EXHIBIT 10.14
DATED
199_
(1) FREEMEDIC PLC
AND
(2) CARDIOTECH INTERNATIONAL INC.
LICENCE AGREEMENT
Xxxxx & Partners
Xxxxxxxxx Xxxxx
Xxxxxxxx Xxxxxx
Xxxxxxx
XX0 0XX
Ref: IV.CAR51.2
THIS AGREEMENT is made the day of 199_
BETWEEN:
1. FREEMEDIC PLC (company number 2776963) whose registered office is at The
Royal Free Hospital School of Medicine, University of London, Xxxxxxx Xxxx
Xxxxxx, Xxxxxx, XX0 0XX ("the Licensor"); and
2. CARDIOTECH INTERNATIONAL INC. a US corporation incorporated under the laws
of the State of Massachusetts and whose principal place of business is at
00, Xxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx, XX 00000 ("the Licensee").
WHEREAS:
(A) The Licensor is the sole owner of the Intellectual Property (as defined).
(B) The Licensor has the right to grant licences of the Intellectual Property
in the Territory (as defined).
(C) The Licensee has requested a licence to use the Intellectual Property for
the Purpose (as defined) within the Territory.
(D) The Licensor has agreed to grant such a licence to the Licensee on the
terms of this Agreement.
NOW IT IS HEREBY AGREED as follows:
1. INTERPRETATION
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1.1. In this Agreement the following words and expressions shall have the
following meanings:
"THE COMMENCEMENT DATE" means the date hereof.
"THE COMPANY" means Cardiotech International
Limited (company no. 3198267) whose
registered office is situate at 0/0
Xxxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx,
Xxxxxxx, XX0 0XX.
"CONFIDENTIAL INFORMATION" means any and all data, results, know-
how (including, but not limited to the
Know-how) plans, business, financial and
technical information and other
information disclosed by either party to
the other, whether orally, in writing or
in any other form, either before or
after the Commencement Date.
"DEVELOPMENT WORK" means the programme of research and
development undertaken by the Company,
the Medical School and the Trust in
respect of Project Two of the Research
Agreement.
"EUROPEAN ECONOMIC AREA" means the countries from time to time
parties to the agreement on the European
Economic Area, including without
limitation, the member states from time
to time of the European Union.
"THE INTELLECTUAL PROPERTY" means the Know how and the Patents.
"KIT" means a kit comprising materials and
equipment for effecting the Process and
developed by the Medical School and/or
the Trust, as may be tested, modified or
improved as part of the
Development Work.
"KNOW-HOW" means all know-how, inventions,
confidential and technical information,
data, processes and techniques
(including any improvements or
modifications to any pre-existing know-
how, techniques or information):-
(i) relating to the Process and/or the
Kit which is vested in the Licensor
as at the Commencement Date of the
Research Agreement as the Licensor
identifies to the Licensee within
30 days of the Commencement Date of
the Research Agreement; and
(ii) relating to the Kit, Process and/or
any Product and arising from or
developed during the course of the
Development Work and which is
vested in the Licensor pursuant to
the terms of the Research Agreement
and which the Licensor is entitled
to use and disclose.
"NET SALE PRICE" means the invoiced selling price of
the Products in the Territory net
of insurance and carriage, so far
as the
same are separately invoiced, and
of all rebates, discounts, and
other reductions actually granted
and exclusive of any Value Added
Tax or other duty payable in
respect thereof.
"PATENTS" means any patent applications filed
by or on behalf of the Licensor,
whether before or after the
Commencement Date which seek to
protect any invention developed or
arising from the Development Work
and relating to the Kit, the
Process and/or any Product and
vesting in the Licensor pursuant to
the terms of the Research
Agreement, any application which
claims priority from any such
application, and any patents which
may be granted in respect of any
such applications.
"PRIMARY PRODUCTS" means:-
(i) any Vascular Graft; and/or
(ii) any Kit incorporating any
Vascular Graft for effecting
the Process in connection with
such Vascular Graft.
"THE PRIMARY PURPOSE" means the manufacture, marketing,
supply and development of the
Primary Products.
"PROCESS" means the process developed by the
Medical School and/or the Trust
relating to the extraction of
endothelial cells from patients,
the seeding of those cells onto
materials used in surgery and the
implantation of such seeded
materials into patients, as such
process may be tested, modified and
improved as part of the Development
Work.
"PRODUCTS" means together the Primary Products
and, where the scope of this
Licence has been extended to cover
the supply of Secondary Products by
or on behalf of the Licensee, such
Secondary Products.
"PURPOSE" means together the Primary Purpose
and the Secondary Purpose.
"QUARTER DAY" means 31st March; 30th June; 30th
September and 31st December in each
year.
"RESEARCH AGREEMENT" means the Agreement entered into
between the Company and the Royal
Free Hospital School of Medicine
dated [_] 1998 a copy of which is
attached at Schedule 1.
"SECONDARY PRODUCTS" means any Kit incorporating any
Stent.
"THE SECONDARY PURPOSE" means the manufacture, marketing,
supply and development of the
Secondary Products.
"STENT" means any stent or stent graft for
use in surgery.
"SUB-LICENSEE" means any third party, including
but not limited to the Company or
any other associate of the
Licensee, to whom the Licensee has
sub licensed, sub-contracted or
otherwise transferred any of the
Licensee's rights and/or
obligations under this Agreement in
accordance with Clause 11.3.
"THE TERRITORY" means all countries in the world;
and `country' shall be construed
accordingly.
"VASCULAR GRAFT" means any vascular graft as may be
tested, modified or improved as
part of the Development Work.
1.2. The headings in this Agreement are inserted only for convenience and
shall not affect its interpretation.
1.3. Where appropriate words denoting a singular number only shall include
the plural and vice versa.
1.4. Reference to any statute or statutory provision includes a reference
to the statute or statutory provision as from time to time amended,
extended or re-enacted.
1.5. Reference to any Schedule or Annex shall be deemed to be reference to
a Schedule of or Annex to this Agreement, and such Schedule or Annex
shall form a part hereof.
1.6. References to any gender shall include the other genders and
references to persons shall include individuals, bodies corporate,
unincorporated associations and partnerships.
1.7. Words and expressions defined in the Research Agreement shall have the
same meaning herein unless otherwise specifically defined.
2. RIGHTS GRANTED
--------------
2.1. During the continuance hereof, the Licensor grants to the Licensee, on
the terms set out in this Agreement, an exclusive licence to use the
Intellectual Property in the Territory for the Primary Purpose under
the terms of this Agreement.
2.2. The Licensee shall not be entitled:-
2.2.1. to supply any Kit with any product other than any Vascular
Graft, save as provided in Clauses 2.3 or 2.4;
2.2.2. to supply any Kit independently from any Vascular Graft save
that with the prior written consent of the Licensor (such
consent not to be unreasonably withheld or delayed), the
Licensee shall be entitled to supply any Kit separately from
any Vascular Graft for practical production or supply reasons,
provided that the Licensee makes such supply only on such
terms as the Licensor may reasonably require and supplies all
Kits on the condition (but without guaranteeing the compliance
by any third party with such condition) that they be used with
a Vascular Graft and that the Kit must not be used with any
product other than the Vascular Graft; and
2.2.3. to use any of the Intellectual Property save as expressly
licensed pursuant to Clause 2.1.
Where in accordance with Clause 2.2.2 the Licensee or any Sub-Licensee
supplies any Kit separately from any Vascular Graft, the definition of
Products shall be deemed to include any such Kit.
Where the Licensee or any Sub-licensee supplies any Kit it will do so
on the condition (but without guaranteeing the compliance by any third
party with such condition) that the Kit is only to be used with the
Vascular Graft.
2.3. Subject to Clause 2.4 and 2.5 below, if at any time during the Minimum
Period the Licensee can demonstrate to the reasonable satisfaction of
the Licensor that:-
(i) it has developed a Stent to which the Process can be applied; or
(ii) it has acquired the right to manufacture and supply any such
Stent; or
(iii) either (i) or (ii) above is imminent;
then the exclusive licence granted pursuant to Clause 2.1 shall in
addition to Primary Products, extend to cover the Secondary Products
and the provisions of clauses 2.1 and 2.2 shall apply mutatis mutandis
to include such Secondary Purpose.
2.4. Subject to Clause 2.5 below, if at any time during the Minimum Period,
provided that no extension of the licence for the Secondary Purpose as
envisaged by Clause 2.3 above shall then have been granted or such
obligation shall have arisen, the Licensor shall receive an approach
from any third party wishing to perform the Secondary Purpose, the
Licensor shall as soon as reasonably practicable thereafter give to
the Licensee details in writing of such approach (subject to any
duties of confidentiality owed by the Licensor to any such third party
provided
that the Licensor shall use all reasonable endeavours to ensure that
such obligations of confidentiality do not restrict the provision by
the Licensor to the Licensee of sufficient information to enable it to
exercise its rights under this Clause 2.4), and shall allow the
Licensee a reasonable period of time (being not less than 60 days) in
which to demonstrate to the reasonable satisfaction of the Licensor
that the Licensee is able to put such Secondary Products as are the
subject of the third party approach into such a form as to enable them
to be sold on the open market in a shorter period than it would have
taken the said third party to do so. If the Licensee is able to
demonstrate such capability in accordance with this Clause 2.4 then
the exclusive licence granted pursuant to Clause 2.1 shall, in
addition to the Primary Products, extend to cover the Secondary
Products and the provisions of Clauses 2.1 and 2.2 shall apply mutatis
mutandis to include such Secondary Purpose.
2.5. If the Licensee is planning to enter into the market for Stents in the
near future, it shall be entitled to request an extension of the
option period provided in clauses 2.3 and 2.4 for a further 12 months
from the expiry of the Minimum Period and the Licensor shall not
unreasonably withhold or delay its consent to such an extension
provided the Licensee demonstrates to the reasonable satisfaction of
the Licensor that it is taking active steps to enter that market.
3. DURATION
3.1. The Licence granted under Clause 2.1 shall commence on the date
hereof.
3.2. With respect to each country within the Territory, subject to the
provisions of Clause 9, the licence granted under Clause 2.1 shall
expire on the last to occur of the following:-
3.2.1. the date upon which last of the Patents (if any) ceases to be
in force in the country concerned; or
3.2.2. 10 years from the date that the Product concerned was first
put on the market by or on behalf of the Licensee or any Sub-
Licensee in the country concerned.
4. COMPLIANCE OF PRODUCTS
The provisions of this Clause 4 shall at all times be subject to the
provisions of the Research Agreement.
4.1. The Licensee shall ensure that all Products supplied by or on behalf
of the Licensee or any Sub-licensee:-
4.1.1. are safe, non-hazardous and comply with all regulatory
requirements applying to such Products in the relevant country
within the Territory.
4.2. The Licensor makes no representations or warranties that the Products
will be safe or non-hazardous. The Licensee will be responsible for
any product liability claims relating to the Products licensed to the
Licensee hereunder and their use and the Licensor, its officers,
employees and agents will have no liability to the Licensee or any
Sub-Licensee whether in contract, tort, negligence or otherwise for
any loss or damage arising out of or in connection with the
manufacture, supply or development of any Products by or on behalf of
the Licensee or any Sub-Licensee which are not safe or are hazardous.
4.3. The Licensee shall indemnify the Licensor and keep the Licensor fully
indemnified against any and all liability, losses damages, costs,
claims and expenses (including legal expenses) actually incurred by
the Licensor, the Medical School and the Trust and arising out of or
in connection with:-
4.3.1. any manufacture, use, distribution or supply of the Products
by or on behalf of the Licensee or any Sub-licensee; or
4.3.2. any use by a third party of any Products manufactured and/or
supplied by or on behalf of the Licensee or any Sub-licensee
where such liability, damages, losses, costs, claims or expenses are
suffered, incurred or experienced by the Licensor (or Medical School
or Trust) as a result of the negligence, breach of statutory duty or
breach of any of the provisions of this Agreement on the part of the
Licensee, its directors, officers, employees, agents or any Sub-
licensee.
5. INTELLECTUAL PROPERTY
5.1. At the Licensor's written request the Licensee will:
5.1.1. ensure that all Products bear a label quoting any relevant
patent numbers and/or stating in English that the Products are
manufactured by the Licensee or Sub Licensee with the
permission of the Licensor, the terms of such wording and its
placing shall be as reasonably requested by the Licensor; and
5.1.2. ensure that all literature relating to the Products includes a
notice in similar terms.
6. OWNERSHIP OF THE INTELLECTUAL PROPERTY
--------------------------------------
6.1. Subject to the provisions of this Clause 6.1 the Licensor hereby
warrants represents and undertakes to the Licensee:-
6.1.1. that it has the right and authority to enter into this
Agreement; and
6.1.2. that it will notify the Licensee in writing immediately upon
it receiving written notification that the use of any of the
Intellectual Property on or in relation to the Products in any
part of the Territory in accordance with the terms of this
Agreement
infringes or is likely to infringe the Intellectual Property
Rights of any third party, but for the avoidance of doubt the
provisions of this clause 6.1.2 will not impose a positive
duty upon the Licensor to make specific enquiries in respect
thereof.
The Licensor acknowledges and confirms that the Licensor has not
sought the consent of Thermedics Inc. or any other third party which
owns any interest in any Patents as defined in the Research Agreement
and the Licensee warrants that such consent is not required for the
purposes of this Agreement.
6.2. Where any of the Know-How is patentable, the Licensor may in its
absolute discretion apply for Patents in any country within the
Territory at the Licensor's cost. Where the Licensor so applies for
any Patent, it will promptly pay all registration, renewal and other
related fees necessary to maintain the registrations of any Patents on
the relevant register of patents ("the Register") within the said
countries within the Territory and where such Patents are applications
shall prosecute the applications with due diligence during the term of
this Agreement.
6.3. If the Licensor notifies the Licensee in writing that it does not
intend to apply for any Patent in any of the countries within the
Territory in accordance with Clause 6.2 above, then the Licensee shall
itself be entitled to apply for any such Patent in the relevant
country in the name of the Licensor at the cost of the Licensee and in
accordance with the reasonable directions of the Licensor and, for so
long as the Licensee shall remain exclusively entitled thereto, shall
promptly pay all registration, renewal and other fees necessary to
maintain the registrations of such Patents on the Register within such
country, and where such Patents are applications, shall prosecute the
applications with due diligence during the term of this Agreement.
6.4. In the event that the Licensor, or where relevant the Licensee applies
for a Patent pursuant to Clauses 6.2 or 6.3 above for the purpose of,
or
in connection with the granting of a licence to the Licensee, then for
so long as such exclusive licence enures for the benefit of the
Licensee, the party so applying shall be entitled to require the other
party to provide such assistance as the applying party may reasonably
request in connection with the prosecution of such application,
subject to the applying party reimbursing the other for all fees,
costs and expenses incurred by it in providing such assistance.
6.5. Each of the Licensor and the Licensee undertakes not to do or permit
to be done any act which would or might jeopardise or invalidate the
registration of any Patent nor to do or permit any act which might
assist or give rise to an application to remove any of the Patents
from the Register or which might prejudice the right or title of the
Licensor to any of the Intellectual Property.
6.6. The Licensee will on request give or procure that there is given to
the Licensor or its duly authorised representative any information as
to the use of the Intellectual Property which the Licensor may
reasonably require.
6.7. The Licensee shall assist the Licensor as may be reasonably necessary
(including by executing any necessary documents) in recording the
Licensee as a licensee of the Patents on the Register and the Licensee
hereby agrees that such entry may be cancelled by the Licensor on
termination of this Agreement, for whatever reason, and that it will
assist the Licensor so far as may be necessary to achieve such
cancellation including by executing or procuring that there is
executed at the request of the Licensor any documents necessary for
that purpose, subject to the Licensor bearing the costs relating to
the removal of such entry where this Agreement is terminated by reason
of breach on the part of the Licensor.
7. INFRINGEMENTS
-------------
7.1. To the extent that the same relates to the exclusive licence or option
granted or to be granted to the Licensee hereunder, each of the
parties hereto shall as soon as it becomes aware thereof give to the
other in writing full particulars of any activity by any person which
amounts or might amount either to infringement of any of the Patents
or misuse of the Know-how.
7.2. To the extent that the same relates to the exclusive licence or option
granted or to be granted to the Licensee hereunder, then without
prejudice to the requirement set out in Clause 6.1.2 above, if either
party hereto becomes aware that any person either alleges that any of
the Patents is invalid or that the use of the Intellectual Property
infringes any Intellectual Property Rights of any third party or the
Intellectual Property is otherwise attacked or challenged such party
shall immediately give to the other full particulars in writing
thereof. Subject to Clause 7.3, the Licensee shall make no comments or
admission to any third party in respect thereof without the prior
written consent of the Licensor.
7.3. Where any third party alleges that the Licensee has infringed its
Intellectual Property Rights as a result of the manufacture, use or
supply of any Products by or on behalf of the Licensee in any of the
Territories, the Licensee shall be responsible for conducting any
proceedings relating to its defence and shall consult with the
Licensor in respect of any such proceedings. The Licensor will give
the Licensee all such assistance as is reasonable in the
circumstances. The Licensee shall be responsible for all costs
relating to such proceedings (including the reasonable costs of the
Licensor in providing such assistance) and shall keep any damages and
costs awarded.
7.4. Where there is any infringement or suspected infringement of any of
the Patents any attack or challenge on any of the Patents or any
unauthorised disclosure or mis-use of the Know-How within any country
within the Territory, the Licensor shall at its own option and expense
have the sole conduct of any proceedings in respect thereof and will
retain any damages and costs awarded to it. The Licensor shall consult
with the Licensee in connection with such proceedings.
7.5. Where there is any infringement or suspected infringement of any of
the Patents or any unauthorised disclosure or misuse of the Know how
within any country within the Territory and where the Licensor
initiates proceedings in respect thereof, then to the extent that such
infringement, disclosure or misuse relates to any of the Products, the
Licensor will at the Licensee's written request use its reasonable
endeavours to join the Licensee in as co-plaintiff in such
proceedings. In such circumstances the Licensee will bear its own
costs and expenses relating to such proceedings and will retain any
damages or costs awarded to it.
7.6. Where the Licensor decides not to take any action in respect of-
(i) any attack or challenge on any of the Patents; or
(ii) any infringement or suspected infringement of any of the Patents
or any unauthorised disclosure or misuse of any of the Know-how
which relates to the Products;
the Licensor shall notify the Licensee and, subject to Clauses 7.7 and
7.8 below, shall permit the Licensee at its own option and expense to
have the sole conduct of any proceedings relating to the same and the
Licensee shall be entitled to retain any damages and costs awarded to
it. The Licensee shall consult with the Licensor in connection with
such proceedings. Where the Licensee commences any infringement
proceedings in accordance with this Clause 7.6 the Licensee shall, at
the Licensor's written request use its reasonable endeavours to join
the Licensor in as co-plaintiff in such proceedings. In such
circumstances
the Licensor will bear its own costs and expenses relating to such
proceedings and will retain any damages or costs awarded to it.
7.7. Where a situation as envisaged by Clause 7.6(i) or 7.6 (ii) above has
arisen but the Licensee is not the sole Licensee in respect of the
Intellectual Property giving rise to such action, then the Licensor
shall, acting reasonably and having full regard of the wishes,
available financial resources and potential loss of such party, decide
which of the Licensee or the other licensee(s) shall take action in
respect of the same. Where procedurally possible, such decisions shall
not preclude the Licensor or Licensee from being joined into such
proceedings as co-plaintiffs in which case the provisions of Clause
7.5 and 7.6 in respect thereof shall apply mutatis mutandis.
7.8. In any proceedings to which either the Licensor or the Licensee (as
the case may be) is a party hereunder pursuant to Clauses 7.4 to 7.7
(inclusive), then the other party shall give the Licensor or the
Licensee (as the case may be) such assistance as that party may
reasonably request in connection with such proceedings, subject to the
Licensor or the Licensee (as the case may be) meeting that other
party's reasonable costs and expenses in connection therewith, save
that where both parties are co-plaintiffs in respect of any such
proceedings, they shall each bear their own costs and expenses
incurred in connection with any such proceedings.
8. SALES AND ROYALTIES
-------------------
8.1. The Licensee will use its reasonable endeavours to promote and develop
the sale of the Products by it or on its behalf in the Territory.
8.2. Subject to the provisions of this Clause 8, and in particular Clause
8.3 below, during the continuance of this Agreement the Licensee shall
pay the Licensor royalties on sales of the Products made by it or on
its
behalf or by its Sub licensees (if any) in the Territory at the
following rates:
8.2.1. In respect of all Products sold by or on behalf of the
Licensee or any Sub-Licensee which have either been
manufactured or sold in any country where any Patent subsists
in respect thereof:
(i) (Pounds)0-5,000,000 of such Products sold by or on
behalf of the Licensee or any Sub-Licensee (calculated
by reference to the aggregate Net Sale Price) = 6%;
(ii) (Pounds)5,000,001-(Pounds)7,500,000 of such Products
sold by or on behalf of the Licensee or any Sub-
Licensee (calculated by reference to the aggregate Net
Sale Price) = 4%;
(iii) (Pounds)7,500,001 + of such Products sold by or on
behalf of the Licensee or any Sub-Licensee (calculated
by reference to the aggregate Net Sale Price) = 2%.
8.2.2. in respect of all Products sold by or on behalf of the
Licensee or any Sub-licensee which have either been
manufactured or sold in any country where no Patent subsists,
a royalty of 2% of the Net Sale Price of all such Products,
irrespective or the quantity of such Products sold.
For the avoidance of doubt, the Licensee will not in any circumstances
be required under Clause 8.2 to pay any royalties twice in respect of
the same unit of Product.
8.3. For the purpose of calculating the royalty payable to the Licensee by
the Licensor hereunder, there shall be a disregard of (Pounds)80,000
with the effect that the Licensee shall be released from any liability
to pay the first (Pounds)80,000 of royalties calculated as due on
sales of the Products by or on behalf of the Licensee pursuant to
Clause 8.2.
8.4. For the avoidance of doubt any royalty calculations made hereunder
shall be based upon the royalty rate prevailing in that part of the
Territory in which the Product was either manufactured or supplied
whichever is the greater.
8.5. In the event that the Licensee or any Sub-licensee supplies any
Products to any connected person, such supply shall be ignored for the
purposes of calculating the royalties due under this Clause 8 and the
Licensee shall pay the Licensor royalties calculated in accordance
with this Clause 8 by reference to the Net Sales Price of the Products
when disposed of by such connected person to an unconnected person.
8.6. If any Products are incorporated in any other equipment or apparatus
or included as part of a larger kit sold by the Licensee or any Sub-
licensee and the price of the Product is included in the price of such
other equipment, apparatus or kit, the Net Sale Price for the purpose
of calculating royalties due under this Agreement shall be deemed to
be that proportion of the Net Sale Price of that other equipment,
apparatus or kit which is fairly attributable to the Products,
comparing the manufacturing cost of the other equipment, apparatus or
other parts of the kit to that of the Products as components thereof.
Notwithstanding the above, where any Product supplied is a Kit
incorporating any Vascular Graft of Stent, the Net Sales Price shall
be the price of the Kit and Vascular Graft or the Kit and the Stent
(as appropriate).
8.7. For the purpose of this Agreement a calendar year will commence on 1st
January in each year and expire on the following 31st December. The
Licensee shall within 30 days of the first Quarter Day following the
Commencement Date and within 30 days of each following (or subsequent)
Quarter Day provide a statement to the Licensor giving particulars of
the sales of the Products by the Licensee and any Sub Licensee during
the preceding quarter (or in the first quarter during the period from
the Commencement Date to the first Quarter Day) showing
the quantity of the Products sold, the price charged in which of the
Territories such Products were both manufactured and sold, any
discounts or other rebates given, the Net Sale Price and the royalty
due and if more than one type of the Products is sold, showing such
information for each type, together with any other particulars as the
Licensor may reasonably require and shall pay the royalties to the
Licensor at the same time as rendering the statement.
8.8. All sums payable hereunder are exclusive of Value Added Tax, which
shall in addition be payable by the Licensee where appropriate. All
royalties and other payments due under this Agreement by the Licensee
shall be paid without deduction or withholding in respect of duties,
taxes or charges levied or imposed by any taxation authority under the
laws of any country unless the deduction or withholding is required by
the law of that country. In which event, the Licensee shall provide to
the Licensor either an official receipt from the relevant taxation
authority in respect of all amounts so deducted or withheld or (if not
available) a certificate of deduction or equivalent evidence to enable
the Licensor to obtain credit for the tax deducted or to claim from
double taxation (if such relief is available).
8.9. The Licensee shall and shall procure so far as it is able that its Sub
Licensee shall keep separate , detailed, true and accurate books and
records of all sales of the Products to enable the Licensor to check
the accuracy of the information contained in the statements rendered
under clause 8.7, such books and records to be retained by the
Licensee and any other Sub-Licensees for at least three years from the
date of their creation. The Licensor shall be entitled at its expense
to inspect such books and records by its authorised representative or
representatives on reasonable notice during business hours and to take
copies of or extracts from such books and records, save that this
right shall not be exercisable in respect of any statement if no
inspection has been made within three years of its being rendered to
the Licensor. In the event
that the statements rendered under clause 8.7 are inaccurate by more
than 5 per cent, the costs of such inspection shall be paid by the
Licensee. Any information about the business of the Licensee which
may be obtained by the Licensor as a result of any such inspection
and which does not relate to the Products shall be kept confidential
by the Licensor.
8.10. The Licensee shall supply to the Licensor within 60 days of the end
of each Year of this Agreement a certificate in writing by its
auditors certifying the aggregate Net Sale Price of the Products sold
or otherwise disposed of by the Licensee or any Sub-Licensee that
Year and the amount of royalty due. The rendering of such certificate
shall not preclude the right of inspection given to the Licensor in
clause 8.8.
9. TERMINATION
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9.1. Either party may terminate this Agreement without prejudice to its
other remedies forthwith by notice in writing to the other if that
other either:
9.1.1. commits a material breach of this Agreement; provided that if
the breach is capable of remedy the notice shall only be given
if the party in breach shall not have remedied the same within
30 days of having been given notice in writing specifying the
breach and requiring it to be remedied; or
9.1.2. is unable to pay its debts or enters into compulsory or
voluntary liquidation (other than for the purpose of effecting
a reconstruction or amalgamation in such manner that the
company resulting from such reconstruction or amalgamation if
a different legal entity shall agree to be bound by and assume
the obligations of the relevant party under this Agreement) or
compounds with or convenes a meeting of its creditors or has a
receiver or manager or an administrative receiver or an
administrator appointed of its assets or ceases for any reason
to carry on business or takes or suffers any similar action
which in the opinion of the party giving notice means that the
other may be unable to pay its debts.
9.2. Termination of this Agreement for whatever reason shall not affect the
accrued rights of the parties arising in any way out of this Agreement
as at the date of termination and in particular but without limitation
the right to recover damages from the other.
9.3. Upon the termination of this Agreement in accordance with the terms of
this Agreement the Licensee shall cease to make any use of the
Intellectual Property and shall cease all manufacture, supply and use
of all Products save that if the Licensee has a stock of Products
existing or in the course of manufacture or unfulfilled orders on hand
at the date of termination of this Agreement the Licensee may, but
only with the Licensor's specific permission, sell such stock on the
terms hereof or such other terms as may be reasonably agreed.
9.4. Upon termination or expiry of this Agreement the following Clauses
shall remain in full force and effect: Clauses 1, 4, 6.7, 8, 9.2, 9.3,
9.4, 10, 13, 14, and 16.
10. CONFIDENTIALITY
---------------
10.1. Each party shall retain ownership of all Confidential Information
(and any copies thereof) disclosed by it to the other and may require
the return of any such Confidential Information and any copies at any
time.
10.2. Each party shall maintain confidentiality of the other's Confidential
Information and, in particular, shall:-
10.2.1. only use such Confidential Information for the purposes of
performing its obligations under this Agreement;
10.2.2. only disclose such Confidential Information to those of its
employees to whom it is necessary to disclose such
Confidential Information for the purposes of this Agreement,
but only to the extent necessary to enable it to perform its
obligations under this Agreement and provided that it shall
remain responsible for procuring that its employees do not
further disclose the Confidential Information or use it for
any purpose other than to assist the receiving party in
performing its obligations under this Agreement.
10.3. Each party shall be responsible for the compliance with this Clause
10 on the part of its employees or any other persons to whom such
Confidential Information is disclosed for the purposes of this
Agreement.
10.4. The obligations set out in this Clause 10 shall not apply to any
Confidential Information which:-
10.4.1. the disclosing party in writing authorises the receiving
party to disclose;
10.4.2. is or comes into the public domain other than through any
act or default either directly or indirectly of the
receiving party, its officers, employees, agents,
representative or Sub-licensees;
10.4.3. the receiving party can prove by documentary evidence was
already in its possession at the time of its receipt from
the disclosing party and that the receiving party was free
from any obligation of confidence in respect of such
information;
10.4.4. is subsequently disclosed to the receiving party by a person
who did not acquire the information directly or indirectly
from the disclosing party and such third party was in lawful
possession of such information and not in violation of any
obligation or confidentiality in respect of such
information; or
10.4.5. the receiving party is obliged to disclose by order of any
competent jurisdiction or a governmental or regulatory body,
provided that the receiving party uses its best endeavours
to limit such disclosure and to provide the disclosing party
with an opportunity to make representations to the relevant
court or governmental or regulatory body.
10.5. For the avoidance of doubt, information shall not be deemed to be
within any of the exceptions included in Clause 10.4 merely because
it is embraced by general disclosure in the public domain or in the
lawful possession of the receiving party, nor shall a combination of
information be deemed to be within any of the exceptions set out in
Clause 10.4 merely because individual items of information are in the
public domain or in the lawful possession of the receiving party,
unless the specific combination of information is itself in the
public domain or in the lawful possession of the receiving party.
11. ASSIGNMENT
----------
11.1. Subject to Clause 11.3, neither party hereto shall assign, transfer,
sub-contract or in any other manner make over to any third party the
benefit and/or burden of this Agreement without the prior written
consent of the other, except that the Licensor shall be entitled
without the Licensee's prior written consent, such consent not to be
unreasonably withheld or delayed, to assign its rights and benefits
under this Licence to University College London (or any other
organisation in the University of London) or any company owned by
University College London (or any such other organisation) in
connection with the proposed merger of the Medical School with
University College London (or any such other organisation) provided
that in the event of such merger save where statutorily inappropriate
the Licensor, the Licensee and University College London (or any such
other organisation) will enter into an agreement novating the
obligations of
the Licensor hereunder to University College London (or such other
organisation).
11.2. In the event of an assignment this Agreement shall be binding upon
such successor or assignee and the name of a party appearing herein
shall be deemed to include the names of any such successor or
assignee.
11.3. The Licensee shall not be entitled to sub-license or sub-contract any
of its rights and/or obligations under this Agreement to any person
without the prior written consent of the Licensor such consent not to
be unreasonably withheld or delayed, save that the Licensee shall be
entitled to sub-license or sub-contract any of its rights to the
Company without the Licensor's consent. The Licensee shall be
entitled to appoint any distributor or agent in respect of the supply
of the Products without the consent of the Licensor.
11.4. In the event that the Licensee sub-licenses or sub-contracts any of
its rights under obligations under this Agreement to any person
(including, for the avoidance of doubt, the Company):-
11.4.1. the Licensee shall be responsible to the Licensor for all
acts and/or omissions of each Sub-Licensee as if such acts
or omissions had been made by the Licensee;
11.4.2. the Licensee shall enter into a written sub-licence
agreement with the Sub-licensee and promptly provide the
Licensor with a copy of any sub-licence agreement;
11.4.3. the Licensee shall ensure that provisions of any such sub-
licence agreement are entirely consistent with the
provisions of this Agreement and shall prohibit further sub-
licensing and sub-contracting by the Sub-licensee without
the prior written consent of the Licensor and the Licensee
such consent not to be unreasonably withheld or delayed; and
11.4.4. the Licensee shall use its reasonable endeavours to procure
that each Sub-Licensee complies fully at all times with the
provisions of its sub-licence agreement in respect of the
subject matter hereof and shall enforce the terms of each
such sub-licence against the relevant Sub-Licensee.
12. FORCE MAJEURE
-------------
12.1. Neither party shall be in breach of this Agreement if there is any
total or partial failure of performance by it of its duties and
obligations under this Agreement except for the obligation to pay any
monies due, occasioned by any act of God, fire, act of government or
state, war, civil commotion, insurrection, embargo, prevention from
or hindrance in obtaining any raw materials, energy or other cause
beyond the control of either party. If either party is unable to
perform its duties and obligations under this Agreement as a direct
result of the effect of one or more of such causes such party shall
give written notice to the other of such inability stating the cause
in question and the date on which such cause commenced. The operation
of this Agreement shall be suspended during the period (and only
during the period) in which the cause continues to have effect.
Forthwith upon the cause ceasing to have effect the party relying
upon it shall give written notice thereof to the other. If the cause
continues to have effect for a period of more than 60 days the party
not claiming relief under this clause shall have the right to
terminate this Agreement upon giving 30 days written notice of such
termination to the other party, but such notice shall not take effect
if the other party gives notice within that period that the cause has
ceased to prevent the operation of this Agreement and forthwith upon
such cessation recommences the full and punctual performance of its
obligations hereunder.
13. ILLEGALITY
----------
13.1. If any provision or term of this Agreement shall become or be
declared illegal, invalid or unenforceable for any reason whatsoever
such term or provision shall be divisible from this Agreement and
shall be deemed to be deleted from this Agreement provided always
that if such deletion substantially affects or alters the commercial
basis of this Agreement the parties shall negotiate in good faith to
amend and modify the provisions and terms of this Agreement so as to
achieve so far as possible the same economic effect without rendering
the Agreement so amended or modified illegal, invalid or
unenforceable.
14. ENTIRE AGREEMENT/AMENDMENT/PRESS RELEASES/COSTS
-----------------------------------------------
14.1. This Agreement constitutes the entire agreement and understanding of
the parties and supersedes all prior oral or written agreements,
understandings or arrangements between them relating to the subject
matter of this Agreement. Neither party shall be entitled to rely on
any agreement, understanding, or arrangement, representation, term or
warranty which is not expressly contained in this Agreement and no
change may be made to it except in writing signed by duly authorised
representatives of both parties save that nothing in this Agreement
shall operate to exclude any provision implied into this Agreement by
English law which may not be excluded by English law or to limit or
exclude any liability, right or remedy to a greater extent than is
permissible under English law.
14.2. Without prejudice to the generality of Clause 14.1, the Licensor does
not give any warranty, representation or undertaking:-
14.2.1. as to the efficacy or usefulness of any of the Intellectual
Property;
14.2.2. that any of the Patents is or will be valid or subsisting or
where any such Patents are applications that, such
applications will proceed to grant; or
14.2.3. that any use of the Intellectual Property and the
manufacture, supply or use of any of the Products will not
infringe the intellectual property or other rights of any
third party.
14.3. No failure or delay on the part of either of the parties to exercise
any right or remedy under this Agreement shall be construed or
operate as a waiver thereof nor shall any single or partial exercise
of any right or remedy preclude the further exercise of such right or
remedy as the case may be. The rights and remedies provided in this
Agreement are cumulative and are not exclusive of any rights or
remedies provided by law.
14.4. The text of any press release or other communication to be published
by or in the media concerning the subject matter of this Agreement
shall require the approval of each of the parties.
14.5. Each of the parties shall be responsible for its respective legal and
other costs incurred in relation to the preparation of this
Agreement.
14.6. Nothing in this Agreement shall create or imply any relationship of
agency, partnership or joint venture between the parties.
14.7. The Licensee shall not act or describe itself as the agent of the
Licensor and shall not represent that it has any authority to bind
the Licensor.
15. NOTICE
------
15.1. Any notice or other document to be given under this Agreement shall
be in writing and shall be deemed to have been duly given if left at
or sent by hand or by registered post; or facsimile to the address
set out above for such party or such other address as one party may
from time to time designate by written notice to the other.
15.2. Any such notice or other document shall be deemed to have been
received by the addressee two working days following the date of
dispatch if the notice or other document is sent by registered post,
or simultaneously with the delivery or transmission if sent by hand
or facsimile.
16. GOVERNING LAW AND JURISDICTION
------------------------------
16.1. The validity, construction and performance of this Agreement shall be
governed by English law, and shall be subject to the exclusive
jurisdiction of the English Courts.
IN WITNESS WHEREOF the parties acting through their duly authorised
representatives have executed this Agreement the day and year first before
written.
Signed by )
for FREEMEDIC PLC in the )
presence of:- )
Signed by
for CARDIOTECH )
INTERNATIONAL INC. )
in the presence of:- )
SCHEDULE 1
----------
Research Agreement
-------------------
SCHEDULE 2
----------
Licensor's Know-how
-------------------
