Base Agreement, by and between Advanced Technology International and Arrevus, Inc., dated May 28, 2021

EXHIBIT 10.12

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BASE AGREEMENT

BETWEEN

ADVANCED TECHNOLOGY INTERNATIONAL (ATI)

315 SIGMA DRIVE

SUMMERVILLE, SC 29486

AND

ARREVUS, INC.

2443 LYNN RD, SUITE 210

RALEIGH, NC 27612

DUNS: 080059821

MEDICAL CBRN DEFENSE CONSORTIUM (MCDC) BASE AGREEMENT NO.: 2021-479

Authority: MCDC Other Transaction Agreement (OTA) No. W15QKN-16-9-1002 and 10 U.S.C. § 2371b.

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This Agreement is entered into between the Advanced Technology International hereinafter referred to as the “Consortium Management Firm (CMF),” and Arrevus, Inc., hereinafter referred to as “Project Agreement Holder.” This Agreement constitutes the entire understanding and agreement between the parties with respect to the subject matter hereof and supersedes all prior representations and agreements. It shall not be varied except by an instrument in writing of subsequent date duly executed by an authorized representative of each of the parties. The validity, construction, scope and performance of this Agreement shall be governed by the laws of the state of South Carolina, excluding its choice of laws rules.

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TABLE OF CONTENTS

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TABLE OF CONTENTS

(continued)

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TABLE OF CONTENTS

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TABLE OF CONTENTS

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ARTICLE I.SCOPE OF THE AGREEMENT

Section 1.01Background

The U.S. Army Contracting Command-New Jersey (ACC-NJ) is entering into an Other Transaction Agreement (OTA) under the authority of 10 U.S.C. § 2371b, with the Medical CBRN Defense Consortium (MCDC). The Joint Project Manager for Chemical, Biological, Radiological, Nuclear - Medical (JPM-CBRN Medical), through the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), will collaborate with the MCDC to carry out a coordinated research and development program designed to develop prototype medical, pharmaceutical, and diagnostic technologies directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components or materials in use by the armed forces. An OTA is being proposed with the purpose of conducting Research and Development into medical, pharmaceutical, and diagnostic technologies to enhance the mission effectiveness of military personnel, collaborating with industry partners for the advanced development of Medical Countermeasures (MCM) for chemical and biological defense. The OTA will allow JPM-CBRN Medical to partner with other agencies in the Department of Defense (DoD) chemical and biological defense enterprise, as well as collaborate with industry on applied research on candidate MCMs and supporting technologies. The MCDC was formed in response to the Government’s expressed interest to engage with an industry consortium comprised of traditional and nontraditional Government contractors, small and large business, for-profit and not-for-profit entities, academic organizations and their affiliates for the purpose of entering into an OTA to develop and mature medical, pharmaceutical, and diagnostic technologies through the execution of prototype projects.

Under the OTA and associated awards, the Government, along with the non-government members from the MCDC, shall perform coordinated planning and research and development prototype efforts designed to encompass the areas contained within the scope of the OTA as listed in Article I, Section 1.03 herein.

Section 1.02Definitions

“Academic Research Institution” means accredited institutions (colleges, universities or other educational institutions) of higher learning in the U.S.

“Agreement” refers to the MCDC Base Agreement.

“Agreements Officer (AO)” is the U.S. Army Contracting Command — New Jersey’s warranted Contracting Officer authorized to sign the final OTA for the Government.

“Agreements Officer’s Representative (AOR)” is the individual designated by the Government on a per project basis to monitor all technical aspects and assist in agreement administration of the specific project; the AOR shall only assist in agreement administration of the specific project to the extent delegated such administration authority in writing, in the AOR delegation letter by the responsible AO.

“Base Agreement” or “OTA” refers to the Prototype OTA under the authority of 10 U.S.C. § 2371b, between the Government and the MCDC, Agreement No. W15QKN-16-9-1002.

“Basket” is an electronic file containing proposals that have been submitted by MCDC Members in response to requests for prototype proposals, reviewed by the Government, and favorably evaluated in accordance with the procedures outlined in Section 1.03 of this Article.

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“Cash Contribution” means a Project Agreement Holder’s (PAH) financial resources expended to conduct a project awarded under a Project Agreement (PA). The cash contribution can be derived from PAH funds or outside sources, or may also come from non-federal contract or grant revenues, or from profit or fee on a federal procurement contract. A PAH’s own source of funds may include corporate retained earnings, current or prospective Independent Research and Development (IR&D) funds, or any other indirect cost pool allocation. New or concurrent IR&D funds can be utilized as a cash contribution, provided those funds identified by the PAH are to be spent on the conduct of a project’s Statement of Work (SOW). Prior IR&D will not be considered as part of the PAH’s cash or in kind contributions, nor will fee be considered on the PAH’s cost sharing portion. Cash contributions include the funds a PAH will spend for labor (including benefits and direct overhead), materials, new equipment (prorated if appropriate), subcontractor efforts expended on a project, and restocking the parts and material consumed under a project.

“Consortium Management Firm (CMF)” refers to the organization acting on behalf of the MCDC to execute and administer the efforts under the OTA for this program, as defined in the specific agreement entered into between the MCDC and the CMF. The current CMF is Advanced Technology International (ATI). The MCDC reserves the right to replace the CMF at any time.

“Contracting Activity” means an element of an agency designated by the agency head, and delegated broad authority regarding acquisition functions. It also means elements or another agency designated by the director of a defense agency, which has been delegated contracting authority through its agency charter.

“Cost Share” means resources expended by the PAH on the proposed project SOW, and subject to the direction of the AOR. There are two kinds of cost share:  cash contribution and in-kind contribution. Cost Share may only be proposed and collected on cost-reimbursement type agreements.

“Date of Completion” is the date on which all work is completed, or the date on which the period of performance ends.

“Development” means the systematic use, under whatever name, of scientific and technical knowledge in the design, development, test, or evaluation of an existing or potential new technology, product or service (or of an improvement in an existing technology, product or service), for the purpose of meeting specific performance requirements or objectives. Development includes the research functions of design engineering, prototyping, and engineering testing.

“Effective Date” means the date of last signature of this MCDC Base Agreement. “Government” means the U.S. Government and its departments and agencies.

“Government Fiscal Year” means the period commencing on October 1 and ending September 30 of the following calendar year.

“In Kind Contribution” means the PAH’s nonfinancial resources expended by the PAH to conduct a project, such as wear and tear on in-place capital assets like machinery or the prorated value of space used for the conduct of a project, and the reasonable fair market value (appropriately prorated) of equipment, materials, and other property used in the conduct of the project.

“JPEO-CBRND” means the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, created to manage our nation’s investments in chemical, biological, radiological, and nuclear defense. The JPEO-CBRND is also the parent organization of JPM-CBRN Medical. The JPEO-CBRND includes an array of stakeholders involved in the development of prototype hardware, software, and system technologies.

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“JPM-CBRN Medical” means the Joint Project Manager for Chemical, Biological, Radiological, Nuclear - Medical Office, created for the advanced development of medical countermeasures for chemical and biological defense. The JPM-CBRN Medical is also the program management office for this overall effort. The JPM-CBRN Medical includes an array of stakeholders involved in the development of prototype hardware, software, and system technologies.

“Medical CBRN Defense Consortium (MCDC)” is the consortium formed by industry in response to the Government’s expressed interest to quickly provide the warfighter with safe and effective chemical, biological, radiological, and nuclear countermeasures. The MCDC is comprised of Traditional and Nontraditional Defense Contractors, including small and large (other than small) businesses, for profit, and not for profit entities, and academic research institutions.

“MCDC Base Agreement” means the agreement between the MCDC’s CMF and the MCDC Member that serves as the baseline agreement for all future PAs, and flows down applicable terms and conditions from this OTA.

“MCDC Executive Committee” is the Executive Committee, comprised of Traditional and Nontraditional Defense Contractors, including small and large businesses, for profit and not for profit entities, and academic research institutions.

“MCDC Members” means the Nontraditional and Traditional Defense Contractors, including small and large businesses, for profit and not for profit entities, and academic research institutions that are members in good standing of the MCDC.

“MCDC Enhanced White Paper (EWP)” means the paper (proposal) submitted by MCDC member that describes a specific technology idea or concept for an indicated research area, in a Government-specified format, as delineated in the Request for Prototype Proposals (RPP). As part of the EWP RPP process, MCDC EWPs are evaluated by the Government to determine selection.

“MCDC White Paper” means the paper submitted by MCDC member that describes a specific technology idea or concept for an indicated research area in a Government-specified format, as delineated in the RPP. As part of the two-step RPP process, MCDC White Papers are evaluated by the Government to determine whether submission of a full proposal on the summarized concept or idea might be warranted.

“Milestone” means a scheduled event signifying the completion of a major deliverable or a set of related deliverables.

“Nonprofit Research Institution” means a university or other institution of higher learning, or an organization of the type described in Section 501(c)(3) of the Internal Revenue Code of 1954 that is exempt from taxation under Section 501(a) of the Internal Revenue Code, or any nonprofit scientific or educational organization qualified under a State nonprofit organization statute.

“Nontraditional Defense Contractor” means an entity that is not currently performing and has not performed, for at least the one-year period preceding the issue date of the RPP, any contract or subcontract for the Department of Defense that is subject to full coverage under the cost accounting standards prescribed pursuant to section 1502 of title 41, and the regulations implementing such section. A nontraditional defense contractor can be at the prime level, team members, subcontractors, lower tier vendors, or “intra-company” business units (provided the business unit makes a significant contribution to the prototype project). Examples of what might be considered a significant contribution include supplying new key technology or products, accomplishing a significant amount of the effort, or in some other way causing a material reduction in the cost or schedule or increase in the performance.

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“Other Transactions for Prototype Projects” refers to the type of OTA this MCDC Base Agreement is under. This type of OTA is authorized by Department of Defense (DoD) Authorization Acts, and is found in the U.S. Code as a Note in 10 U.S.C. § 2371b. 10 U.S.C. § 2371b(a), “Authority of the DoD to carry out certain prototype projects,” authorizes the Secretary of a military department to carry out prototype projects directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces. This type of OTA is treated by the DoD as an acquisition instrument, commonly referred to as an “other transaction” for a research prototype project or 2371b “other transaction.”

“Parties” means the Consortium Management Firm, ATI, and the PAH where collectively identified and “Party” where each entity is individually identified.

“Payable Milestone” means that once a milestone has been met (see defmition of “milestone”), the Government can approve payment to the PAH of a predetermined dollar amount in relation to performance of a particular project under the OTA.

“Program Manager” means the Technical Administrator for the Program (located at the JPM-CBRN Medical) responsible for Government oversight of the MCDC OTA program.

“Project” refers to the scope of work being completed under a PA.

“Project Agreement (PA)” means that agreement between the MCDC, by its CMF, and the MCDC member entity whose proposal is evaluated and competitively selected by the Government for funding, establishing the scope of work, terms, and conditions for the MCDC member entity’s performance and payment under the Government funded project. PAs shall comply with all provisions contained within the OTA and any other supporting documents referenced therein. The PA is initiated by the CMF based on the Technical Direction Letter (TDL) sent by the Government to the CMF.

“Project Agreement Holder (PAH)” means the MCDC member entity issued a PA by the CMF.

“Request for Prototype Proposals (RPP)” means the announcement(s) by the Government to the MCDC, instructing and requesting submissions for an indicated research area.

“Selection Announcement Letter (SAL)” means the Government document to be issued to the MCDC via the CMF, documenting the Government’s decision to make the award of a PA and/or place one (1) or more proposal(s) in the “Basket” and/or reject one (1) or more proposal(s).

“Technical Direction Letter (TDL)” is a Government document to be issued to the CMF, reflecting the Government’s decision to select and fund all or part of a particular proposal submitted by a MCDC member or team of MCDC members, through the RPP process conducted under this OTA. The TDL shall establish the scope of work, terms and conditions for performance and payment, and include the MCDC member proposal selected for Government funding. Where a specific Government agency laboratory, test facility, center or other location will be used by the MCDC member entity or team of MCDC member entities in performance of the PA, it will be identified, and the cost of such use, whether Government-contributed or MCDC member reimbursed, will be identified in the TDL.

“United States Army Contracting Command — New Jersey (ACC-NJ)” means the contracting activity who is designated as the lead Government organization in charge of executing the program.

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Section 1.03Scope

The purpose of this MCDC Base Agreement is to streamline the process for project awards related to prototype medical, pharmaceutical, and diagnostic technologies. Under this MCDC Base Agreement and associated Project Agreements (PA), the Government, along with the non-government members from the MCDC, shall perform coordinated planning and research and development prototype efforts designed to encompass the following three (3) objective areas:

The Government shall determine which research and development endeavors to pursue and projects to fund. The Government shall provide the MCDC, through the Consortium Management Firm (CMF), with a competitive request for prototype proposals, either utilizing Enhanced White Papers (EWP) or White Papers and Full Proposals. The CMF shall make those RPPs available to MCDC Members, who will then decide whether to submit in response to such RPPs and, if so, will prepare their individual documentation or will individually establish a team comprised of MCDC Members to prepare a team proposal(s). The Government shall be solely responsible for evaluation and selection of proposals for project funding from among the proposals submitted. At any time throughout the term of this MCDC Base Agreement, the Government may address the needs for the desired Joint Project Manager for Chemical, Biological, Radiological, Nuclear - Medical (JPM-CBRN Medical) objective areas or other related Government needs, as they arise. The Parties agree that other organizations and agencies within the U.S. Government may participate in the collaborative activities through a Memorandum of Agreement, or other such arrangement. It is anticipated that these other organizations may include the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), Defense Threat Reduction Agency (DTRA), and Biomedical Advanced Research and Development Authority (BARDA).

Request for Prototype Proposals (RPP) Process:

Once the Government identifies a need under one of the goal/objective areas above, the Government will issue a RPP. The RPP will either utilize the EWP or White Paper and Full Proposal approach, via the CMF. Under the White Paper and Full Proposal approach, the Government may require the submission of an initial White Paper for review, prior to the submission of a Full Proposal. Due dates will be indicated for each. The CMF shall in turn issue a similar request to MCDC member entities, for which the Government will review and evaluate all responses. The Government will be solely responsible for evaluation of the submissions, in accordance with the criteria. If the RPP requires a standard MCDC white paper, only members submitting white papers will be permitted to submit full proposal submissions. Based on the evaluation of the white papers, the Government will make a recommendation on whether the member should or should not submit a full proposal submission. However, any member submitting a white paper, regardless of the Government’s recommendation, may submit a full proposal.

MCDC member white papers and proposals shall be submitted to the CMF in accordance with the RPP instructions, which will include evaluation criteria and a Statement of Work (SOW) template, along with applicable due dates. The CMF will review white paper and proposal submissions for completeness and format compliance. The CMF shall in turn prepare and transmit MCDC member’s white papers and proposals to the Government for evaluation. The Government will be responsible for technical evaluation and selection of the projects from the white papers and proposals submitted. Upon completion of Government evaluations, a Selection Announcement Letter (SAL) will be issued to the MCDC via the CMF, documenting the Government’s decision to make the award of a PA and/or place one (1) or more

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proposal(s) in the “Basket” and/or reject one (1) or more proposal(s). Once selected by the Government for award, the MCDC member entity will prepare an updated cost proposal in accordance with RPP instructions. The CMF will provide a copy of the member’s initial cost proposal reasonably upon receipt. Ultimately, the CMF will provide an assessment summary to the Government for review, to include back-up documentation. The Government Agreements Officer (AO) will review the documentation and complete any necessary negotiations, as well as make the final determination regarding whether the negotiated project cost is fair and reasonable. All PAs will be subject to discussions/negotiations and proposal updates, as appropriate, prior to execution.

Once all steps are complete, the Government will issue a Technical Direction Letter (TDL) to the CMF for the authorization and execution of the prototype project to be performed by the selected MCDC member entity(ies). Once the CMF receives notification of selection of a project for funding via TDL, the CMF will enter into a PA with the MCDC member.

A modification will be executed separately by the Government, which will include the funding for the negotiated and agreed-upon project. After receipt of the TDL, and review and execution of the funding modification, the CMF shall enter into a PA with the MCDC member whose project was selected. The MCDC CMF shall administer the Government-funded PAs. The Government’s designated Agreements Officer’s Representative (AOR) for the specific project, will supervise the technical work performed by the MCDC member entity in execution of the PA. The Government reserves the right to revise the terms and conditions of these projects in accordance with Article III, Section 3.04. The above process is subject to change based on annual review meetings.

Placement in the Electronic “Basket File”:

Qualifying proposals, not eligible for current funding, may be entered into an electronic basket and subject to award for up to thirty-six (36) months. The RPP will contain the available ratings and their defmitions to be assigned to proposals as a result of the technical evaluation, as well as which specific ratings will qualify a proposal for inclusion in the basket. The Government reserves the right to determine which, if any, proposals are to be selected according to the published criteria.

Once in the basket, a proposal may be identified for award by the Government based on Government need and availability of funding. The Government reserves the right to 1.) Request that the MCDC member who submitted the identified proposal, scale or otherwise adjust the original proposal, and to 2.) Fund all or part of the identified proposal. The MCDC member will have an opportunity to update their proposal, as applicable, if selected from the basket. The Government will review any updated information provided by the MCDC member and/or CMF. Upon the Government’s decision to fund such a proposal from the basket, the CMF will receive notification of the award decision through a TDL, whereupon the CMF will enter into a PA with the indicated MCDC member, as required.

A selected proposal will reside in the Basket for thirty-six (36) months from the date the corresponding RPP is closed, unless funded or the submitting MCDC member requests in writing beforehand to have it removed.

Small Business Innovation Research (SBIR) Phase III Project Requests:

It will be incumbent upon the MCDC member, on their own, with some general support and guidance from the CMF, to fmd a Government Technical Point of Contact (POC) with both (1) available funding and (2) an interest in furthering technology developed under a current or prior SBIR project. Upon doing so, the Government Technical POC will coordinate the feasibility of placing the award under the Base Agreement

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with the Government AO and OTA Program Manager (PM), and the following areas will be considered when making a determination for appropriateness of award under the Base Agreement:

Should the Government AO and the OTA PM determine it is appropriate to award the SBIR Phase III under the Base Agreement, the Government AO will send a proposal request to the MCDC member through the CMF, as is standard for any Government request under the Base Agreement. The CMF will provide a cost summary to the Government AO for consideration in the Government’s award determination. The Government will evaluate the proposal, conduct any necessary negotiations, and make an award determination. If the Government makes the determination to award to the MCDC member, the Government AO will issue a TDL letter to the CMF, resulting in the issuance of a PA between the CMF and MCDC member.

SBIR Phase III awards under the Base Agreement shall include the data rights provisions and data rights granted to the MCDC member, contained within Article XI of this MCDC Base Agreement. All administrative, reporting, and other aspects of awards made for SBIR Phase III efforts under this MCDC Base Agreement, will be in accordance with the terms and conditions of the OTA. MCDC Members must have been awarded and performed under a previous SBIR Phase I and/or Phase II contract, in order to qualify for SBIR Phase III award under the Base Agreement.

Section 1.04Goals/Objectives

The Government, in conjunction with the MCDC, shall perform coordinated research and development projects that focus on the following:

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Section 1.05Reports

The MCDC member organizations conducting projects in accordance with this MCDC Base Agreement shall maintain records of the activities performed and funding expended under the projects, as well as the results of any studies analyses, tests, and other investigations conducted. Based on the progress of the funded projects and other information known to the AO or authorized designee, the Government Program Office shall review the relevant projects throughout the period to determine if any changes to planning or budget are required. If such a change is expected, which will cause a need to modify the Base Agreement, the TDL or an individual PA may be modified to incorporate such changes. The AO is the only authorized representative of the Government who may make modifications to the Base Agreement. Project Agreement Holders (PAH) shall submit the following reports to the CMF for each PA they have been awarded:

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The Final Technical and Business Status Reports are also required in the event of a termination in accordance with Article II, if sufficient funding is available.

Note:  Deficiencies in regulatory reports must be adequately assessed by the Government, MCDC and the individual performer, or consortium as a whole, to come to resolution. The Government will notify the MCDC if reporting and/or performance are not sufficient, and work collaboratively with the MCDC toward a resolution.

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ARTICLE II.TERM

Section 2.01The Term of this MCDC Base Agreement

The period of performance for this MCDC Base Agreement is from the effective date, which is the date of last signature, to April 7, 2036, unless extended by mutual agreement of the Parties. If at any time funds expended exceed the amount obligated on a PA prior to the expiration of the term, the Parties have no obligation to continue performance and may elect to cease their efforts at that point. Provisions of this MCDC Base Agreement, which, by their express terms or by necessary implication, apply for periods of time other than specified in Article II herein, shall be given effect, notwithstanding this Article.

Section 2.02Termination of the Base Agreement by Mutual Agreement of the Government and MCDC

Except for the rights and obligations with respect to proprietary information and/or specific intellectual property agreements between or amongst the Government, the CMF and the MCDC member organizations, unless extended by mutual written agreement of the Parties, the Base Agreement shall automatically terminate by written agreement of the Government and MCDC. Unless otherwise directed by the AO through the CMF, individual PAs pursuant to this MCDC Base Agreement shall also terminate upon the termination of the Base Agreement.

Section 2.03Termination Provisions

Subject to a reasonable determination that the program, or a project funded under the program, will not produce beneficial results commensurate with the expenditure of resources, the Government may terminate performance of work under this OTA or a specific project, in whole or in part, if the AO determines that a termination is in the Government’s interest. The AO shall terminate by delivering to the MCDC through its CMF, a Notice of Termination specifying the extent of termination and the effective date.

After receipt of a Notice of Termination, and except as directed by the CMF, the PAH shall immediately proceed with the following obligations, regardless of any delay in determining or adjusting any amounts due:

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The requirement for at least 1/3 cost share of the total project cost by the PAH is assessed prior to award. In the event that during the course of the performance of the PA, any of the parties to the PA believe the cost sharing funds available will be insufficient, the PAH shall notify the CMF within twenty-five (25) days of the event that gave rise to the insufficient cost sharing funds. CMF will notify the Government within five (5) days of receiving such notice from the PAH. The Government will determine whether it is in its best interest to either renegotiate the scope and/or terms of the PA to meet the cost share requirement, or terminate the PA in whole or in part.

The proceeds of any transfer or disposition of project property, will be applied to reduce any payments to be made by the Government under that particular project, including credited to the price or cost of the work, or paid in any other manner directed by the CMF.

In the event of a termination of the PA, the Government shall have patent rights as described in Article X, Patent Rights, and rights in data as described in Article XI, Data Rights. Failure of the PAH and Government to agree to an equitable adjustment shall be resolved pursuant to Article VII, Disputes.

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Section 2.04Termination Cost

The CMF will negotiate with the Government and PAH in good faith, equitable reimbursement for work performed toward accomplishment of the task or tasks of individual projects. The Government will allow full credit for the Government share of the obligations properly incurred by a PAH prior to termination. Costs incurred by a PAH during a suspension or after termination of a project are not allowable unless the CMF expressly authorizes them in either the notices of suspension, termination, or subsequently. Other PAH’s costs incurred during a suspension or after termination, which are necessary, and not reasonably avoidable, are allowable if:

Section 2.05Close-out Procedure

If the Government funds an individual PA and then subsequently terminates the agreement, or the requirements of the agreement are met, the following closeout procedures apply:

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Section 2.06Stop Work

As directed by the AO, the CMF may, at any time, by written order to the PAH, require the PAH to stop all, or any part, of the work called for under this MCDC Base Agreement or any PA for a period of ninety (90) days after the written order is delivered to the PAH, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this section. Upon receipt of the order, the PAH shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of ninety (90) days after a stop-work is delivered to the PAH, or within any extension of that period to which the parties shall have agreed, the CMF shall either:

If a stop work order issued under this Article is canceled, the PAH shall resume work. The CMF shall make an equitable adjustment in the delivery schedule or PA estimated cost/price, or both, and the Government’s share of the PA shall be modified, in writing, accordingly, if—

If a stop work order is not canceled and the work covered by the PA is terminated in accordance with Article II, the MCDC CMF shall work with the PAH to negotiate an equitable reimbursement in accordance with Article II. Section 2.03, Termination Provisions.

ARTICLE III.MANAGEMENT, MODIFICATION, AND ADMINISTRATION

Section 3.01The Medical CBRN Defense Consortium (MCDC)

The MCDC, as defined in this MCDC Base Agreement, was formed to work with the Government and provide input in developing medical, pharmaceutical, and diagnostic technologies to enable advanced development of MCM for chemical and biological defense, which are related to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces, ultimately resulting in fully executed research and development prototype projects selected by the Government. Every Member in this MCDC is independent of the other, and there is no affiliation between the MCDC Members within the defmition of 13 C.F.R. 121.103 of the Federal Small Business Regulations, and no such affiliation is intended either by the formation or implementation of the MCDC.

As appointed by the MCDC Executive Committee, the CMF has the authority to manage this OTA on behalf of the MCDC, and has the responsibility for day-to-day overall administration of this MCDC Base Agreement, subject to the supervision of the MCDC Executive Committee.

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Section 3.02The following MCDC decisions are subject to ACC-NJ approval:

Section 3.03Management and Project Structure

Technical and project management of the coordinated research program established under this MCDC Base Agreement shall be accomplished through the management structures and processes detailed in this Article.

The Government competitively selected the MCDC, organized by its CMF, Advanced Technology International (ATI), a Section 501(c)(3) nonprofit organization. The MCDC has entered into an agreement with ATI, authorizing ATI to enter into the OTA as the consortium manager, engage in overall day-to-day management of the MCDC under the guidance of and as designated by the MCDC Executive Committee, including technical, programmatic, reporting, financial, administrative and contractual matters, and administer PAs required for performance under the OTA.

As established by funded projects under the OTA, the Government Program Manager shall fully participate in the appropriate program technical meetings held by the MCDC. The AORs and other Government personnel, as deemed appropriate, also may participate in the technical portion of these meetings.

Section 3.04Modifications

As a result of scheduled meetings, end of program reviews, or at any time during the term of the OTA, research progress or results may indicate that a change in the OTA’s scope, objectives or Term would be beneficial to program objectives. Recommendations for modifications, including justifications to support any changes to the OTA Scope, will be documented in a letter and submitted by the PAH to the CMF, who will then forward it to the Program Manager with a copy to the AO. This documentation letter will detail the technical, chronological, and financial impact of the proposed modification to the OTA. The Program Manager shall be responsible for the review and verification of any recommendations to revise or otherwise modify the OTA Scope or other proposed changes to the terms and conditions of the OTA and subsequently this MCDC Base Agreement

With regard to projects the Government determines to fund as a result of the RPP process specified in the MCDC Base Agreement scope, any PAH recommendations for modifications, including justifications to support any changes to the funded PAs, will be documented in a letter and submitted by the CMF to the AO, with a copy to the Government AOR designated for the particular project. The AO shall be responsible for review of proposed changes, and for all modifications to the terms and conditions of the PA(s). The CMF shall modify the PA(s) in the event of any such modifications or changes to the project.

Management of Projects

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The AOR shall monitor the PAH’s performance with respect to compliance with the technical requirements of the PA.

As such, no verbal or written request, notice, authorization, direction or order received by the PAH shall be binding upon the MCDC, CMF or Government, or serve as the basis for a change in the PA cost, or any other provision of the PA, unless issued (or confirmed) in writing by the MCDC CMF.

ARTICLE IV.AGREEMENT ADMINISTRATION

Administrative and contractual matters under this MCDC Base Agreement shall be referred to the following representatives of the parties:

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Each party may change its representatives named in this Article by written notification to the other parties.

Agreements Officer Representative (AOR):  AOR will be designated by the Government on a per project basis.

ARTICLE V.OBLIGATION AND PAYMENT

Section 5.01Obligation:

Except as specified in Article VII, Disputes, the CMF’s liability to make payments to the PAH is limited only to those funds obligated under the PA(s). The CMF may incrementally fund the PA(s). If modification becomes necessary in performance of projects, pursuant to Article V of this MCDC Base Agreement, the CMF and the PAH shall establish and execute a revised Schedule of Payable Milestones consistent with the current PA.

Section 5.02Project Payments:

The detailed instructions for project payments will be included in the TDL to be issued by the CMF on a project by project basis.

Section 5.03Accounting System Requirements:

Prior to the submission of invoices, the PAH shall have and maintain an established accounting system which complies with Generally Accepted Accounting Principles (GAAP) and the requirements of this MCDC Base Agreement. The PAH shall ensure that appropriate arrangements have been made for receiving, distributing and accounting for Federal funds under this MCDC Base Agreement. Consistent with this stipulation, an acceptable accounting system will be one in which all cash receipts and disbursements are controlled and documented properly.

For expenditure-based or resource-sharing projects, the capability of the MCDC Member’s accounting system will be considered prior to award. Although the Government will not impose requirements that will cause a MCDC Member to revise or alter its existing accounting system, the Government will not enter into a PA that provides for payment based on amounts generated from the MCDC Member’s financial or cost records, if the MCDC Member does not have an accounting system capable of identifying the amounts/costs to individual agreements/contracts.

Allowable Costs:  Although OTAs are not subject to the FAR, the principles included in FAR Part 31 may be applied to determine price reasonableness for individual projects. MCDC Members who are selected for

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awards under the Base Agreement may refer to FAR Part 31 for guidance on allowable costs in preparing their final cost proposal for a project award.

Section 5.04Invoicing Instructions:

Project Payable Milestones:  The PAH shall segregate and track all individual project costs separately and shall document the accomplishments of each Payable Milestone under each PA. A Payable Milestones report shall be detailed on a project basis and submitted with each request to the AOR or designee for approval.

Section 504a.Payment Method Types

Project Agreements will be issued as either a fixed price milestone payment method or a cost reimbursement milestone payment method as described below.

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“I certify that the amounts invoiced are for costs incurred in accordance with the agreement, the work reflected has been performed, and prior payment has not been received.”

Authorized Signature                                                                                     

“I certify that the amounts invoiced are for costs incurred in accordance with the agreement, the work reflected has been performed, and prior payment has not been received.”

Authorized Signature                                                                                           

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“I certify that the amounts invoiced are for costs incurred in accordance with the agreement, the work reflected has been performed, and prior payment has not been received.”

Authorized Signature                                                                                           

Section 5.04b.Submission of Invoices

Invoices may be submitted no more frequently than monthly. The PAH shall submit invoices and any necessary supporting documentation via email to ***@***.

For Cost type Project Agreements, the PAH’s final invoice (completion invoice) will be clearly indicated as such and shall indicate the cumulative amounts incurred and billed to completion, and a written certification of the total hours expended. Actual project costs incurred and cost share performance, if applicable, of each project shall be reported and reviewed each quarter.

Section 5.04c.Payment Terms

Payment terms are NET 30 days after CMF’s receipt of an acceptable invoice. An acceptable invoice is one that meets the conditions described in Article V Section 5.04a. Payment Method Types.

Section 5.05Advance Payments:

On a per project basis, advance payments may be approved by the AO. If the AO has approved advance payments, there will be a requirement to establish a separate interest bearing account. The PAH sets up and maintains funds in a separate interest bearing account, unless one of the following applies:

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Where a separate interest bearing account is set up, any interest earned should be remitted annually to the CMF. CMF shall forward the funds to the Government as directed by the AO. Interest payments shall be made payable to the U.S. Treasury.

Section 5.06Limitation of Funds:

Except as set forth in Article VII, the Government’s fmancial liability will not exceed the amount obligated for projects and available for payment.

Section 5.07Financial Records and Reports:

The PAH shall maintain adequate records to account for Federal funds received under this MCDC Base Agreement and shall maintain adequate records to account for PA funding provided under this MCDC Base Agreement, should cost sharing procedures be implemented for funding a particular project. PAH’s relevant financial records are available and subject to examination or audit on behalf of the ACC-NJ for a period not to exceed three (3) years after final payment of the PAH’s project. The AO or designee shall have direct access to sufficient records and information of the PAH to ensure full accountability for all funding under this MCDC Base Agreement. Such audit, examination or access shall be performed during business hours on business days upon prior written notice and shall be subject to the security requirements of the audited party. Any audit required during the course of the program may be conducted by the Government using Government auditors or, at the request of the PAH, by the requesting PAH’s external CPA accounting firm at the expense of the requesting PAH.

ARTICLE VI.APPROPRIATE USE OF OTHER TRANSACTION AUTHORITY

In accordance with provisions of 10 USC 2371b, the DoD has authority to enter into transactions other than contracts, grants, or cooperative agreements. The DoD has the authority to make awards that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the DoD, or the improvement of platforms, systems, components, or materials in use by the armed forces.

Per 10 U.S.C. § 2371b, each prototype project awarded under this Base Agreement must meet one of the following conditions:

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Throughout the period of performance of any PA, the AO and AOR will actively monitor projects to ensure compliance with this statutory requirement. The Government will take into account any implementation guidance from the Department of the Army and the Office of the Under Secretary of Defense for Acquisition and Sustainment, which includes but is not limited to, the most recent Other Transactions Guide. The MCDC Member awarded a PA will be given the opportunity to become compliant with this statutory requirement should they be found non-compliant by the AO and AOR and as communicated to the PAH by the CMF. Failure to comply may result in termination.

If significant nontraditional / nonprofit participation cannot be fulfilled, the PAH must provide at least one third cost share of the value of the PA awarded to the PAH. Proposals that fail to comply with this requirement, will not be awarded under the OTA.

Cost Sharing is not required under the OTA for projects that contain significant nontraditional / nonprofit participation. Where the Government and PAH agree, cost sharing may be considered on a per project basis under terms and conditions to be agreed to by them, and in accordance with the most recent Other Transactions Guide.

ARTICLE VII.DISPUTES

Section 7.01General

For the purposes of this Article, “Parties” means the CMF, the PAH and the Government where collectively identified and “Party” where each entity is individually identified. The Parties shall communicate with one another in good faith and in a timely and cooperative manner when raising issues under this Article.

Section 7.02Dispute Resolution Procedures

Any disagreement, claim or dispute among the Parties concerning questions of fact or law arising from or in connection with this MCDC Base Agreement and whether or not involving an alleged breach of this MCDC Base Agreement, may be raised only under this Article.

Whenever disputes, disagreements, or misunderstandings arise, the Parties shall attempt to resolve the issue(s) involved by discussion and mutual agreement as soon as practicable. In no event shall a dispute, disagreement or misunderstanding which arose more than three (3) months prior to the notification made under this Article constitute the basis for relief under this article unless the ACC-NJ Division Chief for Emerging Technologies, in the interest of justice, waives this requirement.

Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement, or misunderstanding by notifying the other Party in writing, documenting the relevant facts, identifying unresolved issues, specifying the clarification or remedy sought, and documenting the rationale as to why the clarification/remedy is appropriate. Within ten (10) working days after providing notice to the other Party, the aggrieved Party may, in writing, request a decision by the ACC-NJ, Center Director for Emerging Technologies. The other Party shall submit a written position on the matter(s) in dispute within thirty (30) calendar days after being notified that a decision has been requested. The ACC-NJ Division Chief for Emerging Technologies, will conduct a review of the matter(s) in dispute and render a decision in writing

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within thirty (30) calendar days of receipt of such position. Any such decision is final and binding, unless a Party shall, within thirty (30) calendar days, request further review as provided by this article.

If requested within thirty (30) calendar days of the ACC-NJ Division Chief for Emerging Technologies’ decision, further review will be conducted by the Chair of the MCDC Executive Committee and the ACC-NJ Associate Director. In the event of a decision, or in absence of a decision within sixty (60) calendar days of referral to the Chair of the MCDC Executive Committee and the ACC-NJ, Associate Director (or such other period as agreed to by the parties), either party may pursue any right or remedy provided by law, including but not limited to the right to seek extraordinary relief under Public Law 85-804. Alternatively, the parties may agree to explore and establish an Alternate Disputes Resolution procedure to resolve this dispute.

Section 7.03Limitation of Liability and Damages

In no event shall the liability of the MCDC PAH or any other entity performing research activities under a Project Agreement exceed the funding such entity has received for their performance of the specific PA under which the dispute arises.

No Party shall be liable to any other Party for consequential, punitive, special and incidental damages or other indirect damages, whether arising in contract (including warranty), tort (whether or not arising from the negligence of a Party) or otherwise, except to the extent such damages are caused by a Party’s willful misconduct; Notwithstanding the foregoing, claims for contribution toward third-party injury, damage, or loss are not limited, waived, released, or disclaimed.

ARTICLE VIII.CONFIDENTIAL INFORMATION

Section 8.01Definitions

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stored, compiled, or memorialized physically, electronically, graphically, photographically, or in writing if -

Section 8.02Exchange of Information:

The Government may from time to time, disclose Government Confidential Information to the MCDC for use by the MCDC member entities or MCDC PAHs, their subcontractors or suppliers, in connection with Government solicitations and similar processes or particular projects. The CMF, on behalf of the MCDC, MCDC member entities, or MCDC PAHs, their subcontractors or suppliers, may from time to time disclose information that is Trade Secret or Confidential Information to the Government in connection with this MCDC Base Agreement, a project proposal, or performance under a PA. Neither Party shall be obligated to transfer Confidential Information or Trade Secrets independently developed by the Parties, absent an express written agreement between the Parties providing the terms and conditions for the disclosure.

Section 8.03Authorized Disclosure:

The Receiving Party agrees, to the extent permitted by law, that Confidential Information shall remain the property of the Disclosing Party (no one shall disclose unless they have the right to do so), and that, unless otherwise agreed to by the Disclosing Party, Confidential Information shall not be disclosed, divulged, or otherwise communicated by it to third parties, or used by it for any purposes other than in connection with specified project efforts and the licenses granted in Article X, Patent Rights, and Article XI, Data Rights, provided that the duty to protect such “Confidential Information” and “Trade Secrets” shall not extend to materials or information that:

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Section 8.04Return of Proprietary Information:

Upon the request of the Disclosing Party, the Receiving Party shall promptly return all copies and other tangible manifestations of the Confidential Information disclosed. As used in this section, tangible manifestations include human readable media, as well as magnetic and digital storage media.

Section 8.05Term:

The obligations of the Receiving Party under this Article shall continue for a period of five (5) years from conveyance of the Confidential Information.

Section 8.06Flow Down

The PAH shall flow down the requirements of this Article VIII to their respective personnel, member entities, agents, and subawardees (including employees) at all levels, receiving such Confidential Information under this OTA.

ARTICLE IX.PUBLICATION AND ACADEMIC RIGHTS

Section 9.01Use of Information.

For the purposes of this Article, “Parties” means the PAH and the Government where collectively identified and “Party” where each entity is individually identified.

Subject to the provisions of Article VIII, Confidential Information, Article IX, Publication and Academic Rights, and Article XI Data Rights, the PAH and the Government shall have the right to publish or otherwise disclose information and/or data developed by the Government and/or the respective MCDC PAH under the Research Project. The PAH and the Government (and its employees) shall include an appropriate acknowledgement of the sponsorship of the Research Projects by the Government and the MCDC PAH in such publication or disclosure. The Parties shall have only the right to use, disclose, and exploit any such data and Confidential Information in accordance with the rights held by them pursuant to this Base Agreement. Notwithstanding the above, the Parties shall not be deemed authorized by this paragraph, alone, to disclose any Confidential Information of the Government or the PAH.

Section 9.02Publication or Public Disclosure of Information

If a release of Confidential Information or Trade Secrets is for a classified Project Agreement, the provisions of the DoD Security Agreement (DD Form 441) and the DoD Contract Security Classification Specification (DD Form 254) apply.

The Government AOR is hereby designated as the approval authority for the AO for such releases.

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“Effort sponsored by the U.S. Government under Other Transaction number W15QKN-16-9-1002 between the MCDC, and the Government. The US Government is authorized to reproduce and distribute reprints for Governmental purposes, notwithstanding any copyright notation thereon.”

“The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

The PAH shall flowdown these requirements to its subawardees, at all tiers.

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ARTICLE X.PATENT RIGHTS

Section 10.01Definitions

“Invention” means any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code.

“Made” when used in relation to any invention, means the conception or first actual reduction to practice of such invention.

“Practical Application” means to manufacture, in the case of a composition of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and in each case, under such conditions as to establish that the invention is capable of being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms.

“Subject Invention” means any invention of the MCDC’s PAH or its subcontractors of any tier conceived or first actually reduced to practice in the performance of work on a Project Agreement under this MCDC Base Agreement.

“Background Invention” means any invention, or improvement to any invention, other than a Subject Invention, made by a PAH (or their subcontractors of any tier), which was conceived, designed, developed, produced, and/or actually reduced to practice prior to execution of the PA or outside the scope of work performed under the PA under this MCDC Base Agreement.

Section 10.02Allocation of Principal Rights

The PAH, or its subcontractor to the extent such is proper assignee of the invention, shall retain the entire right, title, and interest throughout the world to each Subject Invention consistent with the provisions of this Article, Executive Order 12591 and 35 U.S.C. § 202. In the event that a PAH consists of more than one entity or person, those entities or persons may allocate such right, title, and interest between themselves or others, as they may agree in writing. With respect to any Subject Invention in which the PAH retains title, the Government shall have a non-exclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the United States, the Subject Invention throughout the world. The PAH may elect to provide full or partial rights that it has retained to other parties. The Government shall have the right to use any products or processes used for test and evaluation (including materials for testing or assays) in any other project pursued on behalf of the U.S. Government.

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Section 10.03Invention Disclosure, Election of Title, and Filing of Patent Application

Section 10.04Conditions When the Government May Obtain Title

Upon written request to the CMF, the PAH shall convey to the Government title to any Subject Invention under any of the following conditions:

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request by the Government through the CMF, the PAH shall continue to retain title in that country; or

Section 10.05Minimum Rights to the MCDC PAH and Protection of the MCDC PAH’s Right to File The Parties agree that:

Section 10.06Action to Protect the Government’s Interest

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administration of patent matters and in a format acceptable to the CMF, each Subject Invention made under this Agreement in order that the CMF on behalf of the PAH can comply with disclosure provisions of Section 10.03 of the Article X, Patent Rights, and to execute all papers necessary to file the patent applications on the Subject Invention and to establish the Government’s rights in the Subject Invention. The PAH acknowledges and shall instruct its employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars.

Section 10.07Lower Tier Agreements

The PAH shall include the Article X, Patent Rights, suitably modified to identify the parties, in all lower tier PAs, regardless of tier, for experimental, development, or research work.

Section 10.08Reporting on Utilization of Subject Inventions

The PAH shall submit, on request during the term of the PA, periodic reports no more frequently than annually on the utilization of a Subject Invention or on efforts at obtaining such utilization that are being made by the PAH or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by the PAH, and such other data and information as the agency may reasonably specify. The PAH also agrees to provide additional reports, as may be requested by the Government, through CMF, in connection with any march-in proceedings undertaken by the Government in accordance with Section 10.10 of this Article X, Patent Rights. Consistent with 35 U.S.C. § 205, the Government agrees it shall not disclose such information to persons outside the Government without permission of the MCDC on behalf of the PAHs.

Section 10.09Preference for American Industry

Notwithstanding any other provision of the Article X, Patent Rights, the PAH is not to grant to any person the exclusive right to use or sell any Subject Invention in the United States or Canada, unless such person agrees that any product embodying the Subject Invention or produced through the use of the Subject Invention, shall be manufactured substantially in the United States or Canada. However, in individual cases, the requirements for such an agreement may be waived by the Government upon a showing by the PAH that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that, under the circumstances, domestic manufacture is not commercially feasible.

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Section 10.10March-In Rights

The PAH agrees that, with respect to any Subject Invention in which its PAH has retained title, the Government, through CMF, has the right to require the PAH to obtain and grant a non-exclusive license to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the PAH refuses such a request, the Government has the right to grant such a licensee itself if the Government determines that:

Section 10.11Opportunity to Cure

Certain provisions of this Article X, Patent Rights, provide that the Government may gain title or license to a Subject Invention by reason of the PAH’s action, or failure to act, within the times required by this Article X, Patent Rights. Prior to claiming such rights (including any rights under Article X, Section 10.10 March-In Rights), the Government will give written notice to the MCDC, through its CMF, and CMF will convey such written notice to PAH, of the Government’s intent, and afford the PAH a reasonable time to cure such action or failure to act. The length of the cure period will depend on the circumstances, but in no event will be more than sixty (60) days. PAH may also use the cure period to show good cause why the claiming of such title or right would be inconsistent with the intent of the Base Agreement in light of the appropriate timing for introduction of the technology in question, the relative funding and participation of the parties in the development, and other factors.

Section 10.12Background Information

In no event shall the provisions set forth in this Article X apply to any Background Inventions or Patents. The PAHs or their subcontractors, shall retain the entire right, title, and interest throughout the world to each such Inventions and Patents that each party has brought through MCDC to the project issued under this MCDC Base Agreement and the Government shall not have any rights under this MCDC Base Agreement. Projects to be funded under this MCDC Base Agreement will list Background Inventions and Patents anticipated to be used on the project; such listing may be amended by the parties, as appropriate, to reflect changes in such plans.

Section 10.13Survival Rights

Provisions of this Article X shall survive termination of this MCDC Base Agreement under Article II.

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Notwithstanding the terms of this Article, differing rights in patents may be negotiated among the Parties to each individual project on a case-by-case basis.

ARTICLE XI.DATA RIGHTS

This is a Data Rights Article specifically tailored for this OTA to address respective rights of the Government and MCDC on behalf of its actual or prospective MCDC PAHs to such Data as is owned, developed, to be developed or used by an actual or prospective MCDC member entity or PAH, (1) as identified in a MCDC member entity(ies) proposal submitted to the Government through the CMF in response to a competitive Government OTA RPP, and (2) when such proposal is selected by the Government for funded performance and the PA is issued by the CMF to that MCDC member entity for performance of such Government OTA project.

Section 11.01Definitions

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Section 11.02Data Categories

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Data under a specific project shall be as identified in the proposal submitted to the Government, and incorporated into PAs.

The Government can only order such Data as is developed under the OTA project, where the order request is made within one (1) year following OTA project completion. In the event the Government orders such Data, it shall pay the PAH the reasonable costs for all efforts to deliver such requested Data, including, but not limited to costs of locating such Data, formatting, reproducing, shipping, and associated administrative costs.

(b)The Government shall have Unlimited Rights in Data,

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of interest in the Data to another party, or the sale or transfer of some or all of a business entity or its assets to another party;

Section 11.03Allocation of Principal Rights

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earlier). Such requests will only be made in those cases where the CMF has provided information from the affected actual or prospective PAH demonstrating the need for this additional restriction on Government use, and shall be submitted to the ACC-NJ AO for approval, which approval shall not be unreasonably withheld. In the event of any dispute regarding approval of this request, the parties agree to treat this as a dispute and shall follow the provisions of Article VII, Disputes.

Following issuance of a TDL and subsequent CMF issuance of the PA to the PAH, the PAH shall update the list to identify any additional, previously unidentified Data, if such Data will be used or generated in the performance of the funded work. Rights in such Data shall be as established under the terms of this MCDC Base Agreement, unless otherwise asserted in a supplemental listing and agreed to by the Government.

Section 11.04Marking of Data

Except for Data delivered with unlimited rights, Data to be delivered under this MCDC Base Agreement subject to restrictions on use, duplication or disclosure, shall be marked with the following legend:

Use, duplication, or disclosure is subject to the restrictions as stated in the Base Agreement between the U.S. Government and the MCDC, Agreement No. W15QKN-16-9-1002, Project Title and the MCDC PA [insert name of company] No.___________.

It is not anticipated that any Category A Data will be delivered to the Government under this MCDC Base Agreement.

In the event commercial computer software and Data is licensed under a commercial computer software license under this OTA, a Special License rights marking legend shall be used as agreed to by the parties.

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The Government shall have unlimited rights in all unmarked Data. In the event that a PAH learns of a release to the Government of its unmarked Data that should have contained a restricted legend, the CMF on behalf of the member entity or PAH, will have the opportunity to cure such omission going forward by providing written notice to the Government AO within three (3) months of the erroneous release.

Section 11.05Copyright

The PAHs reserve the right to protect by copyright original works developed under this MCDC Base Agreement. All such copyrights will be in the name of the individual PAH. The PAH(s) hereby grant to the U.S. Government a non-exclusive, non-transferable, royalty-free, fully paid-up license to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, for Governmental purposes, any copyrighted materials developed under this MCDC Base Agreement, and to authorize others to do so.

In the event Data is exchanged with a notice indicating that the Data is protected under copyright as a published, copyrighted work, and it is also indicated on the Data that such Data existed prior to, or was produced outside of this MCDC Base Agreement, the Party receiving the Data and others acting on its behalf may reproduce, distribute, and prepare derivative works for the sole purpose of carrying out that Party’s responsibilities under this Agreement with the written permission of the copyright holder.

Copyrighted Data that existed or was produced outside of this MCDC Base Agreement and is unpublished - having only been provided under licensing agreement with restrictions on its use and disclosure - and is provided under this MCDC Base Agreement shall be marked as unpublished copyright in addition to the appropriate license rights legend restricting its use, and treated in accordance with such license rights legend markings restricting its use.

The PAHs are responsible for affixing appropriate markings indicating the rights of the Government on all Data delivered under this MCDC Base Agreement.

The Government agrees not to remove any copyright notices placed on Data, and to include such notices on all reproductions of the Data.

Section 11.06Data First Produced by the Government

As to Data first produced by the Government in carrying out the Government’s responsibilities under this OTA, and which Data would embody trade secrets or would comprise commercial or financial information that is privileged or confidential if obtained from the CMF on behalf of any PAH, such Data will, to the extent permitted by law, be appropriately marked with a suitable notice or legend and maintained in confidence by the CMF and any PAH to whom disclosed for three (3) years after the development of the information, with the express understanding that during the aforesaid period, such Data may be disclosed and used by the CMF or any PAH, including its respective employees or subcontractors of any tier, (under suitable protective conditions) by or on behalf of the Government for Government purposes only.

Section 11.07Prior Technology

(1)Government Prior Technology:  In the event it is necessary for the Government to furnish the CMF or any MCDC member entity or PAH, including their respective employees or their subcontractors of any tier, with Data which existed prior to, or was produced outside of this MCDC Base Agreement, and such Data is so identified with a suitable notice or legend, the Data will be maintained in confidence and disclosed and used only for the purpose of carrying out their responsibilities under this MCDC Base Agreement. Data protection will include proprietary markings and handling, and the signing of non-

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disclosure agreements by the CMF, PAHs, PAH subcontractors of any tier and their respective employees to whom such Data is provided for use under the OTA. Upon completion of activities under this MCDC Base Agreement, such Data will be disposed of, as requested by the Government.

(2)CMF and PAH Prior Technology:  In the event it is necessary for the CMF or any PAH to furnish the Government with Data which existed prior to, or was produced outside of this MCDC Base Agreement, and such Data embodies trade secrets or comprises commercial or fmancial information which is privileged or confidential, and such Data is so identified with a suitable notice or legend, the Data will be maintained in confidence and disclosed and used by the Government and such Government Contractors or contract employees, that the Government may hire on a temporary or periodic basis only for the purpose of carrying out the Government’s responsibilities under the Base Agreement. Data protection will include proprietary markings and handling, and the signing of non-disclosure agreements by such Government Contractors or contract employees. Neither the CMF nor any PAH, shall be obligated to provide Data that existed prior to, or was developed outside of this MCDC Base Agreement to the Government. Upon completion of activities under this MCDC Base Agreement, such Data will be disposed of as requested by the CMF on behalf of itself or PAHs.

(3)Oral and Visual Information:  If information which the PAH (including their subcontractors of any tier and their respective employees) considers to embody trade secrets or to comprise commercial or fmancial information which is privileged or confidential, is expressly disclosed orally or visually directly to the Government and/or CMF, the exchange of such information must be memorialized in tangible, recorded form and marked with a suitable notice or legend, and furnished to the Government and/or CMF within ten (10) calendar days after such oral or visual disclosure, or the Government and/or CMF shall have no duty to limit or restrict, and shall not incur any liability for any disclosure and use of such information. Upon Government and/or CMF request, additional detailed information about the exchange will be provided subject to restrictions on use and disclosure.

(4)Disclaimer of Liability:  Notwithstanding the above, neither the Government nor the CMF shall be restricted in, nor incur any liability for, the disclosure and use o£

(a)Data not identified with a suitable notice or legend as set forth in this Article; nor

(b)Information contained in any Data for which disclosure and use is restricted under Article VIII, entitled “Confidential Information” above, if such information is or becomes generally known without breach of the above, is properly known to the Government or CMF or is generated by the Government or CMF independent of carrying out responsibilities under this MCDC Base Agreement, is rightfully received from a third party without restriction, or is included in Data which the PAH has furnished, or is required to furnish to the Government or CMF without restriction on disclosure and use.

(5)Marking of Data:  Any Data delivered under this MCDC Base Agreement shall be marked with a suitable notice or legend.

Notwithstanding the paragraphs in this Article, differing rights in Data may be negotiated among the Parties to each individual project on a case-by-case basis.

Section 11.08Lower Tier Agreements

The PAH shall include this Article, suitably modified to identify the parties, in all subcontracts or lower tier PAs, regardless of tier, or experimental, developmental, or research work.

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Section 11.09Survival Rights

Provisions of this Article shall survive termination of this Agreement under Article II.

Notwithstanding the terms of this in this Article, differing rights in data may be negotiated among the Parties to each individual PA on a case-by-case basis.

ARTICLE XII.EXPORT CONTROL

Export Control

Public Law 90-629, « Arms Export Control Act, » as amended (22 U.S.C. 2751 et. seq.) requires that all unclassified technical data with military application may not be exported lawfully without an approval, authorization, or license under EO 12470 or the Arms Export Control Act, and that such data require an approval, authorization, or license under EO 12470 or the Arms Export Control Act. For purposes of making this determination, the Military Critical Technologies List (MCTL) shall be used as general guidance. All documents determined to contain export controlled technical data will be marked with the following notice:

WARNING- This document contains technical data whose export is restricted by the Arms Export Control Act (Title 22, U.S.C., and Sec 2751, et seq.) or the Export Administration Act of 1979, as amended, Title 50, U.S.C., App. 2401, et seq. Violations of these export laws are subject to severe criminal penalties. Disseminate in accordance with provision of DOD Directive 5230.25.

The PAH shall include this Article, suitably modified, to identify all Parties, in all PAs or lower tier agreements. This Article shall, in turn, be included in all sub-tier subcontracts or other forms of lower tier agreements, regardless of tier.

ARTICLE XIII.TITLE AND DISPOSITION OF PROPERTY

Section 13.01Definitions

In this Article, “property” means any tangible personal property other than property actually consumed during the execution of work under this MCDC Base Agreement.

Section 13.02Title to Property

No significant items of property are expected to be acquired under this MCDC Base Agreement by the PAH. Title to any item of property valued $10,000.00 or less that is acquired by the PAH pursuant to a PA with the MCDC, in performance of the project issued to the PAH under this OTA, shall vest in the PAH upon acquisition with no further obligation of the Parties unless otherwise determined by the Government AO. Should any item of property with an acquisition value greater than $10,000.00 be required, the PAH through the CMF shall obtain prior written approval of the Government AO. Title to this property shall also vest in the MCDC member entity or PAH upon acquisition. That PAH shall be responsible for the maintenance, repair, protection, and preservation of all such property at its own expense. Property acquired

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pursuant to this Article shall not be considered as in exchange for services in performance of the project, but shall be considered a Government contribution to the project.

Section 13.03Government Furnished Property (GFP)

The Government may provide the PAH GFP to facilitate the performance of individual projects under this OTA Such GFP will be specifically identified to a particular project and incorporated into the applicable PA. The GFP shall be utilized only for the performance of that individual project, unless a specific exception is made in writing by the AO.

The PAH shall assume the risk of and be responsible for any loss or destruction of, or damage to, any GFP while in its possession or control, with the exception of reasonable wear and tear or reasonable and proper consumption. All property shall be returned at the end of the Project Agreement in as good as condition as when received, with the exception of said reasonable wear and tear or in accordance with the provisions of the PA regarding its use. The PAH shall obtain explicit written authorization for any transfer or disposition of GFP.

ARTICLE XIV.CIVIL RIGHTS ACT

This MCDC Base Agreement and any resulting PA is subject to the compliance requirements of Title VI of the Civil Rights Act of 1964, as amended (42 U.S.C. 2000-d) relating to nondiscrimination in Federally assisted programs. It is the responsibility of each PAH to assure the PAH has signed an Assurance of Compliance with the nondiscriminatory provisions of the Act (Attachment 1).

ARTICLE XV.NO SMALL BUSINESS AFFILIATION

Reserved

ARTICLE XVI.ANTITRUST

In the MCDC Articles of Collaboration, members agree to comply with all applicable U.S. laws, including U.S. antitrust laws. The MCDC is recognized under the National Cooperative Research and Production Act of 1993, and the MCDC will be similarly filing under the Act.

ARTICLE XVII.SECURITY & OPSEC

All PAH shall comply with DFARS ###-###-#### (Oct 2016):  Safeguarding Covered Defense Information and Cyber Incident Reporting, when applicable.

Covered Defense Information (CDI) will be identified at the PA level. The MCDC Member shall comply with DFARS ###-###-#### (Oct 2016):  Safeguarding Covered Defense Information and Cyber Incident Reporting, which includes implementing on its covered contractor information systems the security requirements specified by DFARS ###-###-####. Nothing in this paragraph shall be interpreted to foreclose the MCDC Member’s right to seek alternate means of complying with the security requirements in National Institute of Standards and Technology (KIST) Special Publication (SP) 800-171 (as contemplated in DFARS ###-###-#### (Compliance with Safeguarding Covered Defense Information Controls) (Oct 2016) and DFARS ###-###-#### (Safeguarding Covered Defense Information and Cyber Incident Reporting (Oct 2016)).

This MCDC Base Agreement is Unclassified, however work performed by a PAH under a PA may involve access to Classified Information, including but not limited to, information classified as Controlled

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Unclassified Information (CUI), Confidential, Secret, or Top Secret. As such, DoD Manual 5200.01 (DoD Information Security Program:  Protection of Classified Information) shall apply and all appropriate measures shall be followed. MCDC Members shall also comply with Distribution Statements, as mandated by DoDI 5230.24 (Distribution Statements on Technical Documents). If a project involves a classified or CUI effort, the below listed Department of Defense Directives, FAR/DFARS Clauses, and supplemental clauses/guidance will be incorporated into the PAs by reference with the same force and effect as if they were given in full text.

The following process shall be utilized in determining Security / Operations Security (OPSEC) requirements, prior to project award:

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for it, and how to protect it. In addition, MCDC shall identify an individual who will be an OPSEC Coordinator. MCDC will ensure this individual becomes OPSEC Level II certified per AR 530-1.

(13)For projects that Require OPSEC Training. Per AR 530-1, Operations Security, new PAH employees assigned by the PAH to perform under a MCDC PA must complete Level I OPSEC Awareness Training within thirty (30) calendar days of their reporting for duty. All PAH employees performing under an OPSEC-designated project must complete annual Level I OP SEC Awareness Training. Level I OPSEC AwarenessTraining is available at the following website:  https://www.cdse.edu/catalog/elearning/GS130.html.

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Flowdown for OPSEC/Security Requirements:

MCDC shall include the aspects of this Article as they pertain to each project requirement. Each project will include specific OP SEC / Security requirements within each SOW and RPP. The requirements delineated within each project, in turn, shall be included in all sub-tier subcontracts or other forms of lower-tier agreements, regardless of tier.

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ARTICLE XVIII.SAFETY

The PAH shall adhere to all local, state, and federal rules and regulations required in maintaining a safe and nonhazardous occupational environment throughout the duration of the project. At a minimum, the PAH shall provide the following reports and materials on an as needed basis:

Accident/Incident Report:  The PAH shall report immediately any major accident/incident (including fire) resulting in any one or more of the following:  causing one or more fatalities or one or more disabling injuries; damage of Government property exceeding $10,000; affecting program planning or production schedules; degrading the safety of equipment under a project, such as personnel injury or property damage, may be involved; identifying a potential hazard requiring corrective action. The PAH shall prepare the report for each incident, in accordance with DI-SAFT-81563.

Material Safety Data Sheets (MSDS):  The PAH shall prepare and maintain MSDS for all materials used and generated in support of this project.

Environmental Requirements include the following:

Pollution Prevention:  Consideration should be given to alternative materials and processes in order to eliminate, reduce, or minimize hazardous waste being generated. This is to be accomplished while minimizing item cost and risk to item performance.

Environmental Compliance:  All activities must be in compliance with Federal, State, and local environmental laws and regulations, executive orders, treaties, and agreements. The PAH shall evaluate the environmental consequences and identify the specific types and amounts of hazardous waste being generated during the conduct of efforts undertaken under the project.

Hazardous Waste Report:  The PAH shall evaluate the environmental consequences and identify the specific types and amounts of hazardous waste being generated during the project. The PAH shall submit a Hazardous Waste Report, in accordance with DI-MGMT-80899.

Disposal Instructions for Residual/Scrap Materials:  The PAH shall dispose of all residual and scrap materials generated under the project, including high explosives. The PAH shall specify the anticipated quantities, methods, and disposal costs.

ARTICLE XIX.REPRESENTATIONS AND WARRANTIES

Section 19.01Representations and Warranties of All Parties

Each Party to this MCDC Base Agreement represents and warrants to the other Parties that, (1) it is free to enter into this MCDC Base Agreement; (2) in so doing, it will not violate any other agreement to which it is a party; and (3) it has taken all actions necessary to authorize the execution and delivery of this MCDC Base Agreement, and the performance of its obligations under this MCDC Base Agreement.

Section 19.02Limitations

Except as expressly provided herein, no party to this MCDC Base Agreement makes any warranty, express or implied, either in fact or by operation of law, by statute or otherwise, relating to, (1) any research conducted under this MCDC Base Agreement, or (2) any invention conceived and/or reduced to practice under this MCDC Base Agreement, or (3) any other intellectual property developed under this MCDC Base

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Agreement, and each party to this MCDC Base Agreement specifically disclaims any implied warranty of merchantability or warranty of fitness for a particular purpose.

ARTICLE XX.LIABILITY OF THE PARTIES

Section 20.01Waiver of Liability

With regard to the activities undertaken pursuant to this MCDC Base Agreement, no Party shall make any claim against the others, employees of the others, the others’ related entities (e.g., Government, contractors, subcontractors, etc.), or employees of the others’ related entities for any injury to or death of its own employees or employees of its related entities, or for damage to or loss of its own property or that of its related entities, whether such injury, death, damage or loss arises through negligence or otherwise, except in the case of willful misconduct.

Section 20.02Damages

The Parties shall not be liable to each other for consequential, punitive, special and incidental damages or other indirect damages, whether arising in contract (including warranty), tort (whether or not arising from the negligence of a Party) or otherwise, except to the extent such damages are caused by a Party’s willful misconduct; Notwithstanding the foregoing, claims for contribution toward third-party injury, damage, or loss are not limited, waived, released, or disclaimed.

Section 20.03Extension of Waiver of Liability

The PAH agrees to extend the waiver of liability as set forth above subawardees at any tier under a PA, by requiring them, by contract or otherwise, to agree to waive all claims against the Parties to this MCDC Base Agreement.

Section 20.04Applicability

Notwithstanding the other provisions of this Article, this Waiver of Liability shall not be applicable to:

Section 20.05Limitation of Liability

In no case shall the CMF, or the PAH’s financial liability exceed the amount obligated by the Government or committed as a Cash Contribution or In-kind Contribution by a MCDC member entity under a PA. Nothing in this Article shall be construed to create the basis of a claim or suit where none would otherwise exist.

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ARTICLE XXI.GENERAL PROVISIONS

Section 21.01Fees

The PAH will not be constrained from the payment of an appropriate fee or profit for the effort being conducted on a PA when cost share is not being contributed. The fees shall be specific to the individual PAs and negotiated on a project by project basis.

Section 21.02Waiver

No waiver of any rights shall be effective unless assented to in writing by the party (Government, MCDC, CMF, or PAH) to be charged, and the waiver of any breach or default shall not constitute a waiver of any other right hereunder, or any subsequent breach or default.

Section 21.03Section Headings

The headings and subheadings of the sections of this MCDC Base Agreement are intended for convenience of reference only, and are not intended to be a part of, or to affect the meaning or interpretation of this MCDC Base Agreement.

Section 21.04Severability

In the event that any provision of this MCDC Base Agreement becomes or is declared by a court of competent jurisdiction to be illegal, unenforceable or void, this MCDC Base Agreement shall continue in full force and effect without said provision; Provided that no such severability shall be effective if the result of such action materially changes the economic benefit of this MCDC Base Agreement to the Parties.

Section 21.05Force Majeure

No failure or omission by the CMF or the MCDC PAH in the performance of any obligation of this MCDC Base Agreement, shall be deemed a breach of this MCDC Base Agreement, or create any liability if the same shall arise from any cause or causes beyond the control of the Parties, including but not limited to, the following:  Acts of God; Acts or omissions of any Government; Any rules, regulations or orders issued by any Governmental authority or by any officer, department, and agency or instrumentality thereof; fire; storm; flood; earthquake; accident; war; rebellion; insurrection; riot; and invasion, and provided that such failure or omission resulting from one of the above causes is cured as soon as is practicable after the occurrence of one or more of the above mentioned causes.

Section 21.06Regulatory Affairs

Development and production of medical products and processes fall under the purview of the FDA and research on these products involving animal or human studies is regulated by other laws, directives, and regulations. Project Awards under this MCDC Base Agreement that involve work in support of or related to FDA regulatory approval, will address contingencies for Government access to regulatory rights in the event of product development abandonment or failure. Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations.

The Government shall ensure performance includes regulatory expertise and guidance for candidate medical countermeasure development efforts:

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Section 21.07Radioactive Materials

PAH shall ensure compliance with the provisions of Title 10 CFR 21. This regulation establishes procedures and requirements for implementation of Section 206 of the Energy Reorganization Act of 1974.

Section 21.08Recombinant DNA

The PAH shall ensure that all work involving the use of recombinant DNA will be in compliance with guidance provided at the following website: https://osp.od.nih.gov/biotechnology/biosafety-and-recombinant-dna-activities/ (National Institutes of Health [NIH] Guidelines for Research Involving Recombinant DNA Molecules).

Section 21.09Required Compliance for Use of Laboratory Animals

Notwithstanding any other provisions contained in this award or incorporated by reference herein, the PAH is expressly forbidden to use or subcontract for the use of laboratory animals in any manner whatsoever without the express written approval of the U.S. Army Medical Research and Development Command, Animal Care and Use Review Office (ACURO). The PAH shall receive written approval to begin research under the applicable protocol proposed for a PA from the U.S. Army Medical Research and Development Command, Animal Care and Use Review Office, ACURO, under separate letter to the PAH and Principal Investigator. A copy of this approval will be provided to the ACC-NJ for the official file. Non-compliance with any provision of this Article may result in the termination of award. Information is provided at the following website https://mrdc.amedd.army.mil/index.cfm/collaborate/research_protections/acuro. The PAH will conduct advanced development/pivotal studies, including human safety studies, animal efficacy studies or clinical studies required for approval using validated endpoints, and other studies as deemed necessary by the FDA for licensure of the candidate product in adherence to current Good Laboratory Practice regulations, current Good Clinical Practice regulations, and all other applicable FDA regulations in the conduct of non-clinical and clinical studies, as defined by FDA guidance (21 CFR Parts 210-211). The PAH shall coordinate with the Government in determining the applicability of requirements, based on the specific project.

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Section 21.10Required Compliance for Use of Human Subjects

Research under this award involving the use of human subjects may not begin until the U.S. Army Medical Research and Development Command’s Office of Research Protections, Human Research Protection Office (HRPO) approves the protocol in accordance with 45 CFR Part 46. Written approval to begin research or subcontract for the use of human subjects under the applicable protocol proposed for this award, will be issued from the U.S. Army Medical Research and Development Command, HRPO, under separate letter, to the funded institution and the Principal Investigator. A copy of this approval will be provided to ACC-NJ for the official file. Non-compliance with any provision of this Article may result in withholding of funds and/or the termination of the award.

Information is provided at the following website: https://mrdc.amedd.army.mil/index.cfm/collaborate/research_protections/hrpo. The PAH shall coordinate with the Government in determining the applicability of requirements, based on the specific project.

Section 21.11Required Compliance for use of Human Anatomical Substances

Research at funded institutions using human anatomical substances may not begin until the U.S. Army Medical Research and Development Command’s Office of Research Protections, Human Research Protections Office, HRPO, approves the protocol. Written approval to begin research or subcontract for the use of human anatomical substances under the applicable protocol proposed for this award, will be issued from the U.S. Army Medical Research and Development Command, HRPO, under separate letter, to the funded institution and the Principal Investigator. A copy of this approval will be provided to ACC-NJ, from the CMF, for the official file. Noncompliance with any provision of this Article may result in withholding of funds and/or the termination of the award. Information is provided at the following web site:  https://mrdc.amedd.army.mil/index.cfm/collaborate/research_protections/hrpo. The PAH shall coordinate with the Government in determining the applicability of requirements, based on the specific project.

Section 21.12Compliance with current Good Manufacturing Processes (cGMP)

Manufacturing Standards, as appropriate for the level of prototype material used for clinical trials, pivotal non-clinical studies, consistency lots, and other uses, as defined in regulatory plans, should be compliant with current cGMP, as defined by FDA guidance (21 CFR Parts 210-211). If at any time during the life of the award, the PAH fails to comply with cGMP in the manufacturing, processing and packaging of this product, and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure), as identified by the FDA, the PAH shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. The PAH shall coordinate with the Government in determining the applicability of requirements, based on the specific project.

Section 21.13Registration with Select Agent Program

Where required, consortium members performing studies and tasks using select biological agent or toxins, should be registered with the program with the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DUBS), or the Animal and Plant Health Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work, in accordance with 42 CFR 73. No Government funds can be used for work involving Select Agents, as defined in 42 CFR 73, if the final registration certificate is denied. Listings of select agents and toxins, biologic agents and toxins, and overlap agents or toxins, as well as information about the registration process, can be obtained on the Select Agent Program Web site at https://www.selectagents.gov/. The PAH shall coordinate with the Government in determining the applicability of requirements, based on the specific project.

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Section 21.14Duty-Free Entry

either as end items or components of end items; and

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(2)Include the following information:

(B) If the shipment will be consigned to other than a military installation, e.g., a domestic contractor’s plant, the shipping document notation shall be altered to include the name and address of the contractor, agent, or broker who will notify Commander, DCMA New York, for execution of the duty-free certificate. (If the shipment will be consigned to a contractor’s plant and no duty-free entry certificate is required due to a trade agreement, the PAH shall claim duty-free entry under the applicable trade agreement and shall comply with the U.S. Customs Service requirements. No notification to Commander, DCMA New York, is required.)

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Section 21.15Follow-On Production

10 U.S.C. § 2371b(f) authorizes the use of a follow-on production contract (FAR) or transaction (OTA). In order to be eligible for follow-on production, the following criteria is required:  (1) the follow-on shall be awarded to the same participants named in the PA; (2) competitive procedures were used to award the PA in question; and (3) the PA was successfully completed. This MCDC Base Agreement was the result of competitive procedures, and competitive procedures are used to award individual projects under this MCDC Base Agreement. The AO shall be responsible for documenting whether or not a PA was successfully completed. Follow-on production efforts shall be strictly limited to the scope of the successfully completed prototype. This MCDC Base Agreement will not be used to award follow-on production efforts; Government customers will be responsible for working with their contracting personnel.

All PAs shall include the following statement:

“In accordance with 10 U.S.C. § 2371b(f), and upon a determination that this competitively awarded prototype project has been successfully completed, this prototype project may result in the award of a follow-on production contract or transaction without the use of competitive procedures.”

Section 21.16Public Readiness and Emergency Preparedness Act (PREP Act)

The PREP Act authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a declaration (PREP Act declaration) that provides immunity from liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.

Prior to award of individual projects under the program, current declarations will be reviewed by the Government via PHE.gov. If upon review, it is determined that a current declaration is applicable to the project to be awarded, appropriate PREP Act language will be incorporated into the SOW in coordination with the prospective PAH.

ARTICLE XXII.ASSIGNMENT OF AGENCY

Section 22.01Assignment.

Neither this Agreement nor any rights or obligations of any party hereunder shall be assigned or otherwise transferred by either party without the prior written consent of the other party.

ARTICLE XXIII.ORDER OF PRECEDENCE

In the event of any inconsistency between the general terms of this MCDC Base Agreement, the inconsistency shall be resolved by giving precedence in the following order:  (1) the Base Agreement; (2) this MCDC Base Agreement; and (3) Attachments to this MCDC Base Agreement; However, specifically negotiated PA terms and conditions and PA attachments will control over the general terms and conditions of this MCDC Base Agreement.

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ARTICLE XXIV.EXECUTION

This MCDC Base Agreement constitutes the entire MCDC Base Agreement of the Parties, and supersedes all prior and contemporaneous agreements, understandings, negotiations and discussions among the Parties, whether oral or written, with respect to the subject matter hereof. This MCDC Base Agreement may be revised only by written consent of the PAH and the CMF Contracting Representative designated in this Agreement.

ARTICLE XXV.USE OF UNDEFINITIZED PROJECT ACTIONS

The Government, when it is in its best interest, has the authority to award prototype projects on an undefinitized basis. The exact terms of the Undefinitized Project Action (UPA), to include the Scope, Not to Exceed Amount, and Definitization Schedule, will be provided on a project-by-project basis.

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Attachment I — Assurance of Compliance with Title VI of the Civil Rights Act of 1964

Statement of Assurance of Compliance with

Title VI of the Civil Rights Act of 1964

For MCDC Member Organizations

ARREVUS, INC. hereby agrees that it will comply with the provisions of the Title VI Civil Rights Act of 1964 as amended (42 U.S.C 2000-d) and all requirements imposed pursuant thereto, to the end that, in accordance with Title VI of that Act and the Regulation, no person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any MCDC Project for which the MCDC member organization receives Federal financial assistance from the Government.

The MCDC member organization agrees that compliance with this assurance constitutes a condition of continued receipt of Federal financial assistance, and that it is binding upon the MCDC member organization, its successors, transferees and assignees for the period during which such assistance is provided.

The MCDC member organization further recognizes and agrees that the United States shall have the right to seek judicial enforcement of this assurance.

The person or persons whose signature(s) appear(s) below is/are authorized to sign this assurance, and commit the MCDC member organization to the above provisions.

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