Pharmacovigilance Agreement. In furtherance of [Section 8.1], the Parties shall negotiate and execute a pharmacovigilance agreement within [​] days of the Effective Date. Bayer will create and maintain a master drug safety database which shall cross-reference adverse events relating to the Licensed Product occurring anywhere in the world. Bayer shall be the sole owner of the master drug safety database. Atara shall submit all data collected by it with respect to adverse events relating to the Licensed Product to Bayer in accordance with the timelines set forth in the pharmacovigilance agreement. After transfer of the [​] to Bayer, Bayer shall be responsible for all reporting of adverse events pursuant to Law with respect to the Licensed Products.

Pharmacovigilance Agreement. ​ the Parties will execute a pharmacovigilance agreement ​ that will provide, among other things, ​ guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports and any other information as determined by the Parties. Such guidelines and procedures shall be in accordance with, and enable the Parties to comply with and fulfill, all Applicable Laws and all local and national regulatory reporting obligations to Regulatory Authorities and other Governmental Authorities.

. Upon request from either Party and in connection with the potential Commercialization of Licensed Product in the Retained Territory, the Parties shall negotiate in good faith, or [[DURECT:Organization]] shall use ​ to facilitate a negotiation between INNOCOLL and a Third Party Licensee to enter into, one or more safety exchange or pharmacovigilance, safety data access agreements (each, a “PV Agreement”) on reasonable and customary terms to ensure compliance with safety reporting requirements of the FDA and regulatory authorities in the Retained Territory by providing detailed procedures regarding the collection, exchange and management of safety data relating to Licensed Product, including but not limited to the establishment and maintenance of a safety database, collection and reporting, and maintenance of core safety information, and each Party (or INNOCOLL and such Third Party Licensee) will have access to such database, the right to query and otherwise use the data (including primary data) included therein. The Parties acknowledge that responsibility for pharmacovigilance (including safety data reporting and management) with respect to Licensed Product in the Licensed Territory will transfer from [[DURECT:Organization]] to INNOCOLL upon transfer of the IND and NDA to INNOCOLL, however, it is understood and agreed that if [[DURECT:Organization]] Commercializes Licensed Product, whether itself or through a Third Party Licensee, in the Retained Territory, INNOCOLL by virtue of this Agreement, has no obligation to be the global safety database holder for the Licensed Product.

Pharmacovigilance Agreement. Within ​ following the Effective Date or such other period as the Parties may agree (but in any case before the first IND filing of the first Product in the Ono Territory), the Parties shall enter into a mutually acceptable pharmacovigilance agreement setting forth the Parties’ respective obligations in detail regarding pharmacovigilance and the exchange of Safety Data during the period before the First Commercial Sale of the first Product in the Ono Territory. Further, at least ​ before the estimated date of the first Regulatory Approval of the first Product in the Ono Territory, the Parties shall amend such pharmacovigilance agreement to set forth the Parties’ respective obligations in the detail regarding pharmacovigilance and the exchange of Safety Data during the period after the First Commercial Sale of the first Product in the Ono Territory.

Pharmacovigilance Agreement. As soon as reasonably practicable following the Effective Date, the pharmacovigilance departments of each of Acorda and Licensee shall meet and determine the approach to be taken for the collection, review, assessment, tracking, exchange and filing of information related to adverse events associated with the Licensed Product, consistent with the provisions of this Section 6.2. Such approach shall be documented in a separate and appropriate written pharmacovigilance agreement between the Parties which shall control with respect to the subject matter covered therein (the “Pharmacovigilance Agreement”). Such agreement will be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to Regulatory Authorities and other applicable Law.

Pharmacovigilance Agreement. As soon as reasonably practicable after the Effective Date, and in any event, prior to the use of the Product in any human clinical trial, the Parties shall enter into a pharmacovigilance agreement setting forth the pharmacovigilance responsibilities of the Parties with respect to the CpG Material (the “Pharmacovigilance Agreement”). Each Party agrees to comply, and to cause its Affiliates and, in the case of Purchaser, Purchaser’s licensees of the Product, to comply, with such Party’s obligations under the Pharmacovigilance Agreement.

Pharmacovigilance. Client will be responsible, at its expense, for all pharmacovigilance obligations for the Product in accordance with Applicable Laws and the monitoring and management of post-marketing complaints and queries at its cost (including, without limitation, the cost of assistance required of Patheon under the Quality Agreement). Unless required by Applicable Law, neither party will be obliged to exchange with the other party any information or data which it compiles in carrying out pharmacovigilance obligations or activities.

Pharmacovigilance. Client will be responsible, at its expense, for all pharmacovigilance obligations for the Products pursuant to Applicable Laws; Patheon shall provide Client any safety information it receives related to the Product on a prompt basis. Unless required by Applicable Law, Client will not be obliged to exchange with the other party any information or data which it compiles pursuant to pharmacovigilance obligations or activities.

The Parties shall execute a separate pharmacovigilance agreement as deemed applicable as soon as practicable after the Effective Date, but no later than the Initiation of the first Phase III Study in the Roche Territory or the first Regulatory Approval in the Roche Territory after the Effective Date (whichever comes first). Such pharmacovigilance agreement shall set forth the responsibilities and obligations of the Parties with respect to the procedures and timeframes for compliance with the applicable laws and regulations pertaining to safety reporting of the Product(s) and their related activities.

Pharmacovigilance. Upon the request of a Party, the Parties will negotiate in good faith and enter into a separate pharmacovigilance agreement at least ​ prior to filing the IND for the first Relay Pipeline Compound in a Relay Pipeline Combination (the “Pharmacovigilance Agreement”), which will govern the exchange of safety data information, adverse events reporting and Licensed Product complaints to ensure timely communication to Regulatory Authorities and compliance with Applicable Law.