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.

　　此合约是由台北市医院委托财团法人私立台北医学大学(以下简称甲方)，以及试验委托者(以下简称乙方)双方所签订。

　　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，实施临床试验____。(试验编号：____。试验主持人：____。试验预计起迄期间：____)。

　　The Parties agree to the following terms and conditions: 特立约遵照条款如下：

　　1. Undertaking 声明

　　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(及乙方复委托之受托研究机构)应合理尽力的依照优良临床试验各项相关规范及准则于期间内执行并完成试验。试验内容应接受试验主持人____之指导，即本合约中所同意的主要试验主持人。

　　若在本合约及计划书中发生任何不一致时，以本合约内容为准。计划书只有在事先经由甲乙双方书面同意后才可进行更动。

　　2. Implementation Period执行期间

　　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.

　　根据本合约，除非因本合约修正而扩大，或因第14条而终止，本合约有效期间应为开始日期____至结束日期____。此试验将依据现行法规于收到甲方之人体试验委员会(IRB)同意及/或行政院卫生署通过后才开始执行。

　　3. Fees费用

　　(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.

　　乙方应根据附件二中列出的预算支付费用给甲方。由各方估算，预算规定的金额将足以支付此试验，但甲方可合理的预期超支的费用，则甲方需提交一份备忘录以要求修订增加的预算。除非本合约另有规定，否则乙方不必支付任何未经事先以书面备忘录核准的超支预算。

　　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.

　　研究经费合计新台币____元整含税。乙方可选择于合约签订后全额汇款付予甲方，甲方可经由双方协商后全权支配此经费，并得视实际需求经双方议定后增减之。或乙方可视实际需求选择下列支付方式。

　　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.

　　乙方应根据附件二临床试验预算表中「消耗费用」总金额，于合约签订后一周内先拨三分之一经费，并同药品管理费，共计新台币____元整，付予甲方，且除本合约另有预算规定外，应于合约日期的三十(30)天之内缴纳费用。

　　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.

　　试验开始后，所产生之各项消耗费用，研究护士工资及其它相关费用，将依据附件二临床试验预算表与研究护士工资付款期程表，依实际消耗支付状况，以每季结算一次方式给付之。

　　无论是否被纳入预算，乙方都了解并同意支付甲方之人体试验委员会审查费用是不可退还的。

　　乙方选择经费拨付方式为：____。(全额汇款或分拨汇款)

　　(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.

　　应支付给甲方之费用，将汇入下列账户：____

　　为确认款项，每次的支付应注明签账单位名称以及主要试验主持人的姓名。

　　4.Supply供应

　　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.

　　乙方应免费提供甲方足够量的研究用产品、耗材、仪器设备以及信息以进行临床试验。除非另有规定，上述物品及信息之所有权仍归于乙方。本试验之研究用产品限于甲方之试验主持人使用于本试验之受试者，不得他用。

　　5. Principle Investigator’s Undertaking试验主持人的保证

　　(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) 甲方之试验主持人承诺负担本试验计划书(附件一)条款中所要求的相应义务，并符合适当的政府法规。

　　(b) 乙方承诺遵守并履行本试验计划书(附件一)条款中，试验主持人及行政院卫生署所要求的相关规定。

　　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:

　　任何与本合约有关的通知或要求，都应以书面、快递邮件、已付邮资的方式邮寄到：

　　7. Independent Contractor 独立签约者

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

　　该甲方是一个独立的签约者，而非乙方的代理人、合伙人或赞助者。

　　8. Independent Clinical Trial 独立临床试验

　　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.

　　无论人员受薪与否，本合约均不得被解释为可限制试验主持人及甲方中的雇员去从事非本合约、乙方以外之团体，所进行之其它类似案件之自由。

　　9. Confidentiality 保密资料

　　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.

　　所有指定需保密的数据在其应被公开之时间以前，均应以书面保密协议之方式被视为机密数据，除了此合约所要达成的目的外，不得被其它团体任意使用。甲乙双方同意当收到由对方提供的机密数据时，将视同己方的机密数据一样妥善管理，并进一步同意若没有事先以书面方式通知对方，将于三(3)年内不向第三方揭露这些机密资料。前述的保密义务不适用于：

　　(a) 揭露时属于公共领域;

　　(b) 在揭露前已被他人得知;

　　(c) 资料来自于对乙方没有保密义务的第三方;或

　　(d) 被法律要求揭露。

　　10. Data Ownership and Intellectual Property Rights 数据的所有权及智能财产权

　　(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.

　　乙方提供之个案报告表及由本试验计划书研究目的而产生的数据结果，其所有权归乙方所有。但病历数据及原始文件之所有权(受试者日志除外)归属甲方所有。但甲方及甲方之试验主持人有权保留此试验产生的数据结果复印件以作为教育及/或学术探讨之用，并可如第十一(11)条所述公开发表其临床试验结果。

　　(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.

　　除本合约另有规定外，试验过程及结果之发明、发现、改良与研发成果与产品，其智能财产权均归属乙方所有。但甲方及其试验主持人，为本计划案所研发、创新之手术、治疗方式及相关医疗技术，其专利权及智慧财产权仍归甲方及其试验主持人所有。

　　(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.

　　除前二项规定外，甲方于试验中如有使用原甲方所有或第三人所有之所有权及/或智能财产权，应于使用前以书面通知乙方，惟其所有权及/或智慧财产权仍归属各该原权利人所有。

　　(d) Specimen Ownership检体的所有权

　　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.

　　若试验所采集的检体样本会在后续进行其它附加研究，甲乙双方同意以下所有的事项：(1)依据行政院卫生署相关规定于受试者同意书中说明此试验受试者提供之检体样本将会进行后续其它的目的。(2)遵守行政院卫生署「研究用人体检体采集及使用注意事项」之规定。(3)受试者的资料将保密并受到受试者同意书中的规定及相关法律所保护。

　　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医疗学术交流并会公开传播其学术活动的成果。因此，甲方有权以口头或是书面方式发表与此试验相关的数据。甲方在出版或发表这些相关资料时，应于三十(30)天前提交一份书面的复印件给乙方。当这些资料被出版或发表时，若涉及专利或其它机密数据，则这些机密数据应被保护。甲方在乙方审查这些书面资料的三十(30)天期间，将最多可延迟六十(60)天来出版或发布相关资料，以使乙方或甲方能提出专利申请。

　　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.

　　如果这是一个多中心的临床试验计划，则甲方同意不会在试验结束前或乙方分析结果出来前发表任何不完整的成果。在多中心试验结果已被公开，或当多中心试验全部结束后十二(12)个月结果仍未被公开时，甲方有权在三十(30)天前将资料送交乙方审查无误后，发布个别的试验成果。然而，当试验主持人认为出于公共卫生、安全、或福利的原因，此试验成果的发布不应被延迟时，此十二(12)个月的发布延迟应被免除。

　　12. Site Entry 场所的进入

　　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.

　　当乙方(及乙方复委托之受托研究机构)或卫生主管机关需要与甲方之试验主持人及其它与此试验相关的人员接触以进行监测或稽核时，应在平常的上班时间内进行，并事先告知。

　　13. Promotion 宣传

　　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).

　　如无事先的书面许可，任一方不得随意进行与此试验相关的产品推广及广告。但这其中不包括此合约附件中已存在的要求(例如经由甲方之人体试验委员会核准之受试者招募广告)。

　　14. Termination 终止

　　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.

　　此合约可能由任一方因任何理由提出终止，惟需于三十(30)天前以书面方式告知另一方。当甲方或乙方在评估之后，或甲方之试验主持人、甲方之人体试验委员会、或卫生主管机关认为此试验不宜进行时，此试验可在任何时间及任何理由下由甲乙任一方径行终止。合约终止时，对于本合约终止之前已发生之合理支出及无法取消的一些未付清的费用，甲方应得到赔偿。

　　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.

　　当本合约终止或甲方收到决定终止的通知时，甲方应将合约终止之前乙方所给付的超额费用退还给乙方。若受试者中止其参与，或试验因任何原因不再继续时，甲方应受到无损失原则的保护，故乙方应按合理的支付甲方已发生之受试者费用及相关试验消费。当本合约期满或因第14条规定而终止时，甲乙双方仍应遵循本合约包括(但不仅限于)第3, 5, 6, 9, 10, 11, 12, 15及17条款等内容。

　　15. Indemnification 赔偿

　　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(及乙方复委托之受托研究机构)应采取积极措施保护甲方及其参与试验人员免于遭受伤害(包括但不限于身体或财物)并赔偿所受之一切损害，包括遭提出之任何要求、诉讼、宣告、清偿及合理之律师费及其它因辩护产生的费用。甲方同意提供乙方合理之必要协助，与该第三人进行谈判、和解及提出抗辩等。

　　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.

　　乙方就下列事项，可不对甲方及其参与试验之人员负赔偿责任：(1)不遵循试验计划书中的相关规定，(2)不遵守行政院卫生署法规的行为。但乙方明了受试者(包括其法定继承人及其它法定请求权人)对乙方(及乙方复委托之受托研究机构)有直接请求权。

　　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.

　　乙方就下列事项，应对甲方、甲方参与试验之人员及/或受试者负赔偿责任：(1)甲方及其参与试验人员按照本试验计划书执行，造成受试者遭受伤害。(2)不包含在受试者的医疗保险费而致使甲方、甲方之参与试验人员及/或受试者所遭受到之损失。(3)非由甲方疏忽或失当所引起而造成之受试者伤害。

　　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.

　　乙方复委托案件予受托研究机构，乙方应使其受托研究机构承担以下责任，并与乙方连带负责：(1)负责赔偿研究用产品缺失所造成受试者及甲方之一切损害;(2)负责赔偿乙方之复委托之受托研究机构所造成受试者及甲方之一切损害。

　　甲乙双方应尽最大努力彼此协商解决任何的冲突或索赔问题。

　　16. Insurance. 保险

　　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.

　　乙方或其受托研究机构应为其临床试验计划投保一般商业责任险、自身责任保险或临床试验保险。上述保险应可足以提供乙方在本合约责任中所需负担的赔偿。乙方应于试验开始前提供此类保险的书面证据给甲方。

　　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.

　　乙方应于上述保险取消、不续约或更改前至少十五(15)天以书面方式告知甲方;乙方若于此十五(15)天的期间内没有找到其它同类的保险取代，则甲方有权在此十五(15)天的期限到期时，不经任何的额外的等候时间且无需通知即有效的径行终止本合约。

　　17. Protection of Privacy 遵从隐私保护

　　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.

　　依据法律及其实施细则所规定，除治疗目的、支付、或为了医疗照护以外，甲方不得在未经当事人授权的情况下任意使用或透露被保护的医疗病历数据。甲方将遵循规定，取得个别进入试验的受试者同意，同意这些被保护的医疗病历数据将为了达到对此试验的进行及监测之目的而被乙方披露及使用。乙方同意除非法律及受试者授权允许，乙方不得对任何人或任何团体揭露被保护的医疗病历资料。

　　18. Guarantee担保

　　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.

　　甲方不担保有关本试验的结果，并且不保证其所有权具有可销售性、适用性等特定的效果。甲方不需为试验结果所引发对乙方或其它团体或个人所造成的任何直接、相应、或其它的损害负责。

　　19. No Waiver 非放弃追究

　　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.

　　放弃追究另一方任何违约或不履行本合约的责任不应被视为继续放弃对任何此类重复的违约行为或其它违约或不履行合约责任的追究。

　　20. Disputes纠纷

　　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.

　　若本合约引起之争执，或违反规定，且上述的争执无法经过谈判及彼此的同意解决争端时，双方同意首先试图真诚地调解纠纷，才诉诸仲裁诉讼，或是寻求其它的争端解决程序来解决。立合约书人同意以台湾台北地方法院为第一审管辖法院。

　　21. Entire Agreement 整体协议

　　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.

　　此合约为双方间与此试验有关的所有协议，并取代所有先前或同时间发生的所有书面或口头的陈述或协议。此合约凌驾于任何存在于乙方及主要试验主持人之间的不一致，除非经双方书面签署，否则不得修订、改变或修正。

　　22. Transfer 转让

　　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.

　　任一方在本契约中之权利及义务，非经他方事前书面同意，不得转让予任何第三人。任一方若企图在没有这样的同意之下让渡此合约，则属无效。

　　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.

　　若此合约中的任何条款在 法律的法庭管辖之下无效时，此类的无效性不应扩及合约中的其余条款，其余的条款仍应继续拥有完全的效力与作用。

　　24. Governing Laws 管辖法令

　　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.

　　此合约应被解释为与 法律并受其管辖，并与法律规则没有抵触，并不受当事人的住所或居住地或财产所在地影响。此合约中的任何解释或实施都应以 为管辖地。因本合约引起之争议，双方愿先行接受有关机关协调，若协调不成，同意台北地方法院为第一审管辖法院。协调费用由乙方负担。

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

　　本契约书一式三份，甲乙双方及甲方之试验主持人各一份。

　　甲方Party A

　　院长：Superintendent: (Signature)

　　Date:

　　我已详读并同意此合约中的事项。

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

　　乙方Party B

　　代表人：Representative Print Name: (Signature)

　　Date: