EXHIBIT 10.12
STRATEGIC PARTNERSHIP AGREEMENT
THIS STRATEGIC PARTNERSHIP AGREEMENT (this "AGREEMENT"), effective as of
June 7, 2005 (the "EFFECTIVE DATE"), is made by and between BRIDGETECH HOLDINGS
INTERNATIONAL, INC., a Delaware corporation ("BRIDGETECH"), and XXXX XXXXXXX
MEDICAL RESEARCH CENTER, a Texas non-profit corporation ("XXXXXXX"), (Xxxxxxx
together with Bridgetech, the "PARTIES").
WITNESSETH
WHEREAS, XXXXXXX is in the business of providing support for the
exploration of investigational vaccine, gene, and cellular therapies with the
goal of expanding treatment options for all cancer patients;
WHEREAS, BRIDGETECH has established Bridgetech CRO, Inc. ("CRO"), a
clinical research organization research operating in the People's Republic of
China, Hong Kong and the Republic of China (Taiwan); (together known as
"CHINA");
WHEREAS, the STATE FOOD AND DRUG ADMINISTRATION ("SFDA") is the regulatory
authority of the People's Republic of China responsible for, among other things,
granting authorization for the consumption, manufacture and distribution of
pharmaceutical products in China;
WHEREAS, the Parties wish to form a strategic partnership in order to
facilitate clinical testing of pharmaceuticals for the purpose of receiving SFDA
approval on said pharmaceutical products for consumption, manufacture and
distribution in China;
NOW THEREFORE, in consideration of the premises and of the mutual
covenants contained in this Agreement, and for other good and valuable
consideration, the receipt and adequacy of which is hereby acknowledged, the
Parties agree as follows.
1. The Project.
1.1 Purpose. The purpose of this Agreement is to set out the basis on
which the Parties will:
(a) agree to handle the referral of prospective pharmaceutical
products identified in Appendix A attached hereto, as the same
may be amended from time to time by the mutual written
agreement of the Parties (the "PRODUCTS") for the CRO in
China;
(b) agree on a royalty structure with regards to the revenue
generated by the manufacture and distribution of the Products
in China;
(all such activities being referred to collectively as the
"PROJECT").
2. Project Terms.
2.1 Preferred Relationship. Except to the extent prohibited by applicable
law, rules and regulations:
(a) Within China, the CRO shall be the exclusive provider of
clinical research services to Xxxxxxx during the Project Term,
pursuant to the specific terms and conditions of a CRO
contract to be negotiated by the Parties with diligence and in
good faith.
(b) Relative to products comparable in nature, Products referred
by Xxxxxxx will be afforded the highest priority in terms of
scheduling by the CRO during the Project Term.
(c) The procedures and protocols provided by Xxxxxxx to the CRO
for conducting clinical hereunder shall not be used by the CRO
to conduct any clinical trials in China for any party other
than Xxxxxxx, except to the extent that Bridgetech can
demonstrate by written evidence that specific procedures or
protocols are already matters of general knowledge and
practice within the healthcare industry.
By way of illustration and not by way of limitation, it is the expectation
of Xxxxxxx that the CRO will provide clinical pricing to Xxxxxxx according
to the following template:
Level 1 Clinical trials - (Oral medication, non toxic) = $250/case/month
Level 2 Clinical trials - ( IV or Injection, moderate toxicity) =
$500/case/month
Level 3 Clinical trials - (Viral Therapies, Immune Therapies,
BioTherapeutics) = $1000/case/month
Costs for trials extending past 90 days to be negotiated on a case-by-case
basis.
2.2 Oversight. For the Products referred to the CRO by Xxxxxxx, Xxxxxxx
will have the right to oversee certain processes and procedures, relative
to work done with the Products, as may be deemed necessary to ensure
adherence to Xxxxxxx'x standards. The Parties agree that such processes
and procedures, and the oversight rights of Xxxxxxx with respect thereto,
shall be agreed upon in writing within 30 days of the Effective Date and
shall be attached hereto as Appendix B.
2.3 Royalties. The Parties agree to the following with regards to
royalties:
(a) For Products Xxxxxxx refers to the CRO in which Bridgetech has
distribution rights in China:
(i) if the Parties agree that the cost of getting the Product
through the SFDA approval process is to be borne by Xxxxxxx, then
Bridgetech shall
-2-
pay a royalty to Xxxxxxx of 40% of all revenues received by
Bridgetech on the sale of the Product in China;
(ii) if the Parties agree that the cost of getting the Product
through the SFDA approval process is not to be borne by Xxxxxxx,
then Bridgetech shall pay a royalty to Xxxxxxx of 15% of all
revenues received by Bridgetech on the sale of the Product in China;
and
(iii) if the Parties are not able to agree on who is to bear the
cost of getting the Product through the SFDA approval process, then
the Parties shall bear such cost in equal shares, and Bridgetech
shall pay a royalty to Xxxxxxx of 27.5% of all revenues received by
Bridgetech on the sale of the Product in China.
2.4 Financial Reports and Payments. Bridgetech shall account to Xxxxxxx
quarterly, within 30 days of the end of each calendar quarter, by
providing a statement detailing all information necessary to calculate the
royalties then due to Xxxxxxx, together with the payment of any amounts
then due. Sales in foreign currencies shall be converted into U.S. dollars
on the last day of the calendar quarter in which such sales occurred.
2.5 Records; Audits. 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 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
royalties or other amounts due pursuant to this Agreement. Bridgetech
shall maintain such records and books of account for a period of not less
than three years following the year to which the records pertain. Upon not
less than 10 days written notice from Xxxxxxx, from time to time
Bridgetech shall allow Xxxxxxx or its agent to inspect and copy such
records and books of account, during reasonable business hours, on
reasonable advance notice, but in any not more than once per year. In the
event of underpayment by Bridgetech, Bridgetech shall promptly pay Xxxxxxx
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 Xxxxxxx,
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. Term and Termination.
3.1 Term. Unless earlier terminated in accordance with the terms hereof,
this Agreement will have an initial term of 10 years (the "PROJECT
TERM"), at the end of which time the Project Term shall
automatically be extended for additional consecutive one-year terms
(all such renewal terms shall be considered part of the "Project
Term"), unless either Party notifies the other no later than 60 days
before
-3-
the end of the then-current Project Term that it does not wish to
extend the Project Term.
3.2 Termination Without Cause. If at least one clinical trial has not
been initiated under this Agreement on or before the first
anniversary of the Effective Date, then either Party may terminate
this Agreement, without any further liability or obligation to the
other Party, by giving the other Party at least 30 days written
notice of such termination.
3.3 Termination For Cause. If there occurs a material breach by either
Party of any representation, warranty, covenant, obligation or other
provision of this Agreement and such Party fail to cure such breach
within 30 days after being given written notice thereof by the other
Party, then the non-breaching Party 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 Party, and such termination shall be effective
as of the date specified in such notice.
4. Representations and Warranties.
4.1 Representations and warranties of the Parties The Parties hereby
represent and warrant as follows:
(a) Status. Bridgetech is a corporation validly existing and in
good standing under the laws of the State of Delaware, U.S.A.
Bridgetech has all necessary legal power and authority to
enter into this Agreement.
(b) Status. Xxxxxxx is a non-profit corporation duly organized,
validly existing and in good standing under the laws of the
State of Texas, U.S.A. Xxxxxxx has all necessary legal power
and authority to enter into this Agreement.
(c) Authorization, etc. The execution, delivery and performance by
the Parties of this Agreement has been authorized by all
necessary action on the part of such entity and its
stockholders, as the case may be, and does not and will not
(i) violate the organizational documents of the Parties or
any applicable law, or
(ii) contravene, conflict with, or result in a default under
any order or judgment of any court or other governmental
authority or any agreement to which the Parties may be
bound.
(d) Enforceability. Its obligations and the obligations of the
Parties under this Agreement and any other agreement entered
into by such entity in
-4-
connection with this Agreement or the Project are and will be
the legal, valid, and binding obligation of the Parties,
enforceable against such entity in accordance with its terms,
subject to applicable bankruptcy, reorganization, insolvency,
moratorium, or similar laws affecting creditors' rights
generally and subject as to enforceability, to equitable
principle of general application regardless of whether
enforcement is sought in a proceeding in equity or at law.
(e) Litigation. There are no suits, proceedings, judgments,
rulings or orders by or before any governmental authority,
court or arbitrator or any pending or threatened action or
proceeding affecting the Parties before any governmental
authority, court or arbitrator that could reasonably be
expected to materially and adversely affect the financial
condition or operations of the Parties or the ability of the
Parties to perform their respective obligations under this
Agreement or any other agreement entered into by such entity
in connection with this Agreement or the Project, or which
purports to affect the legality, validity or enforceability of
this Agreement or any other such agreement.
5. Confidential Information.
5.1 Definition. For purposes of this Agreement "CONFIDENTIAL
INFORMATION" means information provided by a Party to this Agreement
(the "DISCLOSING PARTY") to any other Party to this Agreement (the
"RESTRICTED PARTY") in connection with the transactions and
relationships contemplated by the Project, including but not limited
to:
(a) any data or information that is not generally known to the
public, including, but not limited to, products, planning
information, marketing strategies, plans, finance operations,
sales estimates, business plans, and internal performance
results relating to the past, present or future business
activities of the Disclosing Party and, services and products
provided to or obtained from, the terms of related contracts
with, and the identities of any other identifying information
regarding the customers, clients and suppliers of the
Disclosing Party;
(b) any scientific or technical information, design, process,
procedure, formula, or improvement that is valuable and secret
in the sense that it derives economic value 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;
(c) all confidential or proprietary concepts, documentation,
reports, data (including magnetic tapes), specifications, web
sites, screen formats, computer software, source code, object
code, flow charts, databases, inventions, systems, system
security features, system enhancements,
-5-
information, know-how, show-how and trade secrets, whether or
not patentable or copyrightable;
(d) all documents, inventions, substances, engineering and
laboratory notebooks, drawings, diagrams, specifications,
bills of material, equipment, prototypes and models, and any
other tangible manifestation of the foregoing;
(e) any other information that a Disclosing Party treats as
confidential information provided by an affiliate or other
third party; and
(f) any information derived from any of the foregoing that is
treated as confidential.
5.2 Obligations. Confidential Information belongs to and shall remain
the property of the Disclosing Party, who shall retain ownership and
control of its Confidential Information. All Confidential
Information disclosed or submitted, either orally or in writing
(including without limitation by electronic means) or through
observation, by the Disclosing Party to the Restricted Party
hereunder shall be received and maintained by the Restricted Party
in strict confidence, shall not be used for any purpose other than
the purposes expressly permitted by this Agreement and shall not be
disclosed to any third party other than the Restricted 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.
5.3 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 patent 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 Restricted Party,
the Restricted 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 5, and will use its
commercially reasonable efforts to secure confidential treatment of
such Confidential Information required to be disclosed.
-6-
5.4 Return of Confidential Information. The Restricted Party shall keep
Confidential Information belonging to the Disclosing Party in
appropriately secure locations. Upon the expiration or termination
of this Agreement, any and all Confidential Information possessed in
tangible form by a Restricted 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 Restricted 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.
6. Press Release and Announcements.
The Parties that no public release or announcement concerning the
transactions contemplated hereby shall be issued or made by or on behalf
of any Party without the prior consent of the other Party, except that
either Party may, after consultation with counsel, make announcements that
such Party reasonably may determine are necessary to comply with
applicable law. Xxxxxxx acknowledges and agrees that Bridgetech may be
required to announce the terms of this Agreement and make publicly
available this Agreement and that no breach shall be deemed to result
therefrom. Notwithstanding the foregoing, the Parties cooperate to prepare
a joint press release to be issued in connection with the execution of
this Agreement. The Parties further agree that each shall have the right
to display the others logo on their respective websites.
7. Indemnification.
7.1 Indemnification. Each Party (the "INDEMNIFYING PARTY") will defend,
indemnify, and hold the other Party, it officers, directors,
shareholders, employees, agents and representatives, and each of its
and their successors and permitted assigns (the "INDEMNIFIED
PARTIES"), harmless from and against any and all liabilities,
judgments, losses, actual damages, costs, and expenses (including
without limitation reasonable attorneys' and experts' fees) which
any or all of them may hereafter incur themselves or pay out to
another by reason of any claim, suit, or proceeding brought by a
third party, at law or in equity, that arises out of or relates to
(i) a material breach of any representation, warranty, covenant,
obligation or other provision of this Agreement by the Indemnifying
Party, or (ii) any negligence or willful misconduct of the
Indemnifying Party, except to the extent caused by the gross
negligence or willful misconduct of an Indemnified Party.
7.2 Exclusion of Consequential Damages. NOTWITHSTANDING ANYTHING TO THE
CONTRARY CONTAINED IN THIS AGREEMENT, NEITHER PARTY SHALL, UNDER ANY
CIRCUMSTANCES, BE LIABLE TO THE OTHER PARTY FOR LOST PROFITS,
CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE, OR INDIRECT DAMAGES
ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS
CONTEMPLATED
-7-
HEREUNDER, EVEN IF THE PARTY HAS BEEN APPRISED OF THE LIKELIHOOD OF
SUCH DAMAGES.
8. Miscellaneous.
8.1 Binding Effect. This Agreement shall be binding on and inure to the
benefit of the Parties and their respective successors and permitted
assigns.
8.2 Assignment. This Agreement shall not be assigned by either Party
without the prior written consent of the other Party, not to be
unreasonably delayed or withheld, and any purported such assignment
without such consent shall be void. For purposes of this Section
8.2, a merger involving a Party shall be deemed to result in an
assignment of this Agreement to the surviving entity in the merger,
regardless of whether the Party is the surviving entity or merging
entity to such merger.
8.3 Notices And Other Communications.
(a) Each notice, communication and delivery under this Agreement
(i) shall be made in writing signed by the Party making the
same, (ii) shall specify the Section of this Agreement
pursuant to which it is given, (iii) shall be given either in
person or by telecopier, effective upon such delivery or the
confirmed transmission and (iv) if not given in person, shall
be sent to the applicable Party at the address set forth below
(or at such other address as the applicable Party may furnish
to the other Party pursuant to this subsection) by
international courier delivery service, effective upon the
second business day after such notice is deposited, delivery
charges pre-paid, with such international courier delivery
service. Each Party's notice information is as follows:
BRIDGETECH: Bridgetech Holdings International, Inc.
000 X. Xxxxxxx 000, Xxxxx 000
Xxxxxx Xxxxx, Xxxxxxxxxx 00000
Attn: Xxxxxx X. Xxxx III
Phone: 000-000-0000
Fax: 000-000-0000
With a copy to:
Xxxxxxxxxx Xxxxxx & Xxxxxxx LLP
000 Xxxxxxxxx Xxxxxx, XX
Xxxxxxx, Xxxxxxx 00000
Attn: X. Xxxx Xxxxxxx
Phone: 000-000-0000
Fax: 000-000-0000
-0-
XXXXXXX: Xxxx Xxxxxxx Medical Research Center
0000 Xxxxx Xxxxxx
Xxxxxxx Xxxxxxxx, Xxxxx 000
Xxxxxx, Xxxxx 00000
Attn: Xxxxx Xxxxxxxx
Phone: 000-000-0000
Fax: 000-000-0000
8.4 Severability. If any term or provision of this Agreement, or the
application thereof to any person or circumstance, shall to any
extent be contrary to any applicable law or regulation or otherwise
invalid or unenforceable, the remainder of this Agreement or the
application of such term or provision to persons or circumstances
other than those as to which it is contrary, invalid or
unenforceable shall not be affected thereby and, to the extent
consistent with the overall intent of this Agreement taken as a
whole, shall be enforced to the fullest extent permitted by
applicable law and regulation.
8.5 Governing Law. The Project Documents will be governed by the laws of
Delaware except as specifically provided in such documents, without
regard to principles of conflict of laws.
8.6 Independent Contractors. The Parties are independent contractors and
neither Party shall be deemed to be, nor entitled to the benefits
of, an employee, joint venturer, or partner of the other Party.
Neither Party is authorized or empowered to act as agent for, or to
direct or control the day-to-day activities of the other Party for
any purpose and shall not on behalf of the other Party enter into
any contract, warranty, or representation as to any matter.
8.7 Modification; Waiver. This Agreement may not be modified or amended
except by a document signed by both Parties hereto. No failure of
either Party to exercise 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.
8.8 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.
-9-
8.9 Additional Actions and Documents. Each of the Parties 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.
8.10 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.
(Signatures on the following page)
-10-
IN WITNESS WHEREOF, the Parties have executed this Agreement, or caused it to be
executed by their duly authorized officers or agents all as of the day and year
first above written.
BRIDGETECH HOLDINGS
INTERNATIONAL, INC.
By: /s/ Xxxxxx X. Xxxx III
----------------------------
Name: Xxxxxx X. Xxxx III
Title: EVP & CFO
XXXX XXXXXXX MEDICAL RESEARCH
CENTER
By: /s/ Xxxxx Xxxxxxxx
----------------------------
Name: Xxxxx Xxxxxxxx
Title: President
-11-
