Welcome to the online resource provided by the Forum for Ethics Review Committees in India (“FERCI”). This resource provides access to and use of the FERCI service (“Service”) through the website [insert URL when it is available] and/or related websites (collectively, the “Site”), which include the Interpreter, Simplifier, Check Ethics, and Regulert tools on the Site for individuals and organizations interested in conducting and reviewing clinical trials and research involving human subjects.
By registering for or using an account for the Service (“Account”), you (a) agree to the following terms and conditions of this service agreement (“Agreement”) on behalf of yourself and the company or organization identified as the Account holder (if any) during the registration for the Service (“Registrant”); (b) represent and warrant that you are authorized to accept this Service Agreement on behalf of the Registrant; and (c) agree that such Registrant will be responsible for the acts and omissions of any individual users who register for or use the Account. You agree that this Agreement is enforceable like any written agreement signed by you and is legally binding between you and FERCI. If you do not agree to the terms and conditions of the Agreement, you should not register for an Account and you should leave this Site. Otherwise, the duration of the Agreement shall be as set forth in Section 6.
Section 1. Definitions. Capitalized terms used in this Agreement shall take the meaning of such terms as defined in this Agreement, including those in Supplement A for Definitions at the end of this Agreement.
Section 3. Registration; Account Security.
Account registration is required to use the Service. FERCI reserves the right to refuse registration, or to refuse or limit access to the Service or any features, to anyone in its sole discretion. You will provide accurate, current, and complete information (including about Registrant and Registrant’s users) in any registration or other Account-related forms on the Site (“Registrant Information”) and agree to maintain the security of your username(s) and password(s). You will maintain and promptly update the Registrant Information to keep it accurate, current, and complete.
Section 4. Grant of Rights.
4.1 Grant of Rights. Subject to the terms of this Agreement FERCI hereby grants Registrant a non-exclusive, non-transferable, non-sublicensable right during the Term to access and use the Service solely for Registrant’s purposes as contemplated by this Agreement. The right includes only rights under FERCI’s IP Rights necessary to use the Service in accordance with the Documentation. The right is also limited to use of the version(s) of the tools available on the Site. You assume full responsibility for your use of the Service in accordance with the terms of this Agreement.
4.2 Ownership. Subject to the rights granted to Registrant above, FERCI and its licensors and suppliers own and retain all right, title, and interest in and to the following (collectively, “FERCI Property”): (a) the Service, the Site, and all other software, hardware, technology, documentation, and information provided by FERCI in connection with the Service; (b) all ideas, know-how, and techniques that may be developed, conceived, or invented by FERCI during its performance under this Agreement; and (c) all worldwide patent, copyright, trade secret, trademark and other intellectual property rights in and to the property described in clauses (a) and (b) above.
4.3 Restrictions on Rights. Except as expressly permitted under this Agreement, Registrant shall not directly or indirectly do any of the following: (a) access, use, sell, distribute, sublicense, broadcast, or commercially exploit any FERCI Property or any rights under this Agreement, including without limitation any access or use of any FERCI Property on a service bureau basis or for any Registrant processing services beyond the scope specified in this Agreement (such as for any Third Parties on a rental or sharing basis); (b) introduce any infringing, obscene, libelous, or otherwise unlawful data or material into the Service; (c) copy, modify, or prepare derivative works based on FERCI Property; (d) reverse engineer, decompile, disassemble, or attempt to derive source code from any FERCI Property; or (e) remove, obscure, or alter any intellectual property right or confidentiality notices or legends appearing in or on any aspect of any FERCI Property.
4.4 Access to Data. FERCI is not responsible for providing you with a license to any data or databases external to the System (whether public or private).4.5 Limitations on Rights Granted. This Agreement shall not be construed as a sale, lease, loan, or transfer of FERCI’s IP Rights, nor as the grant of a license to any Third Party for the Service. This Agreement does not provide Registrant with any other rights except those expressly granted in this Agreement.
Section 5. Payment.
Subject to the terms and conditions of this Agreement, you are not obligated to pay any fees to FERCI for the right to use the Service granted to you under this Agreement.
Section 6. Term and Termination.
6.1 Term. This Agreement is effective as of the date of initial access of the Service and expires at such time as all license and service subscriptions have expired in accordance with their own terms (the “Term”). Notwithstanding anything to the contrary, FERCI may terminate this Agreement, for any reason or no reason whatsoever, at any time by delivering a written notice of termination to you. Termination is not an exclusive remedy and the exercise by either Party of any remedy under this Agreement will be without prejudice to any other remedies it may have under this Agreement, by law, or otherwise.
6.2 Technical Support and Upgrades. FERCI may choose to, but shall not be required to, provide Technical Support or deliver Upgrades during any period in which this Agreement is in effect.
6.3 Registrant’s Responsibilities upon Termination. Upon termination of this Agreement, Registrant shall discontinue use of the Service.6.4 Survival. Sections 4.2, 6.3, 6.4, 7, 8, 9, 10.2, 10.3, 10.6, 10.8, and 10.13, and any other provision which by its nature should survive termination of this Agreement, shall survive any expiration or termination of this Agreement.
Section 7. Confidential Information.
7.1 No Disclosure. Each Receiving Party agrees that it will keep in confidence all Confidential Information of the Disclosing Party and that it will not use for any other purpose other than its performance of its obligations under this Agreement, any Confidential Information it receives from the Disclosing Party except with the express written permission of the Disclosing Party. Each Receiving Party also agrees not to disclose to any Third Party the Confidential Information received from the Disclosing Party, except that a Receiving Party may disclose such Confidential Information to its third-party agents who have previously agreed in writing, either as a condition to employment or in order to obtain the Confidential Information, to be bound by terms and conditions at least as stringent as the terms of this Agreement. Each Receiving Party shall only disclose the Disclosing Party’s Confidential Information to those employees and agents with a need to know such Confidential Information. Notwithstanding the foregoing, the Receiving Party shall be permitted to disclose Confidential Information that is required to be disclosed to comply with applicable laws, court order, or governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party and takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure. The prior written notice must be given in sufficient time to permit the Disclosing Party to seek a protective order or some other accommodation to protect its Confidential Information.
7.2 Remedies. FERCI and Registrant each agree that any breach of this Section 7 will cause irreparable harm or injury to the other Party and that such other Party shall be entitled to declaratory, injunctive, or other equitable relief, in addition to any other legal or equitable remedies it may have, for any such breach.
7.3 Return of Confidential Information. Each Party shall return the Confidential Information of the other Party (except that such Party may retain one archive copy in order to monitor its obligations under this Section 7) promptly upon the request of the other Party or upon termination of this Agreement.
Section 8. Disclaimer of Warranty. The Service provided under this Agreement is provided on an “as-is” basis without warranties of any kind, either express or implied, including, but not limited to, implied warranties of merchantability, fitness for a particular purpose, or non-infringement, or of any implied warranty arising from course of performance, dealing, usage, or trade. No advice or information given by FERCI, its affiliates, agents, representatives, or contractors, or their respective employees, shall create a warranty. FERCI does not warrant that the Service, in whole or in part, will meet Registrant’s requirements or operate without interruption or be error free.
Section 9. Limitation of Liabilities and Indemnification.
9.1 Limitation of Liabilities.
(a) No Party shall under any circumstances be liable to the other Party or any Third Party for indirect, incidental, special, consequential, or punitive damages, losses, liabilities, costs, or expenses (including, but not limited to, loss of profits, goodwill, revenue, or business), even if the Party has been advised of the possibility of such damages, (1) resulting from or in any way related to this Agreement or termination of this Agreement, or (2) arising out of, or alleged to have arisen out of, (A) breach of this Agreement, (B) the failure by any Party to comply with the express conditions specified in this Agreement, or (C) any event related to the making or performance of this Agreement. This limitation applies regardless of whether such damages are sought based on breach of contract, breach of warranty, negligence, strict liability, tort, or any other legal or equitable theory. Registrant understands that FERCI is not responsible, and will have no liability, for hardware, software, or other items or any services provided by any persons or entities other than FERCI.
(b) No Third Party vendor or developers of software provided by FERCI for use with the Service shall be liable to Registrant or any Third Party for direct, indirect, incidental, or consequential damages arising from use of the Service.
(c) FERCI assumes no responsibility and is not liable for any loss or damage of data used or stored through use of the Service. Registrant agrees to maintain and be solely responsible for backing-up data and developing and implementing a disaster recovery plan in case of data loss or damage. Registrant shall be responsible for complying with all local, state, and federal laws pertaining to the use and disclosure of any data.
(d) Registrant shall indemnify and hold harmless FERCI and its officers, directors, employees, and agents from and against all claims, damages, losses, and expenses (including reasonable attorneys’ fees) arising out of any Third Party claim involving a breach of Registrant’s obligations under this Agreement.
9.2 Intellectual Property Protection.
(a) Limited Remedies. If the Service is in FERCI's opinion likely to be, or if the Service is held to be, infringing, FERCI shall at its expense and sole discretion either: (i) procure the right for Registrant to continue using the Service; (ii) replace the Service with a non-infringing equivalent; (iii) modify the Service to be non-infringing; or (iv) terminate the Service.
(b) Disclaimer. The foregoing states the entire liability of FERCI and the exclusive remedy for Registrant, with respect to any alleged or actual infringement or misappropriation of patents, copyrights, trademarks, trade secrets, or other IP Rights of a Third Party by the Service.
Section 10. Miscellaneous.
10.1 Legal Status of the Parties. Each Party is an independent contractor and will act as such in accordance with the terms of this Agreement in performing its respective obligations under this Agreement.
10.2 Governing Law; Jurisdiction; Venue. The validity, construction, and performance of this Agreement and the legal relations among the Parties shall be governed by and construed in accordance with the laws of India. The United Nations Convention on Contracts for the International Sale of Goods and the Uniform Computer Information Transactions Act, as currently enacted by any jurisdiction or as may be codified or amended from time to time by any jurisdiction, do not apply to this Agreement. The Parties hereby consent to the exclusive jurisdiction and venue of the courts of India for any action arising under this Agreement. Both Parties hereby agree that process may be served for any such action in the manner provided in this Agreement for giving of notices or otherwise as allowed by the law of India or the jurisdiction in which FERCI is located.
10.3 Attorneys’ Fees and Costs. The prevailing party in any action to enforce this Agreement will be entitled to recover its attorneys’ fees and costs in connection with such action.
10.4 No Third-Party Beneficiaries. This Agreement is intended for the sole benefit of the Parties. Unless expressly provided in this Agreement, no rights or powers shall arise under this Agreement in favor of any Third Party.
10.5 Force Majeure. The failure of any Party to perform under this Agreement is excused as a result of governmental action, laws, orders, or regulations, or as a result of events, such as war, acts of public enemies, fires, floods, earthquakes, or any causes of like kind beyond the reasonable control of such Party for so long as such cause exists, but only to the extent such failure is caused by such law, order, regulation, or event.
10.6 Notices. Formal notices required or permitted under this Agreement shall be given in writing. Written notices may be delivered personally, sent by postal service, or by a nationally-recognized courier service. All notices or other communications required or permitted shall be deemed to have been given: (a) if by personal delivery to the proper address, on the date of such delivery; (b) if by courier service to the proper address, on the date of such delivery; or (c) if mailed to the proper address, postage prepaid certified or registered mail, return receipt requested, on the date of delivery. Any notices shall be sent to the following: If to Registrant: To the address/contact on the most recent contact information provided by Registrant If to FERCI: Forum for Ethics Review Committees in India Dept. of Clinical Pharmacology TN Medical College and BYL Nair Charitable Hospital Mumbai Central Mumbai 400 008 India Attention: Or to such other addresses, numbers, and persons as a Party may designate to the other Party by written notice provided in accordance with this provision.
10.7 Assignment. Registrant may assign its rights and duties under this Agreement only with the prior written consent of FERCI. Any assignment contrary to this Section shall be null and void. All terms and provisions of this Agreement shall be binding upon and inure to the benefit of the Parties and their respective permitted transferees, successors, and assigns.
10.8 Publication. The publication of any manuscript or work based, substantially or in any material way, on information compiled by, or derived, learned, or acquired from use of the Service, or any part thereof, shall give credit to the Service in a manner consistent with industry practice.
10.9 Audit. Upon FERCI’s written request, you shall certify in a signed writing that your use of the Service is in full compliance with the terms of this Agreement. FERCI shall have the right, with reasonable notice to Registrant, to audit Registrant’s use of the Service to assure compliance with the terms of this Agreement. If such inspections or audits disclose that you have accessed or permitted access to the Service in a manner that is not permitted under this Agreement, then FERCI may terminate this Agreement pursuant to Section 6 and you are liable for the reasonable costs of the audit in addition to any other fees, damages, and penalties FERCI may be entitled to under this Agreement and applicable law.
10.10 Amendment and Waiver. Any provision of this Agreement may be amended or waived only by execution of a written document signed by representatives of both Parties. Any amendment or waiver effected in accordance with this Section shall be binding upon the Parties and their respective successors and assigns. Failure to enforce any provision of this Agreement by a Party shall not constitute a waiver of any term of this Agreement by such Party.
10.11 Severability. If any provision of this Agreement shall be adjudged by any court of competent jurisdiction to be unenforceable or invalid, that provision shall be limited to the minimum extent necessary so that this Agreement shall otherwise remain in effect.
10.12 Integration. This Agreement is the complete and exclusive statement of the mutual understanding of the Parties and supersedes and cancels all previous written and oral agreements and communications relating to the subject matter of this Agreement. Notwithstanding the foregoing, if you have entered into a separate written license agreement signed by FERCI for use of the Service, the terms and conditions of such other agreement shall prevail over any conflicting terms or conditions in this Agreement.
10.13 Interpretation. This Agreement will not be construed in favor of or against any Party by reason of the extent to which any Party participated in the preparation of this Agreement.
Supplement A for Definitions
“Confidential Information” means confidential and proprietary information which relates to either Party’s business, products, and services, which (i) if in written form, is marked “Confidential” or “Proprietary”, or (ii) if in other than written form, is identified by the Disclosing Party as confidential upon disclosure, reduced to writing or other tangible form, marked as “Confidential” or “Proprietary”, and a copy delivered to the Receiving Party within thirty (30) days of such disclosure, or (iii) although not marked “Confidential” or “Proprietary” and not otherwise identified by the Disclosing Party as confidential, is of such a nature that a reasonable person would recognize it and believe it to be confidential or proprietary. Notwithstanding the foregoing, Confidential Information shall not include any information which is: (a) known by the Receiving Party at the time of disclosure by the Disclosing Party, free of any obligation to keep it confidential, as evidenced by the Receiving Party’s written records; (b) publicly available or becomes publicly available through authorized disclosure by the owner of such information; or (c) rightfully obtained by the Receiving Party from a Third Party who has the right to disclose such information. Confidential Information shall include non-public information about the System, including FERCI’s trade secrets therein.
“Disclosing Party” means the Party disclosing Confidential Information.
“Documentation” means those documents, whether in writing or electronic format, provided to Registrant for use with the Service.
“IP Rights” means any patents, trademarks, copyrights, trade secrets, know-how, moral rights, and similar rights of any type under the laws of any governmental authority, domestic or foreign, including all applications and registrations relating to any of the foregoing.
“Party(ies)” means FERCI and/or Registrant, as the context requires.
“Receiving Party” means the Party receiving Confidential Information.
“System” means the FERCI system comprised of software and Documentation and Third Party hardware and Third Party software used to run the Service.
“Technical Support” means such preventative, maintenance and remedial services that are necessary to maintain operation of the System substantially in accordance with the Documentation and the System’s designed uses.
“Term” means the length of time for this Agreement, as described in Section 6.1.
“Third Party(ies)” mean an entity or entities other than FERCI and Registrant, as the context requires.
“Upgrade” means a new version of, or patch and other error corrections or minor enhancement issued from time to time with respect to, the Service, or a particular component thereof.