UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 16, 2014
PROTEO, INC.
(Exact name of registrant as specified in
its charter)
Nevada |
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000-30728 |
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88-0292249 |
(State of other jurisdiction
of incorporation) |
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(Commission File Number) |
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(IRS Employer
Identification No.) |
2102 Business Center Drive, Irvine,
California 92612
(Address of Principal Executive Offices)
Registrant’s telephone number, including
area code: (949) 253-4155
Not Applicable
(Former name or former address, if changed
since last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2 below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
o
Soliciting material pursuant to Rule 14A-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry Into a Material
Definitive Agreement.
On May 16, 2014, the
sole subsidiary of Proteo, Inc. (the “Company”), Proteo Biotech AG (“Proteo”), entered into an agreement
(the “Agreement”) with Biotech Development Corp., a Nevada corporation (“Biotech”).
Pursuant to the Agreement,
Biotech has agreed to support the development of Proteo’s orphan medicinal product Tiprelestat (“Elafin”) by
providing certain funding to Proteo to assist with activities related to research, clinical testing, manufacturing, and preparation
and submission of applications for regulatory approvals. Biotech will make upfront payments to Proteo, and then ongoing monthly
payments toward the development of Elafin, which will provide Proteo with total funds of EURO 3.5 million (approximately USD 4.8
million). In exchange, Proteo will pay Biotech on a quarterly basis a share of the net sales of Elafin within the European Union,
subject to an aggregate maximum cap.
The foregoing description
of the Agreement does not purport to be complete and is qualified in its entirety by reference to the text of the Agreement, a
copy of which is attached hereto as Exhibit 10.1.
On May 20, 2014, the
Company issued a press release announcing the Agreement, which is attached hereto as Exhibit 99.1.
Item 9.01 |
Financial Statements and Exhibits. |
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(d) |
Exhibits. The following materials are filed as exhibits to this current report on Form 8-K: |
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Exhibit Number |
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10.1 |
Agreement effective May 16, 2014 between Biotech Development Corp. and Proteo.* |
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99.1 |
Press Release, dated May 20, 2014, entitled “$ 4.8 Million Funding for Proteo's Advanced Orphan Drug Development.” |
*The Company has requested confidential
treatment of portions of the exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934. The confidential portions
of this exhibit have been omitted and are marked accordingly. The confidential portions have been filed separately with the Securities
and Exchange Commission.
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
PROTEO, INC.
Date: May 22, 2014 |
By: |
/s/ BIRGE BARGMANN |
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Birge Bargmann |
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Chief Executive Officer |
Exhibit 10.1
Confidential information has been omitted
from portions of this document, indicated by [*], and filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to this omitted information.
AGREEMENT
This agreement (the “Agreement”)
is made as of May 16, 2014 (the “Effective Date”) by and between Proteo Biotech AG, Am Kiel-Kanal 44, 24106 Kiel, Germany,
(“Proteo”); and Biotech Development Corp,1393 Bennett Circle, Farmington, UT 84025, USA, a Nevada corporation, (“BDC”).
Proteo and BDC are referred to individually and collectively as a “Party” or the “Parties.”
RECITALS
WHEREAS, the European Commission has granted
Orphan Drug Designation to Proteo for Tiprelestat (also known as recombinant human Elafin) for the treatment of esophagus carcinoma;
WHEREAS, Proteo has received advice from
the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) in the context of the Protocol
Assistance (scientific advice for orphan medicines) with respect to the strategy for further clinical development and marketing
authorization of the orphan medicinal product Tiprelestat (Elafin) in the prophylactic treatment of postoperative complications
after resection of esophageal cancer, and Proteo is now interested in proceeding with the development by conducting a pivotal study
within the EU;
WHEREAS, BDC is interested in supporting
this Development (as defined herein) by providing Proteo with the respective funds;
NOW, THEREFORE, in consideration of the
mutual promises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the Parties, intending to be legally bound, agree to the following:
SECTION 1
DEFINITIONS
Unless the context
otherwise requires, the following capitalized terms in this Agreement shall have the following meanings (and if the context so
requires, including any gender, plural or singular thereof and including any capitalized verb, adverb or adjective as relating
to such defined term):
“Affiliate”
shall mean, with respect to a Party, any Person that, directly or indirectly, controls, is controlled by or is under common
control with such Party. For purposes of this definition, “control” and the terms “controlled by” and “under
common control with” or phrases with similar import shall mean the power to direct the management or policies of Person,
whether through the ownership of voting securities, by contract relating to voting rights or otherwise, or by the ownership, directly
or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of a business entity.
“Agreement”
shall have the meaning set forth in the recitals to this Agreement.
“Applicable
Law” shall mean all applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements
of any Regulatory Authorities that may be in effect from time to time.
“BDC”
shall have the meaning set forth in the recitals to this Agreement.
“BDC Payment
Cap” shall have the meaning set forth in Section 2.2.
“BDC Revenue
Sharing Cap” shall have the meaning set forth in Section 3.2.
“Change of
Control” means, with respect to the Parties, their ultimate parent corporations (even if jointly controlling an Affiliate
of either Party) or any successor to the foregoing, (i) any transaction or related series of transactions involving such Person
and any Third Party which results in the control (as control is defined in the definition of “Affiliate”) by such Third
Party or (ii) the sale or other transfer to a Third Party of all or substantially all of such party’s assets which relate
to this Agreement.
“Commercialize”
or “Commercialization” shall mean all activities related to the marketing, promotion or sale of the Product within
the Field.
“Develop”
and “Development” shall mean all activities related to research, preclinical and other non-clinical testing,
test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification
and validation, quality assurance/quality control related to the foregoing manufacturing activities, clinical and other studies,
including purchase of the study drugs in support thereof, statistical analysis and report writing, the preparation and submission
of applications for Regulatory Approvals, regulatory affairs with respect to the foregoing and all other activities otherwise requested
or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval, all of the
aforesaid relating to the Field, and including the commissioning of outside experts (such as Clinical Research Organizations)and
also including - within or outside of the Field - the payment of licensee fees, patent cost and all other cost relating to the
management, financing and conduct of the general businesses of Proteo and its Affiliates (including, for the avoidance of doubt,
payroll-cost).
“Effective
Date” shall mean the effective date of this Agreement as set forth in the recitals.
“Field”
shall mean the intravenous treatment of patients undergoing Esophagus Carcinoma surgery within the European Union (EU).
“Information”
shall mean all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods,
processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs,
drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological,
chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing
and quality control data and information, including study designs and protocols; assays and biological methodology; clinical data(data
that are made, collected or otherwise generated in the performance of or in connection with clinical studies or other studies for
the Product, including any data, reports and results with respect thereto); (whether or not confidential, proprietary, patented
or patentable) in written, electronic or any other form now known to Proteo or hereafter developed or acquired otherwise.
“Knowledge”
shall mean actual knowledge of the chief executive officer of a Party of the facts and information then in possession without
duty to conduct investigations with respect to such facts and information.
“Net Sales”
shall mean the amounts received by Proteo for the sale of the Product within the Field after deduction of trade, cash or quantity
discounts, customs duties or value added or other sales taxes.
“Party”
or “Parties” shall have the meaning set forth in the recitals to this Agreement.
“Pending”
shall mean something of which a Person has been notified in writing.
“Person”
shall mean an individual, (limited) partnership, limited liability partnership, corporation or company, business trust, joint stock
company, trust, unincorporated association, joint venture or other similar entity or organization, including government or political
subdivision, department or agency of a government.
“Product”
shall mean a pharmaceutical composition or preparation that contains Tiprelestat as an active ingredient and is intended to
be used for Net Sales in the Field.
“Proteo”
shall have the meaning set forth in the recitals to this Agreement.
“Regulatory
Approval” shall mean, with respect to a country in the world, any and all approvals, licenses, registrations or authorizations
of any Regulatory Authority necessary to commercially distribute, sell or market the Product in such country, including, where
applicable, pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization
related thereto).
“Regulatory
Authority” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory
agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority
with respect to the Commercialization of the Product in the Field.
“Regulatory
Documentation” shall mean all applications, registrations, licenses, authorizations and approvals (including all Regulatory
Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports
relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests,
relating to the Product and all data contained in any of the foregoing, including but not limited to regulatory drug lists, advertising
and promotion documents, clinical data, adverse event files and complaint files.
“Shared Revenue”
or “Shared Revenues” shall have the meaning set forth in Section 3.1
“Third Party”
shall mean any Person other than Proteo, BDC and their respective Affiliates.
“Tiprelestat”
shall mean the Hansenula polymorpha derived recombinant human Elafin as described as polypeptide formula I in the (expired) European
Patent EP0402068 “Title: Polyeptides and polyeptide analogues with inhibitory activity against human elastase” for
therapeutic application.
SECTION 2
Funding
by BDC
2.1 BDC Funding
Obligation. BDC irrevocably undertakes to make the following payments to Proteo:
(a) Upfront Payments.
At the signing Effective Date BDC shall make a payment of EURO [*] to Proteo, which has already been paid as an advance by
BDC. Latest until May 31st, 2014, BDC shall make a further payment of EURO [*] to Proteo.
(b) Ongoing Payments.
Starting from 1st of July 2014 and payable on the first day of each calendar month, BDC shall throughout the term of
this Agreement and until the BDC Payment Cap (together with the payments under subsection 2.1 (a)) has been reached, make on each
month a payment in the amount of EURO [*] to Proteo. For August 2014 and August 2015 the monthly payments by BDC shall be increased
to an amount of EURO [*]. BDC shall make such additional payments that Proteo reasonably requires for the continuation of the Development.
Ongoing payments shall be made until the aggregate payments under Section 2.1 reach the BDC Payment Cap.
2.2 BDC Payment
Cap. Any and all payment obligations by BDC under this Section 2 shall be limited to the aggregate amount of EURO three million
and five hundred thousand (€ 3,500,000) (the “BDC Payment Cap”).
2.3 BDC Payments
Non-reimbursable. BDC’s Revenue Sharing rights notwithstanding, none of the payments made or to be made by BDC under
or in connection with this Agreement shall be reimbursable to BDC.
SECTION 3
BDC
Rights
3.1 BDC’s
Revenue Sharing Rights. Subject to the following provisions under this Section 3, Proteo shall pay to BDC, during the term
of this Agreement and for each full or partial calendar year on a quarterly basis, [*] of Net Sales of the Product within the European
Union (the “Shared Revenues”).
3.2 The Revenue
Sharing Cap. Any payments by Proteo under this Section 3 shall be limited to an amount of [*]-times the aggregate funds paid
by BDC to Proteo under Section 2 hereof (the “Revenue Sharing Cap”).
3.3 Revenue Sharing
Payments and Statements. Shared Revenues shall be paid on a quarterly basis, within ninety (90) days after the end of
each calendar quarter, based on the Net Sales during such calendar quarter. The Shared Revenues shall be calculated in accordance
with the terms of this Section 3. Each Shared Revenue payment hereunder shall be accompanied by a reasonably detailed statement
of proceeds received by Proteo and the amount of Shared Revenues thus due on such Net Sales.
3.4 Taxes. All
Shared Revenues payable by Proteo to BDC shall be made after deduction or withholding of any taxes, duties, imposts, fees or charges
required by Applicable Law.
3.5 Bank Account
and Currency. All payments to BDC shall be made in EURO to such bank account as BDC may designate to Proteo from time to time.
With respect to sales not made in EURO by Proteo, Shared Revenue payments shall be calculated based on the currency exchange rates
for the calendar quarter for which remittance is made for Shared Revenues. For each calendar quarter and each currency, such exchange
rate shall be applied as is effective at the last day of such calendar quarter; the exchange rates to be derived from the FxConverter
as offered by www.oanda.com or, if not available, from any other online exchange rate converter that Proteo in its discretion deems
appropriate.
3.6 Accounting
and Accounting Disputes. Unless otherwise required by Applicable Law, during the term of this Agreement and for a period of
6 months thereafter, Proteo shall keep and maintain separate, complete and accurate books and records permitting the calculation
and determination of the Shared Revenues payable to Proteo and shall permit BDC upon reasonable notice to examine such books and
records, any such audit by BDC shall only per permitted when covering 12 complete and consecutive calendar months. All reasonable
cost and expenses in connection with such examination shall be borne by BDC, unless the audit reveals a shortfall of more than
ten percent (10%) from the reported amounts. If the parties cannot agree on the amount of Shared Revenues payable by Proteo, Proteo
and BDC shall in good faith try to resolve this dispute. If the Parties are unable to reach a mutually acceptable resolution of
such dispute, Proteo may submit the matter to a well-recognized international certified public accounting firm selected by Proteo
or to such other Person as the Parties shall mutually agree. The decision of the accounting firm shall be final and binding for
the Parties and the outstanding Shared Revenues as well as the cost of the accounting firm (including the cost of the initial examination)
shall be borne and payable by BDC as the accounting firm shall reasonably determine.
3.8 No Further
Rights. Other than those Shared Revenues rights explicitly granted to BDC hereunder, BDC shall have no further rights, claims,
privileges or other entitlements whatsoever, this shall include but shall not be limited to the Product, Proteo’s assets
and businesses or Information.
Section
4
Parties’
Additional Covenants
4.1 Proteo Development.
(a) Proteo Duty
of Care. Proteo shall use reasonable efforts to Develop and try to obtain Regulatory Approvals for the Product and shall thus
apply such efforts and resources as commonly used by companies in the research-based pharmaceutical industry. Proteo shall be solely
responsible for and entitled to the application for Regulatory Approvals for the Product.
(b) Compliance
with Applicable Law. Proteo shall perform any of its Development in good scientific manner and in compliance with Applicable
Laws.
4.2 Proteo Commercialization
of the Product.
If and upon having obtained all Regulatory
Approvals necessary, the following shall apply with respect to the Commercialization of the Product.
(a) Proteo Duty
of Care. Proteo shall use reasonable efforts to Commercialize the Product, subject to the conducting of such activities being
commercially reasonable in Proteo’s discretion.
(b) Reporting on
Commercialization. Proteo shall in reasonable detail report to BDC on a regular basis relating to the Commercialization plans
and activities of the Product.
4.3 Compliance
with Applicable Laws, Adverse Effects.
In the Commercialization
of Product, Proteo shall comply with all Applicable Laws. Proteo shall not be required to undertake any activity relating to the
Product that Proteo believes in its reasonable discretion may violate Applicable Law or may create a risk of adverse results that
could be expected to have an adverse effect on the Development, Manufacturing, Safety or Commercialization of Product.
4.4 Parties’
Non-Solicitation. During the term of this Agreement and for a period of one (1) year thereafter, neither Party shall actively
recruit or solicit any employee of the other Party or its Affiliates.
SECTION 5
Additional
Projects
5.1 Additional
Projects. The subject matter of this Agreement is limited to the Field. If Proteo intends to enter into further developments
relating to the compound Tiprelestat, the Parties may enter into discussions concerning the extension of this Agreement to such
additional development activities. The aforesaid notwithstanding, nothing in this Section 5 shall impose any obligation on any
Party to extend this agreement to other (development) activities.
SECTION 6
CONFIDENTIALITY AND NON-DISCLOSURE
6.1 Confidentiality
Obligations. At all times during the term of this Agreement and for a period of five (5) years following termination or
expiration hereof, BDC shall, and shall cause its Affiliates and its and their officers, directors, employees and agents to, keep
completely confidential and not publish or otherwise disclose and not use, directly or indirectly, for any purpose, any Confidential
Information furnished or otherwise made known to it, directly or indirectly, by Proteo, except to the extent such disclosure or
use is expressly permitted by the terms of this Agreement, or is made in the cause of the exercise of rights afforded to BDC hereunder.
“Confidential Information” means the Information, any other information provided by Proteo to BDC relating to the terms
of this Agreement, the existence of this Agreement and any payments to be made by or payable to BDC under this Agreement, the Product
(including the Regulatory Documentation, the Regulatory Approvals, and any Development or Commercialization of the Product or the
scientific, regulatory or business affairs or other activities of Proteo. Notwithstanding the foregoing, Confidential Information
shall not include any information that:
(a) is or
hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act,
fault or negligence on the part of BDC;
(b) can be
demonstrated by documentation to have been in the BDC’s possession prior to disclosure by Proteo without any obligation of
confidentiality with respect to said information;
(c) is subsequently
received by BDC from a Third Party who is not bound by any obligation of confidentiality with respect to said information; or
(d) has been
published by a Third Party or otherwise enters the public domain through no fault of BDC in breach of this Agreement.
6.2 Press Releases.
Press releases or other similar public communication by BDC relating to this Agreement shall be approved in advance by Proteo,
which approval shall not be unreasonably withheld or delayed, except for those communications required by Applicable Law, disclosures
of information for which consent is not required.
6.3 Insider Trading.
BDC understands and agrees that BDC may not, neither by itself nor through third parties, neither directly nor indirectly,
engage in the purchase or the sale of securities of Proteo Inc. while in possession of Confidential Information or of non-public
information(s) relating to the Securities.
6.4 Publications.
Proteo shall control and shall have the sole right to coordinate, the publication and presentation of this agreement, its content
and the results of studies of the Product or other data generated under this Agreement.
6.5 Return of Confidential
Information. Proteo may at any time request, and BDC shall (i) promptly destroy all copies of such Confidential Information
in the possession of BDC and shall confirm such destruction in writing to Proteo, or (ii) promptly deliver to Proteo all copies
of Confidential Information in the possession of BDC.
SECTION 7
REPRESENTATIONS AND WARRANTIES
7.1 Representations,
Warranties and Covenants. Each Party hereby represents, warrants and covenants to the other Party that, as of the Effective
Date:
(a) Corporate
Authority. Such Party (i) has the power and authority and the legal right to enter into this Agreement and perform its
obligations hereunder and (ii) has taken all necessary action on its part required to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf
of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with
its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor
rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability
is considered a proceeding at law or equity.
(b) Consents and
Approvals. All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons
required to be obtained by such Party in connection with the execution and delivery of this Agreement have been obtained.
(c) Conflicts.
The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not
conflict with or violate any requirement of applicable law or regulation or any provision of the articles of association, limited
partnership agreement or any similar instrument of such Party, as applicable, in any material way, and (ii) do not conflict
with, violate or breach or constitute a default or require any consent under, any contractual obligation or court or administrative
order by which such Party is bound.
7.2 Additional
Representations and Warranties of BDC. BDC represents, warrants and covenants to Proteo that, as of the Effective Date:
(a) BDC (i)
is a corporation duly organized and in good standing under the laws of the State of Nevada and (ii) has full power and authority
and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as
it is contemplated to be conducted by this Agreement.
7.3 Additional
Representations and Warranties of Proteo. Proteo represents, warrants and covenants to BDC that, as of the Effective Date:
(a) Proteo
is a corporation duly organized under the laws of Germany and has full power and authority and the legal right to own and operate
its property and assets and to carry on its business as it is now being conducted and as is contemplated to be conducted by this
Agreement.
(b) Proteo
has not, up through and including the Effective Date, knowingly withheld material information in Proteo’s possession in response
to BDC’s reasonable inquiries in connection with its due diligence relating to the Product, this Agreement and the underlying
transactions contemplated thereby.
7.4 DISCLAIMER
OF WARRANTY. TO THE EXTENT PERMITTED BY THE GOVERNING LAW,EXCEPT FOR THE EXPRESS WARRANTIES
SET FORTH IN THIS SECTION 7 which ARE subject to the Limitations contained to the favour of Proteo in Section 8 hereof, NEITHER
PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE
OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE ExistEnce
or VALIDITY OF ANY PATENTS (if any) OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL
PROPERTY RIGHTS OF THIRD PARTIES.
SECTION 8
Limited
Liability
8.1 Limitation
on Damages and Liability. EXCEPT IN CIRCUMSTANCES OF INTENTIONAL MISCONDUCT,
neither Proteo nor ANY OF its RESPECTIVE AFFILIATES, or any of their directors, Officers or advisors SHALL BE LIABLE FOR any damages
whatsoever, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF or in connection with
ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT.
SECTION 9
TERM AND TERMINATION
9.1 Term. This
Agreement shall commence upon the Effective Date and shall automatically terminate after a period of 15 years following the Effective
Date, or – if earlier - after a period of 10 complete and consecutive years after the first Regulatory Approval of the Product,
in all cases disregarding whether or not payments by Proteo under Section 3 have reached.
9.2 Termination
of this Agreement for Material Breach. In the event that either Party shall be in material default in the performance of any
of its material obligations under this Agreement, in addition to any other right and remedy the other Party may have, such complaining
Party may terminate this Agreement in its entirety by sixty (60) days’ prior written notice to the Breaching Party,
specifying the breach and its claim of right to terminate, provided always that the termination shall not become effective at the
end of the Notice Period if the breaching Party cures the breach complained about during such sixty (60) days’ period.
In case of late payments, the cure period shall be limited to 5 days.
9.3 Termination
Upon Insolvency. Either Party may terminate this Agreement if, at any time, the other Party or its ultimate parent corporation
shall file in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy
or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its
assets, or if the other Party or its ultimate parent corporation shall be served with an involuntary petition against it, filed
in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof, or
if the other Party or its ultimate parent corporation shall propose or be a party to any dissolution or liquidation, or if the
other Party or its ultimate parent corporation shall make an assignment for the benefit of its creditors.
9.4 Consequences
of Termination. In case of any termination, any and all obligations of either of the Parties shall terminate and expire, except
for the following of Sections 6, 7, 8 and 10 that shall survive any termination of this Agreement.
SECTION 10
No VAT
The parties jointly
assume that the payments agreed upon in this Agreement shall not be subject to any value added taxes (VAT). Should any competent
tax authority require VAT to be paid on any of these amounts, then the Party that is obliged to make a respective payment to the
other Party under this Agreement shall pay such additional VAT amounts as are to be made under applicable tax laws, subject to
having received an invoice that allows deduction of respective input tax, if so provided for under applicable tax laws.
SECTION 11
MISCELLANEOUS
11.1 Assignment.
Without prior written consent of the other Party hereto, neither Party shall sell, transfer, assign, or otherwise dispose of,
this Agreement or any of its rights or duties hereunder; however, Proteo may, without such consent, assign this Agreement and its
rights and obligations hereunder to an Affiliate, to a purchaser of Proteo’s Information or to an acquirer of Proteo’s
business.
11.2 Severability.
If any provision of this Agreement is held to be illegal, invalid or unenforceable under any law, such provision shall be fully
severable and this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised
a part hereof and the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by
the illegal, invalid or unenforceable provision or by its severance herefrom. In lieu of any such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in
terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.
11.3 Governing
Law, Jurisdiction, Arbitration and Service
(a) Governing
Law. This Agreement shall be governed by and construed in accordance with the laws of Germany, excluding any conflicts or choice
of law rules or principles that might otherwise refer construction or interpretation of this Agreement to the substantive law of
another jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts
for the International Sale of Goods.
(b) Arbitration.
The Parties hereby irrevocably and unconditionally consent that all disputes arising out of or in connection with this Agreement
shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed
in accordance with the said rules. The place of arbitration shall be Munich, Germany, the arbitration shall be held in the English
language.
(c) Service.
Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth
in Section 11.4 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement
in any such court.
11.4 Notices.
Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall
be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile
transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of
delivery, addressed to the Parties at their respective addresses specified hereafter or to such other address as the Party to whom
notice is to be given may have provided to the other Party in accordance with this Section 11.4. Such Notice shall be deemed
to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second
day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. Any notice delivered
by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter. Notices shall be made as follows:
If to BDC, to: |
|
If to Proteo, to: |
Biotech Development Corp.
Ulrike Dickmann
1393 Bennett Circle
Farmington, UT 84025
USA |
|
Proteo Biotech AG
Birge Bargmann
Am Kiel-Kanal 44
24106 Kiel
Germany |
11.5 Entire Agreement.
This Agreement, together with any Exhibits attached hereto, sets forth and constitutes the entire agreement and understanding
between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations,
whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations
or warranties of the other Party except as specifically set forth herein. No amendment, modification, release or discharge shall
be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.
11.6 English Language.
This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall
be in, the English or - at either Parties discretion - in German.
11.7 Waiver and
Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled
to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf
of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform
or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by
said other Party whether of a similar nature or otherwise.
11.8 Further Assurance.
Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and
cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments,
as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively
the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
11.9 Relationship
of the Parties. It is expressly agreed that Proteo and BDC shall be independent contractors and that the relationship between
the two Parties shall not constitute a partnership, joint venture, other legal entity or Person or agency. Neither Party shall
have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding
on the other Party without the prior written consent of such other Party.
11.10 References.
Unless otherwise specified, references in this Agreement to any Section, Paragraph, Exhibit or Annex shall mean references
to such Section, Paragraph, Exhibit or Annex of this Agreement, references in any section to any clause are references to such
clause of such section and references to any agreement, instrument or other document in this Agreement refer to such agreement,
instrument or other document as originally executed or, if subsequently varied, replaced or supplemented from time to time, as
so varied, replaced or supplemented and in effect at the relevant time of reference thereto.
11.11 Construction.
The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope
or intent of any provision contained in this Agreement.
IN WITNESS WHEREOF,
the parties have executed this Agreement the date first above written.
"Proteo"
Proteo Biotech AG
By:_/s/ Birge Bargmann___________________________________
Vorstand: Birge Bargmann
"BDC"
Biotech Development
Corp.
By:_/s/ Ulrike Dickmann___________________________________
CEO: Ulrike Dickmann
Exhibit 99.1
Company press release
$ 4.8 Million Funding for Proteo's Advanced Orphan Drug Development
Irvine, CA, May 20, 2014 - Proteo Inc. (OTCQB: PTEO)
announced today that its German subsidiary, Proteo Biotech AG, has entered into an agreement with the US company Biotech Development
Corp. (BDC). Proteo Biotech AG is developing the orphan medicinal product Tiprelestat (Elafin) for prophylactic treatment of acute
postoperative inflammatory complications after resection of esophageal cancer in the European Union. In February 2014, Proteo received
Protocol Assistance (scientific advice for orphan medicines) from the Committee for Medicinal Products for Human Use (CHMP) at
the European Medicines Agency (EMA) with respect to the strategy for further clinical development and marketing authorization.
Under the terms of the agreement, BDC will support the future development including a pivotal clinical study by providing Proteo
with total funds of EURO 3.5 million (approx. US$ 4.8 million) in return for a share of future revenues for Elafin in this indication.
About Proteo
Proteo, Inc. is a Nevada corporation and has one wholly owned
subsidiary, Proteo Biotech AG, a German corporation. The Company is a clinical stage drug development company focusing on the development
of anti-inflammatory treatments for rare diseases with significant unmet needs (www.proteo.us).
About BDC
Biotech Development Corp., based in Farmington (UT), is specialized
in financing clinical studies of biopharmaceuticals for rare diseases. BDC's Financing-Revenue Sharing Model is an alternative
or a supplement to equity financing for Startups and Small Business. For more information, visit: www.biotech-dev.com
Forward-Looking Statements
Certain statements in this news release may contain forward-looking
information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of
1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact included in this
release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking
statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual
results and future events could differ materially from those anticipated in such statements. Technical complications that may arise
could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these
forward looking statements and risks and uncertainties involved are further qualified by other factors including, but not limited
to those set forth in the company’s Form 10-K filing and other filings with the United States Securities and Exchange Commission.
The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information,
future events or otherwise.
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