附件10.2

**关于临床试验药品的协议 进行的协议**

[这是原始意大利文档的非官方英文翻译。在所有方面，包括解释，意大利文档应为准。]

“开放标签 阶段1/2研究，旨在评估Temferon（富含CD34+并经人类干扰素-α2基因修饰的自体造血干/祖细胞）单剂量对转移性肾癌患者的安全性、生物反应和疗效。”

**之间**

圣拉斐尔医院有限公司 （以下简称“机构”），注册办公地址为20132 米兰（MI），奥尔格蒂纳街60号，在米兰商会经济行政注册处注册，注册号为 MI-1972938， 具有税号、增值税号和在米兰公司注册处的注册号（股本为60,817,200.00欧元）， 被Gruppo San Donato S.p.A.的单一股东支配和控制，由研究主任安娜·弗拉维亚·达梅利奥·埃瑙迪女士代表。 07636600962 董事。

**和**

Genenta Science S.p.A.， 注册办事处位于 Via Olgettina 58，20132 米兰，增值税 08738490963，由其法定代表人代表 皮尔路易吉·帕拉基博士 （首席执行官），担任 首席执行官 （首席执行官）（以下简称 “赞助商”）。

以下简称为“一方/各方”。

**鉴于：**

A. 赞助商打算根据《欧盟法规(第536/2014号)》(以下简称“法规”)开展一项临床试验，题为“开放标签的第1/2期研究，评估携带CD34+和人干扰素-α2基因修饰的自体造血干细胞对晚期肾癌患者的安全性、生物学反应和疗效的单剂量Temferon”(以下简称“试验”)，涉及 协议版本号为1.0 日期为 2024年5月10日，及其经批准的后续修订版(以下简称“协议”)，EudraCt代码为 2024-512898-27-00，在机构内，在 Andrea Necchi教授作为本合同约定试验的科学监督负责人(以下简称“首席研究员”)，在 肿瘤学，由Michele Reni教授领导 （以下简称“试验中心”）， Fabio Ciceri教授 作为联合研究者，在 血液科和骨髓移植科.

b. 赞助商已指定 卡洛·鲁索博士，首席医疗官兼发展主管，作为其 范围的科学参考。赞助商可以通过书面通知机构更改科学参考。

C。 试验中心具备进行试验的技术和科学专业知识，并且结构合适，可以按照现行法规进行试验。

D. 主要研究员及其直接合作者，有资格自行决定执行方案（以下简称“共同研究员”），以及所有在主要研究员监督下参与试验的其他人员，均有能力按照适用法规进行试验，熟悉方案和良好的临床实践标准，并满足必要的监管要求，包括遵守有关利益冲突的适用法规。

E. 除非另有书面协议，机构应在其设施内独家进行试验。

F. 该机构配备了符合试验方案规定的适当设施。

G.根据《规定》第II章的规定，已经获得了国家授权，于2024年9月30日根据第80条上传到欧盟门户的一项试验，其中包括了国家伦理委员会对爱文思控股临床试验的意见。

根据第76条的规定和适用的国家法规，保荐人已按照本合同第8条的规定购买了保险。

I. 在谈判本合同时，各方已基于2018年1月11日第3号法律第2条第6款所批准的国家协调中心模板达成协议，并根据其中提及的行政、经济和保险方面的同质性，同意补充和/或修改相关条款，以管理试验的特殊性和特殊性，具体原因如下，针对每项增补或修改如下所述：

- **第3条及后续条款**：规定，尽管Andrea Necchi教授（医学肿瘤学）是首席研究员，但研究将在机构的两个独立运营单位进行：血液学和骨髓移植单位（进行自体转导干 细胞移植和Temferon的管理及后续治疗）以及医学肿瘤学单位（负责患者的肿瘤治疗）。

- **第3.8条**：规定了数据收集表交付以及澄清请求解决的时间表。

- **第4条及后续条款**：规定了研究药物的提供方式，提供 Temferon（专有IMP）免费，并对购买其他IMP药物（Plerixafor、Lenograstim、Busulfan、Cabozantinib 和 Pembrolizumab）进行全额报销。没有辅助药物或背景治疗。

- **第4.2条**: 在研究观察期结束后，为曾从临床试验药物中获益的患者提供药物的可能性，不适用于本研究中的基因治疗。

- **第五条**：不得提供借款。

- **第7.2条（期限、终止和解决）**：由于研究的财务管理完全由赞助商管理，与CRO（破产）相关的条款已被移除。

- **第9条（最终报告、所有权和结果的使用）**：机构仅在赞助商事先书面授权并分享使用目的后，才能使用试验数据和结果。

- **第10条（技术和商业信息的保密及结果披露）**：同样的准则适用于 调查员，在未经赞助方事先书面授权的情况下，他只能披露和发表试验结果。 鉴于这是单中心研究，第9.5条已经被简化。

- **附件A（预算 - 省略）**：附件已经修改，以适应研究的特殊要求。

各方同意并约定如下：

文章 1 - 合同的全部内容

1.1 序言、议定书，即使未实际附附，以及所有附件，包括预算（附件A - 省略）和与个人数据保护相关的词汇表（附件b - 省略），均为本合同不可分割的重要组成部分。

文章 2 - 目的

赞助方委托机构根据本合同中指定的条件，在协议书以及任何后续修订以及由此产生的对本合同/预算的修改下，进行试验的执行，并通过必要、及时签署的修订文件正式确立。

赞助方宣称已委任位于米兰、纳税人编号03274820236，统一增值税编号IT03274820236的合约研究机构Alira Health S.r.l.（以下简称“CRO”），该机构遵守2011年11月15日的D.m.法规，并注册于国家药品临床试验观测站（OsSC），以执行与试验相关的活动，并授予其必要的权力及相关授权，代表协议日期为2024年8月22日。机构承认已获悉此委任。

2.2 试验必须严格遵守当前版本的协议书进行，该版本已获得首席研究员接受并获得伦理委员会和主管当局批准，并按照目前关于医疗产品临床试验的规定以及指导医疗专业人员的道德和道德原则进行。

2.3 试验还必须遵守《人权和生物医学公约》、更新版本的《赫尔辛基宣言》、目前的良好临床实践规则，并遵守适用的透明度和反腐败法律，以及依据目前规定的个人资料保护法。

2.4 签署本合同即表明各方已了解并接受上述内容。在必要范围内，并据其所知，各方宣称本合同中所提供的活动不违反其与第三方所做承诺。

保护病人健康是赞助方和首席研究员的义务，当遇到情况，他们可能采取紧急且适当的措施以确保病人安全，例如暂停研究（中止对已参与试验的病人的治疗，或暂停纳入新受试者），遵循欧盟第536/2014号条例第38 条中规定的程序，赞助方有义务及时通知伦理委员会、主管机关和试验中心（然后由试验中心通知研究参与者）任何新事件、采取的措施和必须采取的行动计划，及时完成当前法规所指定的程序。在调查者通报严重不良事件后，赞助方应按照欧盟第536/2014号条例第42条第2款的规定立即向电子数据库报告所有疑似严重不良反应，也应按照第3款的规定进行报告。

机构计划在2025年12月31日前招募约12名患者，但纳入期限可能会根据招募进度、无法确认患者、或治疗前退出研究而改变。各方承认，在机构试验中心所需增加的患者人数必须经各方事先批准，并透过适当的修正提交给伦理委员会和主管机构。双方明确明白，在上述条件下进行的此类增加，若适用于所有额外患者的协议经济条件恪守，则不需要对本协议进行额外协议。

2.7 机构和赞助方将保留与试验相关的文件（机构的永久档案“调查员站点档案”和赞助方的“试验主文件”），保留期限和规格应根据当前法规所示（或根据其他适用法律或机构和赞助方之间协议要求的更长期限）。 在此期限届满后，双方可以就延长保留期限的条款达成协议。

在各自权限范围内，机构和赞助方还承诺使用数位化形式保存前述文件，以符合适用法规。无论与试验相关的文件储存涉及到（根据《欧盟法规》（EU）第679/2016号）GDPR中定义的个人数据（特定或非特定），机构和赞助方必须采取GDPR第32条所要求的所有物理和技术措施，并按照当前法规规定进行必要的安防检查，以保护资料、信息和文件（包括纸质和电子文件）。所使用的存储系统必须保证资料、信息和文件在纸质和电子格式中的完整性，并确保在保留义务的整个期间内可以读取。为履行这一义务，赞助方和机构均可委托外部机构负责管理该存储义务。

2.9 赞助商、机构和主要研究员必须遵守伦理委员会和主管机构提供的指南、指导方针、说明和建议。

文章 3 – 主要研究员和共同研究员

3.1 主要研究员将得到直接协作者的协助，这些协作者根据方案资格应对执行审慎权力进行干预，以及由机构指定的医护和非医护人员。协作者和其他人员将在主要研究员的责任下执行与试验相关的工作。上述个人必须有资格执行试验，并且必须根据赞助厂商的要求，依据当前法规对方案进行适当的预先训练；每个人都必须表示愿意参与试验。特别是，主要研究员有责任监督协作者和其他参与试验的人员的活动的正确进行，尤其是在他们中的某些人在试验中可能出现放射或停止的情况。

强调本次试验将在机构内的两个独立部门进行，分别是血液学和骨髓移植单位（将进行干细胞转染后的自体移植，并给予Temferon并进行后续随访），医疗肿瘤学单位（将负责病人的肿瘤治疗）。

3.2 各方承认，作为机构与赞助商的一般联络人，首席研究员有责任遵守所有目前医药试验法规对机构所加诸的义务。

3.3 赞助商和机构之间存在这种关系。双方均不参与对方与其代表和/或员工（特别是赞助商与机构、首席研究员、协作研究员以及所有参与试验的人员之关系，以及机构与赞助商、CRO或任何其他代表和/或员工之间的关系）。因此，各方就这些个人可能就试验提出的任何索赔而言均予以解除。

3.4 就本合同条款下的试验事项，双方确认已遵守2019年5月14日第52号法令第7条和法律2020年7月17日第77号第11-bis条改编的条例第6条第4款，转换为2020年5月19日第34号法令（「重启法令」）的规定。

如果主要研究员与机构之间的关系因任何原因而结束，机构必须立即以书面形式通知赞助商，指明一位替换者并在欧洲电子数据库中报告。替换者的指定必须获得赞助商和相关道德委员会的批准。机构保证新的主要研究员符合继续进行研究的要求，接受本合同的条款和条件，并承诺遵守协议以进行试验。在等待就更换主要研究员的实质修正获批之时，机构指派的研究员确保试验活动的必要连续性。

如果赞助方不愿接受机构提名的替代人选，或者机构未提名替代人选，赞助方可以按照第7条退出本合同。

3.6 主要研究员或其代表在开始试验之前，必须根据目前临床试验相关法规获得患者或其合法代表的知情同意，并同意根据适用的国家和欧盟关于数据保护的法规处理个人数据，详情请参阅第11条。

3.7 主要研究员有义务详细记录和记录所有不良事件和严重不良事件，并在目前立法规定的期限内向赞助商报告。此外，主要研究员必须提供任何其他与执行实验有关的临床相关资讯，如方案所规定(例如，怀孕)，根据方案、优良临床实践标准以及与药物警戒和医疗产品临床试验相关的法规要求。

3.8 该机构确保根据最高的勤勉标准，由主要研究员和其负责的人员确保试验的适当进行。具体来说：

3.8.1 主要研究员必须在访问完成后的十五（15）个业务日内，按照试验计划和适用法规的要求，将所有数据收集表格（病例报告表格 - CRFs） 正确填写完成并进行匿名处理，无论以纸质或电子格式提供，并且按照试验计划设定的截止期限，及时按照GCP要求提交。

3.8.2 首席研究员亦承诺在完成每次访问后的五 (5) 个业务日内解决由赞助商提出的澄清请求（查询）如在临床试验计划中规定的。

3.8.3 为了验证数据收集表中记录的数据与原始文件（例如临床记录）中包含的数据之间的一致性，机构和首席研究员在监测访问期间以及赞助方进行的任何审计和主管机关进行的检查，包括远程程序时允许直接查阅原始数据，前提是不违反患者隐私和数据保护法律。

3.8.4 在适当通知后，机构和首席研究员必须允许赞助方人员和主管机构在试验中心、医学肿瘤科单位以及血液学和骨髓移植科进行监察、审核和检查活动，以确保试验的正常执行。

3.8.5 赞助方承认机构可能根据其质量系统和程序，在其设施内进行与试验相关的内部质量检查（内部GCP审核）。

3.9 如有主管机关通知检查/审计与试验有关，机构将立即通知赞助商。如果主管机关未明确拒绝，机构将授权赞助商参与，并将收到和/或传递的有关检查/审计的书面通信发送给赞助商。这些活动绝不能以任何方式损害机构的常规机构活动。

3.10 机构及赞助商确保在本合同下进行试验的受试者的生物样本（血液、尿液、唾液等等）或任何所述协议中包含的子研究，将仅用于根据协议和当前法规进行本合同下的试验。任何存储和后续使用都需要获得患者（或其父母/法定监护人）的明确知情同意、获得伦理委员会的批准，并且必须遵守法律和《2019年5月14日法令第52号》第1条第1款第b条所规定的限制和保障。

文章 4 - 调查药品、材料和服务

4.1 The Sponsor commits to provide the Institution, at no cost, with the investigational product (TemferonTM) in quantities deemed necessary and sufficient for the proper execution of the Trial throughout its duration (hereinafter “Investigational Medicinal Product”). Additionally, the Sponsor agrees to reimburse the Institution for other medicines outlined in the protocol, including Plerixafor, Lenograstim, Busulfan, Cabozantinib, and Pembrolizumab, in accordance with Annex 1, point 3, Table I of the Ministerial Decree of December 21, 2007 (hereinafter “Other Investigational Medicinal Products”). Quantities of the Investigational Medicinal Product and Other Investigational Medicinal Products provided by the Sponsor shall correspond to the study’s case numbers and remain solely for Trial use. The Institution shall manage receipt, tracking through batch registration, labeling, and appropriate disposal as required. The Institution will bear the costs of background therapies excluded from comparative therapeutic strategies. The Sponsor further undertakes to supply, at its own expense, all additional materials required for the Trial (hereinafter, “Materials”), as well as laboratory, diagnostic, and monitoring tests necessary for the utilization of the Investigational Medicinal Product and Other Investigational Medicinal Products or for achieving the primary and secondary objectives of the Trial (hereinafter, “Services”).

4.2 The Investigational Medicinal Product shall be dispatched by the Sponsor to the Institution’s Pharmacy, which will manage its registration, appropriate storage, and distribution to the Principal Investigator, as per the Protocol and applicable regulations. The Other Investigational Medicinal Products shall be purchased directly by the Institution’s Pharmacy, which will handle their registration, appropriate storage, and distribution to the Principal Investigator as stipulated by the Protocol and in line with prevailing regulatory standards.

4.3 The Investigational Medicinal Product must be accompanied by an appropriate delivery document addressed to the Pharmacy, specifying the drug type, quantity, batch number, storage requirements, expiration date, and Trial references (protocol code, Principal Investigator, and relevant Trial Center).

4.4 The Institution and the Principal Investigator are required to utilize the Investigational Medicinal Product, the Other Investigational Medicinal Products, and the Materials exclusively within the scope and for the purpose of the Trial. The Institution is prohibited from transferring or assigning to third parties the Investigational Medicinal Product, the Other Investigational Medicinal Products, and/or the Materials/Services provided by the Sponsor under this Agreement.

4.5 Any expired or otherwise unusable Other Investigational Medicinal Products, or those unused upon conclusion of the Trial, shall be disposed of by the Institution at the Sponsor’s expense. The disposal fee set by the Institution’s Pharmacy is €1,500.00 per disposal.

For the disposal of Temferon, the Sponsor shall issue a written disposal request to the Institution, with associated disposal costs also borne by the Sponsor. The Institution agrees to supply the Sponsor with duly certified proof of disposal in conformity with applicable regulations. For the disposal of unused Other Investigational Medicinal Products and related services, the Sponsor will compensate the Institution in accordance with the amount specified in Annex A (paragraph “Fees and Compensation” - part 1) of this Agreement. This amount will be invoiced with standard VAT by the Institution as an “ancillary consideration for the Trial, pertaining to the disposal of expired or unused Other Investigational Medicinal Products.”

Article 5 – Loan for Use

The Parties acknowledge that no assets and/or equipment will be granted to the Institution on loan for use by the Sponsor.

Article 6 – Compensation

6.1 The agreed compensation, previously assessed by the Institution, per eligible, evaluable patient who has completed the experimental treatment in accordance with the Protocol and for whom the relevant CRF/eCRF has been duly completed, inclusive of all expenses incurred by the Institution for the execution of the Trial and all related activities, is detailed in Part 1 of Annex A – Budget “Fees and Compensation.”

6.2 The Sponsor agrees to pay the amounts due under this article based on an adequate, justified accounting statement, agreed upon by the Parties. Payment of the above compensation will be made on a quarterly basis as indicated in the Budget (Annex A, paragraph “Payments and Invoices”), based on the number of patients involved in the respective period, treatments received according to Protocol, and completed and validated CRF/eCRFs, as approved by the Sponsor.

6.3 Plasma concentration monitoring of Busulfan (laboratory test) indicated in Annex A (paragraph “Fees and Compensation,” part 1) and required by the Protocol, as approved by the Ethics Committee, will not incur any costs to the Institution as it will be performed centrally.

6.4 The Institution shall receive no compensation for patients deemed unevaluable due to non-compliance with the Protocol, violations of Good Clinical Practice, or failure to comply with current clinical trial regulations. Additionally, no compensation will be provided for patients included after notification of Trial interruption or completion by the Sponsor, or beyond the maximum number of subjects specified in this Agreement, unless previously agreed upon with the Sponsor.

6.5 The Sponsor will also reimburse the Institution, based on the trial rate in effect at the Institution, for any additional costs arising from medical/diagnostic activities, including possible hospitalizations, not provided for in the Protocol or its subsequent amendments, and not already covered by the above compensations, if these activities become essential for the proper clinical management of the trial participant. Reimbursement will only be made if these activities and their related costs are promptly communicated, justified, and documented in writing to the Sponsor and approved by the Sponsor in writing, while ensuring the codified form of the patient’s personal data.

6.6 If, during the course of the Trial, it becomes necessary to increase financial support for the Institution, the Sponsor may supplement this Agreement with an addendum/amendment to provide for an adequate budget increase.

6.7 In compliance with regulations on mandatory electronic invoicing for the supply of goods and services, including private transactions, the Institution will issue invoices in XML format and send them through the Interchange System (SDI). For this purpose:

6.8 Payments made for services provided by the Institution (i) represent the fair market value of such services, as they align with the applicable fee schedule at the Institution, (ii) have been negotiated on standard commercial terms, and (iii) are not based on the volume or value of prescriptions or any economic activities generated between the Parties. For activities performed or expenses incurred in relation to Patients participating in the Trial, for which the Sponsor is liable, neither the Institution nor the Principal Investigator shall seek other reimbursements or payments from third parties.

6.9 Within the limits and terms set forth in the Protocol and as approved by the Ethics Committee, the Sponsor makes available to Trial participants reimbursement for “out-of-pocket” expenses, provided these are actually incurred, documented, and associated with Trial participation at the Institution, following procedures previously approved by the Ethics Committee. Reimbursement will be physically provided to participants by an external, specialized organization (hereinafter referred to as “Service Provider”), which has been formally commissioned by the Sponsor and designated as the data processor for the patients’ personal data. The Institution will also enter into an agreement with the Service Provider as the data controller for the patients’ personal data. The Service Provider is compensated by the Sponsor but operates independently and may not in any way transfer patients’ personal data to the Sponsor, of which the Sponsor is not the data controller.

Costs related to items not specified in Annex A or not included in the Protocol will not be reimbursed.

The criteria and methods specified in paragraph 3 shall apply, where applicable, to other forms of outsourced services related to the Trial that are regulated by the Protocol and have received favorable evaluation by the Ethics Committee.

Article 7 – Duration, Withdrawal, and Termination

7.1 This Agreement will take effect on the date of its final signature (“Effective Date”) and will remain in force until the actual completion of the Trial at the Institution, as specified in the Protocol, unless modified by mutual agreement between the Parties. Notwithstanding the foregoing, this Agreement will take effect following the issuance of formal authorization by the Competent Authority.

7.2 The Institution reserves the right to withdraw from this Agreement by providing written notice with a 30-day advance notice to the Sponsor via registered mail or PEC in the event of:

- Insolvency of the Sponsor, settlement agreements (even extrajudicial) with the Sponsor’s creditors, or initiation of enforcement proceedings against the Sponsor.

- Transfer of all or part of the Sponsor’s assets to creditors or an agreement with them for a debt moratorium.

The notice will take effect from the time the Sponsor receives it.

7.3 The Sponsor, pursuant to Article 1373, paragraph 2, of the Italian Civil Code, reserves the right to withdraw from this Agreement at any time for just cause by providing written notice via registered mail or PEC with a 30-day notice period. The notice will take effect from the time it is received by the Institution. In the event of Sponsor withdrawal, the obligations undertaken and expenses incurred by the Institution as of the withdrawal notice date will remain unaffected. In particular, the Sponsor shall reimburse the Institution for all documented, irrevocable expenses incurred to ensure the proper and effective execution of the Trial (including, where applicable, expenses incurred by the Institution on behalf of the patient-participants) and compensation accrued to that point. In the case of early termination, the Sponsor retains ownership of all data and results, even partial, obtained by the Institution during the Trial, as well as any subsequent data or results derived from or related to it.

7.4 In the event of an interruption of the Trial, pursuant to applicable regulations, the Sponsor will compensate the Institution for documented expenses and accrued compensation up to that point.

7.5 It is understood that early termination of the Agreement will not entitle either Party to seek indemnification or additional payment beyond what has been agreed.

7.6 The effects of this Agreement will automatically terminate under Article 1454 of the Italian Civil Code if one of the Parties fails to fulfill an obligation within 30 days of receiving a written demand for compliance from the other Party. The applicability of Articles 1218 and following of the Italian Civil Code remains unaffected.

7.7 In the event of termination of this Agreement due to reasons other than the Institution’s breach, the Institution shall be entitled to reimbursement for expenses incurred for the Trial before receiving notice of termination and to compensation for services rendered in accordance with the Protocol and this Agreement, in proportion to the activities performed up to the termination date. The Institution agrees to return any amounts previously paid by the Sponsor for activities not yet performed.

7.8 In all cases of interruption or termination of this Agreement, all precautions will be taken to ensure the utmost protection of patients already involved, in accordance with the Protocol approved by the Ethics Committee, ensuring therapeutic continuity within the limits and methods provided in Article 4.2.

Article 8 - Insurance Coverage

8.1 The Sponsor is required to ensure, in accordance with current legislation, compensation for damages suffered by patients and attributable to their participation in the clinical trial as outlined in the Protocol, commensurate with the nature and scope of the resulting risks.

8.2 Without prejudice to the provisions of Article 76 of the Regulation for low-intervention trials, the insurance coverage provided by the Sponsor covers civil liability for the Sponsor, the Institution hosting the Trial, the Principal Investigator, and other Investigators involved at the Institution’s Trial Center.

8.3 By signing this Agreement, the Sponsor declares that it has taken out appropriate third-party liability insurance (policy no. 390-76845879, with HDI-GLOBAL SE) to cover the risk of possible damages to patients arising from their participation in the Trial, as required by the Ministerial Decree of July 14, 2009. The insurance policy has been deemed legally compliant and adequately protective by the Ethics Committee for the subjects involved in the Trial.

8.4 By signing this Agreement, the Sponsor agrees to bear the consequences of any inadequacies, including unforeseen ones, in the above-mentioned insurance coverage, supplementing it if necessary, in accordance with Article 7.1.

8.5 In particular, should the Sponsor intend to withdraw from the Agreement, it ensures that the insurance company will, in any case, provide coverage for individuals already included in the clinical trial, including the continuation of the Trial, in compliance with Article 2, paragraph 3 of the Ministerial Decree of July 14, 2009.

Article 9 - Final Report, Ownership, and Use of Results

9.1 The Sponsor undertakes to disclose, in accordance with legal requirements and upon completion of the Trial, all study results, even if negative.

9.2 The Sponsor is responsible for preparing the final clinical report and sending a summary of the Trial results to the Principal Investigator and the Ethics Committee within the legally specified timeframe. Regardless of the outcome of a clinical trial, the Sponsor will, within a year of its conclusion, submit a summary of the results to the EU database according to Article 37.4 of Regulation (EU) No. 536/2014.

9.3 All data, results, information, materials, discoveries, and inventions arising from the Trial’s execution, in pursuit of its objectives, are the exclusive property of the Sponsor, except in cases where Investigators, if eligible, have rights to be recognized as authors. If the Sponsor initiates or plans to initiate a patent application process for inventions developed during the Trial, the Institution, and specifically the Principal Investigator, commits to providing the necessary support to the Sponsor, including documentation, at the Sponsor’s expense.

9.4 The Institution may use the Trial’s data and results, over which it is the autonomous data controller by law, solely for its institutional scientific and research purposes, with prior written authorization from the Sponsor. Such use should not, under any circumstances, compromise the confidentiality or patent protection of the Sponsor’s intellectual property rights. The Institution must notify the Sponsor in writing of the purpose of its intended use of data and results.

The Parties mutually acknowledge their ownership of industrial and intellectual property rights related to their pre-existing knowledge (background knowledge).

9.5 The provisions of this article shall remain valid and effective even after the termination or cessation of this Agreement’s effects.

Article 10 - Confidentiality of Technical and Commercial Information and Dissemination of Results

10.1 By signing this Agreement, each Party undertakes to maintain the confidentiality, for the entire duration of this Agreement (extendable through negotiation until the information becomes public domain), of all technical and/or commercial information provided by the other Party and/or developed during the course of the Trial and in pursuit of its objectives (including, but not limited to, the Investigator Brochure, information, data, and materials concerning the investigational medicinal product). Such information qualifies as “Trade Secrets” under Articles 98 and 99 of the Italian Industrial Property Code (Legislative Decree No. 30/2005, as amended by Legislative Decree No. 63/2018 implementing EU Directive 2016/943), adopting all appropriate contractual, technological, or physical measures to protect such information, including from its employees, collaborators, subcontractors, grantors, or successors.

Each Party further declares and guarantees that:

(i) its Trade Secrets have been lawfully acquired, used, and disclosed, with no known legal actions, disputes, or claims for damages or indemnification – even out of court – by third parties asserting ownership of such secrets.

(ii) it will indemnify and hold the other Party harmless from any legal actions, disputes, claims for damages, or indemnification claims, even if pursued out of court, by third parties asserting ownership of such Trade Secrets.

10.2 The Parties are required to ensure the proper and accurate dissemination and publication of the Trial results, as well as their appropriate communication to participating patients and patient representatives. The Sponsor is required, under applicable law, to promptly disclose the results, even if negative, upon completion of the Trial, once data from all participating Centers is available, and in any case, within the deadlines established by applicable EU provisions.

10.3 The Principal Investigator has the right, with prior written authorization from the Sponsor, to disseminate and publish, without limitation, the results of the Trial obtained at the Institution, in compliance with current provisions regarding the confidentiality of sensitive data, data protection, and intellectual property rights, as well as the terms and conditions outlined in this Agreement. To ensure the accuracy of data collection and the veracity of data and results processing from the Trial obtained at the Institution, at least 60 days before any presentation or publication, the Principal Investigator must submit the draft document to the Sponsor. Should issues arise concerning the scientific integrity of the document and/or regulatory, patent, or intellectual property matters, the Parties and the Principal Investigator shall review the document within the following 60 days. The Principal Investigator will consider the Sponsor’s suggestions for presentation or publication, but only if necessary to protect the confidentiality of information, personal data, and intellectual property, provided they do not compromise data reliability or patient rights, safety, and well-being.

10.4 The Sponsor acknowledges it has no right to request the removal of information contained in the document, except when such requests and changes are necessary to protect data confidentiality, data protection, and intellectual property.

10.5 For the purpose of filing a patent application, the Sponsor may request the Principal Investigator to defer the publication or presentation of the document for an additional 90 days, if deemed necessary.

Article 11 - Personal Data Protection

11.1 The Parties, in carrying out the activities provided under this Agreement, agree to process any personal data they may become aware of during the clinical trial in compliance with the objectives stated in the previous articles and in accordance with Regulation (EU) 2016/679 of the European Parliament and Council of April 27, 2016 (“GDPR”), as well as related national legislative and administrative provisions in force, including any subsequent amendments and/or integrations (hereinafter collectively referred to as “Data Protection Laws”). Any institutional regulations of the Parties must be communicated to the Sponsor in advance and in detail.

11.2 The terms used in this article, in the Agreement, in the privacy notice and consent documentation, and in any other document used for the purposes of the clinical trial, must be understood and used in the manner defined in Annex B.

11.3 The Institution and the Sponsor qualify as independent data controllers under Article 4, paragraph 17 of the GDPR. Each Party shall, at its own cost, handle the appointment of Data Processors and assign functions and duties to designated persons operating under its authority in compliance with the GDPR and current legislation.

11.4 For the purposes of the Trial, personal data will be processed for the following categories of data subjects: participants in the trial and individuals working for the Parties. Such individuals are informed of the data processing through appropriate notification. For the purposes of the Trial, the following types of personal data will be processed: personal data as defined in Article 4, paragraph 1 of the GDPR; data falling under “special categories” of personal data, specifically health and sexual life data, and genetic data as per Article 9 of the GDPR. Such data will be processed in compliance with the principles of lawfulness, fairness, transparency, adequacy, relevance, and necessity as provided in Article 5, paragraph 1 of the GDPR.

11.5 The Sponsor may transfer data to affiliates of the Sponsor’s group and third parties operating on its behalf, including entities outside the European Union, only in compliance with Articles 44 and following of the GDPR. In such cases, the Sponsor shall ensure an adequate level of data protection. If the Sponsor is located in a country outside the EU, and the European Commission has determined that such country does not provide an adequate level of protection per Articles 44 and 45 of the GDPR, the Sponsor and the Institution must complete and sign the Standard Contractual Clauses approved by the European Commission, provided in the absence of other legal provisions (this document is not attached to this Agreement).

11.6 The Parties guarantee that authorized personnel processing personal data for the Trial shall comply with principles protecting the right to data protection and confidentiality and that individuals accessing personal data are obliged to process it in accordance with the instructions provided by the data controller, consistent with this article.

11.7 The Principal Investigator is identified by the Institution as the individual authorized to process data under Article 29 of the GDPR and designated under Article 2-quaterdecies of the Italian Personal Data Protection Code (Legislative Decree 196/2003, as amended by Legislative Decree 101/2018).

11.8 The Principal Investigator must inform each patient, in a clear and comprehensive manner, before the start of the Trial (including preparatory and screening phases), about the nature, purpose, results, consequences, risks, and methods of personal data processing. Specifically, the patient must be informed that national and international authorities and the Ethics Committee may access the Trial-related documentation as well as the original medical records as part of monitoring, verification, and research control activities. These authorities, as well as Monitors and Auditors, may view such documents within the scope of their respective competencies.

11.9 The Principal Investigator must obtain from the duly informed patient the consent document not only for participating in the Trial but also for data processing. The Institution is responsible for storing this document.

11.10 Should either Party become aware of a personal data breach, it shall notify the other within 48 hours of discovering the breach. Each Party retains the authority to assess the existence of conditions for and fulfill its obligations under Articles 33 and 34 of the GDPR.

Article 12 - Amendments

12.1 This Agreement and its annexes/addendums, together with the Protocol as an integral part, constitute the entire agreement between the Parties.

12.2 This Agreement may be amended or supplemented only with the written consent of both Parties. Any modifications will be documented in an addendum to this Agreement and will take effect from the date of signing unless otherwise agreed upon by the Parties.

Article 13 - Anti-Corruption and Crime Prevention Regulations

13.1 The Institution and the Sponsor agree to comply with anti-corruption regulations applicable in Italy.

13.2 The Sponsor declares that it has adopted monitoring and control measures to comply with and implement the provisions of Legislative Decree 231 of June 8, 2001, as well as, where applicable and not in conflict with Italian law, the principles of the United States Foreign Corrupt Practices Act and their subsequent amendments. The Institution and its clinical and administrative structures agree to cooperate in good faith, within the limits of Italian law, with the Sponsor’s personnel and management to facilitate the full and correct implementation of these obligations and the Sponsor’s operational procedures for these purposes.

13.3 The Parties also acknowledge that both the Institution and the Sponsor have adopted an organizational, management, and control model in compliance with the principles outlined in the Decree (each a “Compliance Model”), a Code of Ethics (each a “Code of Ethics”), and an Anti-Corruption Policy, available on the Institution’s website at https://www.hsr.it/strutture/ospedale-san-raffaele/trasparenza and on the Sponsor’s website at https://ir.genenta.com/corporate-governance, to prevent liability for the commission of offenses specified by the Decree and the related sanctions.

13.4 The Institution and the Sponsor mutually agree to inform each other immediately of any potential violation of this article of which they become aware and to make all relevant data and documentation available for verification.

13.5 The Parties may disclose the terms of this Agreement or any amendment for any legitimate purpose, within the limits of data protection regulations.

13.6 A violation of the provisions of this article constitutes a material breach of this Agreement pursuant to Article 1456 of the Italian Civil Code, thereby undermining the trust relationship between the Parties.

Article 14 - Transfer of Rights, Assignment of the Agreement

14.1 This Agreement is fiduciary in nature; therefore, the Parties may not assign or transfer it, in whole or in part, to third parties without the prior written consent of the other Party. In any case, the assignee must explicitly accept all terms and conditions of this Agreement. Any transfer of rights not meeting these conditions will be considered null and void.

14.2 In the event of a name change by the Institution that does not alter its legal identity, an amendment to this Agreement will not be required. The Institution is still obliged to promptly notify the Sponsor of such a name change.

Article 15 - Signature and Tax Obligations

15.1 This Agreement is signed digitally in accordance with applicable regulations. Taxes and fees related to the execution of this Agreement, including the stamp duty on the electronic original under Article 2 of Annex A, Part I of DPR 642/1972, and the registration fee, must be paid in compliance with applicable laws. The Parties agree that the stamp duty shall be the exclusive responsibility of the Sponsor, while registration fees are borne by the Party requesting registration.

Article 16 - Governing Law and Jurisdiction

16.1 The law governing this Agreement is that of the Italian Republic.

16.2 For any disputes arising from the interpretation, application, and execution of this Agreement, while the Parties agree to attempt an out-of-court resolution, the exclusive jurisdiction shall be the Court of Milan.

Article 17 - Omitted

Article 18 - Acknowledgment and Acceptance of the Entire Agreement

The Parties acknowledge for mutual clarity that this Agreement, prepared based on the minimum content identified under Article 2, paragraph 6 of Law 3 of January 11, 2018, is considered known and accepted in its entirety by both Parties. Therefore, the provisions of Articles 1341 and 1342 of the Italian Civil Code do not apply.