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Exhibit
10.2
MANUFACTURING
AND DISTRIBUTION LICENSE AGREEMENT
THIS
AGREEMENT, effective
this 22nd day of April, 2005,
BETWEEN:
AlphaRx
International Holdings Limited , a
corporation incorporated under the laws of the British Virgin
Islands, and having its principal place of business at Unit A, 19/F
Sang Woo Building, Nos. 227-228, Gloucester Road, Causeway Bay Hong
Kong.
("Licensor")
- and
-
Alpha AP
Inc. , a
corporation incorporated under the laws of the British Virgin
Islands, and having its principal office c/o Advance Pharmaceutical
Co., Ltd., 2/F, 12 Dai Fu Street, Tai Po Industrial Estate, Tai Po,
New Territories, Hong Kong.
("Licensee")
WHEREAS:
A.
AlphaRx,
Inc. ("AlphaRx") is an emerging specialty pharmaceutical company
that develops, formulates and commercializes innovative therapeutic
products using proprietary drug delivery technologies, and in
particular is focused on the discovery, development and marketing
of products in pain management and inflammation
treatment;
B.
AlphaRx owns
and/or has rights to the Intellectual Property Rights (as defined
herein) relating to a pharmaceutical agent for pain management and
inflammation treatment;
C.
The Licensor
is a wholly-owned subsidiary of AlphaRx;
D.
Pursuant to
a license agreement between AlphaRx and the Licensor, AlphaRx has
granted the Licensor all the necessary rights to enable it to enter
into this Agreement, grant the licenses (including the rights to
the Intellectual Property Rights) and to perform all of its
obligations hereunder;
E.
The Licensee
is a joint venture between the Licensor and Basin Industrial
Limited, a wholly-owned subsidiary of Advance Pharmaceutical Co.,
Ltd., which is being established to specialize in the
manufacturing, distribution and commercialization of pharmaceutical
compounds in the Territory (as defined herein); and
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F. The
Licensee desires to obtain certain manufacturing and distribution
rights to the pharmaceutical agent for pain control and
inflammation treatment (the "Product" as defined herein) in the
Territory, and the Licensor desires to grant such manufacturing and
distribution rights to the Licensee, upon the terms and conditions
set forth herein.
NOW THEREFORE , in
consideration of the foregoing premises and the mutual covenants
herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the
Parties hereby agree as follows:
1.
RECITALS
1.1
The Parties hereby acknowledge and declare that the
foregoing recitals are true and accurate in substance and
fact.
2.
DEFINITIONS
Wherever used
in this Agreement, the following words and terms shall have the
respective meanings ascribed to them as follows:
2.1
"Accounting Period" means a three month period commencing on the
first day of the month and ending on the last day of the month,
with each successive Accounting Period to commence on the first
business day following the close of the preceding Accounting
Period. The Accounting Period will end on the last day of each
March, June, September and December during the term of this
Agreement and any subsequent renewals. The first accounting period
under this Agreement will be for a period commencing on the
Effective Date of this Agreement and concluding on June 30,
2005.
2.2
"Affiliate(s)" means with respect to any corporation, any other
corporation which directly or indirectly controls or is controlled
by or is under direct or indirect common control with such first
mentioned corporation or any corporation which is directly or
indirectly controlled by a corporation which controls the first
mentioned corporation;
2.3
"Agreement" means this Manufacturing and Distribution License
Agreement, and includes authorized amendments and
Schedules;
2.4
"Applicable Laws" means all laws, statutes, codes, ordinances,
decrees, rules, regulations, by-laws, any law, statute, code,
ordinance, decree, rule, regulation, by-law, statutory rules,
principles rule, principle of law, published policies policy and
guidelines guideline, judicial or arbitral or administrative or
ministerial or departmental or regulatory judgments, orders,
decisions, rulings or awards judgment, order, decision, or ruling,
including general principles of common and civil law, and terms and
conditions of any grant of approval, permission, authority or
license of any Governmental Entity, statutory body or
self-regulatory authority;
2.5 "Alpha
IPO" means the initial underwritten public offering of Alpha's
Shares on: (i) a recognized securities exchange in Hong Kong, or
(ii) a recognized securities exchange worldwide if agreed between
the Holders.
2.6 "Alpha
Liquidity Event" means either: (i) an Alpha IPO or (ii) an Alpha
Reverse Takeover;
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2.7 "Alpha
Reverse Takeover" means a reverse takeover whereby the Holders sell
all Shares in Alpha to a public company in exchange for shares of
the public company, such public company to be listed on: (a) a
recognized securities exchange in Hong Kong, or (b) a recognized
securities exchange worldwide if agreed between the
Holders.
2.8
"Confidential Information" means any and all information, in
whatever, form, that is not generally available to third parties or
the public including, without limiting the generality of the
foregoing, all research, data, specifications, plans, drawings,
prototypes, models, documents, recordings, instructions, manuals,
papers, business practices and strategies, business plans,
know-how, inventions, techniques, processes, methods of doing
business, software, personnel data, contracts, purchase
requirements, business plans, forecasts and market strategies,
plans production processes, product specifications and formulas,
methods, technical and product bulletins, data on equipment sold
and serviced, surveys, and research and development programs, or
other materials, of any nature or embodiment whatsoever, whether
written or otherwise, relating to same, as well as the existence of
this Agreement and its terms and conditions. Confidential
Information does not include any information which is publicly
available at the time of disclosure or subsequently becomes
publicly available through no fault of the recipient party, or is
rightfully acquired by the recipient party from a third party who
is not in breach of an agreement to keep such information
confidential;
2.9 "Control"
means with respect to any corporation, the ownership of securities
of the corporation to which are attached more than fifty per cent
of the votes that may be cast to elect directors of the corporation
and the votes attached to those securities are sufficient, if
exercised, to elect a majority of directors of the body
corporate;
2.10
"Contraindication" means any reaction to the Products by a person
that is not a side effect as specified or identified by the
Licensor;
2.11
"Countries" means each of the countries that collectively form the
Territory which countries are listed in Schedule "D" as such
Schedule may be amended from time to time on the mutual agreement
of the parties;
2.12
"Distribution Rights" means the right to use, store, package, sell,
offer for sale, market, advertise, promote or otherwise
commercially exploit the Products;
2.13
"Effective Date" shall mean the date first written
above;
2.14 "Field"
means the use of the Products in pain management and inflammation
treatment;
2.15 "GAAP"
means Generally Accepted Accounting Principles in the
Territory;
2.16
"Governmental Entity" means any (a) multinational, federal,
provincial, state, regional, municipal, local or other government,
governmental or public department, central bank, court,
administrative or regulatory board, agency or body, tribunal,
arbitral body, commission, board, bureau or agency, domestic or
foreign, (b) any subdivision, agent, commission, board, or
authority of or any of the foregoing, or (c) any quasi-governmental
or
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private body
exercising any regulatory, expropriation or taxing authority under
or for the account of any of the foregoing;
2.17 "Gross
Revenue" means the aggregate of all sales and other income from
whatever source derived by the Licensee in relation to Products
whether or not collected by the Licensee, including without
limitation all proceeds from business interruption insurance but
excluding all refunds and discounts made in good faith for Products
that are defective. The date of sale for the purposes of this
agreement shall be the date on which the revenue is recorded in
accordance with GAAP in the Territory;
2.18
"Intellectual Property Rights" means all rights, including common
law and equitable rights and all rights of priority in all patents
and designs, inventions, trade-marks, service-marks, copyrights,
industrial designs, trade names, logos, graphics, commercial
symbols, Confidential Information, Trade Secrets, and other
intellectual property rights, including but not limited to, any
pending applications and rights to file applications for any of the
aforementioned, whether registered or not, that are owned by or
licensed to Licensor or AlphaRx, including all pending applications
and rights to file applications, and any improvements and
discoveries in relation to formulations for topical delivery of
pharmaceutically active ingredients designed for pain management
and inflammation treatment; those applications and registrations
listed in Schedule "A" - Applications and Registrations for
Intellectual Property attached hereto;
2.19
"Manufacturing Rights" means the right to manufacture and produce
the Products and its components;
2.20 "Minimum
Annual Royalty" has the meaning given to such term in Article 6.2
hereof;
2.21 "Minimum
Gross Revenue" means the minimum Gross Revenue identified in
Schedule "C" attached hereto;
2.22 "Minimum
Performance Targets" means the Minimum Gross Revenue and the
Minimum Annual Royalty;
2.23
"Products" means the authorized products as listed in Schedule E
attached hereto, manufactured, purchased, marketed, sold or
otherwise used in association with the Intellectual Property Rights
pursuant to the formulations or product descriptions provided in
said Schedule, as may be amended from time to time at the sole
discretion of the Licensor;
2.24
"Registration Authority" means the appropriate Governmental Entity
in each Country in the Territory whose approval is required by the
Licensee in order for the Licensee to exercise the Distribution
Rights and/or Manufacturing Rights in such Country;
2.25
"Registration Information" means such information as is in the
possession of the Licensor as may be required by the Registration
Authority in each Country in the Territory in order for the
Licensee to obtain the required Regulatory Approvals to permit the
Licensee to exercise the Distribution Rights and/or Manufacturing
Rights in such Country;
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2.26
"Regulatory Approvals" means any and all approvals, consents or
licenses from the any Governmental Entity in the applicable Country
necessary to manufacture, produce, warehouse, store, package, sell,
offer for sale, market, advertise, promote, and otherwise
commercially exploit the Products in the that Country;
2.27
"Regulatory Documents" means, with respect to the Products, all
regulatory documents, materials or other information required by
the applicable Governmental Entity in the applicable Country for
the necessary Regulatory Approvals in the applicable Country
including: (i) new drug applications; (ii) market and reimbursement
approvals; (iii) product labels; and (iv) product
inserts;
2.28
"Reporting Period" means a monthly period commencing on the first
day of the month and ending on the last day of the month, with each
successive Reporting Period to commence on the first business day
following the close of the preceding Reporting Period;
2.29
"Royalty" has the meaning given to such term in Article 6.1
hereof;
2.30
"Schedules" mean schedules annexed and forming part of this
Agreement, as amended from time to time and comprise the
following:
2.30.1
Schedule "A" - Applications and Registrations for Intellectual
Property;
2.30.2
Schedule "B" - Standards of Quality;
2.30.3
Schedule "C" - Minimum Performance Targets; and
2.30.4
Schedule "D" - List of Countries that comprise the
Territory;
2.30.5
Schedule "E" - List of Products
2.31
"Standards of Quality" shall mean the standards specified by the
Licensor and communicated to the Licensee from time to time as
listed in Schedule B to this Agreement as may be amended from time
to time at the sole discretion of the Licensor;
2.32 "Term"
means the Term of this Agreement and any Renewal Terms;
2.33
"Territory" means the geographic area comprised of the
Countries;
2.34
"Trade-marks" means the all common law rights and registrations,
pending applications for registrations and rights to file
applications for trade-marks, including all rights of priority to
trade names, designs, graphics, logos and other commercial symbols
whether registered or not by the Licensor and which are used in
connection with or in association with the Products identified in a
Schedule to this Agreement;
2.35 "Trade
Secrets" shall mean written information, including formulae,
patterns, compilations, programs, devices, methods, know-how,
techniques, process or business information that derives
independent economic value, actual or potential, from not being
generally known to, and not being readily ascertainable by proper
means by, other persons who can obtain economic value from its
disclosure or use, and is the subject of efforts that are
reasonable
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under the
circumstances to maintain its secrecy. However, such disclosure
shall not be considered "Trade Secrets" for the purposes of this
Agreement if and when it:
i)
is made subject to an order by judicial or
administrative process requiring the recipient to disclose any or
all of the Trade Secrets, provided however that the recipient shall
promptly notify the provider and allow the provider reasonable time
to oppose such process before disclosing any of the Trade
Secrets;
ii)
is published or becomes available to the general
public other than through a breach of this Agreement;
iii)
is obtained by the recipient from a third party with a valid right
to disclose it, provided that said third party is not under a
confidentiality obligation to the provider;
iv) is
independently developed by employees, agents or consultants of the
recipient who had no knowledge of or access to the provider's Trade
Secrets as evidenced by the recipient's business records;
or
v) was
possessed by the recipient prior to receipt from the provider,
other than through prior disclosure by the provider, as evidenced
by the recipient's business records;
2.36
"Transfer" means any event pursuant to which rights or obligations
of the affected party under this Agreement are or are attempted to
be sold, disposed of, assigned, pledged, hypothecated, charged,
mortgaged, encumbered, sublicensed or transferred and includes any
transfer by operation of law; and
2.37
"Translated Documents" has the meaning given to such term in
Article 16.1.1 hereof.
3.
GRANT AND TERM
3.1 Subject
to the terms of this Agreement, the Licensor hereby grants to the
Licensee exclusive and non-transferable Manufacturing Rights and
Distribution Rights for the Products and to use the Intellectual
Property Rights in each Country in the Territory for the duration
of the Term to the extent required to practice the exclusive rights
granted herein to the Products, provided such Products conform to
the Standards of Quality defined in the Agreement.
3.2 The grant
of this license by the Licensor is conditional upon the occurrence
of all of the following events:
3.2.1 The
Licensee shall have filed all Regulatory Documents and obtained all
Regulatory Approvals, and any other approvals, consents or licenses
required under Applicable Laws, for the commercial exploitation of
the Products in the applicable Country in the Territory in
accordance with this Agreement;
3.2.2 The
Licensee shall have notified the Licensor in writing, with evidence
satisfactory to the Licensor, in its sole discretion, that the
Licensee has met all of the conditions;
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3.2.3
The Licensor
shall have provided written confirmation to the Licensee that it
accepts that the Licensee has fulfilled its obligations set out in
this Article 3.2.
3.3
The Licensee
shall not manufacture, market, sell or otherwise commercially
exploit or permit to be commercially exploited the Products, either
directly or indirectly outside the Territory granted under this
Agreement.
3.4
This
Agreement shall be for an initial term of Five (5) years commencing
on the Effective Date, and it shall automatically be renewed on
terms as provided in this Agreement.
3.5
This
Agreement will be automatically renewed for additional terms of
[One/Two] (1/2) years each unless:
3.5.1
The Licensee
shall have given to the Licensor at least six (6) months prior
written notice of its election not to renew this
Agreement;
3.5.2
The Licensor
shall have given to the Licensee at least six (6) months prior
written notice of its election not to renew this Agreement;
or
3.5.3
The
Agreement is otherwise terminated pursuant to Article 12
herein.
4.
USE OF THE
INTELLECTUAL PROPERTY BY LICENSEE
4.1
The Licensee
shall take all necessary steps and use its best efforts to
diligently, market, promote, sell and commercialize the Products
under this Agreement within the Territory.
4.2
The Products
shall be commercialized in accordance with or exceed the Standards
of Quality and specifications listed by the Licensor in the
Schedule to this Agreement and applicable laws.
4.3
The Licensee
understands and agrees that:
4.3.1
As between
the Licensor and the Licensee, the Licensor is the exclusive owner
of the Intellectual Property Rights and all goodwill associated
therewith;
4.3.2
Any
unauthorized use of the Intellectual Property Rights is and shall
be deemed an infringement of the Licensor's rights;
4.3.3
Except as
expressly provided in this Agreement, the Licensee acquires no
right, title or interest in the Intellectual Property
Rights;
4.3.4
The Licensee
shall use the Intellectual Property Rights only in connection with
the authorized Products;
4.3.5
The Licensee
shall ensure that all materials bearing the Trade-marks will
properly identify the ownership of the Trade-marks and that the
Trade-mark use by the Licensee is a licensed use, in the form as
provided by the Licensor from time to time;
4.3.6
The Licensee
shall comply with any and all other marking provisions reasonably
designated by Licensor from time to time and as prescribed by
Applicable Laws;
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4.3.7 The
Licensee shall, throughout the Term, meet the requirements of all
Applicable Laws and obtain the permits necessary to perform its
obligations under this Agreement.
4.4 The
Licensee understands and agrees that it shall not:
4.4.1 in any
manner represent that it has any ownership interest in the
Intellectual Property Rights or applications or registration
therefore;
4.4.2 reverse
engineer, or permit its Affiliates or any person to reverse
engineer, the Products;
4.4.3 itself
use, store, sell, offer for sale, market, advertise, promote or
otherwise commercially exploit the Products outside of the Field or
Territory, or otherwise permit any Affiliate or third party to use,
store, sell, offer for sale, market, advertise, promote or
otherwise commercially exploit the Product outside of the Field or
Territory;
4.4.4 retain
any person to exercise any of its rights or obligations under this
Agreement without the prior written consent of the Licensor. Where
the Licensor provides its prior written consent to the Licensee to
subcontract any of its rights or obligations under this Agreement,
the Licensee shall ensure that any permitted subcontractor abides
by all of the provisions of this Agreement as they apply to the
Licensee, including the obligations relating to confidentiality of
information, regulatory approval and reporting of and
Contraindications. Any breach of this Agreement by any
subcontractor will be deemed to be a breach by the
Licensee;
4.4.5
warehouse, store, sell, offer for sale, market, promote or
commercially exploit any Products without first satisfying all of
the requirements of Article 3.2;
4.4.6 alter
the Trade-marks in any manner;
4.4.7 use any
other trade-mark or any trade name or product name or any other
means of designation or commercial identification in connection
with the Products without the express written consent of the
Licensor;
4.4.8 without
the prior written consent of the Licensor, use any word or symbol
or combination thereof which is not a trade-mark in close
association with the Trademarks or any other trade-mark or
business, trade, corporate, partnership or other name or symbol
such that the use thereof would be likely to result in a loss of
distinctiveness or goodwill of the Trade-marks;
4.4.9 use or
advertise the Trade-marks in association with any products other
than the Products or use in any manner any trade mark confusing
with or similar to the Trademarks in association with the Products
or in association with any other wares or services;
4.4.10
without the prior written consent of the Licensor, use any of the
Trade-marks as a verb or in the plural or in any manner that
results in the Trade-marks being incorrectly spelled and/or
depicted;
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4.4.11 use
the Trade-marks as part of its corporate or other business or trade
name and agrees to use, promote and advertise the Products under
the Trade-marks without any prefix, suffix or modifying words,
terms, designs or symbols, unless authorized in writing by
Licensor;
4.4.12 use
the Trade-marks in signing any contract, cheque, purchase
agreement, negotiable instrument or other legal document,
application for any license or permit, or in any manner that may
incur liability of Licensor for any debt or obligation of the
Licensee;
4.4.13 create
any derivative product(s) which could likely compete with the
Products in the opinion of the Licensor.
4.5 The
Licensee shall not sell the Products to any person who might in
turn sell the Products outside the Territory. If there are any
sales of the Products outside the Territory, the Licensee shall
immediately cease such sales and be responsible and accountable any
such sales to the Licensor.
5.
INSPECTION AND QUALITY STANDARDS
5.1 The
Licensee acknowledges the Licensor's right to exercise control over
the character and quality of the wares and services sold by the
Licensee under the Trade-marks.
5.2 The
Licensee shall at all reasonable times permit the Licensor or its
authorized representative, to inspect the premises of the Licensee
where the Products are manufactured, stored, performed or sold to
determine whether the Licensee is maintaining the Licensor's
Standards of Quality.
5.3 The
Licensee shall supply to the Licensor from time to time, upon
request, representative current sample products and packaging of
all use of the Trade-marks and other Intellectual Property
Rights.
5.4 The
Licensee agrees to submit to the Licensor, if requested by the
Licensor for reasonable inspection and testing, samples of every
type of the Products and to withdraw from the course of
manufacture, trade and from the market any Products or items that
do not comply with the Standards of Quality as determined by the
Licensor.
6.
ROYALTIES AND OTHER PAYMENTS
6.1 In
consideration of the ongoing rights, licenses and privileges
granted under this Agreement and subject to the provisions of
Article 6.3 and 6.4, the Licensee shall pay to the Licensor: (a) a
one-time license fee of United States Dollars Ten Million
(US$10,000,000.00) on the Effective Date; and (ii) within thirty
(30) days after the last day of each Accounting Period a royalty of
Five Percent (5% ) of the Minimum Gross Revenue (the
"Royalty") for such Accounting Period.
6.2 The
Minimum Annual Royalty payable by the Licensee to the Licensor
shall be as stated in Schedule "C" to this Agreement.
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6.3 The
Royalty payable within thirty (30) days after the last day of each
Accounting Period by the Licensee to the Licensor under Article 6.1
shall be the greater of:
6.3.1 the
Royalty; or
6.3.2 One
quarter (1/4) of the Minimum Annual Royalty.
6.4
Notwithstanding Article 6.1, the Licensee shall not be required to
pay the lump-sum amount set out in clause 6.1 until the occurrence
of an Alpha Liquidity Event. The Licensee shall pay the Licensor
this amount in the manner directed by the Licensor within ten (10)
days of the Alpha Liquidity Event.
7.
RECORDS AND REPORTS
7.1 The
Licensee shall keep complete and accurate books and records with
respect to the Products and in particular in relation to the
purchasing, marketing, selling and commercializing efforts in
relation to the Products. The Licensee shall grant the Licensor and
its authorized representative reasonable access during business
hours to inspect and audit such portions of such books and records
and make copies thereof. The Licensee shall also permit the
Licensor and its representative to inspect its premises and the
Products and obtain any necessary samples during business hours.
The Licensee shall keep and preserve the accounts and records
referred to in this Agreement for the duration of this Agreement
and its renewals and for a period of six (6) years
thereafter.
7.2 The
Licensee shall keep separate records in sufficient detail to permit
the determination of Royalties payable hereunder. At the request of
the Licensor, the Licensee shall permit independent auditors or
technical consultants selected by the Licensor to examine, during
ordinary business hours, up to a maximum of four (4) times in each
calendar year such records and other documents as may be necessary
to verify or determine the Gross Revenue and Royalties paid or
payable under this Agreement.
7.3 The fees
and expenses of the Licensor's representatives performing any
examination of records under this Agreement shall be borne by the
Licensor. However, if an error or variance in Royalties of more
than ten percent (10.0%) of the total Royalties due is discovered
for any year examined, then the total fees and expenses of these
representatives shall be borne by the Licensee.
7.4 The
Licensee shall submit to the Licensor within thirty (30) days of
each Reporting Period a complete and accurate statement of account
detailing the Gross Revenue within that Reporting Period. All such
statements shall include a calculation of the amount due to the
Licensor for Royalties and be certified as accurate by an officer
of the Licensee.
7.5 The
Royalty payable by the Licensee to the Licensor shall be payable in
United States dollars within thirty (30) days after the last day of
each Accounting Period to the Financial Institution specified by
the Licensor. The Licensee shall also provide a complete and
accurate statement of account detailing the Gross Revenue within
that Accounting Period. All such statements shall include a
calculation of the amount due to the Licensor for Royalties and be
certified as accurate by an officer of the Licensee.
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7.6 If the
Licensee sells the Products to an Affiliate who sells or re-sells
the Products to the consumer at a higher price, the Gross Revenue
shall be based on the greater of the prices charged between the
prices charged to the Affiliate and the process charged by the
Affiliate to the ultimate consumer.
7.7 The
statement of account required for the Reporting Period and the
Accounting Period shall include the following
information:
7.7.1 the
quantity of each item for the Products manufactured and distributed
upon which Royalty has accrued;
7.7.2
identification of the Royalty basis used under Article 6.3 for the
Products;
7.7.3 the
Gross Revenue, the amount of Royalties due for each of the Products
type, all information required to show how such amount has been
calculated, and the aggregate amount of all Royalties due;
and
7.7.4 in the
event no Royalties are due, the Licensee's report shall so
state.
7.8 All
Royalties for the Accounting Period computed on invoiced amounts in
currencies other than United States dollars shall be converted
directly into United States dollars, without intermediate
conversions to another currency, at the Telegraphic Transfer
Selling (TTS) rate quoted by either the edition of the Wall Street
Journal or the head office of Citibank
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