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Date - Oct , 2025
OVIS Access Termination -In case of non-payment of usage charges over 15 days, after the credit period, the OVIS Service Provider has the authority to discontinue the access rights given to the Company- The CRO client.
SERVICE LEVEL AGREEMENT for WWW.OVISBIO.COM
This agreement is effective and binding to the subscriber and user of OVIS service, hereinafter called as the “Company”. The service is offered by M/s Inforcom Technologies Pvt. Ltd., a software consulting firm, having its registered office at 6, North View – II, Opp. L.D. College of Engineering, Navrangpura, Ahmedabad – 380009, Gujarat, India. (PAN No. 24AAA7879N1ZW, CIN U72200GJ2000PTC037951, ROC 04-37951/2000-2001) hereinafter called as the “Service Provider”. The Company and the Service Provider will collectively be referred to as “Parties” and individually as a “Party”.
PREAMBLE
Whereas the Company is in the business of clinical research conducting bioavailability / bioequivalence studies in healthy volunteers (hereinafter called as "subjects" or "volunteers"). The subject(s) participation in the bioequivalence / bioavailability studies being conducted, are based upon the screening and enrollment according to the requirements of study protocol(s). The Online Checking System for Volunteers participation days information used by the leading Contract Research Organizations (CROs) supports in abiding to the Good Clinical Practices and aimed attending the issue of cross participation of volunteers at various CROs. The hopping volunteers affect the results of clinical trial project(s) as well as end up in danger themselves due to frequent participations in such projects. Hence the Company, wishes to verify the number of days a volunteers has cleared from the previous participation and also update the new blocking days, for the enrolled volunteers at the Company's studies, through Internet-based platform for various CROs belonging to a common geographical area.
OVISTM – Online Volunteers Information System – is a trademark application service and software application designed and developed by Inforcom Technologies Pvt. Ltd., Ahmedabad, hereinafter referred as OVIS. All the functions, processes, features, reports and layouts are fully owned by the Service Provider.
WHEREAS, Company is informed by the Service Provider that as requested and subscribed by the Company, the Service Provider is willing to provide the services (hereafter called “Service”) of their SaaS (Software as a Service) product - OVISTM - Online Volunteer Information Services, providing Volunteers Cross Participation Tracking, hereinafter described, after clearly understanding its importance and implications in accordance with the provisions of this Agreement; and
WHEREAS, Company is informed by the Service Provider that it is qualified and certified to perform the Online Volunteer Information Services procedures, all relevant factors considered, and that such performance will be in furtherance of Company’s business.
NOW, THEREFORE, in consideration of the mutual covenants set forth herein and intending to be legally bound, the Parties hereto agree as follows:
1. SERVICES
1.1 Subject to the terms and conditions of this Agreement, the Service Provider grants the Company and its affiliates a non-exclusive chargeable license, during the term of this Agreement, to use the OVIS. The version in reference in ver 4.0
1.2 The Service Provider shall provide the following services to the Company under OVIS:
a) Secured access rights with standard password policy with standard access assignment approach and data confidentiality.
b) Company to upload volunteer information in a secure means, protecting privacy according to the applicable laws of India – Company shall have a facility to upload the following volunteer information: full name, gender, birth date, volunteer’s photo and four finger prints (two thumbs and two pointing fingers) as well as the last sampling date and the blocking days – the mandatory fields, as well as identity proof document name, Aadhar Number, Two permanent blocking options (the optional fields).
c) Data Verification of the uploaded information by participating CROs.
d) Probable matches based on volunteers' fingerprints or names and gender. The output shall offer – volunteers photo, identity proof documents name, remaining days, last sampling date, re-eligible date, days from the last sampling, permanent block information and city of blocking.
e) View volunteers' sharable data.
f) Image viewing for a match with the existing data on web.
g) View the existing status of a volunteer.
h) Assign / Edit new status with audit trails.
i) Data entry editing window and locking facility.
j) View status of any volunteer initialized by the Company by QR code or on screen.
k) Download volunteer status and activity list for printing.
l) Access creation facility with levels – User, Observer, Admin; Activation Status control – Activate, Deactivate, Password setting and profile editing.
m) Audit reports of User creation, Transactions and Access as well as Login processes. The reports and the data shall be archived after the designated time.
Data Backup, Archival, Retention and Restore processes shall be as per the Service Provider’s Policy which shall be in confirmation to the applicable Govt. Regulations, Acts as well as the Guidelines. Any information sent for the Service by a Company shall not be deleted. A Company which populates the data on OVIS, shall have a controlled edit rights to alter its data, which further will be followed by an audit trail generated by the system.
The Service Provider agrees to provide volunteers information contributed by the Company limited to the ‘elapsed days from the last sample date’ to the other participating CROs and vice versa. The Volunteers can avail the information of their eligibility, if issued by the Company. This shall be controlled as per the Service Providers plan and approach.
2. DISCLAIMER
2.1 OVIS Service does not provide any volunteers or guarantees their screening result quality, fitness, behavior / compliance or participation confirmations. OVIS Service involve upto and not beyond the above mentioned information (clause 1.2). The company takes the final call for the enrollment of a volunteer in a study.
2.2 The OVIS software application is developed with the features to satisfy the compliance requirements of a web based service. The Service Provider shall not be responsible for the compliant practice of its use at the Company. This will be implemented by the Company with their SOPs, agreements etc.
2.3 The practice of the Processes and Services, including but not limited to, the Level of Security, System and Data protection, Coding, Response Timing, Output Quality, Documentation, Validation, Testing, Operational Management, Support, Internal Operational Guidelines, Data Archival, Retention, Restore etc. will be at an optimum level as decided by the Service Provider which shall suffice the requirements of the Govt. Regulations, Acts Guidelines. In case these practices of the Service Provider differ than the same practices of other subscribers, which may be of different level of cost or newer technology, it will not be considered a Willful Misconduct or Negligence.
2.4 Further OVIS displays the information as sent by the participating CRO. The identity of the CRO or any identifiable information of the CRO shall not be displayed. Any insufficient, incomplete or incorrect information sent accidentally or intentionally by a participating CRO, shall not be checked, verified or modified. The Service Provider is not responsible for any dishonest or non moral practices of a Company. Further the Service Provider shall not be responsible for the quality and matching results of finger prints due to but not limited to the performance limitation of the Fingerprint capturing equipments, quality of finger prints of the volunteers or any other such influencing factors.
2.5 The Company understands the possible risks and threats, from volunteers, Auditors, Sponsors, Ethics Committees and any other sources, due to the usage of OVIS. The Company shall use OVIS service at their own risk. The Service Provider shall not be liable for legal actions or financial damages, of any type or nature caused due to information shared by the CROs or absence of such information, which can be due to incorrect or late data insertion or data not inserted for any reason, by the other participating CROs, or the unavailability of OVIS service due to circumstances beyond Service Provider’s reasonable control, including but not limited to the Internet or the Hosting Server related issues as well as the internal network of the Company, the Internet Service Provider Status and the Internet connectivity till the server as well as reported Server Hacks.
2.6 OVIS is not designed to detect false identity proof documents. The Service Provider shall not be responsible for any duplicate or fraudulent or forged document presented by a volunteer or any agency or any identity theft, however OVIS shall use best efforts to instruct the CROs about the proper and correct manner of uploading the data and correct usage of the system (required details, timing and format). The OVIS results shall be based on the inputs provided via document or biometrics, as presented by a volunteer or a participating CRO.
2.7 Service Provider ensures that OVIS is available on a 24/7 basis. OVIS availability may change due to any downtime or caused due to any unavailability caused by circumstances beyond Service Provider’s reasonable control. The Support to the Service shall be offered during the normal office hours from Monday to Friday.
2.8 The Service output information provided can vary in terms of its position and format or certain information can be discontinued under certain special circumstances such as changing government policies, legal or criminal or social issues, National or International Quality / Compliance, Auditor’s comments or pertaining to other social responsibilities or the safety of the Service Providers’ personnel etc. The final decision for such alteration shall be that of the Service Provider. The Service Provider shall inform the Company about such changes.
2.9 The Service Provider will not be responsible for any sharing of the usernames and passwords by Company’s employees or an unauthorized use of OVIS by the Company personnel and the resulting outcome due to such sharing or an unauthorized use.
3.0 In case the usage of the Service has created data of multiple locations (under the same user account), the Service Provider shall not separate the data by locations or create separate reports for such multi location usage of OVIS.
3. The Deliverables
3.1 The Service Provider shall provide the installable version of the client side application and drivers / dlls. The Service Provider shall not provide the source code for any part of the application developed.
3.2 The deliverables shall not include the required hardware, accessories, operating system software, database systems, third party tools / applications, connectivity, hosting space / domain name if required, licensing, hardware locks etc.
3.3 21CFR11 compliance self assessment document shall be maintained at the Service Providers premises with the Regulations, Technical Controls / Functionality/ Security required and the Actual noting check list. The Service provider shall arrange to display these documents as per their policy.
3.4 Username and Password for OVIS access – After the registration and payment clearance by the Company, the Service Provider will create an admin username and password and send it to the designated authority as mentioned by the Company. The Company is responsible for maintaining the confidentiality of this username and password, and for all activities occurring under it. The Company agrees to promptly notify the Service Provider of any unauthorized use of Company's username and password. The Company agrees to ensure that it will properly exit the web site at the end of each session.
3.5 The Company will generate reports from the links provided in OVIS. The Service Provider shall not generate reports for the Company. These links are archived after a fix time.
4. PAYMENT AND INVOICING TERMS
a) The Company shall pay to the Service Provider for the Services of OVIS under this Agreement as per the charges mutually agreed and mentioned in the Purchase Order (if practiced by the Company) along with the time frames.
b) OVIS is a Pre-paid service. Invoices will be submitted at the beginning of each usage term. The company shall make the payment within thirty days upon receipt of an invoice. The fee will be paid by a cheque / bank transfer to a bank account disclose by the Service Provider in writing.
c) The Service Provider has the authority to discontinue the access rights given to the Company after written intimation, in case of non-payment of undisputed invoices for the entire term mentioned in the invoice. Please refer to the Termination clause 9.
Certain service may attract additional charges which shall be discussed and informed to the company. OVIS is a continuous service. A break in the access duration longer than 2 months shall attract additional charge of Reconnection / Blocked Volunteers Data.
5. TERMS
This Agreement will commence on the date from which the Company starts logs in to OVIS. The same shall continue till the next update of this document.
6. STANDARD OF CARE
The Service Provider warrants that its services shall be performed by personnel possessing competency consistent with applicable industry standards and from best of its capacity and extend its prompt services.
7. Training, Validation and User Manual
Subject to Company's request, the Service Provider also agrees to provide training to the Company staff as well as other personnel recommended by the Company in control over the process, quality, safety of the information being uploaded, downloaded or updated, the truth or accuracy of the item listed, the ability of the user to fulfill their obligations according to the mutual understanding between the participating CROs. The agreed commercials shall be applicable for the training sessions.
The Service Provider shall carry out the Validation process, onsite or remotely, as per the script developed by the Service Provider, on computers of the Company. The Validation Plan-VP, Installation Qualifications IQ, Operational Qualifications OQ and Performance Qualifications PQ script shall be provided in marked pdf soft copy format for preview purpose if required. The same shall be sent to the Company in hard copy with the signatures of the Service Provider after the validation process. This process shall be carried out at an agreed commercial.
Further, on the effective date of the Agreement the Service Provider shall deliver soft copy of the User Manual to the Company.
8. AFTER SALES SUPPORT
The Service Provider shall provide support service limited to the queries and feature operations of OVIS from their registered office during regular office hours. The Service Provider shall respond to the emails, chats or telephonic modes of the queries in the regular office timings and no later than within 48 hours through the channels in the user manual or release document. Any computer hardware or third party equipment errors or issues at the Company, shall not be attended by the Service Provider. Any visits shall attract additional charge which shall be agreed between Parties in advance and in writing and shall refer to PO.
9. TERMINATION
This Agreement may be terminated by either Party upon thirty (30) days’ written notice to the other Party: (a) if the other Party commits a breach of any terms and conditions agreed upon by the Parties hereto and, if curable, fails to cure that breach within fourteen (14) days after receipt of written notice specifying the breach and/or (b) In the event either Party becomes insolvent, makes an assignment for the benefit of creditors, files a petition for bankruptcy, is the subject of a petition in bankruptcy which is not dismissed within ninety (90) days from the filing thereof, becomes the subject of any receivership proceeding or admits in writing its inability to pay its debts generally as they become due. Either Party may terminate this Agreement, at its sole discretion, upon three (3) months' prior notice to the other Party.
Service Provider has authority to discontinue the access rights given to the Company, with immediate effect with only intimation in case of: the Company is found using OVIS for the purpose other than Volunteers Cross Participation Tracking, any activity that disrupts / damages the Service of OVIS including erroneous data inserts, Server platform Testing, Suspected hacks / virus attack at Company environment, Testing with dummy data, Testing for any other reasons.
Further in case of Non-payment of usage charges for 15 days after the credit period, the Service Provider has authority to discontinue the access rights given to the Company.
10. GOVERNING LAW AND CONSTRUCTION
This Agreement will be governed by and construed in accordance with the laws prevailing in India. The Parties attorn to the jurisdiction of competent and appropriate courts at, Ahmedabad, State of Gujarat, India All disputes, claims arising out of this agreement shall be attempted to be resolved amicably by the both the Parties. However, in case both the Parties are unable to resolve the same amicably, such difference(s)/dispute(s) shall be referred to and finally settled by Arbitration in accordance with the Arbitration and Conciliation Act, 1996. The number of arbitrators shall be two, of whom the Company shall appoint one arbitrator and the Service Provider shall appoint one arbitrator. The Arbitration location can be decided at a later stage mutually. The Arbitration shall be held in English.
11 Registration Obligations
Service Provider holds full, final and undivided rights to offer registration and access to a prospective client requesting for OVIS services. The selection of the applicant will be at discretion of the Service Provider.
Company agrees to: (1) supply true, accurate, current, and complete information about the Company in the Registration form provided to the Service Provider, and (2) maintain and promptly update its registered information to keep it true, accurate, current, and complete.
Service Provider has the right to suspend Company's registration with immediate effect upon providing written notice to the Company if the Company is using OVIS Services in selfish, non-moral and dishonest manner.
12 IPR Infringing
The Service Provides represents and guarantees that OVIS is conceptualized, designed, developed and owned by the Service Provider and OVIS does not infringe any third party’s’ intellectual property rights.
13 SERVICE PROVIDER OBLIGATIONS
• Service Provider shall reasonably assist the Company for audit by authorities. The documents to be disclosed and the timeline for it shall be reasonably agreed between the parties in a good faith. The time frame and the limit of information sharing will be decided by the Service Provider. The location for the same, in person or online shall be informed by the Service Provider. No financial information of the Service Provider or the related finance documents will be disclosed. Certain Charges may apply.
• The Service Provider shall use their own policies for design, development, maintenance including security, tests and processes. The Service Provider will follow the same as planned by the quality personnel of the Service Provider and its topics as well as the schedules.
• Implementation of the external suggestions will be at the discretion of the Service Provider. The optimum level of security required, its processes, level of remedy and its time frame will be decided by the Service Provider. The incidence and event updates distribution or any other internal report distribution will be as per the discretion and the policy of the Service Provider.
• Should the Service Provider engage any third party to support the services or functions furnished to the Company, the Service Provider will bind the third party for all the applicable responsibilities as per the role of the third party. No information of any such association or the related documents exchanges shall be shared to the Company.
• Service Provider shall provide the support to the Company for Audit related queries during and post termination of Services, as per the policies of the Service Provider. This will be limited to the OVIS usage information provided by / to the Company during the pre termination period pertaining to the volunteers screened and blocked and other features offered on OVIS platform. The documents to be disclosed including the information levels and the timeline for the same, shall be decided by the Service Provider. The same will be carried out at mutually agreed commercials. Financial information of the Service Provider or the related finance documents will not be disclosed.
• Service provider shall alter / add features at their own discretion. The version control as well as its change shall also be at the discretion of the service provider. No permission shall be required from the Company for any change in OVISTM, by the Service Provider. The internal documents for changes or proposed changes need not be shared with the Company i.e a subscribers of the OVIS.
If any such change requires an Operating Procedures alteration on the Company side, within the same version, the Service Provider shall inform to the Company for any configuration, version update or hardware or policy upgrade etc., in a reasonable time frame to minimize the impact on the operations of the Company. Any costs involved for such alteration shall be bourne by the Company.
• The Service discontinuation / decommissioning:
The Company does not carry out its financial commitments due to forced or voluntary business shutdown, bankruptcy, for reasons chosen by the sponsor/investigator/auditors etc. (with OVIS service in operation by the Service Provider)
In this case access to all OVIS services, features, reports etc. will not be availed till the committed financials are cleared. Further, to access the data / reports etc., OVIS subscription has to be active by paying the relevant OVIS charges. On payment of the same, the Service Provider shall provide the Company, an access to relevant data, reports and audit trails, which have to be generated by the Company from the links provided. The expired links will attract additional charges.
• Service Provider, as per their internal policy shall share limited information, for the retention and offer a limited access to the Company, to internal product management documentation. The document or a system planned, created and maintained shall be as per the policy of the Service Provider. The internal documents for above requirements need not be shared with the Company i.e a subscribers of the OVIS.
• In case of termination or expiration of this Agreement, Service Provider shall not provide or return all the back-up data of the Company.
- This data is not unique as it is a subset of the data already available at the Company.
- It is shared across the country to the participating CROs, thus would be in possession of many CROs for Cross Participation tracking Audit.
- As this data will offer the matching to other cross participation tracking, removing such data will result in retrospective/future audit failures, for many CROs as well as the Company.
• Service Provider must endeavor to provide Company with reasonable advance time notice of any scheduled downtime for OVIS™.
In case of any unplanned downtime or is foreseen to occur, the Service Provider shall notify Company the estimated downtime, in shortest reasonable time as Service Provider becomes aware of the situation. The period of time from the commencement of an unplanned downtime until the resumption of normal operation of the OVIS™ shall be termed as “Unplanned Downtime Period”. Documents generated and maintained for attending the unplanned downtime shall be as per the internal policy of the Service Provider. The internal documents for such situations and its management need not be shared with the Company.
• The Service Provider shall notify the Company within the shortest period of time of becoming aware of any breach or threatened breach of the data managed by Service Provider. The Company shall implement optimum security measures, security audits and vulnerability assessments, to identify and mitigate any potential risks to protect as far as possible, Company's data on OVIS from unauthorized access, breaches, cyber threats. All the internal confidential reports, for above activities need not be shared with the Company – a subscriber of the service.
• As per the Service Provider’s internal policy and plans, the Service Provider will have a disaster recovery plan in place with its tests, to ensure the timely recovery of Volunteer's data uploaded and managed on OVIS™ in the event of a disaster or a system failure. The management of such measures shall be as per the policy of the service provider, and should be optimum to address such issues. All the internal reports need not be shared with the Company, a subscriber of the service.
14 Other
• No term in this agreement binds the Parties to enter into any other agreements for the subject matter of this document, except for the NDA of OVIS.
• The Service Provider shall not enter in any additional agreements with any other identity including but not limited to, associates of the Company, third parties hired by the Company for valuations, evaluations, testing, advising, consulting etc. Service Provider shall not share any information about its products, the service, the infrastructure, the policies and practices.
• This Agreement will be binding upon and inure to the benefit of the Parties hereto and each Party’s respective heirs, successors, permitted assigns and representatives. Neither Party will assign or transfer any rights or obligations under this Agreement without the prior written consent of the other Party, except that a Party may assign this Agreement without such consent to its successor in interest by way of merger, acquisition or sale of all or substantially all of its assets and except that the Company may assign this Agreement to its affiliated company with intimation to the Service Provider.
• Service Provider shall NOT be liable and responsible to:
1. Return the fees paid by the Company.
2. Pay any order cancellation fees at PO/WO level or during OVIS service usage.
• In case of any dispute amongst the Company and other OVIS users, as well as the Company and a participating volunteer, or the Company and any other entity including but not limited to Auditors, Govt. authorities, Sponsors etc., any Adverse Reactions to a Volunteer during or after the study, the Service Provider will be released from any inquiries, claims – financial or other, demands, and damages of every kind and nature arising out of or in any way connected to such disputes. Service Provider shall not be liable or responsible to indemnify the Company for any / all legal and other expenses incurred on account of seeking legal remedies or other.
• The Company, in case withdraws itself from using OVIS service under any reason not limited to Personal or Requirement from Sponsors or Obligation of Law of India or for its own interest, or finds the OVIS service incompetent or insufficient or has any objection or concerns for any feature, shall not compel the Service Provider to discontinue OVIS service. Further the Company will not have any objection to Service Provider offering this service to anyone anywhere, including sharing the data sent by the Company.
• The Company is the user of OVIS and thus will ensure the data security on all of the Company’s hardware or any additional tools required to safeguard the same. The Service Provider shall not be responsible for any breach related to it or through it.
• Neither Party shall be liable to the other Party for delays or failures in performing its obligations under this Agreement from causes beyond its reasonable control, including, but not limited to, acts of God, labor disputes, riots, terrorism, acts of wars, governmental regulations or any cause outside of a Party’s reasonable control; provided, however, that if such delay shall, in the aggregate, last for a period of more than thirty (30) days, the non-delayed Party, at its option, may terminate this Agreement upon written notice to the delayed Party.
• The Company can use the service name ‘OVISTM’ in their publicity releases, communication with sponsors, advertising or other promotional activities, confirming itself as an OVISTM user. The Service Provider can use the name of the Company to display it as their Client of OVIS.
• The Parties hereby represent that their respective signatories are authorized to execute this Agreement and bind each Party to all the terms in the Agreement.
• The Parties acknowledge and agree that this Agreement may be executed by digital signature or electronic signature, which shall be considered as an original signature for all purposes and shall have the same force and effect as an original signature.
Also this Agreement is limited to the relationship mentioned and will not be a construed in any future business relationships plans, negotiations, functionality etc.
15. Entire Agreement
This Agreement, the Appendices hereto and the NDA constitute the entire agreement between the parties with respect to its subject matter and supersedes all prior agreements, arrangements, dealings or writings between the parties for the said service OVIS. This Agreement may not be varied except in writing and signed by the parties' authorized representatives.
For the avoidance of doubt, in the event of any conflict or inconsistency, for all legal terms and conditions, this Service Agreement shall take precedence for all service features, its limitations and liability as well as responsibilities of the parties, over any other agreement. For all confidentiality related terms and conditions including parties obligations, the Confidentiality and Non-Disclosure Agreement shall take precedence over any other agreement, arrangements, dealings or writings.
There can be intermittent updates in the terms and condition of the usage and service access. The same shall be announced on OVIS service home page. The effect of the same shall be immediate and binding to all the user as well as of the highest precedence. These changes shall be as per the discretion of the vendor.
Each of the Parties accept this Agreement
Designed, Developed and put in force by
Inforcom Technologies Pvt. Ltd.
Ahmedabad, India
(Version October 2025)
(This is an electronically generated document and does not require signature)
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