Common use of Performance of the Study Clause in Contracts

Performance of the Study. 2.1 University shall perform the Study substantially in accordance with the terms and conditions of this Agreement. Sponsor and University may at any time amend the Study and this Agreement by mutual written consent. 2.2 In the event that the Principal Investigator becomes unable or unwilling to continue the Study and a mutually acceptable substitute is not available, both the University and the Sponsor shall have the option to terminate this Agreement. The Principle Investigator and any and all other person involved in the Study (collectively the "Investigator(s)" shall execute the Confidentiality Agreement substantially in the form attached hereto or Exhibit "B", (the "Confidentiality Agreement") prior to beginning any activities associated with the Study. 2.3 Nothing in the Agreement shall be construed to limit the freedom of Investigators, whether participants in this Agreement or not, from engaging in similar studies made independently under other grants, contracts or agreements with parties other than Sponsor, provided said investigations are not in conflict or violate the terms and conditions of this Agreement and the Confidentiality Agreement. 2.4 In performing the Study, University and Principal Investigator shall at all times undertake, comply with, and complete the following: 1. The Protocol; 2. This Agreement; 3. Generally accepted standards of good clinical practice; 4. Instructions provided in writing by Sponsor or Monitor; 5. All applicable federal, state and local laws and regulations applicable to the conduct of the Study and the performance of clinical investigators generally including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration; 6. Prepare an appropriate patient informed consent document sufficient to comply with all local, state, and federal statutory and regulatory requirements and in form acceptable to each of the parties, and thereafter to obtain such written consent from each patient or authorized representative prior to initiation of any procedures required by the Study; 7. Obtain and forward to Sponsor and Monitor evidence of Institutional Review Board ("IRB") approval of the Study and the informed consent document prior to beginning the Study; 8. Obtain and forward to Sponsor and Monitor evidence of ongoing review of the Study and informed consent document by the IRB at least annually; 9. Obtain and forward to Sponsor and Monitor evidence of IRB approval of any advertisement used for the Study prior to the publication or other use of the advertisement; 10. Review the clinical investigators' brochure and all updates as provided; 11. Maintain Study and related medical records according to local, state and federal statutory and regulatory requirements; 12. Immediately notify Sponsor and Monitor, according to procedures specified by Monitor, of any and all serious and/or unexpected adverse events as defined by the Study and promptly record such events on an appropriate case report form ("CRF") agreed to by the parties; 13. Immediately notify Sponsor and Monitor of any pregnancy of any, subject enrolled in the study; and 14. Enroll only qualified subjects in the Study as provided in the Protocol, or as directed by Sponsor and Monitor.

Performance of the Study. 2.1 University Institution shall perform the Study substantially in accordance with the protocol and the terms and conditions of this Agreement. Sponsor and University Institution may at any time amend the Study and this Agreement by mutual written consent. 2.2 In the event that the Principal Investigator becomes unable or unwilling to continue the Study and a mutually acceptable substitute is not available, both the University Institution and the Sponsor shall have the option to terminate this Agreement. The Principle Principal Investigator and any and all other person persons involved in the Study (collectively the "Investigator(s)" ) "shall execute the Confidentiality Agreement substantially in the form attached hereto or Exhibit "B", (the "Confidentiality Investigator Agreement") prior to beginning any activities associated with the Study. 2.3 Nothing in the Agreement shall be construed to limit the freedom of the Investigators, whether participants in this Agreement or not, from engaging in similar studies made independently under other grants, contracts or agreements with parties other than Sponsor, provided said investigations are not in conflict or violate the terms and conditions of this Agreement and the Confidentiality Agreement. 2.4 In performing the Study, University Institution and Principal Investigator shall at all times undertake, comply with, and complete the following: 1. The Protocol; 2. This Agreement; 3. Generally accepted standards of good clinical practice; 4. Instructions provided in writing by Sponsor or Monitor; 5. All applicable federal, state and local laws and regulations applicable to the conduct of the Study and the performance of clinical investigators generally including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration; 6. Prepare an appropriate patient informed consent document sufficient to comply with all local, state, and federal statutory and regulatory requirements and in form acceptable to each of the parties, and thereafter to obtain such written consent from each patient or authorized representative prior parties to initiation of any procedures required by the Study; 7. Obtain and forward to Sponsor and Monitor evidence of Institutional Review Board ("IRB") approval of the Study and the informed consent document prior to beginning the Study; 8. Obtain and forward to Sponsor and Monitor evidence of ongoing review of the Study and informed consent Informed Consent document by the IRB at least annually; 9. Obtain and forward to Sponsor and Monitor evidence of IRB approval of any advertisement used for the Study prior to the publication or other use of the advertisement; 10. Review the clinical investigators' brochure manual and all updates as provided; 11. Maintain Study and related medical records according to local, state and federal statutory and regulatory requirements; 12. Immediately notify Sponsor and Monitor, according to procedures specified by Monitor, of any and all serious and/or unexpected adverse events as defined by the Study and promptly record such events on an appropriate case report form for ("CRF") agreed to provided by the partiesSponsor; 13. Immediately Promptly notify Sponsor and Monitor of any pregnancy of any, any subject enrolled in the studyStudy; and 14. Enroll only qualified subjects in the Study as provided in the Protocol, or as directed by Sponsor and Monitor.

Performance of the Study. 2.1 University Institution shall perform the Study substantially in accordance with the protocal and the terms and conditions of this Agreement. Sponsor and University Institution may at any time amend the Study and this Agreement by mutual written consent. 2.2 In the event that the Principal Investigator becomes unable or unwilling to continue the Study and a mutually acceptable substitute is not available, both the University Institution and the Sponsor shall have the option to terminate this Agreement. The Principle Investigator and any and all other person involved in the Study (collectively the "Investigator(s)" shall execute the Confidentiality Agreement substantially in the form attached hereto or Exhibit "B", (the "Confidentiality Agreement") prior to beginning any activities associated with the Study. 2.3 Nothing in the Agreement shall be construed to limit the freedom of Investigators, whether participants in this Agreement or not, from engaging in similar studies made independently under other grants, contracts or agreements with parties other than Sponsor, provided said investigations are not in conflict or violate the terms and conditions of this Agreement and the Confidentiality Agreement. 2.4 In performing the Study, University Institution and Principal Investigator shall at all times undertake, comply with, and complete the following: 1. The Protocol; 2. This Agreement; 3. Generally accepted standards of good clinical practice; 4. Instructions provided in writing by Sponsor or Monitor; 5. All applicable federal, state and local laws and regulations applicable to the conduct of the Study and the performance of clinical investigators generally including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration; 6. Prepare an appropriate patient informed consent document sufficient to comply with all local, state, and federal statutory and regulatory requirements and in form acceptable to each of the parties, and thereafter to obtain such written consent from each patient or authorized representative prior to initiation of any procedures required by the Study; 7. Obtain and forward to Sponsor and Monitor evidence of Institutional Review Board ("IRB") approval of the Study and the informed consent document prior to beginning the Study; 8. Obtain and forward to Sponsor and Monitor evidence of ongoing review of the Study and informed consent document by the IRB at least annually; 9. Obtain and forward to Sponsor and Monitor evidence of IRB approval of any advertisement used for the Study prior to the publication or other use of the advertisement; 10. Review the clinical investigators' brochure and all updates as provided; 11. Maintain Study and related medical records according to local, state and federal statutory and regulatory requirements; 12. Immediately notify Sponsor and Monitor, according to procedures specified by Monitor, of any and all serious and/or unexpected adverse events as defined by the Study and promptly record such events on an appropriate case report form ("CRF") agreed to by the parties; 13. Immediately Promptly notify Sponsor and Monitor of any pregnancy of any, any subject enrolled in the study; and 14. Enroll only qualified subjects in the Study as provided in the Protocol, or as directed by Sponsor and Monitor.

Performance of the Study. 2.1 University Institution shall perform the Study substantially in accordance with the protocol and the terms and conditions of this Agreement. Sponsor and University Institution may at any time amend the Study and this Agreement by mutual written consent. 2.2 In the event that the Principal Investigator becomes unable or unwilling to continue the Study and a mutually acceptable substitute is not available, both the University Institution and the Sponsor shall have the option to terminate this Agreement. The Principle Investigator and any and all other person involved in the Study (collectively the "Investigator(s)" shall execute the Confidentiality Agreement substantially in the form attached hereto or Exhibit "B", (the "Confidentiality Agreement") prior to beginning any activities associated with the Study. 2.3 Nothing in the Agreement shall be construed to limit the freedom of Investigators, whether participants in this Agreement or not, from engaging in similar studies made independently under other grants, contracts or agreements with parties other than Sponsor, provided said investigations are not in conflict or violate the terms and conditions of this Agreement and the Confidentiality Agreement. 2.4 In performing the Study, University Institution and Principal Investigator shall at all times undertake, comply with, and complete the following: 1. The Protocol; 2. This Agreement; 3. Generally accepted standards of good clinical practice; 4. Instructions provided in writing by Sponsor or Monitor; 5. All applicable federal, state and local laws and regulations applicable to the conduct of the Study and the performance of clinical investigators generally including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration; 6. Prepare an appropriate patient informed consent document sufficient to comply with all local, state, and federal statutory and regulatory requirements and in form acceptable to each of the parties, and thereafter to obtain such written consent from each patient or authorized representative prior to initiation of any procedures required by the Study; 7. Obtain and forward to Sponsor and Monitor evidence of Institutional Review Board ("IRB") approval of the Study and the informed consent document prior to beginning the Study; 8. Obtain and forward to Sponsor and Monitor evidence of ongoing review of the Study and informed consent document by the IRB at least annually; 9. Obtain and forward to Sponsor and Monitor evidence of IRB approval of any advertisement used for the Study prior to the publication or other use of the advertisement; 10. Review the clinical investigators' brochure and all updates as provided; 11. Maintain Study and related medical records according to local, state and federal statutory and regulatory requirements; 12. Immediately notify Sponsor and Monitor, according to procedures specified by Monitor, of any and all serious and/or unexpected adverse events as defined by the Study and promptly record such events on an appropriate case report form ("CRF") agreed to by the parties; 13. Immediately Promptly notify Sponsor and Monitor of any pregnancy of any, any subject enrolled in the study; and 14. Enroll only qualified subjects in the Study as provided in the Protocol, or as directed by Sponsor and Monitor.

Performance of the Study. 2.1 University Institution shall perform the Study substantially in accordance with the protocol and the terms and conditions of this Agreement. Sponsor and University Institution may at any time amend the Study and this Agreement by mutual written consent. 2.2 In the event that the Principal Investigator becomes unable or unwilling to continue the Study and a mutually acceptable substitute is not available, both the University Institution and the Sponsor shall have the option to terminate this Agreement. The Principle Principal Investigator and any and all other person persons involved in the Study (collectively the "Investigator(s)" ) "shall execute the Confidentiality Agreement substantially in the form attached hereto or Exhibit "B", (the "Confidentiality Investigator Agreement") prior to beginning any activities associated with the Study. 2.3 Nothing in the Agreement shall be construed to limit the freedom of the Investigators, whether participants in this Agreement or not, from engaging in similar studies made independently under other grants, contracts or agreements with parties other than Sponsor, provided said investigations are not in conflict or violate the terms and conditions of this Agreement and the Confidentiality Agreement. 2.4 In performing the Study, University Institution and Principal Investigator shall at all times undertake, comply with, and complete the following: 1. The Protocol; 2. This Agreement; 3. Generally accepted standards of good clinical practice; 4. Instructions provided in writing by Sponsor or Monitor; 5. All applicable federal, state and local laws and regulations applicable to the conduct of the Study and the performance of clinical investigators generally including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration; 6. Prepare an appropriate patient informed consent document sufficient to comply with all local, state, and federal statutory and regulatory requirements and in form acceptable to each of the parties, and thereafter to obtain such written consent from each patient or authorized representative prior parties to initiation of any procedures required by the Study; 7. Obtain and forward to Sponsor and Monitor evidence of Institutional Review Board ("IRB") approval of the Study and the informed consent document prior to beginning the Study; 8. Obtain and forward to Sponsor and Monitor evidence of ongoing review of the Study and informed consent Informed Consent document by the IRB at least annually; 9. Obtain and forward to Sponsor and Monitor evidence of IRB approval of any advertisement used for the Study prior to the publication or other use of the advertisement; 10. Review the clinical investigators' brochure manual and all updates as provided; 11. Maintain Study and related medical records according to local, state and federal statutory and regulatory requirements; 12. Immediately notify Sponsor and Monitor, according to procedures specified by Monitor, of any and all serious and/or unexpected adverse events as defined by the Study and promptly record such events on an appropriate case report form for ("CRF") agreed to provided by the partiesSponsor; 13. Immediately Promptly notify Sponsor and Monitor of any pregnancy of any, any subject enrolled in the studyStudy; and 14. Enroll only qualified subjects in the Study as provided in the Protocol, or as directed by Sponsor and Monitor.;