a)	be used only in connection with the legitimate purposes of this Agreement;

b)	be disclosed only to those who have a need to know it; and

c)	be safeguarded with the same care normally afforded confidential information in the possession, custody or control of the party holding the Confidential Information.

 

 

i.	can be demonstrated to have been in the public domain prior to the date of the disclosure; or

ii.	enters the public domain through no fault of the receiving party; or

iii.	was already known to the receiving party at the time of disclosure as evidenced by written records in the possession of the receiving party prior to such time; or

iv.	is subsequently received by the receiving party in good faith from a third party without breaching any confidential obligation between the third party and the disclosing party; or

v.	was independently developed, as established by tangible evidence, by the receiving party without reference to information or material provided by the disclosing party; or

vi.

is required to be disclosed for minimal compliance with court orders, statutes or regulations or SKI/MEMORIAL audits for compliance with such regulatory requirements, provided that prior to any such disclosure to the extent reasonably practicable, the party from whom disclosure is sought shall promptly notify the other party and shall afford such other party the opportunity to challenge or otherwise lawfully seek limits upon such disclosure of Confidential Information.

 

 

 

 

	i.	Screening is the process of identifying potential subjects according to the entrance criteria outlined in the Protocol and of conducting the examinations and test specified in the Protocol necessary to select qualified subjects for the Study. For any given subject, the screen phase ends and the treatment phase begins when the subject has been enrolled into a treatment group under the Protocol and has been dispensed any Study Drug or placebo by SKI/MEMORIAL according to the study design and regimen described in the Protocol.
	ii.	A qualified subject is one who, upon entrance into the treatment phase of the Study, met all of the entrance criteria and none of the exclusion criteria in the Protocol and for whom knowing, written informed consent to participate was obtained in accordance with sub-Article 5.1.i herein.
	iii.	A completed subject is a qualified subject who completed the full term of the Study and met the minimum attendance and compliance standards in the Protocol so that the Study Drug can be evaluated for safety or effectiveness. A completed case report form is a set of Clinical Research Database (CRDB) generated reports submitted to the COMPANY for a completed subject which meets the requirements set forth in the Protocol.
	iv.	An incomplete subject is a qualified subject who started the Study but failed to complete the Protocol satisfactorily because of insufficient clinic attendance, poor compliance, voluntary withdrawal, or other violations of the Protocol.

 

 

 

	i.	For each completed case report form (set OI CRDB generated reports) on a completed subject, COMPANY will pay thirty one thousand one hundred eighty five U.S. Dollars ($31,185).
	ii.	For each case report (CRDB generated report) on an incomplete subject, the COMPANY will pay on a pro-rated basis taking into account that the initialization of the treatment maybe more expensive.
	iii.	SKI/MEMORIAL will receive no compensation for the examinations and tests conducted in non-qualified subjects under the screening or treatment phases of the Protocol.
	iv.	A start-up fee of seventy-nine thousand six hundred and twenty three dollars ($79,623) that includes $17,253 to cover costs required to initiate the study and the remainder to cover study costs through the submission of the first two case reports.

 

 

	i.	SKI/MEMORIAL agrees to use reasonable efforts in accordance with industry custom and practice to follow the Protocol, recruit, screen and enroll qualified subjects, prepare case report forms and any reports required in the Protocol.
	ii.	The parties agree that the screening phase will begin as soon as practicable after the signing of this Agreement. Each subject will be considered to be a completed, or incomplete patient, as appropriate, only after SKI/MEMORIAL has produced all completed case report forms (set of CRDB generated reports) and COMPANY has accepted the completed case report forms (set of CRDB generated reports).

 

 

	iii.	In the event the Study is terminated prior to the anticipated Study completion date as described in Article VII herein, COMPANY will pay actual expenses incurred by SKI/MEMORIAL for all completed and incomplete patients accrued to the date of termination, as detailed above. If the Study is terminated by COMPANY prior to the planned completion date for its convenience and without cause, COMPANY agrees to pay for those subjects active in the treatment phase at the termination date as if they had completed the Study.
	iv.	The dates and financial arrangements in this Agreement can be modified only by written amendment to this Agreement signed and executed by both parties.

 

 

 

a.	$79,623 within thirty (30) days after the execution of this Agreement; and

 

b.	the remainder, as outlined in Sections 5.2 and 5.3, upon COMPANY'S receipt of final case reports (set of CRDB generated reports) on each group of 3 of the patients enrolled into the Study in accordance with the Protocol. SKI/MEMORIAL anticipates enrolling a total of 15 patients.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

	i.	all aspects of SKI/MEMORIAL'S facilities which may be used in the performance of the Study have been fully validated and are in compliance with applicable federal, state and local governmental requirements; it will obtain IRB review and approval of informed consent documentation, Study Protocol, and other relevant documentation prior to initiation of the Study;
	ii.	it will adhere to all aspects of the Protocol, including but not limited to patient enrollment criteria:
	iii.	SKI/MEMORIAL will receive no compensation for the examinations and tests conducted in non-qualified subjects under the screening or treatment phases of the Protocol.
	iv.	it will maintain proper control and inventory over the Actinium-225 and Study Drug. 7

 

 

vi.

Investigators are employees of SKI/MEMORIAL, and are sufficiently qualified by training and experience to conduct the Study and have never been involved in any investigation or research at SKIIMEMORIAL which was terminated by the FDA, National Institutes of Health (NIB) or any sponsor for non-compliance.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SKI/MEMORIAL

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15

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