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3rd Mile Stone, Faridabad-Gurgaon Expressway, Faridabad – 121001

Phone: +91-129-2876431

(Revised document)

Request for Proposal for

procurement of clinical trial insurance policy

(TENDER NO: THSTI/RFP/PBC/1.12.58(1)/2016-17)

14th July, 2016

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INDEX Part. No. Particulars Page No. Part - A Notice Inviting Proposal 3-4 Part - B Schedule of Requirements/Scope of work 5-7 Part - C Instruction to Bidders 8-12 Part - D General conditions of contract (GCC) 13-14 Part - E Special conditions of contract (SCC) 15-15 Part - H Form of Technical bid 16-16 Part-I Form of Financial Bid 17-18

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PART A: Notice Inviting Proposal

1.0 Tender Notice: On behalf of the Executive Director, Translational Health Science and Technology Institute ,

Haryana, INDIA, request for proposals are invited under two-bid system from reputed

insurance companies/agencies and firms engaged in providing insurance services to cover

the liability involved in undertaking the clinical study trial as detail below : -

Tender No. : THSTI/RFP/PBC/1.12.58(1)/2016-17

Name of Work/Service : Providing of clinical trial insurance policy to cover the

liability arising due to no fault compensation during the

conduct of clinical trial entitled “Zinc as an adjunct for

the treatment of clinical severe infection in infants

younger than 2 months” in India.

Location of study/work : India (we need insurance for India only. For Nepal

separate policy will be taken. )

Sale of RFP documents : From 14.07.2016 to 08.08.2016 upto 14.30 hrs

RFP documents can be obtained from THSTI,

Faridabad on all working days (Monday to Friday)

from 9 AM to 5.30 PM or can be downloaded

from THSTI website : www.thsti.res.in

Cost of tender documents : Rs 500/- by DD in favour of THSTI, Gurgaon payable

at Gurgaon. In case of Tender document being

downloaded from website, DD should be submitted

along with the technical bid. The tender fees is non

refundable.

Pre-bid meeting : A pre-bid meeting with all the prospective bidders is

schedule to be held on 21st July, 2016 at 14.00 hours at

THSTI, Faridabad. Interested applicants/ firms are

invited to attend the same with a written statement of

their query.

Notification of amendments : As a result of the pre-bid meeting, if the technical

specification requires any modification, suitable

amendment to the tender document will be issued and

the same will form part of the tender document.

Corrigendum/amendments etc., if any, will be

notified only on the THSTI web site/CPP portal and

no separate advertisement will be released for the

same. Prospective bidders are therefore advised to

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regularly visit the THSTI web site for any such

updates.

Submission of Bids : The sealed bids are required to be submitted/deposited

in the tender box located in the Stores and Purchase

Department, THSTI, Faridabad. Both the Technical bid

and Price bid are required to be sealed and put up in a

single bigger envelope duly superscripted with the

details like tender name, RFP no. etc and should reach

THSTI on or before the last date for the receipt of the

RFP.

Last date and time for submission of bids : 08.08.2016 upto 14.30 hrs (BID DUE DATE)

Date and time of opening of bids : 08.08.2016 at 15.00 hrs (Technical Bid Only)

KINDLY NOTE THAT ONLY BID COMPLETE IN ALL RESPECT WILL ONLY BE CONSIDERED AGAINST THIS TENDER. Further, requests for postponement will not be entertained. Bids send by post/Fax/email bids shall be rejected straightway. Executive Director, THSTI reserves the right to accept/ reject any or all tenders either in part or in full without assigning any reasons thereof.

Store & Purchase Officer

THSTI Note :

1. Corrigendum/amendments etc., if any, will be notified only on the THSTI web site/CPP portal and no separate advertisement will be released for the same. Prospective bidders are therefore advised to regularly visit the THSTI web site or the CPP portal for any such updates.

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PART B : Schedule of Requirements/Scope of work

1.0 Introduction

Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology, Ministry of Science and Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, and is designed as a dynamic, interactive organization with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into tangible products to improve human health.

THSTI has set up niche centres for research in areas relevant to planned translational work. They are: Vaccine and Infectious Disease Research Centre (VIDRC), Pediatric Biology Centre (PBC), Centre for Bio-design & Diagnostics (CBD), Drug Discovery Research Centre (DDRC), Centre for Human Microbial Ecology (CHME) and Policy Centre for Biomedical Research (PCBR). Clinical Development Services Agency (CDSA) and National Bio-design Alliance (NBA) are THSTI’s extramural centres.

The tender is called for providing insurance cover to cover the no fault compensation liability involved in the conduct of the study as mentioned hereunder.

2.0 Details of the Clinical Study

This RFP is to obtain Clinical Trial Insurance for the project entitled “Zinc as an adjunct for the treatment of clinical severe infection in infants younger than 2 months”. The details of this Clinical Trial is given below:

Study Title Zinc as an adjunct for the treatment of clinical severe infection in infants younger than 2 months

Sponsor Pediatric Biology Centre, Translational Health Science and Technology Institute

Funding Agency Research Council of Norway (RCN) under the Research Grant on Global Health and Vaccination Research (GLOBVAC) and CISMAC (Centre for Intervention Sciences in Maternal & Child Health), Norway

Partnering Institutes

Pediatric Biology Centre, Translational Health Science and Technology Institute, Faridabad

Department of Child Health, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal

Centre for International Health, University of Bergen, Norway

Stanford University School of Medicine, USA

Innlandet Hospital Trust, Norway

Radbound University, Nijmegen, The Netherlands

Coordinating Center Pediatric Biology Centre, Translational Health Science and Technology Institute, Faridabad

Study Hospital Sites

Delhi, India • Maulana Azad Medical College (MAMC) and associated Lok Nayak Hospital • Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC & SJH) • Chacha Nehru Bal Chikitsalaya (CNBC) and • Kasturba Hospital (KH)

Nepal

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• Patan Hospital [PH], Kathmandu, • Kanti Children’s Hospital (KCH), Kathmandu and • Institute of Medicine (IOM), Kathmandu.

Protocol Number RCN/ZINCSEVINF/02/2015

Study Intervention 10mg of elemental zinc per day given as oral zinc sulphate drops Vs placebo drops

Study Design Double-blind randomized placebo-controlled parallel group superiority trial.

Duration Of Study Intervention

10 mg elemental zinc given as 5 mg oral drops twice a day 12 hours apart for a total of 14 days

Objectives Of Study

Primary objectives: i. To estimate the efficacy of 10 mg elemental zinc administered orally as an adjunct to standard antibiotic therapy to infants aged 1 day up to 2 months (59 days) hospitalized with ‘clinical severe infection’ against case fatality. ii. Time to death until end of study period defined as the time from enrolment to the time when an infant dies anytime until 12 weeks from the day of enrolment in the study. Secondary objectives: Secondary objectives are to estimate the efficacy of 10 mg elemental zinc administered orally as an adjunct to standard antibiotic therapy to infants aged 1 day up to 2 months (59 days) hospitalized with ‘clinical severe infection’ against the following: i. Failure of treatment ii. Time to cessation of symptoms and signs of clinical severe infection iii. Time to failure of treatment iv. Time to discharge v. Time to death vi. Death at any time after discharge from hospital until end of study period, which is 12 weeks from the day of enrollment. vii. Severe illness requiring hospitalisation at any time after discharge from hospital until end of study period which is 12 weeks from the day of enrolment. viii. Cost-effectiveness analysis ix. To undertake mechanistic studies of immune system

Study Procedures

The trial will be conducted over a period of 3 years and 6 months. This is a multicenter study where recruitment’s will take place in 7 centers, 4 in New Delhi India and 3 in Kathmandu, Nepal. The trial will measure the efficacy of zinc administered orally as an adjunct to standard therapy to infants aged 1 day to 2 months hospitalized with clinical severe infection identified using an adaptation of the WHO Integrated Management of Childhood Illnesses (IMCI) criteria. The participants will be randomized to receive zinc or placebo in a 1:1 allocation ratio. The intervention (zinc/ placebo drops) will be co-administered with the standard therapy which includes intravenous antibiotics and other supportive therapy like intravenous fluids, supplemental oxygen, etc. daily at 12 hourly intervals from the time of enrolment for 14 days. 4140 infants with clinical severe infection will be enrolled (with approx. 2800 infants in the India sites), given intervention for 14 days and followed up till discharge and until 12 weeks from the day of enrollment.

Biospecimen Collection: Blood Sampling For The Study:

At enrollment: 3 ml of venous blood will be collected at admission (enrolment) from the Enrolled infants with clinical severe infection for study related investigations ii. At 48-72 hours: 2-3 ml of blood will be collected iii. At discharge: 2-3 ml of blood will be collected Nasal swab for viral etiology at enrollment

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3.0 Scope of the Insurance Coverages: -

To indemnify the Insured/Assured in respect of claims for compensation first made in writing against the Insured/Assured during the period of the policy in Respect of specific Trials undertaken in India. To indemnify against all sums which the insured shall become legally liable to pay as damages in respect of any claim made by research subjects or their legal heirs in connection compensation for pain, sufferings, mental shock, agony and the like, death and disability arising out of the clinical trials conducted by the insured during the period of insurance. The policy offered should include the following coverages :

COVERAGES: -

Clinical Trial

Professional Negligence

Manslaughter

Defense Costs

Extended Reporting Period – 12 Months

4.0 Technical terms & conditions : -

Wording on Claims Made Basis

No insurance for products guarantee

No insurance for punitive and/or exemplary damages

No insurance for pure financial losses

No insurance for claims originating from SRCC and/or terrorist activities

No insurance cover for genetic injuries, for any claim resulting from any contamination and/or contagion by hepatitisor from idiosyncratic reactions.

An injury to health is deemed to have occurred as soon as the injured has consulted a medical doctor because of symptoms that are then later identified as symptoms of an injury to health caused by the tests

Insurance Companies to provide copy of their policy wordings along with the quotation.

Key Policy exclusions to be highlighted in the quotation clearly.

SLA to clearly include: a. Policy servicing and claims administration Turnaround times.

b. Claims Process to be clearly defined c. Escalation Matrix to be agreed upon

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PART C : INSTRUCTION TO BIDDERS

1. Qualification/Eligibility Criteria

1.1 This invitation for Bids is open to all the Indian and Foreign insurance subsidiary companies of Indian multi-national corporation’s companies/ firms engaged in providing clinical trial insurance to the human clinical studies in the last 5 or more years.

1.2 The bidder must be a Company registered under the Indian Companies Act 1956.

1.3 Registration with IRDA

1.4 The bidder should have been in operation for at least five years as on 30th June 2016

(Incorporation/ Registration Certificate required).

1.5 The bidder must have provided Insurance cover for at least three Clinical trial studies over the last five (5) years.

1.6 Documentary proof for everything is essential without which the proposal will be rejected.

1.7 Bidders declared by Government of India to be ineligible to participate for unsatisfactory past performance, corrupt, fraudulent or any other unlawful or unethical business practices shall not be eligible. Bidders will have to give self-attested certificate towards this.

2. Cost of Bid Document

The bid document can be purchased on payment of Rs 500/- by DD in favour of THSTI, Gurgaon payable at Gurgaon. In case of Tender document being downloaded from website, DD should be submitted along with the technical bid. The tender fees is non refundable.

3. Contents of Bid Document

The Bidder is expected to examine all instructions, forms, terms (GCC/SCC etc.), and specifications in the bidding documents. Failure to furnish all information required by the bidding documents or submission of a bid not substantially responsive shall result in rejection of the bid.

4. Amendment to Bid Document

As a result of the pre-bid meeting, if the technical specification requires any modification, suitable amendment to the tender document will be issued and the same will form part of the tender document. Corrigendum/amendments etc., if any, will be notified only on the THSTI web site and no separate advertisement will be released for the same. Prospective bidders are therefore advised to regularly visit the THSTI web site for any such updates.

5. Documents Comprising the Bid

The bid is required to be submitted in two parts. One part is the Techno- Commercial Unpriced Bid and the other part is the Financial/Price Bid.

5.1 The Techno-Commercial Unpriced Bid prepared by the Bidder shall include the following without indicating the price in the Bid Form.

a. All documents pertaining to the eligibility criteria.

b. Registration certificate about the registration done with IRDA, Government of

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India

c. the Self-Attested copy of the PAN Card

d. Copy of the registration and incorporation of the firm

e. Copies of the previous work/supply orders executed and implemented in the last five years

f. Signed Bid Form.

g. Copy of their policy wordings.

h. Key Policy exclusions to be highlighted.

5.2 The Price/Financial Bid shall comprise the Techno Commercial Bid with price indicated in the bid form.

6. Bid Prices

6.1 The policy can be procured for the first year of the clinical trial or we may also opt for procurement of insurance policy for the complete duration ( i.e 3 years) of the clinical trial. The final decision in this regard will be taken based on the project requirement after considering and evaluating both the options.

6.2 The Bidder shall therefore indicate their best offers for both the options shown in the price bid. Under option –I, the bidder is required to fill his rates for the first year only, whereas under option – II, the rate for providing the insurance cover for the complete duration of clinical trial ( i.e for 3 years ) is required to be filled in by the bidders.

6.3 The L1 bidder will be decided based on the lowest quoted offer both for option-I and option –II separately.

6.4 Prices quoted by the bidder shall remain fixed during the entire period of contract and shall not be subject to variation on any account. A bid submitted with an adjustable price the bid will be treated as non - responsive and rejected.

7. Bid Currencies

Prices shall be quoted in Indian Rupees Only.

8. Documents Establishing Bidder’s Eligibility and Qualifications

8.1 The bidder shall furnish, as part of the technical bid, documents establishing the bidders’ eligibility to bid and qualification to perform the contract if the bid is accepted.

8.2 In case the bidders are not able to submit the relevant documents to prove his

compliance with the qualification criteria, the bid will be rejected straightaway and

will not be evaluated any further.

9. Period of Validity of Bids

Bids shall remain valid for 45 days from the date of opening the bid prescribed by the Purchaser. A bid valid for a shorter period may be rejected by the Purchaser as non-responsive.

10. Format and Signing of Bid

10.1 The Bidder shall submit the bids in two separate envelopes. One envelope shall contain Techno commercial un-priced bid and the other shall contain the priced

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bid.

10.2 The original and all copies of the bid shall be typed or written in indelible ink and shall be signed by the Bidder or a person or persons duly authorized to bind the Bidder to the Contract. The person or persons signing the bid shall initial all pages of the bid, except for un- amended printed literature.

10.3 Any interlineations, erasures or overwriting shall be valid only if the persons or persons signing the bid endorse them.

10.4 The bid once accepted and awarded the contract the bidder will be obliged to execute the contract for the providing the services to THSTI.

11. Sealing and Marking of Bids

11.1 The bidder shall seal the Techno Commercial Unpriced Bid and the Price/Financial Bid in two separate envelops duly marked as “Techno Commercial Unpriced Bid” and “Price/Financial Bid” respectively. Both the envelopes shall then be sealed in one outer (main) envelope.

11.2 The inner and outer envelopes shall

a) Be addressed to the Purchaser at the following address:

Stores and Purchase Officer Translational Health Science and Technology Institute

3rd Milestone, Gurgaon-Faridabad Expressway Faridabad – 121001

b) Bear the Item Name /Reference No./ Last Date For Submission Of Tender / Date of opening of Tender / Firm’s Name & Address and a statement "Do not open before Time hours (IST) on Date."

11.3 If the outer envelope is not sealed and marked as required Clause 11.2, the Purchaser will assume no responsibility for the bid's misplacement or premature opening.

11.4 Fax or E-mail bids will be rejected.

12. Deadline for Submission of Bids

12.1 Bids must be received by the Purchaser at the address specified under Clause 11.2.

12.2 Not later than the time and date specified in the Invitation for Bids. In the event of the specified date for the submission of Bids being declared a holiday for the Purchaser, the Bids will be received up to the appointed time on the next working day.

12.3 The Purchaser may, at its discretion, extend this deadline for submission of bids by amending the bid documents, in which case all rights and obligations of the Purchaser and Bidders subject to the previous deadline will thereafter be subject to the deadline as extended.

13. Late Bids

Any bid received by the Purchaser after the deadline for submission of bids as prescribed by the Purchaser, will be rejected and/or returned to the Bidder.

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14. Modification and Withdrawal of Bids

14.1 The Bidder may modify or withdraw its bid after the bid's submission; provided that written notice of the modification or withdrawal is received by the Purchaser prior to the deadline prescribed for submission of bids.

14.2 The Bidder's modification or withdrawal notice shall be prepared, sealed, marked and dispatched to the purchaser in proper form. A withdrawal notice may also be sent by email but followed by a signed confirmation copy, post marked not later than the deadline for submission of bids.

14.3 No bid may be modified subsequent to the deadline for submission of bids.

14.4 No bid may be withdrawn in the interval between the deadline for submission of bids and the expiration of the period of bid validity specified by the Bidder on the bid form. Withdrawal of a bid during this interval may result in blacklisting the Bidder from participating in any future tendering process..

15. Opening of Bids by the Purchaser

15.1 The Purchaser will open all Techno Commercial Un-priced Bids, in the presence of Bidders' representatives who choose to attend, as per the schedule given in invitation to bids.

15.2 The Bidders' representatives who are present shall sign the quotation opening sheet evidencing their attendance. In the event of the specified date of Bid opening being declared a holiday for the Purchaser, the Bids shall be opened at the appointed time and location on the next working day.

16. Clarification of Bids

To assist in the examination, evaluation and comparison of bids, the Purchaser may, at its discretion ask the bidder for any clarification(s) of its bid. The request for clarification and the response shall be in writing and no change in the price substance of the bid shall be sought, offered or permitted. However, no post Bid clarifications at the initiative of the Bidder shall be entertained.

17. Evaluation & Comparison of Bids

17.1 Conditional tenders/discounts etc. shall not be accepted. Rates quoted without attached conditions (viz. Discounts having linkages to quantity, payment terms etc.) will only be considered for evaluation purpose. Thus conditional discounted rates linked to quantities and prompt/advance payment etc., will be ignored for determining inter-se position. The Purchaser however reserves the right to use the discounted rate/rates considered workable and appropriate for counter offer to the successful tenderers.

17.2 Registration with IRDA

17.3 Previous work experience as mentioned in clause 1.

17.4 The bidders should not be black listed by any government/ private organization during last three years. (Bidder has to himself/herself give the undertaking).

17.5 The L1 bidder will be decided separately for both option-I and option – II based on the premium quoted by the firms for each of the given options. However, the final decision to award the order under either of the above options will be taken by the competent authority based on the project requirements. Further, financial proposal of the most preferred/lowest bidder shall be subject to negotiations/rationalization by Executive Director, THSTI.

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18. Contacting the Purchaser

Any attempt by any Bidder to influence the Purchaser in its decisions on bid evaluation, bid comparison or contract award may result in rejection of the bid.

19. Purchaser's Right To Accept Any Bid and To Reject Any or All Bids

19.1 The Purchaser reserves the right to accept or reject any bid, and to annul the bidding process and reject all bids at any time prior to award of Contract, without thereby incurring any liability to the affected Bidder or bidders or any obligation to inform the affected Bidder or bidders of the grounds for the Purchaser's action.

19.2 Evidence regarding credibility of stable performance and maintenance service capability must be provided. The purchaser reserves the right to make judgment on these scores and rejects bids that, in the purchaser’s view, do not carry sufficient credibility for performance and/or service.

20. Notification of Award

20.1 Prior to expiry of the period of bid validity, the purchaser will notify the successful bidder in writing by Purchase Order.

21. Order Acceptance

21.1 The successful bidder should submit acceptance of the Purchase Order immediately but not later than 21 days in any case from the date of issue of the Purchase Order failing which it shall be presumed that the vendor is not interested and the purchase order will be cancelled and awarded to the next lowest bidder. Further, necessary action will be initiated against the company for refusing to accept the purchase order.

21.2 The Successful bidder has to sign Confidentiality and Non-disclosure agreement with THSTI before any information is shared with the bidder in respect to the clinical trial.

22. Supplier Integrity

The Bidder is responsible for and obliged to conduct all contracted activities in accordance with the Contract using state of the art methods and economic principles and exercising all means available to achieve the performance specified in the contract.

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PART D: GENERAL CONDITIONS OF CONTRACT (GCC)

1 Definitions

In this Contract, the following terms shall be interpreted as indicated:

a) "The Order" means the Purchase Order placed by the Purchaser including all the attachments and appendices thereto and all documents incorporated by reference therein;

b) "The Contract Price" means the price payable to the Supplier under the Order for the full and proper performance of its contractual obligations;

c) “GCC” mean the General Conditions of Contract contained in this section. “

d) “SCC” means the Special Conditions of Contract.

e) “The Purchaser’s country” is “India”.

f) “The Supplier” means the company providing Insurance cover under this contract.

g) “Day” means calendar day.

h) “IRDA” means Insurance Regulatory and Development Authority of India

i) “ DCGI” means Drug Controller General of India

j) “ API” means Active Pharmaceutical Ingredients

k) “ CDSCO” means Central Drug Standard Control Organisation

l) “SAE “ means Serious Adverse Event

2 Application

These General Conditions shall apply to the extent that they are not superseded by provisions in other parts of the Contract.

3 Use of Contract Documents and Information

The bidder shall not, without the Purchaser's prior written consent, disclose the Contract, or any provision thereof, or any specification, plan, drawing, pattern, sample or information furnished by or on behalf of the Purchaser in connection therewith, to any person other than a person employed by the Supplier in performance of the Contract. Disclosure to any such employed person shall be made in confidence and shall extend only so far, as may be necessary for purposes of such performance.

4 Submission of the bids

All bids complete in every respect must reach this office within the last date and time of receipt of bid. No extension shall be allowed for any reason what so ever. Late tenders, Tenders received without Bid cost of bidding documents, if applicable etc. shall be rejected summarily.

5 Payment

100% payment will be made in advance.

6 Prices

All the prices quoted should be in Indian Rupees. Taxes including service tax, if any, should be clearly mentioned in the price bid.

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7 Resolution of Disputes

The Purchaser and the supplier shall make every effort to resolve amicably by direct informal negotiation any disagreement or dispute arising between them under or in connection with the Contract.

If, after thirty (30) days from the commencement of such informal negotiations, the Purchaser and the Supplier have been unable to resolve amicably a contractual dispute, either party may require that the dispute be referred for resolution to the formal mechanisms. These mechanisms may include, but are not limited to, conciliation mediated by a third party, adjudication in an agreed national or international forum, and national or international arbitration.

In case of Dispute or difference arising between the Purchaser and a domestic supplier relating to any matter arising out of or connected with this agreement, such disputes or difference shall be settled in accordance with the Indian Arbitration & Conciliation Act, 1996, the rules there under and any statutory modifications or re-enactments thereof shall apply to the arbitration proceedings. The dispute shall be referred to the Executive Director THSTI and if he is unable or unwilling to act, to the sole arbitration of some other person appointed by him willing to act as such Arbitrator. The award of the arbitrator so appointed shall be final, conclusive and binding on all parties to this order.

8 Applicable Law:

The place of jurisdiction would be Faridabad, Haryana, INDIA.

9 Notices:

For the purpose of all notices, the following shall be the address of the Purchaser and Supplier.

Purchaser: Executive Director,

Translational Health Science and Technology Institute

3rd milestone, Gurgaon- Faridabad Expressway

Faridabad, Haryana -121001

III. Bidder: (To be filled in by the Contractor)

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PART E: SPECIAL CONDITIONS OF THE CONTRACT

1. Bid to be submitted on the basis of the following trail/project assumptions:

a. NAME OF THE INSURED : THSTI

b. Monitoring Agency and Project Management: THSTI

c. Funding Agency: Research Council of Norway (RCN) under the Research Grant on

Global Health and Vaccination Research (GLOBVAC) and CISMAC (Centre for

Intervention Sciences in Maternal & Child Health), Norway

d. Protocol No. : RCN/ZINCSEVINF/02/2015

e. Number of patients: Maximum 2800 infants

f. Covers for sponsor, CRO, sites, investigators and other trial related partners

g. Limits required:

i. Aggregate AOY & AOA Limit: INR 120,000,000

ii. Per patient sublimit INR : No limit

iii. Sublimit: No limit

iv. Maximum deductibles: INR 10,000 per claim

h. Legal defence costs included within Limit of Liability.

i. Extended reporting period: 12 months

2. The policy should indemnify all the technical and medical staff, Principal Investigators, Sponsoring Agency, Investigators and their staff at sites and all others involved in the conduct of the study against any risk relating to professional negligence.

3. The coverage will be subject to following:

a. Compliance with the Declaration of Helsinki developed by World Medical Association

b. Ethical Principles for medical research involving human subjects (in its latest version)

c. Compliance with Good Clinical Practices (GCP) provided by CDSCO in the latest version

d. Compliance with the Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practices (GLP)

e. Compliance with Good Manufacturing Practices (GMP) applied by the pharmaceutical regulators

4. The compensation offered to research subjects for SAE of death and SAE other than death, under policy will be as per the formula devised and revised from time to time by CDSCO and communicated by the Institutional Ethics Committee. However the amount of compensation is subject to revision by any arbitration/legal process as per law and in all such cases the insurance company will be under obligation to pay the revised compensation as per law .

5. The quote to be submitted as per the prescribed format.

6. The coverage should be extended to include negligent act, error or omission of the insured in rendering or failure to render medical professional services which result or may result in the adverse event or death of the participant in the clinical trial.

7. Institutional Ethics Committees or its members that has approved the trial which is the subject of this Policy.

BID FORM

To, The Executive Director,

Translational Health Science and Technology Institute

3rd Milestone, Gurgaon-Faridabad Expressway Faridabad – 121001

Sir,

Having examined the bidding document, the receipt of which is hereby duly acknowledged, we the undersigned offer to provide the insurance cover for the liability involved in no fault compensation during the conduct of the clinical trial.

We undertake if our bid is accepted, to provide the Insurance cover

We agree to abide by this bid for requisite period as fixed for bid opening as per the instructions to the bidders. Further it shall remain binding upon us and accepted at any time before the expiry of that period.

Until a formal contract is prepared and executed, this bid, together with your written acceptance thereof and your notification of award shall constitute a binding contract between us.

We have not been black listed by any Government and Non-Government Agency/ Organization and there is no dispute pending with IRDA for the insurance services so far provided by us.

We understand that you are not bound to accept the lowest or any bid you may receive. Dated this _day of _20_

Signature In the capacity of

Duly authorized to sign the bid for and on behalf of

(For price bid format to be submitted in sealed second envelops duly marked as “Price/Financial Bid”)

(Stamp and Sign of Bidder)

BRIEF SUMMARY OF QUOTATION & CHECKLIST (Not To Be Used For Evaluation/Comparison Purpose)

FOR, ALL QUOTE FILL RELEVANT INFORMATION IN INDIAN Rs ONLY.

(Please complete all information required. Please do not write ‘AS PER QUOTATION’ / ‘PLEASE REFER

TO OUR OFFER’)

CHECKLIST

01 Following things are mentioned on the main (outer) envelope Item name /reference No. /Last date for submission of tender/Date of opening of tender /Firm’s Name & Address

02 Demand draft(s) is/are in favor of “Translational Health Science and Technology Institute “, payable at Gurgaon, Haryana Firm’s name/ref. No. etc. has been mentioned on the reverse of DDs.

03 The bid papers have been PUNCHED with a hole on the Top Left Hand Corner Side and Properly Tagged.

04 Only relevant documents (Brochures/Leaflets etc.) required in support of the quoted Item have been enclosed. No irrelevant papers, user recommendations, and order copies etc. have been enclosed unless specifically asked for.

05 Quotation have been duly signed and stamped by the Authorized & Competent person. All correction/over writings have been duly checked, initialed and stamped. (if applicable)

06 In case of two bid, single combined offer has not been submitted or ‘Price Bid’ has not been enclosed in the envelope marked ‘Technical Bid’

07 In case of two bid system this page will be enclosed with the Price Bid.

We have read and understood the tender terms and conditions. The undersigned is competent to sign the tender document including this page on behalf of the quoting firm.

Date

(Signature with Seal)

PRICE BID / FINANCIAL BID A) OPTION – I :

No. Name of the Item Amount in INR

( For 1st Year trial)

1. Insurance premium for First year of the Clinical trial

Add : Taxes

Total

B) OPTION – II :

No. Name of the Item Amount in INR ( For 3 years

trial )

1. Insurance premium for complete duration of the clinical trail

Add : Taxes

Total

Place: Date: Business Address

Signature of Tenderer

Seal of Tenderer

Note: 1. If there is a discrepancy between the unit price and total price THE UNIT PRICE shall prevail.

2. The bidders are required to offer their best quotes for both the options. Incomplete offer or part offer is liable to be rejected straightaway.

3. THSTI reserves the right to award the order under either option-I or option-II as per the requirement of the project.

4. The bidders will be under obligation to accept the orders placed by THSTI under either of the above options.