EXHIBIT 10.23
AGREEMENT FOR PURCHASE AND SALE
OF RIGHTS FOR PRODUCTS
This Agreement (this "AGREEMENT") is made effective as of April 29, 2006
(the "EFFECTIVE DATE"), between XXXXXX XXXX XXXX ("Seller") and BRIDGETECH
HOLDINGS INTERNATIONAL, INC., a Delaware corporation (together with its
Affiliates, "BRIDGETECH").
RECITALS
A. Seller has developed the Subject Products (as defined below), and Seller
is the sole owner of all the rights relating to the Subject Products in the
Territory (as defined below), including all related Seller Intellectual Property
(as defined below).
B. Bridgetech wishes to obtain and purchase from Seller, and Seller is
willing to sell to Bridgetech, all rights to the Subject Products in the
Territory, all on the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises, the mutual covenants made
herein, and other good and valuable consideration, the receipt and adequacy of
which are hereby acknowledged, the parties hereto agree as follows:
ARTICLE 1. DEFINITIONS
Capitalized terms used herein and not otherwise defined herein shall have
the meaning set forth below.
1.1 "AFFILIATE" shall mean, in respect of any business entity and a
commercially identifiable line of business, that entity and any
business entity directly or indirectly controlling, controlled by or
under common control with that entity. For purposes of this
definition, "CONTROL" shall mean (a) holding a 20% or greater voting
interest, or (b) that the affairs of the one entity in carrying on
such line of business are conducted in accordance with the wishes of
the other entity as the result of the holding of voting capital stock,
voting partnership shares or other similar ownership medium or through
contractual relationships. Each reference to a party herein shall be
deemed to include such party and its Affiliates.
1.2 "FDA" shall mean the United States Food and Drug Administration or any
United States successor agency having the administrative authority to
regulate the approval for testing or marketing of human
pharmaceutical, biological, medical or medical device products.
1.3 "FIRST COMMERCIAL SALE" shall mean the first sale by Bridgetech or its
Affiliates of a Subject Product to a third party in a bona fide arm's
length transaction, but shall not include and shall not be construed
to mean use of a Subject Product by
Bridgetech or its Affiliate for its own internal purposes or in
conjunction with third parties for purposes of evaluating, testing,
and/or test-marketing such Subject Product.
1.4 "FORCE MAJEURE" shall have the meaning set forth in Section 10.11
hereof.
1.5 "GAAP" shall mean United States generally accepted accounting
principles.
1.6 "INTELLECTUAL PROPERTY" shall mean inventions, discoveries, Patents,
Know-How, trade secrets, copyrights and similar rights of any type
under the laws of any governmental authority, domestic or foreign,
including all applications and registrations relating to any of the
foregoing.
1.7 "KNOW-HOW" shall mean all knowledge, ideas, inventions, data,
instructions, tangible or intangible materials, processes, formulas,
expert opinions and information, including without limitation,
pharmaceutical, biological, chemical, analytical, clinical,
manufacturing and quality control data and information, materials,
methods, processes, techniques, and technical and non-technical data
and information, and the results of tests, assays, methods and
processes, and plans, specifications and other documents containing
said information and data.
1.8 "NET SALES" shall mean, in relation to any Subject Product and with
respect to the relevant period, the gross amount invoiced on sales of
such Subject Product by Bridgetech or its Affiliates in arm's length
transactions involving such Subject Product, less the following:
(a) customary trade, quantity, or cash discounts, and non-affiliated
brokers' or agents' commissions, to the extent actually allowed
and taken as a reduction from the amount billed;
(b) amounts repaid or credited by reason of rejection or return and
taken as a reduction of the amount billed;
(c) to the extent separately stated on purchase orders, invoices, or
other documents of sale and included in the gross amount billed,
any taxes or other governmental charges levied on the production,
sale, transportation, delivery, or use of a Subject Product which
is paid by or on behalf of Bridgetech or its Affiliates; and
(d) outbound transportation costs prepaid or allowed and costs of
insurance in transit, but only to the extent separately stated on
purchase orders, invoices, or other documents of sale and
included in the gross amount billed.
In the event of a sale of any Subject Product by Bridgetech to an
Affiliate of Bridgetech, and the subsequent resale of such Subject
Product by such Affiliate, Net Sales shall be computed on the basis of
such subsequent resale.
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In the event that any Subject Product is sold as a component of
another product, "NET SALES" shall mean the portion of such other
product's invoice price that is allocable to the Subject Product based
on the customary price of the Subject Product when sold separately or,
in the absence of such customary price, on the ratio of the cost of
the Subject Product to the total cost of such other product.
1.9 "SELLER INTELLECTUAL PROPERTY" shall mean all Intellectual Property
that Seller owns or has the right to license during the term of this
Agreement applicable to the Subject Products in the Territory.
1.10 "PATENTS" shall mean (i) all patents applicable in the Territory,
including without limitation, all substitutions, reissues, renewals,
reexaminations, patents of addition, and inventor's certificates
thereof; (ii) all term extensions or other government action which
provides exclusive rights to an invention beyond the original patent
expiration date; and (iii) all pending patent applications (including
provisional applications, divisions, continuations, continued
prosecutions and continuations-in-part).
1.11 "REGULATORY AUTHORITY" shall mean the FDA and any similar regulatory
agency or authority in any country or geographic region in the
Territory.
1.12 "SPECIFICATIONS" shall mean all the written specifications, standards,
analytical methods and criteria for each Subject Product as mutually
agreed upon by the parties from time to time, and any supplement or
amendment thereto required by any Regulatory Authority.
1.13 "TECHNICAL FILE" shall mean all information relating to a Subject
Product and including the quality specifications and analyses, the
description of the manufacturing process, the description of the
production facilities and organization, and the packaging of the
Subject Product, as mutually agreed upon by the parties from time to
time, as necessary to support Bridgetech's efforts to receive
regulatory approval for said Subject Product.
1.14 "TERRITORY" shall mean the People's Republic of China, Hong Kong,
Macau, and Taiwan.
1.15 "SUBJECT PRODUCTS" shall mean the four Subject Products outlined in
Appendix A.
ARTICLE 2. PURCHASE AND SALE OF RIGHTS TO PRODUCTS
In consideration of the payments specified in Article 3, Seller hereby
sells and transfers to Bridgetech, and Bridgetech hereby purchases and acquires
from Seller, all of the rights applicable to the Products as follows:
2.1 LICENSE RIGHTS. Seller grants to Bridgetech the exclusive license
under the Seller Intellectual Property, to develop, modify, enhance,
improve, make, have made,
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use, import, offer for sale, sell, and have sold Subject Products
solely in the Territory.
2.2 Commercialization. Seller grants to Bridgetech the exclusive right to
commercialize, distribute and sell the Subject Products in the
Territory.
2.3 No Sublease Rights. Bridgetech is not entitled to grant any
sublicenses to third parties (other than Affiliates) to practice the
Seller Intellectual Property. However, Bridgetech is entitled (i) to
hire contract manufacturers to produce the Subject Products for the
account of Bridgetech, and (ii) to appoint independent distributors to
market and sell the Subject Products which are supplied by Bridgetech.
2.4 Outside Territory. For avoidance of doubt, Bridgetech shall have no
rights to make, use or sell Subject Products outside the Territory, or
to sell Subject Products for others to sell or use outside the
Territory.
ARTICLE 3. PAYMENTS
3.1 INSTALLMENT PAYMENTS. Bridgetech agrees to pay to Seller the following
installment purchase payments:
(a) An Initial Cash Payment of $500,000 on the Effective Date of this
Agreement.
(b) A payment of $1,000,000, twelve months after the Effective Date
of this Agreement. This payment can be either $1,000,000 in cash
or 335,000 shares of Bridgetech common stock, at the sole
discretion of the Seller.
(c) Cash payment of $250,000 within 30 days after first regulatory
approval for conducting a human clinical trial is obtained in the
Territory for the first Subject Product, but not later than June
2007.
(d) Cash payment of $250,000 within 30 days after first regulatory
approval for conducting a human clinical trial is obtained in the
Territory for the second Subject Product, but not later than
March 2007.
(e) Cash payment of $250,000 within 30 days after first regulatory
approval for conducting a human clinical trial is obtained in the
Territory for the third Subject Product, but not later than March
2008.
(f) Cash payment of $250,000 within 30 days after first regulatory
approval for conducting a human clinical trial is obtained in the
Territory for the fourth Subject Product, but not later than
March 2010.
3.2 ROYALTY. Bridgetech agrees to pay to Seller a royalty equal to four
percent (4%) of Net Sales of Subject Products sold by Bridgetech or
its Affiliates.
3.3 REPORTS.
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(a) As of each June 1 and December 1 (commencing with December 2006),
Bridgetech shall provide to Seller a written report as to the
status, progress, and plans for completing development of each of
the four Subject Products, and for becoming ready to file for
regulatory approval for conducting clinical trials.
(b) Once the First Commercial Sale has occurred, Bridgetech shall
provide to Seller, within 30 days following the end of each
calendar quarter, reports of all Net Sales of Subject Products,
together with payment of all royalties due thereon under Section
3.2, together with all information reasonably necessary to
support the calculation of such royalties.
(c) Seller shall provide Bridgetech with updates on a monthly basis
as to the completion status of Subject Products 2, 3 and 4.
3.4 AUDITS. Upon not less than 10 business days written notice from
Seller, from time to time Bridgetech shall allow Seller or its agent
to inspect and copy the records and books of account of Bridgetech,
during reasonable business hours, on reasonable advance notice, but in
any not more than once per year. In the event of underpayment by
Bridgetech under Section 3.2, Bridgetech shall promptly pay Seller all
amounts underpaid, together with interest due on such underpaid
amounts at an interest rate equal to the then existing prime lending
rate as published in The Wall Street Journal, or if less, the maximum
interest rate permitted under applicable law, from the payment due
date until the actual date of payment. The cost of such audit shall be
borne by Seller, unless such audit reveals a discrepancy of greater
than ten percent (10%) of the total amount determined to be actually
due, in which case Bridgetech shall bear such cost.
3.5 COMPLETION. Bridgetech will enter into a contract with Seller to
perform specified research and development work necessary for the
preparation of the initial regulatory filings in the Territory. The
second, third and fourth Subject Products shall be made into such a
state of completion as the first Subject Product was at the Effective
Date. The total cost to be borne by Bridgetech for this work as
outlined in Appendix B is not to exceed $150,000.00
3.6 LATE PAYMENTS. If any required payment is not paid when due, it shall
bear a late payment interest charge of twelve percent (12%) per annum
until paid in full.
ARTICLE 4. ANCILLARY AGREEMENTS
4.1 BRIDGETECH DILIGENCE. Bridgetech shall use commercially reasonable and
diligent efforts to develop, obtain regulatory approvals for,
commercialize, market and sell the four Subject Products, in the
Territory, as soon as is reasonably feasible.
4.2 RIGHT OF FIRST REFUSAL. If Seller acquires rights to a new oncology
product, and if Seller decides to sell or license the rights to
commercialize such new oncology product in the Territory to a third
party, then Seller will give a written notice to Bridgetech of the
terms which Seller proposes to accept from a third party (the "Terms
Notice"). Seller agrees to give Bridgetech a 30-day first right of
refusal
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for Bridgetech to purchase rights in the Territory to such new product
pursuant to the Terms Notice. All rights under this Section 4.2 will
terminate on the first anniversary of the Effective Date, unless the
parties mutually agree to a renewal and specified payments from
Bridgetech for any such renewal. This Article 4 will not be applicable
if Bridgetech is in default of any of its obligations under this
Agreement.
4.3 PATENT MATTERS. The parties acknowledge and agree that Seller shall
remain as the owner of all of the Seller Intellectual Property
(including the Patent Rights), and that Bridgetech is acquiring by
this Agreement an exclusive right to use such Seller Intellectual
Property for the Subject Products in the Territory. Bridgetech will be
responsible for prosecuting, maintaining and managing the Patent
Rights in the Territory, in consultation with Seller and Seller's
selected patent agent. Bridgetech will give due consideration to any
requests or recommendations from Seller concerning the Patent Rights.
Bridgetech will keep Seller informed of all material matters
concerning the prosecution and maintenance of the Patent Rights in the
Territory. Bridgetech will pay all expenses incurred after the
Effective Date for the prosecution and maintenance of the Patent
Rights in the Territory, such as patent attorneys' fees, and fees
payable to governmental patent agencies.
4.4 REGISTRATION. If any country in the Territory requires that this
Agreement be registered, Bridgetech shall be responsible for affecting
such registration.
4.5 To the extent that Seller received any FDA documentation applicable to
the Subject Products (such as applications, clinical trial protocols,
and outcomes), subject to satisfying any confidentiality obligations
applicable to such documentation, Seller will furnish copies of such
documentation to Bridgetech, for Bridgetech to use to support its
regulatory filings in the Territory.
ARTICLE 5. REGULATORY MATTERS
5.1 REGULATORY APPROVALS. Bridgetech shall be responsible for obtaining,
at its expense, such approvals from Regulatory Authorities as
Bridgetech deems necessary or advisable for the manufacture, use and
sale of Subject Products that Bridgetech desires to make, have made,
use, import, offer for sale, sell, or have sold in the Territory.
Seller agrees that each Technical File may be used by Bridgetech and
its customers for filings with all Regulatory Authorities.
5.2 RECORDS. Bridgetech shall maintain, and shall cause its Affiliates,
contract manufacturers and other agents to maintain, all records
necessary to comply with all applicable laws relating to the
manufacture, filling, packaging, storage and shipment of Subject
Products. Bridgetech shall keep and maintain complete and accurate
records and books of account in sufficient detail and form so as to
enable verification of prices or royalties or other amounts due
pursuant to this Agreement, including Bridgetech's Net Sales.
Bridgetech shall maintain such records and books of account for the
period required by applicable laws, but in
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any event for a period of at least three years following the year to
which the records pertain.
5.3 ADVERSE EVENT REPORTING. During the term of this Agreement and for one
year thereafter (or as required by applicable laws), each party shall
(i) provide prompt written notice to the other party of information in
or coming into its possession or control concerning side effects,
injury, toxicity or sensitivity reaction ("Adverse Events") associated
with uses, studies, investigations or tests of any Subject Product,
whether or not determined to be attributable to such Subject Product,
(ii) notify the other party's responsible drug safety department by
telephone and facsimile within 72 hours after such party first becomes
aware of any Adverse Event that gives cause for concern or is
unexpected or that is fatal, life-threatening (as it occurred),
permanently disabling, requires (or prolongs) inpatient
hospitalization, represents a significant hazard, or is a cancer or a
congenital anomaly or represents an overdose, or any other
circumstance that might necessitate a recall, expedited notification
of the FDA or any other relevant Regulatory Authorities or a
significant change in the label of such Subject Product.
5.4 CUSTOMER COMPLAINTS. Bridgetech shall maintain customer complaint
files. Each party will cooperate reasonably with the other parties in
connection with a party's investigation of an Adverse Event.
5.5 MATERIAL COMMUNICATIONS; GOVERNMENT INSPECTIONS. Each party shall
provide the other party, within 30 days of receipt, of copies of all
communications to or from any Regulatory Authority regarding any
Subject Product or the facilities, procedures or processes used in
connection with such Subject Product (including without limitation
Adverse Event reports, 483's and safety reports). The foregoing
notification obligation shall be 24 hours, if a Regulatory Authority
is commencing or threatening seizure of such Subject Product. Each
party shall have the right to consult with the other party on such
other party's responses to a Regulatory Authority.
5.6 NOTIFICATIONS AND RECALL. Each party shall notify the other parties as
soon as possible of any recall known to such party, threatened or
pending, of any Subject Product.
ARTICLE 6. CONFIDENTIAL INFORMATION
6.1 CONFIDENTIALITY. Except as otherwise provided in this Agreement, the
parties agree that, for the term of this Agreement and for five years
thereafter, all non-public, proprietary or confidential disclosures,
of any nature whatsoever, (collectively, "Confidential Information"),
disclosed or submitted, either orally or in writing (including without
limitation by electronic means) or through observation, by one party
(the "Disclosing Party") to the other party (the "Receiving Party")
hereunder shall be received and maintained by the Receiving Party in
strict confidence, shall not be used for any purpose other than the
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purposes expressly permitted by this Agreement and shall not be
disclosed to any third party other than the Receiving Party's
directors, officers, employees, agents, consultants and
representatives that have a need to know such Confidential Information
to achieve the purposes of this Agreement, provided that such party
shall ensure that it and its recipients to whom disclosure is to be
made are bound by, and take commercially reasonable efforts to ensure
compliance with, the confidentiality terms hereof. Each party will
promptly notify the other upon discovery of any unauthorized use or
disclosure of the Confidential Information. Confidential Information
belongs to and shall remain the property of the Disclosing Party.
6.2 EXCEPTIONS. The obligations of confidentiality set forth in Section
6.1 shall not apply to Confidential Information which the Receiving
Party can prove by documentary evidence:
(a) was already in is possession and at its free disposal before the
disclosure to it hereunder; or
(b) is subsequently disclosed to the Receiving Party by a third party
not under any obligations of confidentiality to the Disclosing
Party; or
(c) is or becomes generally available to the public through no
fault of the Receiving Party; or
(d) is independently developed by the Receiving Party without the use
of any other Confidential Information of the Disclosing Party; or
(e) is required by law to be disclosed by the Receiving Party,
subject to Section 6.3 below.
6.3 AUTHORIZED DISCLOSURE. Each party may disclose Confidential
Information hereunder solely to the extent such disclosure is
reasonably necessary in connection with submissions to any
governmental authority in connection with this Agreement or in filing
or prosecuting regulatory applications contemplated under this
Agreement, prosecuting or defending litigation, complying with
applicable laws or for the purposes expressly permitted by this
Agreement; provided that in the event of any such disclosure of the
Disclosing Party's Confidential Information by the Receiving Party,
the Receiving Party will, except where impracticable, give reasonable
advance notice to the Disclosing Party of such disclosure requirement
so that the Disclosing Party may seek a protective order and or other
appropriate remedy or waive compliance with the confidentiality
provisions of this Article 6, and will use its commercially reasonable
efforts to secure confidential treatment of such Confidential
Information required to be disclosed.
6.4 RETURN OF CONFIDENTIAL INFORMATION. The Receiving Party shall keep
Confidential Information belonging to the Disclosing Party in
appropriately secure locations. Upon the expiration or termination of
this Agreement, any and
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all Confidential Information possessed in tangible form by a Receiving
Party and belonging to the Disclosing Party, shall, upon written
request, be immediately returned to the Disclosing Party (or destroyed
if so requested) and not retained by the Receiving Party; provided
however that a party may retain one copy of any Confidential
Information in an appropriately secure location, which by applicable
laws it must retain, for so long as such applicable laws require such
retention but thereafter shall dispose of such retained Confidential
Information in accordance with applicable laws or this Section.
ARTICLE 7. TERM AND TERMINATION
7.1 TERM. This Agreement shall become effective upon the Effective Date
and shall continue in effect for the longer of (i) the life of the
last to expire of the patents included in the Seller Intellectual
Property, and (ii) a period of ten years; unless this Agreement is
terminated earlier in accordance with the terms and conditions of this
Article.
7.2 TERMINATION FOR MATERIAL BREACH.
(a) In the event that any party hereto shall commit any breach of or
default in any of the material terms or conditions of the
Agreement, and also shall fail to remedy such default or breach
within 60 days after receipt of written notice thereof from
another party hereto, the party giving notice may, at its option
and in addition to any other remedies which it may have at law or
in equity, terminate this Agreement by sending notice of
termination in writing to the other parties, and such termination
shall be effective as of the date of the receipt of such notice.
(b) If Bridgetech fails to pay the first $1,750,000 sums payable
under Section 3.1(a), (b) and (c), and said failure is not cured
within 60 days after receipt of a notice of default, Seller may
terminate all of Bridgetech's rights under this Agreement for all
of the Subject Products.
(c) If Bridgetech does timely pay the first $1,750,000 sums payable
under Section 3.1(a), (b) and (c), but Bridgetech thereafter
defaults in any subsequent installment payment obligation under
Section 3.1(d), (e) or (f), then Seller may terminate the rights
of Bridgetech only as to the particular Subject Product for which
the default occurred and for all subsequent Subject Products
(e.g., the second, third or fourth Subject Product).
(d) Upon any termination of this Agreement as to only particular
Subject Products, all rights to such particular Subject Products
shall revert to Seller.
7.3 RIGHTS ON TERMINATION.
(a) In the event that Seller or Bridgetech terminates this Agreement
as permitted by this Agreement, all rights granted and sold by
Seller to Bridgetech hereunder shall revert to Seller; and
Bridgetech and its Affiliates shall cease to make and sell any of
the Subject Products.
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(b) Except as otherwise provided in this Agreement, in the event of
termination (i) Bridgetech shall surrender to Seller, or, at the
sole option of Seller, shall destroy and provide Seller with a
certificate signed by a responsible executive of Bridgetech
attesting to the destruction of, all copies of any Confidential
Information provided by Seller hereunder; and (ii) Seller shall
surrender to Bridgetech, or, at the sole option of Bridgetech,
Seller shall destroy and provide Bridgetech with a certificate
signed by a responsible executive of Seller attesting to the
destruction of, all copies of any Confidential Information
provided by Bridgetech hereunder.
(c) Termination or expiration of this Agreement shall be without
prejudice to any right which shall have accrued to the benefit of
any party prior to such termination or expiration. Such
termination or expiration shall not relieve any party from
obligations which are expressly indicated to survive termination
or expiration of this Agreement.
7.4 SURVIVAL. In addition to those Articles or Sections which expressly
survive throughout the term of this Agreement, the following Articles
and Sections of this Agreement shall survive termination or expiration
of this Agreement: Articles 1, 6, 8, 9 and 10 and Sections 7.3 and
7.4.
ARTICLE 8. REPRESENTATIONS, WARRANTIES, DISCLAIMERS AND INDEMNITY
8.1 ALL PARTIES. Each party represents and warrants to the other that it
has, and shall have, the full legal right and authority to enter into
this Agreement, and to perform its obligations hereunder, including
with respect to Seller, to grant the rights and licenses to Bridgetech
contemplated hereunder.
8.2 GENERAL DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
THE PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND
WHATSOEVER, EITHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTY RELATING TO MERCHANTABILITY,
REGULATORY STATUS, EFFICACY CLAIMS, OR FITNESS FOR A PARTICULAR
PURPOSE.
8.3 DISCLAIMER REGARDING PATENT RIGHTS. Seller does not represent or
warrant that any particular patent claims will ultimately be issued
for any of the pending patent applications, or that any issued patents
will be valid and enforceable.
8.4 SELLER RIGHTS. Seller is the sole owner of all rights relating to the
Subject Properties in the Territory.
8.5 Seller makes no representations whatsoever with regard to the scope of
the Seller Intellectual Property, or that the Subject Products can be
developed and sold without infringing other patents.
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8.6 PRODUCT EFFICACIES AND APPROVAL. Seller does not represent or warrant
that any of the Subject Products will in fact be able to be developed
into (i) commercially viable products, (ii) efficacious products, or
(iii) approvable products.
8.7 LIMITATIONS OF LIABILITY; REMEDIES CUMULATIVE.
(a) EXCEPT FOR ANY CLAIMS RELATED TO ONE PARTY'S INFRINGEMENT OF
ANOTHER PARTY'S INTELLECTUAL PROPERTY OR BREACH BY A PARTY OF ITS
CONFIDENTIALITY OBLIGATIONS HEREUNDER, UNDER NO CIRCUMSTANCES
SHALL A PARTY HEREOF BE LIABLE TO THE OTHER PARTY HEREOF FOR
CONSEQUENTIAL, INDIRECT, INCIDENTAL, PUNITIVE OR SPECIAL DAMAGES.
(b) UNDER NO CIRCUMSTANCE WILL SELLER HAVE ANY POTENTIAL LIABILITY IN
THE AGGREGATE IN EXCESS OF THE PAYMENTS ACTUALLY RECEIVED BY
SELLER UNDER THIS AGREEMENT.
(c) THE REMEDIES PROVIDED IN THIS AGREEMENT ARE CUMULATIVE AND NOT
EXCLUSIVE OR IN LIMITATION OF ANY OTHER REMEDY AVAILABLE AT LAW
OR IN EQUITY. ACCORDINGLY, UNLESS OTHERWISE EXPRESSLY PROVIDED IN
THIS AGREEMENT A REMEDY PROVIDED AS AVAILABLE TO ANY PARTY IS NOT
INTENDED AS AN EXCLUSIVE REMEDY.
8.8 INDEMNITY
(a) Seller hereby agrees to save, defend, and hold Bridgetech, its
Affiliates and their respective officers, directors, employees,
agents and representatives (the "BRIDGETECH INDEMNIFIED Parties")
harmless from and against any and all losses, damages,
liabilities, obligations, costs and expenses (including
reasonable attorneys' fees and expenses that arise in connection
therewith) ("LOSSES") resulting from or arising out of: (a) the
negligence or willful misconduct of Seller or its Affiliates, and
their respective directors, officers, agents, employees, or
representatives, or (b) the material breach by Seller of any
provision of this Agreement.
(b) Bridgetech hereby agrees to save, defend, and hold Seller
harmless from and against any and all losses, damages,
liabilities, obligations, costs and expenses (including
reasonable attorneys' fees and expenses that arise in connection
therewith) ("Losses") resulting from or arising out of: (a) the
gross negligence or willful misconduct of Bridgetech, or (b) the
material breach by Bridgetech of any provision of this Agreement,
or (c) product liability claims for products produced by
Bridgtech or its Affiliates or contractors.
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ARTICLE 9. GOVERNING LAW; DISPUTE RESOLUTION
9.1 GOVERNING LAW. This Agreement shall be governed by, and construed and
interpreted in accordance with, the laws of the State of Delaware,
without regard for conflicts of laws principles.
9.2 DISPUTE RESOLUTION. In the event of any dispute arising under this
Agreement, or any breach of any of this Agreement, the parties shall
refer such dispute to its respective authorized representatives for
attempted resolution by good faith negotiations within 30 days after
such referral is made. In the event such authorized representatives
are unable to resolve such dispute within such 30-day period, either
party may assert its rights in a court of law.
ARTICLE 10. GENERAL PROVISIONS
10.1 INDEPENDENT CONTRACTORS. The parties are independent contractors and
no party shall be deemed to be, nor entitled to the benefits of, an
employee, joint venturer, or partner of any other party. No party is
authorized or empowered to act as agent for, or to direct or control
the day-to-day activities of any other party for any purpose and shall
not on behalf of any other party enter into any contract, warranty, or
representation as to any matter.
10.2 NO PERSONAL LIABILITY. Each action or claim against any party arising
under or relating to this Agreement shall be made only against such
party as a corporation and any liability relating thereto shall be
enforceable only against the assets of such party. No party shall seek
to xxxxxx the corporate veil or otherwise seek to impose any liability
relating to, or arising from, this Agreement against any shareholder,
employee, officer, director, trustee or manager of another party. Each
of such persons is an intended beneficiary of the mutual promises set
forth in this Section and shall be entitled to enforce the provisions
of this Section.
10.3 NO THIRD PARTY BENEFICIARIES. It is the explicit intention of the
parties hereto that, except as expressly provided herein, no person or
entity other than the parties hereto is or shall be entitled to bring
any action to enforce any provision of this Agreement against any of
the parties hereto, and that covenants, undertakings, and agreements
set forth in this Agreement shall be enforceable only by the parties
hereto or their respective successors or permitted assigns.
10.4 ASSIGNMENT. No party may assign this Agreement without the prior
written consent of the other parties hereto, except that any party may
assign this Agreement to the purchaser of all or part of the business
or operations conducted by such party related to this Agreement;
provided that no such assignment shall relieve the assignor as the
primary obligor hereunder. This Agreement shall be binding upon and
inure to the benefit of the successors and assigns of the parties. Any
assignment not in accordance with this Agreement shall be void.
10.5 MODIFICATION; WAIVER. This Agreement may not be modified or amended
except by a document signed by all parties hereto. No failure of
either party to exercise
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and no delay in exercising any right or remedy in connection with this
Agreement will operate as a waiver thereof, nor will any single or
partial exercise of any right preclude any other or further exercise
of such right or the exercise of any other right hereunder.
10.6 NOTICES. All notices must be in writing. Communications regarding this
Agreement shall be between the individuals identified below, who will
act on behalf of the parties respectively. Either party may
re-designate the recipient of communications and correspondence, or
change the address specified below, at any time during the term of
this Agreement by providing the other party with written notice of the
name and address of its new designate.
If to Seller: Xxxxxx X. Chen, Ph.D.
0000 Xxxxxx Xxx
Xxx Xxxxx, XX 00000
If to Bridgetech: Bridgetech Holdings International, Inc.
000 X. Xxxxxxxx, 00xx Xxxxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxx X. Xxxx III
The date of receipt of any notice given under this Agreement shall be
deemed to be (i) the date given if delivered personally (ii) seven
days after the date mailed if mailed by registered or certified mail
return receipt requested, postage prepaid, and (iii) two days after
the date sent if sent by nationally recognized commercial courier, and
addressed to the party to receive such notice.
10.7 SEVERABILITY. If any term or provision of this Agreement is or becomes
invalid or held illegal or unenforceable by a court of competent
jurisdiction, then (i) it is the intention of the parties that the
remaining terms or provisions of this Agreement shall not be affected
thereby and shall be enforced to the fullest extent permitted by law,
and (ii) the parties shall renegotiate in good faith such invalid,
illegal or unenforceable term or provision in order to provide a
reasonably acceptable alternative whose effect on economic and
business objectives shall be as similar as possible to the effect
intended by the parties under the original invalid, illegal or
unenforceable term or provision, it being the intent of the parties
that the basic purposes of this Agreement are to be effectuated.
10.8 ENTIRE AGREEMENT. This Agreement constitutes the entire understanding
of the parties with respect to the subject matter hereof. As of the
Effective Date, there are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral
or written, between the parties other than as set forth herein. No
subsequent alteration, amendment, change or addition to this Agreement
shall be binding upon the parties hereto unless reduced to writing and
signed by the respective authorized officers of the parties. The
headings are for the convenience of the parties and have no legal or
interpretive significance whatsoever.
13
10.9 FORCE MAJEURE. No party shall be liable to the other party for damages
or loss resulting from the failure of performance by such party if
such failure results from earthquake, war, acts of terrorism, fire,
explosion, flood, strike or any other cause beyond the control of the
defaulting party ("Force Majeure"), provided that the party claiming
Force Majeure exerts all commercially reasonable efforts to avoid or
remedy such Force Majeure. In the event a Force Majeure extends for
more than six months, then another party may terminate this Agreement
upon written notice to the non-performing party (so long as such other
party is not itself then in material breach of this Agreement).
10.10 ADDITIONAL ACTIONS AND DOCUMENTS. Each of the parties hereto hereby
agrees to take or cause to be taken such further actions, to execute,
acknowledge, deliver and file or cause to be executed, acknowledged,
delivered and filed such further documents and instruments, and to use
its best efforts to obtain such consents, as may be necessary or as
may be reasonably requested in order to fully effectuate the purposes,
terms and conditions of this Agreement, whether at or after the
execution of this Agreement.
10.11 COUNTERPARTS. This Agreement may be executed in counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
[The following page is the signature page.]
14
IN WITNESS WHEREOF, the parties hereto have caused this Supply and License
Agreement to be executed effective as of the date first above written.
XXXXXX XXXX XXXX
By /s/ Xxxxxx Xxxx Xxxx
------------------------------------
Name: Xxxxxx Xxxx Xxxx
BRIDGETECH HOLDINGS INTERNATIONAL, INC.
By /s/ Xxxxxx X. Xxxx III
------------------------------------
Name: Xxxxxx X. Xxxx III
Title: President & COO
15
APPENDIX A
SUBJECT PRODUCTS SPECIFICATIONS
1. A lyophilized docetaxel intravenous emulsion formulation for cancer treatment
(under US patent application 11/192439 filed on 28-July-2005, WO patent
application US2005/026783 filed on 28-July-2005, and US provisional patent
applications 60/764,061 filed on 1-Feb-2006 and 60/771,816 filed on 8-Feb-2006)
2. A lyophilized paclitaxel intravenous emulsion formulation for cancer
treatment (under US patent application 11/192439 filed on 28-July-2005, WO
patent application US2005/026783 filed on 28-July-2005, and US provisional
patent applications 60/764,061 filed on 1-Feb-2006 and 60/771,816 filed on
8-Feb-2006)
3. A lyophilized vancomycin intravenous emulsion formulation for infectious
diseases (under US patent application 10/889226 filed on 12-Jul-2004, WO
application US2005/024594 filed on 12-Jul-2005 and a future application to be
filed)
4. A lyophilized clarithromycin intravenous emulsion formulation for infectious
diseases (under US patent application 10/895018 filed on 20-Jul-2004 and a
future application to be filed)
The Seller has filed patent applications for and owns exclusive rights to the
Subject Products in the Territory defined above.
00
XXXXXXXX X
Work necessary for the preparation of the initial regulatory filings in the
Territory
1. Definition of product composition and components
2. Description of small-to-pilot scale manufacturing process
3. Six-month stability study
4. Proposed test methods and quality specification
5. Efficacy study in animals according to an established protocol
6. Acute toxicity study in animals according to an established protocol
7. Hypersensitivity study in animals according to an established protocol
8. Vein irritation study in animals according to an established protocol
9. Hemolysis study with animal blood according to an established protocol
17
