| |
SERVICE LEVEL AGREEMENT for WWW.OVISBIO.COM
This agreement is made by and between the subscriber of OVIS service, hereinafter called as the “Company” and 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”.
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 CRO Volunteers Eligibility Checking System used by the leading Contract Research Organizations (CROs) 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 eligibility of enrolled volunteers at the respective participating CRO and also update the eligibility status of 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 and DELIVERABLES
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.
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.
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 services contributed by the Company limited to the eligibility issue to the other participating CROs and vice versa. Service Provider shall avail the volunteers, the information stored in OVIS about them as well as their eligibility status. This shall be controlled as per the Service Providers plan and approach. The same shall be visible to the Company.
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 data protection. 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 and associated guides.
2.3 The service provider shall practice all its activities and Services, as per the Company policy, at the optimum level. These policies shall be in confirmation to the applicable Govt. Regulations, Acts as well as the Guidelines. Thus 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 others, which may be of higher level of cost or newer technology, it will not be considered a Willful Misconduct or Negligence.
2.4 The output information provided can vary in terms of its position. Certain information can be discontinued under certain unavoidable circumstances such as changing government policies, legal or criminal / social issues, auditor’s comments or the safety of the Service Providers’ personnel etc. However the Service Provider shall inform the participating CROs, including the Company, well in advance before applying. Once knowing such changes the Company shall have the right to terminate the Agreement.
2.5 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.
2.6 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.
2.7 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 upload (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.
2.8 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.
2.9 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.
3.0 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.
3.1 In case the usage of the Service has created data of multiple locations, the Service Provider shall not separate the data by locations or create separate reports for such multiplication usage of OVIS.
3. The Deliverables
2.1 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.
2.2 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.
2.3 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 at a mutually convenient time and location.
2.4 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.
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 sufficient written intimation, in case of non-payment of undisputed invoices for the entire term mentioned in the invoice.
Certain service may attract additional charges which shall be discussed and informed to the company.
5. TERMS
a) This Agreement will commence on the date first written above, and unless modified by the mutual written agreement by the parties, shall continue for the period of 1 (one) year.
b) Service Provider shall provide the support to the Company for Audit related information/queries post termination of Services. 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 same will be carried out at mutually agreed commercials. Such obligation shall survive the term of this Agreement.
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 the 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, for routine usage of OVIS or for validation purpose, 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, Testing with dummy data, Testing for any other reasons. The company may further exercise their legal rights to take other actions in such cases. Further in case of Non-payment of usage charges for 6 months, 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 Other
• No term in this agreement binds the Company and the Service Provider to enter into any other agreements for the subject matter of this document, except for the NDA.
• 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.
• The subscription granted to the Company is to use OVIS Services at the company premises only in the mutually finalised location. The Company shall not further provide access to other companies / locations / individual without prior permission from 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.
3. Liable to pay any damages, financial or other in nature, to the Company against any claim arising out of use of the Service OVIS.
• 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 and responsible Indemnify the Company for 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.
• 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.
• Also this Agreement is limited to the relationship mentioned and will not be a construed in any future business relationships plans, negotiations, functionality etc.
• 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.
• 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 a Client.
• 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 generate documents to bind the third party for all the applicable responsibilities associated as per the role of the third party. No information of any such association or the related documents exchanges need to 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.
• 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.
• 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.
• All notices, reports, waivers, consents, correspondence or other communications hereunder shall be in writing and shall be effective upon delivery to the Service Provider, and provided that the sender receives confirmation of transmission, and sends a confirmation copy in one of the foregoing manners, addressed as follows:
If to Company:
(Company address 1)
(Company address 2)
(Company address 3), Company City
Company E-mail -
Attention:
If to Service Provider:
Attention: The Director
Inforcom Technologies Pvt. Ltd.
6, North View – II, Opp L D College of Engg., Navrangapura,
Ahmedabad – 380009, Gujarat, India
Telephone: 079-26307095
E-mail: services@inforcomtech.com, Inforcomtech@gmail.com
This Agreement constitute the 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.
Each of the Parties accept this Agreement
Designed, Developed and put in force by
Inforcom Technologies Pvt. Ltd.
Ahmedabad, India
(Version April 2024)
|
