***由於不重要且是註冊商視爲私人和機密的類型，因此本展品中已排除某些確定身份信息***
科技許可協議
此科技許可協議（以下簡稱“協議”）由iRhythm Technologies，Inc.和BioIntelliSense，Inc.於2024年8月30日簽署生效日期。”），雙方是iRhythm Technologies, Inc.（註冊地點：美國德拉華州699 8th Street, Suite 600, San Francisco, CA 94103）和BioIntelliSense, Inc.（註冊地點：美國德拉華州17301 W. Colfax Avenue, Golden, CO 80401）iRTC”）和BioIntelliSense, Inc.（註冊地點：美國德拉華州17301 W. Colfax Avenue, Golden, CO 80401）BioIS”). iRTC and BioIS may each be referred to herein as a “方方當事人”.
鑑於，iRTC致力於開發和推廣可穿戴生物傳感器產品、基於雲的數據分析以及提供移動式心臟監護服務，重新定義心律失常檢測方式；
鑑於BioIS專注於開發和商業化一系列可穿戴生物傳感器、臨床和患者界面、以及數據分析技術；
鑑於，在兩次先前投資的基礎上，並與本協議的簽署同時進行，iRTC將通過多張可轉債投資額外四千萬美元（4000萬美元）（此類債券稱爲“其他Notes”，總投資額稱爲“額外的注資注資”），其中一張原始本金爲一千萬美元（1000萬美元）的額外注資可用於支付[***]費用（稱爲“[***]注資”) ，其中一張原始本金爲一千萬美元（1000萬美元）的額外注資可用於支付[***]費用（稱爲“[***]注資”) under this Agreement;
鑑此，與本協議的執行和發行附加債券作爲額外債券投資同時進行，各方正在進入[***];
鑑於，iRTC希望獲得BioIS特定知識產權、科技和產品的許可權，並且BioIS願意根據本協議的條款向iRTC授予這些權利，用於在特定領域研究、開發和商業化潛在的下一代產品和服務；
鑑於，各方希望根據本協議的條款和條件，誠實進行談判（i）[***]；和（ii）[***]。
因此，考慮到本協議中所包含的相互約定和承諾，iRTC和BioIS達成如下協議：
1.定義.
1.1“會計準則「」，就一方或其關聯方或轉讓方而言，適用於其財務報告的是其不時遵循的或一貫應用的《通用會計原則》或《國際財務報告準則》。
1.2“ACM” 表示步入式心臟監測。
1.3“ACm計費代碼” 意味着以下任何一種：現有的ACm計費代碼，未來的ACm計費代碼或外文等效的ACm計費代碼。
1.4“ACm臨床試驗使用領域“指的是進行臨床試驗，其中ACm設備的主要指示是評估其他設備或藥物對健康相關的生物醫藥或行爲結果的影響。
1.5“ACm競爭侵權”在第8.5(c)節（許可專利的申請和維持）中已定義。
1.6[***].
1.7“ACm使用領域「」表示根據任何ACm計費代碼或捆綁支付代碼提供的服務符合計費或報銷資格，但是（若不捆綁）本應符合任何ACm計費代碼的報銷資格。爲明確起見，除非以下任何項目否則符合任何ACm計費代碼的資格，否則ACm使用領域不包括：[***]。
1.8“ACM特定專利權”具有第8.5(d)節所規定的含義（許可專利的審查和維持）。
1.9“收購實體「」在第1.20節（控制）中有所定義。
1.10“附屬公司「當事方」指直接或間接控制或被其控制或與其共同受控的公司或其他實體；「控制」指：(a)直接或間接擁有所述實體超過五十個百分點(50%)的資本股權；(b)控制所述實體超過五十個百分點(50%)的表決權；或(c)直接或間接擁有指導或導致指導所述實體的管理或政策的權力（無論是通過證券所有權或其他所有權利、合同或其他方式）。儘管前述，對於BioIS，任何創投或投資基金的投資組合公司，即或與BioIS的任何股東有所關聯的投資組合公司，這些投資組合公司可能被視爲受控、受其控制或與BioIS共同受控，應在本協議中排除在外。
1.11“反腐敗法律「 」指的是美國《反海外腐敗行爲法》，美國《反回扣法》以及其他類似性質的適用法律，旨在防止包括欺詐、腐敗、走私、洗錢和恐怖主義在內的行爲。
1.12“適用法律"對於一方而言，"法律"指的是所有可能在任期內生效並適用於適用方的業務及其根據本協議履行的任何國家、州、地方、國家和超國家法律、法規、規章和規定，包括監管機構、主要國家證券交易所或主要證券上市組織要求的任何規則、法規、指南或其他要求，包括反腐敗法。"
1.13“BioIS受益方”在第9.2節（iRTC賠償）中定義
1.14“[***]「」在第4.1節（[***]採購）中定義。
1.15“日曆季度「」 意味着每個截至3月31日、6月30日、9月30日和12月31日的三個月期間；前提是在任期的第一個季度將從
有效日期至當期日曆季度結束，本期的最後一個日曆季度將從該日曆季度的第一天延長至本協議終止或到期的有效日期。
1.16“控制權變更「當事方」一詞意味着，就當事方而言，直接或間接控制該當事方的公司或其他實體的變更；而「控制」指：（a）直接或間接擁有該實體超過百分之五十（50%）的股本；（b）控制該實體超過百分之五十（50%）的表決權；或（c）直接或間接擁有指導或引導該實體管理或政策的權力（無論是通過證券或其他所有權利益的擁有、通過合同或其他方式）。
1.17“權利「」在第9.1節（BioIS的賠償）中有所指。
1.18“CoC知識產權「」在第1.20節（控制）中有所定義。
1.19“保密信息「」在第6.1節（保密信息）中的含義。
1.20“控制”, “控制Corp受...控制關於BioIS和適用的知識產權或監管批准，""意味着BioIS有能力向IRTC授予任何權利（包括訪問或參考）、許可或轉許可（如適用）這些知識產權或監管批准，而不違反BioIS在此之前與任何第三方達成協議的條款，第一次要求BioIS向IRTC授予此類權利、許可或轉許可的時間，前提是，如果由於IRTC或其關聯公司或被轉許可方根據本協議使用或實施此類知識產權或監管批准而須支付適用第三方的任何款項時，IRTC同意書面承擔此支付責任。儘管前述，如果BioIS發生控制權變更（在此類控制權變更之前，被收購方及其關聯公司，統稱爲"收購實體"，單個單位爲"收購實體"）收購實體採購方收購實體若出售），則BioIS不會被視爲「控制」任何材料、專有技術、法規批准、專利或知識產權，該等材料、專有技術、法規批准、專利權和其他知識產權（統稱爲“CoC知識產權）除非：（a）在變更控制的生效日期之前，此類被收購方或其任何關聯公司也已經控制了該CoC知識產權；或者（b）此類CoC知識產權被納入任何許可技術中，無論是在變更控制的生效日期之前還是之後。
1.21“封面,” “覆蓋「」或「」蓋子就產品或其他有關事項而言，「專利」是指，如果在未獲得專利授予的許可或專利所有權的情況下，製造、使用、銷售、供應或進口該產品或其他有關事項將侵犯該專利；或者指涉及未決專利申請的權利要求，如果該專利在未修改這些權利要求的情況下授予，則製造、使用、銷售、供應或進口該產品或其他有關事項將侵犯這些權利要求。
1.22“當前程序代碼術語「」或「」卡姆登物業信託”意味着美國醫學協會開發的醫療編碼集，使醫生和其他醫療提供者能夠描述
並向政府和私人支付者、研究人員和其他感興趣的各方報告他們進行的醫療、手術和診斷程序及服務。
1.23“披露方「」在第6.1節（保密信息）中的含義。
1.24“9.4節貿易爭端展開的訴訟「」在第12.2節（爭議解決）中所述。
1.25“所有板塊在市場開放時進行「」指任何受委任的第三方，在一個國家分發、推廣和轉售授權產品，無論該第三方是否被授予進一步包裝或獲得有關授權產品的監管批准的附屬權利，只要該第三方不承擔向適用的銷售實體支付依據該實體出售、處置或轉讓有關授權產品所開具或收到金額計算的任何版稅或其他費用的義務。
1.26“ECG「心電圖」表示心電圖。
1.27[***].
1.28 “現有 ACM計費代碼（們）”表示CPt [***]；或任何現有的捆綁支付代碼，如果不是捆綁，則可在CPt [***]下獲得報銷。
1.29“現有的授權專利”表示有效日期之前存在的所有包含在授權知識產權中的授權專利。現有的授權專利包括在 附錄 A.
1.30“現有許可技術”表示BioIS或其附屬公司在生效日期之前生成、創造、開發、製造或以其他方式取得或擁有的所有技術，這些技術體現了或以其他方式必要以實現許可申請。現有許可技術包括技術轉移計劃中列出的技術 附件b。
1.31“第一筆商業銷售「」表示[***]。
1.32“FDA「美國食品藥品監督管理局」，或任何其繼任機構。
1.33“[***]費用”在第5.2節中有所述（[***]費用）。
1.34“[***] 費用” 在第5.3節中具有所述的含義（[***] 費用）。
1.35“FFDCA指的是美國聯邦食品、藥物和化妝品法案，21 U.S.C. 301等及其下發布或發佈的規則、法規、指導方針和要求。”代表美國聯邦食品、藥物和化妝品法案，21 U.S.C. 301等，以及在該法案之下頒佈或發佈的規則、法規、指導和要求。
1.36“外國等價ACm計費代碼” 表示在美國以外的任何司法管轄區需要在提供該服務時使用有效的ACm設備的服務的編碼或分類，且實質上對應於美國現有ACm計費代碼或將來的ACm計費代碼描述的服務。
1.37“出資日期「」在第1.27條（[***]）中有所述。
1.38「未來的ACm計費代碼」 指任何未來和/或修訂的CPt代碼，用於利用有效的ACm設備提供現有ACm計費代碼下描述的服務。爲了澄清，如果設立了新的計費代碼：
(a)使用有效的ACm設備提供產品或服務時，包括[***]，這些服務和用於提供或促進提供此類服務的任何設備將被視爲符合ACm使用範圍。
(b)使用有效的ACm設備提供服務時，包括[***]，此類服務和用於提供或促進提供此類服務的任何設備將被視爲屬於ACm使用範圍內；
(c)使用有效ACm設備[***]提供服務時，這些服務和用於提供或促進提供此類服務的任何設備將被視爲ACm使用範圍內；以及
(d)但對於任何現有的ACm計費代碼相關的更改或擴展，但總體上符合任何現有的ACm計費代碼，這類服務以及用於提供或促進提供這類服務的任何設備將被視爲ACm使用範圍內。
1.39“政府機構「政府當局」指任何：(a)聯邦、州、省、地方、市、縣或其他政府; (b)任何性質的政府或準政府機構(包括任何機構、局、團體、分支、局、委員會、理事會、部門、實體、政府部門、工具機構、辦公室、官員、官員、組織、代表、分部、單位、任何法院或其他法庭);(c)跨國政府組織或機構;或(d)行使或有權行使任何性質的行政、立法、司法、行政、監管、警察、軍事或徵稅權力的實體或機構(包括任何仲裁員)。政府當局包括所有監管當局。
1.40“HST“意味着在家睡眠測試。
1.41“HSt計費代碼「」表示任何HSt計費或報銷代碼，包括CPt代碼 [***]，醫療常用程序編碼系統代碼 [***]，任何未來和/或修訂後的計費或報銷代碼，或任何其他相應或等效的代碼或其他用於在該地區計費或報銷HSt產品或服務的系統。
1.42“HSt使用領域「」表示[***]。
1.43“受保護方「」在第9.3節（賠償程序）中的定義。
1.44“賠償方”在第9.3節（補償程序）中的含義如下。
1.45“醫院內患者監測「」表示在醫院、養老院、長期護理、老年公寓等機構提供的患者監測服務，但這些服務不符合任何ACm計費代碼。
1.46“指公司的專利、專利申請、商標、商標申請、服務標誌、商號、商業祕密、發明、版權、許可證和其他知識產權和類似權利。「」 表示世界任何國家或地區認可的一切知識產權和專有權利，包括（i）與作品相關的權利
包括版權、與計算機程序相關的權利、掩膜版-半導體作品和道德權利；（ii）技術專有信息、商業祕密、硬件、原理圖、設計文檔、設計歷史文件或專有信息相關的權利；（iii）專利、實用新型、設計權以及其他工業設計權利；以及(iv）有關或與前述各項權利有關的註冊、續展、延伸、組合、分割和重新簽發以及權利的申請和對前述（i）至（iii）項權利的優先權主張權。儘管前述，根據本協議的目的，知識產權不包括商標、商號、標誌和服務標記。
1.47“”應指公司之所有發明、作品、開發、進步和/或發明創造。「發明」指根據本協議項下開展的活動構思或實施的任何發明、流程、方法、製造物、發現或發現，無論是否可被專利化。
1.48“iRTC 受益方「」在第9.1節（BioIS的賠償）中有所指。
1.49“許可的應用程序”的意思是：(a) 脈搏血氧測量和/或監測，基於加速度計的心率和呼吸速率測量和/或監測，以及無創趨勢血壓測量(爲明確起見，不包括絕對數值測量)和/或監測（“受限的應用程序”）；和 (b) 基於加速度計的活動測量(包括步數、步態、步伐、對稱性、身體位置)和/或監測，藍牙(設備端)無線傳輸工具，皮膚溫度測量和/或監測，生物電話，以及iOS和Android移動應用程序（“非受限制的應用程序”).
1.50“經許可的數據” 表示任何當前或未來從或關於BioIS產品和服務生成的數據，並含有或包含許可技術（包括 [***]）被用於驗證、開發和獲得有關任何BioIS產品和服務的監管批准，僅在這些數據涉及許可技術時。
1.51“許可改進”指任何改進、修改、增強、衍生物或修訂現有許可技術，(b)是實施或以其他方式使許可應用程序成功的技術，這些技術根據(a)和(b)由BioIS或其關聯公司在[***]期間生成、創建、開發或以其他方式製作。爲避免疑義，在[***]期間由BioIS或其關聯公司開發的任何[***]技術均構成許可的改進。明確的是，BioIS沒有義務向iRTC分享未來對現有許可技術的改進、修改、增強、衍生物或修訂。
1.52“許可的知識產權”表示有效日期或在此後任何時間內由BioIS或其關聯公司控制的任何知識產權，其範圍涵蓋由iRTC、其關聯公司和/或再許可人制作的許可技術，或者（b）實體內或實施該實施方面實施的任何實現，或者對實現許可技術，或者這種實施有幫助的技術。許可的知識產權包括許可專利。
1.53“許可專利” 意味着包含在許可知識產權中的任何專利。許可專利包括現有的許可專利以及由BioIS及其關聯公司控制的所有覆蓋許可改進的專利。
1.54“許可產品「產品」指由iRTC、其關聯公司或被許可方開發、製造或商業化的任何產品或服務，該產品受許可知識產權的保護，包含或體現了任何許可知識產權。
1.55“許可技術「」指現有的許可技術和許可改進。
1.56“損失”在第9節（賠償; 保險）中有所述。
1.57“淨銷售額對於任何期間，"人形機器人-軸承產品版稅"中的"”"表示[***]：
(a)[***];
(b)[***];
(c)[***];
(d)[***];
(e)[***];
(f)[***];
(g)[***]; 和
(h)任何其他類似的、與出售實體的正常慣例和適用會計準則一致的扣除項。
Any of the deductions listed above that involves a payment by the Selling Entity will be [***].
1.58“Open-Source Components” has the meaning set forth in Section 3.3(a) (Dependencies).
1.59“Open-Source License” has the meaning set forth in Section 3.3 (Dependencies).
1.60“Patent” means: (a) any patent or patent application in any country or supranational jurisdiction worldwide, including any provisional patent application; (b) any application claiming priority to any such patent or patent application or any substitution, divisional, continuation, continuation-in-part, reissue, renewal, registration, confirmation or the like of any such patent or patent application; or (c) any extension or restoration by any existing or future extension or restoration mechanism, including revalidation, reissue, re-examination or extension, including any supplementary protection certificate of any of the foregoing.
1.61“Patent Authority” means the Governmental Authority responsible for the granting of Patents in any national, regional, supranational, or international jurisdiction.
1.62“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Governmental Authority or any other entity not specifically listed herein.
1.63“Post-Acute Discharge Setting” means the [***] following a patient’s discharge from an acute care facility.
1.64 “Prescription” means a valid order from a licensed physician or other licensed healthcare practitioner having a valid NPI (National Provider Identifier) or international equivalent. “Prescribe” or “Prescribed” have a correlative meaning.
1.65“Prosecution and Maintenance”, “Prosecution, Maintenance”, “Prosecute and Maintain” or “Prosecute, Maintain” means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as re-examinations, reissues and appeals with respect to such Patent, together with the initiation or defense of interferences, oppositions, inter partes review, derivations, re-examinations, post-grant proceedings and other similar proceedings (or other defense proceedings with respect to such Patent, but excluding the defense of challenges to such Patent as a counterclaim in an infringement proceeding) with respect to the particular Patent, and any appeals therefrom, and actions to obtain patent term extensions and supplementary protection certificates with respect to such Patent and the like. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” will not include any other enforcement actions taken with respect to a Patent.
1.66“[***]” has the meaning set forth in Section 4.1 ([***]).
1.67“Receiving Party” has the meaning set forth in Section 6.1 (Confidential Information).
1.68“Regulatory Approval” means the authorization from a Regulatory Authority that is necessary prior to commercial sale and distribution of a medical device or other regulated product with respect to specific indications for use (e.g., 510(k) clearance, de novo authorization, or Premarket Approval (PMA)).
1.69“Regulatory Authority” means, with respect to any jurisdiction, (a) any supranational, national, state, or local regulatory agency, administration, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval and (b) any court, agency, department, bureau, commission, counsel, authority, or other instrumentality of any national, state, province, county, city or other political subdivision. For clarity, the FDA is a Regulatory Authority.
1.70“Regulatory Documentation” means all (a) applications, registrations, licenses, authorizations and approvals (including Regulatory Approvals); and (b) correspondence, reports and other submissions submitted to or received from any Regulatory Authority and all supporting documents with respect thereto, including all adverse event files and complaint files.
1.71“Remote Physiologic Monitoring” or “RPM” means remote physiologic monitoring services eligible for billing or reimbursement under CPT codes [***] in effect as of the Effective Date (or replacement codes therefor).
1.72“Remote Therapeutic Monitoring” or “RTM” means remote physiologic monitoring services eligible for billing or reimbursement under CPT codes [***] in effect as of the Effective Date (or replacement codes therefor).
1.73“Representatives” means, with respect to a Party, such Party’s Affiliates and such Party’s and its Affiliates’ respective directors, officers, employees, contractors and agents.
1.74“Restricted Applications” has the meaning set forth in Section 1.49 (Licensed Applications).
1.75“Royalty-Bearing HST Product” means any product or service that (a) [***] and (b) [***].
1.76“Royalty Report” has the meaning set forth in Section 5.4(b) (Royalty Reporting).
1.77“Royalty Term” has the meaning set forth in Section 5.4(a) (Royalty Payments).
1.78[***].
1.79“Rules” has the meaning set forth in Section 12.2(b) (Arbitration).
1.80“Securities Regulator” has the meaning set forth in Section 6.5 (Securities Filings; Disclosure under Applicable Law).
1.81“Selling Entity” has the meaning set forth in Section 1.57 (Net Sales).
1.82“Senior Officer” means, with respect to BioIS, Chief Executive Officer or his/her designee, and with respect to iRTC, Chief Executive Officer or his/her designee.
1.83“Soliciting Party” has the meaning set forth in Section 7.4 (Non-Solicitation).
1.84“Source Code” means the human readable source code of the software to which it relates, in the programming language in which such software was written, together with all related flow charts and technical documentation, including a description of the procedure for generating object code, all of a level sufficient to enable a programmer reasonably fluent in such programming language to understand, operate, support, maintain, and develop modifications, upgrades, updates, enhancements, improvements, and new versions of, and to develop computer programs compatible with, such software.
1.85“Sublicensee” means, with respect to iRTC, a Third Party to whom iRTC has granted a sublicense in accordance with Section 2.2 (Sublicensing) under the licenses in Section 2.1 (Licenses to iRTC) to develop, manufacture and/or commercialize Licensed Products, but not, for the avoidance of doubt, any Third Party who acts as a service provider (e.g., contract research organizations, contract manufacturers, academic institutions, clinical trial service providers which perform directly or through multiple tiers services for iRTC), or any Distributor of iRTC or its Affiliate or such Sublicensee.
1.86[***].
1.87“Technology” or “Technologies” means all tangible materials, software (including Source Code), firmware, hardware, know-how, trade secrets, Confidential Information, processes, methods, techniques, specifications, design and manufacturing documentation and any invention, process, method, article of manufacture, discovery, or finding, whether or not patentable.
1.88“Term” has the meaning set forth in Section 11.1 (Term).
1.89“Territory” means worldwide, subject to Section 2.5 (BioIS Products in ACM Field of Use).
1.90“Third Party” means any Person other than the Parties and their respective Affiliates.
1.91“Third Party Materials” has the meaning set forth in Section 3.3(b) (Dependencies).
1.92“Unrestricted Applications” has the meaning set forth in Section 1.49 (Licensed Applications).
1.93“Upfront Fee” has the meaning set forth in Section 5.1 (Upfront Fee).
1.94“Valid ACM Device” means a medical device subject to (a) FDA clearance (or approval by an equivalent regulatory body in a jurisdiction outside the United States) and (b) Prescription, which device (i) is wearable by the patient (as differentiated from implantable or handheld); (ii) has ECG capabilities, and (iii) is used for the primary purpose of screening for, diagnosing, or monitoring of any International Statistical Classification of Diseases and Related Health Problems (ICD) condition that is eligible for billing or reimbursement under any ACM Billing Code.
1.95“Valid Claim” means a claim contained in (a) an issued and unexpired patent, which claim has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is not appealable or has not been appealed within the time allowed for appeal, and has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise, or (b) a patent application that has not been irretrievably cancelled, withdrawn or abandoned and that has been pending for less than seven (7) years from the filing date from which such claim takes priority. If a claim of a patent application that ceased to be a Valid Claim under clause (b) of the preceding sentence because of the passage of time later issues as a part of a patent within clause (a) of the preceding sentence, then it shall again be considered a Valid Claim effective as of the issuance of such patent.
2.LICENSES.
2.1Licenses to iRTC.
(a)Exclusive ACM Field of Use License. Upon payment of the Upfront Fee, BioIS, on its own behalf and on behalf of its Affiliates, hereby grants to iRTC a limited, perpetual, non-terminable, irrevocable, fully paid-up, royalty-free, transferrable (to the extent permitted under Section 12.3 (Assignment)) and sublicensable (through multiple tiers in accordance with Section 2.2 (Sublicensing)) license under all of the Licensed IP Rights to research, develop, make, have made, use, import, distribute, publicly display, copy, make derivative works of, offer for sale, sell, commercialize and otherwise exploit Valid ACM Devices in the ACM Field of Use in the Territory. The foregoing license grant will be exclusive (even with respect to BioIS and its Affiliates) for twenty (20) years after the Effective Date, and thereafter the foregoing license grant will become non-exclusive. For clarity, BioIS retains the right under the Licensed IP Rights to research, develop, make, have made, use, import, distribute, publicly display, copy, make derivative works of, offer for sale, sell, commercialize and otherwise exploit Valid ACM Devices which have application outside of the ACM Field of Use, provided that such Valid ACM Devices are in no event exploited in the ACM Field of Use.
(b)Non-Exclusive HST Field of Use License. Upon payment of the Upfront Fee, BioIS, on its own behalf and on behalf of its Affiliates, hereby grants to iRTC a limited, perpetual, non-terminable, irrevocable, non-exclusive, royalty-bearing, transferrable (to the extent permitted under Section 12.3 (Assignment)) and sublicensable (through multiple tiers in accordance with Section 2.2 (Sublicensing)) license under all of the Licensed IP Rights to research, develop, make, have made, use, import, distribute, copy, publicly display, make derivative works of, offer for sale, sell, commercialize and otherwise exploit products and services in the HST Field of Use in the Territory. Following the expiration of the Royalty Term for a Royalty-Bearing HST Product in a country, the foregoing license
grant to iRTC under Section 2.1(b) shall become fully paid-up and royalty free, for such Royalty-Bearing HST Product in such country.
(c)Non-Exclusive ACM Clinical Trials Field of Use License. Upon payment of the Upfront Fee, BioIS, on its own behalf and on behalf of its Affiliates, hereby grants to iRTC a limited, perpetual, non-terminable, irrevocable, fully paid-up, non-exclusive, royalty-free, transferrable (to the extent permitted under Section 12.3 (Assignment)) and sublicensable (through multiple tiers in accordance with Section 2.2 (Sublicensing)) license under all of the Licensed IP Rights to research, develop, make, have made, use, import, distribute, copy, publicly display, make derivative works of, offer for sale, sell, commercialize and otherwise exploit products and services in the ACM Clinical Trials Field of Use in the Territory.
(d)Non-Exclusive Unrestricted Applications License. Upon payment of the Upfront Fee, BioIS, on its own behalf and on behalf of its Affiliates, hereby grants to iRTC a limited, perpetual, non-terminable, irrevocable, fully paid-up, non-exclusive, royalty-free, transferrable (to the extent permitted under Section 12.3 (Assignment)) and sublicensable (through multiple tiers in accordance with Section 2.2 (Sublicensing)) license under all of the Licensed IP Rights to research, develop, make, have made, use, import, distribute, copy, publicly display, make derivative works of, offer for sale, sell, commercialize and otherwise exploit products and services related to the Unrestricted Applications in any field of use in the Territory.
2.2Sublicensing.
(a)Right to Sublicense. iRTC will have the right, without BioIS’s consent, to grant a sublicense under the licenses in Section 2.1 (Licenses to iRTC) to (a) any of its Affiliates, (b) any patients, prescribers, and other end-users as necessary to use iRTC’s current or future products and/or services, and (c) any Third Party (including but not limited to manufacturers, subcontractors, service providers, development partners, or commercial partners) in connection with the development, manufacturing or commercialization of any current or future iRTC product or service, whether directly or through multiple tiers.
(b)Sublicensing Requirement. The following terms will apply to each sublicense granted by iRTC to any Affiliate or Third Party (other than patients, prescribers and end users): (a) any such permitted sublicense will be consistent with and subject to the terms and conditions of this Agreement and (b) iRTC will continue to be responsible for the performance of its obligations under this Agreement.
2.3BioIS Retained Rights.
(a)[***]. For clarity, BioIS shall not grant to any Third Party any rights to research, develop, make, have made, use, import, distribute, copy, publicly display, make derivative works of, offer for sale, sell, commercialize and otherwise exploit Valid ACM Devices and services in the ACM Field of Use with respect to any Licensed Technologies (including any BioIS products and services that exist as of the Effective Date).
(b)[***].
(i)[***], and BioIS shall (1) contractually require such recipients to comply with this sub-clause 2.3(b)(i), and (2) use diligent efforts to enforce such contractual requirements;
(ii)[***];
(iii)[***], and BioIS shall (1) contractually require such recipients to comply with this sub-clause 2.3(b)(iii)(x) and (2) use diligent efforts to enforce such contractual requirements; or
(iv)[***], and BioIS shall (1) contractually require such recipients to comply with this sub-clause 2.3(b)(iv) and (2) use diligent efforts to enforce such contractual requirements.
Notwithstanding anything to the contrary in this Agreement, neither BioIS and its Affiliates [***], and BioIS shall (1) contractually require such recipients to comply with the foregoing covenant and (2) use diligent efforts to enforce such contractual requirements.
[***].
2.4Embedded Licensed Technologies. The Parties acknowledge that to the extent any Licensed Technology related to the Restricted Applications, whether software or hardware, is embedded in a Licensed Product, if such embedded Technology is deactivated, disabled or removed during the patient wear period, then none of the field of use restrictions set forth in Sections 2.1(a) (Exclusive ACM Field of Use License), 2.1(b) (Non-Exclusive HST Field of Use License), and 2.1(c) (Non-Exclusive ACM Clinical Trials Field of Use License) will apply to the exercise of the rights granted hereunder.
2.5BioIS Products in ACM Field of Use. iRTC may, in its sole discretion, by notice in writing to BioIS in response to BioIS’s reasonable written request, permit BioIS to directly commercialize BioIS products (as identified in iRTC’s notice) in one or more specific country(is) in the Territory in the ACM Field of Use, on a case-by-case basis. For purposes of the foregoing, iRTC may consider any or none of the following factors:
(a)whether iRTC is not commercializing and does not intend to commercialize a product or service in the country in the ACM Field of Use;
(b)whether iRTC is not distributing and does not intend to distribute BioIS’s products or services in the country in the ACM Field of Use;
(c)whether BioIS has contracted with iRTC to be its exclusive provider of ECG analysis and/or IDTF equivalent services in said country; and
(d)whether iRTC retains all other rights in the country pursuant to the licenses granted herein.
2.6No Implied Licenses. Except as expressly set forth in this Agreement, neither Party shall be deemed by estoppel, implication or otherwise to have granted the other Party any license or other right to any Intellectual Property Rights of such Party. For clarity, none of the licenses granted to iRTC in Section 2.1 shall be construed to restrict BioIS in any respect as to research, development, marketing, sales or other activities outside the ACM Field of Use.
3.TECHNOLOGY TRANSFER; REGULATORY MATTERS.
3.1Alliance Managers. Promptly following the Effective Date, each Party shall appoint a representative of such Party as the primary contact for all technical, business and day-to-day matters related to this Agreement (the “Alliance Managers”). The Alliance Managers shall facilitate open and
transparent communication and collaboration between the Parties and shall seek to facilitate resolution of potential and pending issues and potential disputes. Either Party may replace its Alliance Manager at any time upon prior written notification (including by email) to the other Party.
3.2Technology Transfer.
(a)Subject to Sections 3.2(b), 3.2(d), and 3.3, promptly (but in no event later than thirty (30) days) after the Effective Date, BioIS shall make available and securely transfer to iRTC all the Existing Licensed Technologies and all Licensed Data except those related to the Restricted Applications. Such transfer will be in the form and format, and by such means, as may be reasonably requested by iRTC and in accordance with the plan set forth in Exhibit B (Technology Transfer Plan) (“Tech Transfer Plan”).
(i)[***].
(b)[***].
(c)[***].
(d)[***].
(e)All Source Code transferred from BioIS to iRTC will be [***].
3.3Dependencies. Prior to or concurrently with BioIS’s transfer to iRTC of any Licensed Technologies, (i) [***]; and (ii) [***]. Any use of such Open-Source Components by iRTC will be governed by, and subject to, the terms and conditions of the applicable Open-Source Licenses. In this Section 3.3:
(a)“Open-Source Components” means [***]; and
(b)“Third Party Materials” means [***].
3.4Regulatory.
(a)Regulatory Matters - General. Each Party will be responsible for obtaining and maintaining all Regulatory Approvals for its products, including (i) overseeing, monitoring, and coordinating all interactions with Regulatory Authorities; (ii) preparing, filing and maintaining all Regulatory Documentation; and (iii) maintaining all regulatory records as required by Applicable Law; in each case, with respect to such products. BioIS will provide to iRTC such cooperation as may be reasonably requested by iRTC to obtain and maintain Regulatory Approvals for the Licensed Products in the Territory.
(b)[***].
4.[***]; [***]; ADDITIONAL SERVICES.
4.1[***].
(a)Commencing on the Effective Date and for [***] days thereafter, the Parties shall [***] in accordance with the terms and conditions attached as Exhibit C ([***] Agreement Terms and
Conditions). Notwithstanding the foregoing, iRTC may elect, in its sole discretion, to [***]. BioIS will reasonably cooperate with iRTC to [***].
(b)With respect to the [***], in the event iRTC implements the [***] on an iRTC product, such iRTC product will only be subject to the field of use and other restrictions contained herein in the event the [***] is operational, meaning that such [***] is collecting and/or transmitting [***] data.
4.2[***].
4.3[***].
4.4[***].
5.FEES & PAYMENT TERMS.
5.1Upfront Fee. In consideration of the licenses granted by BioIS to iRTC under Section 2.1 (Licenses to iRTC) and subject to the terms and conditions of this Agreement, upon iRTC’s Acceptance of the initial transfer of the Existing Licensed Technologies and Licensed Data pursuant to Section 3.2(a) (Technology Transfer), iRTC will pay to BioIS a one-time payment of Fifteen Million US Dollars (US $15,000,000) (the “Upfront Fee”) in immediately available funds, in accordance with the instructions to be provided by BioIS to iRTC. Upon payment of such Upfront Fee and execution of the Additional Notes for the Additional Note Investment, the licenses granted to iRTC herein shall become irrevocable and the licenses granted in Sections 2.1(a) (Exclusive ACM Field of Use License), 2.1(c) (Non-Exclusive ACM Clinical Trials Field of Use License) and 2.1(d) (Non-Exclusive Unrestricted Applications License) shall be fully paid-up. [***].
5.2[***] Fee. If BioIS has [***], then, and conditioned on the execution of the [***] Agreement, iRTC shall also pay to BioIS a fee of Ten Million US Dollars (US $10,000,000) plus any unpaid accrued interest under the [***] Note upon written notice from BioIS (which includes the [***]) of such [***] (the “[***] Fee”); provided, however, the [***] Fee shall be offset by the outstanding principal amount plus any unpaid accrued interest of the [***] Note and the cancellation of the [***] Note. In the event BioIS has not yet completed [***] by December 31, 2025, Five Million US Dollars (US $5,000,000) plus any unpaid accrued interest on such principal amount due the [***] Note will be forgiven in full satisfaction of the [***] Fee, and no [***] Fee shall be due. For purposes of this Section 5.2, [***]; provided that, prior to [***], (a) BioIS shall provide iRTC (including its Chief Executive Officer, Alliance Manager and legal department) with a copy [***] as reasonably sufficient to confirm compliance with [***], (b) iRTC will have ten (10) days to review and verify such compliance, and (c) during such ten (10) day review period, iRTC may initiate the dispute resolution process in Section 12.2 (Dispute Resolution) if iRTC determines that [***] does not comply with such specifications.
5.3[***] Fee. If BioIS [***] prior to December 31, 2026, then, conditioned on (a) [***] having been completed by December 31, 2025 as set forth in Section 5.2 and (b) the execution of the [***] Agreement, iRTC shall also pay to BioIS a fee of Ten Million US Dollars (US $10,000,000) plus any unpaid accrued interest under the [***] Note upon iRTC’s receipt of written notice from BioIS (which includes a copy of [***]) of such [***] (the “[***] Fee”); provided, however, the [***] Fee shall be offset by the outstanding principal amount plus any unpaid accrued interest of the [***] Note and the cancellation of the [***] Note. For clarity, in the event BioIS has [***] before December 31, 2025, but has not [***] by December 31, 2026, iRTC shall not be required to pay the [***] Fee. For purposes of this Section 5.3, [***] means BioIS’s [***].
5.4Royalties for Royalty-Bearing HST Products.
(a)Royalty Payments. Subject to the terms and conditions of this Agreement, on a Royalty-Bearing HST Product-by-Royalty-Bearing HST Product and country-by-country basis, commencing upon the First Commercial Sale of a Royalty-Bearing HST Product in the applicable country in the Territory and ending upon the later of ten (10) years after such First Commercial Sale and expiration of the last Valid Claim of a Licensed Patent Right that Covers such Royalty-Bearing HST Product in such country (the “Royalty Term”), iRTC shall pay to BioIS a royalty of [***] on Net Sales of such Royalty-Bearing HST Product in such country. [***].
(b)Royalty Reporting. [***].
5.5Exchange Rate; Manner and Place of Payment. All references to dollars and “$” herein shall refer to U.S. dollars. All payments hereunder shall be payable in U.S. dollars. Currencies other than the U.S. Dollars shall be converted into U.S. Dollars at the average of the daily foreign exchange rates published in the Wall Street Journal (New York Edition), or any other qualified source that is mutually acceptable, for the calendar quarter in which such payments accrue, or, for periods less than a calendar quarter, the average of the daily rates published in the Wall Street Journal (New York Edition) for such period. All payments owed to BioIS under this Agreement shall be made by wire transfer in immediately available funds to a bank and account designated in writing by BioIS, unless otherwise specified in writing by BioIS. If the conversion of a local currency in the Territory into dollars or transfer of funds out of a country or jurisdiction in the Territory becomes materially restricted, forbidden, or substantially delayed due to Applicable Law, then iRTC shall promptly notify BioIS and amounts accrued in such country or jurisdiction may be paid by iRTC in local currency into an account in a local bank designated by BioIS, unless the Parties otherwise agree.
5.6Late Payments. [***].
5.7Taxes. [***].
5.8Exclusions. The fees set forth herein do not include charges for the following, which will all generate additional fees:
(a)[***];
(b)[***]; and
(c)[***] and other BioIS products.
5.9Records; Audit. [***].
6.CONFIDENTIALITY.
6.1Confidential Information. “Confidential Information” of a Party means any non-public or other proprietary information disclosed or otherwise made available by or on behalf of that Party (the “Disclosing Party”) to the other Party (the “Receiving Party”), whether made available orally, in writing, or in electronic form, before or during the Term (including with respect to information disclosed or made available by or on behalf of BioIS to iRTC or its Representatives in connection with any due diligence conducted by iRTC prior to the Effective Date) that: (a) if disclosed in writing or in the form of tangible materials, is marked “confidential” or “proprietary” or with a similar designation at the time of
such disclosure; (b) if disclosed orally or presented visually, is identified as “confidential” or “proprietary” at the time of such disclosure, and is summarized in a writing sent by the disclosing party to the receiving party within thirty (30) days after any such disclosure; or (c) due to its nature or the circumstances of its disclosure, a person exercising reasonable business judgment would understand to be confidential or proprietary. The terms and conditions of this Agreement (including the Additional Notes, [***], [***], the [***] agreement, the distribution agreements in Section 4.2, the services agreements in Sections 4.3 and 4.4, and any other ancillary documents to this Agreement) will be the Confidential Information of each Party. Notwithstanding anything to the contrary in this Section 6, any proprietary information, data or know-how disclosed by BioIS to iRTC under this Agreement that are solely applicable to the ACM Field of Use shall constitute the Confidential Information of iRTC.
6.2Exceptions. Notwithstanding Section 6.1, in no event is information Confidential Information if it (i) was, at the date of disclosure, or have subsequently become, generally known or available to the public through no act or failure to act by Receiving Party; (ii) was in Receiving Party’s possession before receipt from Disclosing Party, as documented by contemporaneous written records provided that the foregoing exception shall not apply to iRTC-made Improvements; (iii) is received by Receiving Party from a Third Party who has the right to disclose such information or materials without breach of any obligation of confidentiality; or (iv) is independently developed by Receiving Party without use of or reference to the Confidential Information of Disclosing Party.
6.3Confidentiality Obligations. Each Receiving Party will: (a) maintain the Disclosing Party’s Confidential Information in strict confidence; (b) protect and safeguard it using at least the same degree of care as it uses to protect the confidentiality of its own confidential information of similar importance, but no less than a commercially reasonable degree of care; and (c) not use the Confidential Information of the Disclosing Party except as necessary to perform its obligations or the exercise of its rights under this Agreement (for clarity, the foregoing clause (c) is not a license of Intellectual Property Rights does not modify or expand the Intellectual Property Rights that are licensed pursuant to Section 2 (Licenses) or Section 3.2(c) (if any)). The Receiving Party will not disclose or cause to be disclosed any Confidential Information of the Disclosing Party without first obtaining the prior written consent of the Disclosing Party, except for disclosures expressly permitted pursuant to this Section 6 (Confidentiality). Receiving Party shall immediately, upon discovery of any disclosure or use of Confidential Information not authorized hereunder, notify Disclosing Party and take reasonable steps to prevent any further unauthorized disclosure or unauthorized use of Confidential Information. Receiving Party’s obligations under this Section 6.3 (Confidentiality Obligations) with respect to Confidential Information of the Disclosing Party shall survive for a period of five (5) years following the termination or expiration of this Agreement except with respect to trade secrets, which shall survive as long as such information constitutes a trade secret. To the extent of any conflict between this Section 6 (Confidentiality) and any of Sections 2.1 (Licenses to iRTC) and 3.2 (Technology Transfer), Sections 2.1 (Licenses to iRTC) and 3.2 (Technology Transfer), as applicable, shall govern and control.
6.4Authorized Disclosures. Notwithstanding Section 6.3 (Confidentiality Obligations), the Receiving Party may disclose Confidential Information belonging to the Disclosing Party in the following instances:
(a)to those Representatives of the Receiving Party (including Receiving Party’s confidential advisors such as insurance brokers, lenders, auditors, attorneys and accountants) who have a bona fide need to know such Confidential Information to perform under this Agreement and who are bound by written agreements with non-use and confidentiality obligations at least as protective as those set forth in this Agreement;
(b)in the case of iRTC, to any actual or potential collaborators, partners, sublicensees or subcontractors who have a bona fide need to know such Confidential Information for iRTC or its Affiliates to exercise its rights or licenses hereunder (provided that, for clarity, the foregoing is not a license of Intellectual Property Rights does not modify or expand the Intellectual Property Rights that are licensed pursuant to Section 2 (Licenses) or Section 3.2(c) (if any)) and who are bound by written agreements with non-use and confidentiality obligations at least as protective as those set forth in this Agreement;
(c)disclosure to potential Third Party investors or acquirers in connection with due diligence activities, provided, in each case, that any such Third Party agrees to be bound by reasonable obligations of confidentiality and non-use; and
(d)pursuant to an order of a court or other Governmental Authority of competent jurisdiction, subject to the Receiving Party providing to the Disclosing Party reasonable advance notice to allow the Disclosing Party to seek a protective order or otherwise contest the disclosure. The Receiving Party shall disclose no more than that portion of the Confidential Information which, on the advice of legal counsel, such order or law specifically requires the Receiving Party to disclose.
6.5Securities Filings; Disclosure under Applicable Law. Each Party acknowledges and agrees that the other Party may submit this Agreement to, or file this Agreement with, the U.S. Securities and Exchange Commission or any other securities exchange that may be applicable to a Party in the Territory (each, a “Securities Regulator”) or other Persons as may be required by Applicable Law, and if a Party submits this Agreement to, or files this Agreement with, any Securities Regulator or other Person as may be required by Applicable Law, such Party agrees to consult with the other Party with respect to the preparation and submission of a confidential treatment request for this Agreement. Notwithstanding the foregoing, if a Party is required by any Securities Regulator or other Person as may be required by Applicable Law to make a disclosure of the terms of this Agreement in a filing or other submission as required by such Securities Regulator or such other Person, and such Party has: (a) provided copies of the disclosure to the other Party reasonably in advance under the circumstances of such filing or other disclosure; (b) promptly notified the other Party in writing of such requirement and any respective timing constraints; and (c) given the other Party reasonable time under the circumstances from the date of provision of copies of such disclosure to comment upon and request confidential treatment for such disclosure, then such Party will have the right to make such disclosure at the time and in the manner reasonably determined by its counsel to be required by the Securities Regulator or the other Person. Notwithstanding the foregoing, if a Party seeks to make a disclosure as required by a Securities Regulator or other Person as may be required by Applicable Law as set forth in this Section 6.5 (Securities Filings; Disclosure under Applicable Law) and the other Party provides comments in accordance with Section 6.5 (Securities Filings; Disclosure under Applicable Law), then the Party seeking to make such disclosure or its counsel, as the case may be, will incorporate such comments to the extent legally permissible.
6.6No Publicity. Unless expressly permitted herein, a Party will not issue any press release or other public communication, whether written or oral, relating to this Agreement or the transactions contemplated hereby without the prior written approval of the other Party, not to be unreasonably withheld, conditioned, or delayed. Notwithstanding anything to the contrary in the foregoing, either Party may issue such press releases as it determines reasonably necessary to comply with Applicable Law. Each Party shall provide the other Party with advance notice of any such legally required press release to the extent practicable and consider its comments in good faith. In addition, after the existence of this Agreement, the identity of the other Party, or any terms of this Agreement are publicly disclosed in accordance with this Agreement, either Party shall be free to disclose, without the other Party’s prior
written consent, such information as has already been publicly disclosed in accordance with this Agreement.
6.7Return of Confidential Information. Upon termination or expiration of this Agreement, upon the request of Disclosing Party, Receiving Party shall promptly return to Disclosing Party or destroy Disclosing Party’s Confidential Information in its possession (other than Confidential Information that is treated as Confidential Information of both Parties), except to the extent that retention of such Confidential Information is reasonably necessary for the Receiving Party to exploit any continuing rights it has pursuant to this Agreement and/or to fulfill its obligations contemplated herein, including one copy of the Confidential Information stored in a secure place for the sole purposes of monitoring its compliance under this Agreement or evidence. The return and/or destruction of such Confidential Information as provided above shall not relieve the Receiving Party of its obligations under this Agreement. The obligation to return or destroy shall not apply to copies of electronically exchanged Confidential Information made as a matter of routine information technology backup and to Confidential Information or copies thereof which must be stored by the Receiving Party according to provisions of Applicable Law or the Receiving Party’s generally applicable written internal policies and procedures.
7.REPRESENTATIONS, WARRANTIES AND COVENANTS.
7.1Mutual Representations, Warranties and Covenants.
(a)Authority. BioIS and iRTC each represents and warrants to the other Party that, as of the Effective Date, (i) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and it has full power and authority to enter into this Agreement and carry out the transactions contemplated hereby, (ii) it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action, and (iii) this Agreement is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument, or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it.
(b)Compliance. BioIS and iRTC each represents, warrants and covenants to the other Party that it: (i) will perform its obligations under this Agreement in accordance with Applicable Law; and (ii) will obtain and maintain on an active and current basis, all licenses, permits, registrations, approvals and other authority from all applicable federal, state, and local governments and agencies having jurisdiction over the subject matter of this Agreement as necessary to perform its obligations under this Agreement.
7.2BioIS Representations, Warranties, and Covenants. BioIS represents, warrants and covenants (as applicable) to iRTC that:
(a)BioIS and its Affiliates, as of the Effective Date, are the sole and exclusive owners of the entire right, title, and interest in and to each of the Licensed IP Rights and Intellectual Property Rights in and to the Licensed Technologies (excluding any non-exclusive rights or licenses of Non-Material IP), free and clear of all liens, encumbrances and security interests, other than (i) any lien or encumbrance that arises out of taxes either not delinquent or the validity of which is being contested in good faith by appropriate proceedings, (ii) any lien or encumbrance representing the rights of customers, suppliers and subcontractors in the ordinary course of business under the terms of any contracts to which
the relevant party is a party or under general principles of commercial or government contract law (including mechanics’, materialmen’s, carriers’, workmen’s, warehouseman’s, repairmen’s, landlords’ and similar liens granted or which arise in the ordinary course of business), (iii) any license of Intellectual Property Rights outside of the exploitation of Valid ACM Devices in the ACM Field of Use that does not otherwise conflict with the licenses granted by BioIS under this Agreement and (iv) the [***] Exception (collectively, (i)-(iv), “Permitted Encumbrances”). Exhibit A (Existing Licensed Patents) sets forth a complete and accurate list of all Licensed Patents Controlled by BioIS or any of its Affiliates existing as of the Effective Date. Exhibit B (Technology Transfer Plan) sets forth a complete and accurate list of all Licensed Technologies existing as of the Effective Date. For purposes of this Agreement, “Non-Material IP” means (i) Intellectual Property Rights other than patent rights that (a) are granted to the Company or its Affiliates by providers of research, development, manufacturing or other related services to BioIS or any of its Affiliates in order to enable BioIS or any of its Affiliates to use such services under the relevant agreements and (b) are not material to the exploitation of Licensed Products and (ii) software licenses for commercially available, off-the-shelf software;
(b)[***];
(c)[***];
(d)[***]:
(i)[***]:
(ii)[***].
(iii)[***].
(iv)[***].
(v)[***].
(e)as of the Effective Date, (i) BioIS has complied in all material respects with all Applicable Laws in connection with the Prosecution and Maintenance of the Existing Licensed Patents, including any disclosure requirements of the United States Patent and Trademark Office and any foreign patent office, and has timely paid all filing and renewal fees payable with respect thereto, (ii).neither BioIS nor its Affiliates have received any notice, written or otherwise, of any claim or threat of any claim made by any Person against BioIS or its Affiliates that alleges that any Existing Licensed Patent is invalid or unenforceable and there is no pending adverse action, suit or proceeding against BioIS in relation to any Existing Licensed Patent. BioIS will promptly notify iRTC if BioIS or any of its Affiliates receives any notice, written or otherwise, of any claim or threat of any claim by any Person against BioIS or its Affiliates alleging that any Licensed Patent is invalid or unenforceable;
(f)as of the Effective Date, there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial or legal, administrative or other proceedings, or governmental investigations (each, an “Action”) pending, threatened or, to BioIS’ knowledge, anticipated in writing against BioIS or its Affiliates which could reasonably be expected to adversely affect or restrict the ability of BioIS to consummate or perform the transactions and obligations contemplated under this Agreement, or which would reasonably be expected to adversely affect the Licensed IP Rights, BioIS’s Control thereof or the Licensed Technologies. BioIS will promptly notify iRTC if BioIS or any of its Affiliates
receives any notice, written or otherwise, of any such Action or threat of any such Action by any Person against BioIS or any of its Affiliates;
(g)as of the Effective Date, to its knowledge, BioIS has not misappropriated, infringed or otherwise violated, and will not misappropriate, infringe or otherwise violate, any property (whether Patent, Technologies, or otherwise) of a Third Party in connection with developing the Licensed Technologies. Neither BioIS nor its Affiliates have received any written notice of any claim that any property (whether Patent, Technologies, or otherwise) controlled by a Third Party would be infringed, misappropriated or otherwise violated by the performance of the activities hereunder in accordance with this Agreement, and BioIS will promptly notify iRTC if BioIS or any of its Affiliates receives any notice, written or otherwise, of any such claim or threat of any such claim. To BioIS’s knowledge, no Third Party is infringing, misappropriating or otherwise violating, or threatening to infringe, misappropriate or otherwise violate the Licensed Technologies;
(h)BioIS or its Affiliate have obtained from all individuals who participated, and will obtain from all individuals who participate during the Term, in any respect in the invention, authorship or other creation of any Licensed Technology owned or purported to be owned by BioIS or such Affiliate valid and enforceable written assignments of all rights of such individuals in such Licensed Technology. To BioIS’s knowledge, as the Effective Date, no Person who claims to be an inventor of an Invention claimed in a Licensed Patent owned by or exclusively licensed to BioIS or any of its Affiliates is not identified as an inventor of such Invention in the filed patent documents for such Licensed Patent. As of the Effective Date, no dispute regarding inventorship or ownership has been alleged or threatened with respect to any Licensed Technology owned by or exclusively licensed to BioIS or any of its Affiliates. BioIS will promptly notify iRTC if BioIS or any of its Affiliates receives any notice, written or otherwise, of any such dispute;
(i)as of the Effective Date, neither BioIS nor its Affiliates is a party to any agreement with any Governmental Authority that refers or relates to the Licensed IP Rights, Licensed Patents or Licensed Technologies, or any activity contemplated hereunder;
(j)(a) as of the Effective Date, neither BioIS nor any of its Affiliates has been debarred or is subject to debarment pursuant to the FFDCA or subject to any similar sanction pursuant to any Applicable Law (including outside the United States) or is listed on any excluded list maintained by any Governmental Authority; and (b) neither it nor any of its Affiliates has, to its knowledge, used in any capacity, and will not use in any capacity, in connection with the activities to be performed under this Agreement, any individual or entity that has been debarred pursuant to the FFDCA or subject to any similar sanction pursuant to any Applicable Law (including outside the United States), or that is the subject of a conviction described in the FFDCA or subject to any similar sanction pursuant to any Applicable Law (including outside the United States), or listed on any excluded list maintained by any Governmental Authority; and
(k)BioIS and its Affiliates have taken commercially reasonable measures consistent with industry practices to protect the secrecy, confidentiality and value of all trade secrets and confidential information in the Licensed Technologies, including by requiring all employees, consultants and subcontractors to execute binding and enforceable agreements requiring all such employees, consultants and subcontractors to maintain the confidentiality of all such Licensed Technologies. To BioIS’s knowledge: (i) the trade secrets and confidential information of BioIS or its Affiliates in the Licensed Technology has not been disclosed to, or used or discovered by, any Third Party except pursuant to such confidentiality agreements or as disclosed in any published patent application filed by or on behalf
of BioIS or its Affiliates; and (ii) there has not been a breach by any party of such confidentiality agreements.
7.3[***].
7.4Non-Solicitation. During the period commencing on the Effective Date and ending on the five (5) year anniversary of the Effective Date, each Party (a “Soliciting Party”) shall not, and shall cause its Affiliates (and any other Person engaged by such Soliciting Party or its Affiliate to act on its behalf for such purpose) not to, directly or indirectly, solicit for employment current employees of the other Party without the other Party’s prior written consent (which will not be unreasonably withheld); provided, however, the Soliciting Party and its Affiliates shall not be restricted from (a) hiring or soliciting any employee of the other Party (or its Affiliates) through a general solicitation of employees (including through the use of general advertisement in the mass media, participation in job fairs or website postings) not specifically directed or targeted at any such persons or (b) hiring any employee of the other Party (or its Affiliates) who contacts the Soliciting Party on his or her own initiative without any direct or indirect solicitation from Soliciting Party (or any of its Affiliates).
8.INTELLECTUAL PROPERTY.
8.1Ownership. Inventorship of any Invention and all Intellectual Property Rights therein shall be determined in accordance with principles of inventorship for patent rights under US law. Except as expressly set forth in Section 8.2(b) with respect to iRTC-made Improvements, ownership shall follow inventorship.
8.2Improvements.
(a)BioIS Ownership of Licensed Improvements. BioIS will own all Licensed Improvements, and Intellectual Property Rights in and to the Licensed Improvements Controlled by BioIS shall be automatically included in the Licensed IP Rights. [***].
(b)Assignment of iRTC-made Improvements.
(i)iRTC agrees to assign and hereby assigns to BioIS all of its right, title and interests in and to any iRTC-made Improvements. [***].
(ii)[***].
(iii)[***].
8.3Intentionally Left Blank.
8.4Joint Development. The Parties acknowledge and agree that no joint development work is contemplated hereunder, and any such work by the Parties, if mutually agreed upon by the Parties, will be addressed in a separate joint development agreement.
8.5Prosecution and Maintenance of Licensed Patents.
(a)Except as set forth in Section 8.5(d), BioIS will have sole control, in its sole discretion over the Prosecution and Maintenance of the Licensed Patents and will pay all fees and costs related thereto. BioIS will provide, during the initial twenty-four (24) months quarterly and then annually
thereafter, updates to iRTC with respect to the status and scope of the Licensed Patents. iRTC will promptly notify BioIS if iRTC becomes aware of any known or suspected infringement of the Licensed Patents in the Territory.
(b)Except as set forth in Sections 8.5(c) and 8.5(d), BioIS will have sole control, in its sole discretion over enforcement and defense of the Licensed Patents against third-party infringers. If BioIS initiates any enforcement action against any Third Party infringer, iRTC will reasonably cooperate with BioIS with respect to such action. BioIS will be responsible for all reasonable out-of-pocket costs, expenses, and legal fees incurred by iRTC in connection with such cooperation provided by iRTC, and will be entitled to all damages awarded as a result of or agreed to in a monetary settlement of any such action.
(c)Notwithstanding the foregoing, if BioIS does not initiate an enforcement action to abate an ACM Competitive Infringement within one hundred twenty (120) days following delivery of notice thereof by iRTC to BioIS, then iRTC may upon written notice to BioIS initiate and maintain an enforcement action of the applicable Licensed Patents against the applicable Third Party infringer, at iRTC’s cost and expense, provided that before initiating such action iRTC shall consult in good faith with BioIS, including, to the extent reasonably feasible, providing to BioIS reasonable documentation showing the basis for such action. If iRTC does initiate such action, BioIS will reasonably cooperate with iRTC with respect to such action, and iRTC shall keep BioIS reasonably informed as to the status of any such action and shall consider in good faith the comments of BioIS with respect thereto. iRTC will be responsible for all reasonable out-of-pocket costs, expenses, and legal fees incurred by the BioIS in connection with such cooperation provided by BioIS, and will be entitled to all damages awarded as a result of or agreed to in a monetary settlement of any such action. For purposes of this Section 8.5(c), “ACM Competitive Infringement” shall mean an infringement of the Licensed Patents which adversely affects or could reasonably be expected to adversely affect the development, manufacture or commercialization of Valid ACM Device in the ACM Field of Use by iRTC, its Affiliates and Sublicensees in the ACM Field of Use in the Territory, or any related declaratory judgment or equivalent action.
(d)To the extent any Licensed Technology has any sole application with respect to a Valid ACM Device in the ACM Field of Use, BioIS shall file, in each case as requested by iRTC and at iRTC’s reasonable costs and expense, one or more Patent application(s) (including, if applicable, divisional(s) or continuation(s) based on Existing Licensed Patents) directed to such application(s) (each an “ACM-Specific Patent Right”) and will transfer to iRTC promptly following such filing any related materials, including the prosecution files. iRTC will have sole control over the Prosecution and Maintenance of any and all ACM-Specific Patent Rights and will pay all fees and costs related thereto. iRTC shall provide to BioIS (a) any material documentation received by iRTC from any patent authority in the Territory regarding the prosecution of any ACM-Specific Patent Right, and (b) drafts of all material filings or correspondence planned by iRTC to be submitted to any patent authority in the Territory regarding the prosecution of any ACM-Specific Patent Right sufficiently in advance of submitting so as to allow for a reasonable opportunity for BioIS to review and comment thereon, it being understood that iRTC shall consider in good faith any such comment. In the event that iRTC intends to abandon or cease the Prosecution or Maintenance any ACM-Specific Patent Right, iRTC shall provide reasonable prior written notice to BioIS of such intention to abandon or cease the Prosecution or Maintenance of such abandoned ACM-Specific Patent Right (“Abandoned ACM Specific Patent Right”). Following delivery of such notice (which shall be given no later than thirty (30) days prior to the next deadline for any action that must be taken with respect to any such Abandoned ACM-Specific Patent Right in the relevant patent office), iRTC shall have no responsibility for such Abandoned ACM-Specific Patent Right. In such case,
at BioIS’s sole discretion, and upon written notice to iRTC, iRTC will transfer to BioIS sole control of the prosecution and maintenance of such Abandoned ACM-Specific Patent Right and any related materials, including the prosecution files. Thereafter, BioIS will have sole control over the Prosecution and Maintenance of such Abandoned ACM-Specific Patent Right, and will pay all fees and costs related thereto. Any and all such Abandoned ACM-Specific Patent Rights shall no longer be part of the ACM-Specific Patent Rights, but shall remain Licensed Patents under this Agreement.
(e) iRTC will have sole control over enforcement and defense of any ACM-Specific Patent Right against Third Party infringers, at iRTC’s cost and expense, provided that before initiating such action iRTC shall consult in good faith with BioIS, including, to the extent reasonably feasible, by providing to BioIS reasonable documentation showing the basis for such action. If iRTC does initiate such action, BioIS will reasonably cooperate with iRTC with respect to such action, and iRTC shall keep BioIS reasonably informed as to the status of any such action and shall consider in good faith the comments of BioIS with respect thereto. iRTC will be responsible for all reasonable out-of-pocket costs, expenses, and legal fees incurred by the BioIS in connection with such cooperation provided by BioIS, and will be entitled to all damages awarded as a result of or agreed to in a monetary settlement of any such claim.
9.INDEMNIFICATION; INSURANCE.
9.1Indemnification by BioIS. BioIS shall defend, indemnify and hold iRTC and its Affiliates and their respective directors, officers, employees, and agents (each, a “iRTC Indemnitee”) harmless from and against any and all actions, suits, claims, demands and proceedings (“Claims”) brought by any Third Party, and any liability, damages, loss, cost and expense (including reasonable attorneys’ fees) (“Losses”) resulting therefrom, arising out of or in connection with: (a) BioIS’s breach of this Agreement; (b) the gross negligence or willful misconduct of BioIS or any of its Representatives in connection with its performance under this Agreement or (c)[***]; except, in each case (a)-(c), to the extent such Losses arise out of any activities set forth in Section 9.2 (Indemnification by iRTC) for which iRTC is obligated to indemnify any BioIS Indemnitee under Section 9.2.
9.2Indemnification by iRTC. iRTC shall defend, indemnify and hold BioIS and its Affiliates and their respective directors, officers, employees, and agents (each, a “BioIS Indemnitee”) harmless from and against any and all Claims brought by any Third Party, and any Losses resulting therefrom, arising out of or in connection with: (a) iRTC’s breach of this Agreement; (b) the gross negligence or willful misconduct of iRTC or any of its Representatives in connection with its performance under this Agreement; or (c) the development, manufacture, use, commercialization or other exploitation of any Licensed Product by or on behalf of iRTC, its Affiliates or Sublicensees; except, in each case (a)-(c), to the extent such Losses arise out of any activities set forth in Section 9.1 (Indemnification by BioIS) for which BioIS is obligated to indemnify any iRTC Indemnitee under Section 9.1.
9.3Indemnification Procedure. The Parties’ indemnification obligations set forth in this Section 9 (Indemnification; Insurance) are conditioned upon the Party claiming indemnification hereunder (the “Indemnified Party”) (a) promptly notifying the other Party (the “Indemnifying Party”) of a Claim (provided, however, that failure to provide such notice shall relieve the Indemnifying Party from its liability or obligation hereunder only to the extent of any material prejudice as a direct result of such failure); (b) promptly giving the Indemnifying Party the right to control and direct the investigation, preparation, defense and settlement of such Claim with counsel of the Indemnifying Party’s own choosing; and (c) giving assistance and full cooperation for the defense of same. Without limiting the foregoing, the Indemnified Party shall have the right to reasonably participate, at its own expense, in the
defense or settlement of any Claim. The Indemnifying Party shall not settle any Claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, conditioned, or delayed, unless the settlement involves only the payment of money, no admission of wrong-doing or fault by the Indemnified Party, and no restriction on the future actions or activities of the Indemnified Party. So long as the Indemnifying Party is actively defending the Claim in good faith, the Indemnified Party shall not settle such Claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the Claim as provided above, (i) the Indemnified Party may defend against and consent to the entry of any judgment, or enter into any settlement with respect to, the Claim in any manner the Indemnified Party may deem reasonably appropriate (and, provided that the Indemnified Party consults with and obtains any consent from the Indemnifying Party in connection with such settlement, not to be unreasonably withheld, conditioned, or delayed), and (ii) the Indemnifying Party will remain responsible to indemnify the Indemnified Party as provided in this Section 9 (Indemnification; Insurance).
9.4Insurance. During the Term and for [***] thereafter, each Party, at its own expense, shall maintain commercial general liability insurance and other appropriate insurance in an amount consistent with sound business practice and reasonable in light of its obligations under this Agreement. Each Party shall provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to the other Party upon the other Party’s request.
10.DISCLAIMER; LIMITATION OF LIABILITY.
10.1Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, STATUTE, OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IRTC MAKES NO REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY ADVANCE ANY LICENSED PRODUCT OR DEVELOP, ACHIEVE MARKETING APPROVAL FOR, MANUFACTURE, COMMERCIALIZE OR OTHERWISE EXPLOIT ANY LICENSED PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR SALES LEVEL OR PROFIT OF SUCH LICENSED PRODUCT WILL BE ACHIEVED, AND BIOIS ACKNOWLEDGES THAT ALL BUSINESS DECISIONS HEREUNDER, WITH RESPECT TO THE DESIGN, MANUFACTURE, SALE, PRICE, AND PROMOTION OF LICENSED PRODUCTS, AS WELL AS THE DECISION WHETHER OR NOT TO DEVELOP OR COMMERCIALIZE LICENSED PRODUCTS, WILL BE WITHIN THE SOLE DISCRETION OF IRTC.
10.2Limitation of Liability. EXCEPT FOR (A) A PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD, (B) A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 8, (C) A PARTY’S BREACH OF SECTION 6 (CONFIDENTIALITY), AND (D) A PARTY’S BREACH OF ITS REPRESENTATIONS, WARRANTIES AND COVENANTS UNDER SECTION 7: (1) IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR INCIDENTAL, PUNITIVE, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES OF ANY KIND (INCLUDING LOST PROFITS OR LOST REVENUES), REGARDLESS OF WHETHER THE PARTY WAS ADVISED, HAD OTHER REASON TO KNOW OR IN FACT KNEW OF THE POSSIBILITY OF THE FOREGOING; AND (2) EACH PARTY’S TOTAL CUMULATIVE LIABILITY ARISING FROM OR RELATING TO THE AGREEMENT WILL NOT EXCEED THE AGGREGATE OF THE UPFRONT FEE, ANY FEES THAT ARE DUE AND PAYABLE UNDER SECTION 5.2 OR SECTION
5.2, ANY ROYALTIES THAT ARE DUE AND PAYABLE UNDER SECTION 5.4 AND ALL COSTS AND EXPENSES (INCLUDING REASONABLE ATTORNEYS’ FEES) TO TAKE ACTION IN RESPECT THEREOF.
11.TERM; TERMINATION.
11.1Term. The term of this Agreement shall commence on the Effective Date and continue in full force and effect, unless and until terminated in accordance with this Section 11 (“Term”).
11.2Termination for Convenience. iRTC may terminate this Agreement, as a whole or on a country-by-country or field-by-field basis, at any time by giving BioIS [***] prior notice in writing.
11.3Termination for Breach. Either Party shall be entitled to terminate this Agreement for cause, by written notice to the other Party and with immediate effect, if the other Party breaches any of its material obligations under this Agreement and, if such breach is curable, fails to cure such breach within [***] following its receipt of written notice thereof from the terminating Party. Notwithstanding the foregoing, in the event of a curable non-monetary default, if the default is not cured and not reasonably capable of being cured within the [***] cure period by the defaulting Party and such defaulting Party is making a good faith effort to cure such default, this Agreement will not terminate upon the expiration of such [***] cure period, provided however, that the notifying Party may terminate this Agreement with immediate effect by notice in writing to the breaching Party if such default is not cured within [***] of such original notice of default. Notwithstanding the foregoing, if either Party is alleged to be in material breach as provided herein and disputes such allegation, and the terminating Party’s right to terminate this Agreement based thereon, in good faith and on the basis of detailed reasons through the dispute resolution procedures set forth in Section 12.2 (Dispute Resolution), then upon referral of such Dispute pursuant to Section 12.2(a) (Referral to Senior Officers) provided that such Dispute is referred pursuant to Section 12.2 (Dispute Resolution) on or before the end of such initial ninety (90) day cure period by the Party alleged to be in breach, the beginning of the cure period shall be tolled for so long as the matter is in the dispute resolution process offset forth in Section 12.2 (Dispute Resolution) and the Party alleged to be in breach is diligently pursuing such procedure. Such dispute resolution proceedings referred to in this Section 11.3 do not suspend any obligations of either Party hereunder, and each Party shall use reasonable efforts to mitigate any damage.
11.4Insolvency.
(a)Termination for Insolvency. iRTC may terminate this Agreement by notice in writing to BioIS if BioIS (i) becomes insolvent or admits inability to pay its debts generally as they become due; (ii) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully stayed within [***] or is not dismissed or vacated within [***]; (iii) is dissolved or liquidated or takes any corporate action for such purpose; (iv) makes a general assignment for the benefit of creditors; or (v) has a receiver, trustee, custodian, or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
(b)Rights Upon Insolvency. All rights and licenses granted by BioIS under this Agreement, including all rights and licenses that extend beyond the term hereof, are and shall be deemed to be rights and licenses to “intellectual property”, for purposes of, and as such terms are used in and interpreted under, Section 365(n) of the United States Bankruptcy Code (the “Code”). If BioIS or its estate shall become subject to any bankruptcy or similar proceeding, iRTC shall retain and have the right
to fully exercise all rights, licenses, elections, and protections under this Agreement, the Code and all other applicable bankruptcy, insolvency and similar Laws with respect to any licenses and rights that extend beyond the term hereof. Without limiting the generality of the foregoing, BioIS acknowledges and agrees that, if BioIS or its estate shall become subject to any bankruptcy or similar proceeding:
(i)all rights and licenses granted to iRTC hereunder shall continue and shall not be affected, even by BioIS’s rejection of this Agreement; and
(ii)iRTC shall be entitled to a complete duplicate of (or complete access to, as appropriate) all such intellectual property and embodiments of intellectual property comprising or relating to any Licensed Technologies, and the same, if not already in iRTC’s possession, shall be promptly delivered to iRTC, unless BioIS elects to and does in fact continue to perform all of its obligations under this Agreement.
11.5[***].
11.6Effect of Termination. On any expiration or termination of the entirety of this Agreement, except to the extent that retention of any Confidential Information is reasonably necessary for the Receiving Party to exploit any continuing rights it has pursuant to this Agreement, the Receiving Party shall (a) return to the Disclosing Party all documents and tangible materials (and any copies) containing, reflecting, incorporating, or based on the Disclosing Party’s Confidential Information; (b) permanently erase the Disclosing Party’s Confidential Information from its computer systems; and (c) certify in writing to the Disclosing Party that it has complied with the requirements of this Section 11.6 (Effects of Termination).
11.7Survival. Expiration or termination of this Agreement shall not relieve each Party of any obligation or right accruing prior to such expiration or termination, including for breach of Section 7.1 (Mutual Representations, Warranties and Covenants) or 7.2 (BioIS Representations, Warranties, and Covenants). Except as set forth below or elsewhere in this Agreement, the obligations and rights of the Parties under the following provisions of this Agreement shall survive expiration or termination of this Agreement: Section 1 (Definitions) (to the extent such definitions are used in surviving provisions), Section 2 (Licenses), Section 5 (Fees & Payment Terms), Section 6 (Confidentiality), Sections 7.3 (iRTC Additional Covenant) and 7.4 (Non-solicitation), Section 8.1 (Ownership), Section 8.2 (Improvements), Section 8.5 (Prosecution and Maintenance of Licensed Patents), Section 9 (Indemnification; Insurance), Section 10 (Disclaimer; Limitation of Liability), Section 11.6 (Effect of Termination), Section 11.7 (Survival) and Section 12 (General).
12.GENERAL.
12.1Governing Law. This Agreement will be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to any principles of conflict of laws that would lead to the application of the laws of another jurisdiction.
12.2Dispute Resolution. Any dispute or claim (including non-contractual disputes or claims) arising out of or relating to this Agreement (a “Dispute”), shall be resolved pursuant to this Section 12.2.
(a)[***].
(b)Arbitration. Subject to Sections 12.2(c) (Disputes Related to Patent Rights) and 12.2(d) (Interim Relief) below, any Dispute, which is not resolved pursuant to Section 12.2(a), shall be
referred to and finally resolved by arbitration pursuant to JAMS’ Comprehensive Arbitration Rules and Procedures (the “Rules”) by a panel of three arbitrators appointed in accordance with the Rules, if, however, the aggregate award sought by the Parties is less than [***] and equitable relief is not sought, a single arbitrator shall be chosen in accordance with the Rules. Each arbitrator shall be a lawyer with at least fifteen (15) years of experience with a law firm or corporate law department of over 25 lawyers and at least ten (10) years representing (either as outside counsel or in-house counsel) companies in the same industry as the Parties in connection with licensing transactions, provided that no such individual shall be a current or former employee or director, or a current stockholder, of either Party or any of their respective Affiliates. The place of arbitration shall be Wilmington, Delaware and the language to be used in any such proceeding (and for all testimony, evidence and written documentation) shall be English. The decision rendered by the arbitrators shall be final, binding and non-appealable, and judgment may be entered upon it in any court of competent jurisdiction. Except to the extent necessary to confirm, enforce, or challenge an award of the arbitration, to protect or pursue a legal right, or as otherwise required by Applicable Law or regulation or securities exchange, the existence, content, or results of any Dispute or arbitration hereunder (including any submissions (including exhibits, testimony, proposed rulings, briefs and transcripts) and the arbitrators’ rulings and award) shall be Confidential Information of both Parties.
(c)Disputes Related to Patent Rights. Without prejudice to the generality of Section 12.2(b) (Arbitration), if a Dispute arises in respect to the inventorship, validity, construction, scope, enforceability or infringement, of any Patents, and such Dispute cannot be resolved in accordance with Section 12.2(a) (Referral to Senior Officers) then, unless otherwise agreed by the Parties in writing, such Dispute shall not be subject to an arbitration proceeding pursuant to Section 12.2(b) (Arbitration) and instead either Party may bring an action in any court or administrative agency of competent jurisdiction in which such rights apply, to resolve such Dispute.
(d)Interim Relief. Notwithstanding anything herein to the contrary in this Section 12.2, in the event that a Party reasonably requires relief on a more expedited basis than would be possible pursuant to the procedure set forth in this Agreement, such Party may seek interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party. This Section 12.2(d) (Interim Relief) shall be specifically enforceable.
12.3Assignment. Neither Party may assign or transfer this Agreement, by operation of law or otherwise without the other Party’s prior written consent, which will not be unreasonably withheld, conditioned, or delayed. Any attempt to assign or transfer this Agreement without such consent will be void. Notwithstanding the foregoing, each Party (and, in the case of BioIS, subject to its compliance with the terms of the [***]) may assign or transfer this Agreement to (i) an Affiliate (in the case of BioIS, provided that such Affiliate also acquires in connection with such assignment or transfer all of the Licensed IP Rights and Licensed Technologies) or (ii) any Third Party that succeeds to all or substantially all of the assigning Party’s business and assets relating to the subject matter of this Agreement, whether by sale, merger, operation of law or otherwise. Subject to the foregoing, this Agreement is binding upon and will inure to the benefit of each of the Parties and their respective successors and permitted assigns. Any purported assignment in violation of this Section 12.3 (Assignment) shall be null and void.
12.4Severability. If, for any reason, any part of this Agreement is adjudicated invalid, unenforceable, or illegal by a court of competent jurisdiction, such adjudication shall not affect or impair, in whole or in part, the validity, enforceability, or legality of any remaining portions of this Agreement. The Parties will in such an instance use their best efforts to replace the invalid, unenforceable, or illegal
provision(s) with valid, enforceable, and legal provision(s) that best implement the original intent of the Parties and purposes of this Agreement.
12.5Notices. All notices required or permitted under this Agreement will be in writing, will reference this Agreement, and will be deemed given: (i) when delivered personally; (ii) one (1) business day after deposit with a nationally-recognized express courier, with written confirmation of receipt; (iii) when sent by email, on the date the email was sent without a bounce back message if sent during normal business hours of the receiving Party, and on the next business day if sent after normal business hours of the receiving Party; or (iv) three (3) business days after having been sent by registered or certified mail, return receipt requested, postage prepaid. All such notices will be sent to the addresses set forth below or to such other address as may be specified by either Party to the other Party in accordance with this Section.
In the case of BioIS, to: BioIntelliSense, Inc. 17301 W. Colfax Avenue Golden, CO 80401 Attn: Legal Department with a copy (which shall not constitute notice) to: [***] | In the case of iRTC, to: iRhythm Technologies, Inc. 699 8th Street, Suite 600 San Francisco, CA 94103 Attn: Legal Department with a copy (which shall not constitute notice) to: [***] | ||||
12.6Waiver. Either Party’s failure to enforce any provision of this Agreement will not constitute a waiver of future enforcement of that or any other provision. No waiver of any provision of this Agreement will be effective unless it is in writing and signed by the Party granting the waiver.
12.7Entire Agreement; Amendment. This Agreement, including each exhibit attached hereto (each, an “Exhibit”), is the complete and exclusive agreement between the Parties with respect to its subject matter and supersedes all prior or contemporaneous agreements, communications and understandings, both written and oral, with respect to its subject matter. This Agreement may be amended or modified only by a written document executed by duly authorized representatives of the Parties.
12.8Relationship of the Parties. Nothing in this Agreement shall be construed to place the Parties in an agency, employment, franchise, joint venture, or partnership relationship. Neither Party shall have the authority to obligate or bind the other in any manner. Neither Party shall represent to the contrary, either expressly, implicitly or otherwise.
12.9No Third-Party Beneficiaries. Unless otherwise expressly provided, no provisions of this Agreement are intended or will be construed to confer upon or give to any Third Party any rights, remedies or other benefits under or by reason of this Agreement.
12.10Non-Exclusive Remedies. Except as expressly set forth in this Agreement, the exercise by either Party of any remedy under this Agreement will be without prejudice to its other remedies under this Agreement or otherwise.
12.11Non-Use of Names. BioIS shall not use the name, trademark, logo, or physical likeness of iRTC or its respective officers, directors or employees, or any adaptation of any of them, in any advertising, promotional or sales literature, without iRTC’s prior written consent. BioIS shall require its
Affiliates to comply with the foregoing. iRTC shall not use the name, trademark, logo, or physical likeness of BioIS or its officers, directors or employees, or any adaptation of any of them, in any advertising, promotional or sales literature, without BioIS’s prior written consent. iRTC shall require its Affiliates and Sublicensees to comply with the foregoing.
12.12Construction. This Agreement has been negotiated by each of the Parties and each of their respective counsel. This Agreement shall be fairly interpreted in accordance with its terms and without any strict construction in favor of or against either Party.
12.13Headings; Interpretation. The headings and captions used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement. This Agreement shall be deemed to comprise the language mutually chosen by the Parties and no rule of strict construction shall be applied against any Party. Unless otherwise expressly provided herein or the context of this Agreement otherwise requires, (a) words such as “herein”, “hereof”, “hereby” and “hereunder” refer to this Agreement as a whole; (b) the words “include(s)”, “including”, “such as”, “in particular” and “for example” shall be deemed to be followed by the phrase “but not limited to”, “without limitation” or words of similar import unless otherwise specified; (c) the word “or” shall be deemed to mean “and/or” unless the context dictates otherwise because the subjects of the conjunction are, or are intended to be, mutually exclusive; (d) the terms “will” and “shall” shall be deemed to have the same meaning; (e) unless otherwise provided herein, any reference to “days” means calendar days; and (f) references to Applicable Law includes any amendment or modification to such Applicable Law.
12.14Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument. This Agreement may be executed by electronic signatures and such signatures shall be deemed to bind each Party hereto as if they were the original signatures, and facsimile, .pdf or electronic copies hereof shall be deemed to constitute duplicate originals.
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IN WITNESS WHEREOF, the Parties have caused this Technology License Agreement to be executed by their respective duly authorized representatives as of the Effective Date.
IRHYTHM TECHNOLOGIES, INC. By: /s/ Quentin Blackford Name: Quentin Blackford Title: Chief Executive Officer | BIOINTELLISENSE, INC. By: /s/ James R. Mault Name: James R. Mault Title: Chief Executive Officer | ||||
EXHIBIT A
Existing Licensed Intellectual Property
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EXHIBIT B
Technology Transfer Plan
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EXHIBIT C
[***]Agreement Terms and Conditions
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EXHIBIT D
[***]
ANNEX 1
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