Clinical Research Agreement

EXHIBIT 10.22


CLINICAL RESEARCH AGREEMENT


Agreement made as of 1st November 1995 between [*****] a not-for-profit corporation having a principal place of business at [*****] London, England ("Trust"), [*****], M.D., Department of Radiotherapy and Oncology, [*****], [*****], [*****], London, England ("Investigator"), and Photoelectron Corporation, a corporation having an office at 400-1 Totten Pond Road, Waltham, Massachusetts 02154, United States ("Sponsor").


1. Investigator agrees to act as Principal Investigator at Trust's [*****] for clinical study of the Photon Radiosurgery System (Herinafter referred to as the "Study Device"), including study in accordance with the multi-institution study protocol entitled "A Study of the Safety and Efficacy of the Photon Radiosurgery System in the Treatment of Brain Metastases" (as amended from time to time) and other studies as mutually agreed to by the parties of this Agreement (hereinafter referred to as "Studies"). In the event of any conflict between protocols for the Studies and the provisions of this Agreement, the provisions of this Agreement shall govern. That portion of multi-institution studies that are carried out by Trust are hereinafter referred to as "Institutional Studies". Investigator agrees to comply with all appropriate regulatory and ethical requirements for the conduct of Studies by Trust, including those mandated by regulatory authorities of the United Kingdom and the United States Food and Drug Administration (where applicable), to adhere to Standard Operating Procedures for the Studies, and to maintain the Study Device according to the instructions provided by Sponsor.


2. The Institutional Studies will be conducted by Investigator at Trust with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all English laws and regulations. Investigator shall provide Sponsor with written evidence of review of the Studies by Trust's Ethics Committee prior to the start of Institutional Studies and of the Ethics Committee's continuing review and approval of the Institutional Studies whenever it is reviewed, but at least once per year. All study subjects will meet the legal age requirements of England, the country in which the Institutional Studies are conducted.


3. Investigator will furnish Sponsor or its designated Study Monitor with all data resulting from Institutional Studies in signed case report forms and in other mutually agreed upon forms within one month after completion of a study event. Sponsor shall have the unrestricted right to use such data including, to the extent that subjects' consent have been obtained, subjects' names, any identifying information, and any visual recordings, audio recordings, electronic recordings, or other likenesses. Case report forms to be used will be those supplied by Sponsor. Patient records shall be made available to Sponsor's representatives upon request for comparison with case report forms. Such records will also be made available upon request for review by representatives of English, European Union, and United States FDA regulatory authorities. Records of the Studies, including either the original or a copy of all Informed Consent Forms of subjects of the Studies, shall be retained in conformance with all applicable regulations.


4. It is understood that certain of the Studies are multi-center investigations and publication of results from all participating sites is expected. Investigator shall be free to publish results of Institutional Studies after submission of multi-center results for publication, subject only to the provisions of Paragraph 7 regarding Sponsor's confidential information, only when notification is given by Sponsor to Trust that such a submission is no longer planned or twelve (12) months after the termination of a multi-center Study at all sites, whichever shall occur first. Sponsor will be furnished with a copy of any proposed presentation of information from the Studies for review and comment prior to submission for any form of public dissemination, in the case of manuscripts and such for publication at least thirty (30) days prior to submission and in the case of abstracts and such at least seven (7) days prior to submission. At the expiration of either the thirty(30) or seven (7) day period, whichever applies, Investigator may proceed with submission for presentation.


5. A minimum of one journal article describing the analyzed results of each of the Studies will be submitted for publication at the conclusion of each Study. In addition, since any multi-center Study is to be carried out at a number of institutions, a minimum of one journal article describing the analyzed results from all institutions will be submitted for publication at the conclusion of each such Study. Such manuscript(s) will bear as authors, among others, all Investigators of the Study. The order of authors will be as follows: those who design and implement the Study will be first; the Investigator and other, individuals from the institution contributing the largest number of patients will be listed next; the Investigator and other individuals from the institution contributing the second largest number of patients will be next; and so on.


6. At the conclusion of any multi-center Study and after such time as a minimum of one multi-authored, multi-institution journal article has been published, all Investigators from all participating institutions will be given complete access to all of the patient data accrued in the Study.


7. In order to effectively complete an Institutional Study, it may be necessary or desirable for the parties to disclose proprietary, trade secret and/or other confidential information (hereinafter referred to as "Confidential Information") to one another. Each party agrees that any such Confidential Information disclosed to it or to its employees shall be used only in connection with the legitimate purposes of this Agreement, shall be safeguarded with same care normally afforded such Confidential Information in the possession, custody, or control of the party receiving the Confidential Information, provided, however, that the disclosing party specifies in writing the nature and identity of the Confidential Information and the manner and time of disclosure. The foregoing shall not apply when, after and to the extent the Confidential Information disclosed: A) becomes generally available to the public through no fault of the receiving
party, B) 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 C) 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.


8. Trust and Sponsor agree that the Sponsor shall have the opportunity to acquire by assignment all rights to each invention which constitutes a new use or modification of the Study D ...