展品10.1
合作協議
之間
強度治療
1 Enterprise Drive, Suite 430, Shelton Ct 06484; 美國 ("Intensity").
（以下簡稱“合作伙伴”)
和框架。有關詳細信息，請參閱UBS集團報酬報告
瑞士臨床抗癌醫藥研究團體SAKK
Effingerstrasse 33, CH-Bern, 3008, 瑞士
（以下簡稱”SAKK”)
合作伙伴和 SaKk 以下也稱爲”派對「或聯合」各方”
關於
在早期三陰性乳腺癌（TNBC）患者中進行「腫瘤內注射INT230-6，隨後進行新輔助Pembrolizumab和化療」的臨床試驗SAKk 66/22。這是一項開放標籤的隨機兩隊相2期臨床試驗。INVINCIBLE-4-SAKK
鑑於
SAKk是一家從事臨床抗癌醫藥研究的非營利組織。通過自身開發的試驗，SAKk研究治療方法及其在常見癌症類型中的優化。SAKk對新藥物的開發感興趣，因此也進行一期和二期臨床試驗。
Intensity Therapeutics是一家生物技術公司，處於臨床後期階段，其使命是通過發現、開發和商業化首創的抗癌藥物，減輕腫瘤的副作用，同時訓練患者的免疫系統在全身抵抗癌症，幫助患者活得更長、品質更高的生活。
SAKK進行SAkk 66/22試驗，「腫瘤內INT230-6後繼新輔助Pembrolizumab和化療治療早期三陰性乳腺癌（TNBC）患者。一項開放標籤的隨機兩隊伍第2期臨床試驗。INVINCIBLE-4-SAKK」，以下簡稱「試驗」，如試驗方案及其修訂所述，（以下簡稱「協議」）
合作伙伴希望在方案中指定的試驗方面提供財務支持，並提供INT230-6（以下簡稱爲「試驗藥物」）供試驗使用，並免費交付給參與醫院（以下簡稱「試驗點」）。
主要研究員（CI）是馬庫斯·約格（Markus Jörger），輔助研究員是烏爾西娜·祖瑞（Ursina Zürrer）和安德烈亞斯·穆勒（Andreas Müller），（每個都是「研究員」，共同是「研究員」）；
SAKk和調查員將共同在瑞士的一些地點進行審訊，也許在後期還會在法國進行。瑞士的領先醫院是聖加侖州立醫院（以下簡稱「KSSG」）。
因此，各方特此訂立本協議（以下簡稱「協議」），就試驗相關的互惠權利和義務進行規定。
特此約定：
1. 審判的進行
1.1. SAKk應作爲本協議中獨立由研究人員開發的並作爲本協議中獨立由研究人員開發的試驗的「法律贊助商」（以下簡稱「贊助商」）承擔試驗，該試驗詳見附錄1：協議，並被引用。
1.2. SAKk應獨自負責遵守與試驗進行相關的臨床和/或監管程序。
SAKk將確保所有參與試驗進行的調查員和人員都被告知、接受培訓並遵守本協議的所有適用條款。
1.4. 試驗將由SAKK進行：
根據《議定書》及其任何修改。
1.4.2. 在由SAKK選擇的參與試驗的網站。
1.4.3.根據協議中指定的條件選擇合適的患者。
1.4.4. 所有板塊必須獲取所有必要的法律、監管或其他批准，包括但不限於在研究機構的任何機構審查委員會/獨立倫理委員會以及嚴格按照任何此類批准的條款。
根據赫爾辛基宣言以及ICH主題E6:「良好臨床實踐原則」的規定，根據2011年9月30日的瑞士人類研究法（HRA）以及2013年9月20日的瑞士有關人類研究臨床試驗的法令（ClinO），以及所有適用於瑞士和歐盟其他參與國家的相關法規（如果有）。
1.4.6. SAKk有權對協議進行更改，並在實施任何此類更改之前書面通知合作伙伴，但不得
2
未經合作伙伴事先書面批准，不得對協議進行實質性變更（如下文所定義）。本節中的「實質性變更」指的是以下情況之一：（a）影響臨床試驗藥物的管理（例如劑量、療程、應用等）；（b）可能影響臨床試驗藥物的標籤；或者（c）將改變臨床試驗的時間表。
2.責任
2.1. SAKk應：
2.1.1.根據本協議第一條的規定，將完全負責試點工作；
2.1.2. 使用自己的標準操作程序進行審判準備和進行;
2.1.3.建立和維護試驗主文件（TMF），其中包含對試驗管理至關重要的文件和書面通信。根據ICH GCP的要求，所有文件必須按照要求清楚可辨認的方式存放在TMF中。TMF必須在試驗期間保存在安全地點，並在試驗完成或提前終止後至少25年進行歸檔；TMF的最終電子副本應提供給合作伙伴。
2.1.4.負責試驗數據管理，包括試驗數據的收集和分析，將其納入SAKk數據庫，並根據ICH GCP的要求進行保留；
2.1.5. 協助合作伙伴調查任何不良反應，並提供合作伙伴合理要求的任何後續信息，以便合作伙伴進行調查；
2.1.6. 提供合作伙伴僞名化嚴重不良事件安全報告（另見附錄4）；
2.1.7. 提供合作伙伴根據第7.5節和附錄4中概述的報告
2.1.8. 每年1月初（第2個日曆周）如適用，向合作伙伴提供年度安全報告（ASR）或發展數據更新報告（DSURs）。nd 日曆
2.1.9.同意報告任何不良反應給合作伙伴並不免除SAKk根據要求向倫理委員會和相關機構報告的責任;
2.1.10. 應對並遵守協議和所有適用的法律、法規和指南中的安全報告義務。任何嚴重不良事件（SAE）必須以編碼方式（匿名化）立即報告給合作伙伴，並最遲在24小時（工作日內）通過電子郵件發送至lbender@intensitytherapeutics.com、dfrano@intensitytherapeutics.com和kguedes@intensitytherapeutics.com。如果無法掃描和發送電子郵件報告，則應通過傳真發送至（001）475-286-1893；
3
2.1.11. 提供合作伙伴初步分析的書面報告草稿（以下簡稱「初級臨床研究報告」） 14天內提供審閱，並在術後6個月內提交最終版本，其中包括所有患者手術後病理完全緩解和所有安全數據，一旦可用，採用ICH E3格式。合作伙伴同意遵守第9節和第6節（知識產權）中概述的出版規定。
2.1.12. provide Partner with a draft copy of the written report in ICH E3 format of the trial results (hereinafter “Final Clinical Study Report”) for review within 14 days (see 2.2.9 below) and the final version of the Final Clinical Study Report within twelve (12) months after last patient, last visit (hereinafter “LPLV” or termination of this Agreement, whichever occurs first. If the Trial is terminated early, the Clinical Study Report should include, at a minimum, the results of the Trial up to the date of termination;
2.1.13. require clinical investigators and participating Sites to handle any information provided by Partner in accordance with terms equivalent to the confidentiality provisions of Article 7 of this Agreement.
2.2. Partner shall, upon signing this Agreement:
2.2.1. provide full assistance and information to SAKK in order for SAKK to undertake the Trial and discharge its obligations and responsibilities set out in Article 1 and 2 hereto;
2.2.2. have no other obligations or responsibilities with respect to the conduct of the Trial than those stated in this Agreement;
2.2.3. review potential publications as set out in Article 7;
2.2.4. provide SAKK access to the accurate investigational drug brochures which describes the known properties of the Trial Drug;
2.2.5. provide SAKK access Product Quality Dossier (PQD) or Investigator Medicinal Product Dossier (IMPD);
2.2.6. provide SAKK all documents of Trial Drug required for the submission to the regulatory authority;
2.2.7. provide SAKK stability data of the Trial Drug;
2.2.8. provide SAKK with all new information it has knowledge of that may modify or supplement known data regarding the Trial Drug, in particular all new adverse reactions and data relating to the Product’s tolerance that is likely to reveal a danger to patients;
2.2.9. provide SAKK their review of the Primary Clinical Report and Final Clinical Study Report within 14 days of its receipt.
4
3. SUPPLY OF DRUGS AND INFORMATION RELATING TO DRUGS
3.1. Partner shall provide SAKK the Trial Drug free of charge, in sufficient amount and with sufficient shelf life to be used in the Trial. In case of delays or unavailability of sufficient Trial Drug, SAKK has a right for financial compensation for additional costs related to delays in the conduct of the Trial.
3.2. In case of early termination of the Trial, Partner shall provide Trial Drug free of charge for continuing treatment of patients already enrolled in the Trial until surgery according to the Protocol.
3.3 Details of supply, including the mode of supply, quantity, and timelines of delivery and destination of shipment of the Trial Drug shall be supplied to Partner by SAKK with sufficient advance notice.
3.4 Trial Drug shall be produced, provided free of charge directly to the Sites (including shipment, customs, import declaration etc.) and be packaged and labeled free of charge by Partner in compliance with GMP-, GDP-, GCP-guidelines, applicable local laws and regulations. Partner will ensure safe and appropriate transportation to the Sites according to all precautions and specifications.
3.5. Upon signing this Agreement and throughout the conduct of the Trial, Partner shall provide SAKK with all new toxicological analyses (e.g. via the Investigator Brochure) carried out on Trial Drug and more generally, shall notify SAKK at once of all information that may modify or supplement known data regarding Trial Drug, in particular all new adverse reactions and data relating to the Trial Drug’s tolerance that is likely to reveal a danger to patients.
3.6. Partner hereby guarantees SAKK that Trial Drug is of satisfactory quality and sufficient shelf-life and that it conforms to the information provided pursuant to Article 3 of this Agreement. Each batch of these Products shall be delivered along with complete information regarding manufacture and expiration dates (e.g., QP release documentation), enabling the subsequent regulatory batch release by SAKK.
3.7 SAKK shall instruct the Sites to store the Trial Drug supplied by Partner in a locked, secured area in accordance with storage requirements provided by Partner.
3.8 SAKK shall forward to Partner without undue delay complaints of Trial Drug with regard to supplied IMP and work together with Partner regarding the investigation/assessment of the product quality complaint (PQC). The final decision of the PQC is the responsibility of SAKK as Sponsor. If SAKK receives product complaints, SAKK shall instruct the sites to keep samples for further investigation and send them to Partner, on request. Partner will cover the costs for such a shipment.
3.9 SAKK represents that Trial Drug supplied by Partner hereunder shall be used solely for the Trial only and in accordance with (a) the Protocol as it may be amended from time to time pursuant to Section 1.4.6, and (b) valid regulatory filings with the
5
responsible regulatory authorities in Switzerland where the Trial is conducted. Any other use of Trial Drug constitutes a material breach of this Agreement.
3.10 SAKK ensures that all partially used or expired supplies, vials and boxes of Trial Drug at the Sites shall be destroyed at the Sites, and the destruction certified. Unused vials may be only destroyed at the end of the Trial upon request of Partner. For the event of return, Partner will cover the shipment costs and any reasonable additional pass-through costs incurred by the SAKK; such costs will be reimbursed by Partner upon receipt of valid invoices.
3.11 Partner shall ensure that its Depot in the EU shall provide SAKK directly via the enrolled Sites with supply of the IMP (INT230-6).
4. FINANCIAL SUPPORT
4.1. Partner shall provide financial support to the Trial in the amount of CHF 2’807’309 (excl. VAT; VAT, which is not due as Partner is located in US) as stated in Appendix 2 Budget. The Budget is calculated based on the *** of SAKK [***].
4.1.1. The expenses associated with the initiating and conducting the trial in France, encompassing [***] sites and [***] patients, are detailed in the budget provided in Appendix 2. The costs amount to a total of [***] and cover expenses related to the collaborative efforts of the *** responsible for conducting the trial, as well as the oversight costs incurred by SAKK.
4.1.2. The “Translational Research” part of the Protocol is included in the Budget in Appendix 2. The costs concerning the part of translational research amount to [***]. SAKK will take measures in procuring third-party funds to cover the costs of the Translational Research project within the Protocol. However, uncovered costs of the Translational Research project will be covered by Partner.
4.2. If Partner wishes to get the complete set of data collected in the Trial, Partner has to cover SAKK for its actual effective Trial costs incurred at the SAKK Competence Center (CC), the participating Sites (including in kind contributions) and any further involved party as well as for the costs for providing Partner such electronic copy of and use of the data, with an additional amount of approximately [***] for the sites, The costs at SAKK will be calculated retrospectively on the hourly rate of [***] for non-academic trials which results to approximately [***] as per Budget in Appendix 2 including a Final Data Transfer after data base lock of [***]). Trial data will only be provided by mutual consent and in a pseudonymized form.
4.3. Partner shall finance the Trial in accordance with the Schedule of Payments (Appendix 3). At the end of the Trial, a reconciliation of the costs will be made. SAKK shall then refund to Partner any unspent financial support at the end of the Trial or on termination of this Agreement.
4.4. In case of inevitable costs (external and time spent by SAKK) not covered in the Budget (Appendix 2), Partner shall be notified promptly, at the latest at the reconciliation of costs at the end of the Trial.
6
4.5. Any additional work or data requested by Partner such as (but not limited to), additional amendments, further reports and/or analyses are not covered by the planned budget in Appendix 2. Upon Partner’s request SAKK shall decide within a reasonable time if this can be provided. Such work can be performed after written confirmation of both Parties and shall be invoiced as unbudgeted activities at an hourly rate of [***]. Such additional work must be requested at least 45 days before it is needed or as appropriate based on the lead time needed for specific additional work.
4.6. Transferring bank charges shall be at the expense of Partner.
4.7. Partner shall make payments according to the Schedule of Payments detailed in Appendix 3 with the reference “SAKK 66/22” within 30 (thirty) days upon receipt of an invoice.
5. LIABILITY AND INDEMNITY
5.1 SAKK recognizes that, in all clinical trials, the Sponsor shall be required to provide the undertaking relating to compensation for claims by participants in the Trial in terms compatible with local law and practice and SAKK assumes all obligations and responsibilities deriving thereof.
It is the clear agreement of the Parties that Partner is not the Sponsor and is not providing SAKK with a clinical trial insurance coverage.
SAKK agrees to provide adequate clinical trial insurance as required by applicable regulatory requirements to provide compensation to participants in the Trial suffering injury or death or loss caused by the administration of the Trial Drug or any clinical intervention or procedure carried out in accordance with the Protocol and all legal requirements.
5.1. SAKK agrees to indemnify and hold harmless Partner and its affiliates, employees, directors, sub-contractors, and agents from and against any loss, damage, reasonable costs and expense (including legal fees) incurred in connection with any claim, proceeding, or investigation arising out of, or in connection with tasks and duties of SAKK in this Trial.
5.2. Partner is only responsible for the pharmaceutical quality of Trial Drug. Partner confirms it, or its affiliate, maintains a product liability insurance covering its Trial Drug. Partner shall be liable for claim made against SAKK that arise from the manufacture, packaging, labelling or distribution of Trial Drug unless the claim results from:
5.2.1. failure to use Trial Drug in accordance with the Protocol and Investigator’s Brochure;
5.2.2. negligence, willful misconduct, or omission on the part of SAKK or a Site;
5.2.3. a breach of any applicable law or regulation by SAKK or a Site.
7
Partner liability is conditioned on SAKK having (1) obtained approval of the Trial from appropriate ethics committee; and (2) obtained written informed consent from the patient participating in the Trial in compliance with applicable laws, regulations and ICH GCP guidelines;.
5.3. SAKK does not warrant that the Trial shall lead to any particular result, nor is the success of the Trial guaranteed. SAKK accepts no responsibility for any use that Partner may make of the trial data nor for advice or information given in connection with them. Partner shall indemnify SAKK against any damages or negative consequences arising out of or in connection with any use that Partner may make of the trial data or the results of the Trial.
5.4. Subject to applicable laws, the liability of either Party to the other under or in connection with this Agreement or arising in any other way out of the subject matter of this Agreement shall not extend to the loss of business or profit or to any incidental or consequential losses or damages.
6. INTELLECTUAL PROPERTY RIGHTS
6.1. With the exception of personal and confidential medical records which are the property of the patients, all data and results generated under the Trial (hereinafter referred to as “Data”) shall be the property of SAKK, and Partner therefore agrees that subject to clause 6.2 of this Agreement, SAKK shall be the owner of such Data.
However, SAKK agrees to provide Partner with a copy of the Primary Clinical Study Report. Partner shall agree to keep the Data confidential until the Data of the primary analysis are published or presented at medical conferences (see as well section 9)
SAKK agrees to provide Partner with a copy of the Final Clinical Study Report, and Partner shall have non-exclusive, transferable, indefinite, fully paid and royalty free right to use such report for any purpose.
6.2. Any invention or discovery which results from the conduct of the Trial and which relates to Trial Drug or its use as a treatment or any other Partner product (“Invention”) shall be the exclusive property of Partner. SAKK, the Sites and each Investigator hereby irrevocably assign to Partner (or its nominee) all right, title and interest in all such Inventions, including all intellectual property rights therein, and further agree to assist Partner at Partners cost and to do all such acts and things as Partner may advise are necessary or desirable in connection with any such assignment. Nothing herein, however, shall prevent SAKK, the Sites or the Investigators from using any information generated hereunder for ordinary research and educational purposes.
7. CONFIDENTIALITY AND DATA ACCESS
7.1. The terms and conditions of this Agreement shall be confidential, however the collaboration with SAKK in this Trial shall be mentioned in publications and presentations of Partner. Neither Party shall, without the prior written permission of the disclosing Party, disclose the same to any third party except to the extent this
8
may be required by applicable law or as necessary for the conduct of the Trial. Affiliates of both Parties shall not be considered third Parties for purposes of this Agreement.
“Affiliates” shall mean:
a) an organization, which directly or indirectly controls a Party to this Agreement;
b) an organization, which is directly or indirectly controlled by a Party to this Agreement;
c) an organization, which is controlled, directly or indirectly, by the ultimate parent company of a Party;
d) For SAKK the term “Affiliates” shall include the members of the Scientific Committee and the International advisors of SAKK as well as the members of the SAKK development therapeutics as well as the breast cancer project groups and section pathology.
Control as per a) to c) above is defined as owning more than fifty percent of the voting stock of a company or having otherwise the power to govern the financial and the operating policies or to appoint the management of an organization.
7.2. The obligations of confidentiality set out in Article 7.1 shall not apply to Confidential Information which is (i) published or generally available to the public through no fault of the receiving Party, (ii) in the possession of the receiving Party prior to the date of this Agreement and is not subject to the duty of confidentiality; (iii) independently developed by the receiving Party and is not subject to a duty of confidentiality, (iv) obtained by the receiving Party from a third party and not subject to a duty of confidentiality.
7.3. Neither Party shall, without the prior written permission of the other Parties, disclose any information about the Trial to the public except to the extent this may be required by applicable law or as necessary for the conduct of the Trial.
7.4. Without prejudice to the right to receive pseudonymized serious adverse event data provided in Article 2.1.6 above, the Parties hereto agree that if pseudonymized safety data is required prior to the publication of the Data, for instance to provide information requested by a regulatory body or to assess/question safety, consent to such requested disclosure shall not be unreasonably withheld if such request is in line with applicable law and regulations. All serious adverse event data or additional safety data may only be used for safety purposes.
7.5. Reports of Trial information will be exchanged between Partner and SAKK as outlined in Appendix 4:
7.5.1. The Data will be transferred to Partner without any data analysis by the SAKK statistics team in pseudonymized or aggregated form. The Data is experimental in nature and is provided as a service to the Partner without warranty of completeness,
9
accuracy, merchantability or fitness for a particular purpose or any other warranty, expressed or implied. The Data is made available for evaluative use only. SAKK does not make any representation or give any warranty that the use of the Data will not infringe any patent or other third-party rights.
7.5.2. Partner is aware that the Data will be cleaned by SAKK according to SAKK data cleaning standard procedures (as per SOP and Data Management plan) for primary and final analysis.
7.5.3. The Data for the requested reports (as outlined in Appendix 4) will be additionally cleaned by the responsible SAKK staff before reports are sent out, depending on what the Data is used for (if applicable). SAKK is responsible for performing data cleaning, monitoring, and review in accordance with their SOPs and processes. Nonetheless, Data at the time point of sharing may be inconsistent and may not yet be fully monitored or medically reviewed. Data may therefore change during Trial conduct and be updated.
7.5.4. Partner is aware that the shared data may be used only for Partner’s internal discussions, including Partner’s Board. Any publication of data (i.e. any public disclosures to third parties) has to be done according to SAKK Publication Guidelines.
7.5.5. Partner must always remark in any document, who performed the interpretation of data.
7.5.6. SAKK will not answer questions regarding these shared data (especially efficacy data) as the Trial is ongoing and SAKK does not want to interfere or create any bias due to the continuous assessment/evaluation of e.g. such efficacy data. SAKK will perform the data analysis as per defined time points in the Protocol according to SAKK SOPs.
7.5.7. Partner and SAKK agree that data integrity should be maintained throughout the Trial until final database transfer.
7.6. At the end of the Trial, SAKK will upon request and payment according to Art.4.3 provide Partner with the Data collected in the Trial in pseudonymized form (such as SAS or CSV-files). However, Partner agrees to keep Data confidential until the data of the primary analysis are published as outlined in section 9 of this agreement. SAKK hereby grants Partner an unrestricted, perpetual, worldwide, royalty-free license to make use of and confidentially disclose the received Data for research purposes, subject to applicable law and Patient Informed Consent. Under the foregoing license Partner will be entitled to transfer or sublicense the raw data to third parties only with SAKKs prior written consent. Such consent shall not be unreasonably withheld. SAKK is responsible for informing the patients as part of the informed consent, that patients pseudonymized data may be purchased by the Partner and received according to the applicable law. Partner is only allowed to use the Data for research purposes and according to the patient informed consent. Partner is not allowed to use the Data for any other purposes and is solely responsible for the received pseudonymized Data. Partner may submit the
10
anonymized Data to regulatory authorities as necessary and medical journals or at medical conferences.
8. DATA PROTECTION
8.1. Each Party must process personal data in compliance with applicable data protection laws, especially the Swiss Federal Act on Data Protection (Data Protection Act, FADP), regulations (and where applicable, ethical guidelines) and research governance. Each Party represents and warrants that it will store, use, return or dispose of the personal data or otherwise process the personal data in accordance with the highest standards of skill and care. The Parties are aware that the data subject retains her/his right to decide on the use of its data. The Parties act as independent controllers.
8.2. The Parties shall process personal data in a manner that ensures appropriate confidentiality, integrity, availability and resilience of the systems with regard to processing of the personal data. Partner must in particular ensure appropriate protection against unauthorized or unlawful data access or processing in any form (e.g., reading, copying, altering) and against accidental loss, destruction or damage, using appropriate technical or organizational measures. The effectiveness of such measures shall be regularly assessed, and corrective measures shall be immediately implemented in case of suspected data security breach. Partner shall have in place procedures so that any person it authorizes to have access to the personal data will respect and maintain the confidentiality and security of the personal data.
8.3. Partner confirms that for him the all Data provided by SAKK is pseudonymized. Partner is obliged to check the correct pseudonymization of the Data provided by SAKK immediately. If the Data were not fully pseudonymized, Partner would immediately inform SAKK and destroy/delete all received Data without processing it for any other purposes.
8.4. Partner shall not carry out any procedures with the received Data (linking, comparison, processing) with the intention to identify the data subject, unless requested by a data subject. Partner is responsible for maintaining the pseudonymization of the Data provided by SAKK after the transfer of these Data.
8.5. Both Parties shall secure the exercise of the data subject’s rights, including access rights, the right to rectification and erasure, and the right to object according to Swiss Federal Act on Data Protection (FADP).
9. PUBLICATION
9.1. Publication of the Data shall be made in accordance with the Protocol and the SAKK publication guideline (https://www.sakk.ch/de/fuer-forschende/fuer-forschende). SAKK shall have the right of first publication in a peer-reviewed journal. SAKK or Partner may wish to publish or present scientific papers dealing with the Trial in accordance with accepted scientific practice. SAKK and Partner agree that prior to submission of publications or any other dissemination of Data, SAKK or Partner shall
11
invite the other Party the abstract and final poster or slides to comment on the content of the material to be published or presented according to the following procedure:
9.1.1. At least thirty (30) days prior to submission for publication of the first manuscript of the Trial (“First Publication”) and of any subsequent manuscript, and at least fourteen (14) days prior to submission of any abstract, SAKK shall provide Partner with details of the proposed written publication. Upon written request from Partner, SAKK agrees not to submit such publication for an additional 60 (sixty) days in order to allow for actions to be taken which might be necessary to preserve rights for patent protection.
9.1.2. SAKK shall endeavor to respond to any request Partner may make to change the publication, within the respective period mentioned in 9.1.1 above, insofar as such request is compatible with principles of complete information, exactitude, and prudence applicable to any scientific publication.
9.1.3. SAKK shall remove from the publication any confidential information disclosed by Partner to SAKK.
9.1.4. SAKK shall acknowledge Partner support with clear indication of the type of support e.g. grant, drug supply, safety reporting, scientific advice, etc. in the publication.
9.2. After the first publication of the Data by SAKK, Partner shall be free to publish any Trial related Data under the conditions that Partner shall adhere to the principles that information shall be complete, exact and shall not be misleading.
9.3. SAKK will post the Trial on the clinicaltrials.gov database, which is publicly available. SAKK is responsible for updating posted trial data on a regular basis to ensure complete and up-to-date information.
10. QUALITY ASSURANCE AUDIT
10.1. SAKK warrants that it has a Quality Assurance in place through which SAKK will assure that its work is performed in compliance with all applicable laws, rules, regulations, ICH guidelines as well as applicable standard operating procedures (SOP). The Quality Assurance unit may perform audits to ensure the adequacy of SAKK’s and Sites’ performance and implement quality control procedures. Audit findings concerning the Trial Drug and relevant for the Partner may be shared with the Partner and processed in collaboration with the Partner.
10.2. Partner may at its own expense, upon reasonable notice to SAKK and on mutually agreed dates during normal business hours, audit the facilities and procedures of SAKK directly related to the performance of the work performed under this Agreement during the term of this Agreement. Partner’s right to conduct audits shall be strictly limited to safety and registration purposes. Partner designated staff and quality assurance auditors shall be granted reasonable access to all essential documents. The above auditors shall not be entitled to make copies of the essential documents and/or to take them away, nor shall they be entitled to make copies of the
12
Data from the Trial database. SAKK Quality Assurance unit shall have sole responsibility for auditing the Site(s). Source data verification can exclusively be granted to SAKK monitors and SAKK auditors, to Ethics Committees and to Regulators.
10.3. Should any local and/or national government authority conduct or give notice of intent to conduct an inspection or take any other regulatory action with respect to the Trial, SAKK shall promptly give Partner notice thereof and supply all information pertinent thereto.
11. TERM AND TERMINATION
11.1. This Agreement shall continue until publication of the Final Clinical Study Report by SAKK, which shall be sent to Partner even in case of premature termination of the Trial.
11.2. Any Party may terminate this Agreement forthwith by notice in writing to the other if the other Party commits a material breach of this Agreement, which, in the case of a breach capable of remedy, shall not have been remedied within sixty (60) days of the receipt to the Party in default of a written notice identifying the breach and requiring its remedy. Such notice to terminate this Agreement shall not be issued until the matter in question has been raised in writing and discussed during the said 60-day period.
11.3. The Parties shall be entitled to terminate the Agreement with thirty (30) days’ notice, in whole or in part, in the following circumstances:
11.3.1. forthwith following know-how generated in the Trial that demonstrates the results generated may be of negligible scientific value;
11.3.2. forthwith on the grounds that the safety of the patients in the Trial warrants termination of the whole or part of the Trial;
11.3.3. forthwith on ethical grounds;
11.3.4. if any relevant authorities or Research Ethics Committee revokes any required approval for the Trial.
11.4. In case the Parties have different opinions about the safety of the patients and thus are not able to reach a mutual agreement each Party may terminate the Agreement if reasonable medical judgment makes it prudent to terminate the Trial.
11.5. In case of significant delay in recruitment (delay of >12 months), if after discussion of the Parties no remedy can be found, Partner has the right to terminate the Agreement by notice in writing with payments of the costs for processing the so far recruited patients in accordance with article 11.7.
11.6. SAKK shall be entitled to terminate the Trial if it cannot ensure the financing of the Trial to its end, without possibility for Partner to claim any damages or
13
compensation. It is the clear understanding between the Parties that such termination is just allowed in case of unexpected costs which arise after initiation of the Trial and which would make the financing of the Trial reasonably impossible.
11.7. In the event of premature termination of this Agreement, either partially or totally, on grounds provided for in Articles 11.2 - 11.5 of this Agreement, payments made to SAKK in accordance with Article 4 of this Agreement shall remain property of SAKK.
11.8. In the event premature termination of the Agreement Partner shall pay all costs incurred and falling due for payment up to the date of termination and all reasonable and necessary expenditure falling due for payment after the date of termination which arises from commitments reasonably and necessarily incurred by SAKK the performance of the Trial prior to the date of termination.
11.9. In any event, the Parties shall ensure that the patients taking part in the Trial shall be provided with sufficient medication until the end of the treatment, which shall not be terminated except if desired by the patient respectively for ethical or safety reasons.
11.10. Articles 4 - 9, 11, 15 and 16 of this Agreement shall remain in force after termination of this Agreement.
12. FORCE MAJEURE
If performance of this Agreement by one of the Parties to this Agreement is prevented, hindered or delayed by reason of any cause beyond this Party’s control, the other Party shall release the affected Party from its relevant contractual obligations for the duration of the event of Force Majeure and to the extent the obligations hereunder are affected by such event. The affected Party shall notify the other Party without delay, and within fifteen (15) days thereafter, provide a detailed description of the events, explaining the reason for its inability to perform or its delay in performance and specifying the period for which it is estimated that such inability or delay shall continue.
13. ENTIRE AGREEMENT
This Agreement constitutes the full understanding of the Parties and a complete and exclusive statement of the terms of their Agreement. No terms, conditions, understanding or Agreement purporting to modify or vary the terms of this Agreement shall be binding unless hereafter made in writing and signed by both Parties. The Parties agree that in order to fulfill the written form requirement of this Agreement, as alternative to handwritten signatures on a hardcopy (made in two original copies), also electronic signatures (“eSignature[s]) of duly authorized representatives of the Parties may be used (such as DocuSign).
14. AMENDMENT
This Agreement cannot be amended or modified except by the express written consent of both Parties.
14
15. GENERAL PROVISION
15.1. Partner and SAKK have no obligation to renew this Agreement. Partner is not under any obligation to enter into another type of Agreement with SAKK or any member of SAKK at this time or in the future.
15.2. Both Partner and SAKK warrant and represent to the other that both have the full right and authority to enter into this Agreement and are unaware of any impediment that would inhibit their ability to perform their obligations hereunder.
15.3. Neither Party shall use the name, crest or logo of the other in any press release or product advertising or for any other commercial purpose without the prior written consent of the other.
15.4. Nothing in this Agreement shall create, imply or evidence any partnership between the Parties or the relationship between them of principal and agent.
15.5. SAKK can work with other partners in addition to Partner as far as these collaborations do not result in a change of the agreed Trial design, substantial changes of the Protocol or additional sub-studies, and SAKK agrees to inform Partner about the other collaboration partners involved. The secrecy and intellectual property and patent provisions shall not be affected by the collaboration of SAKK with additional parties. Partner can work with other parties in addition to SAKK as far even if these collaborations are similar to the agreed Trial design in other countries if it does not concern the Trial. The secrecy and intellectual property and patent provisions of this Agreement shall not be affected by the collaboration of Partner with additional parties.
15.6. SAKK and Partner agree to comply with all applicable privacy laws and regulations. SAKK agrees that personal data related to the Investigators may be used by Partner to administer this Agreement and the Trial. Such information may include certain personal data relating to persons who participate or perform work connected to the Trial, such as name, specialization, and contact information. Partner may transfer such personal data to other companies within Partner’s group, to Partner’s research or business partners, or to relevant governmental authorities. Such recipients may be located outside the country in which the Trial is being performed.
15.7. Legal notices under this Agreement should be addressed to:
For SAKK:
Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK)
SAKK 66/22
Effingerstrasse 33
CH-3008 Bern
Switzerland
For Partner:
Intensity Therapeutics, Inc.
1 Enterprise Driver, Suite 430
15
Shelton, CT USA 06484
Attention: CEO
lbender@intensitytherapeutics.com
16. APPLICABLE LAW AND JURISDICTION
16.1. This Agreement will be governed by and construed for all purposes in accordance with the substantive laws of Switzerland without giving effect to its choice of law principles.
16.2. The Parties shall attempt to settle all disputes arising out of or in connection with the present Agreement in an amicable way with discussion, by online mediation or arbitration prior to litigation. In the event that such attempts should fail, the exclusive jurisdiction for the Parties lies in the Courts of Bern.
IN WITNESS WHEREOF, the Parties by their duly authorized representatives have caused this Agreement to be executed as of the date first above written.
Appendices:
Appendix 1: Protocol (Version 1.0, with 15.03.2024)
Appendix 2: Budget
Appendix 3: Schedule of payment
Appendix 4: List of reports from SAKK CC
16
SAKK
NAME: Dr. Hans Rudolf Keller
TITLE: CEO
DATE: 5/6/2024 SIGNATURE: /s/ Hans Rudolf Keller
NAME: Prof. Dr. Miklos Pless
TITLE: President
DATE: 5/6/2024 SIGNATURE: /s/ Miklos Pless
For and on behalf of Partner
NAME: Lewis H. Bender
TITLE: CEO
DATE: 5/6/2024 SIGNATURE: /s/ Lewis H. Bender
17