SUBAWARD AGREEMENT - Hopkins Medicine



SUBAWARD AGREEMENTFunding Agency Name (“Sponsor”)Federal Award ID (FAIN)# Grant/Contract # (“Prime Award”)Federal Award Issue DateTotal Federal Award AmountFederal Award F&A Rate CFDA #CFDA TitleAward TypeResearch and DevelopmentFederal Agency ContactGrants Management SpecialistSubrecipient DUNS #Project/Study Description (“Project”/”Study”)Title of Project or studyJHU Purchase Order #(Replace “Subrecipient” with “Subcontractor” for Prime Contract; Replace “Subagreement” & “Subaward Agreement” with “Agreement” for 800 accounts/JHHC; remove Prime Award references for 800 accounts; use “RESERVED” when an entire Section does not apply) This document constitutes the subaward agreement (“Subagreement”) between the Johns Hopkins University (“JHU”) and Subrecipient’s Name (the “Subrecipient”) under which Subrecipient shall perform the work defined below as the Statement of Work, to enable JHU to complete its obligations under its Prime Award. All terms and conditions of this Subagreement are subject to applicable federal law and regulations and to the provisions of the Prime Award to the extent that the Prime Award terms are incorporated herein as Exhibit D. STATEMENT OF WORKSubrecipient’s work shall conform to its statement of work (“Statement of Work”) approved by JHU, attached and incorporated as Exhibit A. (USE FOR PER PATIENT)Subrecipient is authorized to enroll a minimum of ___ subject and a maximum of ___ subjects in the Study. Subrecipient shall immediately cease enrollment upon written communication from JHU. Time shall be of the essence as to all aspects of the Subrecipient’s performance under this Subagreement.Both parties shall mutually agree upon any change in the Statement of Work in writing, signed by authorized officials of both parties prior to the commencement of Subrecipient’s performance under any such change.[WHEN MTA DRAFTED BY SUB GROUP] JHU shall provide the Subrecipient with materials in support of the Statement of Work, per a Materials Transfer Agreement, which shall be negotiated by the parties prior to the transfer of materials (“Materials Transfer Agreement”).Subrecipient shall submit the deliverable(s)/work product(s) (“Deliverable(s)”) to JHU PI in the expected time frame indicated below:DELIVERABLE(S)/WORK PRODUCT(S)DUE DATE/TIME FRAME EXPECTED FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????PERIOD OF PERFORMANCEThis Subagreement is effective for the period start date through end date (the “Period of Performance”), which shall be extended only by mutual written agreement of the parties. COST AND PAYMENT (USE FOR COST REIMBURSEMENT BUDGET)The total estimated cost for full performance of this Subagreement shall not exceed _________ United States Dollars (USD $____), which includes a/an ____ % indirect cost rate. Reallocation between line-items and increases to the budget total require JHU’s written prior approval per Section 6 (Approvals and Notices). Costs by Subrecipient shall be expended and invoiced in accordance with the Subrecipient’s budget (“Budget”), attached and incorporated as Exhibit B. Any proposed increase must be approved in writing by an authorized official of JHU before such costs or commitments may be incurred. Carry forward of unspent balances into the next period of performance requires JHU’s written prior approval, and Subrecipient must submit all carryover requests to JHU in writing per Section 6 (Approvals and Notices).Payments will be made within thirty (30) calendar days upon receipt of an approved monthly/quarterly invoice, (MONTHLY FOR HIGH RISK) detailing actual costs incurred in the format specified in Exhibit C (unless Subrecipient has a comparable format). Invoices will not be accepted and approved until this Subagreement is fully executed by all parties. Each invoice must be in English, stated in U.S. dollars, and must: (i) be sequentially numbered; (ii) indicate the date(s) of performance by the Subrecipient; (iii) state the JHU Purchase Order number, the title of the Project, and the name of the JHU Principal Investigator; (iv) itemize costs in detail, in correspondence with the Subagreement budget; (v) include both current costs and cumulative costs; and (vi) include the Subrecipient's certification, with authorized official’s signature, that costs are appropriate and accurate and that payment has not yet been received, (USE FOR HIGH RISK) and (vii) be supported by a general ledger report originating directly from the Subrecipient’s financial record keeping system.? JHU may request supporting documentation in certain categories prior to or subsequent to approving the invoice.? Supporting documentation includes, but is not limited to, travel receipts, purchase orders, invoices for services or supplies, or time records. All supporting documentation shall be retained and provided by Subrecipient to JHU upon request in accordance with Section 12 (Inspection and Audit). In addition, with each invoice, an authorized representative of the Subrecipient shall certify that required Deliverable(s) to date have been submitted, and expenditures reported (or payments requested) are for appropriate purposes and in accordance with the Statement of Work, approved Budget and other requirements as set forth in the Subagreement.Subrecipient shall maintain an accurate accounting system for all costs incurred in the performance of this Subagreement. Allow-ability of costs and commitments incurred pursuant to this Subagreement shall be determined in accordance with applicable laws, regulations, and Sponsor policies and must be documented in accordance with generally accepted accounting principles. All costs under this Subagreement shall be based on actual costs and must be reasonable, allocable and allowable. Subrecipient shall submit invoices in the format specified in Exhibit C (unless Subrecipient has a comparable format) to:ENTER Dept. Contact NameJohns Hopkins University School of MedicineAddress Baltimore, MD 212xxPhoneEmail(DOMESTIC SITES ONLY) All payments shall be made to the address provided on the invoice submitted to JHU. A final invoice and cumulative financial Report, as defined in Section 5, which shall include actual costs incurred per budget line item, along with the financial detail required pursuant to Section 3.4, shall be submitted to JHU no later than Month, Day Year (forty-five (45) days following termination or expiration of the Subagreement). Payment will be made after final invoice has been received and verified by JHU that all agreed upon Deliverables, as shown in Exhibit A, have been submitted to JHU by Subrecipient.(FOREIGN SITES ONLY) JHU shall have grant funds wired to the Subrecipient for invoices submitted work performed under this Subagreement to the Subrecipient as specified in the International Wire Information Form, attached as Exhibit E.(FEDERAL PRIME: FOREIGN SITES ONLY) JHU will not pay value added taxes (“VAT”) under this Subagreement. Subrecipient may not include VAT or any other taxes as reimbursable costs in the invoices it submits to JHU. (USE FOR FIXED PRICE BUDGETS)JHU shall pay Subrecipient a maximum of ___ United States Dollars (USD $____) for each subject enrolled/for each ___ test performed/for each visit completed. JHU shall pay Subrecipient ___ United States Dollars (USD $____) for subjects who partially complete the Study. Partial completion is defined as a subject who ____. Subrecipient is required to submit case report forms along with/prior to/instead of invoice(s) before payment will be authorized by JHU. Milestones attained shall be invoiced in accordance with the Subrecipient’s budget (“Budget”), attached and incorporated as Exhibit B. Any proposed increase must be approved in writing by an authorized official of JHU before such commitments may be incurred. In addition, with each invoice, an authorized representative of the Subrecipient shall certify that required Deliverable(s) to date have been submitted, and or payments requested are for appropriate purposes and in accordance with the Statement of Work, approved Budget and other requirements as set forth in the Subagreement.Subrecipient shall submit invoices to:ENTER Dept. Contact NameJohns Hopkins University School of MedicineAddress Baltimore, MD 212xxPhoneEmail(DOMESTIC SITES ONLY) All payments shall be made to the address provided on the invoice submitted to JHU. A final invoice, which includes actual costs per budget line item, shall be submitted to JHU no later than Month, Day Year (forty-five (45) days following termination or expiration of the Subagreement). Payment will be made after final invoice has been received and verified by JHU that all agreed upon Deliverables, as shown in Exhibit A, have been submitted to JHU by Subrecipient.(FOREIGN SITES ONLY) JHU shall have grant funds wired to the Subrecipient for invoices submitted work performed under this Subagreement to the Subrecipient as specified in the International Wire Information Form, attached as Exhibit E.(FEDERAL PRIME: FOREIGN SITES ONLY) JHU will not pay value added taxes (“VAT”). Subrecipient may not include VAT or any other taxes as reimbursable costs in the invoices it submits to JHU. KEY PERSONNEL The Project Director and Technical Representative at JHU for this Subagreement is PI’s name, M.D. (“JHU PI”). JHU PI is not authorized to alter or amend this Subagreement, except that the JHU PI’s written concurrence shall be required to alter or amend Subrecipient’s Statement of Work and/or Budget.The Project Director for Subrecipient shall be SUBRECIPIENT PI, M.D. (“Project Director”). An authorized official of JHU must approve in writing any proposed change in the Project Director. Should JHU not give its approval, this Subagreement shall be terminated in the manner provided below in Section 13 (Termination).REPORTS AND DELIVERABLESSubrecipient shall submit Deliverable(s) as specified in Exhibit A, Statement of Work. (USE IF REPORTS WERE PROVIDED IN THE CHART): In addition to the Deliverables listed in Exhibit A, Subrecipient shall submit the reports (“Deliverable(s)”) to JHU PI in the expected format and time frame indicated below:REPORTFORMATDUE DATE OR TIME FRAME EXPECTEDTECHNICAL FORMTEXT ????? FORMTEXT ?????PROGRESS FORMTEXT ????? FORMTEXT ?????FINANCIAL FORMTEXT ????? FORMTEXT ?????OTHER FORMTEXT ????? FORMTEXT ?????(USE IF NO REPORTS WERE PROVIDED IN THE CHART): In addition to the Deliverables listed in Exhibit A, Subrecipient shall submit monthly/annual (FEDERAL PRIME GRANTS: “ANNUAL”)(ALL HIGH RISK: “MONTHLY) progress reports (“Report”) to the JHU PI. Subrecipient shall submit a final Report no later than forty-five (45) days after expiration of this Subagreement to the JHU PI.Failure by Subrecipient to submit any Deliverable and/or Report by its due date shall be considered just cause for JHU to withhold any payment until such Deliverable or Report is received and accepted by JHU PI. JHU may also terminate this Subagreement in accordance with Section 13 (Termination), should Subrecipient fail to timely provide agreed upon Deliverables or Reports set forth in the Statement of Work and this Section 5 (Reports and Deliverables).APPROVALS AND NOTICESSubrecipient shall submit all notices and requests for approvals regarding alterations or amendments to this Subagreement and requests for carry forward shall be submitted to:Melody Snow, M.H.S.Assistant Director – Outgoing SubawardsOffice of Research AdministrationJohns Hopkins University, School of Medicine1629 Thames Street, Suite 200Baltimore, Maryland 21231443-287-0701Fax: 410-502-6004msnow1@jhmi.edu Notices regarding changes in the Statement of Work, Deliverable(s), Budget or Project Director, and programmatic matters, including publication reviews, should be sent to JHU PI:Name of JHU PIDepartmentJohns Hopkins University School of MedicineAddress Baltimore, MD 212xxPhoneEmailWith a copy to the contact provided in Section 6.1 for changes to the Budget, Statement of Work, and/or Project Director. Subrecipient’s authorized official for receiving notices of alterations or amendments to this Subagreement shall be:Subsite Contract contact nameName of SubrecipientSubrecipient’s Street addressCity, State ZipPhone number EMAILPUBLICITY AND USE OF NAMENeither party shall use directly or by implication the names of the other party, nor any of the other party’s affiliates or contractors, nor any abbreviations thereof, or of any staff member, faculty member, student, or employee of the other party in connection with any products, publicity, promotion, financing, advertising, or other public disclosure without the prior written permission of the other party. All requests for JHU approval shall be forwarded to: Johns Hopkins University Johns Hopkins Medicine Media Relations and Public Affairs officeC/O James Lustek 901 S. Bond Street, Suite 550 Baltimore, MD 21231 (443-287-2549Jlustek1@jhmi.edu PUBLICATIONSEach party shall have the right to publish and disseminate information derived from the performance of work under this Subagreement. Qualification for authorship shall be in keeping with generally accepted criteria. The order of authorship shall be a joint decision of the co-authors in any co-authored publication. Each author shall have participated sufficiently in the work to take public responsibility for the content.Subrecipient shall provide JHU PI with a copy of any proposed publication for review and comment at least thirty (30) days prior to submission. Publications shall carry appropriate acknowledgment of funding support by a statement such as the following:“This publication (journal article, etc) was supported by a Subagreement from the Johns Hopkins University with funds provided by Grant No. prime award number from the name of Sponsor. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the name of Sponsor or the Johns Hopkins University.”CONFIDENTIALITY“Confidential Information” means all non-public information that is marked as “Confidential Information” and which is disclosed by one party to the other, including, but not limited to, software, inventions (whether patentable or not), algorithms, diagrams, drawings, processes, reagents, research, product or strategic plans or collaborations or partnerships, financial information, business models, and information relating to corporate finance and governance. The parties covenant and agree that, with respect to the Confidential Information, each shall not (except as permitted by this Section or with the prior written consent of Sponsor): (i) disclose Confidential Information to any person other than its employees, counsel, auditors and consultants who, in each case, have a need to know and are bound by obligations of confidentiality; or (ii) use Confidential Information in any manner not expressly permitted by this Subagreement or (iii) use Confidential Information for the benefit of a third party not approved by the disclosing party. The recipient shall keep in confidence and prevent the acquisition, disclosure, use or misappropriation by any person or persons of the Confidential Information, provided, however, that the recipient shall not be liable for disclosure of any such information that is disclosed as permitted by this Section or with the prior written consent of the disclosing party. The recipient shall use the same care to avoid disclosure, publication or dissemination of Confidential Information as it uses with its own similar confidential information, provided that the recipient shall use at least reasonable care. Confidential Information shall not include any information disclosed to the recipient that the recipient can demonstrate (i) was previously in its possession, as shown by its pre-existing records, without violation of any obligation of confidentiality; (ii) was received from a third party without violation of any obligation of confidentiality; (iii) was publicly known and made generally available prior to such disclosure; (iv) becomes publicly known and made generally available, through no action or inaction of the recipient, after such disclosure; or (v) was independently developed without use of any Confidential Information by employees or consultants of the recipient who had no access to such information. If the recipient is required by a valid order of a court of other governmental body or otherwise required by law to disclose Confidential Information, it shall give disclosing party timely written notice of such requirement before disclosing any such information and shall cooperate to seek a protective order, confidential treatment or other appropriate measures requiring, amongst other things, that the information and/or documents so disclosed be used only for the purposes for which the order was issued and parts of the information and/or documents so disclosed be redacted to limit the extent of disclosure. JHU and Subrecipient agree to return, upon request any Confidential Information provided by either party, and any copies of such Confidential Information, except for one archival copy to be retained by the receiving party for purposes of observing compliance under the Prime Award.INTELLECTUAL PROPERTYInventions and Patents.(FEDERAL PRIME ONLY) The determination of rights in ownership and disposition of inventions resulting from the performance of the Statement of Work (“Inventions”) and the administration of patents will be in accordance with 37 CFR 401 and the terms of this Subagreement. Subrecipient agrees to comply with regulations regarding Subject Inventions pursuant to 37 CFR Part 401.Subrecipient understands and acknowledges that JHU, through its employees, has knowledge, experience and expertise, which has been acquired over a substantial number of years prior to entering into this Subagreement (“JHU Background Intellectual Property”).? JHU shall retain all rights to such JHU Background Intellectual Property.? Nothing in this Subagreement shall confer any right to Subrecipient to acquire by assignment or license, exclusive ownership or use of JHU Background Intellectual Property.Subrecipient shall (i) retain title to any Inventions first conceived or actually reduced to practice in the performance of the work funded by this Subagreement solely by its faculty member(s) and/or employee(s) and/or student(s), (ii) Subrecipient and JHU shall be joint owners of any Inventions first conceived or actually reduced to practice in the performance of the work funded by this Subagreement jointly by faculty member(s) and/or employee(s) and/or student(s) of Subrecipient and JHU. JHU shall retain ownership of any Inventions first conceived or actually reduced to practice in the performance of the work funded by this Subagreement solely by a JHU faculty member(s) and/or employee(s) and/or student(s). For any jointly owned Inventions, JHU shall have the opportunity to preview and comment on all documents of record used in filing, prosecuting, and maintaining of any patent application and to participate in the selection of the patent attorney.Copyrights. Disposition of any copyrights or any copyrightable material created by Subrecipient in performance of the Statement of Work will be determined by the policy of the Subrecipient. (FEDERAL PRIME ONLY) Any copyrighted materials are subject to a royalty-free, non-exclusive and irrevocable license to the U.S. Government to reproduce, publish or otherwise use the copyrighted material and to authorize others to do so for federal purposes.(FEDERAL PRIME ONLY) Subrecipient shall provide copies of all copyrighted or copyrightable materials to the JHU PI. Subrecipient hereby grants to JHU an irrevocable, royalty-free, non-transferable, non-exclusive right and license to use, reproduce, make derivative works, display, publish, perform and sublicense any copyrights or copyrighted material (including any computer software and its documentation and/or databases) developed under this Subagreement for the purpose of education and research or to the extent required to meet JHU’s obligations under its Prime Award. Data. Subrecipient will own the data it generates under this Subagreement. Subrecipient hereby grants to JHU the right to receive copies of such data and to use data created as provided in the Statement of Work for the purpose of education and research or to the extent required to meet JHU’s obligations under its Prime Award. (FEDERAL PRIME ONLY) Additionally, Subrecipient acknowledges the rights of the U.S. Government to use such data. EQUIPMENT (FOUNDATIONS/COMMERCIAL PRIME: THIS MAY BE THE SPONSOR OWNED)The Subrecipient shall retain title to all equipment purchased under this Subagreement. Purchase of equipment, which is not in the approved Budget, attached as Exhibit B, requires JHU’s written prior approval, and Subrecipient must submit all unbudgeted equipment purchases requests to JHU in writing. The Subrecipient agrees to maintain sufficient records to enable JHU to fulfill its accountability under the provisions of the Prime Award. (FEDERAL PRIME ONLY) Equipment purchased under this Subagreement will be subject to 45 CFR part 74.INSPECTION AND AUDITUSE FOR COST REIMBURSEMENT BUDGET(FEDERAL PRIME ONLY: DOMESTIC NON-PROFIT SITES) Subrecipient agrees to comply with the requirement of 2 CFR, 45 CFR and/or other applicable regulations that ensure proper expenditure of federal funds. (FEDERAL PRIME ONLY: FOREIGN/DOMESTIC FOR-PROFIT SITES) A foreign or for-profit organization in receipt of U.S. federal funds is subject to compliance with 45 C.F.R. §74.26(d), as well as the most current Public Health Service Grants Policy Statement provisions regarding audit requirements. A copy of Subrecipient’s most recently released financial statement and independent audit shall be provided, including, “Findings and Recommendations” via the Federal Audit Clearinghouse or as requested by JHU. JHU reserves the right to inspect, upon JHU’s reasonable advance notice and during normal business hours, Subrecipient’s physical facilities, all aspects of the Statement of Work undertaken under this Subagreement, and all books, records, and documents of any kind pertaining to the Subagreement. Subrecipient agrees to provide copies of any records, receipts, accounts or other documentation to JHU in a timely fashion as reasonably requested by JHU.Subrecipient will keep all usual and proper records and books of accounts in accordance with Generally Accepted Accounting Principles (GAAP) relating to performance of the Statement of Work for a minimum period of three (3)/seven (7) (FEDERAL/COMMERCIAL PRIME CONTRACTS: “7”) years after the date of receipt of the final payment. During this period, JHU or an authorized representative shall have the right to audit, at its own expense, all financial books, accounts, and records of funds received and costs and commitments incurred under this Subagreement. If an audit reveals a material discrepancy or error in reporting, Subrecipient will reimburse JHU upon request for the costs and expenses associated with such audit and will repay the unallowable costs. Subrecipient expressly acknowledges its understanding that its activities pursuant to this Subagreement and all financial books, records, and accounts pertaining thereto may be subject to audit by the Sponsor, and Subrecipient agrees to cooperate fully in the performance of any such audit and repayment of the unallowable cost(s).USE FOR FIXED PRICE BUDGETJHU reserves the right to inspect, upon JHU’s reasonable advance notice and during normal business hours, Subrecipient’s physical facilities, all aspects of the Statement of Work undertaken under this Subagreement, and all records, and documents of any kind pertaining to the Subagreement. Subrecipient agrees to provide copies of any records, other documentation to JHU in a timely fashion as reasonably requested by JHU.Subrecipient will keep all usual and proper books relating to performance of the Statement of Work for a minimum period of three (3)/seven (7) (FEDERAL/COMMERCIAL PRIME CONTRACTS: “7”) years after the date of receipt of the final payment. During this period, JHU or an authorized representative shall have the right to audit, at its own expense, all books and records of funds received and costs invoiced under this Subagreement. If an audit reveals a material discrepancy or error in reporting, Subrecipient will repay the unallowable costs. TERMINATIONThis Subagreement may be terminated by either party at any time upon thirty (30) days written notice to the other party; however, JHU may terminate on less than thirty (30) days’ notice in the event such termination occurs pursuant to a notice of termination from the Sponsor to JHU. ? Upon such notification, Subrecipient shall proceed in an orderly fashion to limit or terminate any outstanding commitments, and to conclude the Project. Subrecipient shall submit a final financial report and/or progress report (if applicable) to JHU within forty-five (45) days of the notice of termination. In the event that the Subagreement is terminated as a result of a breach by Subrecipient, JHU shall be responsible for expenses incurred by the Subrecipient in relation to the Project, but only up to the date that Subrecipient receives the notice of the breach. If the Subagreement is terminated for any other reason, JHU shall be responsible for payment of any non-cancelable obligations incurred by the Subrecipient in relation to the Project, through the date of termination.LIABILITIES AND LOSS(USE FOR NON-STATE INSTITUTION) The work to be performed under this Subagreement will be performed entirely at the Subrecipient’s risk. The Subrecipient shall indemnify, defend, and hold harmless JHU, its trustees, officers, employees, students, and agents against all claims or actions based upon or arising out of damage or injury (including death) to persons or property caused by or sustained in connection with the performance of the Subrecipient or by conditions created thereby, or based upon any Subrecipient violation of any statute, ordinance, code or regulation in connection with its performance under this Subagreement. This obligation to defend and indemnify JHU shall survive the termination of this Subagreement.(USE FOR STATE INSTITUTIONS) It is understood and agreed that neither party to this Subagreement shall be liable for any negligent or wrongful acts, either of commission or omission, chargeable to the other unless such liability is by law, and that this Subagreement shall not be construed as seeking to either enlarge or diminish any obligation or duty owed by one party against the other or against third parties. INSURANCESubrecipient represents that it carries sufficient insurance coverage to comply with the requirements of federal, state and local laws as well as its obligations under this Subagreement. HUMAN SUBJECTS/ANIMAL RESEARCH COMPLIANCE Protection of Human Subjects. (IF NO HUMAN SUBJECTS ARE INVOLVED) Subrecipient agrees that no research involving human subjects will be conducted under this Subagreement. (IF HUMAN SUBJECTS ARE INVOLVED)Subrecipient certifies that it will comply with all requirements relating to human subject protections, including but not limited to those set forth at 45 C.F.R. Part 46 and 21 C.F.R. Part 50 (Protection of Human Subjects). Subrecipient agrees that it will obtain the approval of its institutional review board (the “IRB”) prior to conducting any studies involving human subjects and will comply with all IRB policies and requirements regarding such research. Subrecipient will notify JHU immediately if IRB approval of the study has to be revoked or suspended for any reason.Subrecipient certifies and agrees to provide assurance upon request that its IRB adheres to internationally recognized principles for ethical research such as those stated in the Protection of Human Subjects, Title 45, Code of Federal Regulations, Part 46, and the Belmont Report (a copy of which can be provided to the Subrecipient by JHU if requested), or CIOMS and that the IRB operates in a manner consistent with the international standards for IRB composition, responsibilities, functions, operations, procedures, and records set forth in the International Conference on Harmonization Good Clinical Practices guidelines. The Project Director shall provide assurance of successful training in the area of ethical human-subjects research (i.e., certificate of human-subjects research education). If requested by the Subrecipient, JHU can provide access to this training. Individually Identifiable Health Information. The Subrecipient will comply with the “Standards for Privacy of Individually Identifiable Health Information (45 C.F.R. 164 Subpart E).” This regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 governs the protection of individually identifiable health information.Unanticipated events, drug reactions, or other reports of Project activity that could assist JHU and other Subrecipients, if any, in protecting the health or safety of study subjects will be immediately reported to the JHU PI, in addition to reporting to the extent required to the sponsor and FDA, as applicable.Vertebrate Animals. (IF NO VERTEBRATE ANIMALS ARE INVOLVED) Subrecipient agrees that no research involving the use of vertebrate animals will be conducted under this Subagreement. (IF VERTEBRATE ANIMALS ARE INVOLVED)Subrecipient will comply with all federal government, Public Health Service, and NIH requirements, policies, and guidelines relating to the humane care and use of laboratory animals including but not limited to The Animal Welfare Act as amended, at 7 U.S.C. § 2131 et. seq., and comply with any local or state government laws, regulations or policies concerning such matters. In accordance with the applicable regulations, Subrecipient agrees that any animal research protocol conducted under this Subagreement will be reviewed and approved by Subrecipient’s Animal Care and Use Committee (IACUC) and certifies that this IACUC is in full compliance with all federal regulations and has an approved assurance on file with DHHS.EXPORT CONTROLS (DOMESTIC SITES ONLY)Subrecipient assumes responsibility for determining if it is subject to the jurisdiction of U.S. export control laws and regulations (“U.S. Export Controls”), including but not limited to the Export Administration Regulations (Department of Commerce), the International Traffic in Arms Regulations (Department of State), and sanctions programs embodied in regulations administered by the Department of the Treasury.? Even if Subrecipient is not subject to such jurisdiction, it agrees to facilitate JHU’s compliance with U.S. Export Controls in the manner described below.JHU anticipates that fulfillment of this Agreement may require “Controlled Transactions.”? Controlled Transactions include the exchange of tangible items or information that is identified as being subject to U.S. Export Controls (“Controlled Items”) – such as items that are included on the Commerce Control List (see 15 CFR 774) or the U.S. Munitions List (see 22 CFR 120-130) – as well other transactions which, in the absence of a license or license exemption, would be in violation of a U.S. sanctions program or embargo.If, during its performance under this Agreement, either Party discovers that it needs to release unforeseen (at the time this Agreement was executed) Controlled Items to the other Party, it will first notify the receiving Party of its intent to do so.? The receiving Party will then have the right to elect not to receive the Controlled Items.? Similarly, each Party has the right to elect not to participate in an unforeseen, Controlled Transaction as part of its performance under this agreement.? Controlled Items (foresee or unforeseen) intended for release shall be clearly identified as controlled, before they are exchanged, either in writing or orally.? If a received Item has been identified orally, it will subsequently be identified in a written account of the release that will be provided to the recipient within fifteen (15) days of its release.? Declining to receive unforeseen Controlled Items, export unforeseen Controlled Items, or enter into an unforeseen Controlled Transaction shall not be grounds for terminating this Agreement for default but will be acceptable as grounds for termination or amendment, as provided for in Section 13 (Termination).Neither notice of the type required above, nor other advice or information offered by one Party to another in support of the other’s Controlled Transactions shall constitute the notifying/advising/informing Party’s consent to indemnify the other for its non-compliant, Controlled Transactions.? JHU and Subrecipient shall separately assume full responsibility for their own release of Controlled Items to, or Controlled Transactions with, a foreign country or its citizens.ANTI-TERRORIST COMPLIANCE (DOMESTIC SITES ONLY)Subrecipient is reminded that U.S. Executive Orders and U.S. law prohibits transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Subrecipient to ensure compliance with these Executive Orders and laws. Subrecipient hereby agrees that all funds, including Subawards to lower-tier Subrecipients, will be used in compliance with all applicable United States anti-terrorist financing and asset control laws, regulations, rules and executive orders. This provision must be included in all subagreements issued under this Subagreement.TRAFFICKING IN PERSONS (FEDERAL PRIME ONLY) This Subagreement is subject to requirements of section 106(g) of the Trafficking Victims Protection Act of 2000, as amended (22 U.S.C. 7104).GOVERNING LAW, VENUE AND LANGUAGE (U.S. STATE INSTITUTIONS)Both parties agree to remain silent regarding Governing Law. (FOREIGN AND U.S. NON STATE INSTITUTIONS) This Subagreement shall be governed by and construed in accordance with the laws of the State of Maryland (excepting the application of UCITA any conflict of laws/provisions which would serve to defeat application of Maryland substantive law). Each party agrees that, prior to resorting to litigation to resolve any dispute, it will confer with other party to determine whether other procedures that are less expensive or less time consuming can be adopted to resolve the dispute.Each of the parties hereto agrees to venue in and submits to the exclusive jurisdiction of the state and/or federal courts located within the State of Maryland for any suit, hearing or other legal proceeding of every nature, kind and description whatsoever in the event of any dispute or controversy arising hereunder or relating hereto, or in the event any ruling, finding or other legal determination is required or desired hereunder. Both parties hereto agree to waive their respective rights to a trial by jury.[FOREIGN SITES ONLY] In the event that a translation of this Subagreement is prepared and signed by the parties, this English language version shall be the official version and shall govern if there is a conflict between this English language version and the translation. All disputes (e.g., litigation and arbitration) under this Subagreement shall be resolved and conducted, regardless of the means or authority, in the English language.? JHU will not pay for any translation of this Subagreement.DISPUTES(DOMESTIC SITES) The parties shall attempt to resolve all disputes through informal means. Each party agrees that, prior to resorting to litigation to resolve any dispute, it will confer with the other party to determine whether other procedures that are less expensive or less time consuming can be adopted to resolve the dispute.(FOREIGN SITES) Every effort shall be made to resolve any disputes arising in connection with this Subagreement in an amicable and informal manner. Failing to reach resolution, any dispute shall be finally settled under the Rules of Conciliation and Arbitration of the International Chamber of Commerce by one arbitrator, appointed in accordance with said Rules. Any and all hearings shall be conducted in the English language at a location mutually agreed upon by the parties. Judgment upon the award rendered may be entered into any court having jurisdiction.FORCE MAJEURENeither party will be responsible or liable to the other party for non-performance or delay in performance of any terms or conditions of this Subagreement due to acts or occurrences beyond the control of the nonperforming or delayed party, including, but not limited to, acts of God, acts of government, terrorism, wars, riots, strikes or other labor disputes, shortages of labor or materials, fires, and floods, provided the nonperforming or delayed party provides to the other party written notice of the existence of and the reason for such nonperformance or delay.SPECIAL CONDITIONS (WHEN THERE ARE ANY PRIME AWARD FLOW DOWNS)The Subrecipient is subject to, and agrees to abide by, the additional Prime Award terms and conditions specified in Exhibit D. ORDER OF PRECEDENCEAny inconsistency in this Subagreement shall be resolved by giving precedence in the following order: The Subagreement;Exhibit D, Prime Award clauses; (WHEN THERE ARE FLOW DOWNS)Other documents, exhibits, and attachments.[USE FOR CLINICAL TRIAL] In the event of a conflict between the terms of the Protocol and the terms of this Agreement, the terms of this Agreement shall control all business, legal and financial matters and the Protocol shall govern clinical matters to include Study participant care. ASSURANCES AND CERTIFICATIONSGeneral. Subrecipient represents and certifies that it has filed and will maintain all assurances or other documentation with the appropriate government agencies to the extent such assurances and documentation are required. Debarment. Subrecipient certifies that neither Subrecipient nor any of its employees or agents performing any service under this Subagreement (including the Project Director) are presently debarred, suspended, proposed for debarment, declared ineligible or voluntarily excluded from participation in this transaction, under investigation for a crime or otherwise engaged in conduct for which a person can be debarred by any federal agency, and Subrecipient will immediately notify JHU upon any inquiry concerning commencement of any such proceeding concerning Subrecipient or such person referred to in this subparagraph.(FEDERAL PRIME ONLY) Federal Debt. Subrecipient certifies that Subrecipient is not delinquent on any Federal debt in accordance with OMB Circular No. A-129.Lobbying. Subrecipient certifies that no federally appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of an Member of Congress in connection with this Subagreement, and that if any funds other than federally appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of an Member of Congress in connection with the Prime Award, grant loan or cooperative agreement the Subrecipient will complete and submit standard Form-LLL, “Disclosure Form to Report Lobbying.”(FEDERAL PRIME: DOMESTIC SITES ONLY) Non-discrimination. Subrecipient certifies that the Subrecipient is in compliance with the “Civil Rights Act of 1964”, the “Age Discrimination Act of 1975”, Title IX of the “Education Amendments of 1972”; the “Rehabilitation Act of 1973”; and the “Americans With Disabilities Act” and all implementing regulations.(FEDERAL PRIME: DOMESTIC SITES ONLY) Drug-Free Workplace. By signing this Subagreement, the Subrecipient assures that it is in compliance with the provisions of the “Drug-Free Workplace Act of 1988” (45 CFR Part 76, Subpart F).Changes. Subrecipient agrees to notify JHU promptly if there is any change of status in any of the above.(CLINICAL TRIALS ONLY) Study Registry. JHU assures that it is in compliance with Federal Regulations requiring JHU to register the Study Protocol on . WHISTLEBLOWER PROTECTIONS (FEDERAL PRIME: DOMESTIC SITES ONLY)Employees of Subrecipient may not be discharged, demoted, or otherwise discriminated against as a reprisal for "whistleblowing." In addition, whistleblower protections cannot be waived by any agreement, policy, form or condition of employment.Whistleblowing is defined as making a disclosure "that the employee reasonably believes is evidence of any of the following:Gross mismanagement of a Federal contract or grant;A gross waste of Federal funds;An abuse of authority relating to a Federal contract or grant;A substantial and specific danger to public health or safety; or,A violation of law, rule, or regulation related to a Federal contract or grant (including the competition for, or negotiation of, a contract or grant).To qualify under the statute, the employee's disclosure must be made to:A Member of Congress, or a representative of a Congressional committee;An Inspector General;The Government Accountability OfficeA federal employee responsible for contract or grant oversight or management at the ?? relevant agency;An official from the Department of Justice, or other law enforcement agency;A court or grand jury; or,A management official or other employee of the contractor, subcontractor, grantee, or subgrantee who has the responsibility to investigate, discover or address misconduct.The requirement to comply with, and inform all employees of, the "Pilot Program for Enhancement of Contractor Employee Whistleblower Protections" is in effect for all grants, contracts, subgrants and subcontracts? issued beginning July 1, 2013 through January 1, 2017.RESEARCH MISCONDUCTSubrecipient must have written policies and procedures for addressing allegations of research misconduct and take all reasonable and practical steps to foster research integrity. Research misconduct is defined as the fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. The Subrecipient must ensure that it is conducting its Project in accordance with the approved Statement of Work and Budget and the terms and conditions of the Subagreement. The Subrecipient must carry out its responsibilities with extra care where research misconduct has been found or where a research misconduct investigation has been initiated. The Subrecipient must report promptly to JHU, within five (5) business days, any decision to initiate an investigation of research misconduct. If a misconduct investigation is initiated, Subrecipient must take any necessary steps, in addition to its normal and ongoing responsibilities under the award, to protect the scientific integrity of the Project, protect human subjects and live vertebrate animals, provide reports to JHU and ensure the proper expenditure of funds and continuation of the project during the investigation, if appropriate. Subrecipient is responsible for the actions of its employees and other research collaborators, including third parties, involved in the Project. When the Subrecipient finds research misconduct by anyone working on the Project, whether at the Subrecipient or at a third-party organization, the Subrecipient must assess the effect of that finding on the ability to continue that Project, as originally approved, and must promptly obtain approval of any intended change of the Project Director or other senior/key personnel. Examples of possible sanctions are withdrawal of approval of the Project Director or other senior/key personnel, debarment, disallowance of costs associated with the invalid or unreliable research, withholding of a continuation award, or suspension or termination, in whole or in part, of the current award.Where research misconduct has affected data validity or reliability, JHU may require the Subrecipient and its collaborator authors to submit a correction or retraction of the data to a journal, publish the corrected data, or both. If Subrecipient does not comply with this requirement, JHU may invoke its rights to access the data (including copyrightable material developed under the Subagreement), have the data reviewed, and submit the correction.CONFLICT OF INTEREST DISCLOSURE (FEDERAL PRIME ONLY)In addition to all other reporting and notification requirements set forth in this Subagreement, the Subrecipient will promptly disclose to JHU in writing each of the following:42 CFR Part 50. 604 requires that institutions conducting PHS-funded research “Maintain an up-to-date, written, enforced policy on financial conflicts of interest.” Further, “If the Institution carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), the Institution (JHU) must take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of JHU or that of the Subrecipient will apply to the Subrecipient's Investigators." Option A: SUBRECIPIENT ABIDES BY OWN POLICYIf applying its own financial conflicts of interest policy, by execution of this Subagreement, Subrecipient certifies that its policy complies with 42 CFR Part 50. Subrecipient shall report any financial conflict of interest to the Office of Policy Coordination by email at policy@jhmi.edu. Any financial conflicts of interest identified shall subsequently be reported to the Sponsor. Subrecipient shall report any financial conflict of interest before expenditure of funds authorized in this Subagreement and within forty-five (45) days of any subsequently identified financial conflict of interest. Subrecipient shall update on an annual basis each financial conflict of interest it submits to JHU. The annual update shall be submitted to JHU prior to JHU's submission of the annual progress report for the Project, including multi-year funded Projects, or prior to the time of extension. The annual update shall be submitted by email to the Office of Policy Coordination at policy@jhmi.edu.Option B: SUBRECIPIENT ABIDES BY JHU POLICIES If applying JHU's policy, Subrecipient certifies that it will adhere to the definitions of “investigator” and “significant financial interest” as defined below. Subrecipient further certifies that it will abide by sections A, B(1), C and E of the JHU's Disclosure and Professional Commitment Policy and JHU's Policy on Individual Financial Interests and financial Conflicts of Interest in Research. In accordance with these policies, Subrecipient represents that it will report to JHU any identified significant financial interests of Subrecipient investigators that are directly related to the Subrecipient's work for JHU under this Subagreement. If JHU determines that a Subrecipient's investigator's significant financial interest constitutes a financial conflict of interest, Subrecipient and Subrecipient's investigator with the identified financial conflict of interest will comply with JHU’s management plan to ensure the conflict is managed. Subrecipient shall make no obligations against the funds to be awarded under this Subagreement until any Subrecipient investigator's significant financial interest is reported to JHU and, if necessary, any resulting financial conflict of interest is managed in accordance with this paragraph. If an investigator's significant financial interest arises during the course of the Project, Subrecipient shall report the interest to JHU within ten (10) days subsequent to learning of the interest. Subrecipient shall update on an annual basis each significant financial interest it discloses to JHU. The annual update shall be submitted to JHU prior to JHU's submission of the annual progress report for the Project, including multi-year funded Projects, or prior to the time of extension. An investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants. This definition includes all study team members on PHS-funded IRB applications. This definition is independent of whether one is appointed by or employed by the Subrecipient Institution. Investigators also include the following: Faculty members, if the Subrecipient is an academic institution Any Individual who receives any percent of effort under a PHS Subaward Graduate students at Subrecipient institutions who participate in PHS-supported research, or Any individual who is responsible for the design, conduct, or reporting of PHS-supported research and exercises enough independence to influence the outcome of said research. The final determination regarding who is considered an investigator in PHS-supported research should be made by the PI of the Project. A Subrecipient investigator's significant financial interest means any payment to the investigator and/or an investigator's financial interest or fiduciary role that is directly related to the Subrecipient's work for JHU. This includes, but is not limited to, the following: Income for services (e.g., consulting fees or honoraria that exceeds $5,000 per year) Equity interests (e.g., stock, stock options or other ownership interests) with a fair market value greater than $5,000, but not including equity interests in mutual funds Intellectual property rights and interests (e.g., receipt of royalty payments), upon receipt of income related to such rights and interests Fiduciary role (e.g., Board of Directors member, officer or manager) A significant financial interest does not include payments to the investigator by the Subrecipient institution, provided that the institution employs the investigator.MISCELLANEOUSNeither party may assign this Subagreement or any interest therein without the written consent of the other party. Any attempt to assign without prior written consent is void. [USE FOR COMMERCIAL] No party may assign or otherwise delegate any of its rights or obligations hereunder without the prior written consent of the other parties. Any attempted assignment in violation of this paragraph shall be null and void, without legal force or effect. The Subrecipient is engaged as an independent contractor. Nothing in the Subagreement is intended to, or shall be deemed to, constitute a partnership or joint venture between the parties. No party has the authority to bind any other party in contract or to incur any debts or obligations on behalf of any other party, and no party (including any employee or other representative of a party with responsibility for program matters) shall take any action that attempts or purports to bind any other party in contract or to incur any debts or obligations on behalf of any other party, without the affected party’s prior written approval.Subrecipient certifies and represents that the Statement of Work shall be performed in a professional and workmanlike manner and that any Deliverable shall be original to Subrecipient and will not knowingly infringe on any copyright held by any third party.The Section headings appearing in this Subagreement have been inserted for the purpose of convenience and ready reference. They do not purport to, and shall not be deemed to, define, limit or extend the scope of intent of the Section to which they appertain.If any provision of this Subagreement or any provision of any document incorporated by reference shall be held invalid, such invalidity shall not affect the other provisions of this Subagreement which can be given effect without the invalid provision, and to this end the provisions of this Subagreement are declared to be severable. No waiver of any term or provision of this Subagreement whether by conduct or otherwise in any one or more instances shall be deemed to be, or construed as, a further or continuing waiver of any such term or provision, or of any other term or provision, of this Subagreement. This Subagreement and Exhibits contain the entire agreement between the parties, and no statements, promises, or inducements made by either party or agent of either party that are not contained in this written Subagreement shall be valid or binding; and this Subagreement may not be enlarged, modified, or altered except in writing signed by the parties.This Subagreement may be executed in counterparts, each of which shall be deemed to be an original, but all of which, taken together shall constitute one and the same agreement. Attached ExhibitsExhibit A – Statement of WorkExhibit B – BudgetExhibit C – Sample Cost Reimbursable Invoice (DELETE FOR PER PATIENT AND CHANGE LETTERS FOR REMAINING EXHIBITS)Exhibit D – Sponsor’s Additional Terms and Conditions (WHEN THERE ARE FLOW DOWNS ONLY)Exhibit E – International Wire Information Form (FOREIGN SITES ONLY)[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]Please indicate acceptance of this Subagreement by having a duly authorized official sign this document.ACCEPTED FOR:JOHNS HOPKINS UNIVERSITYSCHOOL OF MEDICINE_______________________________Melody Snow, M.H.S.Assistant Director – Outgoing SubawardsOffice of Research AdministrationDATE: ________________________SUBSITE LEGAL NAME_______________________________Name:Title:Office of Research AdministrationDATE: ________________________READ AND UNDERSTOODName (OF SUBSITE PI)Common Name of Subsite Project DirectorDATE: ________________________ ................
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