In case a separate agreement/s are not executed or if executed but the term of the same has expired or the same becomes null or void, the Terms and Conditions mentioned in the below Service Agreement Terms and Non Disclosure Terms will be in force.
Certain deliverables may differ depending on the OVIS Versions.
NON -DISCLOSURE AGREEMENT for WWW.OVISBIO.COM
This Agreement for Online Volunteers Information System (OVISTM), all versions, a web based service for the eligibility verification of participating volunteers (the "Agreement"), is effective from the days of its usage by the Company as defined below, by and between the OVIS user organisation, (hereinafter called as the "Company"), and, 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 “Recipient”.
1. The Purpose
The Company and the Recipient wish to explore a potential business relationship in connection with which the Company and the Recipient may disclose its volunteers’ Information (as defined below) to each other, for the purpose of Volunteers Cross participation Tracking (The Relationship). The service offer by the Recipient and the service subscribed by the Company is called OVISTM (Online Volunteers Information System). All OVIS versions are under consideration in this document.
2. Definition of Confidential Information
Confidential Information means any information, technical data, or know-how, including but not limited to, that which relates to research, product plans, products, services, customers, markets, software, developments, inventions, processes, designs, drawings, engineering, hardware configuration information, marketing or finances
and any other things, deeds etc of the Company, which all shall be deemed as Confidential Information.
Confidential Information does not include information, technical data or know how which (I) is in the possession of the receiving party at the time of disclosure as shown by the receiving party’s files and records immediately prior to the time of disclosure, or (ii) prior to or after the time of disclosure becomes part of the public knowledge or literature other than as a result of any improper inaction or action of the Recipient or, (iii) is approved in writing by the Company, in writing, for release and (iv) is required for cross participation tracking purpose which will be sent by the company to the Recipient under this agreement.
3. Nondisclosure of Confidential Information.
The Recipient agrees not to use any Confidential Information disclosed to it by the Company other then to carry out discussions concerning, and the undertaking of the Relationship. The Recipient will not disclose any Confidential Information of the Company to parties outside the Relationship or to employees of the Recipient other than employees or agents under appropriate burden of confidentiality and who are required to have the information in order to carry out the discussions regarding the Relationship. The Recipient agrees that it will take all reasonable measures to protect the secrecy of and avoid disclosure or use of Confidential Information of the Company in order to prevent it from falling into the public domain or the possession of employees other than those persons authorized under this Agreement to have any such information. Such measures shall include the highest degree of proper care that the receiving party utilizes to protect its own Confidential Information of a similar nature.
The Recipient will not, without prior written consent of the company, disclose any other person, the fact that Confidential Information of the Company has been disclosed under this agreement, that discussions or negotiations are taking place between the parties, or any of the terms & conditions, status or other facts with respect thereto, except as required by law and then only with prior notice as soon as possible to the Company. The information not considered confidential and statistical in nature and not personal, may be used for various analysis and reporting purpose.
5. Return of Materials.
Any materials or documents considered confidential as defined above, that have been furnished by the Company to the Recipient in connection with the Relationship, will be promptly returned by the Recipient, excluding the data sent to the Recipient required for the cross participation tracking. The same shall continue to be shared with the other remaining parties on the service provided for the purpose.
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) calendar year, unless terminated by either Participant on thirty (30) days written notice.
7. Governing Law.
This agreement shall be governed by and enforced in accordance with the laws of India.
(a) 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.
(b) In the case that there is any dispute amongst the OVIS users, as well as an OVIS user and a participating volunteer, or the OVIS user and any other entity, the Service Provider will be released from any claims, demands, and damages of every kind and nature arising out of or in any way connected to such disputes. The Recipient shall not be liable and responsible under any circumstances to provide any expenses to cure a matter that gives rise to the claim from the Purpose of this document, namely Volunteers Cross participation Tracking service.
(c) Any amendments or modifications, changes or discharge to this Agreement, in whole or in part, shall be valid and effective only if agreed to and made in writing and signed by all the parties to this Agreement;
(d) The Parties warrant that the signatory signing the attached Agreement on their respective behalf is duly authorised to do so and irrevocably binds the respective parties to the Agreement.
(e) This Agreement shall not be construed to constitute, create, give effect to or otherwise imply any joint venture, partnership or any formal business relationship between the Parties.
(f) This Agreement constitutes the entire agreement between the Parties and supersedes all previous understandings, agreements, communications and representations, whether written or oral, relating to the subject matter of this Agreement.
(g) Headings to this Agreement are for convenience only and same shall not be used to restrict the meaning and/or scope of the terms there under or interpret or construe this Agreement.
SERVICE LEVEL AGREEMENT for WWW.OVISBIO.COM
This Agreement for Online Volunteers Information System (OVISTM), all versions, a web based service for the eligibility verification of participating volunteers (the "Agreement"), is effective from the days of its usage by the Company as defined below, by and between the OVIS user organisation, (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 (hereinafter called as the “Service Provider”). The Company and the Service Provider will collectively be referred to as “Parties” and individually as a “Party”.
WHEREAS the Company is in the business of Clinical Research conducting bioavailability / bioequivalence studies in human beings (hereinafter called as subjects). The volunteer(s) participation in the bioequivalence / bioavailability studies being conducted by the Company, are based upon the screening and enrollment according to the requirements of study protocol(s).The safety of the subjects while participating in the studies is of prime most importance and it is the responsibility of the Company to have all facilities or adequate arrangements to protect and safeguard the life and health of the subjects who are participating in the studies.
The subjects participating in the studies – the Human Volunteers, tend to enroll in multiple Clinical Research Studies, without practicing the designated time gap between the studies. These are the hopping volunteers. The multiple participations are called Cross Participation. These 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. The Company requires Human Volunteers Eligibility Checking System abiding to the Good clinical Practices (GCP).
WHEREAS, the Service Provider is in business of Designing and Development of Software Products and Services. OVISTM is a SaaS (Software as a Service) offered by the Service Provider. This web based subscription service offers Cross Participation Tracking of Human Volunteers in Clinical Studies amongst the CROs using the OVIS platform. OVIS offers protection against unwanted results in clinical trial project(s) due to Cross Participation as well as risk mitigation for Human Volunteers health (hereinafter called as the “The Service”). Hence the Company, the leading CRO, informs the Service Provider that it is willing to subscribe to the facilities of OVIS, to verify the eligibility of the enrolled volunteers at its Clinical Studies. This Internet-based platform for Cross Participation Tracking within a common geographical area will help the Company to abide to the GCP Standard.
WHEREAS, Company is informed by the Service Provider that the Service Provider is willing to provide required Online Volunteer Information Services (OVIS) hereinafter described, after clearly understanding its importance and implications in accordance with the provisions of this Agreement; and
WHEREAS, Company is further 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
The Service Provider shall provide the following services to the Company:
a) Secured access rights to The Service.
b) Facility to upload (to the web based Service) volunteer information – full name, gender, birth date, identity proof document name, two permanent blocking options, volunteer’s photo and four finger prints as well as the first and last sampling dates and the blocking days value.
c) Data Verification of the uploaded information (to the Service) with respect to its format only.
d) The details of the matches (of the Volunteers sent for checking by the Company) with the volunteers uploaded by the other participating CROs on The Service, and vice versa.
The output of the matches shall offer – volunteers name, photograph, the remaining days out of the total blocking days, the last sampling date of the previous study, re-eligible date, days from the last sampling, Permanent block information if any, city of blocking and Volunteers Birth date and Identity Proof documents name if supplied.
The above output shall also be provided to the other participating CROs on The Service
e) Edit facility to change the volunteer’s information uploaded by the Company to the Service.
f) New Access (to The Service) creation facility with User levels namely User, Observer and Administrator, Activation Status Control, Password and Profile editing.
g) Audit Reports for the user (of The Service) creation, transactions and access as well as routine processes of OVIS. Download the non editable Audit Reports of the activities of the Company for printing.
Further 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.
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.
The deliverables from Service Provider will include committed uptime of systems for use of volunteer screening at Reliance Life Sciences (RLS). RLS and OVIS will agree on committed availability of systems.
The Service output information provided can vary in terms of its position and format or certain information can be discontinued under certain unavoidable 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. However the Service Provider shall inform the Company well in advance before applying such changes.
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 quality, safety, or legality 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 commercials for the same will be governed through a work order.
Also 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, Installation Qualifications, Operational Qualifications and Performance Qualifications 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.
Further the Service Provider shall deliver electronic copy of the User Manual to the Company.
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 Finger print capturing equipments, quality of finger prints of the volunteers as well as the unavailability of The Service due to, including but not limited to the Internet or Hosting Server related issues.
The Service displays the output information sent by the participating CROs, disseminating on The Service on ‘as is’ basis. Any erroneous, incomplete, late or incorrect information sent by a participating CRO, shall not be checked, modified or verified.
The Service does not supply volunteers or guarantees their screening result quality, fitness and behavior / compliance or participation confirmations. The Company takes the final call for the enrollment of a volunteer in a study.
The Company understands the possible risks 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.
Further, the Service Provider shall not be liable for legal actions or financial damages, of any type or nature caused due to false information or absence of information provided by all other participating CROs.
The OVIS is developed with the features to satisfy the compliance requirements. However, the compliant practice of OVIS shall be the responsibility of the Company, implemented by the SOP (Standard Operating Procedures) of OVIS practice, designed by the Company.
3. PAYMENT AND INVOICING TERMS
a) The Company shall pay to the Service Provider for the information provided as per the charges mentioned in work order. The charges of the same may change in time and will be furnished to the Company well in advance.
b) The regular use Invoices will be submitted quarterly or six monthly as agreed at the beginning of the term, by the Service Provider. The Company shall make the payment within fifteen days from the date of receipt of the bill subject to verification in the entire manner. OVISTM is a pre paid service.
c) The Service Provider has authority to discontinue the access rights given to the Company to user OVIS after prior intimation, in case of non-payment of the undisputed and outstanding dues for the services availed by the Company.
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 1 (one) year from the first usage by the Company, unless terminated by either party as provided under clause 7 below. The parties may mutually agree to renew the said Agreement for further period as agreed in writing from time to time.
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 information provided by the Company during the pre termination period. The same will be carried out at a mutually agreed commercials.
(c) The confidentiality obligations of the Recipient with respect to CRO Name and CRO Related information excluding the information sent by the Company for the cross participation purpose, set forth herein, however, shall continue to apply, for a period of one year post the expiry or termination of this agreement.
5. 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.
6. 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 of the Company. Any computer hardware or third party equipment errors at the Company, shall not be attended by the Service Provider. Any visits for support shall attract additional charge.
7.1 Performance under this Agreement may be terminated by either party with immediate effect by written notice, if
(i) upon thirty (30) days’ written notice on the breach of any terms and conditions agreed upon by the parties hereto which it fails to remedy;
ii) either party becomes the subject of proceedings involving bank¬ruptcy, insolvency, moratorium of payment or liquidation;
iii) either party makes an assignment for the benefit of its creditors;
iv) any law or government-enacted regulation or decree renders the performance by a Party of its obligations hereunder onerous or otherwise inexpedient.
v) either party informs in writing to the other Party if the state of the force majeure continues for more than six (6) months, either Party shall be entitled to terminate this Agreement forthwith by the written notice to the other Party or;
vi) as provided for elsewhere in this Agreement.
8. 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 the other. The Arbitration shall be conducted in English Language and location of Arbitration shall be Ahmedabad.
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.
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.
The Service Provider shall NOT be liable and responsible under any circumstances to –
a. Provide any expenses to cure a matter that gives rise to the claim for which OVIS is responsible.
b. Return the fees paid by The Company along with necessary and adequate compensation for any financial loses, damages, material loss, business loss and any other loss of any type and form.
c. Pay any order cancellation fees at PO/WO level or during OVIS service usage.
d. Indemnify the OVIS user (the Company) against any irreparable damages incurred due to the claims from the customer or clients of the participating CRO.
e. Indemnify the OVIS user (the Company) for all legal and other expenses incurred on account of seeking legal remedies and help to protect you from various claims.
Neither Party shall be liable to the other Party, to such other Party’s Affiliates or to any Third Party for punitive damages or for any indirect, special or consequential damages such as loss of profits, loss of reputation or goodwill. However, the foregoing limitation of liability shall not apply to a) fraud, unlawful or willful intent or gross negligence by the defaulting Party, b) any other liability which may not be excluded or limited in advance by any applicable Law. 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, which may have arise due to the usage of the Service, the Service Provider will be released from any inquiries, claims, demands, and damages of every kind and nature arising out of or in any way connected to such disputes.
Neither Party shall be liable for any failure or delay in performing its obligations under this Agreement if such failure or delay is either wholly or partly due to Force Majeure conditions in whole or in particular such as earthquake, storms, flood, fire, other acts of nature, epidemics, pandemics, war, riots, hostility, public disturbance, acts of public enemies, prohibition or act by a government or public agency, such as ban on imports, strikes, or other labour disputes or work stoppage. The Party affected by such Force Majeure condition shall forthwith notify the other Party of the nature and extent thereof. If case of force majeure lasts for more than 6 months, then either Party shall be entitled to terminate this Agreement forthwith by the written notice of the other Party
The Company, in case withdraws itself from using OVIS, the Service, under any reason personal or as a requirement from Sponsors or obligation of Law or for its own interest, or finds the Service incompetent or insufficient or has any objection or concerns for any feature, shall not compel the Service Provider to discontinue the Service. Further the Company will not have any objection in Service Provider offering this Service to anyone anywhere.
Also all the signatories are authorized to execute this document and binds all the terms in the agreement.
Also this document is limited to the relationship mentioned and will not be a construed in any future business relationships plans, negotiations, functionality etc.
Inforcom Technologies Pvt. Ltd., Ahmedabad
(No Signature required. This is an electronic document)