CLINICAL TRIAL AGREEMENT

a.  

"Study" means the conduct of human research using the Study Drug manufactured by Actinium on Qualified Subjects at the Site pursuant to the protocol which has been reviewed and approved by the IRE and the FDA prior to the commencement of the Study.

b.  

"Protocol" means the details of that certain clinical Study to be performed pursuant to this Agreement entitled A Phase I/II Study of Low Dose Cytarabine and Actinium-255 Hum195 in Older Patients with Untreated Acute Myeloid Leukemia. The Protocol, including any amendments is hereby incorporated by reference. and made part of this Agreement.

c.  

"IRB" means the institutional review board of Site.

d.  

"Study Drug" means the compound known as Actinium-255 Hum 195.

e.  

"Study Data" means all of the data collected and records compiled during the Study relating to the conduct of the Study and/or the Study Drug. Study Data includes without limitation, all records prepared by the Investigator and all clinical research assistants, all Case Report Forms, all Screening records, all records on Qualified Subjects, Completed Subjects, Withdrawn Subjects, Uncompleted Subjects and Non-Qualified Subjects, all Informed Consent forms, all adverse/unexpected/serious or other reportable events, and all modifications, adjustments, suggestions for improvement of the Study Drug.

f.  

"Potential Subject" is a patient or individual who could possibly participate in the Study.

g.  

"Screening" is the process of identifying Potential Subjects and of conducting the examinations and tests necessary to select Qualified Subjects for the Study.

h.  

"Qualified Subject" is a subject who, on inclusion in the treatment phase of the Study, has met all of the inclusion criteria and none of the exclusion criteria in the Protocol and has given his/her written Informed Consent to participate in the Study.

i.  

"Completed Subject" is a Qualified Subject who has completed the Study and met the minimum attendance and compliance standards in the Protocol for evaluation of the safety and effectiveness of the Study Drug,

 j.  

"Withdrawn Subject" is a Qualified Subject who has been withdrawn from the Study because of treatment failure or adverse event, but who otherwise met the Protocol entry requirements.

k.

"Uncompleted Subject" is a Qualified Subject who was initially included in the Study but who failed to complete the Study satisfactorily because of insufficient clinic attendance, poor compliance, voluntary withdrawal, and loss to follow-up or other Protocol violations.

l.

"Non-Qualified Subject" is a subject who has not met the inclusion criteria as defined in the Protocol.

m.  

"Informed Consent Form" means the written form agreed upon by Actiniumand the Site in conformance with all applicable FDA regulations and guidances, and approved by the IRB for use in this Study.

n.  

"Case Report Form (CRF)" means the report in the Actinuim format which is completed by the Investigator or his/her authorized designee documenting the use of the Study Drug in subjects.

o.  

"FDA" means the Food and Drug Administration of the United States Department of Health and Human Services, and any successor government agency.

P.

"Investigator's Brochure" is a document describing the Study Drug, which is provided to the Investigator prior to the start of the Study.

q.

"Investigator" means John Pagel, M.D., Ph.D.

a.  

All parties shall conduct the Study in accordance with all applicable laws, regulations and guidances, as each of the foregoing may be amended from time to time. Without limiting the foregoing, the parties expressly agree to comply with 21 CFR 312 - Investigational New Drug Application, 21 CFR 50 ­Protection of Human Subjects, and 21 CFR 56 — Institutional Review Boards.

b.  

The Site agrees to comply with the terms of this Agreement and all IRB and FDA procedures and applicable decisions for the Study.

a.  

This Study is governed by this Agreement. All parties agree that no Study Drug shall be used on a subject until the 1RB and the FDA have both approved the Study. After the FDA and IRB approval, the Protocol may only be amended when: 1) there is written agreement between the Site, Actinium, and the Investigator to amend the Protocol, and 2) any and all such amendments have been reviewed and approved by the IRB and FDA. No Protocol amendments shall be implemented until receipt of the IRB and FDA written approval. Nothing in this paragraph shall limit the Investigator's ability to act under 21 CFR 312.50, 312.60, 312.62, 312.64 (Subpart D).

b.  

The Site agrees to strictly comply with all IRB procedures and policies which govern the review, approval and conduct of this Study.

c.  

The parties agree that Screening for Qualified Subjects shall begin within thirty (30) days of receipt of the following: 1) written approval of the Study and the Informed Consent by the IRB, 2) notification by Aptly or Actinium that the FDA has granted the Investigational New Drug Application for the Study Drug, and 3) completion of Initiation Visit of the Site by Aptiv and Actinium for Study participation. The goal of the Study is to enroll up to ten (10) Qualified Subjects per year. The Site agrees to use its best efforts to complete subject enrollment as soon as practical, after commencement of Screening at each dose group.

a.  

Actinium represents and warrants that it has the authority to enter into this Agreement on its own behalf.

b.  

Actinium agrees to provide to the Site and the Investigator the information necessary to properly conduct the Study, including without limitation, the Protocol, the Investigator's Brochure and data of any prior investigations of the Study Drug. Actinium agrees to provide any new information related to the safety and efficacy of the Study Drug as such information becomes available during the course of the Study. Actinium advises the Site and the Investigator that the effectiveness and safety in humans of the Study Drug have not been fully investigated.

c.  

Actinium shall provide, free of charge, the necessary quantity of the Study Drug. Actinium or Aptiv shall ship the Study Drug only to the Site.

d.  

Aptly shall monitor the Study and shall require evidence that IRB review and approval are obtained.

e.  

Actinium agrees that Institution, its affiliates and all Study team members shall have the sole authority over the clinical care of the Study subjects and nothing in this Agreement shall prevent Institution or Investigator from taking any action which is, in the reasonable medical judgment of the Study team members, in the Study subject's best interest. Any time Actinium or Aptiv becomes aware of a significant Study subject safety issue it will communicate such information to Institution. Actinium further agrees to promptly report to Institution the results of any monitoring reports that could affect the safety of Study participants, influence the conduct of the Study, alter the Institutional Review Board ("IRB") approval to continue the Study, and/or affect the willingness of Study Subjects to continue in the Study. During the Study and after its completion, Actinium shall promptly report to Institution and the Investigator any Study results that could directly affect the safety or medical care of Study Subjects.

a.  

The Site warrants and represents that Investigator is an employee of the Site, and is sufficiently qualified by training and experience to conduct the Study using the Study Drug. A true and complete copy of the Investigator's current curriculum vitae is attached as Exhibit B and made part of this Agreement.

b.  

The Site warrants that the Investigator has never been involved in any investigation or research at the Site which was terminated by the FDA, National Institutes of Health (1'.411-1) or any sponsor for non-compliance.

c.  

The Site warrants and represents that Investigator has not been disbarred under Section 306 of the Federal Food, Drug and Cosmetic Act, or any other section of said act or its successor, and further, that the Investigator will not use in any capacity, the services of any individual or entity which has been so disbarred, in any aspect of this Study. The Site agrees to notify Actinium immediately if the Investigator or any individual or entity involved in this Study is the subject of a disbarment proceeding or becomes disbarred.

d.  

In addition to and without limiting the obligations of Section 2a above, the Site agrees to conduct the Study in strict accordance with this Agreement, the Protocol, all associated documentation provided by Aptiv (e.g. CRF, CRF Completion guidelines, User Manuals, and Regulatory Binder documentation), applicable regulations, and all conditions of approval imposed by the reviewing IRB or FDA. The Site shall permit the use of the Study Drug only on Qualified Subjects under Investigator's personal supervision only for the purpose of the Study. The Site shall not supply the Study Drug to any other person or entity not authorized under FDA'regulation to receive it, nor to any person for any purpose other than the Study. The Site shall not modify or alter the Study Drug. The Site shall maintain proper control of all Study Drug inventory and return of unused quantities of Study Drug as required by regulation and directed by Actinium. The Site agrees that the Investigator will personally supervise or perform all testing of the Study Drug involving human subjects.

e.  

The Site agrees to maintain all records and make all reports as required by regulation, the Study, the IRB and this Agreement.

f.  

The Site agrees to use best efforts, on a diligent and continuous basis, to recruit Qualified Subjects, to prepare true and accurate Case Report Forms, to make all required reports, to complete the Study within the time limits set forth in this Agreement, and to perform all long-term follow-up examinations, visits and data collection as required by the Study and/or regulation from time to time. In addition, all CRF and Study Data shall be submitted to Aptiv within ten (10) days of written request. This provision shall survive termination or expiration of this Agreement.

g.  

The Site shall exclusively use the Informed Consent. The Site agrees that the IRB approved consent form must be provided to and acknowledged by Actinium prior to use. The Site agrees that the Investigator shall not conduct any screening procedures, enroll any Potential Subject nor use the Study Drug on any Potential Subject who has not given written consent by signing and dating the specified Informed Consent form. The Site agrees that investigator shall personally ensure that all the requirements for obtaining informed consent are met.

h.  

The Site agrees that Investigator will follow good medical practice and exercise the customary standard of care practiced in his professional specialty.

i.  

The Site ensures that Investigator will provide sufficient accurate financial disclosure information to allow Actinium or Aptly to submit a complete and accurate certification or disclosure statement as required under 21 CFR part 54, as it may be amended from time to time. Further, the Site agrees that the Investigator shall promptly update this financial disclosure information if any relevant changes occur during the course of the Study and for one (1) year following completion of the study. The Site also agrees that Investigator will update this financial disclosure information within ten (10) days of request by Actinium or Aptiv. The Site understands that this information shall be submitted in any marketing application involving the Study Drug. This provision shall survive termination or expiration of this Agreement.

j.  

The Site agrees to provide sufficient resources to the IRB to enable the IRB to operate as required by law, regulation and its own procedures.

k.  

During the Study, and subject to the terms of this Agreement, Site agrees to use reasonable efforts to cause the Investigator to conduct the Study pursuant to the Protocol and to provide to Investigator reasonable access to all Site facilities, staff and resources which the Investigator determines necessary or desirable to the conduct of the Study. Without limiting the foregoing, the Site agrees to make available a Study coordinator, qualified by training and experience and reasonably acceptable to Actinium and Aptiv, to manage all administrative functions of the Study, including but not limited to, meeting with Actinium and Aptly. All such Site facilities, staff and resources used in the Study are subject to the supervision of the Investigator.

1.

The Site agrees to provide the facilities necessary to the conduct of the Study, and to notify Actinium and Aptiv promptly, but no later than 1 business day after the discovery, of any failure of the Investigator, the Site or the IRB itself, to follow any of the established protocols for the Study.

m.

The Site agrees to allow Aptiv and Actinium reasonable access to the study site and to facilities and staff as reasonably.needed to conduct long-term follow-up of Study subjects, at Aptiv's expense. The Site will ensure that the Investigator will be available, during regular business hours, to meet with a study monitor to review the status of the Study and discuss any pending issues. Aptiv will provide no less than five (5) days advance notice of monitoring visits and will use all reasonable efforts to coordinate the scheduling of the visits with the Investigator and Study Coordinator.

b.  

Any additional payments must be approved in advance by Actinium in writing.

 

c.  

The Site agrees to be responsible for invoicing Actinium in accordance with the Budget and Payment Schedule (Exhibit C).

 

d.  

Any equipment (except for the Study Drug) purchased by the Site as part of the Protocol shall be owned by the Site, shall be physically located at Site, and shall remain the property of Site following completion of the Study.

 

e.  

In no event is Actinium required to make any payment for any costs incurred with respect to Non-Qualified Subjects entered into the treatment phase of the Study or for any Subject who has not given written Informed Consent to participate in the Study.

 

f.  

Nothing contained herein shall be construed as requiring Site, the Investigator or any Site research staff to work on any project or process which is prohibited by law or by any international treaty to which the United States of America is a party, or which may be harmful or detrimental to public health, patient safety or good clinical care or which may be considered to be immoral. No payment is subject to submission of favorable clinical results or evaluations.

 

g.  

Notwithstanding the foregoing, in no event shall any payment be made under this Agreement which is contrary to 42 USC 1320a-7b, as it or any successor law may be in effect from time to time. In accordance with the statute, in no event shall the Investigator or any member of his immediate family, receive any payment, royalty, form of compensation, or emuneration of any nature, sort or description, for any use of all or any portion of the Study Drug by any hospital, clinic or other Site where he works. In no event shall any request for reimbursement or payment under any private or public health insurance carrier be made which is contrary to law.

The parties recognize that because this is a multi-center Study, there is a need for a coordinated approach to any publication or public disclosure of the data or results of this Study. To that end, there will be no publication or public disclosure of such data or results by the Site or Investigator until a multi-center publication is submitted for publication or presentation by Actinium, or its designee. However, if no multi-site publication is submitted by Actinium or its designee within twelve (12) months of the completion of the Study from all sites, the Site and the Investigator shall be free to publish for non-commercial purposes the Study results from there Site as follows. If the Site or the Investigator wishes to publish or publicly disclose Study and data or results the Site will submit any proposed manuscript or publication to Actinium for comment at least thirty (30) days prior to its submission for publication or other disclosure. The Site will review and consider in good faith comments received from Actinium during such thirty (30) day period. If requested to do so by Actinium, Site agrees to remove confidential information provided by Actinium prior to submitting the manuscript or publication, excluding Study data or results. Actinium will make every reasonable attempt to notify the Site within said thirty (30) days of receipt of the proposed publication whether it is desirable to file a patent application on any inventions contained in the proposed publication. In the event Actinium decides to pursue patent protection, Actinium shall have the right to defer publication for an additional sixty (60) days to permit the filing of any desired patent application.

(1)  

Information that was in the public domain prior to the date of disclosure to the receiving party coming into possession thereof, or becomes part of the public domain by publication or otherwise through no fault or unauthorized act or omission on the part of the receiving party;

(2)  

Information that is disclosed to the receiving party by a third party legally entitled to disclose such information, as demonstrated by competent evidence;

(2)  

Information that is disclosed to the receiving party by a third party legally entitled to disclose such information, as demonstrated by competent evidence;

(3)  

Information that was rightfully in the possession of or already known to the receiving party as demonstrated by prior written records;

(4)  

Information that is independently developed by the receiving party without reference to any confidential information, as demonstrated by competent evidence; or

(5)  

Information that is required to be disclosed to a government authority or by order of a court of competent jurisdiction, provided that (a) such disclosure is subject to all applicable governmental or judicial protection available for like material; (b) reasonable advance notice is given to the disclosing party and disclosing party is provided with an opportunity to comment on such proposed disclosure; and (c) the receiving party take all reasonable steps to limit the scope of such disclosure.

a.  

All rights and remedies hereunder are exclusive and not cumulative.

 

b.  

This Agreement may be amended only by written agreement signed by all parties.

 

c.  

It is expressly agreed by the parties hereto that the Site, the Investigator and Aptly are independent contractors and nothing in this Agreement is intended to create an employer relationship, joint venture, or partnerships between the parties. No party has the authority to bind any other.

 

d.  

This Agreement, including all exhibits, constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all proposal, negotiations and other communications between the parties, whether written or oral, with respect to the subject matter hereof.

 

e.  

If any provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired thereby, and the party against whom the holding is made, shall be entitled to substitute a similar provision that preserves the benefit of the bargain.

 

f.  

The failure of any party to insist on strict performance of any provision of this Agreement or exercise any right hereunder will not constitute a waiver of that provision or right.

 

g.  

This Agreement may be executed in any number of counterparts, each of which shall be deemed an original as against the party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument.

 

h.  

Each party hereto agrees to execute, acknowledge and deliver such further instruments and do all such further acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

i.  

The paragraph headings contained in this Agreement are for reference purposes only and shall not in any way affect the meaning or interpretation of this Agreement.