New Definitions. The following definitions are hereby added in the appropriate alphabetical order to Exhibit A of the Note and Warrant Purchase Agreement:
New Definitions. The following shall be added as new defined terms in Section 1.1 of the Agreement: "Constipation Related Disorder Indication Demonstration of Decision to Proceed" shall have the meaning assigned in Section 5.2(a)(iii)." "Demonstration of Decision to Proceed" shall mean the Constipation Related Disorder Indication Demonstration of Decision to Proceed and the Other Indications Demonstration of Decision to Proceed." "International Co-ordinating Investigator" shall mean an external (i.e. not... employed by AstraZeneca or its Affiliates) physician assigned by or on behalf of AstraZeneca or its Affiliates with the responsibility for the coordination of investigators at different centres participating in a multicentre Clinical Trial for a Licensed Product. AstraZeneca agrees to provide Ardelyx with written notice of the designation of each International Co-ordinating Investigator so assigned by AstraZeneca prior to the end of the Notification Period, and written notice of any change to such designation within five (5) days of such change being made. " "Other Indications Demonstration of Decision to Proceed" shall have the meaning assigned in Section 5.2(a)(ii)." "[***] Patents" shall mean the following United States Provisional Patent Applications: [***], and any such Patents claiming priority to such Patents." "Planned Phosphate 2b Clinical Trial" means the Phase 2b Clinical Trial (No. D5613C00001) of the Lead Licensed Compound in hyperphosphatemia in patients with ESRD that is – as of the Amendment One Effective Date – planned to be conducted by or on behalf of AstraZeneca. The Parties acknowledge and agree that for the purposes of this Agreement the Planned Phosphate 2b Clinical Trial, as currently (as of the Amendment One [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Pages Effective Date) proposed to be designed, shall not be deemed to constitute a Phase 3 Clinical Trial. However, the Parties further acknowledge and agree that the Planned Phosphate 2b Clinical Trial may be deemed to constitute a Phase 3 Clinical Trial solely in the event that (a) the design of the Planned Phosphate 2b Clinical Trial, as manifested by a subsequent (i.e. following the Amendment One Effective Date) submission to the applicable Regulatory Health Authority, is modified in any material respect, including, without limitation, a material extension of the treatment duration of the Planned Phosphate 2b Clinical Trial, such that the Planned Phosphate 2b Clinical Trial can actually be used as a pivotal study for purposes of seeking Regulatory Approval or (b), following completion of the Planned Phosphate 2b Clinical Trial, AstraZeneca seeks and obtains confirmation from the Regulatory Health Authority that the Planned Phosphate 2b Clinical Trial can be used as a pivotal study for purposes of seeking Regulatory Approval, where such confirmation shall be deemed to have been obtained when (but not before) (i) the first meeting with the Regulatory Health Authority that is convened for the purpose of discussing the end of the Planned Phosphate 2b Clinical Trial has occurred, and (ii) the minutes of such meeting prepared by the Regulatory Health Authority confirm concurrence by the Regulatory Health Authority that the Planned Phosphate 2b Clinical Trial can be used as a pivotal study for the purposes of seeking Regulatory Approval.View More
New Definitions. Section 1.2 of the Credit Agreement is hereby amended by adding the following defined terms in their proper alphabetical order: "Fourteenth Amendment Date" shall mean June 29, 2018. "Permitted 2018 Rights Offering" shall mean the options, warrants or other rights given on or about August 2018 to existing shareholders of Equity Interests of Borrowers to acquire such shares, on terms and conditions disclosed to and acceptable to Agent.
