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April 22 1999 Novavax/Cantab - page: 1
NOVAVAX, INC.
- and -
CANTAB PHARMACEUTICALS RESEARCH LIMITED
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LICENCE AGREEMENT
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April 22 1999
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April 22 1999 Novavax/Cantab - page: 2
THIS AGREEMENT is made the day of 1999
BETWEEN
(1) NOVAVAX, INC. a company incorporated under the law of the State of
Delaware, whose principal place of business is at Suite C, 8320
Guilford Road, Columbia, XX 00000, XXX (together with its subsidiaries
(including without limitation its wholly-owned subsidiaries Micro-Pak,
Inc. and Micro Vesicular Systems Inc), "Novavax"); and
(2) CANTAB PHARMACEUTICALS RESEARCH LIMITED (Company number 2270217) a
company incorporated under the laws of England whose registered office
is at 000 Xxxxxxxxx Xxxxxxx Xxxx, Xxxxxx Xxxx, XX0 0XX ("Cantab").
RECITALS
(A) Pursuant to an agreement of 23 December 1997 between Novavax and
Cantab, Novavax granted Cantab an exclusive option to acquire a
worldwide exclusive licence under the Novavax IP (as defined herein).
(B) Cantab has exercised that option and Novavax (including Novavax's
wholly-owned subsidiaries Micro-Pak, Inc., and Micro Vesicular Systems,
Inc., which is/are registered owner(s) of patent rights included in the
Novavax IP as hereinbelow defined, and which have endorsed their
consent to the transaction hereby effected and their agreement to be
bound thereby insofar as their proprietary interests are affected)
hereby grants Cantab an exclusive worldwide licence to the Novavax IP
on the terms and conditions set out herein.
IT IS AGREED AS FOLLOWS:-
1. DEFINITION AND INTERPRETATION
1.1 In this Agreement and in the Schedules to this Agreement the following
words and phrases shall have the following meanings unless the context
requires otherwise:-
1.1.1 "Affiliate" - any company, partnership or other entity which directly
or indirectly Controls, is Controlled by or is under common Control
with, either Party including as a Subsidiary or Holding Company.
1.1.2 "Agreement" - this agreement and any and all schedules, appendices and
other addenda to it as may be varied from time to time in accordance
with the provisions of this agreement.
1.1.3 "Business Day" - 9.30am to 5.30pm (local time at Cantab offices) on a
day other than a Saturday, Sunday, bank or other public holiday in
England and Wales.
1.1.4 "Cantab Net Sales" - shall mean all sums received by Cantab or an
affiliate of Cantab upon the sale by Cantab or such affiliate of any
Licensed Product (net only of any value added or other taxes thereon
and of deductions for freight charges, insurance, allowances
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actually made for returned defective products and customary trade,
quantity or cash discounts to non-affiliated customers to the extent
actually allowed and taken);
1.1.5 "Commencement Date" - the date of execution of this Agreement.
1.1.6 "Competent Authority" - any local or national agency, authority,
department, inspectorate, minister, ministry official, parliament or
public or statutory person (whether autonomous or not) of or of any
government of any country having jurisdiction over either any of the
activities contemplated by this Agreement or the Parties, including the
European Commission and the European Court of Justice.
1.1.7 "Confidential Information" - in the case of obligations on Cantab shall
mean Novavax IP, in the case of obligations on Novavax shall mean
Cantab IP and in the case of obligations on both Cantab and Novavax
shall mean trade secrets, know how or confidential information relating
to the business affairs or finances of the other supplied or otherwise
made available to them or coming into their possession in relation to
the performance of this Agreement.
1.1.8 "Control" - the ownership of more than 50% of the issued share capital
or legal power to direct or cause the direction of the general
management and policies of the Party in question.
1.1.9 "Directive" - includes any present or future directive, regulation,
requirement, instruction, direction or rule of any Competent Authority
including any amendment, extension or replacement thereof then in
force.
1.1.10 "Field" - the use of the Novasomes Adjuvant in the development and
subsequent exploitation of an immunopharmaceutical comprising antigenic
determinants of human papillomavirus for the prevention or treatment of
cervical disease including CIN (cervical intraepithelial neoplasia),
and of an immunopharmaceutical comprising antigenic determinants of
human papillomavirus type 16 or 18 for any other treatment purposes for
which that immunopharmaceutical may be used;
1.1.11 "First Commercial Sale" - the first commercial sale by Cantab or its
sub-licensees or distributors, in any country, of Licensed Product
after grant of required Marketing Authorisation and pricing approval
has been granted by the appropriate Regulatory Authority or other
Competent Authority.
1.1.12 "Force Majeure - in relation to either Party any event or circumstances
which is beyond the reasonable control of that Party which event that
Party could not reasonably be expected to have taken into account at
the date of this Agreement and which results in or causes the failure
of that Party to perform any or all of its obligations under this
Agreement, including act of God, lightning, fire, storm, flood,
earthquake, accumulation of snow or ice, lack of water arising from
weather or environmental problems, strike, lockout or other industrial
disturbance, act of the public enemy, war declared or undeclared,
threat of war, terrorist act, blockade, revolution, riot, insurrection,
civil commotion, public demonstration, sabotage, act of vandalism,
prevention from or hindrance in obtaining in any way materials energy
or other supplies, explosion, fault or failure of plant or machinery
(which could not have been prevented by good industry practice),
Directive or requirement of a Competent Authority governing either
Party provided that lack of funds shall not be interpreted as a cause
beyond the reasonable
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control of that Party.
1.1.13 "Half Year" - shall mean each six month period in any year ending on 30
June or 31 December, and "Half Yearly" shall be construed accordingly.
1.1.14 "Insolvency Event" - in relation to Cantab, means any one of the
following:
(a) a notice shall have been issued to convene a meeting for the
purpose of passing a resolution to wind up Cantab or such a resolution
shall have been passed; or
(b) a resolution shall have been passed by Cantab's directors to seek a
winding up or administration order or a petition for a winding up or
administration order shall have been presented against Cantab's or such
an order shall have been made; or
(c) a receiver, administrative receiver, receiver and manager, interim
receiver, custodian, sequestrator or similar officer is appointed in
respect of Cantab or over a substantial part of its assets or any third
party takes steps to appoint such an officer in respect of Cantab or an
encumbrancer takes steps to enforce or enforces its security; or
(d) a proposal for a voluntary arrangement shall have been made in
relation to Cantab under Part I Insolvency Xxx 0000; or
(e) a step or event shall have been taken or arisen outside the United
Kingdom which is similar or analogous to any of the steps or events
listed at (a) to (d) above; or
(f) that Cantab proposes to readjust, reschedule or defer all or
substantially all of its indebtedness, or proposes or makes any general
assignment, composition or arrangement with or for the benefit of all
or some of its creditors or makes or suspends or threatens to suspend
making payments to all or some of its creditors or submits to any type
of voluntary arrangement; or
(g) Cantab is deemed to be unable to pay its debts within the meaning
of Xxxxxxx 000 Xxxxxxxxxx Xxx 0000.
1.1.15 "Know-How" - unpatented technical and other information which is not in
the public domain including information comprising or relating to
concepts, discoveries, data, designs, formulae, ideas, information
relating to materials, inventions, methods, models, assays, research
plans, procedures, designs for experiments and tests and results of
experimentation and testing (including results of research or
development) processes (including manufacturing processes,
specifications and techniques), laboratory records, chemical,
pharmacological, toxicological, clinical, analytical and quality
control data, trial data, case report forms, data analyses, reports,
manufacturing data or summaries and information contained in
submissions to an information from ethical committees and regulatory
authorities, but at any time does not include any matter that has
become and remains available to the public through no wrongful act or
omission to act of the party (or its sublicensee or distributor) owing
obligation to the other in respect of such matter as part of Know-How,
as from the time when that matter becomes available to the public.
Know-How includes documents containing Know-How. Information will not
be excluded from being Know-How hereunder by reason only of the fact
that it becomes available to the public through a wrongful act or
omission to act of a Party hereto or a sublicensee or distributor of a
Party hereto. The fact that an item is known to the public shall not be
taken to exclude the possibility that a compilation including the item,
and/or a development relating to the item, is (and remains) not known
to the public. Know-
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How includes any rights including copyright, database or design rights
protecting such Know-How.
1.1.16 "Licensed IP" - the Licensed Patent Rights and the Licensed Know-How.
1.1.17 "Licensed Know-How" - any and all Know How within the Field which is
owned by or licensed to Novavax at the Commencement Date or which
becomes owned by or licensed to Novavax during the term of this
Agreement, in either case insofar as it continues to be Know-How.
1.1.18 "Licensed Patent Rights" - the Patent Rights listed in Schedule 1 and
any Patent Rights claiming or covering or otherwise based on inventions
forming part of the Licensed Know How.
1.1.19 "Licensed Product" - a product made for use in the Field and either
sold or to be sold for use in the Field, incorporating or using any
part of the Licensed IP, such that in the absence of the licence
granted by this agreement Cantab's (or Cantab's sublicensee's or
distributor's) acts in relation to manufacture, use or sale of such
product would constitute an infringement of the Licensed IP;
1.1.20 "Major Markets" - United States, United Kingdom, France, Germany,
Spain, Italy and Japan.
1.1.21 "Marketing Authorisation" - any approval required from a Regulatory
Authority to market and sell Licensed Product in any country.
1.1.22 "Materials Transfer Agreement" - the materials transfer agreement
between the Parties dated 16 May 1997.
1.1.23 "Net Cantab Receipts" - shall mean all sums received by Cantab upon the
sale of any Licensed Product by any sublicensee or otherwise received
under the terms of any sublicense agreement authorised hereunder.
1.1.24 "Novasomes Adjuvant" - the adjuvant and associated technology specified
in the Licensed Patent Rights with respect to Paucilamellar
non-phospholipid liposomes.
1.1.25 "Novavax Materials" - physical samples of Novasomes Adjuvant and other
compounds supplied by Novavax to Cantab under the Materials Transfer
Agreement or corresponding term of this Agreement.
1.1.26 "Parties" - Cantab and Novavax.
1.1.27 "Patent Rights" - patent applications or patents, author certificates,
inventor certificates, utility certificates, improvement patents and
models and certificates of addition and all foreign counterparts of
them and includes any divisions, renewals, continuations,
continuations-in-part, extensions, reissues, substitutions,
confirmations, registrations, revalidation or additions of or to them,
as well as any supplementary protection certificate in respect of them.
1.1.28 "Regulatory Authority" - any national, supranational (e.g., the
European Commission, the Council of the European Union, the European
Agency for the Evaluation of Medicinal Products or the FDA), regional,
state or local regulatory agency, department, bureau, commission,
council or other governmental entity other in each country of the
Territory involved in the granting of Marketing Authorisation for the
Licensed Product.
1.1.29 "Subsidiary or Holding Company" - as relates to Cantab, shall have the
meaning ascribed to such expressions by Section 736 of the Companies
Xxx 0000 (as amended),
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and as it relates to Novavax, shall mean any legal entity (such as a
corporation, partnership, or limited liability company) that is
controlled by, under common control with, or controls Novavax. For the
purpose of this definition, control means (i) beneficial ownership of
at least 50% of the voting securities of a corporation or other
business organisation with voting securities or (ii) a fifty percent or
greater interest in the net assets or profits of a partnership or other
business organisation without voting securities.
1.1.30 "Valid Claim" - either:
(a) a claim of an issued and unexpired patent included within Patent
Rights, which has not been held permanently revoked, unenforceable or
invalid by a decision of a court or other governmental agency of
competent jurisdiction, unappealable or unappealed within the time
allowed for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise; or
(b) a claim of a pending patent application included within Patent
Rights, which claim was filed in good faith and has not been abandoned
or finally disallowed without the possibility of appeal or refiling of
said application.
1.2 In this Agreement:
1.2.1 unless the context otherwise requires all references to a particular
Clause, paragraph or Schedule shall be a reference to that Clause,
paragraph or Schedule, in or to this Agreement as the same may be
amended from time to time pursuant to this Agreement;
1.2.2 a table of contents and headings are inserted for convenience only and
shall be ignored in construing this Agreement;
1.2.3 unless the contrary intention appears words importing the masculine
gender shall include the feminine and vice versa and words in the
singular include the plural and vice versa;
1.2.4 unless the contrary intention appears words denoting persons shall
include any individual, partnership, company, corporation, joint
venture, trust, association, organisation or other entity, in each case
whether or not having separate legal personality;
1.2.5 reference to the words "include" or "including" are to be construed
without limitation to the generality of the preceding words; and
1.2.6 reference to any statute or regulation includes any modification or
re-enactment of that statute or regulation.
2. GRANT OF LICENCE
2.1 Subject to this Agreement and in consideration of all of its terms,
Novavax grants Cantab an exclusive world-wide licence to develop, use,
have used, manufacture, have made, exploit, market, sell and have sold
Licensed Products solely for use in the Field and to use the Licensed
IP within the Field. Subject to Cantab's rights under this Agreement,
Novavax shall retain all rights not expressly granted in this Clause
2.1. The licence shall be for the period in which any Licensed IP shall
remain valid and enforceable (the "License Period"), unless earlier
terminated as provided in Section 10
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hereof.
2.2 Cantab shall be entitled to sublicense all or any part of its rights
granted under Clause 2.1 above to third parties in such manner as it
considers appropriate: Cantab shall promptly provide Novavax with
information relating to the terms of such sublicence agreement and
arrangements made in pursuance of such sublicence agreement to the
extent appropriate to enable Novavax to ascertain Novavax's legal
rights and financial expectations and enforce its legal rights arising
in consequence of such sublicence, and such information shall without
limitation include: parties to the agreement and its date of execution;
the scope of the sublicence, as it relates to Licensed IP, including
technical and geographical scope and whether the scope include the
right to make, use and/or sell; the nature of measures taken by the
sublicence terms to protect confidentiality of Novavax's Know-How and
other confidential, proprietary or nonpublic information; and
information relating to the development plan to be undertaken under
such sublicense agreement, sufficient to ascertain the measures to be
taken to achieve the milestones referred to in this agreement and to
achieve and advance product marketing and sales.
2.3 Novavax shall during the term of this Agreement promptly notify Cantab
of all information relating to improvements and/or developments to the
Novasomes Adjuvant, the Licensed IP (including the legal status of the
Licensed Patent Rights) or their application which are of relevance
within the Field to the manufacturing or marketing of Licensed Product
and any such improvements or developments shall form part of the
Licensed IP licensed to Cantab free of any further charge or payment.
2.4 Novavax agrees to deliver, at the request and administrative expense of
Cantab, such documents as may reasonably be necessary to permit Cantab
to record its licensee interest in the Licensed IP, provided That no
such filing shall contain any confidential proprietary or non-public
information of Novavax, and Cantab shall take all action necessary to
ensure that no right title or interest in any licensed IP vests in
Cantab by such recordal except the licence granted Clause 2.1 hereof,
and Cantab shall in the event of termination in whole or in part of
such licence, (upon request of Novavax and at Cantab's administrative
expense) execute or procure for Novavax the execution of and file all
such documents as may reasonably be necessary to record the termination
of any such rights granted to Cantab under this Agreement with any
relevant registry or agency.
3. FEES
3.1 In consideration of the licence granted to Cantab under Clause 2 Cantab
will pay to Novavax the following:
3.1.1 US$ 75,000 on the Commencement Date; and
3.1.2 US$ 75,000 on the first anniversary of the Commencement Date
provided that such licence fees set out in Clauses 3.1.1 and 3.1.2 will
be non-refundable
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and not subject to deduction or set-off for any reason against any
amounts owing to Novavax, including future royalties.
3.1.3 US$ 25,000 upon the execution of the first sub-licence in the United
States of America;
3.1.4 US$ 25,000 upon the execution of the first sub-licence in the United
Kingdom or the European Union;
3.1.5 US$ 12,500 upon the execution of the first sub-licence in Japan; and
3.1.6 US$ 15,000 upon the execution of the first sub-licence in any country
outside the USA, the European Union and Japan;
provided that all such fees set out in Clauses 3.1.3 to 3.1.6 shall be
credited against and deducted from royalties payable pursuant to
paragraph 3.3.
3.2 In addition to the fees set out in Clause 3.1, Cantab shall pay to
Novavax the following milestone fees:-
3.2.1 US$ 50,000 upon the earlier of: (a) the date of entry of the first
patient into a Phase I/lI dose ranging study or the equivalent in any
other country carried out by or on behalf of Cantab or its sublicensee;
(b) 6 months after completion of a Phase I study or the equivalent in
any other country carried out by or on behalf of Cantab or its
sublicensee; or (c) 30 June, 2000;
3.2.2 US$ 50,000 upon the date of the first patient into a Phase II study or
the equivalent in any other country carried out by or on behalf of
Cantab or its sublicensee;
3.2.3 US$ 75,000 upon the date of the first patient into a pivotal efficacy
clinical trial in humans or the equivalent in any other country carried
out by or on behalf of Cantab or its sublicensee; and
3.2.4 US$ 100,000 upon the first PLA filing by or on behalf of Cantab or its
sublicensee of a Licensed Product anywhere, or the equivalent in any
country.
All such milestone fees described in this Clause 3.2 shall be credited
against and deducted from any royalties payable pursuant to Clause 3.3.
Provided that the deduction actually made in any one year of royalty
account is not more than $50,000.
3.3 Cantab shall also pay Novavax the following royalties in respect of
sales of Licensed Product made during the Royalty Period (payable
within 30 days of the end of each Half Year for sales effected in the
preceding Half Year):
3.3.1 10% of Net Cantab Receipts on all sales of Licensed Product effected by
any sublicensee;
3.3.2 2% of Cantab Net Sales on all sales of Licensed Product effected by
Cantab or an affiliate of Cantab, or by a distributor of Cantab or of
an affiliate of Cantab; Such royalties to continue to be payable in
respect of sales of Licensed Product on a country by country basis
until the last to expire of any Licensed Patent Rights in respect of
such country ("Royalty Period").
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3.4 Minimum annual fees in line with standard industry norms for minimum
royalties (but in any event not exceeding US$ 300,000 pa for the first
12 month period commencing 1st January after the date of launch of a
Licensed Product and for each subsequent calendar year) shall be
payable in respect of each calendar year after First Commercial Sale of
a Licensed Product, in respect of the Major Markets for the period in
which royalties shall continue to be payable in respect of Licensed
Product into such Major Markets at a rate to be negotiated in good
faith prior to commercial launch of a Licensed Product by reference to
anticipated and forecast sales of Licensed Product. For the
abovementioned first 12 month period and for each of the three next
following 12 month periods thereafter the minimum annual royalty shall
be $50,000 per 12 month period.
3.5 Cantab shall and shall ensure that its Affiliates and other
sub-licensees shall keep true and accurate records and books of account
containing all data necessary for the calculation of the amounts
payable by it to Novavax pursuant to this Agreement. Those records and
books of account shall be kept for six years following the end of the
calendar year to which they relate and shall, upon reasonable notice
having been given by Novavax, be open on Business Days for inspection,
under terms of confidentiality, by Novavax's accountants or by an
independent firm of accountants appointed by agreement between the
Parties. In the absence of any fraud, obvious error or in connection
with the payment of taxes or other third party investigations, or
actions or claims, any such examination shall take place not later than
two years following the expiration of the period to which it relates
and there shall be no more than one examination per year. The cost of
the inspection shall be the responsibility of Cantab if the certificate
is shown to have underestimated the monies payable to Novavax by more
than two percent and the responsibility of Novavax otherwise. Following
any such certification the Parties shall make any adjustments necessary
in respect of the monies already paid to Novavax in relation to the
period in question.
3.6 Within 60 days of the end of each Half Year, Cantab shall prepare a
statement which shall show on a Product by Product and a country by
country basis for the previous Half Year, all monies due to Novavax
under this Agreement with respect to such Half Year period, including
payments due under Clause 3.3. That statement shall be submitted to
Novavax within 60 days of the end of the period to which it relates
together with remittance for monies due to Novavax, if any.
3.7 All payments to Novavax under this Agreement shall be made in US
Dollars to the account of Novavax at CITIBANK FSB WASHINGTON, sort code
ABA# 000000000, account no. # 00000000, in the name of Novavax, Inc.,
by telegraphic transfer.
3.8 Where revenues are received from sales of Licensed Product or payments
made under sublicense agreements, and for purposes of calculating the
Net Cantab Sales and Net Cantab Receipts for purposes of this Section
3, in a currency other than US Dollars, the
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rate of exchange to be used for converting such other currency into US
Dollars, shall be the rate published in the Wall Street Journal under
the heading "Currency Trading, Exchange Rates, 135$ Equiv." for the
last business day of the period to which the calculation applies.
4. SUPPLY
It is agreed that the provisions, in regard to supply and purchase, of
section 4 in Schedule 2 (form of licence) to the Option Agreement shall
continue to apply until further agreement between the Parties.
5. INTELLECTUAL PROPERTY
5.1 The Licensed Patent Rights shall remain vested in Novavax. Novavax
shall at Novavax' cost and expense be solely responsible for the
prosecution and maintenance of the Licensed Patent Rights and for the
conduct of any claims or proceedings relating to it including any
interference or opposition proceedings. Should Novavax decide at any
time that it does not wish to prosecute or maintain any of the Licensed
Patent Rights it shall notify Cantab in writing and Cantab shall have
the right, insofar as any such patent is not maintained by Novavax or
by a party in privity with Novavax having a right to maintain the same,
to take-over at its own cost and expense the prosecution and
maintenance of the Licensed Patent Rights or part thereof upon giving
written notice to Novavax within 30 days of the date of Novavax'
notice.
5.2 Each of Novavax and Cantab shall as soon as practicable after it
becomes aware thereof give to the other in writing reasonable
particulars of any use or proposed use by another person which in that
Party's view amounts to or might amount to an infringement of the
Licensed Patent Rights. Novavax may, but shall not be obliged to, at
its own cost and expense enforce and defend the Licensed Patent Rights.
Where Novavax does, it shall notify Cantab and Cantab shall lend its
name to any infringement proceedings and shall sign any documents that
Novavax reasonably requests in relation to any such activity or
proceedings and shall give Novavax all reasonable assistance requested
by Novavax in relation to them (at no charge or expense to Novavax,
other than with respect to reasonable out-of-pocket expenses, but
Cantab shall not be bound to incur unreasonable expenses). Novavax
shall keep Cantab informed of the progress of such enforcement or
defence of the Licensed Patent Rights. If Novavax succeeds in any such
proceedings whether at trial or by way of settlement, the parties shall
negotiate in good faith for a reasonable share to Cantab of any sums
recovered or awarded in respect of the infringement to compensate
Cantab as well as Novavax for losses sustained by reason of the
infringement, taking into account Cantab's interest relative to other
interests in the Licensed IP and the nature of the infringement.
5.3 If Novavax decides not to enforce or defend the Licensed Patent Rights,
it shall notify Cantab in writing and Cantab shall be entitled to do so
at its own cost and expense upon
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giving written notice to Novavax within 30 days of the date of Novavax'
notice. Where Cantab does so, Novavax shall lend its name to any
infringement proceedings and shall sign any documents that Cantab
reasonably requests in relation to any such activity or proceedings and
shall give Cantab all reasonable assistance requested by Cantab in
relation to them (at no charge or expense to Cantab, other than with
respect to reasonable out-of-pocket expenses, but Novavax shall not be
bound to incur unreasonable expenses). If Cantab succeeds in any such
proceedings whether at trial or by way of settlement, the parties shall
negotiate in good faith for a reasonable share to Cantab of any sums
recovered or awarded in respect of the infringement to compensate
Cantab as well as Novavax for losses sustained by reason of the
infringement, taking into account Cantab's interest relative to other
interests in the Licensed IP and the nature of the infringement.
5.4 If during the term of this Agreement either Party: (a) receives any
notice, claim or proceedings from any third party alleging infringement
of that third party's intellectual property as a result of either
Party's activities or proposed activities in relation to this Agreement
or use and exploitation of the Licensed Patent Rights; or (b) receives
any information that could reasonably give rise to a potential claim or
proceedings alleging such patent infringement, the Party receiving that
notice shall:
5.4.1 forthwith notify the other Party of such notice, claim or proceedings;
and
5.4.2 make no admission of liability.
In the event of any such claim which alleges that the Licensed IP
infringes such third party's patent or copyright, Novavax agrees to
defend such claim and pay any settlement or judgment arising from such
claim. Such obligation shall be subject to Novavax' receipt of prompt
notice of such claim and its sole control of any such defence and/or
the incurring of any expenses relating thereto. Such obligation shall
not apply to any modification made to the Licensed IP, the method of
practice of the Licensed IP by any person other than Novavax and/or the
combination of any product provided by Novavax with any other product
or technology.
5.5 In the event of any such claim which alleges that the Licensed Product
infringes such third party's intellectual property rights, Cantab
agrees to defend such claim, pay any settlement or judgment arising
from such claim and to indemnify and hold Novavax harmless from and
against any and all liability, loss, damage or expense arising from
such claim other than a claim arising solely from the Licensed IP or
the Novasome Adjuvant. Such obligation shall be subject to Cantab's
prompt notice of such claim and its sole control of any such defence
and/or the incurring of any expenses relating thereto.
6. WARRANTIES
6.1 Subject to the limitations set forth in Clause 11.2 hereto and to the
disclosures set forth in Schedule 1 to this Agreement, Novavax warrants
and undertakes as at the date of this Agreement that:-
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6.1.1 to the best of its knowledge and belief, it is the sole owner with full
title the Licensed IP and, to the best of its knowledge and belief, the
use, exploitation or commercialisation of the Licensed IP under the
terms of this Agreement will not infringe the rights of any third
party, and Novavax has not received notice of any claim or threat of a
claim by a third party alleging that the exploitation of the licensed
IP would infringe such third party's intellectual property;
6.1.2 it will use commercially reasonable efforts to apply for, pursue to
grant, maintain and protect against infringement all Licensed Patent
Rights except as permitted by this Agreement; and
6.1.3 it will not, subject to Clause 10.5 of this Agreement, at any time
during the term of this Agreement while Cantab is in compliance with
its payment and confidentiality obligations hereunder, grant to any
third party any right, title or licence to manufacture, use or exploit
the Licensed IP within the Field in any manner whatsoever nor itself
manufacture, use or exploit any Licensed Product, in the Field (except
for the benefit of Cantab or except as permitted by this Agreement).
6.2 Novavax will name a contact who shall be an authorized representative
of Novavax to conduct Novavax's part in the contacts meetings and
transfers of documentation and other arrangements with Cantab defined
in clauses 7.1.6 and 7.1.7 below.
7. CANTAB'S OBLIGATIONS
7.1 Cantab shall:-
7.1.1 use all commercially reasonable endeavours to market, distribute,
promote and sell the Licensed Product within the Field or procure the
same through a sublicensee;
7.1.2 only to appoint sub-licensees and distributors who have the requisite
experience, staff and resources adequately to perform their obligations
and who will use all reasonable efforts to market, distribute, promote
and sell the Licensed Products;
7.1.3 promptly notify Novavax of any infringement of the Licensed IP which
may come to its attention;
7.1.4 ensure that all Licensed Products sold and developed by it, its
distributors or sub-licensees under this Agreement are of satisfactory
quality and that the manufacture, distribution, promotion, marketing
and sale of such product complies with all laws and regulations in
operation in the jurisdiction in which they are supplied; and
7.1.5 promptly notify Novavax of any product safety, regulatory or marketing
information of which it becomes aware that has the potential adversely
to affect sales of the Licensed Product;
7.1.6 provide personnel including a named contact involved in the development
of the Licensed Product for meetings with Novavax to review research
and clinical testing results and developments, not less frequently than
quarterly unless otherwise agreed between the named contact and the
corresponding named contact from Novavax, which meetings each Party
shall use commercially reasonable efforts to hold face-to-face (or if
agreed impractical to hold face-to-face then by a conference call) at
each Party's facility
13
April 22 1999 Novavax/Cantab - page: 13
on an alternating basis. Cantab and Novavax shall include in their
periodical meetings and reviews under this agreement consideration and
negotiation in good faith of appropriate performance obligations by
Cantab concerning the achievement of milestones 3.2.2-3.2.4;
7.1.7 provide, not less frequently than quarterly, any research reports,
study records, or other material documents in its possession related to
the Novavax Materials, by reliable overnight delivery service;
7.1.8 at Cantab's own expense, comply with, and ensure that each sub-licensee
and/or distributor complies with, all laws, regulations, rules,
ordinances or directives relating to the manufacture, marketing, sale
or distribution of Licensed Products, including any laws, regulations,
rules, ordinances or directives relating to the export or import of
Licensed Products to or from any country and/or relating to the recall
of any Licensed Product.
7.1.9 Cantab agrees to use its commercially reasonable endeavours to find and
enter agreement with a suitable sublicensee, and to use its
commercially reasonable endeavours to ensure that the studies necessary
for the achievement of milestones 3.2.2 to 3.2.4 inclusive are carried
out.
8. LIABILITY
8.1 Cantab shall indemnify and hold harmless Novavax against all liability,
damages or claims arising from the use of the Licensed IP by Cantab for
research or clinical studies and subsequently by the exploitation of
the Licensed Product save and to the extent where any such liability
arises solely from the negligence or willful default of Novavax or
otherwise by reason of any breach by Novavax of warranties given in
this Agreement.
8.2 Novavax shall indemnify and hold harmless Cantab against all liability,
damages or claims arising from the use and exploitation of the Licensed
IP authorized under the terms of this Agreement or the sale by Cantab
(or any sublicense or distributor) of Licensed Product incorporating
Novasomes Adjuvant manufactured by Novavax where such liability arises
from the negligence or willful default of Novavax or otherwise by
reason of any breach by Novavax of warranties given in this Licence
Agreement.
8.3 Neither party shall be liable to the other in contract, tort,
negligence, breach of statutory duty or otherwise for any loss, damage,
cost or expense of any nature incurred or suffered by that party of an
indirect or consequential nature including any economic loss or other
loss of turnover, profits, business or goodwill.
Notwithstanding anything to the contrary in this Agreement, Novavax
shall not be liable to Cantab for any amount in excess of the greater
of the amount actually received by Novavax pursuant to this Agreement
or US$1,000,000.
14
April 22 1999 Novavax/Cantab - page: 14
8.4 Each party acknowledges that it shall be solely responsible for the
performance of its obligations under this Agreement on its premises
including (without prejudice to the generality of the foregoing) the
health and safety of its employees and all other regulatory, legal and
other requirements (including without limitation all health and safety
and environmental legislation and guidelines) relating to the
performance of its obligations under this Agreement and that the other
party shall be in no manner responsible for the same.
9. CONFIDENTIALITY AND SECURITY
9.1 Each Party (the "Recipient Party") shall keep the Confidential
Information of the other Party (the "Disclosing Party") secret and
confidential and shall not without the prior consent of the other Party
directly or indirectly disclose or permit the same to be disclosed to
any third party for any reason or use the same save as expressly
provided by this Agreement or the Option Agreement or the Materials
Transfer Agreement.
9.2 The obligations of confidence referred to in Clause 9.1 shall not
extend to all or any part of such Confidential Information which:-
9.2.1 is or becomes generally available to the public otherwise than by
reason of breach by the Recipient Party of the provisions of this
Agreement;
9.2.2 the Recipient Party can show by documentary evidence was within its
possession or control prior to the date upon which it was received from
the disclosing party free from any obligation of confidentiality; or
which the recipient party can show by documentary evidence came into
its possession or control from a third party free from any obligation
of confidentiality by such third party subsequent to the date of the
Option Agreement; or
9.2.3 is subsequently disclosed to the Recipient Party without obligations of
confidence by a third party owing no such obligations to the Disclosing
Party in respect of that Confidential Information.
The Recipient Party may disclose Confidential Information to the extent
such is required by law to be disclosed (including as part of any
regulatory submission or approval process) and then only after prompt
written notice of this requirement has been given to the Disclosing
Party so that it may, if so advised, seek appropriate relief to prevent
such disclosure provided always that in such circumstances such
disclosure shall be only to the extent so required and shall be subject
to prior consultation with the Disclosing Party with a view to agreeing
timing and content of such disclosure.
9.3 The obligations of the Parties under Clause 9.1 shall survive the
expiration or termination of this Agreement for whatever reason for a
period expiring at the earlier of
15
April 22 1999 Novavax/Cantab - page: 15
five years following such termination or expiration or ten years
following disclosure of the Confidential Information.
10. TERMINATION
10.1 Cantab shall have the right to terminate its rights and obligations
under this Agreement in respect of any part (or the whole) of the
Licensed IP on 120 days written notice. In the event of any partial
termination the rights and obligations of Cantab shall cease in respect
of any terminated part but shall continue thereafter in accordance with
the terms of this Agreement in respect of any and all non-terminated
parts of the Licensed IP.
10.2 Cantab shall have the right to terminate this Agreement upon giving
written notice of termination to Novavax in the event Novavax commits a
material breach of this agreement which is not cured within 30 days of
Novavax's receipt of written notice of breach from Cantab identifying
the breach and requiring its remedy.
10.3 Novavax shall have the right to terminate this Agreement upon giving
written notice of termination to Cantab upon the occurrence of any of
the following events at any time during this Agreement:-
10.3.1 Cantab commits a breach of this Agreement relating to the payment of
money actually due to Novavax which shall not have been cured within 5
days of receipt by Cantab of written notice of breach from Novavax
identifying the breach and requiring its remedy;
10.3.2 Cantab commits any material breach of this Agreement, other than a
breach specified in clause 10.3.1, which shall not have been remedied
within 30 days of the receipt by Cantab of a written notice from
Novavax identifying the breach and requiring its remedy; or
10.3.3 if an Insolvency Event occurs in relation to Cantab.
10.4 In the event of any termination hereunder, Cantab shall promptly return
all Novavax Confidential Information to Novavax. The license granted
hereunder shall cease immediately upon such termination and Cantab
shall no longer have any right or interest to use any Licensed IP or to
manufacture, sell, market, distribute or sublicense the Licensed
Product; provided however, that Cantab (and/or its sublicensee) shall
have the right to continue to sell Licensed Product which has already
been manufactured, for a period of 30 days after the effective date of
such termination, subject to the continued applicability of Clause 3 of
this Agreement to any such sale and time period. In case of partial
termination under clause 10.1, this subclause applies only to the
terminated part. Termination of this Agreement, in whole or in part,
shall be without prejudice to obligations and/or rights accrued prior
to the effective date of such termination.
16
April 22 1999 Novavax/Cantab - page: 16
10.5 Novavax shall have the right, at its option, in the event Cantab
breaches its obligations under Clause 3.4 of this Agreement to convert
the license granted herein to a non-exclusive license, which shall
result in the termination of Novavax' obligations under Clause 6.1.3 of
this Agreement. Such right shall be in addition to any other right
Novavax may have under this Agreement.
Beginning in 2004, in the event that Cantab does not, directly or
indirectly, commence sales and/or marketing of a Licensed Product in a
country in which such sales and/or marketing are planned (a 'Planned
Country'), within six months of the date such sales or marketing are
planned in accordance with Cantab's (or its sublicensee's) marketing
plan, as delivered to Novavax in accordance with Clause 7.1.7 of this
Agreement, which failure to commence sales and/or marketing is not
caused directly by the inability to obtain regulatory approval
necessary to commence such sales and/or marketing after commercially
reasonable efforts to obtain such approval ('regulatory approval
failure'), the Parties hereto shall promptly commence and diligently
pursue discussion regarding such event. Such discussions shall include
whether commercialization of the Licensed Products is reasonable with
respect to the Planned Country and whether the exclusivity set forth in
Clauses 2.1 and 6.1.3 should continue to apply to the Planned Country.
In the event that Cantab and Novavax do not agree to an alternative
plan during the period of 24 months from the date of the planned sale
and/or marketing in the Planned Country, Novavax shall have the right,
upon 10 days written notice to Cantab at the expiration of such 24
month period, if sales and/or marketing in the Planned Country have
not yet commenced and if such failure is not caused directly by
regulatory approval failure, to convert the license granted herein to a
non exclusive license with respect to the Planned Country, which shall
result in the termination of Novavax's obligations under Clause 6.1.3
of this Agreement with respect to the Planned Country.
11. GENERAL
11.1 This Agreement shall be deemed to have effect from the date hereof and
shall supersede any other agreement whether written or oral with
respect to the performance of their respective obligations by the
parties provided that for the avoidance of doubt the Confidentiality
Agreements and the Materials Transfer Agreement (save only as expressly
amended by this Agreement) and clause 4 of Schedule 2 of the Option
Agreement together with clauses 3.1, 5.1 and 8.2.1 of the Option
Agreement shall remain in full force and effect in accordance with
their terms.
11.2 Each party acknowledges that in entering into this Agreement it does
not do so on the basis of and does not rely on any representation,
warranty or other provision save as expressly provided herein and all
conditions, warranties and other terms implied by statute or common law
are hereby excluded to the fullest extent permitted by law.
11.3 Any notice given under this Agreement shall be sufficiently served if
in writing and sent
17
April 22 1999 Novavax/Cantab - page: 17
by both facsimile transmission and air mail post or courier to the
address and fax number of the recipient party set out below:
NOVAVAX, INC.
0000 Xxxxxxxx Xxxx, Xxxxx X
Xxxxxxxx, XX 00000 XXX
Fax No.: (00)(0) 000-000-0000
CANTAB PHARMACEUTICALS RESEARCH LIMITED
000 Xxxxxxxxx Xxxxxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxxx XX0 OWG
Fax No.: (01l)(00) 0000 000000
Notice of any modification or amendment to the address or fax number of
a party must itself be made in writing to the other party in accordance
with the terms of this Clause.
11.4 Neither party is authorised to act as the agent of the other for any
purpose whatsoever and neither party shall on behalf of the other enter
into, or make, or purport to enter into or make or represent that it
has any authority to enter into or make any contract or any
representation or warranty. Nothing in the Agreement shall be deemed to
constitute a partnership between the other parties and neither of the
parties shall do or suffer to be done anything whereby it may be
represented as a partner of the other party.
11.5 Each of the parties shall bear its own cost and expenses incidental to
the preparation, negotiation and execution of this Agreement and the
Supply Agreement.
11.6 This Agreement is personal to Cantab and shall not be capable of
assignment, sublicensing (subject and without prejudice to Section 2.2
of this Agreement) or transfer by Cantab (whether in whole or in part)
without the prior written consent of Novavax, which shall not be
unreasonably withheld. Cantab shall have the right to assign or
transfer this Agreement to an entity into which it is merged or which
acquires all or substantially all of the assets of the business line
using the Licensed IP or all or substantially all of Cantab's capital
stock. Cantab shall give Novavax not less than 45 days advanced written
notice of any such proposed merger or sale. Novavax agrees to notify
Cantab in writing within 20 days of receipt of a notice of a proposed
merger or sale from Cantab, whether the party with which Cantab
proposes entering such merger or sale transaction is a competitor of
Novavax, involved in the field of adjuvants, and whether Novavax
objects to such assignment or transfer of this Agreement on the basis
that such would result in confidential, proprietary or non-public
information becoming known by a competitor. If Novavax so objects,
Cantab shall notify Novavax within 10 days of receipt of Novavax's
notice whether it intends to complete the sale or merger. In the event
Cantab does not provide Novavax such notice or notifies Novavax that
it intends to complete such merger or sale, Novavax may, upon 10 days
notice to Cantab,
18
April 22 1999 Novavax/Cantab - page: 18
terminate this Agreement and the license granted hereby, such
termination to take effect immediately before said sale or merger.
11.7 Any agreement to amend, vary or modify the terms of this Agreement in
any manner shall be valid only if the amended, variation or
modification is effected in writing and signed by duly authorised
representatives of each of the parties hereto.
11.8 No delay by either party in enforcing any of the provisions of this
Agreement shall be deemed a waiver of that party's right subsequently
to enforce such provision.
11.9 If any term or provision or any part thereof contained herein shall be
declared or become unenforceable invalid or illegal in any respect
under the law of any relevant jurisdiction: (i) such term or provision
or part thereof shall be deemed to have been severed from the remaining
terms of this Agreement and the terms and conditions hereof shall
remain in full force and effect as if this Agreement had been executed
without the offending provision appearing herein; and (ii) the parties
shall endeavour to agree and amend which to the fullest extent possible
will give lawful effect to their intentions as expressed in any term or
provision severed under this Clause 11.9.
11.10 Any controversy or claim of whatsoever nature arising out of or
relating in any manner whatsoever to this Agreement or any breach of
any terms of this Agreement shall be governed by and construed in all
respects in accordance with the laws of England, except that claims or
controversies arising out of or relating to Cantab's obligations of
confidentiality and non-disclosure hereunder shall be governed by and
construed in all respects in accordance with the laws of the State of
Maryland, USA. At the request of either party, any claim, dispute or
controversy arising out of or in connection with this Agreement or a
breach thereof shall be settled by arbitration conducted in London in
accordance with the commercial arbitration rules then in effect of the
American Arbitration Association. The costs of arbitration shall be
divided equally between the parties except that the arbitrator(s) shall
have the authority to allocate the costs according to equitable
principles upon the request by either party. The arbitrator(s) shall
have the express authority to award equitable remedies at the request
of either party.
[Schedule 1 follows next:]
19
April 22 1999 Novavax/Cantab - page: 19
SCHEDULE 1
LICENSED PATENT RIGHTS
---------------------------------------------------------------------------------------------------------------
USA Patent Patent Title Date of USA EC
Number Issuance in Expiration Expiration
USA Date Date
---------------------------------------------------------------------------------------------------------------
4,853,228 Method of Manufacturing Paucimellar Lipid 8/1/89 7/28/07
Vesicles
---------------------------------------------------------------------------------------------------------------
4,855,090 Method of Producing High Aqueous Volume 8/8/69 3/13/07
Multilamellar Vesicles
---------------------------------------------------------------------------------------------------------------
4,895,452 Method and Apparatus for Producing Lipid 1/23/90 3/3/08
Vesicles
---------------------------------------------------------------------------------------------------------------
4,911,928 Paucilamellar Lipid Vesicles 3/27/90 3/7/07
---------------------------------------------------------------------------------------------------------------
4,917,951 Lipid Vesicles Formed of Surfactants and 4/17/90 11/24/07
Steroids
---------------------------------------------------------------------------------------------------------------
5,000,960 Protein Coupling Lipid Vesicles 3/19/91 1/19/09
---------------------------------------------------------------------------------------------------------------
5,013,497 Method and Apparatus for Producing Lipid 5/7/91
Vesicles
---------------------------------------------------------------------------------------------------------------
5,032,457 Paucilamellar Lipid Vesicles Using Charge- 8/16/91 7/16/06
localised, single chain, non-phospholipid
Surfaciants
---------------------------------------------------------------------------------------------------------------
5,104,736 Reinforced paucilamellar Lipid Vesicles 4/14/92 6/26/09
---------------------------------------------------------------------------------------------------------------
4,147,723 Paucilamellar Lipid Vesicles 9/15/92 6/8/06
---------------------------------------------------------------------------------------------------------------
5,234,767 Hybrid Paucilamellar Lipid Vesicles 8/10/93 3/27/07
---------------------------------------------------------------------------------------------------------------
5,256,422 Lipid Vesicles Containing Water-in-Oil 10/23/93 3/28/11
Emulsions
---------------------------------------------------------------------------------------------------------------
5,474,848 Paucilamellar Lipid Vesicles 12/12/95 3/13/07 3/8/08
---------------------------------------------------------------------------------------------------------------
5,561,062 Method of Inhibiting viral Reproduction Using 10/1/96 10/1/93
non-phospholipid Paucilamellar Liposomes
---------------------------------------------------------------------------------------------------------------
,*NVR- Vaccines Containing Paucilamellar Lipid *CIP
213CP Vesicles as Immunological Adjuvants
---------------------------------------------------------------------------------------------------------------
OTHER LICENSED PATENT AND APPLICATIONS INCLUDE:
European Patents and Applications: PCT Applications:
0 349 583 WO 88/06881
0 349 579 WO 88/06882
0 352 282 WO 88/06883
0 406 273 WO 89/07929
0 746 338 WO 95/22989
WO 91/04013
Disclosure: L'Oreal opposed European Patent No 0 352 282 of Micro-Pak, Inc. Such
opposition was denied. L'Oreal has appealed such denial.
DISCLOSURE: NOVAVAX HAS LEARNED OF THE FOLLOWING PATENTS AND/OR APPLICATIONS,
WHICH INCLUDE CLAIMS WHICH MAY BE ARGUED TO BE EMCOMPASSED BY THE LICENSED IP:
US PATENT NO. 5,579,353 (WITH WO3/19781) AND W095/109751. NOVAVAX BELIEVES THAT
TO THE EXTENT THAT ANY SUCH CLAIMS WOULD BE INFRINGED BY THE LICENSED
PRODUCTS, SUCH CLAIMS MAY NOT BE VALID
20
April 22 1999 Novavax/Cantab - page: 20
==========================================================================
IN WITNESS WHEREOF the Parties have caused this Licence Agreement to be
executed:
for and on behalf of Novavax, Inc.: [date] 29 April 1999
[signature] /s/ Xxxxxxxx X. Xxxxx
--------------------------------------------
[name and official position of signatory]
Xxxxxxxx X. Xxxxx President & CEO
-----------------------------------------------------------
for and on behalf of Cantab Pharmaceuticals Research Limited
[date] 22 April 1999
[signature] /s/ Xxxxx X. Xxxxxxxx
--------------------------------------------
[name and official position of signatory]
Xxxxx X. Xxxxxxxx CHIEF EXECUTIVE OFFICER
-----------------------------------------------------------
This Agreement is endorsed in accordance with its terms with an
execution for and on behalf of Novavax Inc.'s subsidiaries Micro-Pak,
Inc. and Micro Vesicular Systems, Inc., who agree to be bound hereby to
the extent within written:-
for and on behalf of Micro-Pak, Inc. [date] 29 April 1999
[signature] /s/ Xxxxxxxx X. Xxxxx
--------------------------------------------
[name and official position of signatory]
Xxxxxxxx X. Xxxxx President
-----------------------------------------------------------
for and on behalf of Micro Vesicular Systems, Inc. [date] 29 April 1999
[signature] /s/ Xxxxxxxx X. Xxxxx
--------------------------------------------
[name and official position of signatory]
Xxxxxxxx X. Xxxxx President
-----------------------------------------------------------
