Code Life Ventilator Challenge: MADE for All Competitor Agreement

PRELIMINARY DRAFT

MCGILL UNIVERSITY RESERVES THE RIGHT TO AMEND THE TERMS AND CONDITIONS

OF THIS DRAFT AT ALL TIMES

CODE LIFE VENTILATOR CHALLENGE, MADE FOR ALL
PARTICIPANT AGREEMENT

This Participant Agreement (the “Agreement”) is made by and between: 

The Royal Institution for the Advancement of Learning/McGill University, a university governed by the laws of Quebec, having its head offices at 845 Sherbrooke Street W, Montreal, Quebec, H3A 0G4; (the “Sponsor”) and 

[Participant’s full name], an individual domiciled and residing at [Participant’s full home address]

[NTD: each member of the team must be named and provide his or her address. Add as many lines as necessary. If Participants have made alternative arrangements, such as assigning their IP to an organization that will act as the licensor, or if the IP belongs to another entity such as their employer, please consult with the Sponsor.]

The individuals named above are individually referred to as a “Participant” and collectively referred to as the “Participant Team”;

The Sponsor and each Participant are individually referred to as a “Party” and collectively referred to as the “Parties”.

1. Preamble

WHEREAS the World Health Organization and national health authorities around the world have declared that the COVID-19 coronavirus disease outbreak is a pandemic (the “Pandemic”); 

WHEREAS the Research Institute of the McGill University Health Centre (the “RI-MUHC”) and the Montreal General Hospital Foundation (the “MGH Foundation”) initiated the Code Life Ventilator Challenge as described on its website^[1] (the “PreviousChallenge”) as a response to the Pandemic;

WHEREAS the Previous Challenge aimed to solicit the design of ventilators that are easy to manufacture, maintain and operate, and make them available to manufacturers interested in manufacturing such ventilators for the duration of the Pandemic; 

WHEREAS the Sponsor has initiated the Code Life Ventilator Challenge, Made for All (the “Challenge”) to give certain candidate teams, including the Participant Team, (the “Candidate Teams”) the opportunity to improve, enhance and optimize one of the ventilator designs proposed by the top three (3) finalists of the Previous Challenge;

WHEREAS [insert name of selected Design Team] (the “Design Team”) was selected as a finalist of the Previous Challenge; 

[NTD: if the Participant Team is also the associated Design Team, please consult with the Sponsor to make the required changes to this Agreement]

WHEREAS the Parties and the Design Team wish to collaborate in good faith and in the spirit of the Challenge to improve, enhance and optimize the Design Team’s ventilator design and produce such ventilators that are certified for human use by Health Canada or the United States Food and Drug Administration (the “FDA”) and that can be manufactured at a cost of under $1,000 per unit;

WHEREAS the Participant Team has submitted its proposed project with respect to the Challenge to the Design Team which has accepted to work with and assist the Participant Team in connection with the Challenge; 

WHEREAS the Participant Team and the Design Team (collectively the “Joint Team”) have entered into a Joint Team IP Agreement (as defined below), a copy of which is appended hereto as Appendix A;

WHEREAS it is understood and acknowledged that the Participant Team’s entry in the Challenge does not guarantee selection of the Participant Team as the finalist nor does it guarantee the payment of any prize;

WHEREAS the Parties wish to hereby further define and establish their rights and responsibilities with regards to the Challenge and to set out the terms and conditions which shall apply to the Challenge;

CONSIDERING THE FOREGOING, THE PARTIES AGREE AS FOLLOWS:

1. - Definitions

“Background IP” means all Intellectual Property that is not Foreground IP that is incorporated into the Proposals or that is necessary for the operation of the System and that is proprietary to or the confidential information of the Participant Teams or any third party;

“Claim” means any action, claim, proceeding, opposition and demand or eviction attempt;

“Effective Date” means September 31^st, 2020;

“End of the Pandemic” means eighteen months following the official announcement of the winner(s) of the Challenge, or until the COVID-19 health emergency ceases to be categorized as an active pandemic as reasonably established by the World Health Organization, whichever comes first; 

“Foreground IP” means all Intellectual Property first conceived, developed, produced or reduced to practice as part of the Challenge;

“Intellectual Property” means any information or knowledge of an industrial, scientific, technical, commercial, or creative nature contained in or embodied by the Proposals, whether oral or recorded in any form or medium and whether or not subject to copyright; this includes but is not limited to any inventions, designs, methods, processes, techniques, know-how, show-how, models, prototypes, patterns, samples, schematics, experimental or test data, reports, drawings, plans, specifications, photographs, manuals and any other documents, software, and firmware;

“Intellectual Property Rights” means any domestic or foreign intellectual property right currently recognized by law, or that becomes so recognized in the future including any intellectual property right protected by legislation such as patents (including issued patents, patent applications and reissues, divisions, continuations, renewals, extensions and continuations in part of issued patents or patent applications), copyright, and industrial design, or subject to protection under the law as trade secrets and confidential information.

“Joint Team IP Agreement” means a bilateral intellectual property rights agreement setting out the Design Team’s and Participant Team’s respective arrangements with respect to the ownership and sharing of Intellectual Property Rights in the System (including Background IP and Foreground IP) which must include a clear provision stating that all resulting Intellectual Property Rights embodied in the System will reside with a single entity (either the Design Team, the Participant Team or a joint venture or other entity on which the both the Design Team and the Participant Team exercises common control) (each, a “Granting Entity”).

“Manufacturer License” means a licence granted by the Participants to a System Builder pursuant to Article 4 .

“Person” means any individual, sole proprietorship, general partnership, limited partnership unincorporated association, unincorporated syndicate, unincorporated organization, trust, body corporate, and a natural person in his or her capacity as trustee, executor, administrator, or other legal representatives.

“Previous Agreements” means the Semi Finalist Participant Agreement and the Finalist Participation Agreement entered into by and between the RI-MUHC and the Design Team.

“System” means the ventilator system or any component thereof, including all accessories therefor and documentation related thereto, described in or embodied by the Proposals;

1. – Proposal
   1. The Participant Team hereby undertakes to submit to the Sponsor a Proposal (as defined below) within the 90 days following the Effective Date (the “Submission Period”);
   2. The “Proposal” shall be comprised of a full design for manufacturing package, composed of any documents or other materials such as prototypes, designs, instructions, procedures, methods of construction, compositions of matter, models, specially designed tools, communications, texts, presentations or videos relating to the Challenge, but shall include all and not less than all of the documents and materials listed in Appendix B (the “Proposal Documentation”).
   3. For a Proposal to be considered by the Sponsor, it must meet the following criteria to the full satisfaction of the Sponsor, in its sole discretion:
      1. the System must be certified for human use by Health Canada, or the FDA (the Regulatory Criteria) under interim authorization process (i.e., accelerated COVID-related approval), and therefore must comply with Health Canada Interim Authorization requirements for ventilators for COVID, or the equivalent FDA requirements, provided that, if such requirements change during the course of this Challenge, the Proposal must be amended to reflect such new requirements and it is the sole responsibility of the Participant Team to stay informed of any such new requirements; and
      2. the System’s production cost (material and labour) must be of a maximum of CAD$1,000 (Financial Criteria) under a Canadian-based manufacturing scenario (to be specified by the sponsor) and at a rate of 1000 units a month and for a run of 10,000 units.
   4. The Sponsor reserves the right to seek clarification with respect to the contents of the Proposal or to require a the Participant Team to submit further documentation. 
   5. Proposals received past the expiration of the Submission Period will not be considered by the Sponsor and will be automatically disqualified, provided, however, that the Sponsor reserves the right to extend the Submission Period in its sole discretion if it deems it necessary to attain the objectives of the Challenge.
2. – Eligibility
3. In order to be eligible to participate in the Challenge, each Participant Team must meet the following criteria (the “Eligibility Criteria”):
4. represent the interests of an entity or group of persons having the technical and financial means to produce the manufacturing prototype of the proposed design(s) and obtain Health Canada approval for them (under the interim order; the FDA equivalent to the Health Canada Interim Order may also be accepted);
5. provide materials from a team of at least five members, including, but not limited to:
   1. an independent expert physician or respiratory therapist capable of signing off on the clinical adequacy and performance;
   2. a subject-matter expert, able to guide and attest to the compliance of the device with ISO standards;
   3. an industrial engineer, able to direct the preparation of a professional, optimized manufacturing package; 
   4. an industrial designer, able to direct the optimization of the final device and its usability; 
   5. a technical writer, to prepare compliant documentation for installation and use of the device; and
   6. a software engineer with medical device programming experience, to guide and attest to certifiable software for the devices; and
   7. disclose any direct or indirect relationship with the Sponsor, the affiliated institutions or any judges, advisors, experts or other person involved in the organization of the Challenge; and
   8. not be subject to the laws of any state where the Challenge is prohibited or restricted by law. However, the Challenge is void in countries where it is prohibited or restricted by law.
6. – System Builder Selection and Grant of License
   1. The Participant Team shall have the responsibility to contact and make arrangements with a prospective manufacturer (the “System Builder”), the identity of which shall be presented to the Sponsor, which shall have sole discretion to approve such manufacturer on the basis of reputational risk, if any, and that such System Builder has sufficient technical and manufacturing capacity to produce sufficient quantities of the System at a sufficient level of quality, which approval shall not be unreasonably withheld by the Sponsor. 
   2. The Sponsor may, but is under no obligation to, employ reasonable efforts to assist the Participant Team to initiate discussions with such proposed System Builders to establish the terms of a partnership for the manufacture and offering to the public of the System. 
   3. In any event, even upon Sponsor’s approval, it shall be the Participant Team’s sole responsibility to properly review any System Builder’s commercial, technical and financial capabilities, and to comply with all applicable government legislation or regulation regarding the manufacture and/or use of the System in the country of interest.
   4. The Joint Team shall promptly cause the Granting Entity to grant a license to the Foreground IP and Background IP to the System Builder on terms substantially identical to those of the license template attached hereto in Appendix C (the “License Template”) and maintain such license in force until the End of the Pandemic. The Granting Entity and the Joint Team shall also waive all moral rights to all copyrightable material relating to the Challenge including but not limited to Proposal.
   5. The Joint Team shall provide the Sponsor with a fully executed copy of any license entered into pursuant to Article 4 forthwith upon execution.
   6. The Joint Team shall inform the Sponsor promptly if they wish to grant a license to a System Builder that is not substantially identical to the License Template. In this case, the Parties shall negotiate in good faith to agree on license terms that meet the needs of the Joint Team and the licensee that are consistent with the spirit of the Challenge. The Sponsor may withhold its consent at its sole discretion. The Joint Team shall provide the Sponsor with a fully executed copy of any license entered into pursuant to this Article 4.6, as the case may be.
   7. The Granting Entity shall not grant any licenses to the Foreground IP or to the Background IP except in accordance with this Article 4 during the Term. For greater certainty, licenses granted prior to the Effective Date pursuant to the Previous Challenge shall remain in full force and effect.
   8. The Granting Entity may enter into additional agreements with the System Builder, such as non-disclosure agreements, collaboration agreements or technical assistance agreements, provided that such agreements do not limit the System Builder’s ability to fully exercise its rights to the Foreground IP and Background IP as provided for in the Manufacturer License or otherwise alter the terms of the Manufacturer License, and provided that such agreements do not impede Participant’s ability to enter Manufacturer Licenses with other System Builders.
   9. During the Term, the Granting Entity shall not enter any agreement that would interfere with the ability of current or future System Builders to fully enjoy the rights arising from their Manufacturer’s License. The Granting Entity shall not alienate or encumber any Foreground IP or Background IP, in a manner that would interfere with the ability of current or future System Builders to fully enjoy the rights arising from their Manufacturer’s License. 
7. - Warranty of Non-Infringement
   1. When submitting the Proposal, the Joint Team guarantees to the Sponsor that the Granting Entity is the sole beneficial and legal owner of all Intellectual Property Rights (including the Background IP and Foreground IP) contained or otherwise embodied or incorporated in any tangible or intangible element of the Proposal, and that, if applicable, it has obtained all rights and permissions regarding all pre-existing Background IP and any elements of the Proposal for which it does not hold the relevant rights.
   2. The Joint Team guarantees (i) that its ventilator design forming part of the Proposal is original, and to the best of its knowledge novel and non-obvious; (ii) that it does not infringe or otherwise violate upon the patent rights, copyrights or any Intellectual Property Rights of any third party in any jurisdiction in the world, having undergone reasonable searches on public registers to that effect; (iii) that all the elements of which its Proposal submission (including the documents or other materials such as prototypes, designs, instructions, procedures, methods of construction, compositions of matter, models, specially designed tools, communications, texts, presentations or videos comprising the Participant Team’s submission to the Challenge) are useable, as well as all pieces of contributions and information communicated in the Proposal submission presentation documents are accurate, reliable and complete; and (iv) that the submission of its Proposal does not constitute an act of unfair competition of any kind. Any Proposal involving several Participant Teams constitutes a collaborative work and it should be treated as such in accordance with the applicable regulations in force.
   3. It is compulsory for the Participant Team to indicate the source of any pre-existing Background IP rights of whichever nature and on whichever support that are included in their submitted Proposal.
8. – Reporting
   1. The Participant Team shall obtain reports on the production and sale of Systems by System Builders in the format shown in the report template attached hereto as Appendix D (the “Report Template”) duly completed in accordance with the instructions provided therein. The Participant Team shall provide the Sponsor with a copy of such reports promptly upon receiving them.
9. - Representations and Warranties
10. By participating in the Challenge, the Participant Team hereby represents and warrants to the Sponsor, and acknowledges that the Sponsor is relying on such representation in selecting the successful Proposal and granting the Compensation, that:
11. the Participant Team has all the necessary authority and capacity to participate in the Challenge and carry out its obligations under the Challenge’s terms and conditions;
12. the Participant Team meets all of the Eligibility Criteria;
13. except as disclosed in Appendix E, the Participant Team has no direct or indirect relationship with the Sponsor, the affiliated institutions or any judges, advisors, experts or other Person involved in the organization of the Challenge;
14. neither the participation to the Challenge nor the acceptance by the Participant Team of the terms and conditions of the Challenge will directly or indirectly contravene, conflict with or result in a violation of (a) any contract to which the Participant Team is a party; (b) any applicable law; or (c) give any Person the right to exercise any remedy or obtain any relief against the Sponsor with respect to the Challenge or the Proposal; 
15. the Participant Team is not required to give any notice or obtain approval, consent, ratification, waiver or authorization of any Person in connection with its participation in the Challenge;
16. if any content from a third party has been used in the development of the Proposal, all rights, authorizations, and agreements necessary to submit the Proposal and grant the rights mentioned therein have been obtained;
17. no other individual and/or entity is entitled to claim any rights from the use of the Proposal; and
18. the content of the Proposal does not and will not infringe or violate any rights of any third party or entity, including, without limitation, intellectual property rights, privacy, competition law, confidentiality, or any contractual or extra-contractual right.
19. - Covenants
    1. The Participant Team hereby covenants that:
       1. every statement in its Proposal when submitted in accordance with Article 2.1 shall be accurate and complete;
       2. the Participant Team shall promptly work with the Sponsor to publish summary information regarding the Participant Team’s System and the Sponsor shall have a right to display any non-confidential portions of the Proposal to the public as necessary in Sponsor’s reasonable judgment to promote, report on and otherwise stimulate interest in the Participant Team’s System;
       3. Prior to receiving the Compensation, the Participant shall deliver to the Sponsor an irrevocable and unconditional undertaking not to sell, transfer or otherwise dispose of the information included in the Proposal, including any Intellectual Property Rights embodied therein, to any Person in exchange for any form of remuneration from such Person; and
       4. the Participant Team shall not request or accept any compensation from System Builders in relation to any rights to use the Foreground IP or Background IP until the End of the Pandemic except as agreed-upon in writing with Sponsor or as provided for in the Manufacturer License; furthermore, unless agreed-upon with Sponsor in advance, Participant Teams shall not initiate discussions or negotiations with any third-party manufacturer (including System Builders) prior to the End of the Pandemic without advising Sponsor and obtaining consent, which shall not be unreasonably withheld. 
20. - Disqualification
    1. The Participant Team will automatically be disqualified in the following circumstances:
       1. the Participant Team does not meet the Eligibility Criteria, as determined by the Sponsor in its sole discretion;
       2. the Proposal is not be compliant in all material respects with the requirements, terms and conditions set out in this Agreement or communicated form time to time to the Participant Team by the Sponsor in writing, as determined by the Sponsor in its sole discretion, including, but not limited to, with the Regulatory Criteria, the Financial Criteria and the requirement to provide the full suite of Proposal Documentation; or
       3. the Sponsor determines, in its sole discretion, that (i) the Proposal contains a material inaccuracy or omission of disclosure of conflict of interest or (ii) the Participant Team has a real or perceived conflict of interest and cannot or will not take adequate steps to eliminate or mitigate such conflict of interest, it being understood that the determination of what situations or circumstances give rise to a real or perceived conflict of interest, what constitutes a material inaccuracy or omission of disclosure of conflict of interest, and what steps are sufficient to eliminate or mitigate a conflict of interest, are to be determined by the Sponsor in its sole discretion. 
    2. The Participant Team acknowledges that any misrepresentation of fact in the Proposal, the existence of uncredited third-party contributions in the Proposal, the suspicion that a Proposal infringes on any third party’s rights or any breach of the covenants and representations and warranties contained herein may be grounds for the Sponsor to disqualify the Proposal and/or cancel the Compensation.
21. - Award of Compensation
    1. The Participant Team will, subject to compliance with the terms and conditions of this Agreement, be declared the winner of the Challenge and be awarded a financial compensation of at least $100,000 and up to $300,000 (the “Compensation”) if it is the first Candidate Team to (i) successfully obtain Health Canada’s or the FDA’s regulatory approval (whether obtained prior to or after the date hereof) (the Regulatory Approval) and (ii) complete the Financial Assessment (as defined below, collectively with the Regulatory Approval, the “Objectives”), provided that if two or more Candidate Teams achieve the Objectives within the same week, they will both be deemed winners and the compensation will be shared equally among the winning Candidate Teams.
    2. The “Financial Assessment” shall consist in a panel of experts selected by the Sponsor (the “Financial Panel”) assessing the Proposal to confirm whether, in the opinion of the Financial Panel, the Proposal complies with the Financial Criteria and, in the Financial Panel’s sole discretion, granting its approval with respect the Financial Criteria being met.
    3. The Compensation shall only be paid to the Participant Team once the Participant Team will have disclosed to the Sponsor the entirety of its regulatory dossier submitted to Health Canada or the FDA, as the case may be, forming the basis of the Regulatory Approval and a panel of experts selected by the Sponsor (the “Regulatory Panel”) has confirmed it is satisfied that the Regulatory Approval has been achieved.
    4. If a the Participant Team is declared the winner of the Challenge pursuant to Article 10.1 but cannot be reached after 14 days or is unable to accept the Compensation for any reason, the Sponsor shall have no further obligation to the Participant Team.
    5. No compensation will be provided to the Participant Team if another Candidate Team achieves the Objectives before the Participant Team.
22. – Term and Termination
    1. This Agreement comes into effect on the Effective Date and remains in effect until the End of the Pandemic (the “Term”).
    2. The Sponsor reserves the rights to cancel the Challenge at any time without liability, cost, or penalty to the Sponsor.
23. – Confidentiality
    1. The Sponsor has no obligation to keep the information contained in the Proposal confidential. In general terms, when submitting any Proposal, the Participant Team understands, agrees and accepts that any information contained therein may be publicly disclosed by the Sponsor.
    2. Furthermore, Participant Team acknowledges that the Sponsor may currently or in the future be developing information internally, or receiving information from other parties, that is similar to the information contained in the Proposal. Accordingly, nothing herein shall prohibit the Sponsor from independently acquiring, developing, or having developed for it, products, concepts, systems, services, or techniques that are similar to or compete with the products, concepts, systems or techniques contemplated by or embodied in the Proposal.
    3. The Participant Team recognizes that other Candidate Teams, individuals or entities may have provided the Sponsor or others, or made public, or may in the future submit, or make public, content that is the same or similar to any piece of information contained in the Proposal. Hence, the Participant Team acknowledges, agrees and accepts that the Sponsor shall rely upon representations made to it by a Participant Team with respect to the confidentiality of the disclosed information and make reasonable disclosure of same to the public in accordance with Article 8.1.2 but shall have no obligation to cross-reference such disclosure with the same or similar information disclosed by another Candidate Team.
24. – Amendments
    1. The Sponsor reserves the right to alter any dates and extend any delays relating to the Challenge. The Sponsor will advise the Participant Teams of any change in dates or cancellation of the Challenge.
    2. The Sponsor reserves the right to modify the terms and conditions of the Challenge at any time by giving reasonable advance written notice to the Participant Team, provided such modifications (i) apply the same way to each Candidate Team and (ii) does not unreasonably place a Candidate Team at a material advantage or disadvantage vis-à-vis the other Candidate Teams.
    3. The Sponsor assumes no responsibility for verbal instructions or suggestions provided to the Participant Team, and such instructions or suggestions shall not amend the terms and conditions of the Challenge or this Agreement. 
    4. The Sponsor is not responsible for any fees, costs and expenses incurred by the Participant Teams due to a Participant Team’s reliance upon Sponsor’s instructions or any alleged failure to instruct otherwise than as set out in this Agreement.
    5. Any change in the terms of this Agreement other than those provided for in Articles 13.1 and 13.2 shall be valid only if the change is made in writing, agreed to and signed by all the Parties hereto.
25. – Indemnification and Limitation on Liability
    1. The Sponsor shall not be responsible for any liability associated with (i) the breach by the Joint Team of Article 5 (Warranty of Non-Infringement) or (ii) the design, licensing, manufacture, sale, storage, transportation or use of any System produced under the Challenge unless it arises out of its gross negligence or wilful misconduct.
    2. The Sponsor shall have no liability for the accuracy, completeness and timeliness of any advice, judgment, guidance or assessment communicated to a Participant Team by the Financial Panel and any steps taken or not taken voluntarily by either Design Team and/or Candidate Team acting in reliance of such advice, judgment, guidance or assessment.
    3. The Sponsor shall have no liability for any costs, expenses, loss or damages of the Participant Team in the event that the Sponsor rejects all Proposals submitted by the Candidate Teams, terminates the Challenge or disqualifies the Participant Team pursuant to Article 9 . The determination that a Proposal is non-compliant or does not meet the requirements set out in this Agreement is within the sole and absolute discretion of the Sponsor.
    4. The Sponsor hereby advises each member of the Joint Team (the “Indemnifying Parties”) of its wish to accept the benefit of the indemnification clause provided for in the License Template as incorporated into the Manufacturer License. Each Indemnifying Party shall indemnify, defend, and hold harmless the Sponsor and its directors, officers, employees and agents and any personnel involved in the Challenge, (each the “Indemnitee” and collectively, the “Indemnitees”) from and against any and all liabilities, damages, losses, claims and expenses, including court costs and reasonable legal fees (“Losses”) resulting from or arising out of any third-party Claims arising out of such Indemnifying Party’s involvement in the Challenge, including with respect to any Intellectual Property Rights, in each case to the extent that such Losses do not arise out of any Indemnitee’s: (A) failure to comply with this Agreement; or (B) gross negligence or willful misconduct.
    5. An Indemnitee claiming a right of indemnification or defense under this Agreement shall provide the relevant Indemnifying Party with prompt written notice of any such claim, including a copy thereof, served upon it, and shall cooperate with such Indemnifying Party and their legal representatives in the investigation of any matter regarding the subject of indemnification, at the Indemnifying Party’s expense; provided, however, that failure by an Indemnitee to provide prompt notice shall not relieve the Indemnifying Parties of their obligations hereunder except to the extent that Indemnifying Parties are prejudiced by such failure. The Indemnifying Parties shall have the right to exercise sole control over the defense and settlement of any claim for which indemnification or defense is sought, including the sole right to select defense counsel and to direct the defense or settlement of any such claim; provided that the Indemnifying Parties shall not enter into any non-monetary settlement or admit fault or liability on behalf of any Indemnitee without the prior written consent of such Indemnitee, which consent shall not be unreasonably withheld, conditioned or delayed. An Indemnitee shall have the right to select and to obtain representation by separate legal counsel at the Indemnitee's sole expense.
26. – Dispute Resolution
    1. In case of persistent litigation beyond a period of 15 days after the Participant Team or the Joint Team, as the case may be, (the “Claimant”) has filed a claim, the Sponsor and the Claimant undertake to submit their dispute to an amicable conciliation prior to any legal proceedings. The Party wishing to initiate conciliation shall inform the other Party by means of a registered letter with acknowledgment of receipt in which it will inform such Party of its intentions and will explain the cause. If no agreement is reached between the Parties within 30 days after receipt of the registered letter, the parties shall regain their freedom of action.
27. – No rights to Sponsor’s Trademarks
    1. This Agreement does not give Participant or Design Team, by implication or otherwise, any interest in or to any trademarks, copyright, logos or other indicia of Sponsor, including, without limiting the generality of the foregoing, any trademarks owned or licensed by the Sponsor designated as an “official mark” under Section 9 of the Trademarks Act (“McGill Trademarks”). For greater certainty, Participant agrees not to use any McGill Trademarks, or any trademark confusing therewith, on any business sign, business cards, stationery or forms, or to suggest to the public any partnership, association or business venture with Sponsor, unless otherwise agreed by Sponsor in writing.
28. - Intervention
29. Each of the Design Team and the RI-MUHC hereby intervenes to this Agreement for the purposes of acknowledging and accepting the contents hereof, and more specifically:
30. each of the Design Team and the RI-MUHC hereby acknowledge that should any provision of this Agreement be inconsistent with or be in conflict with any provision of the Previous Agreements, the terms and conditions of this Agreement shall supersede such conflicting or inconsistent provisions in the Previous Agreements; and
31. the Design Teams hereby undertakes to give direct and continued access to the Participant Teams to all material pertaining to the Ventilator Designs in their possession and control.
32. - Miscellaneous
    1. This Agreement constitutes the entire agreement between the Parties and supersedes and extinguishes all previous drafts, agreements, arrangements and understandings between them, whether written or oral, relating to this subject matter, save and except for (i) any rules that may be communicated from time to time by the Sponsor to the Participant Team and the Previous Agreements, to the extent that such rules or such Previous Agreements, as the case may be, are not inconsistent with the contents of this Agreement.
    2. The Participant Team shall be responsible for and shall bear any costs or expenses associated with preparing and submitting the Proposal. The Participant Team assumes all risk of damaged, lost, late, incomplete, invalid, incorrect or misdirected Proposals. 
    3. All amounts and values referred to in this Agreement and the Proposal shall be calculated and payable in Canadian dollars, unless otherwise specified.
    4. Any notices under this Agreement shall be in writing, signed by the relevant Party, and delivered personally, by courier, by registered mail or by facsimile or email transmission to the addresses set out below (or such other addresses as a Party may designate from time to time in writing).

If to RI-MUHC:

      Cinzia Raponi CPA, CMA 

Director, Administration 

The Research Institute of the McGill University 

Health Centre, 2155 Guy Street, Suite 500

Montreal, Quebec, Canada H3H 2R9

Tel: (514) 934-1934, ext. 44515

Fax: (514) 934-8270

Email: cinzia.raponi@muhc.mcgill.ca:

If to Sponsor:

[Insert Sponsor’s representative name, address, fax number and e-mail address]

      If to Participant Team:

      [Insert Participant Team’s name, address, fax number and e-mail address]

      Notices duly delivered to the Participant Team representative named above shall be deemed delivered to all members of a given Participant Team. It is the named Participant Team representative’s responsibility to inform the other team members of the notice. 

1. A waiver of any default, breach or non-compliance of or with this Agreement is not effective unless in writing and signed by the Party or Parties to be bound by the waiver. No waiver shall be inferred from or implied by any failure to act or delay in acting by a Party in respect of any default, breach or non-observance or by anything done or omitted to be done by any other Party. The waiver by a Party of any default, breach or non-compliance under this Agreement shall not operate as a waiver of that Party’s rights under this Agreement in respect of any continuing or subsequent default, breach or non-observance (whether of the same or any other nature).
2. No Party may assign this Agreement without the prior written consent of the other Party, which that Party shall not withhold unreasonably. 
3. This Agreement insures to the benefit of and binds the Parties and their respective successors and permitted assigns, and with respect to Investigator, administrators, heirs and executors.
4. Notwithstanding anything in this Agreement, the Parties agree that neither Party shall be considered the legal partner of the other Party in any respect. This Agreement will not be construed as a teaming agreement, legal partnership or other similar relationship. The Parties are independent contractors as to each other in the performance of the obligations of this Agreement. Nothing in this Agreement or in its performance shall create or imply a joint venture or principal and agent relationship between the Parties. Neither Party shall have any right, power or authority to create any obligation, express or implied, on behalf of the other Party. Both Parties will not represent each other in any way that implies that one is an agent or branch of the other..
5. No Party shall be liable to any other Party or shall be in default of its obligations hereunder if such default is the result of any case of force majeure including but not limited to war, hostilities, terrorist activity, revolution, civil commotion, strike, epidemic, fire, and flood or because of any act of God or other cause beyond the reasonable control of the Party affected. The Party affected by such circumstances shall promptly notify the other Parties in writing when such circumstances cause a delay or failure in performance and shall take whatever reasonable steps are necessary to relieve the effect of such cause as rapidly as reasonably possible.
6. All provisions of this Agreement which, by their nature, ought reasonably to survive the expiry or termination of this Agreement shall survive any such expiry or termination.
7. The interpretation and construction of this Agreement and the rights and obligations of the Parties hereunder shall be governed by the laws of the Province of Quebec and the laws of Canada applicable therein, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. Each of the Parties irrevocably consents to the exclusive jurisdiction of the federal and provincial courts located in the Province of Quebec, District of Montreal.
8. This Agreement may be executed in two or more counterparts, which may be delivered by facsimile or electronic format, each of which shall be deemed to be an original and all of which shall together be deemed to constitute one agreement. If a paper copy with original wet ink signatures is required, the Parties will provide it in a timely manner.
9. The Parties confirm that they accept that this Agreement as well as all other documents relating to this Agreement, including notices, be drawn up in English only. Les Parties aux présentes confirment qu’elles acceptent que la présente convention de même que tous les documents, y compris les avis s’y rattachant, soient rédigés en anglais seulement.
10. The Parties acknowledge that their legal counsel has reviewed and participated in settling the terms of this Agreement and that any rule of construction to the effect that any ambiguity is to be resolved against the drafting party shall not be applicable in the interpretation of this Agreement.

[This space has been left blank intentionally. The Parties’ signatures appear on the following page.]

IN WITNESS WHEREOF, THE PARTIES HAVE SIGNED AND DATED AT THE PLACE INDICATED 

The Royal Institution for the Advancement of Learning/McGill University 

By:       _____________________ 

Name:                                                  Place and date:

Title:

Participant Team

_________________________  _________________________

[Name of Participant]                             Place and date

[NTD: All Participants on the Team must sign. Add as many lines as necessary to accommodate all signatures.]

ACCEPTED AND AGREED

Research Institute of the McGill University Health Centre

By:       ____________________________

Name:                                                  Place and date:

Title:

Design Team

_________________________  _________________________

[Name of Participant]                             Place and date

[NTD: All members of the Design Team must sign. Add as many lines as necessary to accommodate all signatures.]

APPENDIX A TO PARTICIPANT AGREEMENT:

DESIGN TEAM AND PARTICIPANT TEAM INTELLECTUAL PROPERTY AGREEMENT

[NTD: Insert agreement here.]

APPENDIX B TO THE PARTICIPANT AGREEMENT:

PROPOSAL DOCUMENTATION

The Proposal Document shall include the documents and materials listed in the following table, which such list may be updated from time to time by the Sponsor in its sole discretion.

APPENDIX C TO THE PARTICIPANT AGREEMENT

LICENSE TEMPLATE

[IMPORTANT NOTICE: This license template was drafted on behalf of the Sponsor and does not constitute legal advice for Participant Teams in the Challenge. The Participant Teams are hereby advised to seek the advice of independent legal counsel before entering a license with a licensor. Neither the Sponsor nor its legal advisors assume any liability associated with the Participant Team’s use of this license.]

This license agreement (the “License”) is by and between:

[Granting Entity’s full name], a corporation incorporated under the laws of [jurisdiction whose laws govern the licensee’s incorporation], having its head office at [address] (the “Licensor”).

[NTD: Should the Granting Entity not be a corporation, please adjust the last sentence accordingly.]

and

[Full legal name of licensee], a corporation incorporated under the laws of [jurisdiction whose laws govern the licensee’s incorporation], having its head office at [address] (the “Licensee”)

The Licensor and the Licensee are hereinafter referred to individually as a “Party” and collectively as the “Parties”. 

Preamble

WHEREAS the World Health Organization and national health authorities around the world have declared that the COVID-19 coronavirus disease outbreak is a pandemic (the “Pandemic”); 

WHEREAS the Research Institute of the McGill University Health Centre (“RI-MUHC”) and the Montreal General Hospital Foundation (“MGH Foundation”) initiated the Code Life Ventilator Challenge as described on its website^[2] (the “Previous Challenge”) as a response to the Pandemic;

WHEREAS the Previous Challenge aimed to solicit the design of ventilators that are easy to manufacture, maintain and operate, and make them available to manufacturers interested in manufacturing such ventilators for the duration of the Pandemic;

WHEREAS McGill University (the “Sponsor”) has initiated the Code Life Ventilator Challenge, Made for All (the “Challenge”) to give certain candidate teams the opportunity to improve, enhance and optimize one of the ventilator designs proposed by the top three finalists of the Previous Challenge;

WHEREAS the Parties wish to collaborate in good faith and in the spirit of the Challenge to make ventilators that are easy to manufacture, maintain and operate available to as many people in need as possible as quickly as possible and as affordably as possible;

WHEREAS the Licensor participated in the Challenge as a team known as [insert team’s name] (the “Team”);

WHEREAS the Team’s entry in the Challenge was selected by [insert Design Team’s name] (the “Design Team”), a finalist of the Previous Challenge; 

WHEREAS the Team and the Design Team have entered into an agreement pursuant to which all resulting Intellectual Property Rights embodied in the final ventilator design resides with the Licensor; 

WHEREAS the Licensee has expressed its interest in building ventilators based on the Licensor’s design as submitted in the Challenge to the Sponsor;

WHEREAS the Sponsor has made a preliminary determination that the Licensee has the capability to build safe and effective ventilators;

WHEREAS Licensee wishes to obtain a license allowing it to build ventilators based on the Licensor’s design and the Licensor wishes to grant such a license in accordance with the terms of this License;

CONSIDERING THE FOREGOING, THE PARTIES AGREE AS FOLLOWS:

Article 1: Definitions

“Background IP” means all Intellectual Property that is not Foreground IP that is incorporated into the Proposals or that is necessary for the operation of the System and that is proprietary to or the confidential information of the Participant Teams or any third party;

“Effective Date” means the date on which the last Party executes this Agreement;

“End of the Pandemic” means eighteen months following the official announcement of the winner(s) of the Challenge, or until the COVID-19 health emergency ceases to be categorized as an active pandemic as reasonably established by the World Health Organization, whichever comes first; 

“Foreground IP” means all Intellectual Property first conceived, developed, produced or reduced to practice as part of the Challenge;

“Intellectual Property” means any information or knowledge of an industrial, scientific, technical, commercial, or creative nature contained in or embodied by the Proposals, whether oral or recorded in any form or medium and whether or not subject to copyright; this includes but is not limited to any inventions, designs, methods, processes, techniques, know-how, show-how, models, prototypes, patterns, samples, schematics, experimental or test data, reports, drawings, plans, specifications, photographs, manuals and any other documents, software, and firmware;

“Intellectual Property Rights” means any domestic or foreign intellectual property right currently recognized by law, or that becomes so recognized in the future including any intellectual property right protected by legislation such as patents (including issued patents, patent applications and reissues, divisions, continuations, renewals, extensions and continuations in part of issued patents or patent applications), copyright, and industrial design, or subject to protection under the law as trade secrets and confidential information;

“Proposal” means the proposal submitted by the Team in connection with the Challenge;

“Software” means any computer program whether in source or object code (including Firmware), any computer program documentation recorded in any form or upon any medium, and any computer database, including any modification;

“System” means the ventilator system or any component thereof, including all accessories therefor and documentation related thereto, described in or embodied by the Proposal;

“Term” means the period of time between the Effective Date and the End of the Pandemic.

Article 2: License Grant

2.1 Except as provided for herein, Licensor retains all right, title and interest in the Foreground IP and Background IP. 

2.2 Licensor hereby grants to Licensee a license to make, use, sell or have made (wholly or in part), display (wholly or in part), adapt, modify, disseminate any elements which are part of the Proposal, as well as any Background IP or Foreground IP which are embodied or otherwise reasonably necessary for the appropriate manufacturing of the System.

2.3 The license granted in Article 2.2 is non-exclusive, worldwide, non-transferable, and subject to the provisions respecting compensation in Article 6. It comes into force on the Effective Date and ceases to produce its effects at the End of the Pandemic. For greater certainty, except as provided for herein, after the End of the Pandemic, Licensee shall not have any right to exercise the Intellectually Property Rights in the Foreground IP and the Background IP unless otherwise agreed in writing by the Parties. 

2.4 For greater certainty, Licensee’s licensed rights include, but are not limited to:

2.4.1           the right to grant sublicenses on substantially identical terms as the present licence, to the Foreground IP and Background IP, exclusively to sub-contractors and exclusively to the extent necessary for sub-contractors to carry out their obligations under any sub-contracts. For greater certainty, despite any subcontracts it may enter, the Licensor shall remain the manufacturer of the Systems for regulatory purposes; and

2.4.2           the right to reproduce, modify, improve, develop or translate the Foreground IP and Background IP or have it done by a Person hired by the Licensee. Licensee, or a Person designated by Licensee, will own the Intellectual Property Rights associated with the reproduction, modification, improvement, development or translation.

2.5 The Licensor shall make the Background IP, including in the case of Software, the source code, promptly available to Licensee for any purpose mentioned above, except in the case of commercial off-the-shelf software.

2.6 The Licensee acknowledges that the Background IP and Foreground IP may be subject to certain non-exclusive licenses granted to the RI-MUHC, the MGH Foundation and other manufacturers in connection with the Previous Challenge. 

Article 3: Waiver of Moral Rights

3.1 If requested by Licensee, during and after the License, the Licensor shall provide a written permanent waiver of moral rights, as defined in the Copyright Act, R.S., 1985, c. C-42, from every author that contributed to any Foreground IP subject to copyright protection and covered by this License. If the Licensor is an author of the Foreground IP, the Licensor hereby permanently waives the Licensor’s moral rights in that Foreground IP.

Article 4: Reporting

4.1 Licensee shall complete reports on the production and sale of Systems and the use of the Foreground IP and the Background IP in the format shown in the report template attached hereto as Appendix 1 (the “Report Template”) and provide them to Licensor in accordance with the instructions provided therein. Licensee acknowledges that Licensor will provide copies of these reports to Sponsor and to Prof. Reza Farivar-Mohseni and that Sponsor or Prof. Reza Farivar-Mohseni may publish such reports or any part of them in any medium at their sole discretion.

Article 5: Termination 

5.1 Licensor may terminate this Agreement with immediate effect by giving notice to Licensee if:

(a) Licensee is in breach of any provision of this Agreement and (if it is capable of remedy) the breach has not been remedied within thirty (30) days after receipt of written notice specifying the breach and requiring its remedy; or

(b) Licensee becomes insolvent, or if an order is made or a resolution is passed for its winding up (except voluntarily for the purpose of solvent amalgamation or reconstruction), or if an administrator, administrative receiver or receiver is appointed over the whole or any part of the Licensee’s assets, or if Licensee makes any arrangement with its creditors.

5.2 After the expiration of the Term,  Licensee shall immediately cease production and sale of Systems unless the Parties have agreed otherwise in writing.  

5.3 Despite the foregoing, Licensee may sell any Systems that it has produced through the Term and use any parts intended for Systems that it has in inventory after the expiration of the Term. The right to sell Systems and use parts intended for Systems provided for in this Article 5.2 is subject to Licensee not producing or acquiring Systems or parts that are not reasonably expected to be used during the Term. 

5.4 Upon the expiration or termination of this Agreement, Licensee shall return or destroy all materials relating to the Proposal, with the exception of any documentation that is required for the sale of any parts or servicing of any System currently in use.  Maintenance of only necessary documentations may be kept until Licensee’s inventory of parts for sale or servicing is depleted.  

Article 6: Compensation

[NTD: The License may either be (i) royalty-bearing up to a total of $1,000,000.00 CAD in licensing fees from the System Builders, where the aggregate of any licensing fees obtained both through the Challenge and the Previous Challenge (i.e. through the Manufacturer’s License as defined in the Finalist Agreement) will be deemed to be licensing fees obtained through a Code Life Ventilator Challenge Made for All License for the purposes of this Agreement or (ii) a licensing scheme whereby a royalty calculation formula would be based on the amount of produced units, subject to Sponsor’s approval.]

[NTD: Participants and manufacturers may include terms respecting the timing of payment, but may not deviate from the principle that in the spirit of the Challenge, the teams are asked to minimize or waive licensing fees in situations where it may reduce or prevent access in low- or middle-income countries; for example for manufacturers in low and middle-income countries, as defined by the Organization for Economic Co-operation and Development.]

Article 7: Representations and Warranties

7.1 Except as disclosed in Appendix 2, Licensor represents and warrants that to the best of its knowledge it has the right to grant to Licensor the licenses and any other rights to use the Foreground IP and Background IP provided for herein, and that to the best of its knowledge, the use of such Foreground IP and Background IP as contemplated herein does not infringe on the Intellectual Property Rights of any third party. 

[NTD: maintaining the representations and warranties provided for in Article 7.1 is not a condition of Participants’ agreement with the Sponsor.]

Article 8: Disclaimer 

8.1 LICENSEE ACKNOWLEDGES THAT THE MATERIALS INCLUDED IN THE PROPOSAL AND SYSTEMS ARE EXPERIMENTAL IN NATURE AND THAT THEIR USE MAY BE HAZARDOUS. LICENSOR HEREBY EXPRESSLY DISCLAIMS ALL REPRESENTATIONS OR WARRANTIES, WHETHER IMPLICIT OR EXPLICIT, AS TO THEIR MERCHANTABILITY OR FITNESS FOR ANY PURPOSE WHATSOEVER.  THE MATERIALS INCLUDED IN THE PROPOSAL AND SYSTEMS ARE PROVIDED ON AN AS-IS BASIS AND LICENSOR IS SOLELY RESPONSIBLE FOR ASSESSING THEIR SAFETY AND EFFICACY.

Article 9: Indemnification

9.1 The Sponsor shall not be responsible for any liability associated with the design, licensing, manufacture, sale, storage, transportation or use of any ventilator produced under the Challenge unless it arise out of its gross negligence or wilful misconduct.  

Licensee shall indemnify, defend, and hold harmless Licensor and its directors, officers, employees and agents, as well as the Sponsor and its directors, officers, researchers, employees and agents (each the “Indemnitee” and collectively, the “Indemnitees”) from and against any and all liabilities, damages, losses, claims and expenses, including court costs and reasonable legal fees (“Losses”) resulting from or arising out of any third-party claims, actions or proceedings arising out of Licensee’s use of the Foreground IP, the Background IP, and the deliverables, or out of Licensee’s production of Systems in each case to the extent that such Losses do not arise out of any Indemnitee’s: (A) failure to comply with this Agreement; or (B) gross negligence or willful misconduct.

9.2 An Indemnitee claiming a right of indemnification or defense under this Agreement shall provide Licensee with prompt written notice of any such claim, including a copy thereof, served upon it, and shall cooperate with Licensee and their legal representatives in the investigation of any matter regarding the subject of indemnification, at Participants’ expense; provided, however, that failure by an Indemnitee to provide prompt notice shall not relieve Licensee of their obligations hereunder except to the extent that Licensee is prejudiced by such failure. Licensee shall have the right to exercise sole control over the defense and settlement of any claim for which indemnification or defense is sought, including the sole right to select defense counsel and to direct the defense or settlement of any such claim; provided that Licensee shall not enter into any non-monetary settlement or admit fault or liability on behalf of any Indemnitee without the prior written consent of such Indemnitee, which consent shall not be unreasonably withheld, conditioned or delayed. An Indemnitee shall have the right to select and to obtain representation by separate legal counsel at the Indemnitee's sole expense.

9.3 To the extent that this Article 9 relates to the Sponsor, the Parties acknowledge that it is intended to benefit the Sponsor and that the Sponsor shall have the right to exact performance of the promised obligation directly from the Licensee. The Parties further acknowledge that the Sponsor has advised Licensor of its wish to accept the benefit of this Article 9.  

Article 10: Miscellaneous

10.1 This License constitutes the entire agreement between the Parties and supersedes and extinguishes all previous drafts, agreements, arrangements and understandings between them, whether written or oral, relating to this subject matter.

10.2 Any notices under this License shall be in writing, signed by the relevant Party, and delivered personally, by courier, by registered mail or by facsimile or email transmission to the addresses set out below (or such other addresses as a Party may designate from time to time in writing).

      If to Licensor:

      [Insert name and title of contact person, address, fax number and e-mail address]

      If to Licensee:

      [Insert contact person’s name, address, fax number and e-mail address]

      Notices duly delivered to the Licensor named above shall be deemed delivered to all Licensors. It is the named Licensor’s responsibility to inform the other Licensors of the notice. 

10.3      A waiver of any default, breach or non-compliance of or with this License is not effective unless in writing and signed by the Party or Parties to be bound by the waiver. No waiver shall be inferred from or implied by any failure to act or delay in acting by a Party in respect of any default, breach or non-observance or by anything done or omitted to be done by any other Party. The waiver by a Party of any default, breach or non-compliance under this License shall not operate as a waiver of that Party’s rights under this License in respect of any continuing or subsequent default, breach or non-observance (whether of the same or any other nature).

10.4      No Party may assign this License without the prior written consent of the other Party, which that Party shall not withhold unreasonably. 

10.5      This License ensures to the benefit of and binds the Parties and their respective successors and permitted assigns, and with respect to Investigator, administrators, heirs and executors.

10.6      Each of the Parties to this License is an independent contractor. Nothing in this License shall be deemed or construed to constitute a relationship of agency or employment, a partnership or joint venture between or among any of the Parties for any purpose whatsoever. No Party shall have the authority to act on behalf of another Party or to assume or create any obligation or make any commitment on behalf of another Party.

10.7      Any change in the terms of this License shall be valid only if the change is made in writing, agreed to and signed by the Parties.

10.8      No Party shall be liable to any other Party or shall be in default of its obligations hereunder if such default is the result of war force majeure including but not limited to, hostilities, terrorist activity, revolution, civil commotion, strike, epidemic, fire, and flood or because of any act of God or other cause beyond the reasonable control of the Party affected. The Party affected by such circumstances shall promptly notify the other Parties in writing when such circumstances cause a delay or failure in performance and shall take whatever reasonable steps are necessary to relieve the effect of such cause as rapidly as reasonably possible.

10.9      All provisions of this License which, by their nature, ought reasonably to survive the expiry or termination of this License shall survive any such expiry or termination.

10.10    The interpretation and construction of this License and the rights and obligations of the Parties hereunder shall be governed by the laws of the Province of Quebec and the laws of Canada applicable therein, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this License to the substantive law of another jurisdiction. Each of the Parties irrevocably consents to the exclusive jurisdiction of the federal and provincial courts located in the Province of Quebec, District of Montreal.

10.11    This License may be executed in two or more counterparts, which may be delivered by facsimile or electronic format, each of which shall be deemed to be an original and all of which shall together be deemed to constitute one agreement. If a paper copy with original signatures is required, the Parties will provide it in a timely manner.

10.12 The Parties confirm that they accept that this License as well as all other documents relating to this License, including notices, be drawn up in English only. Les Parties aux présentes confirment qu’elles acceptent que la présente license de même que tous les documents, y compris les avis s’y rattachant, soient rédigés en anglais seulement.

10.13 The Parties acknowledge that their legal counsel has reviewed and participated in settling the terms of this License and that any rule of construction to the effect that any ambiguity is to be resolved against the drafting party shall not be applicable in the interpretation of this License.

[This space has been left blank intentionally. The Parties’ signatures appear on the following page.]

IN WITNESS WHEREOF, THE PARTIES HAVE SIGNED AND DATED AT THE PLACE INDICATED 

Licensor

_________________________  _________________________

[Name of Licensor]                                Place and date

[NTD: All Licensors on the Team must sign. Add as many lines as necessary to accommodate all signatures.]

[Name of Licensee]

By:       _________________________  _________________________

            [Name of authorized representative]       Place and date

            [Title of authorized representative]

APPENDIX D TO THE PARTICIPANT AGREEMENT

REPORT TEMPLATE

[NTD: Insert report template here.]

APPENDIX E TO THE PARTICIPANT AGREEMENT :

DISCLOSURE

[NTD: Disclose any potential conflict of interests here.]