licensed Product is being or has been Developed or Commercialized by either Party, its Affiliates, and, in the case of Acorda, its other licensees, and in the case of Licensee, its Third Party Distributors. Appropriate personnel of both Parties, their Affiliates, and in the case of Acorda, its other licensees shall have full and immediate access to such database (including electronic access to the extent practicable), and shall be authorized to submit data from the database to applicable Regulatory Authorities as required or permitted by Law.

Safety Database. CANbridge will own the global safety database with respect to all Products. The Parties will cooperate with regard to the reporting and handling of safety information involving any Product in accordance with Applicable Laws and other regulations on pharmacovigilance and clinical safety.

Global Safety Database. From and after the Effective Date, Licensee will assume responsibility for maintaining a global safety database for the Compound and the Products consistent with industry practices. ​.

Global Safety Database. PARTNER shall establish, hold and maintain the global safety database for Licensed Products for use in the Licensed Field. REGENX shall provide PARTNER with information in the Control of REGENX as necessary for PARTNER to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. [sections 312.32 or 314.80]0] or to foreign Regulatory Authorities under corresponding Applicable Law outside the [[Address A:Address]]), from its Development of a Licensed Product, in each case, in the form reasonably requested by PARTNER. ​.

Global Safety Database. Acer shall set up, hold, and maintain (at Acer’s sole cost and expense) the global safety database for the Licensed Products in the Territory in compliance with Applicable Law.

Global Safety Database. On an Accepted Target-by-Accepted Target basis, no later than the filing of an IND for an [[Organization A:Organization]] Probody, Discovery PDC or Licensed Product, [[Organization A:Organization]] shall set up, hold, and maintain (at [[Organization A:Organization]]’s sole cost and expense) the global safety database for [[Organization A:Organization]] Probodies, Discovery PDCs or Licensed Products. Licensor shall provide [[Organization A:Organization]] with all information necessary or desirable for [[Organization A:Organization]] to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences, from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, Clinical Studies, and commercial experiences with an [[Organization A:Organization]] Probody, Discovery PDC or Licensed Product, in each case in the form reasonably requested by [[Organization A:Organization]].

Global Safety Database. Licensee shall establish, hold and maintain (at Licensee’s sole cost and expense) the global safety database for the Licensed Products.

Global Safety Database. As between the Parties, Verrica shall hold, solely own and be solely responsible for maintaining the global safety database for Product.