英文临床合同模板.doc_第1页
英文临床合同模板.doc_第2页
英文临床合同模板.doc_第3页
英文临床合同模板.doc_第4页
英文临床合同模板.doc_第5页
已阅读5页,还剩13页未读 继续免费阅读

下载本文档

版权说明:本文档由用户提供并上传,收益归属内容提供方,若内容存在侵权,请进行举报或认领

文档简介

CLINICAL RESEARCH ORGANIZATIONSERVICES AGREEMENTBy and BetweenXXX CO., LTD.and*制药有限公司 CLINICAL RESEARCH ORGANIZATIONSERVICES AGREEMENTThis SERVICES AGREEMENT (the “Agreement”) is made and entered into effective as of the ? ?th, 200? (the “Effective Date”) by and between *制药有限公司 (“*”), with its main offices located at*and XXX, with its main offices located at ?, together with its affiliates and subsidiaries (“XXX”). * and XXX may be referred to herein collectively as the “Parties” or individually as a “Party”.RECITALSWHEREAS, XXX is engaged in the business of Clinical Trials Management and other related services (“Services”) for the pharmaceutical industry; and WHEREAS, * desires to engage XXX to perform such Services in connection with Clinical Trial Protocol “Tazocin, Antibiotics intervention study” (the “Study”), in accordance with and subject to the terms of this Agreement.NOW THEREFORE, in consideration of the premises and the mutual covenants and conditions hereinafter set forth, the parties agree as follows:AGREEMENT1PROJECT SPECIFICATIONSXXX hereby agrees to perform Services for * as mutually agreed by the Parties and set forth in the Budget Proposal (the “Proposal”) attached hereto as Exhibit A (proposal no. ?), and incorporated herein. The Proposal shall include information concerning the Services to be provided and the project budget. . * reserves the right to make reasonable amendment to the Proposal from time to time which needs to be agreed by XXX2BUDGET ESTIMATES, PAYMENT SCHEDULE, AND TERMS2.1* agrees to pay XXX for Services rendered pursuant to the Proposal or amendment thereto. As compensation for XXXs performance of the Services, * shall pay XXX a total Service fee of RMB? (the “Total Budget”), based upon the listing of Services and budget set forth in Exhibit A.2.2The payment schedule will be as the following:MilestoneAmount(in RMB)Upon receipt of the signed agreement?(Paid)One month before close-out visit report?TotalsRMB?Final reconciliation of all Total Budgets will be made prior to completion of the Services.2.3XXXs invoices shall be provided to the Accounting Department of *, and shall be payable within fifteen (15) days of *s receipt of such invoices. Any unpaid overdue invoices shall be subject to the following interest and penalties:2.3.1 1% of the invoice amount will be billed by XXX and paid by * as a penalty if a particular payment remains overdue for a period of 30 days from *s receipt of the XXX invoice, as such invoice is due and payable.2.3.2 2% of the invoice amount will be billed by XXX and paid by * as a penalty if a particular payment remains overdue for a period of 60 days from *s receipt of the XXX invoice, as such invoice is due and payable. 2.4 Payment Survival. If the Agreement is prematurely terminated by *, *s obligations to pay Service fee to XXX for the Services performed under the Agreement prior to termination set forth in Article 11 or expiration of the Agreement shall survive such termination or expiration. The amounts of said Service fee shall be calculated and paid based upon actual work completed and costs incurred at the time of termination set forth in Article 11, plus an additional 1% of the Total Budget to compensate the work for termination by * (hereinafter “Additional Compensation”). No Additional Compensation shall be paid if the Agreement is terminated by XXX or as a result of force majeure as provided in Article 17 hereof. 2.5 Payment in connection with the Services will be made to: 帐户名:XXX有限公司开户行:帐号:XXX shall be responsible for keeping * informed of its updated bank account information and * shall not be responsible for any delay as a result of XXXs failure to do so. 3WARRANTIES AND REPRESENTATIONS:3.1Representations and Warranties of *:* represents and warrants that it has the legal right and power to enter into this Agreement.3.2Representations and Warranties of XXX:3.2.1 XXX warrants that it will render the Services requested by * in accordance with high professional standards and that such Services will be completed in conformance with the Proposal. 3.2.2 APEX warrants that the personnel assigned to perform the Services under this Agreement shall be compliant to the conduct of ICH-GCP and acceptable to *, whose consent will not unreasonably withheld.3.2.3 XXX further warrants that it shall perform the Services in compliance with the applicable laws of the Peoples Republic of China (“China” or “PRC”), including any protocols in clinical studies adopted in the PRC.3.3.4The warranties contained in this Agreement are in lieu of all other warranties, expressed or implied.4 COMMUNICATIONSAny notice required or permitted under this Agreement shall be in writing and shall be deemed given if delivered personally, mailed by prepaid, first class mail, or sent by express courier service, to the party to be notified at the addresses set forth below (or such other address as shall be designated by written notice; provided that notices of a change of address shall be effective only upon receipt thereof):If to *If to XXX:*制药有限公司 XXX有限公司*Attention: *Attention: 5 NON SOLICITATIONEach Party agrees not to solicit any employee of the other with whom such Party has had contact during a project assignment under this Agreement without the prior written permission of the other Party during the term of the project assignment and for a period of 6 months thereafter.6 OWNERSHIP AND CONFIDENTIALITY6.1 Ownership of Confidential Information. * and XXX agree that the other party is the owner of its respective Confidential Information.6.1.1 XXX acknowledges that * has a proprietary interest in the protocol, data specifications, documentation, or any information in any form disclosed to XXX by * before, during, or after the term of this Agreement, or developed by XXX solely for * (collectively, “* Confidential Information”), and that such * Confidential Information is the exclusive and confidential property of *, and XXX shall have no rights or claims to such * Confidential Information or any research derived from such * Confidential Information.6.1.2 Similarly, * acknowledges that all computer programs, software, applications, global data management system, the Proposal and other documentation generally used by XXX and not directly related to or developed solely for * are the exclusive and confidential property of APEX or the third parties from whom APEX has secured the right of use. * agrees that any improvement, alteration or enhancement to XXXs systems, software, applications or processes which are developed or implemented during the course of the Services shall be the confidential property of XXX (the “APEX Confidential Information”).6.2 Confidentiality 6.2.1 * shall not disclose the XXX Confidential Information to any person or third party other than its employees or consultants who are bound by similar obligations of confidentiality, and agree not to use any of the other partys Confidential Information at any time except for the purposes of this Agreement or except as expressly authorized by this Agreement. 6.2.2 XXXXXX shall not disclose the * Confidential Information to any person or third party other than its employees or employees of affiliated companies of the XXX Group who are bound by similar obligations of confidentiality and who need to know such information in order to perform their duties in carrying out the Proposal hereunder. XXX agree not to use any of the other partys Confidential Information at any time except for the purposes of this Agreement or except as expressly authorized by this Agreement.6.3 ExceptionsThe Parties acknowledge and agree that each recipient hereunder shall have no liability to the other party with respect to use or disclosure to others not parties to this Agreement of such information that:a. has been already publicly known by the recipient prior to its disclosure by * or XXX, as the case of may be, of such information to the recipient; orb. has become publicly known, without fault on the part of the recipient or through any act or omission of the recipient in breach of this Agreement, subsequent to disclosure by * or XXX, as the case may be, of such information to the recipient; orc. has been developed or obtained by the recipient without use of, or independent from, information received from the other party; ord. has been received by the recipient at any time from a source other than the other party, lawfully having possession of such information and who is under no obligation to any other party with respect to such information at the time of disclosure. 6.4 Authorized Disclosure. In the event Confidential Information must be disclosed to governmental agencies or is otherwise required to be disclosed by law, the recipient may not make such disclosure without giving the disclosing party prior written notice of such obligation to disclose with such notice being given as early as reasonably possible.6.5 Survival. This Article 6 shall survive the termination or expiration of this Agreement.7 SECURITY AND DISPOSITION OF COMPUTER FILES AND STUDY MATERIALS7.1 Materials. The Parties will exchange research materials related to the Services hereunder. XXX will take reasonable and customary precautions, including periodic backup of computer files, to prevent the loss or alteration of *s data, documentation, and correspondence. Upon termination of this Agreement, APEX will dispose of * computer-stored files and study materials according to *s standard operating procedures. * may communicate any special request for the disposition of materials in writing to XXX. * shall bear all costs incurred by XXX in complying with any such written instructions furnished by *. XXX will provide a written estimate to *, and * will provide written approval, of all such costs prior to any action by XXX.7.2 XXX shall have the right to retain one copy of any study materials, documentation, and correspondence that XXX deems necessary to meet regulatory or XXXs own internal audit requirements.8 OBLIGATIONS OF CLIENT8.1 * agrees that performance of the Services by XXX will require the cooperative involvement of both Parties, and * hereby agrees to provide such reasonable assistance as necessary to enable XXX to perform the Services. 9 LIABILITY FOR DIRECT AND INDIRECT DAMAGES9.1 In no event shall XXX be liable to * for any indirect, incidental, special, or consequential damages, punitive or exemplary damages or lost profits arising out of its provision of the Services to *, even if XXX has been advised of the possibility of such damages, except to the extent that such damages result from the negligence, recklessness, or willful misconduct of XXX, its employees, or agents. 9.2 This Article 9 does not apply to breaches or liabilities arising under Articles 6 and 10.10 INDEMNIFICATION10.1 INDEMNIFICATION BY *:10.1.1 * hereby agrees to indemnify, defend and hold harmless XXX, its directors, officers, stockholders, employee, agents and representatives (hereafter “XXX”) against any and all losses, costs, expenses and damages (including but not limited to reasonable attorneys fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts legally obligated to pay because of any claim or claims against it to the extent that such claim or claims (1) result from *s activities under this Agreement, (2) arise out of the breach or alleged breach of any representation or warranty by * hereunder, or (3) are due to *s own negligence, misconduct or failure to perform its obligation and responsibilities. 10.1.2 This promise set forth in Section 10.1.1 provided that (1) XXX shall tender to * with prompt written notice of any such claim and the right to defend (with the reasonable cooperation and aid of XXX) or settle any such claim and (2) such indemnities shall not apply to the extent that any such claim is incurred or covered by XXXs indemnity set forth in Section 10.2 below.10.1.3 In the event that a claim or suit is or may be asserted, XXX reserves the right to claim indemnity from * in accordance with Section 10.1.1 above upon resolution of the underlying claim, notwithstanding the provisions of Section 10.1 above requiring APEX to tender to * the right to defend such claim or suit at *s own expenses. The right includes selecting and obtaining representation by separate counsel at XXXs own expenses. XXX may not settle or compromise a claim or suit without the express prior written approval of *. 10.1.4* hereby further agrees to indemnify, defend and hold harmless XXX, against any and all damages in accordance with Exhibit B. 10.2 INDEMINIFICATION BY XXX 10.2.1 XXX hereby agrees to indemnify, defend and hold harmless *, its directors, officers, stockholders, employee, agents and representatives (hereafter “*”) against any and all losses, costs, expenses and damages (including but not limited to reasonable attorneys fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts legally obligated to pay because of any claim or claims against it to the extent that such claim or claims (1) result from XXXs activities under this Agreement, (2) arise out of the breach or alleged breach of any representation or warranty by XXX hereunder, or (3) are due to XXXs own negligence, misconduct or failure to perform its obligation and responsibilities.10.2.2 This promise set forth in Section 10.2.1 provided that (1) * shall tender to XXX with prompt written notice of any such claim and the right to defend (with the reasonable cooperation and aid of *) or settle any such claim and (2) such indemnities shall not apply to the extent that any such claim is incurred or covered by *s indemnity set forth in Section 10.1 above.10.2.3 In the event that a claim or suit is or may be asserted, * reserves the right to claim indemnity from XXX in accordance with Section 10.2.1 above upon resolution of the underlying claim, notwithstanding the provisions of Section 10.2 above requiring * to tender to APEX the right to defend such claim or suit at XXXs own expenses. The right includes selecting and obtaining representation by separate counsel at *s own expenses. * may not settle or compromise a claim or suit without the express prior written approval of XXX which shall not be unreasonably withheld. 11 TERM AND TERMINATION11.1 Term. This Agreement herein shall commence as of the EFFECTIVE DATE and, shall continue until completion of the Services unless sooner terminated as provided in this Article 11.11.2 Termination for Breach. If either Party breaches this Agreement in wanton negligence or material default which includes the following, the non-breaching Party may terminate the Agreement with thirty (30)-day prior written notice to the other. 11.2.1 * fails to make payment for any payment payable and due hereunder and such failure continues for thirty (30) days after receiving XXXs written notice thereof.11.2.2 Any Partys material breach of any provisions hereof that is not cured within fifteen (15) days upon written notice thereof from the non-breaching Party.11.2.3If the Agreement is terminated pursuant to this Section 11.2, the non-breaching Party shall have the right to pursue the breaching Party for any damages caused by that Partys breach pursuant to this Agreement.11.3 Termination for Non-Breach. Notwithstanding the forgoing provisions hereof, * may terminate this Agreement without XXXs written consent for reasonable non-breaching causes upon thirty (30)-day prior written notice to XXX. 11.4 Survival Provisions. Upon the termination provided in this Article 11, the obligations and rights of the Parties under Articles 2, 5, 6, 7, 9, 10, 1220 will survive such termination. 12 PUBLICATIONXXX shall not publish or present data from this Study until the complete Study has been presented in full or for two (2) years after the termination of the Study, whichever comes first. Subsequent publications must refer to the multicenter findings. Thereafter, subject to the terms of this Section 12, if APEX expects to participate in the publication of data generated from this Study, it shall submit reports, abstracts, manuscripts and or other presentation materials to * for review prior to submission for publication or presentation. * shall have a minimum of sixty (60) calendar days to respond with any requested revisions, including without limitation, the deletion of Confidential Information. XX agrees to act in good faith upon requested revisions, except XXX shall delete any Confidential Information from such proposed publication. XXX will delay submission of such publication or presentation materials for up to an additional ninety (90) calendar days in order to have a patent application(s) filed pursuant to *s request upon review of the proposed publication or presentation materials.13 ENTIRE AGREEMENTThis Agreement contains the full understanding of the parties with respect to the matters described herein and supersedes all existing Agreements and all other oral, written or other communication

温馨提示

  • 1. 本站所有资源如无特殊说明,都需要本地电脑安装OFFICE2007和PDF阅读器。图纸软件为CAD,CAXA,PROE,UG,SolidWorks等.压缩文件请下载最新的WinRAR软件解压。
  • 2. 本站的文档不包含任何第三方提供的附件图纸等,如果需要附件,请联系上传者。文件的所有权益归上传用户所有。
  • 3. 本站RAR压缩包中若带图纸,网页内容里面会有图纸预览,若没有图纸预览就没有图纸。
  • 4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
  • 5. 人人文库网仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对用户上传分享的文档内容本身不做任何修改或编辑,并不能对任何下载内容负责。
  • 6. 下载文件中如有侵权或不适当内容,请与我们联系,我们立即纠正。
  • 7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。

最新文档

评论

0/150

提交评论