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UHN REF # 2016-0698 University Health Network Software License Agreement This Software License Agreement (“Agreement”) is entered into effective as of the 13th day of June, 2017 (“Effective Date”) by and between: (1) University Health Network, an Ontario not-for-profit corporation incorporated under the University Health Network Act , 1997, with a business office at 101 College Street - Suite 150, Toronto, Ontario, M5G 1L7 (“UHN”); and (2) International Retinoblastoma Consortium (IRbC), a not-for- profit corporation having its primary offices at 11 Rose Ave, Toronto, Ontario M4X 1N6 (“Licensee”). UHN and Licensee may be individually referred to as a “Party” and together as the “Parties”. WHEREAS, in the field of retinoblastoma, members of a Patient’s Circle of Care, as defined hereunder, wish to have better communication and researchers wish to have better access to medical data, WHEREAS UHN has developed certain software which is useful for storing, retrieving, accessing, visualizing, and viewing health data stored on a secure “cloud” server (such as Microsoft Azure) a s further described in Schedule A attached to this Agreement (the “UHN Software” as further defined below), WHEREAS Licensee wishes to use the UHN Software for the Purpose (as defined below), WHEREAS Licensee wishes to allow Sites and Authorized Users to access the UHN Software for the Limited Purpose (as defined below), WHEREAS UHN is willing to license the right to Licensee to allow use of the UHN Software on the terms provided herein, and is further willing to provide installation and service support for the UHN Software pursuant to a separate Service Agreement (as

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Page 1:  · Web view, 1997, with a business office at 101 College Street - Suite 150, Toronto, Ontario, M5G 1L7 (“

UHN REF # 2016-0698

University Health Network

Software License Agreement

This Software License Agreement (“Agreement”) is entered into effective as of the 13th day of June, 2017 (“Effective Date”) by and between:

(1) University Health Network, an Ontario not-for-profit corporation incorporated under the University Health Network Act, 1997, with a business office at 101 College Street - Suite 150, Toronto, Ontario, M5G 1L7 (“UHN”); and

(2) International Retinoblastoma Consortium (IRbC), a not-for-profit corporation having its primary offices at 11 Rose Ave, Toronto, Ontario M4X 1N6 (“Licensee”).

UHN and Licensee may be individually referred to as a “Party” and together as the “Parties”.

WHEREAS, in the field of retinoblastoma, members of a Patient’s Circle of Care, as defined hereunder, wish to have better communication and researchers wish to have better access to medical data,

WHEREAS UHN has developed certain software which is useful for storing, retrieving, accessing, visualizing, and viewing health data stored on a secure “cloud” server (such as Microsoft Azure) as further described in Schedule A attached to this Agreement (the “UHN Software” as further defined below),

WHEREAS Licensee wishes to use the UHN Software for the Purpose (as defined below),

WHEREAS Licensee wishes to allow Sites and Authorized Users to access the UHN Software for the Limited Purpose (as defined below),

WHEREAS UHN is willing to license the right to Licensee to allow use of the UHN Software on the terms provided herein, and is further willing to provide installation and service support for the UHN Software pursuant to a separate Service Agreement (as defined herein) entered into concurrently with this Agreement and attached hereto as Schedule C;

NOW THEREFORE in consideration of the mutual covenants made in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows.

1. Interpretation.

(a) Definitions . For purposes of this Agreement, unless otherwise stated in the text of this Agreement, the following definitions shall govern.

“Agreement” shall have the meaning given to it in the preamble to this Agreement.

Nadine D'Aguiar, 2018-08-29,
To be discussed. What is the appropriate effective date, of this and the Services Agreement at Schedule C?
Rapaport, Lesley [2], 2018-08-29,
As I understand it – Software was developed to be stored/hosted at UHN. DePict is responsible for choosing cloud server (or perhaps UHN is assisting via Service Agreement?)
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UHN REF # 2016-0698

“Applicable Laws” shall mean all applicable laws, statutes, regulations, treaties, judgments and decrees and (whether or not having the force of law) all applicable official directives, rules, consents, approvals, by-laws, permits, authorizations, guidelines, orders and policies of any governmental or regulatory body having authority, including all applicable privacy laws and laws governing the protection of personal information or personal health information.

“Authorized User” shall mean end users of the Licensed UHN Software that are members of a Patient’s Circle of Care.

“Business Day” shall mean any day except Saturday, Sunday or a day that is a civic or statutory holiday in the city of Toronto, Ontario.

“Circle of Care” means any individual that provides care for a retinoblastoma Patient, and for the purposes of this Agreement, includes the retinoblastoma Patient (and in the case of a minor Patient, includes the parents/legal guardian),. A Patient’s circle of care may include clinicians, nurses, allied healthcare providers, administrative support staff, parents/legal guardians, relatives, friends and the Patient.

“Confidential Information” shall mean information that is designated as confidential or proprietary by the Discloser at the time of disclosure and that is any non-public information of a party, in oral, written, graphic or machine-readable form, research, product plans, products, inventions, processes, designs, algorithms, source code, programs, business plans, agreements with third parties, services, customers, marketing or finances; provided that the existence of this Agreement between the parties is not considered Confidential Information. For the avoidance of doubt, the Documentation is UHN’s Confidential Information.

“Contributed Data” means any data of or relating to a Patient from the Site, entered by the Site or its representatives, into the Licensed UHN Software Patient Account.

“Data” shall have the meaning as set out in Section 7(ba)(ii).

“Discloser” shall mean a party disclosing Confidential Information to the other party under this Agreement and pursuant to and subject to the provisions of Section 98 (Confidentiality) of this Agreement.

“Documentation” shall mean any manuals, product descriptions, product specification sheets, and other written materials that relate to the UHN Software provided by UHN to Licensee under this Agreement.

“Effective Date” shall have the meaning given to it in the preamble to this Agreement.

“Fees” shall mean the Initial Fee and the Annual Service Fee (each as defined in the Service Agreement).

2

Rapaport, Lesley [2], 2018-08-29,
Note that Circle of Care as defined here is much broader then typical meaning of circle of care – and also is inconsistent with the draft Service agreement that is proposed for each site. Relatives/friends should be excluded – but we should include reference to legal guardians.
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“Field” means the diagnosis, care and/or treatment of patients with, and research relating to retinoblastoma.

“Intellectual Property Rights” shall mean all worldwide intellectual property rights, including, but not limited to, patents, copyrights, rights in databases, authors’ rights, trademarks, trade names, know-how, and trade secrets, whether registrable or otherwise, including any rights in applications and rights to make applications in respect thereof (where applicable), and all other intellectual property rights of a similar or corresponding character that may now or in the future subsist irrespective of whether any such rights arise under Canadian, foreign, or international intellectual property, unfair competition, or trade secret laws.

“Licensed UHN Software” shall mean the UHN Software, Updates, and related Documentation.

“Licensed User” shall mean end users of the Licensed UHN Software who are Sites responsible for creating and managing Patient Accounts. Licensed Users are also Authorized Users.

“Licensee” shall have the meaning given to it in the preamble to this Agreement.

“Limited Purpose” shall mean to access and use the database platform supported by of the UHN Software, installed on a database platform as chosen by Licensee (“Database Platform”) in order to transfer, store and access Contributed Data solely for the purposes of facilitateing communication within the Circle of Care. For clarity, not all Authorized Users or Licensed Users will have equal permissions and some Authorized Users and Licensed Users will have read-only permissions. Licensee will be responsible for ensuring that permission levels are appropriate for each Authorized User and Licensed User.

“Patient” means a current or former patient (alive or deceased) of the a Site , who has consented to (or, in the case of a minor, whose parents/legal guardian has consented to) participate in having his/her personal information, personal health information and/or other information transferred, stored and accessed with the Licensed UHN Software for communication purposes (and optionally, where specifically consented to as part of a research consent form, for research purposes).

“Patient Account” means the Licensed UHN Software record pertaining to a specific Patient from the a Site, and accessible online by the Patient’s Circle of Care.

“Purpose” shall mean to: (1) provide Authorized Users and Licensed UsersSites access to the database platform supported by the UHN Software via the Database Platform, in order to facilitate communication within a Circle of Care; and (2) provide Research Coordination Services.

3

Rapaport, Lesley [2], 2018-08-29,
Let’s discuss this. I am not comfortable with IRbC passing on responsibility solely to the Sites to ensure that they have appropriate approvals and consents to allow research sharing. To the extent that IRbC wants to allow for research data sharing – they are going to have to take responsibility for developing the “protocol” and the consents used to allow for sharing (ensuring compliance with GDPR)
Nadine D'Aguiar, 2018-08-28,
This was moved to Section 2(a) and re-worded slightly.
Nadine D'Aguiar, 2018-08-28,
Since this is a subset of the Purpose, it cannot be broader than that.
Rapaport, Lesley [2], 2018-08-29,
As I understand it – where IRbC host software is at IRbC’s choosing.
Kaitlyn Hougham, 2018-07-23,
Researchers will not have access to the software.As Michelle has noted, Licensed User may not be appropriate, given that we are not licencing the software to anyone. Each Site signs a Service Agreement with IRbC. Then the Site may permit authorized individuals at their Site (including patients) to use the software. Users have different read and write privileges. Some users are responsible for the creation and management of Patient Accounts.Do we need a term to distinguish Sites (i.e., hospitals that execute our Service Agreement) from the users (e.g., clinicians, patients etc.)?
Michelle Moldofsky, 2018-07-21,
Please note Licensed Users are not sublicensees so is this the right term? They are receiving services and setting up the accounts for the patients. Do we need this term? What if everyone was simply an Authorized User?
Rapaport, Lesley [2], 2018-06-08,
We may want to differentiate between users who are clinicians as part of circle of care – and users for the research access portion (e.g. see the two parts of the Limited Purpose
Nadine D'Aguiar, 2018-08-28,
See the definition of Site(s) below. The concept is generally the same but I think the term is more appropriate.
Rapaport, Lesley [2], 2018-08-29,
Note – Let’s discuss Updates. This may tie in to what rights to a license we will allow to survive termination.
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UHN REF # 2016-0698

“Recipient” shall mean a party receiving Confidential Information from the other party under this Agreement and pursuant to and subject to the provisions of Section 98 of this Agreement.

“Research Coordination Services” shall mean that Licensee will (1) cCoordinate relationships with researchers on behalf of Sites; (2) rReview requests to access de-identified coded or aggregated Contributed Data across multiple Sites; (3) eExecute data transfer agreements with researchers, on behalf of participating Sites; (4) tTransform Contributed Data of Patients, who have consented to allow research use of their data, into de-identified coded or aggregated form.

“Regulatory Authorities” shall mean any (a) multinational, federal, provincial, territorial, state, municipal, local or other governmental or public department, board, bureau or agency, domestic or foreign, (b) any subdivision or authority of any of the above, or (c) any quasi-governmental or private body exercising any regulatory authority under or for the account of any of the above, including, to the extent applicable, Health Canada.

“Service Agreement” shall mean the separate service agreement to be executed concurrently with this Agreement, a copy of which will be attached hereto as Schedule “C”.

“Site(s)” shall mean user(s) of the Licensed UHN Software which are retinoblastoma treatment centres and are responsible for creating and managing Patient Accounts.“Site” shall mean a retinoblastoma treatment center.

“Territory” shall mean Worldwide.

“UHN” shall have the meaning given to it in the preamble to this Agreement.

“UHN Indemnitee” shall have the meaning given to it in Section 11.

“UHN Software” shall have the meaning given to it in the preamble to this Agreement.

“Updates” shall mean all reasonable bug fixes, patches, maintenance releases, minor modifications or minor revisions directly related to the Licensed UHN Software, but does not include improvements or modifications including any complimentary modules or significant new functionality of the UHN Software.

(b) Interpretation . In this Agreement: (i) words denoting the singular include the plural and vice versa and words denoting any gender include all genders; (ii) all usage of the word “including” or “include” or the phrase “e.g.,” in this Agreement shall mean “including, without limitation”; (iii) the division of this Agreement into separate Sections, Subsections and Schedule(s) and the insertion of headings is for convenience of reference only and shall not affect the construction or interpretation of this Agreement; (iv) words or abbreviations

4

Rapaport, Lesley [2], 2018-08-29,
I take this to mean that there is a plan to have greater oversight for the governing of protocol/consents for research services.
Gallie Brenda, 2018-07-21,
There is extensive process in governance and processes for each Site that will join in using DEPICT HEALTH.
Michelle Moldofsky, 2018-06-27,
Needs to be worldwide.
Rapaport, Lesley [2], 2018-06-08,
Can be Canada – but we need some assurances re regulatory authority to utilize in each jurisdiction in the Territory.
Nadine D'Aguiar, 08/29/18,
This definition is a slight variation on the previous definition of Licensed User which was removed.
Rapaport, Lesley [2], 2018-08-29,
For discussion – for the research services – theIRbB is still the “Controller” e.g. for purposes of GDPR – so again not comfortable with how IRbB is considering its role in the research aspect.
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UHN REF # 2016-0698

which have well-known or trade meanings are used herein in accordance with their recognized meanings; (v) if any payment is required to be made or other action is required to be taken pursuant to this Agreement on a day which is not a Business Day, then such payment or action, as the case may be, shall be made or taken on the next Business Day; (vi) time shall not be of the essence in the performance of this Agreement; (vii) the terms and conditions hereof are the result of negotiations between the parties and the parties agree that this Agreement shall not be construed in favour of or against any party by reason of the extent to which any party or its professional advisors participated in the preparation of this Agreement; and (viii) unless otherwise specified herein, all amounts specified in this Agreement are expressed in Canadian dollars.

(c) Schedules . The following Schedules are incorporated into, and form an integral part of, this Agreement:

Schedule A: UHN SoftwareSchedule B: Third Party ProductsSchedule C: Service Agreement

2. Grants and Restrictions.

[(a)] Grant . Subject to the terms and conditions of this Agreement, UHN hereby grants to Licensee a non-exclusive, royalty-free, non-transferable license to: use, copy and display:

(i) use, copy and display for the Purpose and in the Field, the Licensed UHN Software within the Territory; and

[(ii)] to grant rights to agreements with the Sites, and to Authorized Licensed Users (either directly or through the Sites) to access and use for the Limited Purpose, the Licensed UHN Software within the Territory;

(together, the “Software License”).

For clarity, some Sites and some Authorized Users may have different permission levels (eg. read-only), and as between the Parties, Licensee shall be solely responsible for ensuring that permission levels are appropriate for each Site and each Authorized User.

(b) Access . For greater certainty, none of the Licensee or the Licensed UsersSites will receive copies of the UHN Software source code or object code. Licensed UsersSites and Authorized Users will obtain access to the Licensed UHN Software features and functionality (other than Documentation) through a secure internet portal to the Database Platform, a third party service provider which will execute the UHN Software.

(c)

5

Kaitlyn Hougham, 2018-07-23,
Addressed in section 7 below.
Rapaport, Lesley [2], 2018-06-08,
UHN wants assurances that the not-for-profit is putting in reasonable controls/protections regarding privacy of their third party service provider
Rapaport, Lesley [2], 2018-08-29,
For discussion – I believe there are two third parties being contemplated – a Database Platform provider (Cloud provider) aka Azure, and then Service support to execute the UHN Software on the cloud (e.g. currently UHN- Tran)
Nadine D'Aguiar, 2018-08-28,
This was moved here from the definition of Limited Purpose.
Kaitlyn Hougham, 2018-07-23,
As noted by Michelle, and above, researchers do not have access to the software.
Michelle Moldofsky, 2018-06-27,
Agreements with the Licensed Users (Sites) and they create Patient Accounts for the Authorized Users (Patient/family/circle of care). Researchers do not get access. IRBC provides Research Coordination Services to researchers.
Rapaport, Lesley [2], 2018-06-08,
Would like to split up license into the two different Limited Purposes – as each has different concerns (e.g. REB required for research/circle of care access for other)
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UHN REF # 2016-0698

[(b)] Compliance by Sites and Authorized Terms Applicable to Licensee Users . Licensee shall ensure that all Licensed UsersSites and Authorized Users are required to comply with the applicable terms and conditions of this Agreement, and any breach of a term of this Agreement by a Licensed UserSite or an Authorized User shall be considered a breach by the Licensee. Furthermore, any agreement entered into by Licensee and a Licensed UserSite with respect to the Licensed UHN Software shall have terms that obligate the Licensed UserSite to:

(A) comply with, and ensure that all its Authorized Users comply with restrictions at least as stringent as those set out at Section 2 (e) of this Agreement,

(B) comply with insurance requirements at least as stringent as those set out at Section 6(c) of this Agreement; and

[(C)] comply with confidentiality terms and obligations at least as stringent as those set out at Section 97 of this Agreement.

(C) Ensure that Patients, or, in the case of a minor, parents/legal guardians, have provided appropriate consents to the sharing of Data as contemplated by this Agreement.

(d)[(c)] Sites . Upon request, Licensee shall provide to UHN a list of all Sites.

[(d)] Restrictions. Licensee shall not, and shall ensure that each of its Sites Authorized Users (excluding UHN) shall not, except as otherwise expressly provided herein: (i) reproduce, copy, download, modify, create derivative works or distribute the Licensed UHN Software; (ii) provide, disclose, sublicense or otherwise permit any person who is not an Authorized User to access, use, distribute, copy or display the Licensed UHN Software; (iii) attempt to adapt, translate, change, customize, enhance, augment, partially delete or alter, or otherwise modify the Licensed UHN Software in any manner or to any extent whatsoever, whether in whole or in part; (iv) attempt to access the source code, or disassemble, decompile, reverse engineer, or otherwise in any manner deconstruct all or any part of the Licensed UHN Software; (v) use the Software to act as a “service bureau” or in a time-sharing, application service provider or other similar model to provide the benefit of the use of the Licensed UHN Software to any person other than an Authorized User; (vi) attempt to alter any proprietary notices appearing in the Licensed UHN Software; (vii) access the Licensed UHN Software via any means other than over the internet using authorized login credentials.

(e) Third Party Licenses and hardware. Licensee shall be responsible for the provision, support, and maintenance of all third party software, hardware and other licenses that may be required to use the Licensed UHN Software to ensure full functionality, including but not limited to any software and hardware listed at Schedule B including any expenses relating to the foregoing. Licensee shall

6

Nadine D'Aguiar, 2018-08-28,
Ensure that these are listed at Schedule B (in addition to third party license listed there.)
Nadine D'Aguiar, 2018-08-28,
This is re-instated. If this cannot be agreed to please explain why.
Nadine D'Aguiar, 2018-08-28,
For discussion/consideration by UHN.
Schwartz, Noah, 2018-06-01,
If there is intention to have parents access – we will want clarity on terms of end user agreement as it applies to “read only” users vs. circle of care – greater access users.
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furthermore comply with the third party licenses provided in Schedule B (Third Party Products).

(f) Installation . UHN will be responsible for the installation of the UHN Software on a third party server pursuant to a separate service agreement (“Service Agreement”) to be executed concurrently with this Agreement and attached hereto as Schedule “C”.

(g) Updates . UHN shall make arrangements with Licensee to provide and install Updates on a third party server, when available, at no cost to Licensee. For clarity, all Updates shall be provided at UHN’s sole discretion and UHN shall be under no obligation to provide any Updates other than those specified in the Service Agreement.

[(h)] Access. UHN will use reasonable efforts to make the core functions and features of the Licensed UHN Software available to Licensee, the Licensed UsersSites and Authorized Users. UHN will use reasonable efforts to conduct routine maintenance at times that minimize disruption of use of the Licensed UHN Software, but UHN does not warrant or guarantee the continuous availability of the Licensed UHN Software and reserves the right to perform maintenance at any time.

3. Ownership and Other Rights.

(a) UHN Software . As between the parties, Licensed UHN Software (and all Intellectual Property Rights therein) shall be the sole property of UHN. Licensee acknowledges and agrees that as between the parties, UHN retains all right, title and interest in and to the Licensed UHN Software and any improvements and modifications thereof.

(b) Software Improvements.

[(i)] In the event that Licensee has suggestions for modifications or improvements that it would like made to the Licensed UHN Software (“Proposed Improvements”), if agreed upon by UHN, UHN will provide Proposed Improvements for a fee-for-service rate of $125 per hour (inclusive of appropriate institutional overhead charges).

(i)[(ii)] Any Proposed Improvements shall be owned by UHN, and if applicable, Licensee shall, at UHN’s expense, execute any document or provide such assistance as is reasonably required to effect or otherwise memorialize, document or record such sole UHN ownership and title.

(c) Non-Exclusive License. Nothing in this Agreement shall be deemed or construed to prevent or otherwise restrict UHN from entering into any further development and/or licensing agreements with any other third party in respect of the Licensed UHN Software and any Proposed Improvements. Furthermore, UHN shall retain its right(s) to utilize and exploit, directly or indirectly, all Licensed UHN Software

7

Rapaport, Lesley [2], 2018-08-29,
Why not move details of this to service agreement (which will be needed as between IRbB and UHN (Tran)
Michelle Moldofsky, 2018-06-27,
Under review.
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UHN REF # 2016-0698

and any Proposed Improvements for any purpose, including but not limited to internal clinical, academic and research purposes.

4. Royalties.

Royalty. In consideration of Licensee’s status as a non-for-profit organization and in consideration that Licensee will not be charging anyone a fee to access or use the Software, UHN is providing the Software to Licensee with no royalty fee or licensing fee. For purposes of clarity, Licensee must still pay the service and support fees outlined in Section 3 of Schedule C (titled Service Agreement).

5. Diligence

Diligence. Licensee commits to the following diligence provisions in order to maintain the license

a. Diligence provision 1

[b.] Diligence provision 2

In the event that Licensee fails to meet these diligence provision, and fails to rectify the failure within 60 days written notice from UHN, the Software License shall terminate.

6. Software Support and Maintenance.

[(a)] Documentation. UHN shall provide Documentation to Licensee for purposes of allowing Licensee to provide the Documentation to Licensed UsersSites and Authorized Users to use and operate the Licensed UHN Software.

(a)[(b)] Additional Services. Other than as specifically provided herein, no additional services are provided pursuant to this Agreement. Any additional consulting, support and/or development services by UHN to Licensee shall be covered in the concurrent Service Agreement unless otherwise agreed to by the Parties in writing.

7. Regulatory and Compliance.

(a) Approvals.

Licensee, in its sole discretion, cost and expense, and with UHN’s reasonable assistance (which shall further be at Licensee’s expense), will be responsible to seek and obtain all regional, federal, provincial and local regulatory approvals, including those approvals (if any) required from the Regulatory Authorities (“Regulatory Approvals”), that are necessary for the use and access of Licensed UHN Software by the Licensee, Sites and Authorized and Licensed Users within each new region within the Territory prior to use in that Territory. In the event that source code is required for regulatory purposes, UHN will

8

Michelle Moldofsky, 2018-06-19,
Given the nature of the relationship between the parties, this diligence section should be removed.
Rapaport, Lesley [2], 2018-06-08,
I don’t think we need diligence provisions perse, but certainly should take into account status of software and use in contemplating termination
Nadine D'Aguiar, 2018-08-28,
To be discussed. If a certain minimum number of Sites are not set up then the license may be terminated.
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provide the source code provided that the Parties sign agreement limiting the use of the source code for regulatory purposes.

(b) Compliance.

[(i)] Applicable Laws. In performing its obligations or exercising its rights under this Agreement, each Pparty agrees to comply fully with all Applicable Laws. In addition, Licensee shall ensure that each of the Authorized UsersSites agrees to comply fully with all Applicable Laws with respect to its use of the Licensed UHN Software, and furthermore shall ensure compliance by its Authorized Users with all Applicable Laws with respect to its use of the Licensed UHN Software. For greater certainty, in addition to its obligations under Section 6(a), Licensee agrees that it is solely responsible to otherwise ensure that all access to, and use of the Licensed UHN Software under this Agreement is in full compliance with all Applicable Laws.

[(ii)] Data and Privacy Laws . The PartiesLicensee agree and acknowledge that the data of Patients to be transferred and stored in Patient Accounts by the Licensed UserSitess (the “Data”) may include information which meets the definition of “personal health information” as that term is defined in Ontario’s Personal Health Information Protection Act (“PHIPA”), “individually identifiable health information” as that term is defined in the United States’ Health Insurance Portability and Accountability Act (“HIPAA”), “data concerning health” as that term is defined in Europe’s General Data Protection Regulation (“GDPR”) (collectively, “PHI”). As such, each Party Licensee represents and warrants with respect to itself, and in relation to this Agreement, that:

[(A)] it shall comply with all applicable requirements and obligations under local applicable data and privacy laws (whether it be PHIPA, HIPAA, GDPR, or other) which are applicable to it, and in the case of the Licensee, which are applicable to itself, its ensure appropriate compliance by Sites and Authorized Users;

[(B)] it will further require that its employees and agents, as well as (if applicable) any third parties to which it provides access to the Data as contemplated under this Agreement under this Agreement, also comply with local applicable data and privacy laws ;

(A)[(C)] it employs appropriate safeguards to prevent theft, loss and unauthorized access, copying, modification, use, disclosure or disposal of PHI;

(B) it shall (a) require all of its employees and independent contractors to sign confidentiality agreements, unless otherwise bound by

9

Nadine D'Aguiar, 2018-08-29,
This is added to address the comments directly above.
Schwartz, Noah [2], 2018-03-06,
change
Rapaport, Lesley [2], 2018-08-29,
All PHI obligations are on IRbB. To the extent PHI obligations on UHN – this falls under Service Agreement.
Kaitlyn Hougham, 2018-07-23,
Meaning that we will not necessarily be compliant with every requirement and obligation globally at launch. But rather, before deploying in a region, we will comply with applicable regulations and laws.
Kaitlyn Hougham, 2018-07-20,
TT: We only need to comply when in that region
Kaitlyn Hougham, 2018-07-23,
We may suggest a few additional mutual privacy clauses, recommended to us during the PIA. I will refine these and share in the next draft.
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institutional obligations of confidentiality, prior to accessing the Data; (b) conduct periodic privacy and security training and testing for each of its employees and maintain a record of such training and testing; (c) maintain an incident and breach management policy with protocols for incident and breach notifications; (d) confirm its compliance with its privacy policy within 30 days of a request from the other PartyUHN; and (e) periodically provide to the other PartyUHN documentation regarding threat and vulnerability assessments that relate to the use of the Licensed UHN Software or the Service Agreement. Each Party shall assign personnel to oversee and audit the performance of its privacy obligations who possesses skills and knowledge appropriate for the role.

[(D)]

(C)[(E)] when used for research in which Data is coded,

i. the de-identified coded Data shall not be used to re-identify or contact any individual whose PHI is included in the Data; and

ii. the coded Data shall not be used or disclosed in a form from which any individual may be identified.

Licensee furthermore represents and warrants that it, its employees and agents, including but not limited to the Sites and Authorized Users, will comply with any limitations on the use of the PHI imposed by the provider of the Data, and such Data shall only be used by Licensee in accordance with the terms of the applicable consent. Licensee represents and warrants that it has or will, prior to providing access to the Licensed UHN Software, enter into written agreements with the Sites in which the Site has provided a representation and warranty that it has obtained all necessary consents, permissions and approvals to carry out the intended activites with respect to the Data.

[(iii)] Licensee is a Health Information Network Provider . The Parties agree and acknowledge that Licensee is a “health information network provider” as that term is defined in the regulations promulgated under PHIPA (O.Reg. 329/04, s.6(2)) (“HINP”). Licensee agrees to comply with all applicable requirements including those set forth in the PHIPA regulations.

[(iv)] No Conflicting Agreements . Licensee further represents and warrants that it has not, and shall not, enter into any agreements with third parties, including but not limited to its SitesMembers, which conflict with or are inconsistent with any of the terms of this Agreement.

8. Term and Termination

10

Nadine D'Aguiar, 2018-08-29,
As between the Parties, Licensee must be responsible for the Users and the Authorized Users so that is made clear here.
Rapaport, Lesley [2], 2018-08-29,
Perhaps we just need more clarity on what is meant by coded.
Nadine D'Aguiar, 08/29/18,
UHN to confirm compliance with these obligations.
Rapaport, Lesley [2], 08/29/18,
Any obligations by UHN re PHI should be under Service Agreement – and not here.
Michelle Moldofsky, 06/27/18,
Additional clause added because UHN (as well as Licensee) will have access to personal health information.
Rapaport, Lesley [2], 08/29/18,
Any privacy obligations of UHN because of access to PHI via Service Agreement should be included int eh Service Agreement – not here.
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(a) Term: The term of this Agreement shall be perpetual (the “Term”), unless earlier terminated in accordance with the terms of this Agreement.

[(b)] Termination for Cause: Notwithstanding the foregoing, either Pparty may earlier terminate this Agreement immediately upon the occurrence of any of the following events:

(i) Licensee losing its status as a non-for-profit organization in Canada;

[(ii)] Licensee charging a Licensed UserSite fees for using the UHN Software;

(ii)[(iii)] the other party failing to cure a material breach committed by it, including but not limited to a breach of Section 5 (Diligence), any breach of Applicable Law or any failure to pay the Initial Fee or Annual Service Fee (as both terms are defined in Section 3 of Schedule C) when due, within thirty (30) days after receiving written notice thereof;

(iii)[(iv)] the institution of voluntary proceedings by the other party under bankruptcy or insolvency laws, for corporate reorganization, receivership or dissolution, or similar proceedings;

(iv)[(v)] the pendency for more than ninety (90) days of involuntary proceedings against the other party under bankruptcy or insolvency laws, for corporate reorganization, receivership or dissolution, or similar proceedings;

[(vi)] the other party making a general assignment for the benefit of creditors.;

[(vii)] within (30) days of receiving notice of the other party ceasing to do business or to do the business relevant hereunder. For the avoidance of doubt, this ground of termination shall include UHN ceasing to support or to license the UHN Software, for any reason.

[(c)] Effect of Termination.

[(i)] On the date of termination of this Agreement for a material breach under Section 8.(b)(i), or upon the occurrence of any of the events contemplated in Sections 8.(b)(iv) through (vi), the license granted under this Agreement, and all licenses rights granted to Licensee Sites and Authorized Users Members thereunder, shall immediately terminate.

(v)[(ii)] Upon termination of this Agreement:

[(A)] Licensee shall no longer have the right to provide Licensed Sites and Authorized Users access to Licensed UHN Software;

(A)[(B)] Licensee shall return or destroy (at UHN’s option) any physical or electronic copies of Documentation;

11

Rapaport, Lesley [2], 2018-08-29,
Note we agreed to allow licensee to continue to use the Software – but this is contingent on how we deal with Updates.
Nadine D'Aguiar, 2018-08-29,
The right for UHN to terminate on this basis is removed, in order to address this.
Michelle Moldofsky, 2018-06-27,
Please let us know how the Licensee will continue access to the Licensed UHN Software in this event? Some kind of escrow for the source code? Some assignment to a purchaser of the rights to the UHN Software?
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(B)[(C)] UHN shall provide Licensee or its authorized designee with a complete copy of its Data in a readable format agreed upon by the Parties; and

(C)[(D)] The Service Agreement shall also terminate.

[(d)] Survival. Sections 1, 8, 10, 10, and 11 and 12 in their entirety, Section 3 (except for Section 3(b), Section 4 (to the extent monies are owing post termination/expiration), Section 6(b)(ii), Section 7(c), this Section 7(d), and Section 132 (as required to give effect to any surviving clause), shall survive expiration or earlier termination of this Agreement.

9. Confidentiality

(a) Treatment of Confidential Information. Each Recipient receiving Confidential Information from a Discloser pursuant to this Agreement shall:

[(i)] hold confidential all Confidential Information provided by the Discloser and not disclose to persons or entities other than Recipient individuals having a reasonable need to know the Confidential Information in connection with the permitted purposes hereunder, without the prior written consent of the Discloser; provided however that Licensee may provide to Licensed UsersSites Documentation, and other information necessary to access and use the Licensed UHN Software, under obligations of confidentiality at least as stringent as those set out herein, for the sole purpose of enabling the Licensed Sites and Authorized Users to access and use the Licensed UHN Software;

(i)[(ii)] use the Confidential Information only for the purposes for which it is delivered to the Recipient, and for no other purposes whatsoever, except with the prior written consent of the Discloser; and

[(iii)] return the Confidential Information (with all copies thereof and all portions of documents prepared by or for the Recipient that contain Confidential Information) to the Discloser (or, at the option of the Discloser, destroy all Confidential Information, including all copies thereof and all portions of the documents containing Confidential Information, and provide the Discloser with a certificate of an officer of the Recipient stating that the destruction has occurred) within thirty (30) days of termination of this Agreement or upon receipt by the Recipient of a written request therefor from the Discloser except to the extent the Recipient shall have a continuing right to retain one (1) archival copy of the Confidential Information pursuant to this Agreement in order to ensure compliance with its rights and obligations provided herein. With respect to Documentation and other information necessary to access and use the Licensed UHN Software that has been provided to LicenseeLicensed Users in accordance with this Agreement, the Licensee and each Site,

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each Licensed User shall also have a continuing right to retain one (1) archival copy of the Confidential Information in order to ensure compliance with its rights and obligations.

[(b)] Acknowledgement. Recipient acknowledges and agrees that: (i) it is responsible for compliance of Recipient individuals (including, with respect to the Licensee, the Sites and Licensed Authorized Users) in possession of Discloser’s Confidential Information with the terms and conditions of this Agreement; and (ii) a breach of any Recipient’s obligations pursuant to this Agreement by any Recipient individual (including, with respect to the Licensee, the Sites and and LicensedAuthorized Users) shall be deemed to be a breach by Recipient. Recipient agrees to cause Recipient individuals (including, with respect to the Licensee, the Sites Licensed Users, and Authorized Users) to comply with the terms of this Agreement, as if such individuals were Recipient, and shall cause said individuals to comply with any other legal or equitable obligation of Recipient. Licensee shall ensure that the Licensed UsersSites and Authorized Users be are responsible for the security and confidentiality of any usernames or passwords granted to Licensed UsersSites and Authorized Users to access the UHN Software, and to limit disclosure of such usernames and passwords to its Authorized Users.

[(c)] Exceptions. The obligations imposed by Section 9.(a)9(a) of this Agreement shall not apply, or shall cease to apply, to any Confidential Information if or when, and to the extent that, the Confidential Information:

(ii)[(i)] was known to the Recipient prior to the receipt of the Confidential Information from the Discloser or Discloser’s affiliates;

(iii)[(ii)] was, or becomes through no breach of the Recipient’s obligations hereunder, known to the public;

(iv)[(iii)] becomes known to the Recipient from sources other than the Discloser under circumstances not involving any breach of any confidentiality obligation between the source and the Discloser;

(v)[(iv)] is independently developed by the Recipient, without any use of or reference to the Discloser’s Confidential Information; or

(vi)[(v)] is required to be disclosed by law or applicable legal process, provided that the Recipient making the disclosure shall:

(A) give the Discloser as much prior notice thereof as is reasonably practicable so that the Discloser may seek such protective orders or other confidentiality protection as it, in its sole discretion and at its sole expense, may elect; and

(B) reasonably cooperate with the Discloser in protecting the confidential or proprietary nature of the Confidential Information

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that must be so disclosed (with this duty of cooperation not requiring the Recipient or Recipient’s individuals to initiate or participate in any litigation or incur more than de minimus out-of-pocket costs).

This obligation of confidentiality in respect of any particular Confidential Information shall survive for a period of five (5) years from the expiration or earlier termination of this Agreement.

(b)[(d)] Equitable Relief. Recipient acknowledges and agrees that due to the unique nature of the Discloser’s Confidential Information, there can be no adequate remedy at law for any breach of the Recipient’s confidentiality and use-restriction obligations under this Agreement, that any such breach may result in irreparable harm to the Discloser, and that therefore, upon any such breach or threat thereof, the Discloser shall be entitled to seek appropriate equitable relief, including injunctive relief, in addition to any remedies it may have available at law.

(c)[(e)] Exception . Notwithstanding the confidentiality obligations herein, each party shall be permitted to disclose the terms of this Agreement without the prior written consent of the other Party to those of its staff, employees, agents, advisors, accountants, auditors, shareholders, investors, potential investors, underwriters and others on a need to know basis under circumstances that reasonably ensure the confidentiality thereof, or to the extent required by law.

(d)[(f)] Confidential Information and Personal Health Information . For greater certainty, each Party acknowledges that information which is Confidential Information as defined in the Agreement may also be (but is not necessarily) personal health information, and vice versa, and that where information is both personal health information and Confidential Information, the requirements applicable to each category shall apply to it so as to subject it in each case to the more rigorous requirement.

10. Warranties and Disclaimers

(a) General Warranty. Each party represents and warrants to the other party that:

(i) the party has the full corporate right, power and authority to enter into this Agreement; and

(ii) when executed and delivered by the party, this Agreement will constitute the legal, valid and binding obligation of the party, enforceable against the party in accordance with its terms.

(b) Disclaimer. LICENSED UHN SOFTWARE IS PROVIDED “AS IS”. THE PARTIES EXPRESSLY DISCLAIM THE MAKING OF, AND EACH PARTY ACKNOWLEDGES THAT NEITHER PARTY HAS RECEIVED OR RELIED UPON, ANY REPRESENTATION, WARRANTY, CONDITION OR

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GUARANTY, EXPRESS OR IMPLIED, RELATING TO THE LICENSED UHN SOFTWARE, USE OF THE LICENSED UHN SOFTWARE FOR THE PURPOSE, OR THE RELATIONSHIP BETWEEN THE PARTIES THAT IS ADDITIONAL TO OR DIFFERENT FROM THE TERMS SET FORTH IN THIS AGREEMENT, INCLUDING ANY REPRESENTATION, WARRANTY, CONDITION OR GUARANTY AS TO THE AMOUNT OF PROFITS, INCOME OR OTHER REVENUE THAT EACH PARTY MAY EARN, OR THE AMOUNT OF INVESTMENT REQUIRED, AS A RESULT OF THE PARTIES’ RELATIONSHIP. FURTHERMORE, EXCEPT AS SET FORTH HEREIN, THE PARTIES DISCLAIM ALL OTHER EXPRESS OR IMPLIED WARRANTIES AND CONDITIONS INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OR CONDITION OF MERCHANTABILITY AND ANY IMPLIED WARRANTY OR CONDITION OF FITNESS FOR A PARTICULAR PURPOSE.

UHN DOES NOT REPRESENT OR GUARANTEE THAT THE LICENSED UHN SOFTWARE AND THE DATA HOSTED BY UHN UNDER THIS AGREEMENT WILL BE FREE FROM LOSS, CORRUPTION, ATTACK, VIRUSES, INTERFERENCE, HACKING, OR OTHER SECURITY INTRUSION, AND UHN DISCLAIMS ANY LIABILITY RELATING THERETO EXCEPT TO THE EXTENT ARISING FROM UHN’S GROSS NEGLIGENCE OR WILFUL MISCONDUCT.

11. Limitation of Liability.

EXCEPT FOR DAMAGES ARISING FROM EACH PARTY’S OBLIGATIONS UNDER SECTION 98 (CONFIDENTIALITY) AND LIABILITY UNDER THE INDEMNITY PROVISIONS OF THIS AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE HEREUNDER OR OTHERWISE, WHETHER FOR BREACH OF CONTRACT, NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE, FOR LOSS OF PROFITS, INDIRECT, INCIDENTAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES OF ANY KIND (EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES) ARISING FROM BREACH OF THIS AGREEMENT OR THE SERVICE AGREEMENT, OR ANY OTHER PROVISION OF THIS AGREEMENT OR THE SERVICE AGREEMENT, OR IN CONNECTION WITH THE UHN SOFTWARE, INCLUDING ANY INTELLECTUAL PROPERTY RIGHTS ASSOCIATED THEREWITH. THE ENTIRE RISK AS TO ANY USE OF THE LICENSED UHN SOFTWARE (AND ANY INTELLECTUAL PROPERTY ASSOCIATED THEREWITH), INCLUDING DATA, CONCLUSIONS OR RESULTS ASSOCIATED WITH USE OF THE LICENSED UHN SOFTWARE (AND ANY INTELLECTUAL PROPERTY ASSOCIATED THEREWITH) IS ASSUMED ENTIRELY BY LICENSEE, WITHOUT ANY LEGAL OR EQUITABLE RECOURSE TO UHN EXCEPT TO THE EXTENT THAT THE LOSSES WERE CAUSED BY UHN’S NEGLIGENCE OR WILLFUL MISCONDUCT.

12. Indemnification and Insurance.

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[(a)] Indemnity . Licensee agrees to indemnify, save harmless, and defend UHN, its affiliates, and its and their directors, officers, researchers, inventors, employees, staff, students, and agents (the “UHN Indemnitees”), against any and all losses, damages, costs, fees, and expenses (including reasonable legal expenses) (“Losses”) incurred in connection with any third party claim, suit, demand or proceeding, to the extent arising from: (a) a material breach by Licensee, a Licensee MemberSite (excluding UHN) or an Authorized Licensed User of any term of this Agreement or the Service Agreement, including failure to ensure that the necessary consents, permissions and approvals were obtained respecting the Data, failure to comply with Applicable Law or failure of Licensee to pay any Fees when due, (b) use of the Licensed UHN Software by Licensee, a Licensee MemberSite (excluding UHN) or an Authorized Licensed User, or (c) use or exploitation of the data, results, conclusions, and products derived from, arising out of, or resulting from use of Licensed UHN Software under this Agreement, including but not limited to the use of the Data, any databank utilizing the UHN Software or the data contained with it; provided that the aforementioned obligation to indemnify shall not apply to the extent that the Losses were caused by UHN’s negligence or willful misconduct. In addition, Licensee hereby agrees to indemnify and hold harmless UHN from all costs, damages, fines, penalties or other liabilities arising out of a breach of its obligations under PHIPA, or any other applicable privacy legislation and regulations and this Agreement with respect to the Licensee’s failure to comply with the privacy and security terms and conditions of this Agreement, provided that this obligation to indemnify shall not apply to the extent that the costs, damages, fines, penalties or other liabilities were caused by UHN’s negligence or willful misconduct.

[(b)] Insurance. During the Term of this Agreement and for the duration of its obligations surviving expiration or termination of this Agreement, Licensee shall and shall ensure that the Licensee Members shall obtain and maintain general liability insurance in an amount of not less than $52,000,000 per occurrence and $52,000,000 aggregate. Licensee shall provide to UHN a certificate of insurance on behalf of itself and on behalf of each Licensee Member at such times as UHN may reasonably request from time to time during the Term or for a period of five (5) years thereafter.

13. General.

(a) Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the Province Ontario and the federal laws of Canada applicable therein, and each party consents to the exclusive jurisdiction of the relevant courts of Ontario and all courts competent to hear appeals therefrom.

(b) Independent Contractors. In performing their respective obligations hereunder, each party shall act at all times as an independent contractor. Nothing in this Agreement shall be construed or applied to create a relationship of principal and agent or employer and employee between the parties, and neither of them shall

16

Nadine D'Aguiar, 2018-08-29,
The changes to this section have not yet been addressed. To be discussed. Consider adding a finite duration to this agreement (eg. 2-3 years), which may be extended upon consent provided that the Licensee can agree to higher levels of insurance more in line with what UHN typically requires.
Michelle Moldofsky, 2018-06-27,
KH: We struggled to get insurance being a new operation. Working with an experienced broker, the best insurance we could qualify for was:2 million single policy with a Commercial General Liability coverage combined with an Errors and Omissions Liability coverage1 million cyber liability2 million directors and officers
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make any commitment, take any action or incur any expense in the name of or purporting to bind the other party or its affiliates.

(c) Further Assurances. The parties shall, and shall cause their respective employees, agents and representatives to prepare and execute and deliver, at the request and expense of the other party, any and all documents or instruments reasonably necessary or appropriate to create, evidence, or confirm the grant, discharge or release, as the case may be, of any right, interest or obligation required by the provisions of this Agreement.

[(d)] Entire Agreement and Amendment. This Agreement (which includes all Schedules including the Service Agreement) represents the entire understanding and agreement of the parties with respect to the non-exclusive license from UHN to Licensee of the Licensed UHN Software and supersedes all prior communications, agreements and understandings between the parties relating to such subject matter. In the event of a conflict between this Agreement and any extraneous exhibit or purchase order, this Agreement shall govern. This Agreement may not be modified or amended except by a written instrument duly executed by both parties.

(d)[(e)] Costs and Legal Fees. The prevailing party in any action to enforce this Agreement shall be entitled to recover reasonable costs and expenses in connection with the enforcement, including reasonable legal fees and expenses.

(e)[(f)] Waivers. No right under this Agreement or breach hereof may be waived except in writing signed by the parties. The failure of either party to require performance of any provision of this Agreement shall not be construed as a waiver of that party’s rights to insist on performance of the provision or any other provision at some other time.

(f)[(g)] Assignment and Binding Effect. This Agreement may not be assigned by either party without the prior written consent of the other; provided, that either party may assign this Agreement in its entirety to an affiliate or successor in interest to the business of the party, upon written consent of the other party which consent shall not be unreasonably withheld, if the affiliate or successor agrees in writing with the other party to fulfill the obligations of the assigning party. This Agreement shall be binding on, and inure to the benefit of, the respective successors of the parties thereto.

(g)[(h)] Counterparts . This Agreement may be executed by the parties in counterparts by facsimile or electronically, each of which so executed or delivered will be deemed to be an original and all will constitute one agreement.

[(i)] Notices. Any notice, consent, approval or other communication in connection with this Agreement, unless otherwise expressly provided for herein, shall be in writing, in English, and delivered by hand (including commercial delivery or courier services), confirmed email or facsimile, or after being mailed, postage

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prepaid, certified or registered mail, return receipt requested, to the address as set forth on the signature page below, or such other address as a party designates by giving notice to the other party in accordance with this Section 132(i). Any such notice, consent, approval or other communication is deemed to have been delivered and received on the date of delivery or transmission was received by the recipient party prior to 5:00 pm (Toronto time) and otherwise on the next Business Day.

(h)[(j)] Severability . Each provision of this Agreement shall be deemed separate, severable and distinct. If any part of any provision of this Agreement is found by a court to be invalid, illegal or unenforceable in any way, the finding shall not limit or affect the validity, legality or enforceability of the remaining provisions.

(i)[(k)] Force Majeure. Neither party shall be responsible for any failure to perform or delay in performing any of its obligations hereunder (including under the Services Agreement) where and to the extent that the failure or delay results from causes outside the reasonable control of the party.

The parties have caused their duly authorized representatives to execute and deliver this Agreement to be effective as of the Effective Date.

INTERNATIONAL RETINOBLASTOMA CONSORTIUM UNIVERSITY HEALTH NETWORK

Per: Per:Name: Name:Title: Title:

Address (for correspondence/notices):International Retinoblastoma Consortium11 Rose AvenueToronto, Ontario M4X 1N6Tel (416) 294-9729Email: [email protected]

Address (for correspondence/notices):Technology Development & CommercializationMaRS Centre, Heritage Building101 College StreetSuite 150Toronto, Ontario M5G 1L7Tel (416) 581-7400Fax (416) 977-4765Email [email protected] (Attn: Director)

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Schedule A – UHN Software

Description of UHN Software

The Licensed UHN Software is a browser based web application that provides user friendly web forms for the collection of point-of-care clinical data on retinoblastoma patients.

1. The system is composed of the following forms: Staging EUA – Exam Form Staging EUA – Imaging Form Staging EUA – Tumor Findings Form Staging EUA – Diagnosis Form Staging EUA – Procedures Form Staging EUA – Images Form Staging EUA – Plan Form EUA Form EUA – Exam Form EUA – Imaging Form EUA – Tumor Findings Form EUA – Diagnosis Form EUA – Procedures Form EUA – Images Form EUA – Plan Form Initial Visit – Visit Details Form Initial Visit – History Form Initial Visit – Exam Form Initial Visit – Findings Form Initial Visit – Plan Form Clinic Visit - Visit Details Form Clinic Visit – Exam Form Clinic Visit – Imaging Form Clinic Visit – Tumors Form Clinic Visit – Procedures Form Clinic Visit – Plan Form Imaging Form Chemotherapy Form Chemo – Toxicity Form Radiation Form Pathology (Eye) Form Genetic Testing Form Stem Cell Transplant Form Other Surgery Form Additional Cancer Form Extraocular Extension Form Intra-arterial Chemotherapy Form Toxicity Form

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Periocular Chemotherapy Form Intravitreal Chemotherapy Form Patient Status Form Demographics and Circle of Care Tool for research data cuts

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2. Visual representation summarizes the patient’s treatment history created from coded data.

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3. Dynamic annotation tool graphically records findings and interventions.

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Schedule B – Third Party Products

Third Party Software, Hardware and other Licenses that May be Required by Licensee to Use the Licensed UHN Software to Ensure Full Functionality:

[Insert or specify “None”]

Third P p arty software Licenses   :

JSON (http://www.json.org/license.html)

License to JSON is as follows:

Copyright (c) 2002 JSON.org

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.

Rapheal (http://raphaeljs.com/)

License to Rapheal is as follows:

Copyright © 2008 Dmitry Baranovskiy

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

23

Nadine D'Aguiar, 2018-08-29,
To be completed.
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The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.

JQuery (https://jquery.org/license/)

License to JQuery is as follows:

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.

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Schedule C – Service Agreement

This Service Agreement (the “Service Agreement”) is entered into effective as of the 13th day of June, 2017 (“Effective Date”) by and between:

University Health Network, an Ontario not-for-profit corporation incorporated under the University Health Network Act, 1997, with a business office at 101 College Street - Suite 150, Toronto, Ontario, M5G 1L7 (“UHN”); and

The International Retinoblastoma Consortium having its primary offices at 11 Rose Avenue, Toronto, Ontario M4X 1N5 (“Licensee” ).

UHN and Licensee may be individually referred to as a “Party” and together as the “Parties”.

WHEREAS UHN and Licensee have entered into a Software License Agreement effective as of ___________, 2018 with respect to the Licensed UHN Software, as defined therein (the “Software License Agreement”) ;

WHEREAS Licensee wishes to have UHN provide installation and service support to allow Authorized Users to access and use the Licensed UHN Software, and UHN is willing to provide such services pursuant to this Service Agreement in accordance with the terms set out herein;

NOW THEREFORE in consideration of the mutual covenants made in this Service Agreement, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows.

1. Software License Agreement . The provisions of the Software License Agreement are incorporated herein and shall apply to this Service Agreement. Should there be any discrepancy between the terms of the Software License Agreement and the terms of this Service Agreement, the terms of the Software License Agreement shall govern and apply unless specifically stated otherwise herein. All capitalized terms in this Service Agreement have the respective meanings given to them in the Software License Agreement.

2. Services . UHN will provide the services in a professional and diligent manner and as further detailed in Appendix 1 (as amended) (the “Services”) through the health informatics research group at UHN (“HIR”), provided that Licensee has fulfilled its obligations as required in the Software License Agreement and in this Service Agreement. Unless otherwise explicitly agreed to in writing by the parties, UHN will not be involved in the provision of any other service, or engage in other activity, further to this Service Agreement other than the Services unless agreed to otherwise by the Parties in writing.

3. Fees . The Parties confirm that this is a fee for service arrangement as follows:

a. A one-time initial fee of $_xxxxxx__ paid by Licensee to UHN for installation, configuration, and integration of the Licensed UHN Software, including training,

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Kaitlyn Hougham, 2018-07-20,
Currently being discussed by TT and NS
Michelle Moldofsky, 2018-06-19,
Effective date?
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as further outlined as part of the Services in Appendix “1” (“Initial Fee”) which is due upon signing.

Amount Due Estimated dates

$xxx Upon signing

$xxx Upon implementation of approved updates

$xxx Upon completion of code legacy data migration

$xxx Upon system deployment

$xxx Upon implementation of post-go live enhancements

[b.] An annual service support fee of $5,000 (“Annual Service Fee”) shall be due and payable within thirty (30) days of the completion of system deployment of the Licensed UHN Software, and thereafter, prior to the anniversary of the Effective Date, as a condition precedent to renewal pursuant to Article 6. The Initial Fee and the Annual Service Fee are inclusive of an institutional overhead rate of twenty percent (20%) which amounts to $xxxxx for the Initial Fee and $833 for the Annual Service Fee.

4. Ownership of Intellectual Property and Data . As between the parties, UHN will own all intellectual property and related information specifically and directly related to the Licensed UHN Software (which includes, without limitation, any and all modifications, coding, and new integration and methodologies related to the UHN Software arising from the provision of the Services). Notwithstanding the foregoing, ownership of any Data incorporated into the UHN Software shall be unaffected by this Service Agreement.

5. Privacy Laws .

[a.] Compliance with PHIPA . UHN warrants and represents that its use of the Data is, and will be, in compliance with PHIPA, HIPAA and GDPR, as applicable, and UHN shall use the PHI for the sole and exclusive purpose of fulfilling its obligations under this Service Agreement and for no other purpose whatsoever. Such information shall also be appropriately protected by UHN against loss, theft, unauthorized access, copying, or modification. UHN will further require that its employees and agents, as well as any third parties to which it provides access to the Data under this Service Agreement, also comply with PHIPA, HIPAA and GDPR, as applicable.

a.[b.] Additional Obligations. In the event that any other local or provincial privacy legislation applies to the activities of UHN required under this Service

26

Nadine D'Aguiar, 2018-08-29,
UHN to confirm compliance with this requirement.
Nadine D'Aguiar, 2018-08-29,
UHN to confirm compliance with this requirement.
Kaitlyn Hougham, 2018-07-20,
Per above – under review by TT and NS
Schwartz, Noah, 2018-06-08,
Needs to be updated by Tran
Schwartz, Noah, 01/06/18,
To be revised to meet IRbC goals/needs
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Agreement, or the Software License Agreement, in relation to the Data, which requires additional obligations other than those specifically provided herein, Licensee shall be responsible for ensuring compliance with such obligations, and prior to the importation of any such Data to the Licensed UHN Software, shall notify UHN and obtain UHN’s written agreement to such additional obligations.

6. Term, Renewal and/or Termination. This Service Agreement will be in force for a period of one (1) year from the Effective Date, renewable each year, upon receipt of the Annual Service Fee, or otherwise as agreed to in writing by the Parties. At the time of any such renewal the Parties shall review and update information under Section 9 (Notices) of this Service Agreement. Notwithstanding the foregoing, either Party may:

a. upon written notice, terminate this Agreement for cause as a result of a material breach of this Service Agreement by the other Party which breach remains uncured thirty (30) days after written notice, or

b. terminate, in the Party’s sole discretion upon the provision of sixty (60) days written notice to the other Party.

7. Effects of Termination .

a. In the event of termination of this Service Agreement by the Licensee pursuant to Section 6(a) or (b) of this Service Agreement, or if UHN terminates this Service for cause in accordance with Section 6(a) of this Service Agreement, thenthe Parties shall immediately cease all unnecessary activities and shall cooperate to minimize all costs associated with this cessation/termination of activities associated with the provision of said Services.

[b.] In the event of termination of this Service Agreement by the Licensee pursuant to Section 6(a) of this Service Agreement, for cause, in addition to the actions set forth in Section 7(c)(i)-(iii) of this Service Agreement, UHN shall refund an amortized portion of the Annual Service Fee for the time remaining from the date of cessation of the Services to the anniversary of the Effective Date, minus all reasonable expenses and un-cancellable commitments incurred as of the date of the cessation of the Services.

b.[c.] In the event of termination of this Service Agreement by UHN pursuant to Section 6(b) of this Service Agreement, then:

i. the Parties shall immediately cease all unnecessary activities and shall cooperate to minimize all costs associated with this cessation/termination of activities associated with the provision of said Services and Licensee shall only be obligated to pay for costs of the Initial Fee that have been properly incurred up to the date of termination; and

ii. UHN shall refund an amortized portion of the Annual Service Fee for the time remaining from the date of the cessation of Services to the anniversary of the Effective Date, minus all reasonable expenses and un-

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cancellable commitments incurred as of the date of the cessation of the Services.

8. Exclusion of Warranties. EXCEPT AS EXPRESSLY PROVIDED IN THIS SERVICE AGREEMENT, UHN (WHICH INCLUDES ITS DIRECTORS, OFFICERS, EMPLOYEES, STAFF MEMBERS, STUDENTS, RESEARCH TRAINEES AND AGENTS) MAKES NO CONDITIONS, REPRESENTATIONS, WARRANTIES, UNDERTAKINGS, PROMISES, INDUCEMENTS OR AGREEMENTS OF ANY KIND, WHETHER DIRECT, INDIRECT, COLLATERAL, EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, THE CONDITION, ORIGINALITY, OR ACCURACY OF THE SERVICES, OR ANY OTHER DELIVERABLE OR MATTER ARISING FROM THE PROVISION OF THE SERVICES, WHETHER TANGIBLE OR INTANGIBLE, AND ANY INTELLECTUAL PROPERTY ASSOCIATED THEREWITH, CONCEIVED, DISCOVERED, OR DEVELOPED UNDER OR AS A RESULT OF THIS SERVICE AGREEMENT; OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF SAID DATA, CONCLUSIONS OR PRODUCTS OR ANY OTHER DELIVERABLE OR MATTER ARISING FROM THE PROVISION OF THE SERVICES, AND ANY INTELLECTUAL PROPERTY ASSOCIATED THEREWITH, INCLUDING WITHOUT LIMITATION, ANY REPRESENTATIONS AND WARRANTIES IN RESPECT OF INTELLECTUAL PROPERTY ASSOCIATED WITH THE PROVISION OF ANY SERVICES OR IN RESPECT OF ANY DELIVERABLE OR OTHER MATTER ARISING FROM THE PROVISION OF THE SERVICES.

9. Notices. Notices may be sent by fax or mail, or as otherwise described in the Software License Agreement, as follows:

a. For UHN

i. Concerning this Service Agreement:

John ReidDirector, Technology Development & CommercializationUniversity Health Network101 College Street – Suite 150Heritage Building – MaRS CentreToronto, OntarioM5G 1L7 CanadaTel: (416) 581-7410Fax: (416) 977-4765

ii. For invoicing:

Cheryl SzombatiCompliance SpecialistTechnology Development & CommercializationUniversity Health Network 101 College Street – Suite 150Heritage Building – MaRS Centre

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Toronto, OntarioM5G 1L7 CanadaTel: (416) 581-7400Fax: (416) 977-4765

iii. For scheduling or other matter(s) re. Services:

Tran [email protected]

b. For Licensee:

Brenda GallieInternational Retinoblastoma Consortium11 Rose AvenueToronto, Ontario M4X 1N6Tel (416) 294-9729Email [email protected]

10. Disputes. The Parties shall attempt to resolve any dispute relating to this Service Agreement promptly by negotiation between officials with authority to settle the matter who are at a higher level of responsibility than the persons with direct responsibility for the administration of this Service Agreement. All negotiations under this provision shall be considered confidential and shall be treated as compromise and settlement negotiations and deemed to be “off the record” and without prejudice.

11. Survival.

a. Sections 1, 5, 7, 8, 10 and 11 shall survive the expiration or earlier termination of this Service Agreement, until such time as the Parties mutually agree to the release of the obligations contained therein. In addition, the terms and provisions contained in the Software License Agreement which by the terms thereof require their performance by the Parties after the completion or termination of this Service Agreement shall remain in force notwithstanding such completion or other termination of this Agreement.

IN WITNESS WHEREOF, the Parties hereto have executed this Service Agreement by their respective authorized representatives to be effective as of the date first written above.

THE INTERNATIONAL RETINOBLASTOMA CONSORTIUM

By: ________________________________

UNIVERSITY HEALTH NETWORK .

By: ____________________________

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Name:

Title:

Name:

Title:

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APPENDIX 1DESCRIPTION OF “SERVICES”

“Services” Detail(s):

The Services to be provided by UHN in accordance with this Service Agreement are as follows:

Initial setup

Deliverable/Task Responsible Est Time for Completion

Est Date of Completion*

1.

2.

3.

Installation, configuration and set-up of the Software on a third party server located in Canada, as agreed upon by the Partiesthe cloud;

Installation and configuration of the following forms Staging EUA – Exam Form Staging EUA – Imaging Form Staging EUA – Tumor Findings Form Staging EUA – Diagnosis Form Staging EUA – Procedures Form Staging EUA – Images Form Staging EUA – Plan Form EUA Form EUA – Exam Form EUA – Imaging Form EUA – Tumor Findings Form EUA – Diagnosis Form EUA – Procedures Form EUA – Images Form EUA – Plan Form Initial Visit – Visit Details Form Initial Visit – History Form Initial Visit – Exam Form Initial Visit – Findings Form Initial Visit – Plan Form Clinic Visit - Visit Details Form Clinic Visit – Exam Form Clinic Visit – Imaging Form Clinic Visit – Tumors Form

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Schwartz, Noah, 2018-06-08,
This section will need to be filled out by Tran
Kaitlyn Hougham, 2018-06-20,
Per above – under review by TT and NS
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Clinic Visit – Procedures Form Clinic Visit – Plan Form Imaging Form Chemotherapy Form Chemo – Toxicity Form Radiation Form Pathology (Eye) Form Genetic Testing Form Stem Cell Transplant Form Other Surgery Form Additional Cancer Form Extraocular Extension Form Intra-arterial Chemotherapy Form Toxicity Form Periocular Chemotherapy Form Intravitreal Chemotherapy Form Patient Status Form Demographics and Circle of Care Tool for research data cuts

First Line Support is defined as gathering customer information and detailed description of software system issues, attempting to identify the underlying problem, and sorting through possible documented solutions. This also encapsulates training or teaching sessions on how to use various modular components of the system.

Second Line Network Support. Second Line Network Support consists of issues related to server and network infrastructure which are supported by the cloud provider. This includes, but is not restricted to:

o Web and database server downtimes, backups, upgrades and maintenanceo All other server administration issues that affect the functionality of the applicationo Network connection failureso All other network issues that affect the functionality of the program

Application Support, which includes Adaptive Maintenance (as defined below) and Corrective Maintenance (as defined below) and Bug Fixes (as defined below) will be provided with respect to Software by telephone or e-mail during regular business hours between 0900 and 1700 EST Monday through Friday excluding statutory holidays. Technical support personnel will attempt to resolve the question or problem immediately. If the question or problem cannot be resolved immediately a resolution or follow-up plan will be provided within 3 business days o Corrective Maintenance is activities associated with Bug-Fix isolation and resolution. o Adaptive Maintenance. Adaptive maintenance is defined as specific application

customization activities relating to infrastructure upgrades or major changes relating to new versions of an operating system, application server, or database software.

o Bug Fixes are emergency repairs of any system operation that does not comply with the current system specification of the Software. This includes system errors, “hung” or halted screens, or unexpected results within the system that render it unusable for the purpose for which it was designed.

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Absent a separate agreement between the Parties, the following services and activities are explicitly excluded from the Services to be provided hereunder this Service Agreement.

On-Call Support Management. UHN support personnel are not required to be on-call outside of normal business hours to support the Software. If at a later date, the Recipient requires support personnel to be on call for a specific purpose, or on a longer term basis, a separate agreement shall be formulated outlining the appropriate terms, including logistics and compensation.

Perfective Maintenance. Perfective Maintenance is defined as activities relating to enhancements, with effort of two (2) days or more that are designed to provide additional functionality to the application. Perfective maintenance includes but is not limited to new development and modifications to the original application specifications. New development and modifications can be requested and will be charged at $120/hour (inclusive of overhead).

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Nadine D'Aguiar, 2018-08-29,
To be discussed.
Kaitlyn Hougham, 2018-06-21,
Above suggests fee-for-service rate of $125