This is an HTML version of an attachment to the Freedom of Information request 'Privacy mechanisms in CPRD'.

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Draft:  
 
 
 
 
 
Research Services 
Agreement 
between 
 
The Secretary of State for Health 
 
Acting through the GPRD Group of the MHRA 
 
and 
 
[enter legal name].              
as Customer 
 
 
relating to 
Production and Supply of a Report of a Study conducted  
using the  General Practice Research Database 
 
 
 

 
CONTENTS 
1. Interpretation ....................................................................................................................... 1 
2. 
Scope of Agreement............................................................................................................ 3 
3. 
Conduct of Study and Production of Reports ...................................................................... 4 
4. 
Changes to Study ................................................................................................................ 4 
5. 
Payment of Fee and Invoicing Arrangements ..................................................................... 5 
6. 
Consequences of Late Payment ......................................................................................... 5 
7. 
Use of Report ...................................................................................................................... 6 
8. Confidentiality ...................................................................................................................... 7 
9. Intellectual 
Property 
Rights ................................................................................................. 8 
10. 
Warranties and Indemnity by Customer .............................................................................. 9 
11. 
Limitation of Liability and Disclaimer ................................................................................... 9 
12. Force 
Majeure ................................................................................................................... 10 
13. Termination ....................................................................................................................... 11 
14. 
Consequences of Suspension or Termination................................................................... 11 
15. 
Alternative Dispute Resolution .......................................................................................... 12 
16. Notices .............................................................................................................................. 13 
17. Entire 
agreement ............................................................................................................... 13 
18. Assignment........................................................................................................................ 13 
19. Variation ............................................................................................................................ 13 
20. Severability ........................................................................................................................ 13 
21. Waiver ............................................................................................................................... 14 
22. Survival.............................................................................................................................. 14 
23. Execution........................................................................................................................... 14 
24. 
Contracts (Rights of Third Parties) Act 1999 ..................................................................... 14 
25. Applicable 
law ................................................................................................................... 14 
SCHEDULE 1 TO RESEARCH SERVICES AGREEMENT.......................................................... 16 
 
 
 

Blank Study Agreement July 2010 

 
THIS AGREEMENT is made 
 
BETWEEN: 
 
(1) 
THE SECRETARY OF STATE FOR HEALTH, acting through the GENERAL PRACTICE 
RESEARCH DATABASE GROUP within the MEDICINES AND HEALTHCARE 
PRODUCTS REGULATORY AGENCY of 151 Buckingham Palace Road, London SW1W 
9SZ (the "GPRD Group") of the one part; and 
 
(2) [Enter legal name,] (the “Customer”), whose registered office is at [enter legal address] 
of the other part .  
 
 
 

Blank Study Agreement July 2010 

 
Background: 
(1) 
The Crown acting through the General Practice Research Database Group within the 
Medicines and Healthcare Products Regulatory Agency (an Executive Agency of the 
Department of Health) has developed and controls all rights to the Database, and is 
offering to conduct non-profit-making research using the Database in accordance with the 
terms and conditions referred to below. 
(2) 
The Customer wishes to engage the GPRD Group to conduct a single study for non-profit-
making Medical and Health Research Purposes using Data from the Database to be 
conducted in accordance with a protocol approved by the Independent Scientific Advisory 
Committee. 
(3) 
The GPRD Group has agreed to conduct the Study and produce a Report setting out the 
results of the Study for the Customer and  the Customer will be licensed to use the Report 
thereafter in accordance with the terms and conditions of this Agreement. 
NOW IT IS HEREBY AGREED as follows: 
1. 
Interpretation 
1.1 
In this Agreement (the “Agreement”), unless the context otherwise requires, 
the following expressions shall mean: 
Affiliated Companies 
Any company controlling, controlled by or under 
common control with the Customer by ownership, 
directly or indirectly, of 50% or more of the total 
ownership, or by the power to control the policies 
and actions of such company; 
Data 
Data from time to time obtained from contributing 
general medical practices using VAMP Medical (also 
known as VM)  software or Vision software as are 
contained in the Database or any such data as are 
added to the Database by the GPRD Group, or any 
part of such data; 
Database 
The  General Practice Research Database 
containing an electronic and relational record of 
anonymous patient data collected, aggregated and 
developed by the GPRD Group  and as may be 
amended or updated with Data by the GPRD Group 
from time to time; 
Effective Date 
The date set out in Section 2 of Schedule 1 for 
commencement of the Study; 
Fee 
The fee payable by the Customer for the production 
of and right to use the Report of the Study as 
specified in Schedule 1; 
 

 
Force Majeure 
Any event or occurrence which is outside the control 
of the Party concerned and which is not attributable 
to any act or failure to take preventative action by the 
Party concerned, including but not limited to acts of 
God, war, riot, civil commotion, malicious damage, 
computer viruses or other malicious software or 
program code, inability to obtain supplies, accident, 
breakdown of plant or machinery including 
telecommunications equipment, interruption to 
electricity supply, explosions, fire, flood, storm, 
default of suppliers, strikes, lockouts or other 
industrial disputes except where such strikes, 
lockouts or other industrial disputes occur within 
either of the Parties’ organisations; 
Intellectual Property Rights 
Patents, trademarks and service marks, present and 
future copyrights, topography rights, design rights 
and database rights (including, without limitation, 
rights of extraction), whether or not any of them are 
registered and including applications for registration 
of any of them, trade secrets and rights of 
confidence, and all rights or forms of protection of a 
similar nature or having equivalent effect to any of 
them which may subsist anywhere in the world; 
Marketing 
Authorisation 
Holder 
The holder, in one or more countries, of an 
authorisation, licence or approval necessary to 
market or place on the market a medicinal product in 
one or more countries, including without limitation 
the United Kingdom or the European Union; 
Medical and Health Research Population-based studies in health outcomes, drug 
Purposes 
safety, health economics, drug utilisation, public 
health research, drug formulary research and 
disease management, or such other purposes as are 
authorised by the GPRD Group; 
non-profit-making 
Not having the object of making a profit year on year;
Parties 
The GPRD Group and the Customer or their 
successors in title, each of them being referred to as 
a “Party”; 
Protocol 
The protocol approved by the ISAC and annexed to 
the Schedule in accordance with which the Study is 
to be conducted; 
Report 
The results of the Study which are to be provided to 
the Customer in writing by the GPRD Group under 
this Agreement as described in the Schedule hereto; 
Independent  Scientific  Advisory  The body or any successor body nominated by the 
GPRD Group to review the scientific acceptability of 
 
 

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Committee or ISAC 
studies at the GPRD Group’s request; 
Study 
The single study for non-profit-making Medical and 
Health Research Purposes which is to be performed 
by the GPRD Group under this Agreement as 
described in the Schedule; 
Work Plan 
The timing, sequence and work schedule for the 
Study as set out in Section 2 of Schedule 1. 
1.2 
In this Agreement: 
(A) 
the headings are included for convenience only and shall not affect the 
construction of this Agreement; and 
(B) 
the Interpretation Act 1978 shall apply to this Agreement in the same 
way as it applies to an enactment. 
2. 
Scope of Agreement 
2.1 
Subject to the terms of this Agreement and in consideration of the payment in 
full by the Customer of the Fee the GPRD Group shall conduct the Study, 
produce the Report and deliver it to the Customer for use all in accordance 
with the Work Plan, the tables and information described in Schedule 2,  and 
the licence in clause 7. 
2.2 
The Parties acknowledge that the times and dates specified in the Work Plan 
are indications only and the GPRD Group shall not be liable in any form 
whether in contract, tort (including negligence) or otherwise for any delay in 
conducting the Study or producing or delivering the Report. 
3. 
Conduct of Study and Production of Reports 
3.1 
The GPRD Group will use reasonable endeavours to commence work on the 
Study on or after the Effective Date. 
3.2 
The GPRD Group will use reasonable endeavours to conduct the Study and 
deliver the Draft Report to the Customer in accordance with the Work Plan. 
3.3 
The format of the draft Report will be agreed in advance in writing by the 
Parties. The Customer shall provide the GPRD Group with any comments 
which it may have upon the first draft of the Report or, if it has no comments, 
shall inform the GPRD Group to that effect, within 15 working days of receipt. 
If the Customer provides any such comments on the draft Report content the 
GPRD Group shall be entitled, at its sole discretion, to amend the Report as it 
sees fit and re-submit the revised Report to the Customer. The GPRD Group 
will make changes to the format of the Report as reasonably requested by the 
Customer. 
3.4 
The Customer acknowledges and agrees that the Report shall not represent 
the opinions or conclusions of the Medicines and Healthcare Products 
Regulatory Agency as an Executive Agency of the Department of Health as 
executive arm of the UK Licensing Authority and the contents of the Report 
 
 

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will be non-binding on the Medicines and Healthcare Products Regulatory 
Agency in this capacity. 
3.5 
The GPRD Group shall retain any computer files or datasets used during the 
conduct of the Study and the production of the Report for a minimum of 5 
years following their completion for reference purposes in the event that the 
Customer during that period raises any queries concerning them. 
4. 
Changes to Study 
4.1 
If during the course of the Agreement the Customer wishes to alter the Study 
in any way the Customer shall give notice to the GPRD Group of the 
proposed change. 
4.2 
The GPRD Group shall advise the Customer within a reasonable time of 
receiving the Customer’s request for a change and in its sole discretion 
whether the proposed change falls outside the scope of the Protocol and if it 
considers the proposed change to fall within the scope of the Protocol of the 
anticipated additional work, costs and impact on the Work Plan.  The 
Customer shall within a reasonable time of the response from the GPRD 
Group, indicate, whether: 
(A) 
in the case that a proposed change falls outside the scope of the 
Protocol it wishes the GPRD Group to proceed with an application to 
ISAC to amend the Protocol or wishes to abandon the proposed 
change; 
(B) 
in the case that a proposed change falls within the scope of the 
Protocol it wishes to proceed with the change and amend the Work 
Plan and Fee accordingly or wishes to abandon the proposed change. 
4.3 
If the Customer wishes to pursue a change that requires a change to the 
Protocol, the GPRD Group shall, on the Customer’s behalf, re-submit a 
revised Protocol to ISAC for review. The GPRD Group shall advise the 
Customer within a reasonable time of receiving a decision from ISAC, 
whether the proposed change to the Protocol has been approved by ISAC or 
not and if the change has been approved the anticipated additional work, 
costs and impact on the Work Plan.  The Customer shall within a reasonable 
time of the notice from the GPRD Group, indicate, whether: 
(A) 
in the case that a proposed change has been approved by ISAC, it 
wishes to proceed with the Study on the basis of the amended 
Protocol or wishes to abandon the proposed change; or 
(B) 
in the case that the proposed change has not been approved by ISAC, 
whether it wishes to abandon the proposed change or proceed on the 
basis of the unamended Study. 
4.4 
If the Customer wishes to proceed with the Study amended pursuant to either 
clause  4.2 or clause 4.3 the Study, the Work Plan and the Fee shall be 
amended accordingly. 
 
 

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4.5 
The Customer acknowledges that whether or not the proposed change results 
in a change to the Study, the GPRD Group shall be entitled to payment for all 
time and expenses incurred as a result of or in connection with a proposed 
change on the basis of the calculation of additional fees for the Study, which 
shall be added to the Fee. 
4.6 
The GPRD Group’s obligations under clause 3.2 above shall be suspended 
pending ISAC’s decision and the Agreement shall then either continue without 
any change or be varied or terminated as appropriate. For the avoidance of 
doubt, if the Agreement is varied the Fee payable and the time periods for 
delivery of the Report under the Agreement may also be varied. 
Notwithstanding the provisions of clause 4.4 above, in the event that ISAC 
approves the proposed change to the Protocol under clause 4.3, the GPRD 
Group shall be under no duty to re-commence its work hereunder unless and 
until an amended Fee is agreed between the Parties. 
5. 
Payment of Fee and Invoicing Arrangements 
5.1 
The Customer shall make the payment of the Fee upon receipt of an invoice 
from the GPRD Group, with payment due within 30 days of the receipt of an 
invoice.  
5.2 
The Customer shall, if subject to VAT, pay VAT on the Fee at the rate 
applicable at the time payment is made as specified on the GPRD Group’s 
invoice. Invoices shall be made as specified in Schedule 1, Sections 2.3 and 
2.4  which shall be modified in the event of a change in the applicable 
legal requirements. 
6. 
Consequences of Late Payment 
6.1 
In the event of a delay in payment, interest after due date will be 
charged at a rate of 0.25% above the London Interbank Offered Rate 
(LIBOR). The date of the payment order will be taken to be the day of 
payment. 
6.2 
If at the end of a further period of 30 days the payment together with interest 
accrued has not been received by the GPRD Group, the GPRD Group may 
immediately suspend the Customer’s licence granted under clause 7.1 
without notice until payment (including interest) is made.  Whether or not the 
GPRD Group chooses to suspend the Customer’s licence in accordance with 
the provisions of this clause, interest shall continue to accrue on the amount 
unpaid at the rate specified at clause 6.1 above. 
6.3 
If any payment due under this Agreement is outstanding for more than 8 
weeks after the initial 45 day period from the date of the invoice for payment 
has expired, the GPRD Group may terminate the licence granted under 
clause 7.1 and this Agreement without further notice. 
7. 
Use of Report 
7.1 Subject 
to 
clause 
7.2 the GPRD Group grants the Customer an exclusive and 
perpetual licence to use and make copies of the Report and to sublicense 
Affiliated Companies and other third parties to use and make copies of the 
 
 

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Report, solely for Medical and Health Research Purposes on a non-profit-
making basis, without payment of any copyright royalties to the GPRD Group, 
which, for the avoidance of doubt, shall not prevent the Customer (a) from 
recovering its reasonable direct operating costs associated with that research 
and (b) from recovering a profit from any application of the results in the 
report provided that such profit is only attributable to the value added by the 
Customer in its further analysis or interpretation of the Data in the report. 
7.2 
The licence granted under clause 7.1 is subject to the following restrictions 
and conditions: 
(A) 
it is the responsibility of the Customer to ensure that any of its 
Affiliated Companies or any other third party to whom it grants access 
to the Report are aware of and comply with the obligations and the 
restrictions in respect of the use of the Report as set out in this 
Agreement;  
(B) 
the Customer shall not and shall ensure that its Affiliated Companies 
and any other third parties shall not make any adaptation of the Report 
(an “Adaptation”) or, save as permitted pursuant to clause 7.1, issue to 
the public or otherwise publish any work reproducing the Report or any 
part of it or any Adaptation;  
(C) 
the Customer shall not permit the Affiliated Companies or any third 
party to do any of those acts described in clause 7.2(B);  
(D) 
any act or omission of any Affiliated Company or other third party 
which would have been a breach of this Agreement if such Affiliated 
Company or other third party had been a party hereto shall be treated 
as a breach by the Customer for which the Customer shall be liable, 
and the GPRD Group shall have the right to obtain injunctive relief in 
addition to any other legal or financial remedies to which the GPRD 
Group may be entitled; and 
(E) 
the Customer, if a Marketing Authorisation Holder in respect of any 
product which is the subject matter of the Report, shall discharge fully 
any of its statutory, legal or regulatory reporting requirements world 
wide and indemnify the GPRD Group from any liability it may incur 
from the Customer’s failure to fully discharge such statutory, legal or 
regulatory duties world wide in respect of any findings in the Report 
and in particular in respect of any pharmacovigilance requirements. 
7.3 
The GPRD Group may suspend or terminate with immediate effect the licence 
granted under clause 7.1 and require the return of the Report and all copies 
thereof: 
(A) 
to comply with any law, regulation, court order, or other governmental 
request or order, or to protect the GPRD Group from any legal liability, 
or if it considers it in the public interest to do so; or 
(B) 
if the GPRD Group reasonably believes that the Customer, its 
Affiliated Companies or any third parties to whom the Customer has 
distributed the Report may be using the Report for any purpose not 
 
 

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authorised by this Agreement.  If the GPRD decides to suspend the 
licence granted under clause 7.1 such suspension will be lifted on the 
GPRD Group being satisfied that the Report has not been used for an 
unauthorised purpose; or 
(C) 
if any invoice is not paid within 45 days pursuant to clause 5.1; or 
(D) 
in any circumstances under which the GPRD Group has the right to 
terminate this Agreement pursuant to clause 13
7.4 
Subject to clause 7.5 no compensation will be paid by the GPRD Group nor 
will the Fee be rebated for any suspension of the licence granted under 
clause 7.1. 
7.5 
The restrictions on using and copying the Report shall survive the termination, 
variation or expiry of the Agreement (subject to clause 7.3). 
8. 
Confidentiality 
8.1 
Subject to the rights granted under clause 7 and the provisions of clauses 8.2 
and 9.2 below, the GPRD Group shall not without the prior written consent of 
the Customer release or otherwise make available to third parties information 
relating to the Agreement or the Study. 
8.2 
Each Party shall at all times use its best endeavours to keep confidential (and 
to procure that its employees and agents shall keep confidential) any 
information which is marked as confidential or stated to be confidential by the 
other Party which it or they may acquire during the course of this Agreement 
in relation to the business and affairs of the other Party, and shall not disclose 
such information except with the consent of the other Party, or where 
expressly ordered to do so by a court of competent jurisdiction, or under any 
governmental request, law or regulation, or in connection with any legal 
proceedings arising out of this Agreement, or where such disclosure may 
otherwise be lawful. 
8.3 
The obligations of each of the Parties contained in clause 8.2 above shall 
continue without limit in point of time, save that they shall cease to apply to 
any such information which comes into the public domain otherwise than by a 
breach by either Party of its obligations under this clause. 
9. 
Intellectual Property Rights 
9.1 
The Crown is the maker of the Database, copyright in the Database is Crown 
copyright and any database rights in the Database belong to the Crown. 
Intellectual Property Rights, including copyright, in the Data, the Study and/or 
the Report, or any part thereof, shall remain the property of the Crown and the 
Customer shall not acquire any title, copyright or other Intellectual Property 
Rights therein under this Agreement, save to the extent that the Customer is 
granted the right to use, copy and distribute the Report under clause 7. 
9.2 
The GPRD Group shall have the right, to submit for publication the Study 
findings after delivery of the final Report to the Customer,. Journal 
requirements on disclosure of funding sources will be adhered to by the 
 
 

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GPRD Group. The GPRD Group will send a copy of any such publication, 
including any abstract, to the Customer, at least 30 working days before the 
proposed date of submission for publication, for the Customer's comment.  All 
Customer comments shall be considered before submission, and GPRD 
agrees to reasonably delay any such publication upon Customer's reasonable 
request (e.g. preparation of own publication etc.). Nothing in this Agreement 
shall be interpreted as precluding the GPRD Group from conducting research 
on the same topic as is covered by the Study as may be commissioned by 
other parties. 
9.3 
Copyright in any independent reports produced by the Customer, or any other 
Intellectual Property Rights, arising from the Customer’s use of the Report in 
accordance with this Agreement shall belong to the Customer. However, prior 
to seeking publication of any document arising from use of the Report the 
Customer shall seek the consent of the GPRD Group, such consent not to be 
unreasonably withheld. If no comments are provided by the GPRD Group 
within 30 working days of receipt of the draft report the Customer may 
proceed with the publication. Any such publication shall include the statement 
This report has been produced with reference to a study conducted, and a 
report produced, by the General Practice Research Database Group within 
the UK Medicines and Healthcare products Regulatory Agency using the  
General Practice Research Database. However, the interpretation and 
conclusions contained in this report are those of the author/s alone
”.   
9.4 
The Customer shall send a copy of any publication including any abstract 
arising from use of the Report under this Agreement to the GPRD Group 
within 2 weeks of publication. 
9.5 
The Customer may not remove, suppress or modify in any way any 
proprietary marking, including any trademark or copyright or database right 
notice, on or in the Report. If the Customer copies the Report pursuant to 
clause 7.1, it shall ensure that any such proprietary or rights notices are fully 
reproduced in any copies, and it shall procure that any Affiliated Companies 
or other third parties who copy the Report as per clause 7.1 fully reproduce 
any such proprietary or rights notices in any copies. 
9.6 
The Customer shall notify the GPRD Group immediately if the Customer 
becomes aware of any unauthorised use or copying of any part of the Report 
by any person. 
10. 
Warranties and Indemnity by Customer 
10.1 
The Customer warrants to the Licensor that: 
(A) 
The Customer has the requisite power and authority to enter into and 
perform its obligations under this Agreement; and 
(B) 
This Agreement constitutes binding obligations of the Customer in 
accordance with its terms. 
10.2  The Customer shall indemnify the GPRD Group, and keep the GPRD Group 
fully and effectively indemnified against all losses, claims, costs, charges, 
expenses, liabilities, demands, proceedings and actions which the GPRD 
 
 

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Group may sustain or incur, or which may be brought or established against it 
by any third party which arise out of a breach of this Agreement by the 
Customer or out of a breach caused by the act or omission of any of the 
Customer’s Affiliated Companies or any third party, including, but not limited 
to, any failure to draw any third party’s attention to the notice set out in clause 
9.3 and the disclaimer in clauses 11.2 and 11.3 or any infringement or alleged 
infringement of Intellectual Property Rights held by any third party. 
11. 
Limitation of Liability and Disclaimer 
11.1 
Except as specified in this Agreement, the provisions of this clause 11 specify 
the entire liability of the GPRD Group arising out of this Agreement whether 
arising in contract, tort (including negligence) or otherwise. 
11.2 
Subject to clause 11.7, the Customer acknowledges that, although the Report 
shall be produced by the GPRD Group based on the specification in the 
Schedule, it is the Customer’s responsibility to ensure that the nature of the 
Data meet the Customer’s requirements for conducting the Study.  The GPRD 
Group does not give medical or other professional advice and the Report 
does not constitute such advice.  The GPRD Group does not accept any 
liability for any decisions the Customer makes in consequence of or in 
connection with the Report whether in respect of its business, operations, 
medical analyses or otherwise and the Customer accepts sole responsibility 
and liability for any actions it chooses to take in consequence of or in 
connection with the Report. 
11.3  Subject to clause 11.7 the Customer acknowledges that the Report made 
available under this Agreement is provided “as is”, without any representation 
or endorsement made and, to the extent permitted by law, without warranty or 
condition of any kind, whether express or implied, statutory or otherwise, 
including but not limited to implied terms of satisfactory quality, fitness for a 
particular purpose, or as to the use of reasonable skill and care, as may be 
appropriate. In particular, the GPRD Group does not accept any liability for 
any errors, omissions or inaccuracies in the contents of the Data as recorded 
by and received from the contributing general medical practitioners which may 
affect the Study, nor does it warrant that any such errors, omissions or 
inaccuracies will be corrected. 
11.4  Subject to clause 11.7 the GPRD Group shall not be liable under this 
Agreement (whether in contract, tort or otherwise) for direct, indirect or 
consequential loss or damage, or financial losses, loss of contracts or 
opportunity, loss of operation time, loss of data, wasted management time, 
damage to goodwill, or loss or damage claimed by the Customer or any 
clients of the Customer arising out of or in connection with the use of the 
Study and/or the Report. 
11.5 
Subject to prior written agreement on the format of the Report as indicated in 
Article 3.3. herein above, the GPRD Group shall be entitled to supply the 
Report in such electronic form as the GPRD Group may in its sole discretion 
elect.  If the GPRD Group so elects, the GPRD Group warrants that the 
electronic form supplied is free from defective workmanship. Subject to clause 
11.7, if the electronic form is defective then the GPRD Group’s liability arising 
in contract, tort (including negligence) or otherwise, shall be limited to the 
 
 

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value of the retail price of such form as available from its manufacturer and 
the Customer’s sole remedy shall be to have a new copy of the Report 
supplied after return of the old Report to the GPRD Group. 
11.6 
Subject to clause 11.7 and notwithstanding anything in this Agreement to the 
contrary the total liability of the GPRD Group in contract and tort (including 
without limitation negligence) shall not exceed in aggregate the amount of the 
part of the Fee paid by the Customer in respect of time spent in preparing the 
Report but excluding any part of the Fee relating to the use or licensing of the 
Data. 
11.7 Notwithstanding 
clause
11.1 to 11.6 above, the liability of each Party to the 
other for death or personal injury resulting from its own negligence shall not 
be limited. 
11.8 
The Customer acknowledges and agrees that the allocation of risk and liability 
contained in this Agreement is reasonable in all the circumstances. 
12. 
Force Majeure 
12.1  Neither Party shall be liable to the other by reason of any failure or delay in 
performing all or any of its obligations under this Agreement (except for 
payment obligations) which is due to Force Majeure where there is no 
reasonably practicable means available to the Party concerned to avoid such 
failure or delay. 
12.2  If either Party becomes aware of any circumstances of Force Majeure which 
give rise to any such failure or delay, or which appear likely to do so, that 
Party shall give notice of those circumstances as soon as reasonably 
practicable thereafter and shall inform the other Party of the period for which it 
estimates that the failure or delay will continue. However, failure to provide 
such a notice shall not prevent that Party from relying on the remaining 
provisions of this clause. 
12.3  Where a Party is unable to perform any or all of its obligations under this 
Agreement (except for payment obligations) due to Force Majeure its duty to 
perform shall be suspended for so long as the circumstances continue and for 
such time after they cease as is necessary for that Party, using all reasonable 
endeavours, to recommence its affected operations in order to perform its 
obligations.  For the avoidance of doubt the licence fees shall not be rebated. 
12.4 
If any event of Force Majeure continues for a period exceeding 60 days either 
Party shall be at liberty to terminate this Agreement immediately on written 
notice to the other Party. 
13. 
Termination 
13.1  If the Customer commits any breach of any of the terms of this Agreement 
(other than those relating to payment or those which provide for immediate 
termination of the Agreement) which, being capable of remedy by the 
Customer acting alone, is not remedied within 30 days after written notice by 
the GPRD Group requiring the same, the GPRD Group may terminate this 
Agreement. 
 
 
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13.2 
If the Customer enters into liquidation, other than for the purposes of effecting 
a solvent reconstruction, whether compulsory or voluntary, or compounds with 
its creditors, or has a receiver or administrative receiver or administrator 
appointed over all of its assets, or takes or suffers any similar action in 
consequence of a debt, or for any reason ceases to carry on business the 
GPRD Group may terminate this Agreement forthwith by notice in writing to 
the Customer. 
13.3 
Termination of this Agreement shall be without prejudice to the rights of either 
Party which shall have accrued by reason of, or be subsisting at, the date of 
termination. 
14. 
Consequences of Suspension or Termination 
14.1  If this Agreement is terminated or the licence granted under clause 7 is 
terminated for any reason the Customer will return the Report and any other 
information obtained by the Customer or its Affiliated Companies under this 
Agreement to the GPRD Group within 4 weeks and destroy any copies which 
it or its Affiliated Companies may have made of the Report and any other 
information obtained by the Customer or its Affiliated Companies under this 
Agreement, and shall use reasonable endeavours to have returned all copies 
of the Report which it may have distributed to any third parties, or authorised 
any third parties to make.  Unless otherwise expressly agreed by the GPRD 
Group, the Customer agrees that following termination or suspension as 
described above it will make no further use of the Report and shall obtain 
written confirmation from its Affiliated Companies and any third parties to 
whom it may have distributed the Report that they will not thereafter use the 
Report or any of its contents. The Customer shall issue a certificate within 6 
weeks of termination that it has fully complied with its obligations under this 
clause 14.1. 
14.2 
If the GPRD Group terminates this Agreement under clause 13, or under any 
other clause herein which provides for termination, save where explicitly 
stated the GPRD Group shall not be obliged to repay the Customer any 
proportion of the Fee and the Customer shall pay the GPRD Group on the 
basis of time and materials together with all reasonable costs and expenses 
duly justified and  expended up to and including the date of termination, 
calculated on the reasonable rates and charges charged by the GPRD Group 
for its services. 
15. 
Alternative Dispute Resolution 
15.1 
In the event of any dispute arising between the Parties in connection with this 
Agreement which is not resolved by initial correspondence, senior 
representatives of the Parties shall, within 21 days of a written request from 
either Party to the other, meet in good faith to attempt to resolve the dispute.  
15.2  If the dispute is not resolved at the meeting referred to in clause 15.1 either 
Party may propose to the other within 21 days of its conclusion that the matter 
be referred for either an expert determination, if the matter is within the 
expertise of a technical expert, or a mediation, if the dispute is of a more 
general nature, and the other Party may accept or reject that proposal. If that 
 
 
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proposal is rejected either Party may refer the matter to the courts in 
accordance with clause 25.2. 
15.3 
If the Parties agree that an expert or a mediator should be appointed but are 
unable to agree on the person to be appointed within 21 days then the Parties 
shall by agreement refer the matter to the head of an appropriate professional 
body to appoint such an expert or to the Centre for Dispute Resolution, 
London or such other body as the parties may agree from time to time to 
appoint such a mediator. 
15.4  The Parties shall, within 14 days of the appointment of such an expert or 
mediator, meet with the expert or mediator to agree a programme for the 
exchange of any relevant information and the structure to be adopted during 
the alternative dispute resolution process. 
15.5 
The Parties agree that the decision of any expert appointed shall be final and 
binding (except on any points of law as opposed to fact) and that if any 
mediation results in a resolution of the dispute, such agreement shall be 
placed in writing and, once signed by the duly authorised representatives of 
both Parties, shall be final and binding (except on any points of law as 
opposed to fact). 
15.6  The Parties shall bear their own costs arising from any such expert 
determination or mediation but shall share equally the costs of the expert or 
mediator.  
15.7 
The Parties agree that all negotiations connected with the dispute that do not 
result in a formal resolution of the matter shall be conducted in confidence 
and without prejudice to the rights of either Party in any future court 
proceedings. 
15.8  Notwithstanding any dispute arising which is referred to a means of 
alternative dispute resolution under this clause or to the courts, this 
Agreement shall continue in force, as shall the obligations on the Parties 
under this Agreement, unless the dispute concerns a matter which entitles the 
GPRD Group to terminate the Agreement under the provisions herein. 
15.9 
Notwithstanding the above provisions of this clause 15 the GPRD Group has 
the right to seek and obtain such urgent or interim relief as the GPRD Group 
deems appropriate in any court of competent jurisdiction. 
16. 
Notices 
16.1  All notices and other communications between the Parties relating to this 
Agreement shall be given by recorded delivery or by facsimile transmission 
provided that a hard copy is subsequently sent by recorded delivery, sent to 
the Parties’ addresses as set out in the Schedule to this Agreement, or such 
other address as has been notified in writing to the other Party in accordance 
herewith. A copy of any such notice issued by the GPRD Group shall be sent 
to the Customer’s Legal Department, at the address set out in the schedule to 
this Agreement. 
 
 
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16.2 
Any notice given by recorded delivery shall be deemed to have been received 
two working days after the date of posting, and any notice given by facsimile 
transmission shall be deemed to have been received at the time when the 
sender’s equipment records successful dispatch. 
17. 
Entire agreement 
17.1  This Agreement and the Schedule hereto (over which the Agreement takes 
precedence) constitute the entire agreement between the GPRD Group and 
the Customer and supersede all prior negotiations, representations and 
undertakings, whether written or oral, except that this clause shall not exclude 
liability in respect of any fraudulent misrepresentation. 
18. 
Assignment 
18.1 
The Customer may not assign or otherwise sub-license or transfer its rights or 
obligations under the terms of this Agreement. 
19. 
Variation 
19.1  No amendments to this Agreement shall be effective unless made in writing 
and signed by duly authorised representatives of both the GPRD Group and 
the Customer, such variations to be agreed at the sole discretion of the GPRD 
Group. 
20. 
Severability 
20.1  If any part of any provision of this Agreement shall be held by a court of 
competent jurisdiction to be to any extent invalid or unenforceable that shall 
not affect the validity or enforceability of the remainder of that provision or of 
any other provision herein which shall continue in full force and effect as if the 
Agreement had been executed with the invalid or unenforceable provision or 
part eliminated. 
20.2  In the event of a holding of invalidity so fundamental as to prevent the 
accomplishment of the purpose of this Agreement, the GPRD Group and the 
Customer shall immediately commence negotiations in good faith to remedy 
the invalidity. 
21. 
Waiver 
21.1 
The failure of either of the GPRD Group or the Customer to exercise any right 
or remedy shall not constitute a waiver of that right or remedy.  
21.2  No waiver shall be effective unless it is communicated in writing and notice 
delivered in accordance with clause 16 above. 
21.3 
A waiver of any right or remedy arising from a breach of this Agreement shall 
not constitute a waiver of any right or remedy arising from any other breach of 
this Agreement. 
 
 
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22. 
Survival 
22.1  In addition to the restrictions on use in clause 7, terms of this Agreement 
which from their nature or context it is contemplated that they are to survive 
termination, expiry or variation, shall remain in full force and effect 
notwithstanding the termination, expiry or variation of this Agreement. 
23. 
Execution 
23.1  This Agreement shall be executed by first being signed by a duly authorised 
representative of the Customer, and then being signed by a duly authorised 
representative of the GPRD Group. 
23.2  The date at which the Agreement is signed on behalf of the GPRD Group 
shall be the date of execution of the Agreement, and that date shall be 
entered by the GPRD Group’s signatory on the front page of this Agreement. 
24. 
Contracts (Rights of Third Parties) Act 1999 
24.1  Pursuant to section 1(2) of the Contracts (Rights of Third Parties) Act 1999, 
the Parties do not intend that any term of this Agreement may be enforced by 
any Affiliated Companies or other third parties. 
25. 
Applicable Law and Jurisdiction 
25.1 
The law of England and Wales shall be the law applicable to this Agreement. 
25.2 
In relation to any legal action or proceedings to enforce this Agreement or 
arising out of or in connection with this Agreement (“proceedings”) each of the 
Parties irrevocably submits to the exclusive jurisdiction of the English courts 
and waives any objection to proceedings in such courts on the grounds of 
venue or on the grounds that the proceedings have been brought in an 
inappropriate forum. 
 
IN WITNESS WHEREOF this Agreement has been executed as an agreement. 
 
London,  

 
 
 
Signed on behalf of 
The Secretary of State for Health  
by its duly authorised officer: 
 
 
 
 
 

 
 
 
 
 
Name Jon Ford 
 
 
 
 

 
 
 
 
 
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Blank Study Agreement July 2010 

 
Signed on behalf of  
[enter company name]
. 
by its duly authorised officer: 
 
 
 
 

 
 
 
 
 
Name (please print):  
 
 
 
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SCHEDULE 1 TO RESEARCH SERVICES AGREEMENT 
 
1. 
Nature of the Study 
1.1 
In accordance with the terms of this Agreement, the Customer wishes to 
engage the GPRD Group to conduct a Study in accordance with the Protocol 
number XX_xxx submitted to and approved by ISAC (a copy of which is 
appended hereto as Annex B): 
 
2. 
Work Plan 
2.1 
The Study 
The Study shall be conducted, the Report shall be prepared and the Fee shall 
be payable in accordance with the following provisions: 
Commencement Date: Upon Licence Agreement 
2.2 
Delivery Date:  
Four months from Licence Agreement. [TBA] 
2.3 
The Fee 
a)  The Fee is payable upon commencement of study 
2.4 
Estimated cost of study conduct  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
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3. 
Description of the Report to be supplied under the Agreement 
To be supplied 
4. 
Notices 
4.1 
The addresses to which notices may be given by the Parties under the 
provisions of clause 16 of the Agreement are as follows: 
(A) 
For the GPRD Group 
Address: 
The GPRD Group, 
Medicines and Healthcare products Regulatory Agency, 
151 Buckingham Palace Road 
London, SW1W 9SZ, 
United Kingdom. 
For the attention of: Jon Ford 
 
Facsimile number: 
+44  020 3080 6041 
Email address: 
[email address] 
 
(B) 
For the Customer 
Address: 
Email address:   
 
4.2 
In cases of emergency the Parties may be contacted by telephone as follows: 
(A) 
For the GPRD Group: 
GPRD Group Reception: +44 20 3080 6206 
 
For the Customer: Phone  
 
 
 
 

 
 
 
 
 
 
 
 
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Document Outline