This Schedule B forms part of the Agreement. Complete every item; write “None” where an item does not apply. Modifications recorded in items B-8 and B-9 are effective only if this Schedule B is initialed by both Parties.
Read the full Agreement below. Scroll to the end to enable the signature section. A complete copy will be emailed to you on submission.
This Confidential Disclosure Agreement (this “Agreement”) is entered into as of the Effective Date identified below by and between OncoFirm™ Diagnostics Corporation, a New York State corporation having its principal place of business at 24 Dolphin Grn, #H2C, Port Washington, NY 11050 (“OncoFirm”), and the individual or entity identified in the Recipient Information block below (“Recipient”). OncoFirm and Recipient are each referred to as a “Party” and together as the “Parties.”
RECITALS
A.OncoFirm researches, develops, validates, and commercializes oncology diagnostic technologies and maintains an ongoing program for identifying, preparing, submitting, negotiating, administering, and reporting on grants, cooperative agreements, contracts, prizes, and other external funding for those activities (the “Grant Program”).
B.In connection with the Grant Program, OncoFirm has engaged or intends to engage Recipient — whether as an independent consultant, grant writer, service provider, collaborator, employee, intern, or volunteer — to perform the services, activities, or role described in Schedule B (the “Engagement”), and in the course of the Engagement OncoFirm will disclose or make available Confidential Information to Recipient.
C.OncoFirm’s Confidential Information — including its scientific concepts and preliminary data, its funding strategy, the content of its Grant Materials, and the feedback it receives from Funders — is highly valuable and competitively sensitive, and its unauthorized use or disclosure could cause OncoFirm severe and irreparable harm, including the loss of funding, the loss of patent rights, and the loss of competitive advantage.
D.Recipient wishes to receive access to Confidential Information solely for the purpose of performing the Engagement and agrees to the terms of this Agreement as a condition of that access.
NOW, THEREFORE, in consideration of Recipient’s Engagement (including, for a Staff Recipient, Recipient’s employment or continued employment, internship, or volunteer position), OncoFirm’s disclosure of Confidential Information, the mutual promises set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1 — DEFINITIONS
1.1“Affiliate” means any entity that directly or indirectly controls, is controlled by, or is under common control with a Party, where “control” means ownership of more than fifty percent (50%) of the voting interests of an entity or the power to direct its management and policies.
1.2“Confidential Information” means all information, in any form or medium (written, oral, electronic, visual, or by inspection or demonstration), that is disclosed or made available by or on behalf of OncoFirm or its Affiliates to Recipient, or that Recipient otherwise learns or observes in connection with the Engagement, whether before, on, or after the Effective Date, and whether or not marked or identified as confidential, including:
(a)Grant Materials and all other information concerning the Grant Program, including OncoFirm’s funding strategy, target Funders and Funding Opportunities, submission timelines, prioritization decisions, application status, scores, percentile rankings, summary statements, reviewer critiques, communications with program officers and other Funder personnel, award terms, budgets, and negotiating positions;
(b)scientific and technical information, including research concepts, hypotheses, specific aims, experimental designs, protocols, assay and biomarker information, algorithms, source code, models, validation data, clinical and analytical performance data, preliminary and unpublished results, laboratory notebooks, specimens and other biological materials, and know-how relating to OncoFirm Technology;
(c)intellectual property information, including invention disclosures, unpublished patent applications, patent and trade-secret strategy, freedom-to-operate analyses, and licensing discussions;
(d)regulatory and quality information, including strategy, submissions, correspondence, and audit or inspection findings relating to the U.S. Food and Drug Administration, the Clinical Laboratory Improvement Amendments, the College of American Pathologists, state licensure authorities, or any other regulatory body;
(e)business and financial information, including business plans, commercialization plans, market analyses, pricing, cost data, financial statements and projections, capitalization, investor and lender information, and fundraising activities;
(f)information concerning OncoFirm’s personnel, advisors, consultants, collaborators, customers, suppliers, licensors, and Funders, including biographical sketches, salary and effort information, letters of support, and the nature and terms of those relationships;
(g)Personal Data and, if any is disclosed, Protected Health Information;
(h)information of third parties that OncoFirm holds under obligations of confidentiality;
(i)the existence, terms, and status of this Agreement and the Engagement, and the fact that OncoFirm is pursuing, has applied for, or has obtained any particular funding; and all notes, analyses, compilations, forecasts, studies, summaries, drafts, and other materials prepared by or for Recipient that contain, reflect, or are derived from any of the foregoing (“Derivative Materials”).
1.3“Funder” means any governmental agency (federal, state, local, or foreign), foundation, non-profit organization, corporation, consortium, prize sponsor, or other person or entity that provides or may provide grants, cooperative agreements, contracts, awards, or other funding, together with its reviewers, study sections, review panels, advisory councils, program officers, grants-management personnel, and contractors.
1.4“Funding Opportunity” means any notice of funding opportunity, request for applications, request for proposals, program announcement, broad agency announcement, challenge, prize competition, or other solicitation or opportunity for funding, whether public or by invitation.
1.5“Grant Materials” means all letters of intent, pre-applications, applications, proposals, white papers, specific aims, research strategies and narratives, budgets and budget justifications, biographical sketches, letters of support, facilities and resources descriptions, data management and sharing plans, commercialization plans, human subjects and vertebrate animal sections, milestone plans, just-in-time submissions, progress and final reports, resubmission and revision plans, and all related drafts, outlines, templates, checklists, scoring, reviewer feedback, summary statements, Funder correspondence, and award documents, in each case prepared by or for OncoFirm or otherwise relating to the Grant Program.
1.6“OncoFirm Technology” means OncoFirm’s current and planned products, services, assays, tests, biomarkers, panels, devices, platforms, software, algorithms, data sets, and related technologies and methods, including all improvements to any of them.
1.7“Personal Data” means any information relating to an identified or identifiable natural person. “Protected Health Information” or “PHI” has the meaning given in the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, each as amended (“HIPAA”).
1.8“Purpose” means Recipient’s performance of the Engagement for the benefit of OncoFirm as described in Schedule B, and no other purpose.
1.9“Representatives” means, with respect to an Entity Recipient, its and its Affiliates’ directors, officers, employees, students, trainees, agents, and approved subcontractors who (a) have a need to know Confidential Information in order to carry out the Purpose, (b) have been informed of the confidential nature of the Confidential Information, and (c) are bound by written obligations of confidentiality and non-use at least as protective of OncoFirm as those in this Agreement. An Individual Recipient has no Representatives unless OncoFirm approves a specific person in advance in writing.
1.10“Trade Secrets” means Confidential Information that qualifies as a trade secret under the Defend Trade Secrets Act of 2016 (18 U.S.C. § 1836 et seq.), the laws of the State of New York, or other applicable law.
1.11“Work Product” has the meaning set forth in Section 8.1.
1.12Recipient Categories. “Individual Recipient” means a Recipient who is a natural person. “Entity Recipient” means a Recipient that is a corporation, limited liability company, partnership, university, hospital, research institute, or other organization. “Staff Recipient” means an Individual Recipient who is an employee, intern, or volunteer of OncoFirm. “Institutional Collaborator” means an Entity Recipient that is an academic, medical, or research institution (or an investigator acting through such an institution) and is identified as such in the Recipient Information block. A provision of this Agreement that refers to a Recipient Category applies only to a Recipient of that category; every other provision applies to every Recipient.
1.13Interpretation. In this Agreement, “including” means “including without limitation”; “or” is not exclusive; headings are for convenience only and do not affect interpretation; references to Articles, Sections, Schedules, and Exhibits are to those of this Agreement; and a requirement that something be “written” or “in writing” is satisfied by an email sent by an authorized representative of OncoFirm.
ARTICLE 2 — PURPOSE; PERMITTED USE
2.1Limited Purpose. OncoFirm may, in its sole discretion, disclose Confidential Information to Recipient solely for the Purpose. Recipient shall use Confidential Information only for the Purpose and for no other purpose whatsoever, including any purpose that benefits Recipient, any other client or employer of Recipient, or any other third party.
2.2No Obligation to Disclose or Proceed. Nothing in this Agreement obligates OncoFirm to disclose any particular information, to begin or continue any Engagement, to pursue any Funding Opportunity, or to submit any application. OncoFirm may at any time, with or without cause, cease disclosing Confidential Information and may modify or terminate Recipient’s access to it.
2.3Prior Disclosures. Confidential Information disclosed to Recipient before the Effective Date in anticipation of the Engagement is governed by this Agreement as if disclosed after the Effective Date.
2.4Systems and Credentials. Any credentials, accounts, or access to OncoFirm systems, shared drives, document repositories, or Funder systems (including eRA Commons, ASSIST, Grants.gov, SAM.gov, Research.gov, and comparable portals) or third-party tools that OncoFirm provides to Recipient are provided for the Purpose only, may not be shared with any other person, and must be used in compliance with OncoFirm’s written policies and the applicable system’s terms of use. Recipient shall not access any OncoFirm or Funder system on OncoFirm’s behalf except as expressly authorized in writing by OncoFirm.
ARTICLE 3 — CONFIDENTIALITY OBLIGATIONS
3.1Non-Disclosure. Recipient shall hold all Confidential Information in strict confidence and shall not disclose, publish, or otherwise make available any Confidential Information to any person or entity other than (a) OncoFirm personnel designated by OncoFirm and (b) in the case of an Entity Recipient, its Representatives in accordance with Section 3.4.
3.2Non-Use. Recipient shall not use, reproduce, adapt, reverse engineer, decompile, analyze the composition or sequence of, or otherwise exploit any Confidential Information (including any biological materials, data, or software) except as necessary for the Purpose. Without limiting the foregoing, Recipient shall not use Confidential Information (a) to develop, seek funding for, or commercialize any product, service, or technology that competes with or is similar to OncoFirm Technology; (b) to prepare, support, or advance any grant application, proposal, or funding request for any person or entity other than OncoFirm; (c) to trade in any securities or to advise any other person regarding trading; or (d) to solicit or interfere with any relationship of OncoFirm.
3.3Standard of Care. Recipient shall protect Confidential Information using at least the same degree of care that Recipient uses to protect its own most sensitive confidential information, and in no event less than a reasonable degree of care, including the safeguards described in Section 3.6.
3.4Representatives of Entity Recipients. An Entity Recipient may disclose Confidential Information only to those of its Representatives who satisfy the requirements of Section 1.9. An Entity Recipient shall (a) maintain a current list of its Representatives who have received Confidential Information and provide that list to OncoFirm upon request; (b) upon OncoFirm’s request, cause each Representative who will have access to Grant Materials or to scientific or technical Confidential Information to sign the Individual Acknowledgment attached as Exhibit D before such access is granted; and (c) be fully responsible and liable for any act or omission of any of its Representatives or former Representatives that would constitute a breach of this Agreement if committed by Recipient.
3.5No Subcontracting Without Consent. Recipient shall not subcontract or delegate any part of the Engagement that involves access to Confidential Information without OncoFirm’s prior written consent, and any approved subcontractor shall be treated as a Representative for all purposes of this Agreement.
3.6Security Safeguards. Recipient shall:
(a)store electronic Confidential Information only on devices and in accounts protected by strong authentication, encryption, and current security updates and, where OncoFirm so directs, only within systems controlled by OncoFirm;
(b)not transfer Confidential Information to personal email accounts, personal cloud storage, removable media, messaging applications, or third-party services that OncoFirm has not approved in writing;
(c)not photograph, screen-capture, or record Confidential Information except as necessary for the Purpose;
(d)keep tangible Confidential Information in a locked location when not in use and transmit Confidential Information only by secure means;
(e)limit access to Confidential Information to persons authorized under this Agreement and promptly revoke the access of any person who ceases to need it; and comply with any additional security requirements that OncoFirm communicates in writing, including those listed in Schedule A.
3.7Artificial Intelligence and Automated Tools. Recipient shall not input, upload, paste, dictate, or otherwise disclose any Confidential Information to any generative artificial intelligence, large language model, machine-translation, transcription, summarization, note-taking, or similar thirdparty tool or service (including public chatbots, browser extensions, and “AI assistant” or “copilot” features embedded in productivity software) unless (a) OncoFirm has approved the specific tool and its configuration in writing (including in Schedule B), and (b) the tool is configured so that Confidential Information is not used to train or improve any model, is not retained beyond the immediate session, and is not accessible to the tool’s provider or to any other third party. Recipient acknowledges that Funders may restrict the use of artificial intelligence in preparing applications and may decline to consider applications that are substantially developed by artificial intelligence, and Recipient shall (i) comply with OncoFirm’s instructions and all applicable Funder policies regarding such use and (ii) disclose to OncoFirm in writing any use of such tools in preparing any Grant Materials.
3.8Notice of Security Incidents. Recipient shall notify OncoFirm in writing immediately, and in any event within twenty-four (24) hours, after becoming aware of any actual or suspected loss, theft, unauthorized access to, or unauthorized use or disclosure of Confidential Information, or any other breach of this Agreement (each, a “Security Incident”). Recipient shall cooperate fully with OncoFirm to investigate, contain, and remediate the Security Incident and to recover the affected Confidential Information, at Recipient’s expense to the extent the Security Incident arises from a breach of this Agreement by Recipient or its Representatives, and shall not notify any third party of a Security Incident involving Confidential Information without OncoFirm’s prior written consent, except as required by law.
3.9Marking Not Required. The absence of a confidentiality legend or other marking does not affect the confidential status of any information. OncoFirm may, but is not required to, mark information as “Confidential” or confirm oral or visual disclosures in writing.
3.10Third-Party Information. Recipient acknowledges that Confidential Information may include information belonging to OncoFirm’s collaborators, licensors, customers, or other third parties, and shall comply with any additional restrictions on such information that OncoFirm communicates to Recipient.
ARTICLE 4 — EXCLUSIONS
4.1Excluded Information. Recipient’s obligations under this Agreement with respect to Confidential Information do not apply to information that Recipient can demonstrate by contemporaneous written records:
(a)was generally available to the public at the time of disclosure to Recipient, or subsequently became generally available to the public through no act or omission of Recipient or its Representatives;
(b)was rightfully known to Recipient, free of any obligation of confidentiality, before its disclosure by or on behalf of OncoFirm;
(c)was rightfully received by Recipient from a third party that was free to disclose it without restriction and without breach of any obligation owed to OncoFirm; or was independently developed by Recipient without use of or reference to any Confidential Information and by persons who had no access to Confidential Information.
4.2Limits on Exclusions. Information is not excluded from Confidential Information merely because (a) it is embraced by more general information that is publicly available or in Recipient’s possession, or (b) individual features, components, or elements of it are publicly available or in Recipient’s possession, unless the particular combination itself, and its principle of operation, are publicly available or in Recipient’s possession. Personal Data and PHI are not subject to the exclusion in Section 4.1(a). Recipient bears the burden of proving that an exclusion applies.
4.3Funder Releases. Recipient acknowledges that the possibility that a Funder may release portions of a funded application or award (for example, under the Freedom of Information Act or by publishing abstracts and award summaries) does not place the remainder of the Grant Materials, OncoFirm’s underlying data, or its proprietary information in the public domain, and Recipient shall continue to treat all such information as Confidential Information except to the extent it has actually been made generally available to the public.
ARTICLE 5 — LEGALLY REQUIRED DISCLOSURES
5.1Compelled Disclosure. If Recipient is required by law, regulation, subpoena, court order, or other governmental or judicial process to disclose any Confidential Information, Recipient shall, to the extent legally permitted, (a) give OncoFirm prompt written notice before disclosure so that OncoFirm may seek a protective order or other appropriate remedy; (b) cooperate with OncoFirm, at OncoFirm’s expense, in any effort to limit or prevent the disclosure; (c) disclose only that portion of the Confidential Information that Recipient is legally required to disclose, as advised by counsel; and (d) use reasonable efforts to obtain confidential treatment for any Confidential Information so disclosed. A disclosure made in compliance with this Article 5 does not otherwise affect the confidential status of the information.
5.2Protected Rights Preserved. Nothing in this Article 5 limits Recipient’s rights under Article 14 (Protected Rights; Defend Trade Secrets Act Notice).
ARTICLE 6 — SPECIAL PROVISIONS FOR THE GRANT PROGRAM
6.1No Authority to Bind OncoFirm. Recipient has no authority to, and shall not, (a) submit, withdraw, or modify any application, report, certification, assurance, or other document to or with any Funder in OncoFirm’s name; (b) make any representation, commitment, or certification on OncoFirm’s behalf; (c) register OncoFirm or any OncoFirm personnel in any Funder system or designate any person as an authorized organizational representative or signing official; or (d) accept, decline, or negotiate any award, in each case unless expressly authorized in writing by an officer of OncoFirm. All Grant Materials are submitted, if at all, by OncoFirm through its authorized officials.
6.2Communications with Funders. Recipient shall not communicate with any Funder, program officer, scientific review officer, reviewer, study-section or panel member, advisory council member, or Funder contractor regarding OncoFirm, its Grant Materials, its Funding Opportunities, or OncoFirm Technology, except (a) as expressly authorized in advance by OncoFirm in writing and (b) in accordance with the applicable Funder’s rules. Recipient shall promptly forward to OncoFirm, without responding, any communication that Recipient receives from a Funder regarding OncoFirm.
6.3Review Information. Recipient acknowledges that Funder reviewer comments, summary statements, scores, percentile rankings, funding decisions, and council actions are among OncoFirm’s most sensitive Confidential Information, shall not disclose any of them to anyone outside OncoFirm, and shall not use them for any purpose other than the Purpose.
6.4Proprietary Markings; Public Records. OncoFirm alone determines what information is included in Grant Materials and how it is marked. Recipient shall (a) follow OncoFirm’s instructions for identifying and marking proprietary, trade secret, and confidential commercial information in Grant Materials in the manner the applicable Funder’s instructions require; (b) not remove, alter, or omit any confidentiality or proprietary legend; and (c) promptly alert OncoFirm if Recipient believes that any Grant Material contains Confidential Information that has not been marked or that should not be disclosed to the Funder. Recipient acknowledges that information submitted to a governmental Funder may become subject to public-records laws, and that OncoFirm’s decision to submit information to a Funder is not a waiver of confidentiality as against Recipient.
6.5Integrity of Grant Materials. Recipient shall not, in connection with any Grant Materials, (a) fabricate, falsify, or plagiarize any data, text, figure, citation, or result; (b) misrepresent any qualification, effort commitment, preliminary result, resource, letter of support, or other fact; (c) copy or incorporate any text, data, figure, or other material of any third party — including material from the applications of Recipient’s other clients or institutions, or from applications that Recipient has reviewed for any Funder — without authorization and appropriate attribution; or (d) include any material that infringes or misappropriates the rights of any third party. Recipient shall promptly inform OncoFirm of any inaccuracy that Recipient discovers in any Grant Materials, whether or not prepared by Recipient.
6.6Conflicts of Interest; Reviewer Roles. Recipient represents that Recipient has disclosed to OncoFirm in writing, and shall promptly disclose in writing in the future, (a) any current or anticipated engagement by, employment with, or financial interest in any person or entity that develops or commercializes products or technologies competitive with OncoFirm Technology; (b) any role as a reviewer, study-section or panel member, advisory council member, program officer, consultant, or employee for or of any Funder in connection with any Funding Opportunity for which OncoFirm is applying or, to Recipient’s knowledge, may apply; and (c) any other circumstance that could reasonably be expected to create a conflict of interest with respect to the Purpose. Recipient shall not serve as a reviewer of, or otherwise participate in any Funder’s evaluation of, any application submitted by OncoFirm or, while in possession of relevant Confidential Information, any application that competes with an OncoFirm application, and shall comply with all applicable Funder conflict-of-interest and confidentiality rules.
6.7Compliance with Funder Requirements. Recipient shall comply with all Funder rules, policies, and terms applicable to the Purpose that OncoFirm communicates to Recipient, including rules concerning the confidentiality of review, the use of artificial intelligence in preparing applications, research integrity, disclosure of other support and foreign components, and restrictions on lobbying with appropriated funds (including 31 U.S.C. § 1352).
6.8Eligibility; No Debarment. Recipient represents and warrants that neither Recipient nor, for an Entity Recipient, any of its Representatives who will perform the Purpose (a) is debarred, suspended, proposed for debarment, excluded, or otherwise declared ineligible to participate in federal programs or federally funded activities, or (b) has been found to have committed research misconduct or has been convicted of, or is subject to pending charges relating to, fraud or any offense involving a government program. Recipient shall notify OncoFirm in writing immediately if any such status arises during the term of this Agreement.
6.9Other Support and Required Disclosures. If Recipient or any of its Representatives will be named as senior or key personnel, a subawardee, a consultant, or other participating personnel in any Grant Materials, Recipient shall provide OncoFirm, accurately, completely, and on a timely basis, all information that the Funder requires regarding Recipient’s current and pending or other support, foreign affiliations, appointments, and funding, participation in foreign talent programs, financial conflicts of interest, and similar matters, and shall promptly update that information whenever the Funder requires. Recipient acknowledges that OncoFirm will rely on that information in making certifications to Funders.
6.10Records. Recipient shall maintain accurate records identifying the sources of all data, text, figures, and other material that Recipient contributes to Grant Materials and shall make those records available to OncoFirm upon request so that OncoFirm may respond to Funder inquiries, audits, and investigations.
ARTICLE 7 — PERSONAL DATA, PROTECTED HEALTH INFORMATION, AND EXPORT CONTROLS
7.1Personal Data. Recipient shall process any Personal Data included in Confidential Information (including the biographical, salary, effort, and contact information of OncoFirm personnel, collaborators, and letter-writers) only for the Purpose, in accordance with applicable dataprotection laws and OncoFirm’s instructions, and shall not sell, share, or further disclose any Personal Data.
7.2Protected Health Information. OncoFirm does not intend to disclose PHI to Recipient under this Agreement. Recipient shall not request, access, or use PHI unless and until Recipient and OncoFirm (or the applicable covered entity) have executed a business associate agreement or other agreement required by HIPAA and applicable state law. If Recipient receives PHI inadvertently, Recipient shall immediately notify OncoFirm, refrain from using or further disclosing the PHI, and return or destroy it as OncoFirm directs. Recipient shall not attempt to re-identify any de-identified, coded, or aggregated data and shall not contact any research participant or patient.
7.3Research Data, Specimens, and Consent Restrictions. Recipient shall comply with all informedconsent, institutional review board, data-use, and material-transfer restrictions that OncoFirm identifies as applicable to any data, specimens, or materials made available for the Purpose.
7.4Export Controls and Sanctions. Recipient acknowledges that Confidential Information may be subject to United States export-control and economic-sanctions laws, including the Export Administration Regulations, and shall not export, re-export, release, or transfer any Confidential Information to any foreign country, foreign person, or restricted party, or otherwise use it, in violation of those laws. OncoFirm will endeavor to identify in writing any Confidential Information that it knows to be export-controlled. To the extent Confidential Information is export-controlled, Recipient shall inform OncoFirm in writing before providing access to any Representative who is not a “U.S. person” under those laws, and OncoFirm may restrict or condition such access.
ARTICLE 8 — OWNERSHIP; WORK PRODUCT; ASSIGNMENT OF INTELLECTUAL PROPERTY
8.1OncoFirm Property; Work Product. All Confidential Information and all Grant Materials are and shall remain the sole and exclusive property of OncoFirm. All work product, deliverables, documents, drafts, narratives, budgets, analyses, templates, figures, presentations, data compilations, correspondence, and other materials, and all ideas, inventions, discoveries, improvements, know-how, processes, designs, software, data, and works of authorship, that Recipient (alone or with others) conceives, develops, prepares, or reduces to practice in the course of or as a result of the Engagement, or that use, incorporate, or are derived from Confidential Information (collectively, “Work Product”), are works made for hire for OncoFirm to the fullest extent permitted by law, and OncoFirm owns all right, title, and interest in and to the Work Product and all intellectual property rights therein.
8.2Assignment. To the extent any Work Product does not qualify as a work made for hire or does not otherwise vest in OncoFirm by operation of law, Recipient hereby irrevocably assigns, and agrees to assign, to OncoFirm all of Recipient’s right, title, and interest in and to the Work Product and all patent, copyright, trade-secret, trademark, database, and other intellectual property rights therein, throughout the world, without additional consideration. Recipient irrevocably waives, and agrees never to assert, any moral rights or similar rights in the Work Product. An Entity Recipient shall cause each of its Representatives who contributes to Work Product to be bound by written agreements sufficient to give full effect to this Article 8.
8.3Pre-Existing Materials. If Recipient incorporates into any Work Product any materials, templates, tools, or intellectual property that Recipient owned or developed before, or independently of, the Engagement and that are identified in Schedule B (“Pre-Existing Materials”), Recipient retains ownership of the Pre-Existing Materials and hereby grants OncoFirm a perpetual, irrevocable, worldwide, royalty-free, fully paid-up, transferable, and sublicensable license to use, reproduce, modify, distribute, display, perform, and otherwise exploit the Pre-Existing Materials as part of or in connection with the Work Product and the Grant Program. Recipient shall not incorporate into Work Product any third-party material — including material belonging to another client, employer, or institution, and any open-source or automatically generated content subject to restrictive terms — without OncoFirm’s prior written consent.
8.4Disclosure; Further Assurances; Power of Attorney. Recipient shall promptly disclose to OncoFirm in writing all inventions and other Work Product, shall keep adequate written records of them, and shall, during and after the Engagement, at OncoFirm’s request and expense (but without additional compensation to Recipient), execute all documents and take all actions reasonably necessary to perfect, register, maintain, enforce, or defend OncoFirm’s rights in the Work Product. If Recipient fails or refuses to execute any such document within ten (10) business days after OncoFirm’s request, Recipient hereby irrevocably appoints OncoFirm and its officers as Recipient’s attorney-in-fact, which appointment is coupled with an interest, to execute the document in Recipient’s name.
8.5Excluded Inventions; Notice Under New York Labor Law § 203-f (Staff Recipients). In accordance with New York Labor Law § 203-f, the assignment obligations of this Article 8 do not apply to an invention that a Staff Recipient develops entirely on the Staff Recipient’s own time without using OncoFirm’s equipment, supplies, facilities, or trade secret information, except for those inventions that either (a) relate, at the time of conception or reduction to practice, to OncoFirm’s business or to OncoFirm’s actual or demonstrably anticipated research or development, or (b) result from any work performed by the Staff Recipient for OncoFirm. A Staff Recipient may list in Schedule B any inventions made before the Engagement that the Staff Recipient wishes to exclude from this Article 8; if none are listed, the Staff Recipient represents that there are none. Any comparable protection afforded by the law of another state that applies to a Staff Recipient is incorporated to the extent that law requires.
8.6Institutional Collaborators. If Recipient is an Institutional Collaborator, then, unless otherwise provided in Schedule B or in a separate written collaboration, sponsored research, subaward, or license agreement between the Parties (a “Collaboration Agreement”): (a) OncoFirm owns all Grant Materials and all Work Product consisting of drafts, narratives, budgets, and other application documents prepared for OncoFirm’s applications, including the Institutional Collaborator’s contributions to them; (b) inventions and data generated by the Institutional Collaborator in performing funded research are governed by the applicable Collaboration Agreement and the Funder’s terms (including, for federal awards, 35 U.S.C. §§ 200–212 and 37 C.F.R. Part 401); and (c) each Party retains ownership of its background intellectual property, and no license to background intellectual property is granted by this Agreement except as provided in Section 8.3. Where the Institutional Collaborator’s policies require modification of this Article 8, the Parties shall record the agreed modifications in Schedule B, which shall control to the extent of any conflict with this Article 8.
8.7No License. Except for the limited right to use Confidential Information for the Purpose, nothing in this Agreement grants Recipient any license or other right, by implication, estoppel, or otherwise, under any patent, copyright, trademark, trade secret, or other intellectual property right of OncoFirm or its Affiliates.
ARTICLE 9 — NON-SOLICITATION AND NON-INTERFERENCE
9.1Personnel. During the Engagement and for twelve (12) months after it ends (the “Restricted Period”), Recipient shall not, directly or indirectly, on Recipient’s own behalf or on behalf of any other person or entity, solicit, recruit, induce, or encourage any employee, consultant, advisor, or contractor of OncoFirm with whom Recipient had contact, or about whom Recipient obtained Confidential Information, during the Engagement (a “Covered Person”) to terminate or reduce his or her relationship with OncoFirm, or hire or engage any Covered Person; provided that a general advertisement or search not targeted at OncoFirm personnel shall not, by itself, breach this Section 9.1.
9.2Funders, Collaborators, and Business Relationships. During the Restricted Period, Recipient shall not, directly or indirectly, (a) use Confidential Information to induce or encourage, or otherwise knowingly induce or encourage, any Funder, collaborator, licensor, licensee, investor, supplier, or customer of OncoFirm with which Recipient had contact, or about which Recipient obtained Confidential Information, during the Engagement to cease, reduce, or adversely modify its relationship or dealings with OncoFirm; or (b) knowingly interfere with any pending or prospective application, award, collaboration, or transaction of OncoFirm.
9.3Institutional Collaborators. For an Institutional Collaborator, Section 9.1 does not restrict ordinary academic recruitment or the movement of students, trainees, and faculty, and applies only to the targeted solicitation of Covered Persons through the use of Confidential Information. The Parties may further modify this Article 9 in Schedule B.
9.4Reasonableness. Recipient acknowledges that the restrictions in this Article 9 are reasonable in scope and duration, are no broader than necessary to protect OncoFirm’s legitimate interests in its Confidential Information, goodwill, and relationships, and do not prevent Recipient from earning a livelihood or, for an Entity Recipient, from conducting its business.
ARTICLE 10 — NON-CIRCUMVENTION; NO COMPETING APPLICATIONS
10.1No Competing Applications. During the Engagement and for twenty-four (24) months after it ends, Recipient shall not, directly or indirectly, on Recipient’s own behalf or for any other person or entity, prepare, contribute to, submit, or support any letter of intent, application, proposal, or funding request that (a) is directed to a Funding Opportunity for which OncoFirm has applied, is preparing to apply, or has identified as a target during the Engagement, and (b) proposes research, development, products, or technology that is competitive with, or substantially similar to, OncoFirm Technology or the subject matter of OncoFirm’s Grant Materials (a “Competing Application”). In addition, and without regard to any time limit other than the survival period in Section 12.2, Recipient shall never use any Confidential Information in connection with any funding request made by or for anyone other than OncoFirm.
10.2Non-Circumvention. Recipient shall not, directly or indirectly, use Confidential Information (including OncoFirm’s identification of Funders and Funding Opportunities, its relationships with program officers and other Funder personnel, reviewer feedback, scientific concepts, or commercialization strategies) to circumvent OncoFirm, to pursue for Recipient or any third party any funding, partnership, licensing, investment, or commercial opportunity that OncoFirm is pursuing or has identified, or to obtain for Recipient or any third party any benefit from any such opportunity, in each case without OncoFirm’s prior written consent.
10.3Opportunities and Ideas. If, during the Engagement, Recipient conceives of or becomes aware of any funding opportunity, idea, or strategy relating to OncoFirm Technology or the Grant Program, Recipient shall promptly disclose it to OncoFirm and shall not pursue it for Recipient’s own benefit or for the benefit of any third party.
10.4Other Clients; Information Barriers. Nothing in this Article 10 prohibits Recipient from providing grant-writing, advisory, or similar services to other clients in fields unrelated to OncoFirm Technology, provided that Recipient does so without using or disclosing any Confidential Information and otherwise complies with this Agreement. Recipient shall maintain reasonable safeguards — including separate files and, for an Entity Recipient, appropriate information barriers between personnel — to prevent Confidential Information from being used for, or disclosed to, any other client.
10.5Institutional Collaborators. For an Institutional Collaborator, Section 10.1 does not prevent the institution or its investigators from pursuing independent research funding that does not use Confidential Information and is not a Competing Application, and the Parties may further modify this Article 10 in Schedule B.
ARTICLE 11 — RETURN OR DESTRUCTION OF MATERIALS
11.1Return and Destruction. Upon the earliest of OncoFirm’s written request, the completion or termination of the Engagement, and the termination or expiration of this Agreement, Recipient shall, within ten (10) business days, (a) deliver to OncoFirm complete copies of all Work Product not already in OncoFirm’s possession; (b) return to OncoFirm all Confidential Information and Work Product in tangible form, including all Grant Materials; (c) permanently delete all Confidential Information and Work Product in electronic form from every device, account, and system within Recipient’s possession or control (including email, cloud storage, collaboration tools, backups accessible in the ordinary course, and any third-party tools); and (d) deliver to OncoFirm a certificate substantially in the form of Exhibit C, signed by Recipient or, for an Entity Recipient, by an authorized officer.
11.2Limited Retention. Recipient may retain (a) one archival copy of Confidential Information solely to the extent required by applicable law or by a bona fide, generally applied document-retention policy, and (b) copies stored in automatic electronic backup systems that are not readily accessible and are overwritten in the ordinary course, in each case subject to this Agreement for as long as they are retained and without any right to access or use them for any purpose other than compliance with the applicable requirement. An Institutional Collaborator may also retain copies to the extent required by a Funder’s record-retention requirements applicable to a funded award.
11.3Continuing Obligations. The return or destruction of Confidential Information does not relieve Recipient of any obligation under this Agreement.
ARTICLE 12 — TERM AND SURVIVAL
12.1Term. This Agreement is effective as of the Effective Date and continues until the later of (a) five (5) years after the Effective Date and (b) the date on which the Engagement (including any extension of it and any subsequent engagement of Recipient relating to the Grant Program) ends, unless earlier terminated by OncoFirm on written notice to Recipient.
12.2Survival. Recipient’s obligations under this Agreement with respect to Confidential Information survive the termination or expiration of this Agreement and of the Engagement for five (5) years after the later of that termination or expiration and the date of the last disclosure of Confidential Information to Recipient; provided that (a) obligations with respect to Trade Secrets survive for as long as the information remains a trade secret under applicable law; (b) obligations with respect to Personal Data and PHI survive indefinitely; (c) obligations with respect to unpublished patent applications and invention disclosures survive until the relevant information is published by a patent office; and (d) obligations with respect to Grant Materials for any application that remains pending, unfunded, or eligible for resubmission survive for as long as those materials have not been made generally available to the public. Articles 1, 4, 5, 7, 8, 11, 12, 13, 14, 15, 16, 17, and 18, Article 9 for the Restricted Period, and Article 10 for the period stated in it also survive.
12.3Effect of Termination of the Engagement. The termination of the Engagement, for any reason and by either Party, does not terminate this Agreement.
ARTICLE 13 — REMEDIES
13.1Equitable Relief. Recipient acknowledges that Confidential Information is unique and valuable, that any breach or threatened breach of this Agreement would cause OncoFirm irreparable harm for which monetary damages would be an inadequate remedy, and that OncoFirm is entitled to seek temporary, preliminary, and permanent injunctive relief, specific performance, and other equitable relief to prevent or restrain any breach or threatened breach, without the necessity of proving actual damages and without posting a bond or other security (or, if a court nonetheless requires security, upon posting a bond not exceeding $1,000), in addition to every other remedy available at law or in equity.
13.2Damages; Accounting. OncoFirm is entitled to recover all damages resulting from any breach of this Agreement, including lost funding, lost profits, and the costs of investigating and remediating the breach, and to an accounting and disgorgement of all profits, funding, and other benefits that Recipient or any third party obtains through a breach.
13.3Indemnification. Recipient shall indemnify, defend, and hold harmless OncoFirm and its Affiliates and their respective directors, officers, employees, and agents from and against all losses, damages, liabilities, fines, penalties, costs, and expenses (including reasonable attorneys’ fees and expert fees) arising out of or relating to any breach of this Agreement by Recipient or its Representatives or any Security Incident caused by Recipient or its Representatives. For a Staff Recipient, this Section 13.3 applies only to the extent permitted by applicable law and only with respect to willful or grossly negligent breaches.
13.4Enforcement Costs. If OncoFirm prevails in any action or proceeding to enforce this Agreement, Recipient shall reimburse OncoFirm for its reasonable attorneys’ fees, expert fees, and costs incurred in that action or proceeding.
13.5Tolling. To the extent permitted by law, the Restricted Period and the period specified in Section 10.1 shall each be extended by any period during which Recipient is in breach of Article 9 or Article 10, respectively, so that OncoFirm receives the full benefit of the bargained-for restriction.
13.6Cumulative Remedies. The rights and remedies provided in this Agreement are cumulative and are in addition to, and not in substitution for, any rights or remedies available at law, in equity, or under any other agreement or policy.
ARTICLE 14 — PROTECTED RIGHTS; DEFEND TRADE SECRETS ACT NOTICE
14.1Protected Activity. Nothing in this Agreement prohibits or restricts Recipient or any Representative from:
(a)filing a charge or complaint with, communicating with, providing truthful information to, or participating in any investigation or proceeding conducted by any federal, state, or local governmental agency or self-regulatory organization — including the Securities and Exchange Commission, the Equal Employment Opportunity Commission, the National Labor Relations Board, the Occupational Safety and Health Administration, the Department of Health and Human Services (including its Office of Inspector General and Office of Research Integrity), the New York State Division of Human Rights, the New York State Department of Labor, and the inspector general of any Funder — in each case without notice to or approval from OncoFirm;
(b)receiving an award for information provided to any governmental agency;
(c)testifying truthfully under subpoena or court order;
(d)speaking with an attorney retained by Recipient, or disclosing or discussing unlawful discrimination, harassment, or retaliation, or any other conduct that Recipient has reason to believe is unlawful;
(e)for a Staff Recipient who is a non-supervisory employee, exercising rights under Section 7 of the National Labor Relations Act, including discussing wages, hours, and other terms and conditions of employment; or
(f)exercising any other right that cannot be waived by agreement under applicable law, including under New York Labor Law § 740.
14.2Defend Trade Secrets Act Notice. Pursuant to 18 U.S.C. § 1833(b), Recipient is hereby notified that an individual shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that (a) is made (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. An individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the individual’s attorney and use the trade secret information in the court proceeding, if the individual (x) files any document containing the trade secret under seal and (y) does not disclose the trade secret, except pursuant to court order. Nothing in this Agreement authorizes conduct that is otherwise prohibited by law, such as unlawfully accessing material by unauthorized means. An Entity Recipient shall provide this notice to each of its Representatives who is an individual performing work as an employee, contractor, or consultant in connection with the Purpose.
ARTICLE 15 — PUBLICATIONS, PRESENTATIONS, AND PUBLIC STATEMENTS
15.1No Public Statements. Recipient shall not issue or make any press release, public announcement, social-media post, website listing, case study, client-list entry, marketing material, résumé or biographical statement, conference remark, or other public statement that discloses Confidential Information, describes the Engagement in more than general terms, identifies OncoFirm as a client, or refers to any OncoFirm application, score, or award, without OncoFirm’s prior written consent.
15.2Publications by Institutional Collaborators. Consistent with principles of academic freedom, an Institutional Collaborator and its investigators may publish or present the results of their own independent research; provided that any proposed publication, presentation, abstract, poster, thesis, dissertation, or other public disclosure that contains or refers to Confidential Information or Work Product (a “Proposed Publication”) shall be submitted to OncoFirm at least sixty (60) days before its submission for publication or other public disclosure. Within that period OncoFirm may (a) require the removal of Confidential Information (other than the results of the Institutional Collaborator’s own research), and (b) require a delay of up to an additional ninety (90) days to permit the filing of patent applications. An Institutional Collaborator shall not disclose in any Proposed Publication the content of any OncoFirm Grant Materials, reviewer feedback, or unpublished OncoFirm data.
15.3Names and Marks. Recipient shall not use the name, logo, or trademarks of OncoFirm (including OncoFirm™) or the name of any OncoFirm personnel in any manner without OncoFirm’s prior written consent, except within Grant Materials prepared for OncoFirm at OncoFirm’s direction.
ARTICLE 16 — REPRESENTATIONS; NO WARRANTY; RELATIONSHIP OF THE PARTIES
16.1Recipient’s Representations. Recipient represents and warrants that (a) Recipient has full power and authority to enter into and perform this Agreement and, for an Entity Recipient, the individual signing on its behalf is duly authorized to do so; (b) Recipient’s execution and performance of this Agreement do not and will not breach any agreement with, or obligation owed to, any current or former employer, client, institution, or other third party, including any confidentiality, inventionassignment, non-solicitation, or non-competition obligation; (c) Recipient will not use in performing the Engagement, or disclose to OncoFirm, any confidential information or trade secret of any third party (including the grant materials of any other client or institution); and (d) all information that Recipient has provided to OncoFirm regarding Recipient’s qualifications, conflicts of interest, and eligibility is accurate and complete.
16.2No Warranty by OncoFirm. All Confidential Information is provided “AS IS.” OncoFirm makes no representation or warranty, express or implied, as to the accuracy, completeness, noninfringement, or fitness for any purpose of any Confidential Information, and shall have no liability to Recipient arising from Recipient’s use of, or reliance on, any Confidential Information.
16.3Relationship of the Parties; Other Agreements. This Agreement does not create any partnership, joint venture, agency, franchise, fiduciary, or (except where a Staff Recipient is already an employee of OncoFirm) employment relationship between the Parties. This Agreement is not itself a services, consulting, employment, or collaboration agreement, does not obligate OncoFirm to pay any compensation, and does not modify any such agreement between the Parties, except that, if any provision of another agreement between the Parties conflicts with this Agreement, the provision that is more protective of OncoFirm’s Confidential Information and intellectual property controls unless the other agreement expressly refers to this Agreement and states that it is intended to supersede the conflicting provision.
ARTICLE 17 — GOVERNING LAW; VENUE; JURY WAIVER
17.1Governing Law. This Agreement, and all claims and causes of action (whether in contract, tort, statute, or otherwise) arising out of or relating to this Agreement or the Engagement, shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflict-of-laws rule or provision that would result in the application of the laws of any other jurisdiction, and, to the extent applicable, the federal laws of the United States, including the Defend Trade Secrets Act of 2016.
17.2Venue. Each Party irrevocably submits to the exclusive jurisdiction of the state courts of the State of New York sitting in New York County and of the United States District Court for the Southern District of New York for any action or proceeding arising out of or relating to this Agreement, and waives any objection to venue in those courts based on inconvenient forum or lack of personal jurisdiction; provided that OncoFirm may seek injunctive or other equitable relief, or enforce a judgment, in any court of competent jurisdiction in which Recipient resides, is located, or has assets, or in which a breach has occurred or is threatened.
17.3Waiver of Jury Trial. TO THE FULLEST EXTENT PERMITTED BY LAW, EACH PARTY KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ANY RIGHT TO A TRIAL BY JURY IN ANY ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ENGAGEMENT.
17.4Service of Process. Each Party consents to service of process in any such action or proceeding by any method of delivery permitted for notices under Section 18.6, in addition to any other method permitted by law.
ARTICLE 18 — GENERAL PROVISIONS
18.1Entire Agreement; Other Obligations. This Agreement, including its Schedules and Exhibits, constitutes the entire agreement of the Parties with respect to its subject matter and supersedes all prior and contemporaneous confidentiality agreements, understandings, and communications regarding that subject matter; provided that this Agreement is in addition to, and does not limit, any confidentiality, invention-assignment, or restrictive-covenant obligation of Recipient under any other agreement with OncoFirm, any OncoFirm policy, or applicable law, and OncoFirm may enforce whichever obligation is most protective of OncoFirm.
18.2Amendment; Waiver. This Agreement may be amended only by a written instrument signed by both Parties and, on behalf of OncoFirm, by an officer of OncoFirm. No waiver is effective unless it is in writing and signed by the waiving Party, and no waiver of any breach is a waiver of any other or subsequent breach. No failure or delay in exercising any right operates as a waiver of that right.
18.3Severability; Reformation. If any provision of this Agreement is held invalid, illegal, or unenforceable in any respect, that provision shall be enforced to the maximum extent permissible, the court making that determination is authorized and requested to modify the provision (including by reducing the duration, geographic scope, or scope of restricted activity of any covenant) to the minimum extent necessary to make it enforceable, and the remaining provisions of this Agreement shall continue in full force and effect.
18.4Assignment; Successors. Recipient may not assign or transfer this Agreement, or any right or obligation under it, by operation of law or otherwise, without OncoFirm’s prior written consent, and any purported assignment in violation of this Section 18.4 is void. OncoFirm may assign this Agreement without consent to any Affiliate or to any successor to all or substantially all of the business or assets to which this Agreement relates. This Agreement binds and benefits the Parties and their respective heirs, legal representatives, successors, and permitted assigns.
18.5Third-Party Beneficiaries. OncoFirm’s Affiliates are intended third-party beneficiaries of this Agreement and may enforce it directly. Except as stated in the preceding sentence, this Agreement confers no rights on any third party.
18.6Notices. Notices under this Agreement must be in writing and delivered by hand, by nationally recognized overnight courier, by certified mail (return receipt requested), or by email with confirmation of transmission, to Recipient at the address or email set forth in the Recipient Information block and to OncoFirm at: OncoFirm™ Diagnostics Corporation, Attention: Corporate Secretary, Allision Smith, Email: [email protected], with a copy (which does not constitute notice) to [email protected], or to such other address as a Party designates by notice given in accordance with this Section 18.6. A notice is effective upon receipt or upon refusal of delivery.
18.7Counterparts; Electronic Signatures. This Agreement may be executed in counterparts, each of which is an original and all of which together constitute one instrument. Signatures delivered by facsimile, by portable document format (PDF), or through a recognized electronic-signature service are binding as originals, and the Parties consent to the use of electronic signatures and records under the New York Electronic Signatures and Records Act and the federal Electronic Signatures in Global and National Commerce Act.
18.8Construction; Schedules and Exhibits. Each Party has had the opportunity to review this Agreement with counsel of its choosing, and no rule of construction resolving ambiguity against the drafting Party applies. The Schedules and Exhibits are incorporated into this Agreement. In the event of a conflict between the body of this Agreement and a Schedule or Exhibit, the body of this Agreement controls, except where Schedule B expressly modifies a provision that this Agreement permits to be modified in Schedule B.
18.9Notice to Future Employers, Clients, and Collaborators. Recipient consents to OncoFirm providing a copy of this Agreement (excluding Schedule A) to any subsequent employer, client, or collaborator of Recipient, or to any Funder, to the extent OncoFirm reasonably deems necessary to protect its rights under this Agreement.
18.10Acknowledgment. RECIPIENT ACKNOWLEDGES THAT RECIPIENT HAS READ AND UNDERSTANDS THIS AGREEMENT, HAS HAD THE OPPORTUNITY TO CONSULT INDEPENDENT COUNSEL BEFORE SIGNING IT, AND IS ENTERING INTO IT KNOWINGLY AND VOLUNTARILY.
SCHEDULE A — GRANT PROGRAM AND CONFIDENTIAL INFORMATION
This Schedule A forms part of the Confidential Disclosure Agreement between OncoFirm™ Diagnostics Corporation and the Recipient identified in the Recipient Information block. OncoFirm may update this Schedule A by written notice to Recipient; a failure to list information here does not exclude it from Confidential Information.
A-1.Description of the Grant Program. The Grant Program is OncoFirm’s continuing, company-wide program to secure and manage external, non-dilutive funding for the research, development, analytical and clinical validation, regulatory clearance or approval, manufacturing, and commercialization of OncoFirm Technology. This description supplements Recital A and is illustrative; it does not narrow the definition of the Grant Program, Grant Materials, or Confidential Information.
(a)Multiple submissions. The Grant Program is not limited to any single application, Funder, Funding Opportunity, funding mechanism, or funding cycle. It includes every letter of intent, pre-application, white paper, application, proposal, resubmission, renewal, revision, supplement, continuation, and post-award submission that OncoFirm prepares, submits, or participates in during the term of this Agreement — whether now contemplated or later identified, and whether OncoFirm acts as the applicant, a subawardee, a subcontractor, a consortium member, or a research or commercial partner on an application led by another organization. Confidential Information disclosed in connection with any such submission is covered by this Agreement, and no separate agreement, schedule, or amendment is required for additional submissions.
(b)Subject matter. The Grant Program concerns OncoFirm Technology as defined in Section 1.6 — OncoFirm’s current and future oncology diagnostic products, assays, tests, biomarkers, panels, devices, platforms, software, algorithms, and data sets, together with the underlying science, clinical evidence, regulatory strategy, and commercialization plans. The Grant Program currently focuses on Antigens, Lateral Flow, Fluorescent Lateral Flow Technology and AI systems; this focus is illustrative and does not limit the Grant Program.
(c)Funders and mechanisms. Funders within the Grant Program include, without limitation: (i) United States federal agencies and programs, including the National Institutes of Health and the National Cancer Institute (including SBIR and STTR Phase I, Phase II, Phase IIB, Fast-Track, and Direct-to-Phase II awards, and R-, U-, and P-series grants and cooperative agreements), the Department of Defense (including the Congressionally Directed Medical Research Programs), the Advanced Research Projects Agency for Health, the National Science Foundation, the Biomedical Advanced Research and Development Authority, and the Food and Drug Administration; (ii) state, regional, and local governments and economic-development agencies, including New York State life-sciences and innovation programs; (iii) private foundations, disease-focused and patient-advocacy organizations, and venture-philanthropy funds; (iv) industry, consortium, public–private partnership, accelerator, and prize or challenge programs; and (v) foreign and multinational governmental and non-governmental funders.
(d)Activities. The Grant Program includes identifying, evaluating, and prioritizing Funding Opportunities; developing funding strategy and timelines; designing the scientific, clinical, regulatory, and commercialization content of applications; preparing all Grant Materials; assembling and coordinating investigators, consultants, subawardees, and collaborating institutions; registering with and submitting through Funder systems; communicating with Funders; responding to reviewer feedback and preparing resubmissions; negotiating and accepting awards; and administering awards, including progress and financial reporting, prior-approval requests, audits, and closeout.
