DATE OF THIS AGREEMENT:
THE PARTIES:
(A)
University Hospitals Bristol NHS Foundation Trust whose administrative office is at
Trust Headquarters, Marlborough Street, Bristol, BS1 3NU (the "Trust"); and
(B)
XXXXXXX● whose [registered][administrative] office is at ● (the "Recipient").
THE BACKGROUND:
(A)
The Trust is the custodian of the Material.
(B)
The Recipient wishes to use a sample of the Material for a specified use (a
"Scheduled Purpose") pursuant to the Human Tissue Act 2004 (the "Act")
(C)
This Agreement does NOT apply where the Scheduled Purpose is transplantation or
a “human application” pursuant to the Human Tissue (Quality and Safety for Human
Application) Regulations 2007.
AND
The Material is held with approval by a recognised research ethics committee, being
either a research ethics committee established under and operating to the standards
set out in the governance arrangements issued by the UK Health Departments
(www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuid
ance/DH_4005727); or a research ethics committee recognised by United Kingdom
Ethics Committee Authority or a person or committee recognised for that purpose by
the Secretary of State, the National Assembly of Wales or the Department of Health,
Social Services and Public Safety in Northern Ireland or any such equivalent under
Applicable Law (www.opsi.gov.uk/si/si2004/20041031.htm). Therefore the Trust is
able and willing to provide a sample of the Material on the terms and conditions of
this Agreement and the Recipient agrees to comply with such terms and conditions.
THE "MATERIAL" is both anonymised patient data and anonymised saliva, blood and tissue
samples which have been collected for the purposes of the research trial sponsored by the
Trust entitled: Head and Neck 5000 as further described in the Annex being "relevant
material" for the purposes of the Act and includes any and all materials, documents and
information that the Trust may provide to the Recipient under or in connection with this
Agreement:
THE "SCHEDULED PURPOSE(S)"
OR
Where the Scheduled Purpose is “research in connection with disorders or the
functioning of the human body” the NHS Research Ethics Committee (the
"NHS REC") or other applicable research ethics authority favourable opinion
or pending favourable opinion approval reference number and the anticipated
expiry date are: [●]. The Investigator is the following named officer or
employee of the Recipient [●].
THE "TERM" of this Agreement: [●].
THE "INVESTIGATOR" the following named officer or employee of the Recipient: [●].
THE "PREMISES" where the Scheduled Purpose will be conducted: [●].
TO THE BEST OF THE TRUST’S KNOWLEDGE CONSENT (IF IT IS REQUIRED) has
been given for the Scheduled Purpose(s).
This Agreement comprises the main body of this Agreement, the Annex and the
Standard Terms and Conditions attached.
SPECIAL CONDITIONS: [●]
All full papers and press releases must be sent to the Head and Neck 5000 Executive for approval
(headandneck5000@uhbristol.nhs.uk) along with a completed papers checklist prior to submission.
We request that we are provided with an electronic copy of any reports, theses and other publications
that use the Head and Neck 5000 resource as soon as possible
The Director and/ or one or more nominated member(s) of the Head and Neck 5000 Executive should
also be included as an author on papers using data from Head and Neck 5000 resource. This person
must see and sign off the final version of the paper to ensure it is accurate and does not bring the
study into disrepute
The following standard acknowledgements section must be included in all papers:
We would like to thank the people with head and neck cancer who took part in this study. We would
also like to thank the research and clinical staff who supported this study. This publication presents
independent research funded by the National Institute for Health Research (NIHR) under its
Programme Grants for Applied Research scheme (RP-PG-0707-10034). The views expressed in this
publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the
Department of Health.
AGREED by the parties through their authorised signatories on the date appearing above.
Signed by
for and on behalf of the Trust
as an authorised representative
of the University Hospitals Bristol NHS Foundation Trust.
Signed by
for and on behalf of the recipient
as an authorised representative
of
UH Bristol Version No.1 22.05.15
ANNEX: Further description of the Material & the Scheduled Purpose
Section 1: To be completed by the Recipient
Project Title
Named Collaborators and their
host organisations
Scheduled Purpose
(please delete as appropriate)












Anatomical examination
Determining the cause of death
Establishing after a person’s death the efficacy of any
drug or other treatment administered to him
Obtaining scientific or medical information about a living
or deceased person which may be relevant to any other
person (including a future person)
Public display
Research in connection with disorders, or the
functioning, of the human body
Transplantation
Clinical audit
Education or training relating to human health
Performance assessment
Public health monitoring
Quality assurance
Lay summary of proposal
(max 200 words)
Study proposal / protocol
Peer review
Funding
Material requested
Description
Quantity
Frequency of delivery
Disposal policy
UH Bristol Version No.1 22.05.15
Section 2: To be completed by the Trust
Storage conditions
Data to be stored within provision of Data Protection Act
Living/deceased donor
Information released with
Material
e.g.
Relevant
donor
info/medical
history,
circumstances of donation
Proposed processing of the
Material
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Standard Terms & Conditions
1.
Definitions
"Publications" means any proposed
or draft publications, including (but not
limited to) papers, letters, reports,
presentations
and
funding
applications, which describe the work
carried out under the Scheduled
Purpose and which are intended for
public disclosure.
Under these terms and conditions,
unless the context otherwise requires,
the following definitions shall apply:
"Applicable Law" means all laws,
rules, regulations, codes of practice,
research governance or ethical
guidelines, or other requirements of
any Regulatory Authority, that may
apply to the use of the Material by the
Recipient from time to time, including
(but not limited) to the Human Tissue
Act 2004 or the Human Tissue
(Scotland) Act 2006, the Human
Tissue (Quality and Safety for Human
Application) Regulations 2007, the
Human Fertilisation and Embryology
Act 1990 (as amended), the EU
Tissues
and
Cells
Directive
(2004/23/EC)
and
Commission
Directives
2006/17/EC
and
2006/86/EC, the Human Tissue
Authority Directions and Codes of
Practice, and the Medicines for Human
Use (Clinical Trials) Regulations 2004,
as updated and amended from time to
time and, where relevant, the national
implementations of the same.
A "Regulatory Authority" is the
Human Tissue Authority, the Human
Fertilisation and Embryology Authority,
the
Medicines
Healthcare
and
products Regulatory Agency, or any
other competent authority in relation to
the use of the Material under
Applicable Law.
A "research ethics authority" is:
"Confidential Information" includes
(but is not limited to) information
relating
to
the
Material,
any
information relating to a donor of the
Material, any Invention, the Scheduled
Purpose results, any Publication or
any technical information disclosed by
the Trust or any other information
disclosed by the Trust under this
Agreement
and
identified
as
confidential.

a Research Ethics Committee (a
"REC") established under and
operating to the standards set out
in the governance arrangements
issued by the UK Health
Departments
www.dh.gov.uk/en/Publicationsan
dstatistics/Publications/Publication
sPolicyAndGuidance/DH_4005727
; or

a REC recognised by United
Kingdom
Ethics
Committee
Authority
(the
"UKECA")(www.opsi.gov.uk/si/si20
04/20041031.htm) or a person or
committee recognised for that
purpose by the Secretary of State,
the National Assembly of Wales or
the Department of Health, Social
Services and Public Safety in
Northern Ireland or any such
equivalent under Applicable Law.
“Intellectual Property” means any
Invention and any intellectual property
rights, including all patents, patent
applications, copyright, and other
similar proprietary rights, data, and all
intangible rights and privileges of a
nature similar to any of the foregoing,
and whether or not registered and
including all granted registrations and
all applications for registration in
respect of any of the same
2.
Supply & use of the Material
2.1
The Recipient agrees to be bound by
the
terms
and
conditions
in
consideration of the Trust making the
Materials available to the Recipient for
the Scheduled Purpose.
An "Invention" means any new
discovery, improvement, invention or
product relating to the Material.
2.2
The Trust hereby grants the Recipient
a non-exclusive licence to use the
Material solely for the Scheduled
To "use" means (as applicable) to
procure, test, process, use for a
Scheduled Purpose, import, store,
return and dispose of the Material.
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Purpose at the Premises. Any use of
the Material outside the scope of the
Scheduled Purpose or outside the
Premises requires the prior written
consent of the Trust. Subject to the
Recipient complying with clause
2.4(b), if the Recipient is NHS REC
approved the Recipient may remove
Material from the Premises without the
Trust’s prior written consent for use
within the scope of the REC protocol.
2.3
2.4
(e)
2.5
The Material is supplied without cost,
but the Recipient shall reimburse the
Trust for all costs that the Trust may
incur when preparing and sending the
Material to the Recipient. Supply of
the Material is subject to availability.
The Recipient shall:
(a)
(b)
as applicable, provide written
evidence to the Trust and its
DI: (i) that the Scheduled
Purpose has been granted a
favourable opinion by a
research ethics authority or
that such a favourable opinion
is pending OR (ii) of an
appropriate licence granted by
a Regulatory Authority OR (iii)
if the Scheduled Purpose is
being
conducted
outside
England, Wales and NI, such
equivalent
evidence
as
required under Applicable Law
OR (iv) that the Scheduled
Purpose has been approved
by a licensed tissue bank;
procure that the Investigator
and any other employees,
students, officers or other
representatives
of
the
Recipient or third party
collaborators involved in the
Scheduled Purpose and with
access to the Material abide
by these terms and conditions;
(c)
use the Material only for the
Scheduled Purpose;
(d)
keep the Material secure at
the Investigator's laboratory or
applicable offices (for data
only) at the Premises and
ensure that no-one other than
the Investigator and those
individuals
under
the
Investigator’s supervision have
access to the Material; and
not remove the Material from
the Premises.
The Material shall be immediately
returned (or if the Trust so requires,
disposed of in accordance with
Applicable Law):
(a)
on
termination
of
this
Agreement for any reason; or
(b)
in the event that the Recipient
is in breach of any of these
terms and conditions or
(c)
at any other time on request of
the Trust or the DI; or
(d)
on
completion
of
Scheduled Purpose; or
(e)
in respect of any donor if the
donor withdraws consent to
the use of Material pertaining
to them as advised by the
Trust.
the
3.
Intellectual Property
3.1
Except as provided by clause 2.2, no
licence under any Trust Intellectual
Property or material is granted or
implied by this Agreement.
3.2
In the event that the Recipient makes
or observes an Invention then the
Recipient will promptly bring this to the
attention of the Trust.
3.3
The Trust will, at all times, retain the
right to use an Invention and any
results arising under the Scheduled
Purpose for non-commercial research
or teaching purposes.
3.4
Save as provided in this clause 3 the
Recipient shall own all Intellectual
Property in the results of the
Scheduled Purpose.
4.
Publications & Acknowledgements
4.1
If identified as a Special Condition, the
Recipient shall send to the relevant
person at the Trust (such person to be
identified in the Special Condition) a
copy of any Publications for review by
the Trust not less than 30 days prior to
publication. The Trust shall be entitled
to delay publication for a period not
exceeding 60 days in order to protect
intellectual property or remove the
Trust's
confidential
information
disclosed in the Publication. Until their
publication the parties shall treat
UH Bristol Version No.1 22.05.15
Publications
information.
4.2
confidential
(c)
In any Publications arising from the
Recipient’s use of the Materials the
Recipient shall:
(a)
acknowledge the Trust as the
source of the Material; and
(b)
provide (where customary and
appropriate) authorship to
those
Trust
officers
or
employees involved in the
Scheduled Purpose; and
(c)
5.
as
6.2
acknowledge the participation
of any funder advised to you
by the Trust.
Confidentiality
Save to the extent that the Confidential
Information has come into the public
domain through no fault of the
Recipient or as required by Applicable
Law, the Recipient shall not disclose
Confidential Information disclosed by
the Trust to the Recipient to any third
party and shall only disclose such
Confidential Information to those of its
officers or employees as need to
know. The Recipient shall treat the
Trust's Confidential Information with
the same degree of care as it treats its
own confidential information.
6.
Warranties & Liability
6.1
The Material is experimental in nature
and provided "as is" to the Recipient.
The Trust makes no representation
and gives no warranty or undertaking
in relation to the Material.
As
examples, but without limiting the
foregoing, the Trust gives no warranty
that:
(a)
(b)
it is the custodian of all
necessary property and other
rights in the Material and that
their use will not infringe any
intellectual property rights of
any third party; or
the Material is free from
disease or infection, fit for any
particular purpose, has been
developed with reasonable
care and skill or tested for the
presence of pathogens or
otherwise, or is viable, safe or
non-toxic; or
that all necessary consents or
authorisation
have
been
obtained from the donors
(whether deceased or living)
or
licenses
have
been
obtained from the Regulatory
Authority.
The Trust shall have no liability to the
Recipient, whether in contract, tort or
otherwise, in relation to:
(a)
the supply of the Material to
the Recipient; or
(b)
the use of the Material by
Recipient or by any other
person; or
(c)
the consequences of its use;
to the maximum extent permitted
under Applicable Law.
6.3
The Recipient warrants that:
(a)
it shall comply with all
Applicable Law in the storage,
use and disposal of the
Material or as otherwise
applicable to the Scheduled
Purpose;
(b)
it may lawfully use the Material
for the Scheduled Purpose
and that it has the full power
and capacity to enter into this
Agreement;
(c)
where the Scheduled Purpose
is research, the Scheduled
Purpose has received a
favourable opinion by a
research ethics authority or
that a favourable opinion is
pending,
or
that
an
appropriate licence has been
granted by the Regulatory
Authority to use the Material,
or that there is approval from a
licensed tissue bank;
(d)
for Scheduled Purposes other
than research, the Recipient
holds an appropriate HTA
Licence (or equivalent issued
by the relevant Regulatory
Authority) for the storage and
use of the Material; and
(e)
if the Material is supplied by
the Trust in an anonymised
form, the Material will be kept
anonymised and the Recipient
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shall not attempt to identify
any donor or, if information is
given to the Recipient whether
intentionally or not that could
lead to identification of one or
more donors of the Material,
then the Recipient shall treat
that information as confidential
information in accordance with
clause 5 of this Agreement.
6.4
In relation to the supply and use of the
Material the Recipient undertakes to
indemnify the Trust and keep it
indemnified fully at all times against all
claims,
demands,
actions,
proceedings, damages, losses or
costs (including not limited to any,
expenses, fines, prosecutions or
charges) which are made or brought
against or incurred by the Trust in
respect of the use of the Material by
the Recipient, including (without
limitation), claims and losses arising
from:
(a)
injury to the Recipient's
employees,
officers,
contractors, agents or any
other person;
(b)
infringement of third party
intellectual property rights;
(c)
failure by the Recipient to
abide by Applicable Law; or
(d)
use of the Materials within or
outside the scope of this
Agreement.
7.
Term & Termination
7.1
This Agreement shall commence on
the date of signature and shall
continue in force for the Term unless
terminated earlier in accordance with
this clause.
7.2
Any breach of the terms of this
Agreement by the Recipient or any
event of insolvency involving the
Recipient shall result in immediate
termination of this Agreement.
7.3
The following clauses and any other
clauses which are either expressed to
survive termination or, from their
nature or context are intended to
survive termination shall survive
termination of this Agreement for any
reason: clauses 3, 4, 5, 6 and 7 and
any special conditions.
8.
General
8.1
The Recipient shall not assign,
transfer, or part with any of its
interests, rights, duties or obligations
under this Agreement without the prior
written consent of the Trust.
8.2
This Agreement sets out the entire
agreement
and
understanding
between the parties and supersedes
all prior agreements, understandings
or arrangements (oral or written) in
respect of the subject matter of this
Agreement.
8.3
The Recipient acknowledges that it
has entered into this Agreement in
reliance only on the representations,
warranties promises and terms
contained in it and, save as expressly
set out in this Agreement, the Trust
shall have no liability in respect of any
other representation, warranty or
promise made prior to the date of this
Agreement unless it was made
fraudulently.
8.4
No purported variation of this
Agreement shall be effective unless it
is in writing and signed by or on behalf
of each of the parties’ authorised
representatives.
8.5
To the extent that any provision of this
Agreement is found by any court or
competent authority to be invalid,
unlawful or unenforceable in any
jurisdiction, that provision shall be
deemed not to be a part of this
Agreement, it shall not affect the
enforceability of the remainder of this
Agreement nor shall it affect the
validity, lawfulness or enforceability of
that provision in any other jurisdiction.
8.6
The Trust may, in whole or in part,
release,
compound,
compromise,
waive or postpone, in its absolute
discretion, any liability owed to it or
right granted to it in this Agreement by
any the Recipient without in any way
prejudicing or affecting its rights in
respect of that or any other liability or
right not so released, compounded,
compromised, waived or postponed.
8.7
No single or partial exercise, or failure
or delay in exercising any right, power
or remedy by the Trust shall constitute
a waiver by it of, or impair or preclude
any further exercise of, that or any
UH Bristol Version No.1 22.05.15
right, power or remedy arising under
this Agreement or otherwise.
8.8
The Recipient shall not use the name
or trade marks of the Trust in any way,
including (but not limited to) in any
advertising, press release, sales
literature or fund raising event, without
the prior written consent of the Trust.
8.9
Unless expressly provided in this
Agreement, no term of this Agreement
is enforceable pursuant to the
Contracts (Rights of Third Parties) Act
1999 by any person who is not a party
to it.
8.10
Any notice to a party under this
Agreement shall be in writing signed
by or on behalf of the party giving it
and shall, unless delivered to a party
personally, be left at, or sent by
prepaid first class post in the case of
the Trust to the address set out on
page 1 of this Agreement and in the
case of the Recipient to the
Investigator at the Premises or as
otherwise notified in writing from time
to time.
9.
Governing law
English law shall apply to this
Agreement, and the English courts
shall have exclusive jurisdiction.
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