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    Grant Agreement

    September 17, 2013

    Dr. Leonid LeccaDirectorSocios en Salud Sucursal del Per

    Av. Merino Reyna N 575Carabayllo

    Lima 41,Peru

    Dear Dr. Lecca,

    Re: Grand Challenges Canada Grant Number 0351-03Saving Brains: Community-based Family Coaching for Children with

    Developmental Risks in Lima, Peru

    Grand Challenges Canada is pleased to award Socios en Salud Sucursal del Per (theGrantee) a grant up to the amount of $270,000 CAD for the period beginning September 30,2013 (the Start Date) for 24 months (the "Grant Period"). This agreement (the "Grant

    Agreement") contains the terms and conditions of this grant.

    The Grantee agrees that the payment of any funds under the Grant Agreement is subject to itscompliance with the conditions set out herein, including those in Attachments A, B, C, D, E, F, G,H, I, J and K, which form an integral part of this Grant Agreement.

    A. Purpose of the Grant

    The purpose of this grant is to support work that is called Community-based Family Coachingfor Children with Developmental Risks in Lima, Peru, as described in the Grantee's proposal(the "Proposal") submitted in response to a Grand Challenges Canada Request forProposals, with a deadline of February 11, 2013, and a final negotiated budget dated

    September 4, 2013 (the Budget), and Project Framework and Results-based ManagementAccountability Framework (RMAF) dated September 3, 2013, (together, the "Project"). Forinterpretive purposes, this Grant Agreement supersedes any attached documents.

    B. Use of Grant Funds

    Grant funds may only be used for the Project. Any grant funds unexpended or uncommittedat the end of the Grant Period must be promptly returned to Grand Challenges Canada. AnyBudget category change of more than 10% and equivalent to $10,000 CAD or more must be

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    Grant Number: #0351-03 2

    approved in writing by Grand Challenges Canada in advance. The Grantee may not use thegrant funds to reimburse any expenses incurred prior to the Start Date and after theconclusion of the Grant Period. In regards to travel, the use of grant funds must be

    consistent with the Grand Challenges Canada Travel Policy (Attachment F), provided that, inall instances, all Grantee airline travel must be through economy class or equivalent. If theGrantee has its own travel policy, the Grantee will use the lower cost policy.

    The Grantee hereby represents and warrants that the specific activities funded pursuant tothis Grant Agreement are not already funded by another Grand Challenges Canada grant orfunding agreement.

    C. Investment of Grant Funds

    Grant funds must be invested in highly liquid investments (such as interest-bearing bankaccounts) with the primary objective of preservation of principal, so that they are available forthe Project. Grand Challenges Canada requires the Grantee to report the amount of any

    interest or other income generated by the grant funds, including currency conversion gains(collectively "Interest"). Any Interest must be used for the Project. At the end of the GrantPeriod, any remaining Interest must be applied to another Grand Challenges Canada-fundedproject (current or under consideration), or returned to Grand Challenges Canada if no otherGrand Challenges Canada-funded projects exist with the Grantee's institution.

    D. Compliance with Anti-Terrorism Principles

    The Grantee acknowledges that Grand Challenges Canada is subject to and must complywith CanadasAnti-Terrorism Act 2001, c.41 (hereinafter ATA), including the provisions ofthe Criminal Codeof Canada R.S.C. 1985, c. C-46 (hereinafter Code) brought into effect bythe ATA, namely Part II.1 of the Code (seehttp://laws.justice.gc.ca/en/C-46/index.html),which Code provisions create offences related to the participation in, financing, facilitationand carrying out of terrorism and support for entities affiliated with terrorism. GrandChallenges Canada is committed to adhering to the provisions and principles of the ATA inall work it undertakes and supports.

    During and after the term of this Grant Agreement, with regard to the Project and all Propertyprovided by Grand Challenges Canada to the Grantee pursuant to this Grant Agreement, theGrantee shall ensure that the Property is not used in any manner that would constitute abreach of the ATA or the Code.

    The Grantee further agrees to comply with any other instructions regarding compliance withthe terms and conditions of this Section, which Grand Challenges Canada may be requiredto issue during the term of this Grant Agreement in response to changes to Canadian law.

    For the purposes of this Section, the term Property includes real and personal property ofevery description, and deeds and instruments relating to or evidencing the title or right toproperty, or giving a right to recover or receive money or goods, and all funds transferredfrom Grand Challenges Canada to the Grantee pursuant to this Grant Agreement bywhatever means of transfer.

    http://laws.justice.gc.ca/en/C-46/index.htmlhttp://laws.justice.gc.ca/en/C-46/index.html
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    Grant Number: #0351-03 3

    E. Anti-Corruption

    The Grantee declares and guarantees that no offer, gift or payment, consideration or benefitof any kind, which constitutes an illegal practice, has been or will be made to anyone by theGrantee, either directly or indirectly, as an inducement or reward for the award or executionof this Grant Agreement. Any such practice is grounds for terminating the Grant Agreementor taking any other corrective action as required.

    The Grantee shall declare in writing to Grand Challenges Canada if the Grantee, its officers,employees or independent contractors included in the project:

    were convicted during a period of three years prior to the signing of the GrantAgreement by a court of law in Canada or in any other jurisdiction for an offenceinvolving bribery or corruption, or

    are under sanction for an offence involving bribery or corruption, imposed by a

    government, a governmental organization or an organization providing developmentassistance.

    The Grantee shall require its subcontractors to declare to the Grantee in writing if they or anyof their officers, employees or independent contractors involved in the project:

    were convicted during a period of three years prior to the submission of the Projectproposal by a court of law in Canada or in any other jurisdiction for an offenceinvolving bribery or corruption, or

    are under sanction for an offence involving bribery or corruption, imposed by agovernment, a governmental organization or an organization providing developmentassistance.

    The Grantee shall make such declarations it receives from its subcontractors known toGrand Challenges Canada by providing Grand Challenges Canada with a copy of suchdeclarations.

    Grand Challenges Canada may terminate this Grant Agreement forthwith for default where itis found that the Grantee has made a false declaration.

    F. Compliance with National Laws

    In carrying out this project, the Grantee shall, subject to its privileges and immunities, beresponsible for complying with all applicable laws and regulations of the countries in whichthe Project will be carried out and to which Project personnel may have to travel as part ofthe Project.

    G. Indemnification

    a) Assumption of Risk and IndemnificationGeneral

    The Grantee shall indemnify and hold harmless Grand Challenges Canada, theconsortium members (Canada's International Development Research Centre and theCanadian Institutes of Health Research) and the Government of Canada or their affiliates

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    Grant Number: #0351-03 4

    or the officers, employees, agents, independent contractors, subcontractors or licenseesof any of them (the Indemnified Parties), against, and assumes the risk of, any claims,actions, losses, expenses (including legal fees and disbursements) and damages arising

    out of or resulting from, or that are alleged to arise out of or result from, a breach of anymaterial term or representation or warranty of this Grant Agreement, or any other claimby a third party arising out of or resulting from, or that are alleged to arise out of or resultfrom, Project activities or use of Project outputs conducted by the Grantee or its affiliates,or their officers, employees, independent contractors, subcontractors and subgrantees,agents, or licensees.

    b) Assumption of Risk and Intellectual Property Indemnification

    The Grantee assumes the risk of claims, actions, losses, expenses (including legal feesand disbursements) and damages arising out of actual or alleged infringement ofintellectual property rights committed in the course of or in relation to the Project by theGrantee or its affiliates or the officers, employees, independent contractors,

    subcontractors, subgrantees, agents, or licensees of any of them, and shall indemnifyand hold the Indemnified Parties harmless against same.

    c) Insurance

    The Grantee will acquire and maintain reasonable insurance to cover its indemnificationobligations, as would be acquired and maintained by a reasonable and prudentorganization carrying on a similar line of activities in the relevant market.

    H. Warranty

    To the best of the knowledge of the Principal Investigator and his or her team, having notperformed a patent or other intellectual property search, neither the outputs of the Project nor

    the use of the outputs of the Project by the Grantee is or will violate or infringe upon theintellectual property of any third party.

    To the best of the knowledge of the Principal Investigator and his or her team, neither theoutputs of the Project nor the use of the outputs of the Project by the Grantee is or will violatethe privacy rights of anyone, nor will they defame anyone.

    I. Insolvency

    At the discretion of Grand Challenges Canada, this Grant Agreement shall immediatelyterminate without notice if the Grantee (i) ceases to operate, (ii) commits an act of bankruptcywithin the meaning of Canadas Bankruptcy and Insolvency Act, R.S. 1985, c.B-3, asamended, or under any comparable legislation in any other jurisdiction, (iii) is deemedinsolvent within the meaning of Canadas Winding Up and Restructuring Act, R.S. 1985, c.W-11, as amended, or under any comparable legislation in any other jurisdiction, (iv) makesan assignment for the benefit of creditors or has a receiving order made against it, him or herunder applicable bankruptcy or insolvency legislation in any jurisdiction, or in respect ofwhom a receiver, monitor, receiver-manager or the like is appointed, or (v) becomes insolventor makes an application to a court for relief under Canadas Companies Creditors

    Arrangement Act, R.S. c. C-25, as amended, the Bankruptcy and Insolvency Act, the WindingUp and Restructuring Actor under any comparable legislation in any other jurisdiction

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    Grant Number: #0351-03 5

    (collectively or severally referred to as Act of Insolvency). In the event Grand ChallengesCanada does not terminate this Grant Agreement as a result of an Act of Insolvency, it shallbe entitled, in its sole discretion, to suspend or modify its payment obligations under this

    Grant Agreement.In the event of termination arising out of an Act of Insolvency, the Grantees ownership rightsin any intellectual property and other Project outputs funded by Grand Challenges Canadaand developed in pursuit of the Project objectives shall be deemed to have automaticallytransferred to Grand Challenges Canada on the date immediately preceding the actual Act ofInsolvency and will be subject to Grand Challenges Canadas Global Access Policy.

    J. Sufficiency of Funds

    Notwithstanding anything to the contrary contained in this Grant Agreement, GrandChallenges Canadas obligations herein are subject to sufficient funds being made availableto Grand Challenges Canada by the International Development Research Centre (IDRC)

    during the Grant Period. For purposes of clarity, third-party donor funds that are contributedto Grand Challenges Canada in relation to the Project and which are to be provided by GrandChallenges Canada to the Grantee would necessitate the negotiation of an amendment tothis Grant Agreement, or a separate agreement, as between Grand Challenges Canada andthe Grantee, in order to supplement the Grantee funds provided to the Grantee pursuant tothis Grant Agreement. It is understood that, on receipt of reliable information indicating thatsufficient funds may not be made available to Grand Challenges Canada in relation to theProject, Grand Challenges Canada shall immediately notify the Grantee in writing. In anysuch event, Grand Challenges Canada and the Grantee shall work together to develop a planfor the orderly management of the Project in light of any financial shortfalls, includingensuring that irrevocable commitments to third parties made in good faith before the date ofany written notice from Grand Challenges Canada to the Grantee are met.

    K. Environmental Assessment

    Under the Canadian Environmental Assessment Act("CEAA"), aspects of this Project may berequired to undergo an environmental assessment before financial assistance is provided tocarry out such aspects of the Project by Grand Challenges Canada. A determination as towhether an environmental assessment is required will be made by Grand ChallengesCanada. Should an environmental assessment be required, the Grantee shall conduct suchan assessment, upon direction from Grand Challenges Canada, and prepare a report inaccordance with the CEAA.

    Grand Challenges Canada reserves the right to take any action necessary to ensurecompliance with the requirements of the CEAA or to ensure environmental protection more

    generally, including but without being limited to the termination of the Grant Agreement or theimposition of any mitigation or follow-up measures necessary to reduce, eliminate or controlany adverse environmental effects of the Project.

    If an environmental assessment is required, Grand Challenges Canada shall determinewhether the Project is likely to cause significant adverse environmental effects on receipt ofthe environmental assessment report provided by the Grantee, and any other information thatGrand Challenges Canada deems to be relevant. The Grantee shall not in any way

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    Grant Number: #0351-03 6

    implement or carry out the aspects of the Project covered by an environmental assessmentreport until Grand Challenges Canada has provided its authorization to do so in writing.

    L. Subgrants and Subcontracts

    The Grantee has the exclusive right to select subgrantees and subcontractors for the Project,with the exception of considerations related to Canada'sAnti-Terrorism Act 2001referencedin Section D above. All subgrantees and subcontractors shall become a party to anagreement with the Grantee that is substantially consistent with the Grantees obligationsunder this Grant Agreement. The Grantee recognizes that the selection, removal orreplacement of a subgrantee, subcontractor, Co-Principal Investigator or Co-Investigator canrepresent a significant change within the meaning of Section Q (Termination) below, and thuscan be sufficient grounds for termination or suspension of the grant or withholding of paymentby Grand Challenges Canada. Grand Challenges Canada has not earmarked the use of thegrant funds for any specific subgrantee or subcontractor. The Grantee, and not GrandChallenges Canada, is responsible for ensuring that all subgrantees and subcontractors' use

    of grant funds is consistent with this Grant Agreement and the Proposal. Neither the Granteenor subgrantees nor subcontractors may make any statement or otherwise imply to donors,investors, media, the general public or any other party that Grand Challenges Canada directlyfunds the activities of any subgrantee or subcontractor. At the discretion of the Grantee, anindividual or organization involved in this project may state publically:

    ______________________ is a _______________________ on the ProjectInsert name of individual Insert name of role

    Community-based Family Coaching for Children with Developmental Risks in Lima, Perufunded by Grand Challenges Canada to the Grantee Socios en Salud Sucursal del Per.

    Any agreements with subgrantees and subcontractors the Grantee engages to assist with theProject must include the following language:

    "Your organization has been selected to participate in this Project at our discretion. You maynot make any statement or otherwise imply to donors, investors, media, the general public orany other party that you are a direct Grantee of Grand Challenges Canada. You may statethat Socios en Salud Sucursal del Per is a Grantee of Grand Challenges Canada and thatyou are a subgrantee or subcontractor of Socios en Salud Sucursal del Per for the Project.You are subject to the same grant clauses as the original grant to Socios en Salud Sucursaldel Per. This subgrant agreement is subordinate to the original grant to Socios en SaludSucursal del Per by Grand Challenges Canada. By signing this agreement, you admit noticeof the original grant to Socios en Salud Sucursal del Per by Grand Challenges Canada. Tothe extent that this subgrant agreement conflicts in any way with the obligations of theGrantee under the original grant agreement, the Grantee shall act in accordance with itsobligations under the original grant agreement and may modify the terms of the subgrantagreement without the subgrantee's consent to ensure that they are consistent with the termsof the Grant Agreement.

    In addition, any agreements with the subgrantee or subcontractors may include the followinglanguage with respect to Co-Investigators and Co-Principal Investigators:

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    Grant Number: #0351-03 7

    You may state:______________________ is a _______________________ on the Project

    Insert name of individual Insert name of role

    Community-based Family Coaching for Children with Developmental Risks in Lima, Perufunded by Grand Challenges Canada to the Grantee Socios en Salud Sucursal del Per.

    M. Payments and Reports

    Please refer to Attachment A for the Project Framework, Attachment B for the Results-basedManagement Accountability Framework (RMAF) and Attachment E for the Schedule ofReports and Payments. Where indicated, Grand Challenges Canadas payment is contingenton satisfaction of the listed deliverable and/or milestone. Grand Challenges Canada mayauthorize changes to the payment and reporting schedules from time to time, whereappropriate. Grand Challenges Canada will confirm any such changes in writing.

    Grand Challenges Canada expects its grantees to be focused on results. The RMAF

    approach to project management is designed to help outline the expected results of a projectand to allow the Grantee and Grand Challenges Canada to monitor progress in achievingproject results. Grantee will be required to complete and update the RMAF table semi-annually, and upon request.

    N. Report Templates

    The Grantee is required to submit one or more reports regarding the expenditure of grantfunds and your progress on the Project. Please refer to Attachment D for the ReportingProgress Guidelines. Grand Challenges Canadas progress report templates and submissionguidelines for this grant will be provided to the Grantee at an appropriate time.

    These templates and guidelines are subject to change. Please submit reports electronicallyto your Project Coordinator. Grand Challenges Canada will send the Grantee an email withthe contact information for these individuals. The Grantee also agrees to submit such otherreports that Grand Challenges Canada may reasonably request from time to time.

    O. Record Maintenance and Inspection

    Grand Challenges Canada requires that the Grantee maintain adequate records for theProject, to enable Grand Challenges Canada to easily determine how the grant funds wereexpended. These records are to be maintained for a minimum of two years after theconclusion of the Grant Period. The Grantees books and records must be made available forinspection by Grand Challenges Canada or its designee at reasonable times, to permit us tomonitor and conduct an evaluation of operations under this grant.

    At the request of Grand Challenges Canada, the Grantee will permit representatives of GrandChallenges Canada or its designees to visit the Grantees premises and any Project sites attimes convenient to the parties concerned, and will facilitate the discussion of the results andprogress of the Project between Grand Challenges Canada representatives and Projectpersonnel.

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    Grant Number: #0351-03 8

    P. Change of Principal Investigator

    Grand Challenges Canada shall receive prior notice in writing of any proposed change in thePrincipal Investigator for the Project. Grand Challenges Canada shall be consulted andprovided the opportunity to provide input on the selection of any new Principal Investigator forthe Project.

    Q. Termination

    Grand Challenges Canada has the right, at its discretion, to terminate or suspend the grant orwithhold payment if (i) Grand Challenges Canada is not reasonably satisfied with theGrantee's progress on the Project, (ii) significant leadership or other changes occur thatGrand Challenges Canada believes may threaten the Project, (iii) Grand Challenges Canadadoes not approve any change in the Principal Investigator of the Project (the applicant whogenerated the idea that forms the basis of this Project), (iv) the Grantee or Grand ChallengesCanada receives a complaint, including a legal claim, that in the opinion of Grand Challenges

    Canada raises a risk of liability, (v) the Grantee fails to comply with any term or condition ofthis Grant Agreement, (vi) any of the representations or warranties of the Grantee set forth in

    Attachment K is not true, correct and complete in all material respects, or (vii) activitiesfunded by this Grant Agreement are taking place in, or relate to, countries not on GrandChallenges Canadas Country Eligibility List. On termination, if requested by GrandChallenges Canada, the Grantee agrees to promptly return to Grand Challenges Canada anyunspent and uncommitted grant funds (as of the date of termination) previously distributed tothe Grantee by Grand Challenges Canada for the Project.

    R. Publication

    The Grantee agrees that it will make available to the public through open access channels

    the results of the research emerging from the Project, or any reports or other publicationsregarding the Project funded by this grant (collectively, the "Materials"), and anticipates thatthe Materials will be published in a treatise, thesis, trade publication or in any other formatthat is available for the interested public as soon as practical, consistent with the need to firstsecure intellectual property rights in a manner that maximizes the benefits to developingworld interests.1Specifically, the Grantee is expected to use good faith efforts and work in acollaborative fashion with its subcontractors and funders associated with the Project tofacilitate broad dissemination and accessibility of the Materials in the developing world.

    S. Global Access, Ethics and Data

    The Grantee acknowledges that it understands and commits to compliance with the GrandChallenges Canada Ethics Policy, Grand Challenges Canada Global Access Policy andGrand Challenges Canada Data Access Policy, which are integral parts of this Grant

    Agreement and have been included as Attachments G, H and I.

    1For the purposes of this Grant Agreement, developing world will be defined as the countries listed aslow-, lower-middle- and upper-middle-income countries in the World Banks Income Classification Schemeat the time of implementation or commercialization.

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    Grant Number: #0351-03 9

    The principles of the Global Access Policy are (1) making Project technologies and solutionsaccessible, both in terms of price and availability, to those in need, particularly in thedeveloping world, (2) broadly and promptly disseminating knowledge and information gained

    through the Project to the global scientific community and beyond, and (3) commercializationof any Project outputs is encouraged but must be done in a manner consistent with theprinciples of the Global Access Policy. The Grantees commitment to GlobalAccess withregard to Project technologies and information survives the Grant Period and will lastindefinitely.

    The principles of the Grand Challenges Canada Ethics Policy are (1) research involvinghuman participants will be conducted in a manner that demonstrates, protects and preservesrespect for persons, concern for the welfare of individuals, families and communities, and

    justice, (2) research involving animals must be conducted in a manner that ensures theirhumane care and treatment, and (3) certain research endeavours, including but not limited toresearch with recombinant DNA, biohazards and genetically modified organisms, may besubject to enhanced regulation and oversight.

    The principles of the Data Access Policy are (1) Data will be shared as broadly and aspromptly as possible to foster innovation and optimize prospects for the translation ofknowledge into life-saving solutions. Data access should enhance the value of research andadvance the objectives of Grand Challenges programs; (2) Respect for cultural diversity,scientific integrity, and the privacy of individuals and communities that contribute data will beensured in all data access activities. Respect must also be given to matters of attribution asthey pertain to researchers and institutions that share data; (3) Those who collect, produce,share and use data are responsible for ensuring data quality, security, and modes of accessand use that are consistent with applicable laws, regulations, and standards of ethicalresearch conduct as outlined in Grand Challenges Canada Ethics Policy; (4) A proportionalapproach will be adopted when balancing the needs of investigators against those of

    communities and sponsors that expect health benefits to arise from the activities to whichthey contribute data or resources. The risks and benefits of data access will be consideredand accounted for when sharing data; and (5) The aim of benefitting the individuals andcommunities who enable and support inquiry, be they research participants or investigators,should be furthered to the extent possible and is of particular importance when involvingindividuals and communities from developing countries. The sharing of data that can beused to foster breakthrough solutions to global challenges is one way to ensure benefits arereturned.

    T. Non-exclusive License

    In furtherance of your commitment to the Global Access Policy, you hereby grant to Grand

    Challenges Canada a non-exclusive license and an agreement not to assert, as set out inAttachment J. You hereby acknowledge that the consideration for this license and agreementnot to assert is the monies forwarded, or to be forwarded, to you under this Grant Agreement,the sufficiency of which is hereby acknowledged by you.

    You will have the Principal Investigator, and all your employees, collaborators, contractors,subcontractors, subgrantees, consultants, partners, investors and/or affiliates who will beinvolved in this Project, review Attachment J and execute the undertaking therein.

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    Grant Number: #0351-03 10

    You also agree to assist Grand Challenges Canada in perfecting or confirming this non-exclusive license, by executing any documents that may be required, including but not limitedto a confirmatory license, for filing with national regulatory authorities, such as intellectual

    property offices. Should it be necessary, you agree to negotiate in good faith and execute adetailed license agreement containing at least the terms set out at Attachment J.

    U. Grant Announcements, Public Reports and Use of Grand Challenges Canadas Nameand Logo

    Grand Challenges Canada will include information on this grant in its periodic public reports,and may make grant information public at any time on its web page and as part of pressreleases, public reports, speeches, newsletters and other public documents. In all of theGrantees publications and presentations, the Grantee will acknowledge the support of GrandChallenges Canada. If the Grantee wishes to use Grand Challenges Canadas logo in anypublications, presentations, materials, videos or any other public documents, the Granteemust obtain and use an unaltered digital copy of the logo from the websitewww.grandchallenges.ca/brandguidelines and comply with all terms and conditions set out onthat website. If the Grantee wishes to issue a press release or announcement regarding theaward of this grant, it must obtain advance approval from Grand Challenges Canada of thepress release and the date of release. Please note that Grand Challenges Canada willensure that all consortium members of the Development Innovation Fund will beappropriately credited. The Grantee also agrees to obtain advance approval from GrandChallenges Canada for any other use of Grand Challenges Canada's name or logo. TheGrantee agrees to [email protected] at least two weeks before any pressrelease, announcement or other publication date.

    V. Representations and Warranties

    Grand Challenges Canada is entering into this Grant Agreement in reliance upon yourrepresentations and warranties set forth in Attachment K, which representations andwarranties shall be continuing beyond the term of this Grant Agreement except for those that,by their terms, are limited to a specific date.

    W. Counterparts: Original

    This Grant Agreement, including any amendments, may be executed in counterparts which,when taken together, will constitute one Grant Agreement. Copies of this Grant Agreementwill be equally binding as originals, and faxed or scanned and emailed counterpart signatureswill be sufficient to evidence execution, though Grand Challenges Canada may require theGrantee to deliver original signed documents.

    X. Assignment Clause

    This Grant Agreement or any of the rights or obligations under this Grant Agreement may notbe assigned without Grand Challenges Canadas prior written consent. An assignmentincludes (i) any transfer of the Project, (ii) an assignment by operation of law, including amerger or consolidation, or (iii) the sale or transfer of all or substantially all of the Granteesassets.

    http://www.grandchallenges.ca/brandguidelinesmailto:[email protected]:[email protected]://www.grandchallenges.ca/brandguidelines
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    Grant Number: #0351-03 11

    Y. Entire Agreement, Severability and Amendment

    This Grant Agreement is our entire agreement and supersedes any prior oral or writtenagreements or communications between us regarding its subject matter. The provisions ofthis Grant Agreement are severable so that if any provision is found to be invalid, illegal orunenforceable, such finding shall not affect the validity, construction or enforceability of anyremaining provision. This Grant Agreement may be amended only by a mutual writtenagreement of the parties.

    Z. Governing Law

    The construction, enforceability, validity and interpretation of this Grant Agreement shall be inaccordance with the laws of the Province of Ontario and the laws of Canada.

    AA. Relationship

    The Grantee undertakes the Project on its own behalf and not on behalf of Grand ChallengesCanada or any institutions providing Grand Challenges Canada with funding, and this Grant

    Agreement and the funds flowing from it shall in no way be construed as creating therelationship of principal and agent, of partnership in law, or of joint venture as between theGrantee and Grand Challenges Canada or any institutions providing Grand ChallengesCanada with funding, including but not limited to Canada's International DevelopmentResearch Centre.

    Neither Grand Challenges Canada nor any institutions providing Grand Challenges Canadawith funding assume any liability with respect to any accident to any person or any loss ordamage to any person or property arising from the Project.

    BB. Survival

    The terms of this Grant Agreement shall remain in full force and effect during any period inwhich Grand Challenges Canada has suspended the grant or withheld any payment.Following the termination of the grant, this Grant Agreement shall terminate and be of nofurther force and effect, provided that the following sections shall survive and continue in fullforce and effect indefinitely: Section G (Indemnification), Section O (Record Maintenanceand Inspection), with respect to record maintenance only, Section R (Publication), Section S(Global Access, Ethics and Data), Section T(Non-exclusive License), Section U (Grant

    Announcements, Public Reports and Use of Grand Challenges Name and Logo), Section V(Representations and Warranties) and Section Z. (Governing Law).

    CC. Special ClauseIndirect Costs

    The Grantee will provide an overview (no more than one page) by the first financial reportonhow the indirect costs associated with this grant agreement will be used during the course ofthe Project.

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    Grant Number: #0351-03 12

    This grant award offer is only valid 10 days from the date of this offer (September 17, 2013).Therefore, the Grantee must sign and return this letter to Janne Dingemans, Project Coordinator,Grand Challenges Canada, no later than September 27, 2013 to receive a Saving Brains grant

    award. Please keep a copy for your records. If you have any questions, please contact JanneDingemans by email at [email protected] or by telephone at +1 (416) 673-6558.

    On behalf of Grand Challenges Canada, may we extend every good wish for the success of yourwork.

    Sincerely

    GRAND CHALLENGES CANADA

    By:______________________ By:______________________

    Karlee SilverDirector of Targeted ChallengesGrand Challenges Canada

    Claude BriandDirector of Finance and

    AdministrationGrand Challenges Canada

    Accepted and agreed to by:

    Socios en Salud Sucursal del Per

    ______________________ Date:_________________

    Leonid LeccaDirectorSocios en Salud Sucursal del Per

    Acknowledged by:

    __________________________ Date:__________________Leonid LeccaPrincipal Investigator

    __________________________ Date:__________________Llubitza Maribel Muoz ValleCo-Principal Investigator

    mailto:[email protected]:[email protected]
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    rant Number: #0351-03 13

    Attachment A: Project Framework

    bjectives Activities Critical milestones Estimated dates Estimated C(CAD)

    bjective 1: Development of a community-basedoup intervention to coach caregivers of childrenrisk for NDD and provide caregivers witheaningful social support, encouragement and

    ocial connectedness

    Activity 1.1: Review group interventions aimed at childdevelopment for the target age range.

    Brief report on key features of evidence-based group interventions aimed at childdevelopment compiled and presented to the Peru team.

    Month 1-2 $

    Activity 1.2: Develop group community based earlyintervention (GROUP-CBEI) model and supportingimplementation materials

    Intervention model designed for (i) delivery by a CHW and peer facilitator as 12 weeklysessions over 3 months to groups of 4-10 dyads, across a diverse spectrum in terms ofage and developmental status and (ii) retain core elements and sequential steps of theSPARK approach to early intervention (eg, coaching parents on stimulation of their childsdevelopment, and providing parents with social support and encouragement.)

    Finished "tool kit" for community-based group early intervention, including trainingmanual, fidelity and monitoring protocol, CHW manual, & supplies for eachsession. (Month 8)

    Month 1-8 $1

    bjective 2: Implement & evaluate proposedterventions to three study arms.

    Activity 2.1: Seek ethics approval from the NationalInstitute of Health in Peru

    Proof of ethics approval from the National Institute of Health in Peru submitted toGrand Challenges Canada (Month 4).

    Month 4

    Activity 2.2. Train field supervisor, study coordinator,and data collector to deliver the EEDP, and EASQ aswell as HOME a nd GROUP CBEIs.

    Field supervisor, study coordinator, and data collector competent to deliver the EEDP,EASQ, HOME and GROUP CBEIs as measured by written exams, inter-rater agreementbetween trainee and trainer, video review of intervention delivery simulations.

    Month 1-3 & Month 9 $1

    Activity 2.3. Train community health workers (CHWs) inCBEI and EEDP through workshop-style trainingsessions (2 days on EEDP, 4 days on HOME CBEI, 4days on GROUP CBEI).

    2 CHWs trained in HOME-CBEI (Month 4). Sufficient training indicated by fidelityassessment protocol (trainers review a video-recorded mock CBEI session delivered to avolunteer family using the fidelity assessment form)

    2 CHWs trained in GROUP-CBEI (Month 9). Competency will be assessed as a teamwith field supervisor following fidelity assessment protocol. Trainers will review a video-recorded mock CBEI group session delivered to a volunteer group of families andevaluate using the fidelity assessment form.

    4 CHWs trained in EEDP and EASQ. Competency indicated by 100% agreement betweenwritten assessments of the trainer and trainee.

    Trainees who do not demonstrate competency receive additional coaching and feedbackand mock role-play until competency is established.

    Month 4 & Month 9 $1

    Activity 2.4: Enroll 60 children from health six healthcenters/community botiquins/home visits in Carabayllo,

    Peru for HOME-CBEI 60 children 6-24 months of age screened using the EEDP and enrolled into the studyaccording to eligibility criteria:1) Age between 624 months of age; 2) EEDP assessment; 3) Known primary caregiver(parent or legal guardian) living with child; 4) Living within the catchment area of the 6Health Centers that comprise the study zone.

    30 of the at-risk children and their primary caregivers are enrolled into HOME-CBEIintervention arm based on health centre catchment area and a ccording toadditional eligibility criteria (Month 6):5) No known medical condition that would make the child unresponsive to earlyintervention; 6) Family does not anticipate moving within the next three months.

    Month 5-6 $3

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    Activity 2.5: Enroll 60 children from health six healthcenters/community botiquins/home visits in Carabayllo,Peru for GROUP-CBEI

    60 children 6.24 months screened using the EEDP and enrolled into the study accordingto eligibility criteria listed for Activity 2.4.

    30 of the at-risk children and their primary caregivers are enrolled into GROUP-CBEI intervention arm based on health centre catchment area and according toadditional eligibility criteria listed for Activity 2.4 (Month 11).

    Month 10-11 $3

    Activity 2.6: Deliver CBI and monthly nutritional supportto participants.

    20 dyads received nutritional assistance (monthly food packet) alone for 3 months

    20 dyads received HOME-CBEI

    20 dyads received HOME-GROUP + nutritional assistance for 3 months

    Month 5 - 14 $4

    Activity 2.7: Collect and analyze data. Complete baseline data (demographics, anthropomorphic & health data, HOME, ASQ)entered into database within 3 weeks of participant enrollment.

    Tables and brief report produced.

    Complete 3-month follow-up data (anthropomorphic & health data, HOME, ASQ) enteredinto database within 3 weeks of last participant completing the study

    Month 5- Month 14 $6

    bjective 3: Obtain multi-sector support forogrammatic implementation of pilot strategy.

    Activity 3.1: Meet with local stakeholders to introducepilot and obtain support for scale up.

    Four meetings held to present the study plan and invite input from1) Peruvian Ministry of Health leaders Jose Luis Sebastian Mesones, NationalCoordinatorPrevention and Control of STIs, HIV and AIDS Strategy, and Estela RoederCarbo, Director- Department of Communications, Ministry of Health, Peru;2) leaders at the level of lima,3) municipality leaders in Carabayllo Rafael Alvarez Espinoza, Mayor of Carabayllo;4) Flix Rodriguez Crdenas, General Coordinator, Carabayllo Health Coordinator(COSACA) and5) CHWs.

    Leaders at the level of Lima and/or Carabayllo support programmatic dissemination(Month 12)

    Month 1- 12 $

    Activity 3.2: Prepare for scale-up Revise and submit Theory of Change document to Grand Challenges Canada(Month 6)

    Month 6

    Activity 3.3: Disseminate findings to internationalcolleagues.

    Web-conference to discuss findings with Haitian and Rwandan health care providers,leaders, and CHWs held.Priorities and common strategies between international sites identified.

    Four academic articles written: 1) performance of evaluation instruments in this cohort,including EASQ and EEDP; 2) process evaluation of delivery of CBEI by CHWs; 3)

    factors associated with NDD in Carabayllo (baseline); 4) final outcome results anddescriptions of populations that benefit most from which intervention.

    Month 22-23 $

    Activitiy 3.4: Develop an implementation plan in Lima orCarabayllo.

    Draft implementation plan clearly defining resources, roles, and monitoring activities forscale-up developed jointly by Socios En Salud and leaders of the city of Lima and/orCarabayllo

    Month 24 $

    Total Cost: 25

    Please note that the total cost does not include the amount ($20,000 CAD, including indirect costs) provided by Grand Challenges Canada for participation in our community meetings.

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    Attachment B: Results-based Management Accountability Framework (RMAF)

    Description ofOutcome/ Output

    Description of IndicatorPROJECT RESULTS - EXPECTED

    Data Source# / % Indicator

    A. Lives savedand improved inlow- and middle-income countries(LMICs)

    Changes in percentage (x% to y%) ofpeople with improved health outcomes

    32 Children with any developmental improvement inintervention arm after 3 month intervention. (assuming80% or 32 of the 40 children in the intervention armmeet indicator).

    To assess the impact of CBEI on NDD risk among 60 at-risk children, we will compare change in age-adjusted EASQ Z-scorechange from month 0 to month 3) among CBEI versus control groups (from Peru findings in Fernald et al). Areas of developmebe measured include the Core Metrics Areas of: general cognition, reception and expressive language, fine and gross motor sand general socio-emotional development. Methodology: EASQ will be administered by CHWs during patient home visits. SoWe will apply EASQ to 120 kids enrolled prospectively through 10 Carabayllo health centers and botiquines. Of those, 60 with at least one area will be enrolled in the observational study. Remaining 60 children will be tested using the EASQ and EEDP abaseline and 3 months to understand correlation between instruments among non-delayed children. Measuring endpoints at 3 will assess for on-intervention effects. We will use "intention-to-treat" analyses. Sample size: Calculations for recruitment sizebased on 71% delayed as reported by Socios En Salud child development project in Carabayllo.) Note that Home and GROUPwill be compared as a single group with the control group for these analyses.

    # people with improved health outcomes

    A. Changes inaccess for

    BENEFICIARIES toproducts orservices

    Change in percentage (x% to y%) of

    BENEFICIARIES who have access toproducts and / or services

    36

    34

    Children who experience improved quality ofinteraction with their parent. (assuming 90% or 36 of40 children in intervention group meet indicator)

    Increase in children exposed to cognitive stimulation(assuming 85%, or 34 of 40 of children in interventiongroup meet indicator)

    Quality of parent-child interactions will be evaluated by videotaped home visits and reviewed using pre-selected criteria standa

    to Peru. A selection of total visits (20%) will be videotaped to measure quality of parent-child interactions. A member of the fiewill join the CHW to manage the video camera and ensure informed consent.

    B. Changesin knowledge,attitudes orbehaviours ofBENEFICIARIES

    Change in percentage (x% to y%) ofBENEFICIARIES with improvedknowledge, attitudes or behaviours

    # of BENEFICIARIES with improvedknowledge, attitudes or behaviours

    C. Changesin knowledge,attitudes orbehaviours ofINTERMEDIARIES/PROVIDERS

    Change in percentage (x% to y%) ofINTERMEDIARIES/PROVIDERS withimproved knowledge, attitudes orbehaviours

    34 Parents with increase in HOME score, parentresponsivity and parent involvement (assuming 85%,or 34 of 40 intervention recipients meet indicator).

    HOME: The HOME global score will assess quality of parent-child interactions and home environment for early stimulation bycomparing 3 month mean scores to baseline scores in intervention vs. CBEI. This instrument is designed to measure the qualiquantity of stimulation & support available to a child in home environment. Parent responsivity, parent involvement, and cognitstimulation are subscales in the HOME questionnaire at 3 months intake compared to baseline. Used in Latin-American cohorincluding urban Peru. Takes 45-90 minutes to administer. HOME: Methodology: CHWs will administer HOME during home visPower calculations: Power depends on standard deviation, but detecting statistically significant impact is not our primary objecNote that HOME and GROUP CBEIs will be compared as a single group with the control group for these analyses.

    32 Caregivers with improved knowledge on childdevelopment, parenting behaviour change, self-efficacy and perceived social support (i.e., ranked at 4questions as either very effective or effective)(assuming 80%, or 32 of 40 intervention recipientsmeet indicator)

    Four Likert-response questions and two open-ended questions administered by CHW after each CBEI session to assess caregknowledge on child development, parenting behavior change, self-efficacy and perceived social support. Surveys questions wientered into excel database and analyzed using variables - "very effective", "effective", "moderately effective", and "not effectiv

    D. Changes inskills/training ofINTERMEDIARIES/PROVIDERS

    # of INTERMEDIARIES/PROVIDERS withincreased training or skills

    E. Changesin awareness ofINTERMEDIARIES/PROVIDERS andBENEFICIARIES

    Change in percentage (x% to y%) ofpeople reached through awareness-building outputs

    # of people reached through awareness-building outputs

    F. Changesin policy, legislationand/or regulation

    # of policies developed through the project# of policies adopted as a result of theproject

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    A. BuildingTools and Capacityto Execute

    1. # of innovative prototypes and/orservice delivery models developed

    1 Group CBE intervention model

    2. # of curriculum changes recommended

    3. # of policy recommendations developed 2policy recommendations in the form of implementationplans (if political leaders show interest): 1) Politicalleaders in Lima; 2) municipality leaders in Carabayllo

    4. # of patents filed (expected) / granted(achieved)

    5. # of public awareness outputs (videos,news releases, radio shows, etc.)

    2

    1 interview on television news channel

    1 web-conference will be held to present and discussfindings with Haitian and Rwandan health careproviders, leaders,

    6. # of analytical models developed

    7. # of papers (expected ) / published

    (achieved)

    4

    Papers drafted for publication on 1) performance ofevaluation instruments in this cohort, including EASQand EEDP; 2) process evaluation of delivery of CBEIby CHWs; 3) factors associated with NDD in

    Carabayllo (baseline); 4) final outcome results anddescriptions of populations that benefit most fromwhich intervention.

    8. $ Funds leveraged $8,000

    9. # of total members of project team 18

    10. # of total members of project team inLMIC

    12

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    Attachment C: Budget2

    2Please note that more detailed project budget information is contained in a separate Excel file, with adocument title of (20130904_Detailed_Budget_0351-03), sent in the same email with this final GrantAgreement.

    Budget category Year 1 Year 2 Total

    Total Personnel (Direct FTE Costs) 126,711 126,711 253,422

    Total Travel (Direct Travel Costs) 24,303 24,303 48,606

    Total Consultants (Direct Consulting Costs) 41,685 41,685 83,370

    Total Direct Supplies and Services (Direct Supplies) 17,085 18,630 35,715

    Total Equipment (Direct Equipment) 0 0 0

    Total Other Research (Direct Research) 66,855 20,161 87,016

    Total Sub-grants and Subcontracts 74,114 75,249 149,364

    Total Indirect project costs 44,813 39,149 83,962

    Total Project in Local Currency 395,565 345,889 741,454

    Total Project in CAD 144,045 125,955 270,000Indirect Costs % (must be 13% or less) 12.8% 12.8% 12.8%

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    Attachment D: Reporting Progress Guidelines

    The overall purpose of progress reporting is to ensure that your project stays on track and that

    Grand Challenges Canada can effectively assist you in identifying and resolving anyissues/barriers/gaps as they emerge.

    Progress against Project milestones (Attachment A) and results achieved (Attachment B) will bereported regularly to Grand Challenges Canada through video/teleconferences/in-personmeetings with your Program Officer(s), the submission of semi-annual progress reports, and afinal report. Grant expenditures against the Project budget (Attachment C) will be reportedregularly as per the Schedule of Reports and Payments (Attachment E). Payment of grantinstallments is conditional upon satisfactory progress and reporting.

    Below we summarize the elements of these reports; templates will be provided to assist you withthe submission of formal reports. Please note that Grantees are encouraged to reach out to their

    Program Officer(s) proactively and as needed outside of defined reporting structures to discussany developing issues or opportunities.

    PROGRESS AGAINST PROJECT MILESTONES

    Quarterly Updates

    When requested by either the Grantee or their Program Officer(s), Grantees will meet with theirProgram Officer(s) on a quarterly basis via video/teleconference/in-person meetings to discussprogress, challenges and gaps in project execution. No formal report or presentation is required,although you may, at your discretion, submit a summary document in advance of the discussion.Topics to be covered during the meeting shall include:

    a. Progress against anticipated results, critical milestones and associated budget asoutlined in the Results-based Management Accountability Framework (RMAF) andProject Framework, including explanation of any variances;

    b. Major achievements/outcomes in this quarter (e.g. conference posters/presentations;invited talks; publications; citations; participation in media/public events; patents; etc) andanticipated achievements/outcomes for the upcoming quarter;

    c. Key learnings over the past quarter;

    d. Current thinking on Path to Scale/Theory of Change and any progress against initial plan.Have partners/consultants (business, technical, social, as appropriate) been engaged topromote advancement along Path to Scale/Theory of Change?

    e. Re-examination and ranking of risks associated with the Project Framework and Path toScale/Theory of Change, and potential mitigation strategies, including action steps;

    f. Any proposed changes/amendments to any aspect of the project;

    g. Areas where Grand Challenges Canada can help.

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    Semi-Annual Reporting

    The Grantee is expected to submit a written progress report to Grand Challenges Canada everysix months. A report template will be provided for this purpose. The content of these reports will

    be used by Grand Challenges Canada to assess progress, extract lessons and tailor communitymeetings to effectively support the success of your project and that of the portfolio of projects.The reporting template, which will be provided by Grand Challenges Canada, shall include thefollowing elements:

    a. Progress and key accomplishments against:

    Anticipated results

    Critical milestones and associated budget;

    Path to Scale / Theory of Change;

    b. Description of project plan for the next 6 months and anticipated outcomes;

    c. Re-examination and ranking of risks associated with the project, and potential mitigationstrategies, including action steps;

    d. Areas where Grand Challenges Canada can help;

    e. Input and considerations relevant to the community of innovators (key research findings,input from solution end-users, lessons learned, developments in the field, etc.);

    f. Questions/issues relevant to the community of innovators that should be addressed /discussed.

    Go/No-go Milestones

    The Grantee is expected to submit sufficient evidence of successful completion of all Go/No-goMilestones to Grand Challenges Canada. Payments linked to Go/No-go Milestones will not bereleased until sufficient evidence to support their successful completion has been submitted.Go/No-go Milestones are highlighted in bold in the Critical Milestones column within the ProjectFramework (Attachment A). They are also referenced in the Schedule of Reports and Payments(Attachment E), which outlines the deadlines for submission of evidence and the payment theyare associated with.

    FINANCIAL REPORTING

    Periodic Reporting

    The Grantee will be provided with a financial reporting template to be completed and submittedon a periodic basis as defined in the Schedule of Reports and Payments (Attachment E). Thereporting template, which will be sent to the Grantee, will include the following elements:

    a. Budget for the reporting period, by category and line item;

    b. Actual expenses for the reporting period, by category and line item;

    c. Variance between budget expenses and actual expenses, and by category and line item;

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    d. Explanations for major variances (+/- 10%) by line item;

    e. Forecasts for the subsequent reporting period;

    f. Confirmation of payment(s) received, by date and amount

    The analysis of the financial report will allow Grand Challenges Canada to assess how theproject funds have been used in relation to the progress reports against project milestones. Theanalysis will also allow Grand Challenges Canada to estimate the subsequent payment to bemade to the Grantee.

    FINAL REPORT

    The Grantee will be provided with a reporting template detailing project achievements andexpenditure, to be completed and submitted within 30 days of project completion (details tofollow). Please note that 5% of project funding will be withheld pending submission of a

    satisfactory Final Report.

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    Attachment E: Schedule of Reports and Payments

    This table outlines when financial reports, progress reports and a milestones proof of completion must be submitted. It also outlines when paymewill be issued and any associated specific conditions for payment. Note that all payments are conditional upon satisfactory financial reportand progress against project milestones.

    PaymentNo. Report PeriodEnd Report/paymentDue Date

    PaymentAmount FinancialReport ProgressReport Specific conditions for payment Go / no gomilestone?

    1 5,613 CAD (1)

    2 September30, 2013

    113,000 CAD

    3 March 31, 2014 April 30, 2014 57,000 CAD Yes Proof of ethics approval fromthe National Institute of Healthin Peru submitted to GrandChallenges Canada (Month 4)

    2 CHWs trained in HOME-CBEI (Month 4)

    30 of the at-risk children andtheir primary caregivers areenrolled into HOME-CBEIintervention arm based onhealth centre catchment areaand according to additionaleligibility criteria (Month 6)

    Revise and submit Theory ofChange document to GrandChallenges Canada (Month 6)

    Yes

    Yes

    Yes

    Yes

    Yes

    4 September 30,2014

    October 31,2014

    Based onanalysis of

    financial

    Yes Yes Finished ""tool kit"" forcommunity-based group earlyintervention, including training

    Yes

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    report(2) manual, fidelity and monitoringprotocol, CHW manual, &supplies for each session.(Month 8)

    2 CHWs trained in GROUP-CBEI (Month 9)

    30 of the at-risk children and theirprimary caregivers are enrolledinto GROUP-CBEI interventionarm based on health centrecatchment area and according toadditional eligibility criteria listedfor Activity 2.4 (Month 11).

    Leaders at the level of Limaand/or Carabayllo supportprogrammatic dissemination(Month 12)

    Yes

    March 31, 2015 April 30, 2015 Yes

    5 September 30,2015

    October 31,2015

    Up to 13,500CAD Based onanalysis of final

    financialreport(3)

    Yes Yes .

    * Notwithstanding the proposed payment schedule set forth above, payments may be accelerated, delayed or withheld, and the amount of any payment may be changed, in eachcase at the sole discretion of Grand Challenges Canada** Financial report must be submitted within 30 days after the end of each reporting period

    (1) Calgary meeting expenses (June 2013) paid by Grand Challenges Canada. The amount should be recorded as a payment received from Grand Challenges Canada and asactual expenses under Travel category (GCC Community meetings)

    (2) Payment amount will be determined based on analysis of the funds available at the end of the previous reporting period and the funds needed for the subsequent period(3)Final payment amount will be determined based on analysis of the actual expenses incurred versus the approved budget

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    Attachment F: Extract of Travel Policy3

    The following policy is based on the principles and guidelines of the respective travel policies of

    the Treasury Board of Canada Secretariat, the International Development Research Centre andGenome Canada.

    The specific rates associated with the provisions in this policy will be outlined in the GrandChallenges Canada Travel Expenses Claim Form and will be based on the rates provided by theTreasury Board of Canada Secretariat.

    1. INTRODUCTIONAll individuals who travel on approved Grand Challenges Canada business are entitled to thereimbursement of travel expenses as outlined in the travel policy. This travel policy reflectsGrand Challenges Canadas responsibility to have in place provisions and guidelines which arereflective of accepted travel expenses reimbursement practices.

    2. PURPOSEThe purpose of this travel policy is to facilitate travel in support of Grand Challenges Canadasmission while maintaining effective controls and promoting accountability.

    This is achieved by:a) Ensuring employees, consultants and participants travel securely, comfortably in a cost-

    effective manner;b) Facilitating the travel process so that travellers can focus their efforts on core

    responsibilities; andc) Providing senior management and travellers with the proper guidelines and tools to

    manage and control their business travel-related expenses.

    3. APPLICATION, AUTHORIZATION AND APPROVAL OF TRAVELThis travel policy applies to all individuals travelling on Grand Challenges Canada business,including non-employees of Grand Challenges Canada and recipients of Grand ChallengesCanada funding.

    All travel must be authorized prior to the travel being undertaken. Travel approval (verbalapproval is deemed acceptable) implies that consideration has been given as to the necessity ofthe travel, and that travel arrangements accommodate both the travellers needs and GrandChallenges Canadas operational requirements. Prior approval by the Chief Finance Officermust be provided for deviations from the provisions stated in this policy.

    Exceptions to the policies below maybe approved in special cases and with appropriatedocumentation from the Chief Executive Officer (and in the case of the Chief Executive Officer,the Chair of the Board).

    3Grand Challenges Canada also refers to this Travel Policy as the Expense Policy

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    4. USE OF A DESIGNATED TRAVEL AGENCYTravellers are permitted to make their own travel arrangements or use the services of GrandChallenges Canadas designated travel agency which is authorized to handle travel reservations

    under specific directives and guidelines.

    5. MODE OF TRANSPORTATIONGeneral allowances for private, non-commercial accommodation, meals and incidentals providedfor in this policy will be reviewed and confirmed April 1 of each year.

    Travellers have the option of selecting a preferred mode of transportation as long as the choiceis based on cost, duration, safety, convenience, practicality, and represents good value to GrandChallenges Canada. Travellers are encouraged to book as far in advance as is reasonable totake advantage of travel discounts.

    a. Air

    The standard fare class for air travel is economy.

    Personal UpgradesPersonal miles or coupons can be used to upgrade to business class, or a traveller may opt topay personally for the price difference between economy and business class.

    Documentation of the fare differentials must be clear, specific, maintained by the employee, andincluded with the receipts.

    Air Mileage ProgramsFrequent flyer upgrades are facilitated by the traveller. Any associated costs are at the travellersexpense. Managing the travellers air miles accounts is the responsibility of the traveller. Airlinemiles earned while travelling on Grand Challenges Canada business are retained by thetraveller. Frequent flyer miles or benefits are not reimbursable by Grand Challenges Canada,even if they are used on Grand Challenges Canada business.

    Grand Challenges Canada travellers are ultimately accountable for the class of ticket issued.They must be prepared to justify the purchase of non-refundable or otherwise restrictive low-faretickets when such tickets are later cancelled or changed, resulting in additional expenses.

    Accordingly, due diligence is required so as to promote proper planning.

    Exceptions to this policy and purchase of business class fares must be approved by the ChiefFinance Officer of Grand Challenges Canada.

    b. RailFirst class rail travel is permitted with roomette or equivalent accommodation being provided forovernight travel. For rail travel outside of Canada, the standard for rail travel would be theequivalent to first class rail travel in Canada.

    c. GroundTravellers may rent cars to their destination. Travellers have the option of renting a car at theirdestination when it is more cost-effective and convenient than other local ground transportationmodes such as taxis, limousine services and airport shuttles.

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    For travel outside of Canada, the kilometric rates and other general allowances including perdiems for meals and incidentals will be applied.

    Private CarTravellers may use their personal car for Grand Challenges Canada approved travel. It is thetravellers responsibility, as the owner of the vehicle being used for business, to carry adequateinsurance coverage for their protection and for the protection of any passengers.

    Travellers will be reimbursed the kilometric rate posted on the Grand Challenges Canada TravelExpense Reimbursement Form. This rate is reviewed and confirmed April 1 of each year.

    Rental CarThe recommended standard for rental cars is up to a mid-size vehicle. Rental cars beyond therecommended standard shall be authorized based upon factors such as, but not limited to,

    safety, the needs of the traveller and the bulk or weight of goods transported. It is the travellersresponsibility to have adequate insurance coverage for their protection and for the protection ofany passengers. Collision and damage insurance for the car rental must be purchased at thetime of the rental if this coverage is not provided through a credit card. Reimbursement shallinclude the cost of the car rental including gas charges and the insurance purchase.

    TaxisFor local ground transportation, taxis, airport shuttles and limousine services are acceptablemodes of transportation. Reimbursement will be for actual expenses including gratuity. Alloriginal receipts are required.

    ParkingParking charges shall be reimbursed where it is practical and economical to leave a privatevehicle at the public carrier's terminal during the period of absence.

    6. RECEIPTSIn order to facilitate the processing of expense claims, Grand Challenges Canada travellers mustsubmit original receipts with their expense claim to justify allowable expenses in excess of $20CDN. Where the traveller certifies that the receipt was lost, accidentally destroyed orunobtainable, a personal declaration may replace the receipt.

    7. TRAVEL ADVANCESIf requested, Grand Challenges Canada employees can be provided with a travel advance tocover travel expenses where Grand Challenges Canada approved services and products are notprepaid.

    8. TRAVEL HEALTH REQUIREMENTSGrand Challenges Canada bears the costs incurred in obtaining immunizations, prophylacticmedication, and medical consultations required for Grand Challenges Canada-related travel.

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    9. MEDICAL TRAVEL INSURANCE AND PASSPORTS/VISASAll Grand Challenges Canada approved travellers must be covered by medical travel insurance.If not included in the Grand Challenges Canada employer group medical insurance, the cost of

    medical travel insurance will be reimbursed by Grand Challenges Canada.

    Grand Challenges Canada approved travellers will be reimbursed the costs incurred in obtainingrequired passports, visas, and related photographs.

    10. ACCOMMODATIONGrand Challenges Canada will reimburse expenses for accommodation. The standard foraccommodation is a single room, in a safe environment, conveniently located and comfortablyequipped. A variety of options for accommodation are available for travel. Generally theseinclude hotels, motels, corporate residences, apartments, private non-commercialaccommodation, and government and institutional accommodation.

    Although travellers generally stay in commercial accommodation, private non-commercialaccommodation is encouraged. Cost effectiveness shall be determined by comparing the totalcost of accommodation and transportation in the private non-commercial accommodation withavailable commercial or government and institutional accommodation and the associatedtransportation costs. A traveller who chooses private non-commercial sleeping accommodationwill be reimbursed as per the rate posted on the Grand Challenges Canada Expense Claim form.This rate is reviewed and confirmed April 1 of each year.

    For periods of travel status of more than 30 consecutive calendar days at the same location,accommodation at corporate residences, apartments, private non-commercial accommodation orgovernment and institutional accommodation is encouraged. Travellers who choose to stay in ahotel after the 30thday when apartments or corporate residences are available in the areasurrounding the workplace shall be reimbursed up to the cost of the average apartment orcorporate residence available.

    Grand Challenges Canada will often arrange accommodation for Grand Challenges Canadaapproved activities in Toronto, with the basic room charge plus taxes being charged to a masteraccount. If an individual makes their own accommodation arrangements, hotel receipts(originals) are required.

    11. MEALSFor each calendar day, a traveller shall be reimbursed the applicable meal allowance forbreakfasts, lunches and dinners taken while on Grand Challenges Canada approved business.Meal allowances shall be reimbursed as per the rates posted on the Grand Challenges CanadaExpense Claim form. These rates are reviewed and confirmed April 1 of each year

    In the event that a meal is provided at no cost to the traveller, the corresponding per diem cannotbe claimed.

    12. INCIDENTALSAn incidental expense allowance is an allowance to cover the costs of items that can beattributed to a period in travel, but for which no other reimbursement or allowance is providedunder this directive, and which helps offset some of the expenses incurred as a result of having

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    to travel. The allowance is provided to cover the costs of items which can be attributed to aperiod in travel, and includes but is not limited to such items as gratuities, business centreexpenses, bottled water, phone calls home, and shipping of some personal effects.

    Business related calls, either local or long-distance, and internet connections are not included inthe incidental expense allowance and will be reimbursed with presentation of appropriateinvoices or receipts. Reasonable expenses for personal calls will be reimbursed withpresentation of appropriate invoices or receipts. An incidental expense allowance will bereimbursed as per the rates posted on the Grand Challenges Canada Expense Claim form.These rates are reviewed and confirmed April 1 of each year.

    13. HOSPITALITYReasonable hospitality-type expenses may be incurred by Grand Challenges Canada employeeswhile conducting Grand Challenges Canada business. The actual amount plus gratuities may beclaimed. The submission of receipts should indicate the purpose of the expense, date, and

    number/name of participants and will exclude alcohol.

    14. PREPARATION AND SUBMISSION OF AN EXPENSE CLAIMGrand Challenges Canadas travel expense claim form must be used for the submission of anexpense claim on Grand Challenges Canada approved travel. Travellers are encouraged tosubmit their expenses claims as soon as possible after the end of the trip. All expenses must besupported by original receipts if over $20 CDN, as applicable, except for meal expenses whichare reimbursed according to a per diem allowance.

    Receipts should indicate the purpose of the expense, the date and the location. In instanceswhere there are a significant number of receipts, they should be affixed to a letter-sized page toensure that they are not lost. Where the nature or reason for the expense is not self-evident, adescription of the reason for the expense should be included on the receipt.

    For Grand Challenges Canada personnel, all travel expense claims signed by their supervisordenotes authorization for reimbursement of the expenses. The expense claims of the ChiefExecutive Officer will be signed by the Chair of the Audit and Finance Committee or Chair of theBoard of Directors of Grand Challenges Canada. Non-employee travel expense claims will besigned by a designated Grand Challenges Canada officer.

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    Attachment G: Ethics Policy

    It is the policy of Grand Challenges Canada that research involving human participants, research

    with animals, and research subject to additional regulatory requirements must be conducted inaccordance with the highest internationally recognized ethical standards. The purpose of thispolicy is to set out clear protocols for the ethical conduct of research funded by GrandChallenges Canada. In order to receive funds from Grand Challenges Canada, initially andthroughout the course of a research project, researchers must affirm and document compliancewith the ethical principles and standards outlined below.

    A. GUIDING PRINCIPLES

    1. Research involving human participants must be conducted in a manner that demonstrates,protects and preserves respect for persons, concern for the welfare of individuals, familiesand communities, and justice.4

    2. Research involving animals must be conducted in a manner that ensures their humane careand treatment.

    3. Certain research endeavours, including but not limited to research with recombinant DNA,biohazards, and genetically modified organisms, may be subject to enhanced regulation andoversight.

    B. RESEARCH INVOLVING HUMAN PARTICIPANTS

    Research ethics guidelines and oversight mechanisms are intended to ensure that researchinvolving human participants is conducted in a manner that demonstrates, protects and

    preserves respect for persons, concern for the welfare of individuals, families and communities,and justice.

    Ethical requirements for health research involving human participants in low and middleincome countries (LMIC)5:

    1. If and when conducted or supported by researchers and/or sponsors based inindustrialized nations (e.g., Canada), research involving human participants in LMIC mustconstitute a collaborative partnership between the researchers and/or sponsors inindustrialized nations and researchers and/or policy makers and communities in LMIC;

    2. Prospective research participants must provide voluntary and informedconsent to

    participate;

    4Modified from the core principles articulated in the draft second edition of TCPS 2(http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/#toc01-1b)5Modified from Emanuel EJ, Wendler D, Grady C. (2000) What Makes Clinical Research Ethical? JAMA.283(20): 2701-11; and, Emanuel EJ, Wendler D, Killen J, and Grady C. (2004) What Makes ClinicalResearch in Developing Countries Ethical? The Benchmarks of Ethical Research. J Infect Dis. 189(5):930-7.

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    3. The proposed research must be designed in a manner that demonstrates and preservesrespect for potential and enrolled participants;

    4. Prospective research participants must be selected fairly, and no individual or groupshould be disproportionately burdened by or excluded from participation without

    justification;

    5. Individuals involved in the conduct and/or support of research are obligated to avoid, ifpossible, and disclose and appropriately address any financial or personal conflicts ofinterest germane to the research project (please see Grand Challenges Canada Policyon Conflict of Interest);

    6. The proposed research must be scientifically valid, have potential social or scientificvalue, and have a favourable ratio of potential benefits to risk of harm; and,

    7. Research proposals must undergo independent review by an appropriately constitutedresearch ethics committee6.

    Which Standards?

    Grantees must follow local research ethics processes and conform to local research ethicsstandards at the site where the research is being conducted. These local processes, where theyexist, must meet internationally recognized standards; however, all research should conform tothe Council for International Organizations of Medical Sciences (CIOMS) International EthicalGuidelines for Biomedical Research Involving Human Subjects7(CIOMS Guidelines). To theextent that research is not strictly biomedical in nature, but rather more broadly health related,the principles of the CIOMS Guidelines should be adhered to, to the extent to which they can beapplied. In circumstances where GCC co-funds a grant with another funding organization, GCCand the other funder will work together to align the research ethics requirements of both funders.

    Research to be carried out at Canadian institutions, or outside of Canada by individuals underthe auspices of a Canadian institution8, must conform to Canadian Tri-Council Policy Statement:Ethical Conduct for Research Involving Humans9(TCPS). GCC will conduct due diligence toensure the project is consistent with Canadian ethics guidelines.

    6

    Review should be performed by a committee at the site where the research is to be conducted and at theinvestigators home institution(s) if different from the institution where the research will take place (see, forexample, TCPS 2 Chapter 1 Section C at http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/#toc01-1c); if no such committee is available at the research site, review may beprovided by an appropriately constituted external committee.7http://www.cioms.ch/publications/layout_guide2002.pdf) ; NOTE: a particular aim of the CIOMSGuidelines is to reflect the conditions and the needs of low-resource countries, and the implications formultinational or transnational research in which they may be partners.8 http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/9TCPS 2 (http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf)

    http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/#toc01-1chttp://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/#toc01-1chttp://www.cioms.ch/publications/layout_guide2002.pdfhttp://www.cioms.ch/publications/layout_guide2002.pdfhttp://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdfhttp://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdfhttp://www.cioms.ch/publications/layout_guide2002.pdfhttp://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/#toc01-1chttp://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/#toc01-1c
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    Documentation

    Grantees must provide Grand Challenges Canada with documentation of approval obtained froman appropriately constituted research ethics review committee10before any human participants

    are enrolled to participate and/or human materials requiring oversight are utilized in the researchproject. Documentation of ongoing approval must be provided to Grand Challenges Canada insemi-annual and/or annual project reports.

    C. RESEARCH WITH ANIMALS

    Grantees using animals11in their research must follow local processes and conform to localstandards for the humane care and treatment of animals at the site where the research is beingconducted. These processes must meet internationally recognized standards. In the absence ofa relevant national standard, research should, at minimum, conform to the CIOMS InternationalGuiding Principles for Biomedical Research Involving Animals12.

    Grantees at Canadian institutionsincluding Canadian researchers conducting research outsideof Canadamust, at a minimum, conform to the policies13and guidelines14of the CanadianCouncil on Animal Care (CCAC). Multi-institutional animal research involving Canadianresearchers must conform to the CCAC guidelines forAnimal-Based Projects Involving Two orMore Institutions15.

    DocumentationGrantees must provide Grand Challenges Canada with documentation of approval from therelevant institutional animal care committee16at the time of grant award or before animalresearch can be initiated. Documentation of ongoing review and approval must be provided toGrand Challenges Canada in semi-annual and/or annual project reports.

    10i.e., a Research Ethics Board (REB) in Canada or an Institutional Review Board (IRB), Research EthicsCommittee (REC) or independent ethics committee (IEC) outside of Canada, that meets theaforementioned minimum standard.11Defined as any live, vertebrate animal used or intended for use in research, research training,experimentation, biological testing or for related purposes.12 http://www.cioms.ch/publications/guidelines/1985_texts_of_guidelines.htm;NOTE: International

    guidelines for the use of animals in research developed by the World Organization for Animal Health areexpected to come into effect in 2010; once in force, these will supersede the CIOMS Guidelinesas theminimum acceptable standard.13 http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/policy.htm14 http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Guidelis.htm and, in particular,http://www.ccac.ca/en_/standards/policies/policy-ethics_animal_investigation.15http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/ProjectsInvolvingTwoorMoreInstitutions.htm16Institutional Animal Care Committee (ACC) in Canada or Institutional Animal Care and Use Committee(IACUC) or equivalent abroad

    http://www.cioms.ch/publications/guidelines/1985_texts_of_guidelines.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/policy.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Guidelis.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/ProjectsInvolvingTwoorMoreInstitutions.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/ProjectsInvolvingTwoorMoreInstitutions.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/ProjectsInvolvingTwoorMoreInstitutions.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/ProjectsInvolvingTwoorMoreInstitutions.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/ProjectsInvolvingTwoorMoreInstitutions.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Guidelis.htmhttp://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/policy.htmhttp://www.cioms.ch/publications/guidelines/1985_texts_of_guidelines.htm
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    D. RESEARCH SUBJECT TO ADDITIONAL REGULATORY REQUIREMENTS

    Certain research endeavours may be subject to enhanced regulation and oversight. Examples

    include, but are not limited to, research involving recombinant DNA, biohazards

    17

    , humanpluripotent stem cells, or the release of genetically modified insect vectors, genetically alteredplants, or other genetically modified organisms into the environment. All such research must beconducted in accordance with relevant national and/or international guidelines and may besubject to enhanced oversight by relevant institutional, regional or national regulatory bodies.

    Research conducted by grantees at or affiliated with Canadian institutions must be in compliancewith the Human Pathogens and Toxins Act18and/ortheCanadian Institutes of Health Research(CIHR) Guidelines for Human Pluripotent Stem Cell Research19. Grantees at non-Canadianinstitutions must be in compliance with recognized international standards for research identifiedas posing biosafety and/or biosecurity risks20in addition to institutional and/or jurisdictional laws,regulations and/or guidelines applicable at the site where the research is being conducted.

    Research involving the import or export of genetically modified organisms must be conductedpursuant to the Cartagena Protocol to the United Nations Convention on Biological Diversity21, inaddition to any local standards at the site of the research.

    DocumentationGrantees must inform Grand Challenges Canada of the relevant standard(s) with which they willcomply and their justification for choosing those standards. Furthermore, grantees must provideGrand Challenges Canada with documentation of approval from any and all relevant oversightbodies22before research can be initiated; documentation of any required ongoing review andapproval must be provided to Grand Challenges Canada in semi-annual and/or annual projectreports.

    17i.e., biological agents and toxins that have the potential to pose a severe threat to public, animal or planthealth, or to animal or plant products (e.g., select agents as designated by the US government:http://www.selectagents.gov/)18

    An Act To Promote Safety And Security With Respect To Human Pathogens And Toxins, the purpose ofwhich is to establish a safety and security regime to protect the health and safety of the public against therisks posed by human pathogens and toxins; available at:http://www2.parl.gc.ca/HousePublications/Publication.aspx?Docid=3865169&file=419 http://www.cihr-irsc.gc.ca/e/34460.html;Note: these guidelines will be incorporated by reference into the

    second edition of TCPS; once that edition is in force, the specific reference herein to these guidelines will

    become redundant, as Canadian grantees already will be required under this policy to follow TCPS.20

    For example: the Human Pathogens and Toxins Act(Canada), the National Institutes of Health (NIH)Guidelines for Research Involving Recombinant DNA Molecules (US;http://oba.od.nih.gov/rdna/nih_guidelines_oba.html) , World Health Organization (WHO) biosafetyguidelines (http://whqlibdoc.who.int/publications/2004/9241546506_partI.pdf) .21http://www.cbd.int/biosafety/articles.shtml?a=cpb-0122Research involving biohazards must be reviewed and approved by an Institutional Biosafety Officer(BSO) or Institutional Biosafety Committee (IBC), or relevant local equivalent, operating in accordance withrelevant national or international standards (e.g., in Canada, BSOs and IBCs must function in accordancewith the Public Health Agency of Canadas Laboratory Biosafety Guidelines(http://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index-eng.php))

    http://www.selectagents.gov/http://www2.parl.gc.ca/HousePublications/Publication.aspx?Docid=3865169&file=4http://www.cihr-irsc.gc.ca/e/34460.htmlhttp://oba.od.nih.gov/rdna/nih_guidelines_oba.htmlhttp://whqlibdoc.who.int/publications/2004/9241546506_partI.pdfhttp://www.cbd.int/biosafety/articles.shtml?a=cpb-01http://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index-eng.phphttp://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index-eng.phphttp://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index-eng.phphttp://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index-eng.phphttp://www.cbd.int/biosafety/articles.shtml?a=cpb-01http://whqlibdoc.who.int/publications/2004/9241546506_partI.pdfhttp://oba.od.nih.gov/rdna/nih_guidelines_oba.htmlhttp://www.cihr-irsc.gc.ca/e/34460.htmlhttp://www2.parl.gc.ca/HousePublications/Publicat