Development Reports. Licensee shall provide Merck with reasonably detailed reports describing its progress with respect to its Development efforts under this Agreement (hereinafter “Development Reports”). Such Development Reports shall be furnished annually until the First Commercial Sale. Each Development Report shall include the following information for the Licensed Product: a description of the Development work conducted during the year in reasonable detail, including clinical studies, formulation work, manufacturing work, and other testing work and regulatory activity; timelines for such work; and key decision gates and milestones anticipated for such work. All Development Reports created by Licensee shall be deemed the Proprietary Information of Licensee and are subject to the confidentiality obligations of Article IX.

Development Plan. An initial development plan is attached hereto as Exhibit A (such plan, as may be amended by time to time pursuant to this Agreement, the “Development Plan”). The Development Plan is a high-level summary of the Development activities Allergan anticipates being necessary to obtain Regulatory Approval for Licensed Products for the First Indication in the U.S. and ​ [[Unknown Identifier]] Countries for which Allergan is using Commercially Reasonable Efforts to Develop and seek Regulatory Approval for a Licensed Product in the First Indication. For as long as Development activities under this Agreement are ongoing, on or before each anniversary of the Effective Date, Allergan shall prepare an amendment, as appropriate, to the then-current Development Plan to reflect material changes or additions to the Development of Licensed Products for the First Indication in the U.S. and ​ [[Unknown Identifier]] Countries. Allergan shall submit all amendments to the Development Plan to UroGen and, upon such submission, the amended Development Plan will become effective and supersede the previous Development Plan.

Development Records. Allergan shall maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities hereunder, in sufficient detail to verify compliance with its obligations under this Agreement and which shall be appropriate for patent and regulatory purposes, in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Development activities hereunder, which books and records shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such books and records shall be retained by Allergan for at least ​ years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.

A $2,000,000 economic development loan from the Department of Business and Economic Development, a principal department of the State of Maryland ("DBED"), to Emergent under a Loan Agreement, dated as of May 14, 2015, by and between DBED and Emergent.

“OECD” means the Organization for Economic Cooperation and Development.

Economic Sanctions Law means any economic or financial sanctions administered by the United Nations, the European Union or any member state thereof, any agency of the US government, or any other national economic sanctions authority.

No Government Obligor. The Obligor on the Receivable is not the United States or any State or any local government, or any agency, department, political subdivision or instrumentality of the United States or any State or any local government.

AE Reporting. Provider agrees to maintain, on a continuous basis, designated staff and resources for prompt management of technical complaints and adverse event reports related to the Product. Provider shall within twenty-four (24) hours notify Company, if it receives any information that relates, refers or pertains to adverse events. Reporting shall be done using the form provided by Company. Adverse event reports shall be provided to Company in a manner mutually agreed to by the parties. An adverse event shall include, but is not limited to, the following:

The Executive will report directly to the Company President and promptly upon request will provide such information and reports as reasonably requested from time to time.

Reporting Status. Until the date on which the Buyers shall have sold all of the Securities (the “Reporting Period”), the Company shall timely file all reports required to be filed with the SEC pursuant to the 1934 Act, and the Company shall not terminate its status as an issuer required to file reports under the 1934 Act even if the 1934 Act or the rules and regulations thereunder would no longer require or otherwise permit such termination.