Clinical Research Services Master Agreement between the Company and the CRO dated May 8, 2024

DEFINITION

“Adverse Events or AE” shall be defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the Investigational Medical Device.

“Affiliate” means, with respect to a particular Party, a person, corporation, firm or other entity that controls, is controlled by or is under common control with such Party. For the purposes of this definition, “control” means the actual power, either directly or indirectly to direct or cause the direction of the management and policies of such entity, whether by the ownership

“Investigational Medical Device” or “Test Medical Device” means medical device being assessed for safety or performance in a clinical investigation.

“Clinical Investigation” means the systematic study of an Investigational Medical Device in or on human participants to assess its safety, performance or effectiveness

"Clinical Trial Site" means any hospital or institute or any other clinical establishment having the required facilities to conduct a clinical trial

“Clinical Investigation Plan/ Protocol” means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical investigation.

“Services” shall mean the Clinical Trial related services provided to Sponsor by [Omitted] under the terms of this Agreement and shall include services in the area of conducting clinical trials, and any other agreed upon services associated with Sponsor’s Test Medical Device and other services as may be required by Sponsor under the Work Order.

“Work Order (WO)” shall mean the details of the Service to be performed by [Omitted] including timelines, Deliverables, acceptance criteria and any other details as may be required by Sponsor pursuant to this Agreement and that is mutually agreed by the Parties in the format provided in Exhibit A

“Serious Adverse Event or SAE” means an untoward medical occurrence that leads to

a death; or

a serious deterioration in the health of the subject that either-

“Third Party CRO/ Provider” shall mean any person approved by Sponsor and which are qualified by the [Omitted] as their CRO in accordance with its SOP/s (whether in writing or in a Work Order) that performs ancillary services for a Study or the Services pursuant to a contract entered into by either Sponsor or [Omitted], or any agent or representative of either. Third Party CROs/ Providers include, but are not limited to, central laboratories, drug depots, meeting planners, transportation companies, translation CROs, scale providers, equipment providers, electronic data capture (EDC) providers or any other CRO performing services not within those offered by CRO. For purposes of clarification, Third Party CROs/ Providers shall not include [Omitted] Personnel, Investigators or Clinical Trial Sites or Subcontractors.

“Deliverables” shall have the meaning as described in the applicable Work Order.

“Data” shall mean health-related information that is associated with patient care or as part of the clinical trial program or any information related to Monogram products and their performance. Data shall include electronic copies of raw data along with all other documents, including source documents.

“Regulatory Agency” shall mean an independent governmental body established by legislative act in order to set standards in a specific field of activity, or operations, in the private sector of the economy and then to enforce those standards.

“Laws” shall mean a system of rules that regulate the conduct of a community, and is often enforced by a controlling authority through penalties.

“Subjects” shall mean an individual who participates in a clinical trial either as a recipient of the investigational product(s) or as a control. The term “subject” is part of the federal regulation and may be used interchangeably with participants.

“Results” shall mean health-related information that is associated with patient outcomes as part of the clinical trial program or any information related to Monogram products and their performance in the clinical trial program.

“Acceptance Criteria” shall mean patient eligibility criteria for inclusion in the study.

“Ethics Committee” shall mean an independent body that ensures that the trial is conducted in accordance with GCP guidelines and to safeguard the safety and well-being of subjects participating in a clinical trial.

Services: [Omitted] will provide the Sponsor with various Services in connection with Studies for its products.

Scope of the Agreement: Sponsor shall outsource exclusively to [Omitted] all Services concerning its clinical Studies of its Investigational Medical Device product in India.  The data generated from the Studies are to be used as data for submission to Regulatory Agencies and Sponsor is free to use such data as needed.

Work Orders: The specific details of each clinical trial study (hereinafter referred to as ‘Study’ or plural “Studies”), including but not limited to timelines and the agreed price shall be negotiated in good faith and agreed upon in the Work Orders entered into between the Parties from time-to-time and on a product-to-product basis before commencement of a Study with respect to that particular product. Upon the execution of a Work Order, [Omitted] will provide Services as described on a Study-specific basis in individual Work Order. Each Work Order shall include the Study-related details including, but not limited to, the nature and scope of Services, timelines, budget, payment schedules, and Deliverables that [Omitted] shall be obligated to deliver to Sponsor under such Work Order, and must be signed by both parties before forming part of this Service Master Agreement.  A Work Order may also include terms and requirements that are specific to that Study. Each Work Order is incorporated by reference into this Master Agreement upon its execution.

Change Order: Any change in the details of a Work Order or the assumptions upon which the Work Order is based including, but not limited to, changes to the design, the agreed number of subjects participating in the study and/or suspension of the Study by the Sponsor may require changes in the budget and shall require a written amendment to the Work Order (a “Change Order”). Each Change Order shall detail the requested changes to the applicable task, responsibility, duty, budget, timeline or other matter. The Change Order will become effective upon the execution of such Change Order by both Parties, and [Omitted] will be given a reasonable period of time within which to implement the changes, unless implementation is otherwise explicitly addressed in the Change Order, and if so, the Change Order timelines will prevail. Both Parties agree to act in good faith and promptly when considering a Change Order requested by the other Party

The parties acknowledge and agree that their respective Affiliates may execute Work Orders under this Master Agreement. In that event, such Affiliate(s) shall be bound by all terms and conditions of this Master Agreement and the applicable Work Order, and entitled to all rights and protections afforded under this Master Agreement. While this Master Agreement creates certain obligations between the parties, it does not create an obligation on the part of Sponsor or any Sponsor Affiliate to engage [Omitted] to provide services, or an obligation on the part of [Omitted] or any [Omitted] Affiliate to provide services; such obligations shall arise only upon the execution of a Work Order, or a Change Order.

Each Party understands and agrees that the other Party or its Affiliates may be in a business similar to or offer products or services the same as the other Party (or one or more of its Affiliates) and may already have developed, be in the process of developing, or plan to develop products, services and information similar to those owned or developed by the other. Nothing

[Omitted] shall conduct the Study for the Sponsor in accordance with this Master Agreement, Protocol (as amended from time to time), Good Clinical Practices (GCP)during the Term, and approval of the Ethics Committee and all applicable Laws.

[Omitted] agrees to provide such personnel, facilities and resources to the Sponsor as [Omitted] deems necessary to perform the Study under this Master Agreement.

In order to provide these Services, [Omitted] will use investigators, investigative sites or related subcontractors as per recommendation and approval of the Sponsor. In performing the Services, all such personnel, investigators and subcontractors shall be bound by confidentiality obligations and compliance to local regulatory requirements including FDA requirements. The separate agreement between Sponsor and investigators will be executed to conduct the Study at different Clinical Trial Sites.

With regard to any Work Order related to the development and consultation of any Protocols designed for the Study, [Omitted] shall consult on design, objectives, inclusion and exclusion criteria, procedures for reporting Adverse Events, statistical analysis or any other relevant issues, in line with all applicable Laws of both Indian and US jurisdictions, and industry standards.

For any Study described in a Work Order, [Omitted] shall prepare informed consent forms (“Informed Consent Forms”) and Case Record Forms (“CRFs”) for the Study. If described in a Work Order, [Omitted] shall submit Informed Consent Forms and CRFs in the agreed form to the applicable Regulatory Authorities and/or applicable Ethics Committee as required by Indian regulatory requirements.

[Omitted] shall deliver the Study within stipulated timelines as agreed in the Work Order with Sponsor. Any delay in Deliverables should be communicated as soon as practically possible but not to exceed one week.

[Omitted] shall support Sponsor with all reasonable efforts to provide Sponsor with the information requested by the Sponsor without undue delay.

[Omitted] shall complete the Study in accordance with the Protocol and all identified methodologies. In case of any deviation, [Omitted] shall promptly notify the Sponsor.  The Protocol may be amended from time to time provided that any such amendments are mutually agreed in writing and signed by the Parties and as per the prevalent local regulations and GCP.

[Omitted] and site shall immediately notify the Sponsor and EC of any occurrences of an investigator’s deviations from Protocol due to a Subject’s safety or the terminations of the

[Omitted] shall ensure that Clinical Trial Sites shall enroll a requisite number of Subjects in the Study, who meet the Subject selection criteria described in the Protocol and only after the approval of the Ethics Committee and the Regulatory Authority.

[Omitted] shall prepare and deliver a final report based on the findings of the Results of the Study (“Report”) (together with copies of the CRFs) to the Sponsor, compliant with GCP and applicable regulatory requirements and submit one copy (soft) to the Sponsor.  [Omitted] agrees to make any reasonable corrections to the Report requested by the Sponsor and deliver the revised Report to the Sponsor.

[Omitted] will ensure through its Quality Assurance Unit (QA), that services under this Master Agreement are performed in compliance with applicable Laws and [Omitted]’s Standard Operating Procedures (SOPs).

[Omitted] shall comply and cooperate with Sponsor’s auditing team, which will have the right to audit / inspect at reasonable times and in a reasonable manner, the SOPs and facilities of [Omitted] and also verify any records as may reasonably be required to determine whether the Services are being performed in compliance with the provisions of this Master Agreement and /or the relevant Work Order.

[Omitted] shall ensure that the Clinical Trial Site retains electronic copies of raw data along with all other documents, including source documents, for a period of at least fifteen years or the minimum required by Indian or US based regulations after the submission of the final Report, which will be open to inspection and copying by Sponsor and thereafter transfer the same to Sponsor.

During the course of the Study, [Omitted] shall keep the Sponsor informed of routine progress in the conduct of every phase of the Study.

For each Study conducted, [Omitted] shall report any occurrence of SAEs to local Central Licencing Authority, the Sponsor or its representative, as required by current local regulation and as specified in the study-specific Protocol. Sponsor shall be responsible for reporting SAEs to the relevant Regulatory Authorities outside India, as applicable.

Unless specifically mentioned in the applicable Work Order, upon satisfactory completion of the Study, [Omitted] shall prepare a final Report with respect to the Study in the ICH-E3/eCTD format. If in an event Sponsor requires a hard copy of the Report, [Omitted] shall provide the same to the Sponsor and courier it to Sponsor at Sponsor’s cost.

[Omitted] shall not disclose its working relationship with Monogram with any third party unless required for the execution of its obligations under this Master Agreement.

[Omitted] will be responsible for monitoring of the study on the behalf of the Sponsor conducted at Clinical Trial Site under this Agreement.

The timelines described in this Master Agreement are contingent on [Omitted] receiving inputs as relevant in a timely manner.

The Sponsor shall provide the Test Product/ Test Medical Device described in the Work Order to Clinical Trial Site. Sponsor shall define the reliability, performance and other relevant characteristics of the Test Medical Device.

Sponsor shall certify to the effect that the Test Medical Devices are manufactured and tested as per relevant regulations.

For performance of the Services, Sponsor shall pay [Omitted] the amounts specified in Work Order(s) in accordance with the Payment Schedule described therein. Unless agreed otherwise, the amount stated in the Work Order shall be net of all taxes which will be levied in addition to the amount stated in the Work Order as per prevalent provisions of law. All quotes shall include estimates of applicable taxes. [Omitted] shall be reimbursed for its documented expenses, if any such expenses shall be incurred by [Omitted], after receipt of Sponsor’s approval.

All payments shall be made by Sponsor to [Omitted] in US Dollars or INR to the bank information provided on the applicable invoice. [Omitted] shall submit the invoices to Sponsor by email. Sponsor shall make the payment within 30 days from the date of the invoice. Payments shall be made in INR or in USD at the prevailing INR: USD exchange rate on the date of invoice. In case of any delay in payment more than thirty (30) days past the due date, interest at 18% per annum shall be paid by Sponsor. All quotes shall be inclusive of all estimated taxes (GST).

The Parties agree to hold in confidence all the information and data disclosed by one Party (the “Discloser”) to the other (the “Recipient”) in confidence, including any and all data and/or other information connected to the Services and or the Parties’ business, and not to use the same except for the purpose of carrying out their obligations pursuant to this Master Agreement. Nothing contained herein shall be construed or interpreted as limiting the Sponsor's right to make any and all use (including but not limited to publication) of all Results and/or data from any Study, as it sees fit. For the purposes of this Master Agreement, “Confidential Information” shall mean any information, including but not limited to data, techniques, Protocols or Results, or business, financial, commercial or technical information (including but not limited to information concerning Sponsor Materials, clinical trial protocols, clinical data and analysis, formulae, data, software programs and source documents; the Report and the Research Information, disclosed by Discloser to Recipient or generated by Recipient and owned by Discloser. For clarity, [Omitted] Technology and [Omitted] IP (as defined herein) are Confidential

The obligations of confidence shall not apply to any of the following:

information which can be proved by evidence in writing that it was known to the other Party before its disclosure; or

Recipient may disclose Discloser’s Confidential Information, including materials containing or embodying such Confidential Information, to the extent required by applicable law or regulation; provided, however, that before such legally required disclosure Recipient shall give prompt written notice of such required disclosure to Discloser. In the event of a limited disclosure of Discloser’s Confidential Information that is required by law or regulation, Recipient shall continue to treat such disclosed information as Discloser’s Confidential Information for all other purposes and subject to the other terms and conditions of this Master Agreement.

Both Parties agree that they will at any time upon the request by the other return or otherwise dispose of all written or other documentary Confidential Information or copies thereof given to it or resulting from the Master Agreement.

The confidentiality obligations of this Master Agreement shall continue for a period of seven (7) years after termination of this Agreement. The provisions of this section will survive the termination or expiry of this Master Agreement for any reason.

Each Party represents that it is authorized to enter into this Master Agreement, and any Work Order issued hereunder, and that the terms of this Master Agreement are not inconsistent with or a violation of any contracted or other legal obligation to which it is subject.

Each Party represents that in performing under this Master Agreement it shall (a) conduct business in conformance with sound ethical standards of integrity and honesty and in compliance with all applicable Laws; (b) comply with Article XXI.

[Omitted] represents and warrants that it shall perform the Services in a good and professional manner, in line with highest level industry standards.

The Sponsor shall provide, without charge, Test Medical Device and related component to be used by Clinical Trial Site investigators and monitored by [Omitted] in performing Services as further described in the applicable Work Order. The Test Medical Device shall be made available at the Clinical Trial Sites in appropriate condition and in accordance with the Protocol.

Clinical Trial Site nor [Omitted] shall use Test Medical Device for any purposes other than to perform the Services contemplated in this Agreement.

[Omitted] agrees to comply with any audit and inspection requests by Regulatory Agencies, and shall cooperate with such inspection. Upon request by Sponsor and at Sponsor’s cost, [Omitted] shall cooperate with the request, inquiry, investigation, audit or proceeding with applicable governmental regulatory authority, at Sponsor’s expense. [Omitted] shall respond promptly to the queries raised by regulatory authorities on the conduct of the Study by [Omitted]. Sponsor shall notify [Omitted] in writing promptly after becoming aware of any audits of the Study to be conducted by regulatory authorities. [Omitted] shall have the right to recover from Sponsor the expenses involved in preparing the reports in accordance with the regulatory guidelines of the country of any audit submission under this Section. The expenses incurred for audits under this Section would be charged to Sponsor at the prevailing rate. The cost of which shall be mutually agreed on later date.

[Omitted] shall notify Sponsor within five (5) business days, of receipt of communication letter, in writing of any Regulatory Authority wishing to conduct inspections or inquiring about any Study conducted for Sponsor by [Omitted].

[Omitted] shall indemnify, defend and hold the Sponsor, its Affiliates, officers, directors, employees, agents, ,(“Sponsor Indemnitees”) harmless from any and all direct losses, direct damages, liabilities, reasonable attorney fees, court costs and expenses (collectively “Losses”) arising out of (i) [Omitted] Indemnitee’s deviation or omission or gross negligence in the performance of its obligations under this Master Services Agreement and/or under a Task/Work Orders; and (ii) [Omitted] Indemnitee’s failure to comply with applicable Laws except to the extent that such Losses arise from: (i) any negligent act or omission, or wilful misconduct, of any Sponsor Indemnified Party, or (ii) any breach of this MSA by Sponsor.

The Sponsor shall indemnify and hold harmless [Omitted] and its Affiliates, and its directors, officers, employees and agents,  (each, a “[Omitted] Indemnitees”), from and against any and all Losses resulting or arising from any third-party claims, actions, proceedings,  or litigation relating to or arising from (i) Sponsor Indemnitee’s negligent acts or omissions under this Agreement, any Work Order or the Services contemplated herein including, any Losses arising from or in connection with any study, test, device, product or potential product to which this Agreement or any Task/Work Order relates; or (ii), death or injury to ( a.) a participant/subject in a Study performed by [Omitted] on behalf of Sponsor, as specified in the applicable Work Order (“Clinical Investigation”) or (b) any employee or contractor of [Omitted] involved in the performance of a Study or Services hereunder, in which death or personal injury arises from or is attributable to the Test Medical Device; or (c ) the procedures set forth in the Study protocol/clinical investigation plan; or (d) arise directly or indirectly from Sponsor’s use, or a third party’s use pursuant to Sponsor’s authority, of Study Report provided by [Omitted] under this MSA, except to the extent that such Losses (i)-(ii) arise from: (ix) any gross negligent act or omission, or wilful misconduct, of any [Omitted] Indemnitees , or (y) any breach of this MSA by [Omitted]. Each Party’s obligation under the above Article X is conditioned upon timely written notice of any such claim, proceeding or investigation (including a copy thereof). Notwithstanding the foregoing, a Party’s failure to give timely written notice of any such claim, proceeding or investigation shall not limit the other Parties’ right to indemnification except to the extent such failure affects the ability of such Party to defend against such claim, proceeding or investigation. The indemnifying Party must consent to the settlement of a claim, and such consent shall not be unreasonably withheld.

Neither party shall have any claim or right against the other, whether in contract, warranty, tort (including negligence), strict liability or otherwise, for any special, indirect, incidental, or consequential damages of any kind or nature whatsoever, such as but not limited to loss of

The results of the Study together with the Data of the Study (together, “Results”) and the final Report containing the Results provided by [Omitted] as part of the Work Order, shall remain the property of Sponsor as the case may be.

All data, ideas, methods, inventions, discoveries, information, reports and other proprietary or protectable materials which relate to the Sponsor, Sponsor’s products and their applications, Sponsor’s business and/or relating to the Investigational Medical Devices and arising out of the Study performed under this Master Agreement which are developed by [Omitted] or submitted by Sponsor to [Omitted] (“Sponsor Material”) are owned by Sponsor.

Sponsor hereby grants [Omitted] and its affiliates, a non-exclusive, fully paid-up, sub-licensable and non-transferable limited license for the term of the Master Agreement, in and to the Sponsor Material and Sponsor IP for the sole purpose of conducting the Study in accordance with the Work Order.

Either Party shall have the right to terminate this Agreement at any time upon written notice to the other Party, if the other Party has reasonable basis for believing the other Party is about to become insolvent or bankrupt, the other Party shall be adjudicated insolvent or have filed petition for or consent to any relief under any insolvency, re-organization, receivership, liquidation, compromise, or any moratorium statute, whether now or hereafter in effect, or shall make an assignment for the benefit of its creditors, or shall petition for the appointment of a receiver, liquidator, trustee, or custodian for all or a substantial part of its assets, or if a receiver, liquidator, trustee or custodian is appointed for all or a substantial part of its assets and is not discharged within thirty (30) days after the date of such appointment.  In the event that any of the events contemplated in this Article occur, that Party must immediately notify the other, in writing, of its occurrence.

Any written termination notice shall identify the specific Work Order that is being terminated. Unless specifically terminated the outstanding work Order will continue to be valid and subsisting until the obligations thereof are performed under this Master Agreement.

In the event this Master Agreement or any Work Order is terminated, the Parties shall promptly meet to prepare a close-out schedule and the Sponsor shall pay [Omitted] for all Services performed under this Master Agreement and reimburse [Omitted] for all costs and expenses including non-cancellable costs incurred in performing those Services up to the effective date of termination. Sponsor shall also reimburse any outstanding investigator fees/expenses, including any investigator or clinical trial site, non-cancellable third-party obligations which cannot be mitigated through reasonable efforts of [Omitted] or the institution, and any other obligations agreed to by Sponsor and [Omitted] for the purpose of winding down the Study. Upon termination of a Work Order, [Omitted] shall forward all Sponsor Materials pertinent to such Work Order and all Sponsor Materials related to all outstanding Work Orders to Sponsor.  In the event that an individual Work Order is terminated, the remainder of this Master Agreement shall otherwise remain in full force and effect, unless otherwise agreed to by the Parties.

In the event, the Study is terminated due to Adverse Events, then Sponsor agrees to pay [Omitted] for all documented and approved costs, expenses and obligations actually incurred/ committed till the date of such termination.

In the event of Study termination, [Omitted] shall inform promptly to all sites and Local Regulatory Authority. Site shall promptly inform the concerned Subjects and the Ethics Committee of such termination and the reason for the same. Study termination notices should go to Subjects (future enrolled and patients that have already undergone a procedure),.

The pending payment from Sponsor, if any, should be settled by Sponsor in accordance with the Payment Terms, Article IV.

In case the Work Order is terminated during the continuance of any phase, the proportionate amount appropriate to the work completed or irrevocably committed to be completed shall be payable by Sponsor. If payments under a Work Order are milestone-based, and the Master Agreement or applicable Work Order is terminated after costs have been incurred by [Omitted] toward achieving a milestone, but that milestone has not yet been completed, then [Omitted] shall be entitled to receive the proportionate amount appropriate to the milestone completed and reimburse/refund the balance amount proportionate to work not completed to the Sponsor.

For the purposes of this Master Agreement, the Parties hereto are independent contractors and nothing contained in this Master Agreement shall be construed to place them in the relationship of partners, principle and agent, employer/employee or joint ventures. [Omitted] agrees that it shall have no power or right to bind or obligate the Sponsor, nor shall [Omitted] hold itself out as having such authority.

Any notices between [Omitted] and the Sponsor shall be in writing and sent by delivery service or registered mail, and shall be deemed given on the date received to the following addresses.

This Master Agreement constitutes the entire Master Agreement between [Omitted] and the Sponsor with regard to its subject matter, and supersedes all previous written or oral representations, Master Agreements and understandings between the Parties. This Master Agreement may be amended only by written document signed by both [Omitted] and the Sponsor.

In the event that any one or more of the provisions contained in this Master Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Master Agreement, and all other

In the event there is a conflict between the terms of this Master Agreement and a Work Order, then the terms of this Master Agreement unless otherwise explicitly stated in a Work Order is executed.

Subcontractor is a person or entity who has a direct contract with [Omitted] to perform Service as determined by CRO. The term “Subcontractor” is referred to throughout this Agreement as if singular in number and means a Subcontractor or an authorized representative of the Subcontractor. In the event that a Subcontractor, in the ordinary course of its business, retains the services of any other corporation, professional associate or subcontractor, a Subcontractor and [Omitted] shall ensure that such other corporation, professional associate or subcontractor is subject to the same terms and conditions set forth in this Agreement and [Omitted] shall be liable for any actions of such other corporation, professional associate or subcontractor with regards to this Agreement

[Omitted] shall have the right to sub-contract all or part of the Services to a Subcontractor provided that the prior written consent of the Sponsor, which shall not be unreasonably withheld, is obtained. In the event of such a sub-contract, [Omitted] shall remain fully liable for and shall ensure that the Services, whether provided by a Subcontractor or [Omitted], are performed in strict accordance with the terms of this Agreement and any Work Order issued pursuant to this Agreement