Pharmacovigilance. Within […​…] after ​ proceeds with the In-Licensing, the Parties shall determine if it is necessary to, and if so, enter into an agreement to initiate a process for the exchange of safety data (including post-marketing spontaneous reports received by each Party and its Affiliates) in a mutually agreed format in order to monitor the safety of the Licensed Compounds or Licensed Products and to meet reporting requirements with any applicable Regulatory Authority.

“Pharmacovigilance Agreement” has the meaning set forth in [Section 3.2.3].

Safety Database. The Parties shall in good faith negotiate and execute a mutually acceptable pharmacovigilance agreement addressing drug safety and adverse event reporting and compliance (the “Pharmacovigilance Agreement”) within ninety (90) days following the Effective Date. Before the execution of such Pharmacovigilance Agreement, the terms of this [Section 3.2.3] apply. Allergan shall establish, hold and maintain (at Allergan’s cost and expense) a safety database for Licensed Products. UroGen shall provide Allergan with all information necessary for Allergan 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]]0] or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with an RTGel Product or Licensed Product. Allergan shall provide UroGen a copy of all Information maintained by Allergan in the Allergan safety database for Licensed Products or otherwise, to the extent such Information is related to RTGel Products or otherwise as necessary for UroGen to comply with Applicable Law or a request by a Regulatory Authority.

REGENXBIO, and AbbVie as reasonably requested by REGENXBIO, and to disclose the same information in such 3-way discussions that Clearside would otherwise share or disclose directly to REGENXBIO under this Agreement, including any Quality Agreement or Pharmacovigilance Agreement entered into pursuant to this Agreement, provided that AbbVie is bound by a confidentiality agreement containing terms of confidentiality and non-use at least as stringent as the applicable terms set forth in this Agreement. Further, REGENXBIO may share any information with AbbVie that Clearside has shared or disclosed directly to REGENXBIO under this Agreement, including any Quality Agreement or Pharmacovigilance Agreement entered into pursuant to this Agreement, and including but not limited to information related to obtaining Regulatory Approvals pursuant to [Section 4.2.1(a)], provided that AbbVie is bound by a confidentiality agreement containing terms of confidentiality and non-use at least as stringent as the applicable terms set forth in this Agreement.”

Exchange. Both Parties agree to promptly exchange all relevant information that relates to the safety of the TLC Products, including, without limitation, any threatened or pending action by any governmental authority and especially all adverse TLC Products reactions, and cooperatively co-work to perform Pharmacovigilance in compliance with regulations.

As soon as reasonably practicable but in no case later than […​…] days of the Commencement Date, the parties shall enter into a global pharmacovigilance agreement (“PVA”) setting forth details with respect to the management of safety information including adverse events reports related to the Development and the Commercialization of the Products as well as a Safety Governance Structure and provisions ensuring Neuren has full rights of access to all such information and data.

Agreement. Each of this Agreement and the Paying Agency Agreement have been duly authorized, executed and delivered by the Company, and, assuming due authorization, execution and delivery by the other parties hereto and thereto, constitutes the legal, valid and binding obligations of the Company, enforceable against the Company in accordance with its terms, except as enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting creditors’ rights generally or by general equitable principles.

Agreement. The Administrative Agent (or its counsel) shall have received a counterpart of this Agreement (which may include facsimile transmission or electronic mail transmission of a signed signature page of this Agreement) that, when taken together, bear the signatures of each Borrower and each Lender.

Agreement. This Agreement evidences the award to the Participant of the cash amount set forth above. This Cash Award is the right to receive the amount of cash reflected above as described in [Section 4] of the Agreement. The Agreement and the Cash Award shall be subject to the following terms and conditions and the provisions of the Plan, which are hereby incorporated by reference. A copy of the Plan may be obtained by the Participant from the office of the Secretary of Adtalem or from the stock administrator’s website.

Agreement. Notwithstanding any other provision of this Plan and as a condition to becoming entitled to receive Payments, the Company may require the Officer to enter into a severance agreement prior to or after the Employment Severance Date. Such severance agreement will incorporate the Release and may, # modify the terms of any then-effective agreement between the Officer and the Company; or # include all provisions necessary to implement the terms of the Plan. Such agreement may include Post-Employment Covenants, the Company’s right to seek an injunction, forfeit future Payments, and require repayment of Payments made, and any other provisions deemed appropriate by the Company in its sole discretion.