HUMAN CLINICAL TRIAL AGREEMENT WITH HOSPITAL

　　This Agreement is made between Hospital (hereinafter Party A) and the trial sponsor _____ (hereinafter Party B). (Party B’s Name______) has an office in ____ and is governed by the laws of the Republic of China. Party A is a medical institution situated in Taipei City, Taiwan, the Republic of China and is governed by the laws of the Republic of China.

　　此合約是由臺(tái)北市醫(yī)院委托財(cái)團(tuán)法人私立臺(tái)北醫(yī)學(xué)大學(xué)(以下簡(jiǎn)稱甲方)，以及試驗(yàn)委托者(以下簡(jiǎn)稱乙方)雙方所簽訂。

　　Party A accepts Party B’s request to implement the clinical trial protocol named Protocol Name. (Protocol Number: ____ . Principle Investigator: Dr. ____ . Expected Commencement and End Dates of the Trial: ____ ).

　　甲方接受乙方委托，實(shí)施臨床試驗(yàn)____。(試驗(yàn)編號(hào)：____。試驗(yàn)主持人：____。試驗(yàn)預(yù)計(jì)起迄期間：____)。

　　The Parties agree to the following terms and conditions: 特立約遵照條款如下：

　　1. Undertaking 聲明

　　Party B (including the delegated trial institution sub-delegated by Party B) shall make reasonable efforts to provide a complete clinical trial project based on the date and title of the clinical trial protocol and in accordance with the Good Clinical Practice). A copy of the Clinical Trial Protocol (Attachment 1) is attached to this Agreement for reference. The contents of the clinical trial shall be guided by the [Principle Investigator], who shall be the Principle Investigatoras agreed under this Agreement.

　　In case of any discrepancy between this Agreement and the Clinical Trial Protocol, this Agreement shall prevail. The Clinical Trial Protocol can only be amended after prior written agreements by both Parties.

　　乙方(及乙方復(fù)委托之受托研究機(jī)構(gòu))應(yīng)合理盡力的依照優(yōu)良臨床試驗(yàn)各項(xiàng)相關(guān)規(guī)范及準(zhǔn)則于期間內(nèi)執(zhí)行并完成試驗(yàn)。試驗(yàn)內(nèi)容應(yīng)接受試驗(yàn)主持人____之指導(dǎo)，即本合約中所同意的主要試驗(yàn)主持人。

　　若在本合約及計(jì)劃書中發(fā)生任何不一致時(shí)，以本合約內(nèi)容為準(zhǔn)。計(jì)劃書只有在事先經(jīng)由甲乙雙方書面同意后才可進(jìn)行更動(dòng)。

　　2. Implementation Period執(zhí)行期間

　　In accordance with this Agreement, unless the scope of this Agreement is extended by amendment, or this Agreement is terminated in accordance with Article 14, the implementation period of the clinical trial shall be from (Commencement Date) to (End Date). This clinical trial shall only be implemented after the approval from Party A’s Institutional Review Board (IRB) and/or the approval from the Department of Health of the Executive Yuan.

　　根據(jù)本合約，除非因本合約修正而擴(kuò)大，或因第14條而終止，本合約有效期間應(yīng)為開始日期____至結(jié)束日期____。此試驗(yàn)將依據(jù)現(xiàn)行法規(guī)于收到甲方之人體試驗(yàn)委員會(huì)(IRB)同意及/或行政院衛(wèi)生署通過(guò)后才開始執(zhí)行。

　　3. Fees費(fèi)用

　　(a) Party B shall pay to Party A the budged fees under Attachment 2. Based on both Parties’ estimates, the amount of the budget will be sufficient for this clinical trial. However, Party A may reasonably incur fees exceeding the budget, in which case Party A shall submit a Memorandum of Understanding for the purpose of amending and increasing the budget. Unless otherwise stipulated under this Agreement, Party B shall not be obliged to pay any fee exceeding budget which has not been previously approved by a written Memorandum of Understanding.

　　乙方應(yīng)根據(jù)附件二中列出的預(yù)算支付費(fèi)用給甲方。由各方估算，預(yù)算規(guī)定的金額將足以支付此試驗(yàn)，但甲方可合理的預(yù)期超支的費(fèi)用，則甲方需提交一份備忘錄以要求修訂增加的預(yù)算。除非本合約另有規(guī)定，否則乙方不必支付任何未經(jīng)事先以書面?zhèn)渫浐藴?zhǔn)的超支預(yù)算。

　　The total research budget is ____ New Taiwan Dollars (NT$ ____ ) including tax. Party B may choose to pay the full amount to Party A upon signature of this Agreement. Following negotiation by between the Parties, Party A may dispose of this amount at its own discretion. The amount may be increased or decreased based on actual needs following negotiations between the Parties. Party B may also choose to make the payments in accordance with the following based on actual needs.

　　研究經(jīng)費(fèi)合計(jì)新臺(tái)幣_(tái)___元整含稅。乙方可選擇于合約簽訂后全額匯款付予甲方，甲方可經(jīng)由雙方協(xié)商后全權(quán)支配此經(jīng)費(fèi)，并得視實(shí)際需求經(jīng)雙方議定后增減之。或乙方可視實(shí)際需求選擇下列支付方式。

　　Within one week from signing this Agreement, Party B shall pay to Party A one-third of the total amount of the Expense-Based Costs listed in Attachment 2 – Clinical Trial Budget Table – as well as the Medical Management Fees, totaling ______ New Taiwan Dollars (NT$ ____ ). Unless stipulated in this Agreement with regard to budget, the fees shall be paid in full within thirty (30) days from the date of this Agreement.

　　乙方應(yīng)根據(jù)附件二臨床試驗(yàn)預(yù)算表中「消耗費(fèi)用」總金額，于合約簽訂后一周內(nèi)先撥三分之一經(jīng)費(fèi)，并同藥品管理費(fèi)，共計(jì)新臺(tái)幣_(tái)___元整，付予甲方，且除本合約另有預(yù)算規(guī)定外，應(yīng)于合約日期的三十(30)天之內(nèi)繳納費(fèi)用。

　　Following the commencement of the trial, various Expense-Based Costs incurred, the Employee Salary Expenses and other related expenses shall be calculated and paid at once on a quarterly basis based on actual consumption and payment situations in accordance with Attachment 2 – Clinical Trial Budget Table and Employee Salary Expenses Schedule.

　　Party B understands and agrees that the submission fee by Party A’s Institutional Review Board cannot be reimbursed, whether it has been included in the budget or not.

　　Party B chooses to pay the fees by: installment payment/full payment.

　　試驗(yàn)開始后，所產(chǎn)生之各項(xiàng)消耗費(fèi)用，研究護(hù)士工資及其它相關(guān)費(fèi)用，將依據(jù)附件二臨床試驗(yàn)預(yù)算表與研究護(hù)士工資付款期程表，依實(shí)際消耗支付狀況，以每季結(jié)算一次方式給付之。

　　無(wú)論是否被納入預(yù)算，乙方都了解并同意支付甲方之人體試驗(yàn)委員會(huì)審查費(fèi)用是不可退還的。

　　乙方選擇經(jīng)費(fèi)撥付方式為：____。(全額匯款或分撥匯款)

　　(b) Fees to be paid to Party A shall be wired into the following bank account:

　　China Trust Commercial Bank Tun Nan Branch 163538122106

　　Account Name Taipei Medical University – Municipal Wan Fang Hospital

　　In order to confirm the amount wired, each payment shall be accompanied by the name of the paying institution and the name of the main investigator of the trial.

　　應(yīng)支付給甲方之費(fèi)用，將匯入下列賬戶：____

　　為確認(rèn)款項(xiàng)，每次的支付應(yīng)注明簽賬單位名稱以及主要試驗(yàn)主持人的姓名。

　　4.Supply供應(yīng)

　　Party B shall supply Party A, free of charge, with sufficient volumes of investigational products (or equipment) in order to implement the clinical trial. It shall also provide other compound substances, raw materials, instruments, equipment and information that are designated in other protocols or those deemed necessary by Party B. Unless otherwise stipulated, the ownership of all such investigational products (or equipment), compounded substances, raw materials, instruments and equipment shall belong to Party B. Such investigational products (or equipment) shall be limited to be used on subjects of this Clinical Trial Protocol by Party A’s (human) principle investigator and shall not be used for any other purposes.

　　乙方應(yīng)免費(fèi)提供甲方足夠量的研究用產(chǎn)品、耗材、儀器設(shè)備以及信息以進(jìn)行臨床試驗(yàn)。除非另有規(guī)定，上述物品及信息之所有權(quán)仍歸于乙方。本試驗(yàn)之研究用產(chǎn)品限于甲方之試驗(yàn)主持人使用于本試驗(yàn)之受試者，不得他用。

　　5. Principle Investigator’s Undertaking試驗(yàn)主持人的保證

　　(a) Party A’s principle investigator guarantees to undertake all relevant obligations required under the provisions of the Clinical Trial Project (Attachment 1) and to comply with appropriate government laws and regulations.

　　(b) Party B undertakes to comply with and to perform the relevant requirements by the investigator and by the Department of Health of the Executive Yuan under the provisions of the Clinical Trial Protocol (Attachment 1).

　　(a) 甲方之試驗(yàn)主持人承諾負(fù)擔(dān)本試驗(yàn)計(jì)劃書(附件一)條款中所要求的相應(yīng)義務(wù)，并符合適當(dāng)?shù)恼ㄒ?guī)。

　　(b) 乙方承諾遵守并履行本試驗(yàn)計(jì)劃書(附件一)條款中，試驗(yàn)主持人及行政院衛(wèi)生署所要求的相關(guān)規(guī)定。

　　6. Notice通知

　　Any notice or request in relation to this Agreement shall be done in writing and shall be mailed or faxed to the following addresses by express pre-paid courier:

　　任何與本合約有關(guān)的通知或要求，都應(yīng)以書面、快遞郵件、已付郵資的方式郵寄到：

　　7. Independent Contractor 獨(dú)立簽約者

　　Party A is an independent contractor and is not an agent, partner, or a sponsor.

　　該甲方是一個(gè)獨(dú)立的簽約者，而非乙方的代理人、合伙人或贊助者。

　　8. Independent Clinical Trial 獨(dú)立臨床試驗(yàn)

　　Whether the employees receive a salary or not, this Agreement may not be construed to restrict the freedom of the investigators and Party A’s employees to engage in other similar cases outside this Agreement and for entities other than Party B.

　　無(wú)論人員受薪與否，本合約均不得被解釋為可限制試驗(yàn)主持人及甲方中的雇員去從事非本合約、乙方以外之團(tuán)體，所進(jìn)行之其它類似案件之自由。

　　9. Confidentiality 保密資料

　　All information which has been designated as confidential shall be, prior to their public divulgation, deemed as confidential information in the manner of written confidentiality undertakings. The confidential information may not be used by any other entity for any purpose other than this Agreement. Upon receipt of confidential information provided by the other Parties, each Party agrees to handle them as if they are its own confidential information, and shall not divulge such confidential information to any third party within three (3) years unless prior written notification is sent to the other Party. The above mentioned confidentiality obligations shall not apply to the following:

　　(a) Information of the public domain at the time of divulgation;

　　(b) Information known to others prior to its divulgation;

　　(c) Information obtained from third party without confidentiality obligations; or

　　(d) Divulgation required by laws.

　　所有指定需保密的數(shù)據(jù)在其應(yīng)被公開之時(shí)間以前，均應(yīng)以書面保密協(xié)議之方式被視為機(jī)密數(shù)據(jù)，除了此合約所要達(dá)成的目的外，不得被其它團(tuán)體任意使用。甲乙雙方同意當(dāng)收到由對(duì)方提供的機(jī)密數(shù)據(jù)時(shí)，將視同己方的機(jī)密數(shù)據(jù)一樣妥善管理，并進(jìn)一步同意若沒(méi)有事先以書面方式通知對(duì)方，將于三(3)年內(nèi)不向第三方揭露這些機(jī)密資料。前述的保密義務(wù)不適用于：

　　(a) 揭露時(shí)屬于公共領(lǐng)域;

　　(b) 在揭露前已被他人得知;

　　(c) 資料來(lái)自于對(duì)乙方?jīng)]有保密義務(wù)的第三方;或

　　(d) 被法律要求揭露。

　　10. Data Ownership and Intellectual Property Rights 數(shù)據(jù)的所有權(quán)及智能財(cái)產(chǎn)權(quán)

　　(a) Party B shall retain ownership over the case report forms (CRF) and the data generated as the result of the purpose of the Clinical Trial Protocol. However, Party A shall retain ownership over the medical history information and source data (except the daily record of the subjects). However, Party A and its principle investigator have the right to keep a photocopy of the clinical trial data generated as the result of the clinical trial for educational and/or academic research purposes, and it may publicize the results of the clinical trial in accordance with Article 11.

　　乙方提供之個(gè)案報(bào)告表及由本試驗(yàn)計(jì)劃書研究目的而產(chǎn)生的數(shù)據(jù)結(jié)果，其所有權(quán)歸乙方所有。但病歷數(shù)據(jù)及原始文件之所有權(quán)(受試者日志除外)歸屬甲方所有。但甲方及甲方之試驗(yàn)主持人有權(quán)保留此試驗(yàn)產(chǎn)生的數(shù)據(jù)結(jié)果復(fù)印件以作為教育及/或?qū)W術(shù)探討之用，并可如第十一(11)條所述公開發(fā)表其臨床試驗(yàn)結(jié)果。

　　(b) Unless stipulated in this Agreement, the intellectual property rights of the inventions, discovered, improvement of the trial courses and results, and the trial results and its products are owned by Party B. However, any innovative operations, therapies and relative to medical technologies for this Clinical Trial Protocol researched or invented by Party A and/or Party A’s principle investigator, the patent and intellectual property rights are belonged to Party A and its principle investigator.

　　除本合約另有規(guī)定外，試驗(yàn)過(guò)程及結(jié)果之發(fā)明、發(fā)現(xiàn)、改良與研發(fā)成果與產(chǎn)品，其智能財(cái)產(chǎn)權(quán)均歸屬乙方所有。但甲方及其試驗(yàn)主持人，為本計(jì)劃案所研發(fā)、創(chuàng)新之手術(shù)、治療方式及相關(guān)醫(yī)療技術(shù)，其專利權(quán)及智慧財(cái)產(chǎn)權(quán)仍歸甲方及其試驗(yàn)主持人所有。

　　(c) Except the above-mentioned (a) and (b), in the event that the investigational products (or equipment) used by Party A in the trial and those property rights/or intellectual property rights belong to Party A or any third party, Party A shall notify Party B in writing prior using them, but those property rights and/or intellectual property rights still belong to original owners.

　　除前二項(xiàng)規(guī)定外，甲方于試驗(yàn)中如有使用原甲方所有或第三人所有之所有權(quán)及/或智能財(cái)產(chǎn)權(quán)，應(yīng)于使用前以書面通知乙方，惟其所有權(quán)及/或智慧財(cái)產(chǎn)權(quán)仍歸屬各該原權(quán)利人所有。

　　(d) Specimen Ownership檢體的所有權(quán)

　　If specimens collected for the clinical trial are used by other subsequent additional experiments, each Party agrees the followings: (a) According to the stipulation provided by Department of Health, Executive Yuan, R. O. C., it shall be made statement in the Informed Consent Form that specimens supplied by the subjects of this clinical trial will be used by other subsequent additional experiments for other purposes. (b)complying with Regulations for collecting and using of humans for research that provided by Department of Health, Executive Yuan, R. O. C. (c)Information of the subjects shall be kept confidential and shall be protected in accordance with the provisions of the Informed Consent Form and relevant laws.

　　若試驗(yàn)所采集的檢體樣本會(huì)在后續(xù)進(jìn)行其它附加研究，甲乙雙方同意以下所有的事項(xiàng)：(1)依據(jù)行政院衛(wèi)生署相關(guān)規(guī)定于受試者同意書中說(shuō)明此試驗(yàn)受試者提供之檢體樣本將會(huì)進(jìn)行后續(xù)其它的目的。(2)遵守行政院衛(wèi)生署「研究用人體檢體采集及使用注意事項(xiàng)」之規(guī)定。(3)受試者的資料將保密并受到受試者同意書中的規(guī)定及相關(guān)法律所保護(hù)。

　　11. Publication 公布出版

　　Party B understands that Party A is focused on the exchange of medical and academic information and may publicize the results of its academic activities. Thus, Party A has the right to publicize information that is related to this clinical trial verbally or in writing. For Party A’s publication or disclosure of these related information, a written photocopy shall be provided by Party B thirty (30) days prior to the publication or disclosure. If the publication or disclosure of information involves patents or other confidential information, the confidential information shall be protected. During Party B’s review of written information within the thirty (30) day period, Party A may delay its publication or disclosure of related information for a maximum of sixty (60) days in order for Party B or Party A to file a patent application.

　　乙方明了甲方乃致力于醫(yī)療學(xué)術(shù)交流并會(huì)公開傳播其學(xué)術(shù)活動(dòng)的成果。因此，甲方有權(quán)以口頭或是書面方式發(fā)表與此試驗(yàn)相關(guān)的數(shù)據(jù)。甲方在出版或發(fā)表這些相關(guān)資料時(shí)，應(yīng)于三十(30)天前提交一份書面的復(fù)印件給乙方。當(dāng)這些資料被出版或發(fā)表時(shí)，若涉及專利或其它機(jī)密數(shù)據(jù)，則這些機(jī)密數(shù)據(jù)應(yīng)被保護(hù)。甲方在乙方審查這些書面資料的三十(30)天期間，將最多可延遲六十(60)天來(lái)出版或發(fā)布相關(guān)資料，以使乙方或甲方能提出專利申請(qǐng)。

　　If this is a multi-agency clinical trial project, then Party A agrees not to publicize any incomplete results prior to the completion of the trial or prior to results of Party B’s analysis. After publication of the multi-agency trial results, or if the results are not publicized after twelve (12) months following the full completion of the multi-agency trial, Party A has the right to publicize its individual clinical trial results after sending the information for Party B’s review and confirmation thirty (30) days prior to the publication. However, if the investigator deems that the publication of the trial results should not be delayed for public health, safety or benefit reasons, the delayed publication of twelve (12) months shall be exempt.

　　如果這是一個(gè)多中心的臨床試驗(yàn)計(jì)劃，則甲方同意不會(huì)在試驗(yàn)結(jié)束前或乙方分析結(jié)果出來(lái)前發(fā)表任何不完整的成果。在多中心試驗(yàn)結(jié)果已被公開，或當(dāng)多中心試驗(yàn)全部結(jié)束后十二(12)個(gè)月結(jié)果仍未被公開時(shí)，甲方有權(quán)在三十(30)天前將資料送交乙方審查無(wú)誤后，發(fā)布個(gè)別的試驗(yàn)成果。然而，當(dāng)試驗(yàn)主持人認(rèn)為出于公共衛(wèi)生、安全、或福利的原因，此試驗(yàn)成果的發(fā)布不應(yīng)被延遲時(shí)，此十二(12)個(gè)月的發(fā)布延遲應(yīng)被免除。

　　12. Site Entry 場(chǎng)所的進(jìn)入

　　In accordance with the laws and regulations of the Department of Health of the Executive Yuan, when Party B or the Department of Health requires contact with the investigator, other personnel or equipment related to this clinical trial, medical records, records of the subjects, individual case report tables and other records which are directly related to this clinical trial in accordance with relevant laws and regulations, it shall do so during normal business hours with prior notice.

　　當(dāng)乙方(及乙方復(fù)委托之受托研究機(jī)構(gòu))或衛(wèi)生主管機(jī)關(guān)需要與甲方之試驗(yàn)主持人及其它與此試驗(yàn)相關(guān)的人員接觸以進(jìn)行監(jiān)測(cè)或稽核時(shí)，應(yīng)在平常的上班時(shí)間內(nèi)進(jìn)行，并事先告知。

　　13. Promotion 宣傳

　　Without prior written consent, neither Party may promote or advertise the products related to this clinical trial. However, this does not include pre-existing requirements included in the attachment to this Agreement (such as recruitment advertising for subjects approved by the IRB).

　　如無(wú)事先的書面許可，任一方不得隨意進(jìn)行與此試驗(yàn)相關(guān)的產(chǎn)品推廣及廣告。但這其中不包括此合約附件中已存在的要求(例如經(jīng)由甲方之人體試驗(yàn)委員會(huì)核準(zhǔn)之受試者招募廣告)。

　　14. Termination 終止

　　This Agreement may be terminated by either Party with any reason, with a simple thirty (30) day prior written notice to the other Party. If based on Party A’s or Party B’s evaluation, or if the investigator, Party A’s IRB or the Department of Health of the Executive Yuan considers that this clinical trial is inappropriate, unrealistic or unsuitable to be continued, this clinical trial may be terminated by Party A or Party B at any time for any reason. Upon termination of this Agreement, Party A shall be compensated for reasonable expenses incurred prior to the termination of this Agreement and fees which cannot be canceled and which have not been paid.

　　此合約可能由任一方因任何理由提出終止，惟需于三十(30)天前以書面方式告知另一方。當(dāng)甲方或乙方在評(píng)估之后，或甲方之試驗(yàn)主持人、甲方之人體試驗(yàn)委員會(huì)、或衛(wèi)生主管機(jī)關(guān)認(rèn)為此試驗(yàn)不宜進(jìn)行時(shí)，此試驗(yàn)可在任何時(shí)間及任何理由下由甲乙任一方徑行終止。合約終止時(shí)，對(duì)于本合約終止之前已發(fā)生之合理支出及無(wú)法取消的一些未付清的費(fèi)用，甲方應(yīng)得到賠償。

　　Upon termination of this Agreement or when Party A receives the notice for the termination of this Agreement, Party A shall return to Party B all fees which Party B has overpaid prior to the termination of this Agreement. If a subject terminates his or her participation, or if the trial is discontinued for any reason, Party A shall be protected by the principle of no losses, and therefore Party B shall pay to Party A expenses related to these subjects based on a reasonable proportion, or pay fees to Party A in accordance with the payment timetable which was already agreed upon.

　　When this Agreement expires or is terminated by one or both Parties in accordance with this Agreement, both Parties shall start to comply with relevant provisions with regard to post-termination of the Agreement. Such provisions shall include (but are not limited to) Articles 3, 5, 6, 9, 10, 11, 12, 15 and 17.

　　當(dāng)本合約終止或甲方收到?jīng)Q定終止的通知時(shí)，甲方應(yīng)將合約終止之前乙方所給付的超額費(fèi)用退還給乙方。若受試者中止其參與，或試驗(yàn)因任何原因不再繼續(xù)時(shí)，甲方應(yīng)受到無(wú)損失原則的保護(hù)，故乙方應(yīng)按合理的支付甲方已發(fā)生之受試者費(fèi)用及相關(guān)試驗(yàn)消費(fèi)。當(dāng)本合約期滿或因第14條規(guī)定而終止時(shí)，甲乙雙方仍應(yīng)遵循本合約包括(但不僅限于)第3, 5, 6, 9, 10, 11, 12, 15及17條款等內(nèi)容。

　　15. Indemnification 賠償

　　Party B (including the delegated trial institution sub-delegated by Party B) shall compensate, hold harmless and protect Party A and its agents, representatives, contractors, officers and employees (the Indemnified) from any damages from demands, suits, claims, declarations or reimbursements (including reasonable attorneys’ fees and other fees incurred for the defense) for personal injuries (including but not limited to death) or property damages arising out of or related to the implementation of this clinical trial. Party A agrees to reasonably provide Party B with necessary assistance to proceed with negotiations, settlements and defenses with third parties. Party B understands and agrees that the subjects (including their legal successors and other legal claimants) have a direct right of claim against Party B(including the delegated trial institution sub-delegated by Party B).

　　乙方(及乙方復(fù)委托之受托研究機(jī)構(gòu))應(yīng)采取積極措施保護(hù)甲方及其參與試驗(yàn)人員免于遭受傷害(包括但不限于身體或財(cái)物)并賠償所受之一切損害，包括遭提出之任何要求、訴訟、宣告、清償及合理之律師費(fèi)及其它因辯護(hù)產(chǎn)生的費(fèi)用。甲方同意提供乙方合理之必要協(xié)助，與該第三人進(jìn)行談判、和解及提出抗辯等。

　　Party B is not responsible for losses or damages incurred by Party A for (1) failure to comply with relevant provisions of the Clinical Trial Protocol and (2) failure to comply with provisions required by the Department of Health of the Executive Yuan or other government agencies.

　　乙方就下列事項(xiàng)，可不對(duì)甲方及其參與試驗(yàn)之人員負(fù)賠償責(zé)任：(1)不遵循試驗(yàn)計(jì)劃書中的相關(guān)規(guī)定，(2)不遵守行政院衛(wèi)生署法規(guī)的行為。但乙方明了受試者(包括其法定繼承人及其它法定請(qǐng)求權(quán)人)對(duì)乙方(及乙方復(fù)委托之受托研究機(jī)構(gòu))有直接請(qǐng)求權(quán)。

　　If the subjects are insufficient or dysfunctional due to the manufacturing of the drugs or equipment, or side effects related to this clinical trial, or steps required under this clinical trial, including (1) Party A’s use of trial drugs or equipment in accordance with the Clinical Trial Protocol, (2) medical expenses which are not included in the subjects’ drug or medical insurance fees, and (3) damages or adverse effect which are not caused by Party A’s negligence or improper behavior, Party B shall compensate Party A of reasonable and necessary loss of medical expenses.

　　乙方就下列事項(xiàng)，應(yīng)對(duì)甲方、甲方參與試驗(yàn)之人員及/或受試者負(fù)賠償責(zé)任：(1)甲方及其參與試驗(yàn)人員按照本試驗(yàn)計(jì)劃書執(zhí)行，造成受試者遭受傷害。(2)不包含在受試者的醫(yī)療保險(xiǎn)費(fèi)而致使甲方、甲方之參與試驗(yàn)人員及/或受試者所遭受到之損失。(3)非由甲方疏忽或失當(dāng)所引起而造成之受試者傷害。

　　For cases sub-delegated by Party B, Party B shall ensure that the delegated trial institution bear the following responsibilities and shall bear joint liability with the delegated trial institution: (1) all losses suffered by the subjects and Party A due to the insufficiency of the trial drugs or equipment shall be compensated by the manufacturers of the trial drugs or equipment; (2) all losses suffered by the subjects and Party A caused by contract research organizations shall be compensated by the contract research organizations.

　　Both Parties shall make their best effort to negotiate and resolve any conflict or compensation issues.

　　乙方復(fù)委托案件予受托研究機(jī)構(gòu)，乙方應(yīng)使其受托研究機(jī)構(gòu)承擔(dān)以下責(zé)任，并與乙方連帶負(fù)責(zé)：(1)負(fù)責(zé)賠償研究用產(chǎn)品缺失所造成受試者及甲方之一切損害;(2)負(fù)責(zé)賠償乙方之復(fù)委托之受托研究機(jī)構(gòu)所造成受試者及甲方之一切損害。

　　甲乙雙方應(yīng)盡最大努力彼此協(xié)商解決任何的沖突或索賠問(wèn)題。

　　16. Insurance. 保險(xiǎn)

　　Party B shall take out general commercial liability insurance or be self-insured for the Clinical Trial Protocol. The general commercial liability insurance or self-insurance should cover the level of compensation that Party B shall bear under its contractual responsibilities. In accordance with needs, Party B shall provide written proof of such insurance to Party A prior to the commencement of the clinical trial.

　　乙方或其受托研究機(jī)構(gòu)應(yīng)為其臨床試驗(yàn)計(jì)劃投保一般商業(yè)責(zé)任險(xiǎn)、自身責(zé)任保險(xiǎn)或臨床試驗(yàn)保險(xiǎn)。上述保險(xiǎn)應(yīng)可足以提供乙方在本合約責(zé)任中所需負(fù)擔(dān)的賠償。乙方應(yīng)于試驗(yàn)開始前提供此類保險(xiǎn)的書面證據(jù)給甲方。

　　In case of cancellation, non-renewal or amendment of such insurance, Party B shall inform Party A in writing at least fifteen (15) days prior to the incident. If Party B does not find similar insurance for substitution within a period of fifteen (15) days, Party A has the right to terminate this Agreement effectively without any further waiting time and without any notification upon the expiry of the fifteen (15) day period.

　　乙方應(yīng)于上述保險(xiǎn)取消、不續(xù)約或更改前至少十五(15)天以書面方式告知甲方;乙方若于此十五(15)天的期間內(nèi)沒(méi)有找到其它同類的保險(xiǎn)取代，則甲方有權(quán)在此十五(15)天的期限到期時(shí)，不經(jīng)任何的額外的等候時(shí)間且無(wú)需通知即有效的徑行終止本合約。

　　17. Protection of Privacy 遵從隱私保護(hù)

　　In accordance with the laws and implementation rules of the Republic of China, other than for the purpose of treatment, payment or medical care provision, Party A may not use or disclose any protected medical history information without authorization from the concerned parties. Party A shall comply with the regulations and shall obtain consents from individual subjects who participate in the trial and agree that the such protected medical history information shall be used and disclosed by Party B for the purpose of implementing and monitoring the trial. Party B agrees that unless authorized by laws or by the subjects, Party B shall not disclose the protected medically history information to any person or any entity.

　　依據(jù)法律及其實(shí)施細(xì)則所規(guī)定，除治療目的、支付、或?yàn)榱酸t(yī)療照護(hù)以外，甲方不得在未經(jīng)當(dāng)事人授權(quán)的情況下任意使用或透露被保護(hù)的醫(yī)療病歷數(shù)據(jù)。甲方將遵循規(guī)定，取得個(gè)別進(jìn)入試驗(yàn)的受試者同意，同意這些被保護(hù)的醫(yī)療病歷數(shù)據(jù)將為了達(dá)到對(duì)此試驗(yàn)的進(jìn)行及監(jiān)測(cè)之目的而被乙方披露及使用。乙方同意除非法律及受試者授權(quán)允許，乙方不得對(duì)任何人或任何團(tuán)體揭露被保護(hù)的醫(yī)療病歷資料。

　　18. Guarantee擔(dān)保

　　Party A does not guarantee the results of this clinical trial, and does not guarantee the marketability and suitability of its ownership. Party B shall not be responsible for any direct, consequential or other damages suffered by Party B or any other person or entity due to the results of the clinical trial.

　　甲方不擔(dān)保有關(guān)本試驗(yàn)的結(jié)果，并且不保證其所有權(quán)具有可銷售性、適用性等特定的效果。甲方不需為試驗(yàn)結(jié)果所引發(fā)對(duì)乙方或其它團(tuán)體或個(gè)人所造成的任何直接、相應(yīng)、或其它的損害負(fù)責(zé)。

　　19. No Waiver 非放棄追究

　　Waiver of any breach of contract or failure to perform any responsibility under the contract by the other Party shall not be deemed to be a continued waiver of any similar repeated breaches or other breaches or failure to perform responsibilities under the contract.

　　放棄追究另一方任何違約或不履行本合約的責(zé)任不應(yīng)被視為繼續(xù)放棄對(duì)任何此類重復(fù)的違約行為或其它違約或不履行合約責(zé)任的追究。

　　20. Disputes糾紛

　　Disputes or violations or provisions arising out of this Agreement, if irreconcilable through negotiations, the Parties agree to attempt to mediate the dispute on genuinely friendly basis before referring them to arbitration and litigation or seek other dispute resolution procedures to resolve them. The Parties agree that the Taipei District Court shall be the first instance court with jurisdiction.

　　若本合約引起之爭(zhēng)執(zhí)，或違反規(guī)定，且上述的爭(zhēng)執(zhí)無(wú)法經(jīng)過(guò)談判及彼此的同意解決爭(zhēng)端時(shí)，雙方同意首先試圖真誠(chéng)地調(diào)解糾紛，才訴諸仲裁訴訟，或是尋求其它的爭(zhēng)端解決程序來(lái)解決。立合約書人同意以臺(tái)灣臺(tái)北地方法院為第一審管轄法院。

　　21. Entire Agreement 整體協(xié)議

　　This Agreement is the entire agreement between the Parties with regard to this trial, and supersedes all prior or simultaneous written or verbal statements or agreements. This Agreement supersedes all discrepancies between Party B and the investigator. Unless otherwise signed by both Parties in writing, this Agreement may not be amended, changed or supplemented.

　　此合約為雙方間與此試驗(yàn)有關(guān)的所有協(xié)議，并取代所有先前或同時(shí)間發(fā)生的所有書面或口頭的陳述或協(xié)議。此合約凌駕于任何存在于乙方及主要試驗(yàn)主持人之間的不一致，除非經(jīng)雙方書面簽署，否則不得修訂、改變或修正。

　　22. Transfer 轉(zhuǎn)讓

　　The rights and obligations of either Party under this Agreement may not be transferred to any third party unless prior written agreement from the other Party is obtained. If a Party attempts to transfer this Agreement without such agreement, the transfer shall be invalid.

　　任一方在本契約中之權(quán)利及義務(wù)，非經(jīng)他方事前書面同意，不得轉(zhuǎn)讓予任何第三人。任一方若企圖在沒(méi)有這樣的同意之下讓渡此合約，則屬無(wú)效。

　　23. Severability 分割

　　If any provision of this Agreement is invalid under the laws of the Republic of China in a court of jurisdiction, such invalidity shall not be expanded to the other provisions of the Agreement. The remaining provisions shall continue to enjoy full validity and effect.

　　若此合約中的任何條款在 法律的法庭管轄之下無(wú)效時(shí)，此類的無(wú)效性不應(yīng)擴(kuò)及合約中的其余條款，其余的條款仍應(yīng)繼續(xù)擁有完全的效力與作用。

　　24. Governing Laws 管轄法令

　　This Agreement shall be construed in accordance with and be governed by the laws of the Republic of China, without its conflict-of-law principles, and shall not be affected by the domicile or residence or property location of the Parties. All interpretation or implementation of this Agreement shall be subject to the jurisdiction of the Republic of China. In case of any dispute arising out of this Agreement, the Parties are willing to first accept medication by relevant authorities, failing which the Taipei District Court is agreed to be the first instance court of jurisdiction. The mediation expenses shall borne by Party B.

　　此合約應(yīng)被解釋為與 法律并受其管轄，并與法律規(guī)則沒(méi)有抵觸，并不受當(dāng)事人的住所或居住地或財(cái)產(chǎn)所在地影響。此合約中的任何解釋或?qū)嵤┒紤?yīng)以 為管轄地。因本合約引起之爭(zhēng)議，雙方愿先行接受有關(guān)機(jī)關(guān)協(xié)調(diào)，若協(xié)調(diào)不成，同意臺(tái)北地方法院為第一審管轄法院。協(xié)調(diào)費(fèi)用由乙方負(fù)擔(dān)。

　　This Agreement is made in triplicates, with Party A, Party B and Party A’s trial principle investigator each holding one copy.

　　本契約書一式三份，甲乙雙方及甲方之試驗(yàn)主持人各一份。

　　甲方Party A

　　院長(zhǎng)：Superintendent: (Signature)

　　Date:

　　我已詳讀并同意此合約中的事項(xiàng)。

　　I have carefully read and agree to the provisions of this Agreement.

　　乙方Party B

　　代表人：Representative Print Name: (Signature)

　　Date: