1
LICENSE AND SUPPLY AGREEMENT
THIS AGREEMENT (the "License and Supply Agreement") is made as of
October 21, 1999 (the "Effective Date") by and between Parkedale
Pharmaceuticals, Inc., a Michigan corporation having its principal place of
business at 000 Xxxxxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("Parkedale"), and
Novavax, Inc., a Delaware corporation having its principal place of business at
0000 Xxxxxxxx Xxxx, Xxxxxxxx, Xxxxxxxx 00000 ("Novavax").
WITNESSETH:
WHEREAS, Novavax has certain proprietary know-how in the field of
encapsulated drug delivery systems and has developed certain proprietary
adjuvants, such as a Novasome(R) delivery system; and
WHEREAS, Parkedale has certain proprietary know-how in the field of
vaccines and has developed and continues to develop proprietary vaccines,
especially a vaccine comprising antigenic determinants of an influenza virus;
WHEREAS, Parkedale has developed and currently markets, distributes and
sells a Fluogen(R) trivalent influenza vaccine;
WHEREAS, the parties hereto desire for Parkedale to develop,
manufacture, market, distribute and sell a product for treating or preventing
influenza virus and/or infection, such as a vaccine comprising antigenic
determinants of an influenza virus, like Fluogen(R), which includes a
proprietary adjuvant developed by Novavax; and
WHEREAS, the parties hereto desire for Novavax to supply such
proprietary adjuvants to Parkedale, so that Parkedale can develop products, such
as a vaccine comprising antigenic determinants of an influenza virus, like
Fluogen(R), which incorporate proprietary adjuvants developed by Novavax to
treat or prevent influenza virus and/or infection;
NOW, THEREFORE, for and in consideration of the premises and mutual
covenants and agreements hereinafter set forth, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged and
accepted, the parties hereto agree as follows;
2
ARTICLE I
Definitions
1.01 "Adjuvant(s)" shall mean any and all agents which enhance a
product or method involved in or concerned with the treatment or prevention or
infection of influenza virus, e.g., an immune response of an influenza virus
vaccine, which are owned, controlled, and/or developed by Novavax and/or its
Affiliate(s), or to which Novavax and/or its Affiliate(s) has a license or right
to use, such as Novasome(R) delivery system(s).
1.02 "Affiliate(s)" shall mean any corporation or other business
entity controlled by, controlling, or under common control with Parkedale or
Novavax, as the case may be. For this purpose, "control" means direct or
indirect beneficial ownership of at least fifty percent (50%) of the voting
stock in the case of a corporation, or of the right to receive distributable net
income in the case of any other business entity.
1.03 "Confidential Information" as used in this License and Supply
Agreement shall mean and include any and all confidential and proprietary
information and Know-How which is not in the public domain, whether in oral,
written, machine-readable or graphic form, and all prototypes or samples of an
Adjuvant, a Novasome(R) delivery system, a Parkedale Product and/or an Influenza
Product, which is furnished by one Party or its Affiliate (the "Disclosing
Party"), either directly or indirectly, pursuant to and under this License and
Supply Agreement, to the other Party or its Affiliate (the "Receiving Party"),
and which the Receiving Party has a reasonable basis to believe is confidential
to the Disclosing Party or is treated by the Disclosing Party as confidential,
unless such information: (a) was known to the Receiving Party prior to receipt
from the Disclosing Party, as documented in written records or publications that
lawfully are in the possession of the Receiving Party; (b) was lawfully
available to the trade or to the public prior to receipt from the Disclosing
Party; (c) becomes lawfully available to the trade or to the public after
receipt from the Disclosing Party through no act on the part of the Receiving
Party; (d) was received in good faith by the Receiving Party from any third
Party without an obligation of confidentiality; (e) is in the general public
domain other than as a result of a breach of this confidential relationship; (f)
information is embodied in an agreement entered into by the parties hereto in
writing which releases such information from the terms of this confidentiality
obligation; (g) information that at any time is received in good faith by the
Receiving Party from a third Party, which information was lawfully in possession
of the third Party, and which the third Party had the right to disclose and did
not receive from either of the parties to this License and Supply Agreement; or
(h) is independently developed by an employee or agent of the Receiving Party
without access to the Confidential Information, prior to receipt of such
Confidential Information from the Disclosing Party, as demonstrated by
contemporaneous written records. A Party receiving Confidential Information may
disclose such information to the extent required by applicable law or pursuant
to the requirement of a governmental or judicial entity; provided, however, that
such Receiving Party shall give notice to the Disclosing Party of such
requirement and shall cooperate with the Disclosing Party in its efforts to
maintain the confidentiality of the Confidential Information.
2
3
1.04 "Field" shall mean (a) the use of Novavax IP in any manner
whatsoever to develop, create, invent, manufacture, promote, market,
offer-for-sale, sell, import and/or export an Influenza Product involved in or
concerned with the treatment or prevention of influenza virus or any other
purpose for which an Influenza Product may be indicated, and (b) the subsequent
exploitation of an Influenza Product in the Territory.
1.05 "Influenza Product(s)" shall mean any Parkedale Product together
with at least some portion or aspect of the Novavax IP, such as an Adjuvant and
especially a Novasome(R) delivery system which is used to treat influenza.
1.06 "Joint Improvement(s)" shall mean any and all ideas, conceptions,
reductions to practice, modifications, changes, alterations, adaptations,
revisions, or improvements relating to and/or derivatives of any intellectual
property or product that accrue or result from the joint activities of Novavax
and/or its Affiliates with Parkedale and/or its Affiliates outside of the Field
during the term of this License and Supply Agreement.
1.07 "Know-How" shall mean all tangible and intangible technical and
other information including, but not limited to ideas, conceptions,
reductions-to-practice, discoveries, data, designs, chemical structures,
formulae, materials, intermediates, inventions (whether patentable or not),
methods, models, prototypes, samples, influenza technology, works (whether
copyrightable or not), assays, research plans, procedures, designs, experiments,
tests, results of experimentation and testing (including results of research or
development), processes (including manufacturing processes, uses, specifications
and techniques), laboratory records, note books, chemical, pharmacological,
toxicological, clinical, analytical and quality control data, trial data, case
report forms, data analyses, reports, manufacturing data, summaries and
information contained in submissions to and from ethical committees and
regulatory authorities, which relates to or concerns an Adjuvant, a Parkedale
Product, Patent Rights, a Novasome(R) delivery system, a Novavax Improvement, a
Parkedale Improvement and/or an Influenza Product. Know-How includes all
documents and copies thereof (whether in written, machine-readable, physical or
graphic form) and other things (such as prototypes, materials, samples, models,
etc.) which contain, embody or refer to the Know-How. Such information,
documents or things will not be excluded from being Know-How hereunder by reason
of the fact that they become available to the public only 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-How includes, but is not limited to, any and all rights that protect the
Know-how, such as copyrights software, rights, trade secret rights, database
rights and/or design rights.
1.08 "Novavax IP" shall mean the Adjuvants, Novasome(R) delivery
system, Patent Rights, Novavax Improvements, and Novavax's Know-How, which is
useful in the Field.
1.09 "Novavax Improvement(s)"shall mean any and all ideas, conceptions,
reductions to practice, modifications, changes, alterations, adaptations,
revisions, or improvements relating
3
4
to and/or derivatives of an Adjuvant, a Novasome(R) delivery system, Patent
Rights, and/or Novavax Know-How that accrue or result from the activities of
Novavax and/or Novavax' Affiliates or which are assignable to Novavax and/or
Novavax' Affiliates.
1.10 "Net Sales" or "Net Selling Price" shall mean, with respect to the
Influenza Products, the gross amount invoiced by Parkedale or its Affiliates to
unrelated third parties for sales of the Influenza Products, less:
(a) Transportation, freight, and insurance charges and/or
allowances actually or granted;
(b) Trade, quantity, cash and/or other discounts, if any,
allowed and paid by Parkedale to unrelated third parties in arms-length
transactions;
(c) Credits or allowances made or given on account of
rejects, returns, recalls or retroactive price reductions for any amount not
collected;
(d) Any tax, customs, duty and/or other governmental charges
relating to the sale, transportation, use, delivery or services, which is paid
by Parkedale and not recovered from the unrelated third Party purchaser; and
(e) Any and all costs paid to Novavax by Parkedale concerning
any Novavax raw materials, including but not limited to an Adjuvant, which are
used in connection with, inter alia, the development and/or manufacture of an
Influenza Product.
For purposes of calculating and paying royalties, Influenza
Products shall be deemed "sold" the earlier of when invoiced or shipped.
1.11 "Parkedale Improvement(s)" shall mean any and all ideas,
conceptions, reductions to practice, modifications, changes, alterations,
adaptations, revisions, or improvements relating to and/or derivatives of a
Parkedale Product, Parkedale's Know-How, and/or an Influenza Product that accrue
or result from the activities of Parkedale and/or Parkedale's Affiliates or
which are assignable to Parkedale and/or Parkedale's Affiliates.
1.12 "Parkedale Product(s)" shall mean any preparations, product, or
pharmaceutical which is free of Novavax IP involved in or concerned with the
treatment or prevention of an influenza virus, such as Fluogen(R), or any other
purpose for which a Parkedale Product may be indicated.
1.13 "Patent Right(s)" shall mean: (a) any and all United States and
foreign (i) pending and abandoned patent applications, (ii) patents issuing from
such patent applications, and (iii) issued patents, together with any and all
divisions, reissues, reexaminations, continuations, continuations-in part,
extensions and additions thereof, which describe, relate to and/or claim an
Adjuvant (including, but not limited to, an Adjuvant either alone or in
combination, use of an
4
5
Adjuvant. and manufacture of an Adjuvant or an intermediate therefor) as of the
date of this License and Supply Agreement; (b) any and all inventions which
describe, relate to or concern a Novavax Improvement; (c) any and all United
States and foreign (i) pending and abandoned patent applications, and (ii)
patents issuing from such patent applications, together with any and all
divisions, reissues, reexaminations, continuations, continuations-in part,
extensions and additions thereof, which describe, relate to and/or claim a
Novavax Improvement, now or in the future; and (d) any and all other United
States and foreign pending and abandoned patent applications and issued patents
necessary, useful or which permit Parkedale to accomplish the objectives of or
to practice under the exclusive license and rights granted under this License
and Supply Agreement. Each Patent Right shall be identified in detail on EXHIBIT
A attached hereto by: (1) country; (2) serial number(s); (3) filing date(s); (4)
priority date(s); (5) patent number; (6) issue date; (7) all related properties;
(8) title; (9) assignee(s); (10) inventor(s); (11) applicant(s); and (12) status
thereof.
1.14 "Regulatory Authority(ies)" shall mean any national, supranational
(e.g.. the FDA, the European Commission, the Council of the European Union or
the European Agency for the Evaluation of Medicinal Products), regional, state
or local regulatory agency, department, bureau, commission, counsel or other
governmental entity other in each country of the Territory involved in the
granting of marketing authorization for the Influenza Product.
1.15 "Territory" shall mean the entire world, except for those
countries specifically identified on EXHIBIT B attached hereto.
ARTICLE II
License for Novavax Know-How and Patent Rights
2.01 License. Novavax hereby grants to Parkedale the exclusive right
and license in, to, and under the Novavax IP in the Field within the Territory.
Novavax shall retain all rights not expressly granted under this Article II, not
inconsistent, however, with other rights granted to Parkedale under this License
& Supply Agreement. The exclusive license shall be for the period in which any
Novavax IP or patents covering the Joint Improvement(s) shall remain valid and
enforceable, unless earlier terminated as provided in Article IX hereof.
2.02 Parkedale Exclusivity. Consistent with Article II, Paragraph 2.01,
Article IV, Paragraph 4.06 and Article V, Paragraph 5.07, Novavax agrees, during
the term of this License and Supply Agreement, that it and its Affiliate(s) will
not license, sublicense, approve a license for, approve a sublicense for or
assign to another Party or entity the Novavax IP for use in the Field within
the Territory.
2.03 Ownership of Intellectual Property. Each Party will retain
ownership of all information, data, Know-How, inventions, discoveries, programs,
copyrights, improvements, devices, designs, apparatus, patents, patent
applications, practices, processes, methods, products, techniques, trade
secrets, ideas, or other intellectual property owned by it at the commencement
of this License and Supply Agreement. The parties hereto agree that Novavax
will own the
5
6
Novavax IP and an undivided joint interest in the Joint Improvements (with
Parkedale) and that Parkedale will own the Parkedale Products and the Influenza
Products (each to the extent that such products do not constitute Novavax IP,
the Parkedale Know-How and an undivided joint interest in the Joint Improvements
(with Novavax). Either Party shall be required to get approval from the other
Party to use a Joint Improvement outside of the Field. The joint rights set
forth herein shall include, without limitation, the right to domestic and
foreign copyright, copyright renewal, trademark, and/or patent protection
therein, and the right to register and claim priority therein (jointly with the
other Party hereto, under any applicable law, treaties, or conventions. Nothing
in this section shall grant Novavax any rights to the Influenza Product,
Improvements in the Field, or any other technology that Parkedale may acquire or
license.
2.04 Development. The parties hereto acknowledge that development of an
Influenza Product and other related processes and products pursuant to this
License and Supply Agreement may necessitate the modification, adaptation,
improvement or revision of Novavax IP, a Parkedale Product, Parkedale Know-How,
an Influenza Product, a Parkedale Improvement, existing technology or Know-How
which is proprietary, controlled or licensed by a Party or the development of
new products or processes by a Party hereto based upon such existing technology
or Know-How. The parties hereto agree that each Party shall retain the sole and
exclusive right, title and interest in and to any and all its own technology,
information, data, Know-How, inventions, discoveries, programs, improvements,
devices, designs, apparatus, practices, processes, methods, products,
techniques, trade secrets, ideas or other intellectual property, which is
proprietary, controlled or licensed by a Party and the development of new
products or processes by a Party based upon such existing technology or
Know-How, subject to its obligations and agreements set forth herein, and the
right to domestic and foreign copyright, copyright renewal, trademark and/or
patent protection therein, and the right to register and claim priority therein
under any applicable law, treaties or conventions.
2.05 Execute and Deliver. Parkedale and Novavax each agree to execute
and deliver to the other all reasonable copyright, patent and other
applications, assignments and instruments tendered by the other, and perform
such acts, as may be reasonably necessary or advisable for obtaining such rights
and/or of vesting and maintaining the title to the rights of the tendering Party
set forth in this Article II. The provisions of this Article II, Paragraphs
2.03, 2.04, and 2.05, shall survive the termination or other expiration of this
License and Supply Agreement.
2.06 Novavax Trademark. Parkedale agrees that the Influenza Products,
created, developed, invented, purchased, and/or licensed hereunder will be sold
by Parkedale under the trademark or trade name of Parkedale and/or its
Affiliate(s). No Influenza Products shall be marketed or sold under any Novavax
trademark, trade name, or logo. Novavax, however, agrees that Parkedale may use
with prior approval the Novavax trademark, Novasome(R) delivery system, on a
nonexclusive basis only for the duration of this License and Supply Agreement
and solely for advertising, displaying, marketing, promoting, using,
manufacturing, offering-for-sale, selling, distributing, importing and/or
exporting the Influenza Products in accordance with this License and Supply
Agreement.
6
7
ARTICLE III
License Payments
3.01 License Payments. Parkedale shall pay to Novavax the following
amounts:
(a) One million U.S. dollars ($1,000,000.00) upon execution of
this License and Supply Agreement by both parties hereto;
(b) One hundred thousand U.S. dollars ($100,000.00) upon the
commencement of the first Phase I product study or the equivalent in any other
country for the Influenza Product;
(c) One hundred thousand U.S. dollars ($100,000.00) upon the
date of entry of the first patient into a Phase II study or the equivalent in
any other country, for the Influenza Product;
(d) One hundred thousand U.S. dollars ($100,000.00) upon the
earliest of the date of entry of the first patient into a Phase III study, or
the submission of an amended PLA filing, or, with respect to either, the
equivalent in any other country, for the Influenza Product; and
(e) Five hundred thousand U.S. dollars ($500,000.00) upon the
granting by a Regulatory Authority of a PLA (or amended PLA), or the equivalent
in any other country, for the Influenza Product.
The parties hereto agree that the maximum License Payments
that may be due under Paragraph 3.01(a) - (e) is $1,800,000.00. The parties
therefore agree that each of the License Payments set forth in this Paragraph
3.01(a) - (e) shall be paid by Parkedale to Novavax only one time and that once
each of the License Payments set forth in this Paragraph 3.01(a) - (e) have been
paid one time by Parkedale, these License Payments shall be deemed paid in full
and Parkedale shall owe no Further License Payments under this Paragraph 3.01(a)
- (e).
3.02 Research and Development Support Payments. Parkedale shall pay to
Novavax its cost of research and development for the Adjuvant for the term
during which Novavax supplies Adjuvant to Parkedale, to a maximum of $100,000
per year. Notwithstanding the foregoing, Parkedale agrees to pay Novavax such
maximum research and development costs for a period of not less than 24 months
from the execution of this License and Supply Agreement. Novavax agrees to use
commercially reasonable efforts to support the development and supply of the
Influenza Product in accordance with the time-lines set forth herein, including
the provision of reasonable research and development resources. One-twelfth of
such costs will be paid monthly, on the 15th day of each month (except for the
initial such payment, which will be
7
8
made upon execution of this License and Supply Agreement, in the event that this
License and Supply Agreement is executed in any month after the 15th day
thereof).
3.03 Royalties. Parkedale agrees to pay royalties only on the Net Sales
of Influenza Products as follows: (a) an annual rate of 4% of Net Sales of the
Influenza Products in the United States of America and its territories, Canada,
all European countries, Finland, Norway, South Africa, South America and Sweden;
and (b) an annual rate of 5% of Net Sales of Influenza Products in all other
countries in the Territory. Such royalties on Net Sales are payable ninety (90)
days after the end of each calendar year in which Influenza Products are sold
during the term of this License and Supply Agreement. Parkedale shall keep
adequate and complete records showing all Net Sales of Influenza Products with
respect to which royalties are due under this License and Supply Agreement. Such
records shall include all information necessary to verify the total amount and
computation of royalties due hereunder, and shall be available once per year to
inspection by or on behalf of Novavax during normal business hours to verify the
amounts thereof or to ascertain such amounts in the event of a failure of
Parkedale to report. Parkedale shall retain such records for not fewer than five
(5) years after the close of any calendar year to which they relate or such
period as required by FDA. Parkedale agrees to make prompt adjustment, if
necessary, to compensate for any errors or omissions disclosed by such
inspection. Should such inspection reveal a shortfall of more than three percent
(3%) between the royalties reported and those actually owed by Parkedale, the
cost of such inspection shall be paid by Parkedale.
ARTICLE IV
Clinical Influenza Product Supply
4.01 Clinical Influenza Product Supply. Parkedale shall place purchase
orders for Adjuvant for combination with a Parkedale Product, to be used for the
phase I and phase II clinical trials of an Influenza Product (the "Clinical
Influenza Product") pursuant to the terms and conditions set forth in this
License and Supply Agreement (an "Order") and Novavax agrees to use commercially
reasonably efforts to produce the Clinical Influenza Product in accordance with
the terms and conditions set forth in this License and Supply Agreement.
Consistent with this License and Supply Agreement, Novavax grants Parkedale the
right to use the proprietary Know-How of Novavax required to combine an Adjuvant
and a Parkedale Product and agrees to train Parkedale and its Affiliate(s), at
Parkedale's expense, to perform such combination, for the purpose of permitting
Parkedale and/o its Affiliate(s) to manufacture an Influenza Product for Phase
III clinical trials and for production of an Influenza Product. The transfer of
technology and training necessary to enable Parkedale and its Affiliate(s) to
produce an Influenza Product with an Adjuvant will be made at Parkedale's
expense; Parkedale shall reimburse Novavax for all reasonable costs and expenses
Novavax incurs in connection with such transfer and training, including without
limitation equipment, material, labor and travel expense (coach airfare and
compact car rental only). Novavax agrees to produce Adjuvant for the Clinical
Influenza Product in accordance with its product specifications and other
applicable U.S. federal, state and local laws. Novavax agrees to notify
Parkedale of any information of which it becomes aware which would be reasonably
likely to have a material adverse effect on Parkedale's ability to
8
9
obtain marketing approval from a Regulatory Authority for an Influenza Product
in the Territory, or which is reasonably likely to result in an action by a
Regulatory Authority materially adverse to the marketing of an Influenza
Products in the Territory, after the granting of marketing approval by such
Regulatory Authority.
4.02 Forecasts and Purchase Orders. Parkedale shall provide Novavax
with a rolling 12-month forecast of the quantity of Clinical Influenza Product
that Parkedale reasonably anticipates it will order. The first three months of
such forecast shall be binding upon Parkedale, and the last nine months shall be
a non-binding planning estimate. Parkedale will provide a written Order to
Novavax in support of the deliveries that are scheduled in the three firm months
of the forecast. On the first of each month, Parkedale will provide Novavax with
an updated 12 month forecast and new Orders for deliveries in the three-month
firm period. In the event of any cancellation of an order, Parkedale shall
reimburse Novavax for the reasonable cost of the materials required for such
Order. Unless Parkedale requests otherwise, all Clinical Influenza Products
shall be packed for shipment and storage in accordance with Novavax' standard
commercial practices. Except to the extent expressly otherwise provided herein,
and notwithstanding any provisions of any purchase order submitted by Parkedale,
shipment of and payment for Clinical Influenza Product shall be made
in accordance with the terms and conditions of sale set forth in this License
and Supply Agreement. Such terms shall replace and supersede Novavax'
and Parkedale's standard purchase Order forms, if any, and any other
documentation presented by either Party, including without limitation, any and
all standard terms and conditions appearing thereon.
4.03 Shipment and Delivery. Shipments will be made to an address
designated by Parkedale. Unless specified by Parkedale, Novavax will select the
carrier on behalf of Parkedale. Novavax will use reasonable efforts to meet
Parkedale's requested delivery schedules for Clinical Influenza Product. It is
each Party's obligation to notify the other Party of any special packaging
requirements in writing. In the event that Novavax fails or is unable to timely
meet Parkedale's delivery schedule for Clinical Influenza Product, Parkedale
shall have the right to seek alternative suppliers of the Adjuvants, and Novavax
shall be responsible for and pay immediately any and all costs and expenses
incurred by Parkedale resulting therefrom or associated therewith.
4.04 Prices and Payment. All prices are FCA Novavax' facility (in
accordance with INCOTERMS 1990) and are exclusive of all taxes, assessments or
duties of any nature, other than taxes measured solely by Novavax' net income,
now in force or enacted in the future, all of which shall be paid by Parkedale.
In the event Novavax is required to pay or pays any such tax, the amount thereof
shall be added to and become a part of the amounts payable by Parkedale
hereunder. Parkedale agrees to pay all expenses incurred by Novavax in the
shipment and delivery of ordered Adjuvant, including without limitation freight
charges, export and import duties and insurance premiums. The purchase price for
the Clinical Influenza Product sold under the License and Supply Agreement shall
be Novavax's fully allocated costs therefor plus 30%. The parties hereto agree,
however, that Parkedale shall not pay or owe any royalty under Article III for
any Clinical Influenza Product for which Parkedale has paid Novavax.
9
10
4.05 Payment with Offset. Parkedale agrees to pay appropriate amounts
invoiced by Novavax, for the Clinical Influenza Product within thirty (30) days
from the date of invoice. All payments are to be made in U.S. dollars.
4.06 Exclusivity of Supply. Consistent with Article II, Paragraphs
2.0l and 2.02, Novavax agrees that it and its Affiliate(s) shall not
supply or caused to be supplied Adjuvant or any other Novavax IP to any third
Party or entity in any manner whatsoever for use in the Field within the
Territory during the term of this License and Supply Agreement. Also consistent
with Article II, Paragraphs 2.01 and 2.02, and to the extent that the Novavax IP
qualifies as Confidential Information, Novavax agrees that it and its
Affiliate(s) shall not disclose, teach or make available or cause to teach,
disclose or make available the Novavax IP to any third Party or entity in any
manner whatsoever for use in the Field within the Territory.
ARTICLE V
Obligations.
5.01 Efforts. Parkedale hereto shall use all reasonable efforts,
whenever applicable, to develop, create, invent, manufacture, market, distribute
and sell and to assist in the developing, creating, inventing, manufacturing,
marketing, distributing and selling of Influenza Products in the Field within
the Territory, or to procure the same.
5.02 Notification of Information. Each Party hereto shall promptly
notify the other Party in writing of any product safety, regulatory or marketing
information of which it becomes aware that has the potential to adversely affect
sales of the Influenza Product. Each Party shall promptly notify the other Party
hereto in writing of any actual or suspected infringement of the Novavax IP or
Influenza Products within the Territory which may come to its attention.
5.03 Meetings and Presentations. Each Party hereto shall provide at its
own expense personnel, including a named contact involved in the development of
Novavax IP and an Influenza Product, for all meetings and presentations (which
may include, for example, in person or teleconference meetings or
presentations,) with one another or a third Party to review research and
clinical testing results and developments and whenever required by a regulatory
or other governmental body, agency or entity, but in no event less frequently
than quarterly. Each Party also agrees to provide at its own expense personnel,
including a named contact involved in the development of Novavax IP and an
Influenza Product, for meetings and presentations concerning the Novavax IP and
an Influenza Product which is required by law or involves a regulatory or other
governmental body, agency or entity.
5.04 Studies. Each Party hereto shall cooperate to its fullest with one
another and use its reasonable commercial efforts to comply with its respective
obligations pursuant to this License and Supply Agreement to ensure that all
steps, studies and other actions necessary
10
11
for the development of the Influenza Product can be accomplished to the
satisfaction of Parkedale.
5.05 Reports. Each Party, to the extent applicable, shall provide, not
less frequently than annually, any development reports, research reports, study
records, or other material documents in its possession related to the Novavax IP
or the Influenza Product, by reliable overnight delivery service.
5.06 Indemnification. Parkedale hereto shall indemnify and hold
harmless Novavax from and against all liability, damages, or claims arising from
its own development, manufacture, and/or use of the Influenza Product for
research or clinical studies, and subsequently the exploitation of the Influenza
Product, only in the event that such liability, damages, or claims concern only
Parkedale know-how or a Parkedale product and not Novavax IP unless such
liability arises from the negligence or willful default of Novavax or otherwise
by reason of any breach by Novavax warranties given in this License and Supply
Agreement. Novavax hereto shall indemnify Parkedale and hold Parkedale harmless
from and against all liability, damages, or claims concerning or arising out of
the Novavax IP.
5.07 Non-Compete. Novavax agrees that, during the term of this License
and Supply Agreement, it and/or its Affiliate(s) shall not, directly or
indirectly: (a) compete with or against Parkedale or its Affiliates in the Field
within the Territory in the Field; (b) compete with or against Parkedale or its
Affiliates in connection with the manufacture, use, sale, importation or
exportation of any Influenza Product in the Field within the Territory; (c)
engage in any activity or take any action that is inconsistent with this License
and Supply Agreement or that will cause or result in the manufacture, marketing,
introduction, distribution, offer-for-sale, sale, importation or exportation of
any product that will directly or indirectly compete with any Influenza Product
in the Field within the Territory; or (d) collaborate with any person, third
Party or entity that will cause or result in the manufacture, marketing,
introduction, distribution, offer-for-sale, sale, importation or exportation of
a product that will compete with any Influenza Product in the Field within the
Territory. Novavax further agrees that it and its Affiliate shall not provide
or caused to be provided any Novavax IP to any person, third Party or entity
that Novavax knows or should reasonably know directly or indirectly use the
Novavax IP or cause the Novavax IP to be used in the Field within the Territory
during the term of this License and Supply Agreement.
ARTICLE VI
Confidential Information
6.01 Use of confidential Information. Consistent with Article I,
Paragraph 1.03, the Receiving Party (which term, for purposes of this paragraph
shall include such parties' employees, agents, shareholders, officers, directors
and Affiliates) shall not, either during the Term of this License and Supply
Agreement or at any time thereafter, use for its own benefit or disclose to or
use for the benefit of any person, third Party or entity other than the
Receiving Party, any Confidential
11
12
Information or other confidential or proprietary information of the Disclosing
Party, whether or not embodied in writing or other tangible form. All originals
and copies of any of the foregoing, however, and whenever produced, shall be the
sole property of the Disclosing Party of such Confidential Information. The
Receiving Party agrees that it sha1l make the Confidential Information of the
Disclosing Party available to its employees or agents, only on a "need to know"
basis, and further agrees that it shall require all of such employees, agents,
or others who have access to any of such Confidential Information to comply with
the obligations in Article I, Paragraph 1.03 and this Paragraph 6.01 and shall
exercise reasonable diligence to obtain compliance with such obligations. Upon
the termination or expiration of this License and Supply Agreement, the
Receiving Party shall promptly surrender to the Disclosing Party all
Confidential Information of the Disclosing Party that is in tangible form,
including that Confidential Information which has been reduced to or placed on
one or more writings, drawings, schematics, tapes, disks, or other forms of
documentation, together with any materials, things, prototypes, samples and
equipment belonging to the Disclosing Party, and the Receiving Party shall not
thereafter retain or deliver to any other person, third Party or entity any of
the foregoing or any summary memorandum thereof. Each Party hereby agrees that
it shall be responsible for the obligations of its employees and agents
hereunder and executes this License and Supply Agreement on behalf of itself and
such employees and agents.
6.02 Degree of Care. In addition to its other obligations under this
Article VI, the parties hereto agree that the Receiving Party shall use at least
the same degree of care (which at a minimum shall be reasonable) to avoid
unauthorized dissemination of Confidential Information as it employs for its own
information of a similar nature that it does not want to have disseminated. In
the event a Receiving Party is requested or required by a governmental,
quasi-governmental, judicial or quasi-judicial entity to disclose Confidential
Information it received from the Disclosing Party, it shall not be a violation
of this License and Supply Agreement to comply provided, however, that the
Receiving Party so requested or required shall notify the Disclosing Party of
such request or requirement, promptly upon receipt of the same.
6.03 Commercial Use. The parties hereto agree that neither shall put
the Confidential Information of the other Party to any use, except as expressly
provided under this License and Supply Agreement.
ARTICLE VII
Representations and Warranties
7.01 Laws. Each Party hereto, at its own expense, shall at all times
during the term of this License and Supply Agreement, and any extension or
renewal thereof, comply with all applicable laws, statutes, codes, regulations,
rules, ordinances, orders or directives of any applicable country, state,
county, city, town, province, territory, government entity, agency or body
wheresoever in effect including all export laws and regulations.
7.02 Licensee's Remedy. Except as set forth in Paragraph 7.03 below, a
remedy in the event of defect is repair or replacement of all defective
Adjuvant. Unless otherwise instructed in writing
12
13
by Parkedale, Novavax shall replace all defective Adjuvant with new Adjuvant at
Novavax's sole expense. Novavax warrants such replacement Adjuvant on the same
terms and conditions as the original.
7.03 Limitations. The warranties and remedies specified in this Article
VII shall not apply if an Adjuvant is defective due to (i) natural disasters,
including fire, smoke, water, earthquakes or lightning, (ii) the misuse or
improper storage of an Adjuvant or other failure to comply with the instructions
set forth in the documentation accompanying an Adjuvant, or (iii) use of an
Adjuvant in a manner for which it was not designed.
7.04 Infringement Warranty. Novavax represents and warrants that the
Adjuvants, the Novasome(R) delivery system, the Novasome(R) delivery system
trademark, the Novavax Improvements, the Novavax Know-How, the Patent Rights and
the Novavax IP do not and will not infringe upon or violate any valid patent,
copyright, trademark or any other intellectual property rights in the Territory.
7.05 Validity and Ownership. Novavax represents and warrants that the
Patent Rights and the trademark, Novasome(R) delivery system, are valid and
enforceable, and that Novavax is the rightful, lawful and sole owner of the
Patent Rights, the Adjuvants, the Novasome(R) delivery system, the Novasome(R)
delivery system trademark, the Novavax Improvements, the Novavax Know-How, and
the Novavax IP.
7.06 Organization and Standing. Novavax represents and warrants that it
is a company duly organized, validly existing and in good standing under the
laws of the jurisdiction of its incorporation or formation.
7.07 Power and Authority. Novavax represents and warrants that it has
all requisite corporate power and authority to execute, deliver, and perform
this License and Supply Agreement and the other agreements and instruments to be
executed and delivered by it pursuant hereto and thereto and to consummate the
transactions contemplated herein and therein. The execution, delivery, and
performance of this License and Supply Agreement by Novavax does not, and the
consummation of the transactions contemplated hereby will not, violate any
provisions of Novavax's organizational documents, by laws, any law or regulation
applicable to Novavax, or any agreement, mortgage, lease, instrument, order,
judgment, or decree to which Novavax is a Party or by which Novavax is bound or
result in the creation or acceleration of any lien charge, security interest, or
other encumbrance on or concerning the Adjuvants, the Novasome(R) delivery
system, the Novasome(R) delivery system trademark, the Patent Rights, the
Novavax Know-How and/or the Novavax Improvements.
7.08 Corporate Action; Binding Effect. Novavax represents and warrants
that it has duly and properly taken all action required by law, their
organizational documents, or otherwise, to authorize the execution, delivery,
and performance of this License and Supply Agreement and the other instruments
to be executed and delivered by them pursuant hereto and thereto and the
consummation of transactions contemplated hereby and thereby. This License and
Supply
13
14
Agreement has been duly executed and delivered by Novavax and constitutes, and
the other instruments contemplated hereby when duly executed and delivered by
Novavax will constitute, legal, valid, and binding obligations of Novavax
enforceable against them in accordance with their respective terms, except as
enforcement may be affected by bankruptcy, insolvency, or other similar laws and
by general principles of equity.
7.09 Consents. Novavax represents and warrants that no consent or
approval of, or filing with or notice to, any federal, state, or local
governmental or regulatory authority, agency, or department or any other person
not a Party to this License and Supply Agreement is required or necessary to be
obtained by Novavax or on its behalf in connection with the execution, delivery,
and performance of this License and Supply Agreement or to consummate the
transactions contemplated hereby, except which has been obtained prior to the
execution of this License and Supply Agreement.
7.10 Litigation or Disputes. Except as disclosed in EXHIBIT C attached
hereto, Novavax represents and warrants that there is no actual or potential
claim, outstanding commitment to any governmental regulatory agency, action,
suit, proceeding, investigation or arbitration, either pending, known to Novavax
or threatened against Novavax, which relates to or concerns the Adjuvants, the
Novasome(R) delivery system, the Novasome(R) delivery system trademark, the
Patent Rights, the Novavax Know-How, the Novavax Improvements and/or the Novavax
IP. Novavax further represents and warrants that it is not in violation of or in
default with respect to any applicable law, rule, regulation, judgment, order,
writ, injunction, award, or decree of any arbitrator, court, or administrative
body, the result of any of which, either individually or cumulatively, would
have a materially adverse effect on the Adjuvants, the Novasome(R) delivery
system, the Patent Rights, the Novavax Know-How, the Novavax Improvements or the
Novavax IP in the Territory or Novavax's compliance with and performance under
the terms of this License and Supply Agreement.
7.11 Influenza Product Competition. Novavax represents and warrants
that: (a) Novavax and its Affiliates have no plans or intentions to manufacture,
market, license, sublicense, distribute, introduce, offer-for-sale and/or sell
an Influenza Product in the Territory; and (b) Novavax and its Affiliates have
no plans or intentions to import into or export from the Territory an Influenza
Product or import or export within the Territory an Influenza Product.
7.12 Patent Rights. Novavax represents and warrants that:
(a) all Patent Rights to accomplish the objectives of this License and
Supply Agreement, i.e., to develop, manufacture, market, introduce, distribute,
offer-for-sale, sell, import and/or export an Influenza Product in the Field
within the Territory, are identified in detail on EXHIBIT A pursuant to Article
I, Paragraph 1.12, and that EXHIBIT A recites all Patent Rights to which Novavax
and/or its Affiliates has a right, title and/or interest which concern or relate
to the objectives of this License and Supply Agreement, e.g., all issued patents
and pending and abandoned patent applications, domestic or foreign, which
concern, refer to, describe, disclose
14
15
and/or claim one more Adjuvants, the use of one or more Adjuvants and/or the
manufacture of one or more Adjuvants or intermediates therefor, either alone or
in combination;
(b) Other than those Patent Rights identified on EXHIBIT A, Novavax and
its Affiliates have no interests, rights and/or titles of any kind or nature
whatsoever in any other issued patents and/or pending or abandoned patent
applications, domestic or foreign, which concern, refer to, describe, disclose
and/or claim one more Adjuvants, use of one or more Adjuvants and/or manufacture
of one or more Adjuvants or intermediates therefor, either alone or in
combination, and/or which concern or relate to the objectives of this License
and Supply Agreement;
(c) However, should Novavax, after the date of this License and Supply
Agreement (and during the term of this License and Supply Agreement), discover
that Novavax has omitted one or more patents or patent applications from the
Patent Rights as set forth on EXHIBIT A, the parties shall immediately amend
EXHIBIT A following such discovery to include such omitted patents and/or patent
applications;
(d) No other person, entity or third Party has any option, license,
sublicense or other right with respect to any Influenza Products or the Patent
Rights, as identified on EXHIBIT A, which concern, relate to, describe, disclose
and/or claim any Influenza Products; and
(e) Novavax and its Affiliates have disclosed to Parkedale all matters
of fact and known allegations which under the circumstances could materially
adversely impact, defeat and/or contradict the rights granted to Parkedale
pursuant to this License and Supply Agreement.
7.13 Rights. Novavax represents and warrants that it and its Affiliates
own or otherwise possess all rights in, to and under the Novavax IP that are
necessary to grant the rights and licenses to Parkedale pursuant to this License
and Supply Agreement.
7.14 Disclosure. Novavax represents and warrants that this License and
Supply Agreement, including the exhibits attached hereto, do not contain and
will not contain any untrue or materially misleading statement or fact, and do
not omit and will not omit to state a material statement or fact necessary in
order to make the statements made herein or therein, in light of the
circumstances under which they were made, not materially misleading.
7.15 Influenza Product Infringement. Novavax represents and warrants
that to the best of its and its Affiliates knowledge, the manufacture, use,
distribution, offer-for-sale, sale, importation or exportation of the influenza
Products do not and will not infringe upon or violate any patent, trademark,
copyright or other intellectual property right in the Territory.
7.16 Adjuvants. Novavax hereby represents and warrants that, during the
term of this License and Supply Agreement, it and its Affiliates shall not, and
it and its Affiliates shall cause their respective, licensees, sublicensees and
distributors and any person, third Party or entity to not, directly or
indirectly, market, license, sublicense, distribute, offer-for-sale or sell any
Adjuvant,
15
16
including the Novasome(R) delivery system, to anyone who will or intends to: (a)
use or cause to be used, directly or indirectly, such an Adjuvant with or in an
Influenza Product in the Territory; (b) market, license, sublicense, distribute,
offer-for-sale or sell, directly or indirectly, an Influenza Product in the
Territory; (c) cause to be marketed, licensed, sublicensed, distributed,
offered-for-sale or sold, directly or indirectly, an Influenza Product in the
Territory; (d) develop or manufacture or cause to be developed or manufactured,
directly or indirectly, an Influenza Product in the Territory or outside of the
Territory for importation into the Territory; or (e) import or export, directly
or indirectly, an Influenza Product into or from the Territory, respectively, or
cause an Influenza Product to be directly or indirectly imported into or
exported from the Territory.
7.17 Organization and Standing. Parkedale represents and warrants that
it is a corporation duly organized, validly existing and in good standing under
the laws of the State of Michigan.
7.18 Power and Authority. Parkedale represents and warrants that it has
all requisite corporate power and authority to execute, deliver, and perform
this License and Supply Agreement, and the other agreements and instruments to
be executed and delivered by it pursuant hereto and to consummate the
transactions contemplated herein and therein. The execution, delivery, and
performance of this License and Supply Agreement by Parkedale do not, and the
consummation of the transactions contemplated hereby will not, violate any
provision of Parkedale's articles of incorporation, by laws, any law or
regulation applicable to Parkedale, or any agreement, mortgage, lease,
instrument, order, judgment, or decree to which Parkedale is a Party or by which
Parkedale is bound.
7.19 Corporate Action: Binding Effect. Parkedale represents and
warrants that it has duly and properly taken all action required by law, its
articles of incorporation, its by laws, or otherwise, to authorize the
execution, delivery, and performance by it of this License and Supply Agreement
and the other instruments to be executed by it pursuant hereto and the
consummation of the transactions contemplated hereby and thereby. This License
and Supply Agreement has been duly executed and delivered by Parkedale and
constitutes, and the other instruments contemplated hereby when duly executed
and delivered by Parkedale will constitute, legal, valid, and binding
obligations of Parkedale enforceable against it in accordance with their
respective terms, except as enforcement may be affected by bankruptcy,
insolvency, or other similar laws and by general principles of equity.
7.20 Consents. Parkedale represents and warrants that no consent or
approval of, or filing with or notice to, any federal, state, or local
governmental or regulatory authority, agency, or department or any other person
not a Party to this License and Supply Agreement is required or necessary to be
obtained by Parkedale or on its behalf in connection with the execution,
delivery, and performance of this License and Supply Agreement or to consummate
the transactions contemplated hereby, except which have been obtained prior to
the execution of this License and Supply Agreement.
7.21 Influenza Products. Novavax represents and warrants that, during
the term of this License and Supply Agreement, it shall not, and Novavax shall
cause its Affiliates and any person, third Party or entity: (a) to not
manufacture, advertise, market, promote, license, sublicense, deliver,
16
17
introduce, distribute, offer-for-sale or sell or cause to be manufactured,
advertised, marketed, promoted, licensed, sublicensed, delivered, introduced,
distributed, offered-for-sale or sold, directly or indirectly, any Influenza
Product in the Territory; or (b) to import into or export from or cause to be
imported into or exported from, directly or indirectly, the Territory any
Influenza Product.
7.22 Adjuvants and Influenza Products. Novavax further represents and
warrants that, during the term of this License and Supply Agreement, it shall
cause any person, third Party or entity, which is acquired by, or which
acquires, Novavax or any of its Affiliates through a stock or asset purchase,
merger, consolidation or other transaction, or which merges with Novavax or any
of its Affiliates, whether through the formation of a new company or otherwise,
in each case, whether in a single transaction or a series of transactions, to
not develop, manufacture, market, license, sublicense, introduce, distribute,
offer-for-sale or sell, or cause to be developed, manufactured, marketed,
licensed, sublicensed, introduced, distributed, offered-for-sale or sold,
directly or indirectly, any Influenza Product in the Field within the Territory.
7.23 Competing Product. Novavax further represents and warrants that,
during the term of this License and Supply Agreement, if Novavax or any of its
Affiliates divest a product that competes with an Influenza Product during this
License and Supply Agreement, Parkedale shall have a right of first offer to
acquire such competing product. Novavax shall provide Parkedale with written
notice of its intention to divest such competitor product, including the
material terms upon which Parkedale may acquire such competitor product.
ARTICLE VIII
Infringement.
8.01 Claim. In the event of any claim, action or allegation by a third
Party asserting or involving a patent, copyright or trademark or any other
intellectual property right, which concerns (a) an Influenza Product, or (b) an
Influenza Product in which an Adjuvant, a Novasome(R) delivery system, Novavax's
Know-How, a Novavax Improvement, the Novavax IP and/or Patent Rights, or any
portion or aspect thereof, is utilized in connection therewith or incorporated
therein, Novavax will pay all damages, royalties and costs awarded in any such
action, and all attorney's fees and costs incurred by Parkedale in its defense
to any such allegation, claim, and/or action. Parkedale agrees to notify Novavax
promptly upon learning that the claim might be asserted. Novavax agrees that
Parkedale and Novavax shall have joint control over the defense of any
allegation, claim, and/or action and any negotiation for its settlement or
compromise, and Parkedale and Novavax shall have the right to jointly settle any
claim on behalf of Parkedale and Novavax. Any recovery from a third Party for an
infringement action regarding Influenza Product shall belong to Parkedale and
shall be subject to the royalty provisions of this Agreement. Both parties agree
to provide reasonable assistance in the defense of any such allegation, claim,
and/or action without the express authorization of the other Party hereto.
8.02 Indemnification. In the event a claim, action or allegation of
infringement or violation of any other intellectual property right is made
against the Novavax IP in connection with
17
18
its use with or in an Influenza Product or Parkedale's use thereof, or an
injunction or order shall be obtained against Parkedale's use of the Novavax IP,
or any portion or aspect thereof, by reason of any such claim, action or
allegation, Parkedale shall have the right, without in any way limiting the
foregoing, and at Novavax's expense, to (a) procure for Parkedale the right, to
continue using the Novavax IP; (b) replace or modify the Novavax IP so that it
becomes non-infringing, or (c) in the event (a) and (b) are not practical,
terminate the license, and this License and Supply Agreement shall terminate as
of the date upon which Parkedale first notified Novavax, or Novavax otherwise
obtained knowledge, of the existence of the applicable allegation, claim and/or
of infringement or violation. Novavax agrees to indemnify and hold Parkedale
harmless for all costs and damages incurred by Parkedale as a result of any such
allegation, claim, and/or action.
8.03 Non-Influenza Product Claim. In the event of any claim, action or
allegation by a third Party asserting or involving a patent, copyright or
trademark or any other intellectual property right, which solely concerns an
Adjuvant, a Novasome(R) delivery system, Novavax's Know-How, a Novavax
Improvement, the Novavax IP and/or Patent Rights, or any portion or aspect
thereof, which is outside of the Field and has no bearing on the development,
manufacture, use, offer-for-sale, sale, importation and/or exportation of an
Influenza Product of any kind whatsoever, Novavax will pay all damages,
royalties and costs awarded in any such action, and all attorney's fees and
costs incurred by Novavax in its defense to any such allegation, claim and/or
action. Novavax agrees to notify Parkedale promptly upon learning of any such
allegation, claim and/or action and that such allegation, the claim and/or
action might be asserted. Novavax agrees that it shall not adopt, advocate or
willingly accept any position that will in any frustrate or negatively impact
upon the terms and/or purpose of this License and Supply Agreement. Parkedale
agrees that Novavax shall have sole control over the defense of any such
allegation, claim and/or action and any negotiation for its settlement or
compromise, and Novavax shall have the right to settle any claim on behalf of
Novavax, so long as such settlement or compromise in no way frustrates or
negatively impact upon the terms and purpose of this License and Supply
Agreement. Parkedale agrees to provide Novavax with reasonable assistance, at
Novavax's expense, in the defense of any such allegation, claim, and/or action.
8.03 Notice of Third Party Infringement. If either Novavax or Parkedale
learns that the Novavax IP, or any portion or aspect thereof, is allegedly
infringed or contributorily infringed or misappropriated by a third Party, the
Party learning of the alleged infringement or contributory infringement shall
promptly notify the other Party. Within 30 days after learning of such
infringement or contributory infringement, the parties shall jointly determine
whether or not to bring an action against the alleged infringer or
misappropriator, and who shall bring such action.
8.04 Parkedale Action for Third Party Infringement. In the event that
Parkedale brings an action for infringement, contributory infringement,
misappropriation and/or violation of any other intellectual property right
concerning an Influenza Product or the Novavax IP, or any aspect or portion
thereof, in the name of Novavax and/or the name of Parkedale, Novavax shall
cooperate with Parkedale, and Parkedale will bear all costs and the expenses
relating to the litigation, including those incurred by Novavax. Parkedale shall
be entitled to keep all damages, royalties, legal fees, costs, and other
recoveries awarded in such litigation. Novavax agrees that Parkedale shall have
the
18
19
first right to prosecute any claims and/or actions concerning an Influenza
Product or the Novavax IP, or any portion or aspect thereof, which relates to,
concerns or results from its use with or in an Influenza Product.
8.05 Novavax Right to Prosecute Third Party Infringement. In the event
that Parkedale decides not to initially bring an action for infringement, for
contributory infringement, misappropriation and/or any other intellectual
property violation of the Novavax IP, then Novavax shall have the right, but not
the obligation, to bring an action in the name of Novavax and/or the name of
Parkedale. Parkedale will cooperate with Novavax at Novavax's expense. Novavax
shall bear all costs and expenses relating to the litigation, including those
incurred by Parkedale, and Novavax will be entitled to all damages and other
recoveries awarded in such litigation.
8.06 Novavax Right to Join Parkedale Prosecution of Third Party
Infringement. If, after Novavax fails to cause such infringement,
misappropriation or any other intellectual property right violation to terminate
or cease or to bring a suit or action to compel termination or cessation
pursuant to Paragraph 8.05 above, and Parkedale elects to initiate suit or
action to compel termination or cessation, Novavax independently shall have the
right to join any such suit or action brought by Parkedale and, in such event,
Novavax shall pay one-half of the cost of such suit or action from the date of
joining.
8.07 Recovery in a Third Party Infringement Action. Upon final
disposition of any event described in Paragraphs 8.05 or 8.06 above,
any recovery obtained shall be distributed as follows: (a) each Party shall be
reimbursed for any expenses incurred in the action; (b) as to ordinary damages,
Parkedale shall receive an amount equal to its lost profits or a reasonable
royalty on the infringing sales (whichever measure of damages the court shall
have applied), less a reasonable approximation of the royalties (I) that
Parkedale would have paid to Novavax if Parkedale had sold the infringing
products and services rather than the infringer, or (ii) of the reasonable
royalty on the infringing sales awarded to Parkedale (whichever measure of
damages the court shall have applied), which amount will be distributed to
Novavax; and (c) Parkedale shall receive 100% of any special, punitive or other
damages. Parkedale may offset any expenses incurred under this Article VIII
against any royalty payments due to Novavax.
8.08 Cooperation of Each Party in Third Party Infringement Action. In
any infringement, misappropriation and/or intellectual property violation suit
as either Party may institute to enforce the Patent Rights pursuant to this
License and Supply Agreement, the other Party hereto shall, at the request and
expense of the Party initiating such suit, cooperate in all respects and, to the
extent possible, have its employees testify when requested and make available
relevant records, papers, information, samples and the like.
19
20
ARTICLE IX
Term and Termination.
9.01 Term. The term of this License and Supply Agreement shall be the
period beginning on the date of execution by both parties to this License and
Supply Agreement, i.e., the Effective Date, and continuing for the period that
any portion or aspect of the Novavax IP is proprietary to Novavax, unless
earlier terminated under Paragraphs 9.02 and 9.03 below or otherwise,
and so long as this License and Supply Agreement provides Parkedale with
exclusivity with respect to the Influenza Product in the Territory (the "Term").
Thereafter, this License and Supply Agreement shall automatically be renewed for
successive 12-month periods (the "Renewal Periods"), unless either Party gives
notice of non-renewal to the other Party at least ninety (90) days before the
then-current expiration date. In the event that a generic product to an
Influenza Product is approved for use in the Field within the Territory, Novavax
agrees that the obligation for Parkedale to pay royalties pursuant to Article
III, Paragraph 3.03 above shall cease and terminate upon such immediate generic
approval.
9.02 Termination by Novavax. Novavax may terminate this License and
Supply Agreement upon ninety (90) days written notice to Parkedale, upon the
occurrence of any termination event as follows: (a) Parkedale or any of its
employees breaches any obligation under this License and Supply Agreement,
including without limitation violation of any payment terms, if such breach is
not cured within thirty (30) days after Novavax demands its cure in writing; or
(b) Parkedale becomes insolvent, enters into reorganization or bankruptcy, makes
a general assignment for the benefit of creditors, admits in writing its
inability to pay debts as they mature, suffers or permits the appointment of a
receiver for its business or assets, or avails itself of or becomes subject to
any other judicial or administrative proceeding related to insolvency or
protection of creditors' rights (and, if such action or proceeding is
involuntary on the part of Parkedale, such action or proceeding is not dismissed
within 90 days).
9.03 Termination by Parkedale. Parkedale may terminate this License and
Supply Agreement upon ninety (90) days written notice to Novavax, upon the
occurrence of any termination event as follows: (a) Novavax or any of its
employees breaches any obligation under this License and Supply Agreement,
including without limitation violation of any payment terms, if such breach is
not cured within thirty (30) days after Parkedale demands its cure in writing;
or (b) Novavax becomes insolvent, enters into reorganization or bankruptcy,
makes a general assignment for the benefit of creditors, admits in writing its
inability to pay debts as they mature, suffers or permits the appointment of a
receiver for its business or assets, or avails itself of or becomes subject to
any other judicial or administrative proceeding related to insolvency or
protection of creditors' rights (and, if such action or proceeding is
involuntary on the part of Novavax, such action or proceeding is not dismissed
within 90 days).
9.04 Effect of Termination. From and after the date of any expiration
or termination of this License and Supply Agreement, neither Party shall have
any further rights, privileges, or obligations hereunder except that: (a) such
expiration or termination shall not relieve either Party of any
20
21
liability or obligation accrued prior to the effective date of expiration or
termination; (b) such expiration or termination shall not affect the continued
operation or enforcement of any provision of this License and Supply Agreement
which is to survive expiration or termination; and (c) upon such expiration or
termination, each Party shall immediately return to the other Party all
Confidential Information as required by Article VI of this License and Supply
Agreement. In no event upon the expiration or termination of this License and
Supply Agreement shall the terminating Party (or in the case of expiration of
this License and Supply Agreement, any Party) be liable to the other Party for
any damages, indemnities, loss of profits, loss of revenues, or other losses by
reason of any such expiration or termination, unless the License and Supply
Agreement is wrongfully terminated.
ARTICLE X
Miscellaneous
10.01 Authority. Each Party represents and warrants to the other that
it has the right, and has obtained all necessary corporate approvals, to enter
into this License and Supply Agreement and perform the obligations to be
performed by it under this License and Supply Agreement and that this License
and Supply Agreement constitutes its valid, binding and enforceable obligation,
enforceable against it in accordance with its terms.
10.02 Force Majeure. The failure of either Party hereto to perform any
obligation under this License and Supply Agreement (except any payment
obligation hereunder of Parkedale to Novavax) due to acts of God, acts of
government, civil disturbances, wars, strikes, transportation problems,
unreasonable delay by vendors in delivery, failure to provide products or
materials by its vendors, or other causes beyond its reasonable control shall
not be deemed to be a breach of this License and Supply Agreement; provided,
however, that the Party so prevented from complying herewith shall immediately
give notice thereof to the other Party and shall continue to take all
commercially reasonable actions to comply as fully as possible herewith. After
removal of the basis for the nonperformance, the Party failing to perform shall
resume performance within a reasonable time.
10.03 Entire Agreement. This License and Supply Agreement, together
with its Exhibits, constitutes the sole and entire agreement between the parties
relating to the subject matter herein, and terminates and supersedes any and all
prior agreements and understandings between the parties.
10.04 Waiver and Amendment. No change in, addition to, or waiver of
any of the terms and provisions herein shall be binding upon any Party unless
approved by it in writing by both parties hereto.
10.05 No Waiver. The failure by any Party to exercise or to enforce any
of the terms or conditions of this License and Supply Agreement shall not
constitute or be deemed a waiver of that Party's right thereafter to enforce
each and every term and condition of this License and Supply Agreement.
21
22
10.06 Severability. Should a court of law or arbitrator hold that any
one or more of the provisions in this License and Supply Agreement is invalid,
illegal or unenforceable, no other provision of this License and Supply
Agreement shall be affected thereby, and the remaining provisions of this
License and Supply Agreement shall be both construed and reformed and shall
continue with the same effect as if such unenforceable, illegal or invalid
provision shall not have been inserted in this License and Supply Agreement.
10.07 Governing Law. This License and Supply Agreement and the
respective rights and obligations of the parties hereto shall be governed by and
determined in accordance with the domestic internal laws of the State of
Maryland, without giving effect to conflict of laws principles thereof.
10.07 Independent Parties. Novavax and Parkedale are independent
parties. It is understood and agreed that Novavax is not by this License and
Supply Agreement or anything herein contained, constituted or appointed the
legal representative or agent of Parkedale, nor shall Novavax have the right or
authority to make any representation, warranty, covenant, guarantee or
commitment or assume, create or incur any liability or any obligation of any
kind, expressed or implied, in the name of or otherwise on behalf of Parkedale,
whether directly or indirectly. It is understood and agreed that Parkedale is
not by this License and Supply Agreement or anything herein contained,
constituted or appointed the legal representative or agent of Novavax, nor shall
Parkedale have the right or authority to make any representation, warranty,
covenant, guarantee or commitment or assume, create or incur any liability or
any obligation of any kind, expressed or implied, in the name of or otherwise on
behalf of Novavax, whether directly or indirectly.
10.08 Notices. All notices and other communications which are required
or permitted under the terms or conditions of this License and Supply Agreement
shall be in writing and sent by overnight courier, or registered or certified
mail, postage prepaid, to the receiving Party at the following addresses:
If to Novavax: Novavax, Inc.
0000 Xxxxxxxx Xxxx
Xxxxxxxx, XX 00000
with a copy to: White & XxXxxxxxx, P.C.
00 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxx White, Esq.
If to Parkedale: Parkedale Pharmaceuticals, Inc.
22
23
000 Xxxxxxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: Corporate Counsel
with a copy to: King Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxx 00000
Attention: General Counsel
or to any other address that the receiving Party may have provided to the
sending Party in writing as provided aforesaid. Any notice or other
communication sent by overnight courier shall be deemed to have been received on
the business day after it is delivered to the courier. Any notice or other
communication sent by registered or certified mail shall be deemed to have been
received on the third business day after its date of posting.
10.09 Binding on Successors: Assignment. This License and Supply
Agreement and each and every covenant, term, and condition herein shall be
binding upon and inure to the benefit of both the parties hereto and their
respective successors. Neither this License and Supply Agreement nor any rights
hereunder may be assigned or otherwise transferred by either Party without first
receiving the express prior written consent of the other Party; except that
without such consent, either Party may assign or transfer this License and
Supply Agreement and all of its rights hereunder to any corporation which
beneficially owns a majority in interest of the equity of such Party or to a
majority-owned subsidiary of such Party or to any successor of such Party by
merger or consolidation or to any person, third Party or entity to which all or
substantially all of the assets of such Party are sold.
10.10 Counterparts. This License and Supply Agreement may be executed
in one or more counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument.
10.11 Survival. The provisions of Articles I, V, VI, VII, VIII, IX, and
X shall survive the expiration or termination of this License and Supply
Agreement.
23
24
IN WITNESS WHEREOF, Novavax and Parkedale have caused this License and
Supply Agreement to be executed by their duly authorized representatives as of
the date first set forth above.
NOVAVAX, INC.
By: [SIG]
--------------------------------------
Name: /s/ Xxxx Xxxxxx
--------------------------------------
Title: President & CEO
--------------------------------------
Dated: 10/21/99
--------------------------------------
PARKEDALE PHARMACEUTICALS, INC.
By: [SIG]
--------------------------------------
Name: Xxxxxxxxx X. Xxxxxxx
--------------------------------------
Title: President & CEO
--------------------------------------
Dated: October 21, 1999
--------------------------------------
24
25
EXHIBIT A
Novavax Novasome Patent Portfolio Relative to Adjuvants and Vaccines
Date of USA
USA Patent # Patent Title Issuance Expiration
in USA Date
---------------------------------------------------------------------------------------------------------
4,853,228 Method of Manufacturing Unilamellar Lipid Vesicles 08/01/89 07/28/07
4,855,090 Method of Producing High Aqueous Volume 08/08/89 03/13/07
Multi-lamellar Vesicles
4,895,452 Method and Apparatus for Producing Lipid Vesicles 01/23/90 03/03/08
4,911,928 Paucilamellar Lipid Vesicles 03/27/90 03/07/07
4,917,951 Lipid Vesicles Formed of Surfactants and Steroids 04/17/90 11/24/07
5,000,960 Protein Coupling to Lipid Vesicles 03/19/91 01/19/09
5,013,497 Method and Apparatus for Producing Lipid Vesicles 05/07/91
5,032,457 Paucilamellar Lipid Vesicles Using 07/16/91 07/16/06
Charge-Localized, Single-Chain, Nonphospholipid
Surfactants
5,104,736 Reinforced Paucilamellar Lipid Vesicles 04/14/92 06/26/09
5,147,723 Paucilamellar Lipid Vesicles 09/15/92 06/08/06
5,160,669 Method of Making Oil-Filled Paucilamellar Lipid 11/03/92 10/16/10
Vesicles
5,234,767 Hybrid Paucilamellar Lipid Vesicles 08/10/93 03/27/07
5,256,422 Lipid Vesicle Containing Water-In-Oil Emulsion 10/26/93 03/28/11
5,474,848 Paucilamellar Lipid Vesicles 12/12/95 03/13/07
5,561.62 Method of Inhibiting Viral Reproduction Using 10/01/96
Nonphospholipid Paucilamellar Liposomes
NVR 213CP Vaccines Containing Paucilamellar Lipid Vesicles
as Immunological Adjuvants *CIP
*Continuation in-part filing
25
26
EXHIBIT B
Countries Excluded from the Territory
Japan
Australia
Singapore
Indonesia
Malaysia
Thailand
26
27
EXHIBIT C
Nothing to Disclose
27
