Clinical Trial Agreement

Draft agreement

CLINICAL TRIAL AGREEMENT

THIS AGREEMENT made in duplicate this > day of <month>,<year>.

BETWEEN:

<insert name and address>

(Hereinafter referred to as the "Sponsor"),

OF THE FIRST PART,

- and -

THE UNIVERSITY OF MANITOBA

207 Administration Building

Winnipeg, ManitobaCanadaR3T 2N2

(Hereinafter referred to as the "University"),

OF THE SECOND PART.

WHEREAS:

A.Dr. Peter Jones, an academic staff member of the University at the Richardson Centre for Functional Foods & Nutraceuticals (hereinafter referred to as the "Principal Investigator") has certain expertise in <define area>.

1. The Sponsor wishes to retain the University to conduct the Clinical Trial (defined below) and to use the facilities and certain resources of the University for the purposes of doing so, and theUniversity has agreed to perform such services and provide such facilities, in accordance with the terms of this Agreement.

NOW THEREFORE the parties hereto agree as follows:

ARTICLE 1 – DEFINITIONS

1.1“Clinical Trial” or “Trial” means the clinical trial that is to be conducted at the University under the supervision and direction of the Principal Investigator pursuant to this Agreement and in accordance with the Protocol attached hereto as Schedule “A”.

1.2“Inventions” means any inventions, discoveries, or innovations, products, processes, formulations, technologies and compounds whether patentable or not, arising directly from the performance of the Clinical Trial under this Agreement or using Clinical Trial funds or otherwise arising out of use of the Study Product.

1.3“Protocol” means the study entitled <“insert title”>, as amended in writing from time to time.

1.4 “REB” means the institutional Research Ethics Board responsible for review and approval of the Protocol.

1.5“Research Subjects” means individuals that are properly enrolled and participating in the Clinical Trial.

1.6“Study Product” means <define study product, if applicable>, the product being studied in the Clinical Trial.

ARTICLE 2: CONDUCT OF THE CLINICAL TRIAL

2.1The Sponsor is sponsoring the Clinical Trial and hereby retains the University to conduct the Clinical Trial in accordance with this Agreement. The Clinical Trial shall take place under the supervision and direction of the Principal Investigator, at the University, and solely on Research Subjects. The University shall use the facilities, employees and resources of theUniversity and the Principal Investigator to conduct the Clinical Trial, and the University agrees to furnish and make available to the Principal Investigator such facilities, employees and/or resources as may be necessary or desirable for the proper conduct of the Clinical Trial.

2.2The University shall perform the Clinical Trial in strict compliance with this Agreement, the Protocol, and all applicable laws and regulations. The University shall also at all times comply with the requirements of the REB, the policies of the University, and all reasonable directions and requests of the Sponsor. In the event of a conflict between the foregoing requirements, the University shall comply with the most stringent requirement. Furthermore, if there is a conflict between the terms of the Protocol and the terms of this Agreement, the terms of this Agreement will govern with respect to commercial and contract terms, but the Protocol will govern with respect to the conduct of the Clinical Trial and with respect to patient welfare issues.

2.3The University shall have the full responsibility for all aspects of the Clinical Trial including, but not limited to, its conduct, protocol and design, and the training of all staff and site personnel as to the procedures and other relevant information specified in and relating to the Protocol. The Sponsor shall have the right to monitor the Clinical Trial and shall conduct such clinical monitoring during the course of the Clinical Trial at reasonable intervals to be determined in consultation with the University.

2.4The University shall prepare and maintain accurate and complete records of the work performed in connection with the Clinical Trial under this Agreement. The University shall, if requested by the Sponsor, make such research records, and other records relating to expenditures incurred in connection with the Clinical Trial, available for inspection by the Sponsor, or by any authorized governmental or regulatory agency. The University shall collect and store the original Clinical Trial data in a safe and secure location.

2.5The University and/or the Principal Investigator shall be responsible for obtaining REB approval of the Protocol, including informed consent form(s), and any advertisement(s) pertaining to the enrollment of Research Subjects in the Clinical Trial, prior to the beginning of the Clinical Trial. Written, fully informed consent must be obtained by the University from each Research Subject enrolling in the Clinical Trial prior to commencement of treatment. The method of explanation to Research Subjects and the obtaining of their consent shall comply with Canadian law, regulations and guidelines, and with the ethical principles in the Declaration of Helsinki, whichever represents the greater protection for the individual.

2.6The University and the Principal Investigator shall report any adverse experiences and adverse events observed in the Clinical Trial to the Sponsor, the REB, Research Subjects and their guardians (if applicable), their health care professionals and any authorized governmental or regulatory agency as appropriate..

ARTICLE 3: STUDY PRODUCT

3.1The Study Product, as well as the documents and the material necessary to conduct the Clinical Trial, as described in the Protocol, shall be supplied free of charge to the University by the Sponsor.

3.2All the Study Product supplied pursuant to this Agreement shall remain at all times the property of the Sponsor and shall be used only and exclusively pursuant to the Protocol. It is understood that the Study Product is provided by the Sponsor for the sole purpose of conducting the Clinical Trial.

3.3All unused Study Product shall be promptly returned to the Sponsor upon the completion of the Clinical Trial as directed by the Sponsor, or upon earlier termination of this Agreement, unless written authorization to destroy the Study Product is given by Sponsor.

ARTICLE 4 - FINANCES

4.1The Sponsor shall pay to the University for the Clinical Trial the amount of <$insert amount> Cdn [or USD] pursuant to the "Schedule of Payments" set out in Schedule "B" attached hereto.

4.2Total financial obligation of the Sponsor under this Agreement is limited to the amount set out in subsection 4.1 which amount shall not be exceeded without the written authorization of the Sponsor.The funds shall be used in a manner consistent with the Protocol and the approved budget (the “Budget”) which is attached as Schedule “C” hereto.

4.3The budget is all inclusive and is intended to include all supplies, laboratory fees, Research Subject costs, professional fees, nursing salaries, University surcharges and administrative costs.

4.4All cheques shall be made payable to the University with reference to the Principal Investigator’s name. All cheques will be sent to the attention of the University at the following address: Budget & Grant Accounting Services, 404 Administration Building, Winnipeg, ManitobaR3T 2N2, attention:<insert contact name>.

ARTICLE 5 - TERMINATION

5.1This Agreement is effective as of <insert date> and will terminate on <insert date> being the anticipated completion date of the Clinical Trial, unless such date is altered upon the mutual written agreement of the parties.

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Draft agreement

5.2The University may, at its option, earlier terminate this Agreement by written notice to such effect and avail itself of such other legal remedies as are appropriate, in the event that the Sponsor shall:

(a)at any time become insolvent in the opinion of the University, or make an assignment for the benefit of creditors, or have a petition in bankruptcy filed for or against it; or

(b)at any time default in payments under Article 4, or commit any breach of any covenant herein contained, or make any false report, and shall fail to remedy any such default, breach or report, within thirty (30) days after written notice thereof by the University.

5.3The University or the Sponsor may earlier terminate this Agreement thirty (30) days subsequent to receipt of written notice of intent to terminate from one to the other. Either party may terminate this Agreement immediately upon written notice if, in its discretion, deems termination necessary to protect the health and safety of the Research Subjects.

5.4In the event this Agreement is terminated, the Sponsor shall pay to the University all costs, compensable under Article 4, incurred to the effective date of termination, plus any additional costs mutually agreed upon in writing for relevant and documented expenses incurred by the University in connection with terminating the Clinical Trial including uncancellable commitments.

5.5If the amount paid by the Sponsor to the University prior to such termination exceeds the amount that is actually earned, the University shall reimburse such excess to the Sponsor within forty-five (45) days after the date of termination.

5.6Immediately upon termination by either party pursuant to this Article, the University shall stop enrolling Research Subjects in the Clinical Trial, and the Sponsor shall cooperate with the University to continue monitoring Research Subjects enrolled prior to the termination date if necessary.

5.7The parties shall return all Confidential Information (as defined in Article 6 hereof) owned or controlled by one party and in the possession of the other party.

5.8Articles 1, 5, 7, 8, 9, 10 and 13.3 shall survive termination of this Agreement. The obligations of confidentiality under Article 6 shall continue for a period of five (5) years from the date of termination of this Agreement.

ARTICLE 6 - CONFIDENTIAL INFORMATION

6.1The Sponsor and the University may disclose technical, scientific, business or marketing information one to the other to facilitate work under this Agreementin writing or other tangible form (“Confidential Information”). Such Confidential Information clearly marked as "Confidential", “Protected Business Information” or "Not for Publication" shall be safeguarded and not disclosed to anyone within the Sponsor or the University without a "need to know" or to any third party, except with the prior written approval of the other party. If initially disclosed orally, the information shall be summarized and confirmed in writing as “Confidential” within thirty (30) days after the date of oral disclosure.

6.2The Sponsor and the University undertake not to use the Confidential Information for any other purpose than the purposes of this Agreement. The obligation of confidentiality contained in this paragraph shall not apply to Confidential Information which:

(a)at the time of receipt by the receiving party is in the public domain; or

(b)is lawfully obtained from third parties; or

(c)after its receipt by the receiving party is made public by a third party, through no fault of the receiving party; or

(d)was in the possession of the receiving party before receipt from the disclosing party or was developed independently by the receiving party without reference to the Confidential Information as evidenced by written records; or

(e)is the subject of a valid subpoena or is otherwise required by law to be disclosed, provided that prompt notice is given to the disclosing party of the requirement of such disclosure; or

(f)must be disclosed to potential Research Subjects during the recruitment process, and to Research Subjects who are or were enrolled in the Clinical Trial, or any of their lawful representatives, in order to obtain and maintain informed consent or as the information relates to their health, safety or diagnosis; or

g)must reasonably be disclosed to regulatory authorities, clinicians, the REB of the University or the REBs of other participating sites; or

h)is published in accordance with Article 8 hereof.

6.3The parties warrant that they shall adhere to and comply with applicable laws and regulations regarding protection of personal and/or health information including any and all applicable provisions of the Canadian Personal Information Protection and Electronic Documents Act (or PIPEDA), the Manitoba Personal Health Information Act (or PHIA) and/or the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (or TCPS).

6.4In the event that the Sponsor has access to individually identifying health information, the Sponsor shall comply, and shall ensure that any third party acting through the Sponsor shall comply, with any conditions or requirements imposed by the University, including without limitation: (a) use the health information only for the purposes of the research as proposed and approved; (b) not disclose or publish the health information in a form that could reasonably enable the identity of an individual who is the subject of the information to be readily ascertained except as required by law; (c) not make any attempt to contact an individual who is the subject of the health information to obtain additional health information unless the individual has consented to such contact; or (d) to be liable for the actions of its employees, agents, consultants or other persons for whom it is in law responsible respecting the collection, use or disclosure of health information and for ensuring compliance by these persons.

6.5The obligation of confidentiality shall not apply to professional expertise which the Principal Investigator or the University has upon execution of this Agreement, or which is further developed or enhanced as a result of performing work under this Agreement.

ARTICLE 7 - OWNERSHIP/LICENSES

7.1The parties have no rights in respect of background intellectual property of the other existing prior to the Effective Date of this Agreement.

7.2The University shall retain possession of all original documents and materials used and developed during the course of the Clinical Trial, including but not limited to notes, reports, records and data for its own non-commercial research, educational and patient care purposes and for compliance with federal and provincial regulations. Pursuant to subsection 8.1, the University agrees to provide copies of the foregoing documents to the Sponsor at the request of the Sponsor.

7.3The parties acknowledge that the Clinical Trial may result in Inventions. Notwithstanding the University’s ownership rights in any Inventions pursuant to University of Manitoba Policy 225 (Patent and Copyright), the sole and exclusive right to any Inventions shall be the property of the Sponsor. The University or the Principal Investigator will promptly notify the Sponsor in writing of any such Inventions, and at the Sponsor’s request, and expense, the University and the Principal Investigator will cause to be assigned to the Sponsor all right, title, and interest in and to any such Inventions and provide reasonable assistance to obtain patents including causing the execution of any invention assignment or other documents. Subject to the terms of Article 6, the Sponsor shall be permitted to sublicense the Inventions in its sole discretion.

7.4The Sponsor grants to the University a non-exclusive, perpetual, royalty free license to use the Inventions without identification of, or connection to, the Sponsor for teaching and non-commercial internal research purposes subject to Article 8; provided, however, that the University’s use of the Inventions will not include disclosing, licensing or sublicensing any of the Inventions to any commercial enterprise at any time.

ARTICLE 8 - PUBLICATIONS AND REPORTING

8.1The University agrees to deliver the results of the Clinical Trial, both progress and final, to the Sponsor as set out in the Protocol. All results submitted to the Sponsor will be subject to the access and disclosure provisions of the applicable laws and regulations regarding protection of personal and/or health information.

8.2The University agrees that the Sponsor shall have the right to publish or present the information and/or data and results arising from the Clinical Trial as it may find appropriate. The parties acknowledge that it is part of the University’s function to disseminate information and to make it available for the purpose of scholarship. If the results of the Clinical Trial are not published within twelve (12) monthsafter conclusion, abandonment or termination of the Clinical Trial, the University may publish or present the results from the Clinical Trial for academic purposes provided such proposed publication or presentation shall be provided in confidence to the Sponsor for its review at least thirty (30) days prior to presentation or submission for publication.

OR

[The parties acknowledge that it is part of the University’s function to disseminate information and to make it available for the purpose of scholarship. The Sponsor agrees that the University shall have the right to publish or present the results from the Clinical Trial for academic purposes provided that the University will provide the proposed presentation or publication in confidence to the Sponsor for its review at least thirty (30) days prior to presentation or submission for publication.]

8.3TheUniversity will not include any Confidential Information provided by the Sponsor in the proposed publication or presentation without the written approval from the Sponsor. Further, the University shall remove all Confidential Information provided by the Sponsor at the request of the Sponsor.

8.4If the proposed publication or presentation contains information for which the Sponsor wishes to obtain patent protection, the University shall delay disclosure of such proposed publication to any third party for up to an additional ninety (90) days to permit the Sponsor to file a patent application, if applicable, after which time the University shall be free to publish. If the Sponsor requests and at the Sponsor’s expense, the University shall use its best efforts to assist the Sponsor in filing a patent application covering such subject matter.

8.5The Sponsor at its option may require that its contribution to the Clinical Trial be acknowledged in all written and oral presentations of the Clinical Trial, including scientific articles, public lectures and abstracts unless otherwise indicated.

ARTICLE 9 - LIABILITY AND INDEMNITY

9.1The University makes no representation or warranty with respect to any particular result of the Clinical Trial or fitness for a particular purpose. Further, the University makes no representations as to the potential for any claim of intellectual property infringement based on the use of the Inventions or Clinical Trial results; nor shall the University be responsible for procuring for the Sponsor, the use of any product based on the Inventions or results of the Clinical Trial in the event such product becomes the subject of a claim for intellectual property infringement.