EXHIBIT 10.7
LICENSE AGREEMENT
This license agreement (the "Agreement") is made as of August 9, 2007 (the
"Effective Date") by and between Proteo Biotech AG, a German joint stock
corporation, Am Xxxx Xxxxx 00, 00000 Xxxx, Xxxxxxx ("Proteo Biotech"); and Rhein
Minapharm Biogenetics SAE, an Egypt company Societe Anonyme Egyptienne Xxxx
Xxxxxx, Xxxxxxxxxx Xxxx X0#0, 10th of Ramadan, Egypt ("Licensee"). Proteo
Biotech and Licensee are referred to individually and collectively as a "Party"
or the "Parties."
RECITALS
WHEREAS, Proteo Biotech has certain rights with respect to the compound Elafin
and has received an Orphan Drug Status by the EMEA for Pulmonary Arterial
Hypertension;
WHEREAS, Licensee is a joint venture company established by Minapharm
Pharmaceuticals S.A.E. and Rhein Biotech AG, and is experienced in the
development, manufacturing and commercialization of biopharmaceuticals,
including immune modulators and cytokines;
WHEREAS, Licensee desires to obtain a license, to Develop, Manufacture and
Commercialize (each as defined below) the compound Elafin and related Know-how,
and Proteo Biotech is willing to grant such license to Licensee in accordance
with the terms and conditions set forth in this Agreement;
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):
"ADVERSE ACTIVITIES" shall have the meaning set forth in Section 4.4.
"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.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 1 of 24
"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.
"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.
"CLINICAL DATA" shall mean all information with respect to the Licensed
Products and the Licensed Compound, made, collected or otherwise generated in
the performance of or in connection with clinical studies or other studies for
the Licensed Products, including any data, reports and results with respect
thereto.
"COMBINATION PRODUCT" shall mean a Licensed Product that contains the
Licensed Compound as an active ingredient together with one or more other active
ingredients that are sold either as a fixed dose or as separate doses in a
single package.
"COMMERCIALIZATION" shall mean any and all activities related to the
marketing, promotion or sale of the Licensed Product(s).
"CONTROL" shall mean, with respect to any item of Information, Regulatory
Documentation, Patent or Intellectual Property Right, possession of the right,
whether directly or indirectly, and whether by ownership, license or otherwise
(other than by operation of the assignments, license and other grants in this
Agreement), to assign or grant a license, sublicense or other right to or under,
such Information, Regulatory Documentation, Patent or Intellectual Property
Right as provided for herein without violating the terms of any agreement or
other arrangement with any Third Party.
"DERIVATIVE COMPOUND" means an analogue or derivative of the Licensed
Compound. For the avoidance of doubt, a Derivative Compound is not an
Improvement.
"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 manufacturing in support thereof, statistical analysis and report
writing, the preparation and submission of Drug Approval Applications,
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.
"DRUG APPROVAL APPLICATION" shall mean a new drug application filed with
the applicable Regulatory Authority of a country in the Licensee Territory.
"EFFECTIVE DATE" shall mean the effective date of this Agreement as set
forth in the recitals to this Agreement.
"EXPLOIT" and "EXPLOITATION" shall mean to make, have made, import, use,
sell or offer for sale, including to research, Develop, Commercialize, register,
Manufacture, have Manufactured, hold or keep (whether for disposal or
otherwise), have used, export, transport, distribute, promote, market or have
sold or otherwise dispose of.
"FIELD" shall mean medical applications intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man but shall exclude
all other uses such as the uses for oral care, dental care, cosmetics, medical
devices, research reagents and animal health.
"FIRST INDICATION" shall mean the treatment of patients [ * ].
"FURTHER INDICATION(S)" shall mean each indication, other than the First
Indication.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 2 of 24
"GAAP" shall mean the generally accepted accounting principles consistently
applied as applied in Egypt.
"IMPROVEMENT" shall mean any modification, variation or revision to a
compound, product or technology or any discovery, technology, device or process
or formulation related to such compound, product or technology, whether or not
patented or patentable, including any enhancement in the efficiency, operation,
manufacture (including any manufacturing process), ingredients, preparation,
presentation, formulation, means of delivery, packaging or dosage of such
compound, product or technology, any discovery or development of any new or
expanded indications for such compound, product or technology or any discovery
or development that improves the stability, safety or efficacy of such compound,
product or technology; provided that, Improvements shall exclude any Derivative
Compound.
"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; (whether or not confidential, proprietary,
patented or patentable) in written, electronic or any other form now known or
hereafter developed.
"INTELLECTUAL PROPERTY RIGHTS" shall mean Trademarks, service marks, trade
names, registered designs, design rights, copyrights (including rights in
computer software), database rights, trade secrets and any rights or property
similar to any of the foregoing (other than Patents) in any part of the
Territory whether registered, capable of being registered or not registered,
together with the right to apply for the registration of any such rights.
"JOINT KNOW-HOW" shall have the meaning set forth in Section 2.5.
"JOINT PATENTS" shall have the meaning set forth in Section 2.5.
"KNOWLEDGE" shall mean actual knowledge of the vice presidents or the chief
executive officers of a Party of the facts and information then in their
possession without any duty to conduct any investigation with respect to such
facts and information.
"LEGAL ACTION" shall have the meaning set forth in Section 6.1.
"LICENSED COMPOUND" shall mean Elafin as described in the European Patent
EP0402068 "Title: Polypeptides and polypeptide analogues with inhibitory
activity against human elastase.
"LICENSED PRODUCT" shall mean any form, mode of administration or dosage of
a pharmaceutical composition or preparation that contains the Licensed Compound
as an active ingredient, including any Improvements thereto and including the
licensed product being attached to a polymer ("Pegylation"), whether such
Pegylation has been made by Licensee or Licensor.
"LICENSEE" shall have the meaning set forth in the recitals to this
Agreement.
"LICENSEE IMPROVEMENT" shall mean any Improvement conceived or used by or
on behalf of Licensee in connection with the Development of the Licensed Product
under this Agreement.
"LICENSEE KNOW-HOW" shall mean all Information, including any Licensee
Improvements and Clinical Data, that is Controlled as of the Effective Date or
during the term of this Agreement by Licensee that is not generally known and
(i) is developed or acquired by or licensed to Licensee under or in connection
with this Agreement or otherwise used by or on behalf of Licensee in the
Exploitation of the Licensed Product or the Licensed Compound or (ii) is
necessary for the Exploitation of the Licensed Product or the Licensed Compound.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 3 of 24
"LICENSEE PATENTS" shall mean all Patents Controlled by Licensee that are
necessary (or with respect to Patent applications, would be necessary if such
Patent applications were to issue as Patents) for the Exploitation of the
Licensed Product, the Licensed Compound or any Licensee Improvement thereto,
including those that claim or cover any Licensed Compound, Licensed Product,
Licensee Know-How, any Licensee Improvement thereto or the Exploitation of any
of the foregoing.
"LICENSEE TERRITORY" shall mean Egypt and Middle East North Africa (MENA)
Region as defined in ANNEX A
"MANUFACTURE" and "MANUFACTURING" shall mean all activities related to the
production, manufacture, processing, filling, finishing, packaging, labeling,
shipping and holding of the Licensed Product or any intermediate thereof,
including process development, process qualification and validation, scale up,
pre-clinical, clinical and commercial manufacture and analytic development,
product characterization, stability testing, quality assurance and quality
control.
"MINIMUM ROYALTY" shall have the meaning set forth in Section 3.2.
"NET SALES" shall mean the gross amounts invoiced by Licensee to Third
Parties within the Territory for the sale of Licensed Product (the "Invoiced
Sales"), and, only if being separately charged on customer invoices, after
deduction of (i) usual trade, cash or quantity discounts, (ii) customs duties or
(iii) value added or other sales taxes.
"PARTY" or "PARTIES" shall have the meaning set forth in the recitals to
this Agreement.
"PENDING" means something of which a Person has been notified in writing.
"PERSON" shall mean an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated
association, joint venture or other similar entity or organization, including a
government or political subdivision, department or agency of a government.
"PROTEO BIOTECH" shall have the meaning set forth in the recitals to this
Agreement.
"PROTEO BIOTECH IMPROVEMENT" shall mean any Improvement conceived or used
by or on behalf of PROTEO Biotech in connection with the Development of the
Licensed Product under this Agreement.
"PROTEO BIOTECH KNOW-HOW" shall mean all Information, including any PROTEO
Biotech Improvements and Clinical Data, that is Controlled by PROTEO Biotech as
of the Effective Date or during the term of this Agreement that is not generally
known and (i) is developed or acquired by or licensed to PROTEO Biotech under or
in connection with this Agreement or otherwise used by or on behalf of PROTEO
Biotech in the Development or Commercialization of the Licensed Product or (ii)
is necessary for the Development or Commercialization of the Licensed Product.
"PROTEO BIOTECH TERRITORY" shall mean the entire world, other than the
Licensee Territory.
"REGULATORY APPROVAL" shall mean, with respect to a country in the
Territory, any and all approvals (including Drug Approval Applications),
licenses, registrations or authorizations of any Regulatory Authority necessary
to commercially distribute, sell or market the Licensed Product in such country,
including, where applicable, (i) pricing or reimbursement approval in such
country, (ii) pre- and post-approval marketing authorizations (including any
prerequisite Manufacturing approval or authorization related thereto), (iii)
labeling approval and (iv) technical, medical and scientific licenses.
"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 Exploitation of the Licensed
Compound or the Licensed Product in the Territory.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 4 of 24
"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 Licensed Product and all data contained in any of the
foregoing, including Drug Approval Applications, regulatory drug lists,
advertising and promotion documents, Clinical Data, adverse event files and
complaint files.
"SALES PLAN" shall mean the plan (as amended) for the Commercialization of
the Licensed Product(s) in the Field in the Licensee Territory as set forth in
Section 5.1.
"THIRD PARTY" shall mean any Person other than PROTEO Biotech, Licensee and
their respective Affiliates.
"THREATENED" means a Proceeding, claim, dispute, action, or other matter
which will be deemed to have been "Threatened" if any respective written demand
or written statement has been received by a Person or any notice has been given
in writing.
SECTION 2
LICENSE GRANTS
2.1 LICENSE GRANT. PROTEO Biotech hereby grants to Licensee, subject to the
terms and conditions of this Agreement, (i) an exclusive and royalty-bearing
license (without the right to grant sublicenses) under the PROTEO Biotech
Know-How to obtain, maintain and hold Regulatory Approvals for and
toCommercialize the Licensed Product in the Field in the Licensee Territory,
however, with respect to countries in the Licensee Territory other than Egypt,
the license shall be subject to the Parties agreement on the royalty rates under
Section 3.2.2, (ii) an exclusive license to Manufacture or have Manufactured the
licensed Product in Egypt and (iii) a non-exclusive license to Manufacture or
have Manufactured the licensed Product in the other countries of the Licensee
Territory.
Licensee irrevocably acknowledges that the PROTEO Biotech Know-How is
confidential and substantial and that without PROTEO Biotech Know-How Licensee
would not be able to obtain and maintain Regulatory Approvals, access to PROTEO
Biotech Know-How will provide Licensee with a competitive advantage in the
marketplace and thus, the PROTEO Biotech Know-How has a substantial commercial
value and the payments set forth in Section 3 are, in part, intended to
compensate PROTEO Biotech for such exclusivity, competitive advantage and
commercial value.
2.2 EXCLUDED RIGHTS. PROTEO Biotech retains all right, title and interest
in and to the PROTEO Biotech Patents, the PROTEO Biotech Know-How, the Hansenula
Sublicense, the Regulatory Data and the PROTEO Biotech Corporate Name as may be
necessary or useful (i) to obtain, maintain and hold Regulatory Approvals for,
and to market, sell, have sold and otherwise Commercialize and Exploit, the
Licensed Product in the PROTEO Biotech Territory, (ii) to Develop and Exploit
the Licensed Product in the Territory to exercise its rights and perform its
obligations hereunder and to market, sell and have sold and otherwise
Commercialize the Licensed Product in the PROTEO Biotech Territory, and (iii) to
Manufacture and have Manufactured the Licensed Compound and the Licensed Product
in the Territory. Except as expressly provided herein, PROTEO Biotech grants no
other right or license (express or implied), not otherwise expressly granted
herein and Licensee shall refrain from any activities whatsoever outside the
field and outside the Licensee Territory. Licensee shall at any time refrain
from any activities including Commercialization and Exploitation of the Licensed
Compound and the Licensed Product(s) outside the Field, outside the Licensee
Territory and outside the scope of this Agreement.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 5 of 24
2.3 GRANT BACK LICENSE. Licensee hereby grants to PROTEO Biotech: a
perpetual, irrevocable royalty-free license, with the right to sublicense
through multiple tiers of sublicensees, under the Licensee Patents and the
Licensee Know-How (i) to obtain, maintain and hold Regulatory Approvals for the
Licensed Product in the PROTEO Biotech Territory, which license shall be
exclusive, (ii) to Exploit the Licensed Compound and the Licensed Product in the
Territory as necessary or useful to exercise its rights and perform its
obligations hereunder, and the right to otherwise Exploit the Licensed Compound
and the Licensed Product in the PROTEO Biotech Territory, which license shall be
exclusive in the PROTEO Biotech Territory, and (iii) to Manufacture / have
Manufactured the Licensed Compound and the Licensed Product in the Territory,
which grant shall be non exclusive.
2.4 OWNERSHIP OF JOINT PATENTS AND JOINT KNOW-HOW. [ * ].
SECTION 3
REMUNERATION
3.1 GENERAL. In consideration of the licenses and other rights granted
herein, Licensee shall make the following payments to PROTEO Biotech:
(A) UPFRONT PAYMENTS. Licensee shall make a payment of United States
[ * ] to Proteo Biotech to reimburse certain past development cost of PROTEO
Biotech in connection with the Licensed Compound. United States Dollar [ * ]
thereof shall be a non-reimbursable and non-creditable payment payable by
Licensee on the Effective Date. A further non-creditable payment of United
States Dollar [ * ] shall be made by Licensee within 10 days after issuance of
an approval relating to the commencement of a clinical Development of any of the
First Indication or any other Further Indication by the competent Egyptian
authority. This payment [ * ] shall only be reimbursable by Proteo Biotech to
Licensee, if within [ * ] from the approval relating to the commencement of a
clinical Development (i) the Regulatory Approval by the Egyptian Drug Approval
Authority is incontestably rejected or (ii) the results of clinical trials
relating to the First Indication and any other Further Indication prove that no
Regulatory Approval for such indications could be reasonably be expected to be
obtained. If any such decision Egyptian Drug Approval Authority is made later
than [ * ] after an approval relating to the commencement of a clinical
Development, this payment will not be reimbursed. Licensee's request for
reimbursement of the payment [ * ] shall be deemed a default of Licensee under
Section 10.2 hereof and Licensor shall be entitled to terminate this Agreement
in its entirety.
(B) MILESTONE PAYMENTS. Licensee shall make non creditable and
non-reimbursable milestone payments provided below within ten (10) days
following achievement, after the Effective Date, of the respective milestones:
(a) Upon obtaining the first Regulatory Approval in a country in the [ * ]
Territory for the First Indication or any of the Further
Indications (whichever occurs first)
(b) Upon the start of Commercialization for the First Indication or [ * ]
any of the Further Indications in any of the countries within the
Licensee Territory
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 6 of 24
3.2 ROYALTIES. Subject to the following provisions under this Section 3,
Licensee shall pay to PROTEO Biotech, during the term of this Agreement and for
each full or partial calendar year on a quarterly basis, royalties based on
aggregate Net Sales of the Licensed Product in the Licensee Territory:
(a) for Net Sales of the Licensed Product in Egypt, the royalty rate shall
be [ * ];
(b) for Net Sales of the Licensed Product in the other countries in the
Licensee Territory, the royalty rate shall be between a minimum of
[ * ] and a maximum of [ * ], depending on the net export sales price
for each country, to be agreed to between the Parties on country by
country basis.
(c) In the event that Licensee intends to sell the Licensed Product as a
Combination Product, the Net Sales shall be equitably calculated upon
the estimated commercial values of the proprietary active components
of such Combination Product, and the Parties shall negotiate and agree
upon such Net Sales prior to any sale of such Combination Product.
(d) In the event that sales of the Licensed Products are made from
licensee to an Affiliate of Licensee, the royalties payable by
Licensee shall be calculated on the basis of the Net Sales effected or
made by such Affiliate.
Depending on the approved indication(s), both parties shall agree on an
equitable minimum annual royalty for each country within the Territory on the
basis of the Sales Plan, subject to annual review (the "MINIMUM ROYALTY")
3.3 ROYALTY PAYMENT AND STATEMENTS. Running royalties 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 royalties shall be
calculated in accordance with GAAP and with the terms of this Section 3. Each
royalty payment hereunder shall be accompanied by a statement showing the
invoiced sales and the Net Sales, the number of units of Licensed Product sold
on a country-by-country basis ands on a size-by-size basis during the applicable
calendar quarter, any deductions from invoiced sales, and the amount of
royalties due on such Net Sales.
3.4 TAXES. All amounts payable by Licensee to PROTEO Biotech shall be made
without set-off and without deduction or withholding of any taxes, duties,
imposts, fees or charges, except as required by Applicable Law. If a tax treaty
for the avoidance of double taxation or any similar treaty is applicable, Proteo
Biotech may provide to Licensee or the appropriate governmental authority the
respective forms and documentation necessary to benefit from the advantages for
such treaty and Licensee shall assist Proteo Biotech to achieve such benefits.
All Payments are exclusive of value added or similar tax. If any such tax is
chargeable in respect of any payments, Licensee shall in addition pay or
reimburse and hold harmless, as the case may be, to Proteo Biotech such tax.
3.5 BANK ACCOUNT AND CURRENCY. All payments to PROTEO Biotech shall be made
in USD to such bank account as Proteo Biotech may designate to Licensee from
time to time. With respect to sales not made in USD by Licensee, royalty
payments shall be calculated based on the currency exchange rates for the
calendar quarter for which remittance is made for royalties. 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 "xxx.xxxxx.xxx" or, if not available, as otherwise
agreed by the Parties.
3.6 INTEREST ON LATE PAYMENT. If any payment due to Proteo Biotech is
overdue, then Licensee shall pay interest thereon at an annual [ * ].
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 7 of 24
3.7 ACCOUNTING AND ACCOUNTING DISPUTES. Unless otherwise required by
Applicable Law, during the term of this Agreement and for a period of 6 months
thereafter, Licensee shall keep and maintain (and shall cause its Affiliates to
keep and maintain) separate, complete and accurate books and records permitting
the calculation and determination of the royalties payable to Proteo and shall
permit (and shall cause its Affiliates to permit) Proteo Biotech upon reasonable
notice to examine such books and records. All reasonable cost and expenses in
connection with such examination shall be borne by Proteo Biotech, unless the
audit reveals a shortfall of more than three percent (3%) from the reported
amounts. If the parties cannot agree on the amount of royalties payable by
Licensee, PROTEO Biotech and Licensee shall in good faith try to resolve this
dispute. If the Parties are unable to reach a mutually acceptable resolution of
such dispute, Proteo Biotech may submit the matter to a well recognized
international certified public accounting firm selected by Proteo Biotech or to
such other Person as the Parties shall mutually agree. The decision of the
arbitrator shall be final and binding for the Parties and the outstanding
royalties as well as the cost of the arbitration (including the cost of the
initial examination) shall be borne and payable by Licensee as the arbitrator
shall determine.
SECTION 4
PARTIES' ADDITIONAL COVENANTS
4.1 DEVELOPMENT RESPONSIBILITIES.
(A) LICENSEE DUTY OF CARE. Licensee shall use reasonable best efforts
to Develop and obtain Regulatory Approvals for the Licensed Products in the
Licensee Territory and shall thus apply such efforts and resources as commonly
used by companies in the research-based pharmaceutical industry.
(B) COMPLIANCE WITH APPLICABLE LAW. Licensee shall perform (and cause
to be performed) any of its Development obligations in good scientific manner
and in compliance with all Applicable Law, and shall allocate sufficient time,
effort, equipment and skilled personnel to complete such Development
successfully and promptly.
4.2 DEVELOPMENT SUPPORT.
(A) PROTEO INITIAL SUPPORT. Subject to receipt of the payments payable
by Licensee under Section 3.1.1 on the Effective Date and subject to the
reimbursement of Proteo Biotech's respective cost, as soon as practical after
the Effective Date, Proteo Biotech shall [ * ] of the Licensed Compound [ * ],
to the extent Controlled by Proteo Biotech and to the extent existing at the
premises of Proteo Biotech. In this respect, Proteo Biotech has already
delivered to Licensee a [ * ] the Licensed Compound as [ * ] (see Annex B) and
shall deliver, provide or give access to Licensee the following under its
Control: (i) [ * ], all as specified in Annex C.1, (ii)[ * ], all as specified
in Annex C2and (iii) [ * ], all as described in Annex D.
(B) PARTIES DEVELOPMENT SUPPORT. To the extent Controlled by them,
each Party shall (as soon as possible after respective availability) provide to
the other Party copies of all Clinical Data and non-clinical data, and all other
results and analyses with respect to any Development and Manufacturing
activities relating to the Licensed Product(s). Proteo Biotech shall perform
such activities subject to Licensee having in advance and in writing agreed to
reimburse Proteo Biotech for its reasonable costs and expenses associated
therewith.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 8 of 24
(C) MANUFACTURING PROCESS. The manufacturing process relating to the
Licensed Compound shall be installed by Licensee at Licensee's own cost and
expenses in Licensee's premises as shown in the Notice Section. The parties in
this respect shall agree on the details of the making available of the
respective manufacturing know how.
4.3 REGULATORY MATTERS AND RESPONSIBILITY.
(A) GENERAL RESPONSIBILITY. Licensee shall be solely responsible for
the Development of and for any Drug Approval Applications and other Regulatory
Approvals for the Licensed Products in the Licensee Territory and any
communication related thereto; however Licensee shall have no right to apply for
and shall refrain from doing so with respect to (i) Regulatory Approvals outside
the Licensee Territory and (ii) Adverse Activities.
(B) COMMUNICATION. Licensee shall prepare and submit to PROTEO Biotech
as soon as possible all submissions and communications (including such of its
Affiliates, Sublicensees or Distributors and including any supplements or
modifications thereto, in all cases together with true English translations) to
the Regulatory Authorities in the Licensee Territory. Proteo Biotech shall have
the right to review and comment on the content and subject matter of, and
strategy for, each Drug Approval Application and other filing for Regulatory
Approval, all correspondence submitted to the Regulatory Authorities related to
the design of clinical or other studies, and related communications and
decisions with the Regulatory Authorities.
(C) SERIOUS ADVERSE EXPERIENCES. Either Party shall as soon as
practicable provide to the other Party documentation concerning serious adverse
experiences required to be reported to a Regulatory Authority pursuant to
Applicable Law. The Parties shall collaborate in order to establish a system of
reporting to each other of such experiences in the application of the Licensed
Product. This system shall enable both Parties to discharge any regulatory
requirements they may have with respect to the disclosure of such information.
(D) MEETINGS AND RECORDS. Licensee shall provide Proteo Biotech as
soon as possible with prior written notice of any meeting with any Regulatory
Authority in the Licensee Territory (including their advisory councils or
committees, experts or Persons of similar capacity) in order to give Proteo
Biotech a reasonable opportunity to attend such meetings. PROTEO Biotech shall
be entitled but shall not be obliged to have reasonable representation present
at all such Major Meetings relating to the Licensed Product in the Licensee
Territory. Licensee shall maintain records of its respective Development
activities with respect to the Licensed Product in sufficient detail and in good
scientific manner appropriate for regulatory purposes, which shall be complete
and accurate and shall fully and properly reflect all work done and results
achieved in the performance of its respective Development activities, and which
shall be retained by Licensee for at least 6 months after the termination of
this Agreement, or for such longer period as may be required by Applicable Law.
Proteo Biotech shall have the right, during normal business hours and upon
reasonable notice, to inspect and copy any such records. Licensee shall provide
PROTEO Biotech with such information regarding the Licensee Activities as PROTEO
Biotech may reasonably request from time to time.
4.4 ADVERSE ACTIVITIES. Licensee shall not have the right to undertake any
activity or action with respect to the Licensed Product where such activity or
action creates a risk of adverse results that could be expected to have an
adverse effect on the Development, Commercialization or Exploitation of Licensed
Product(s) in the PROTEO Biotech Territory.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 9 of 24
SECTION 5
LICENSEE COMMERCIALIZATION DUTIES
5.1 COMMERCIALIZATION OF THE LICENSED PRODUCT.
(A) LICENSEE'S GENERAL OBLIGATIONS. Licensee shall use reasonable best
efforts to Commercialize the Licensed Product in each country in the Licensee
Territory where conducting such activities would be commercially reasonable
after having obtained all Regulatory Approvals necessary in such country in the
Licensee Territory. Licensee shall allocate sufficient time, effort and skilled
personnel to at least meet the objectives of the Sales Plan.
(B) SALES PLAN. The Commercialization of the Licensed Product in the
Licensee Territory shall be conducted pursuant to a sales plan and budget to be
prepared by Licensee pursuant to this Section with respect to the Licensee
Territory on a country by country basis (the "Sales Plan"). With respect to
either of the Countries within the Licensee Territory, the following shall
apply: No later than [ * ] after having obtained the regulatory approvals in
each such country in the Licensee Territory, Licensee shall submit for approval
to Proteo Biotech a draft Sales Plan for Commercialization of the Licensed
Product within such country from the envisaged date of the first Licensed
Product launch [ * ] through the consecutive [ * ] after such launch. As soon as
practicable, Proteo Biotech shall review and the Parties shall agree on such
proposed plan(s). The Parties shall agree from time to time and on a regular
basis on commercially reasonable updates of the Sales Plan.
5.2 COMPLIANCE WITH APPLICABLE LAW.
(A) PUBLIC STATEMENTS. Licensee shall be responsible for the issuance
and dissemination of accurate information regarding the Licensed Product in
compliance with Applicable Laws.
(B) COMPLIANCE WITH LAWS. Licensee shall comply with all Applicable
Law with respect to the Commercialization of Licensed Product. Neither Party
shall be required to undertake any activity relating to the Commercialization of
the Licensed Product that it believes, in good faith, may violate Applicable
Law.
5.3 UNAUTHORIZED SALES. Licensee with respect to the Licensee Territory,
and PROTEO Biotech with respect to the PROTEO Biotech Territory shall, and shall
cause its distributors - if any - to, distribute, market, promote, offer for
sale and sell the Licensed Product only in its respective part of the Territory,
and shall not, and shall not permit such distributors to, distribute, market,
promote, offer for sale or sell the Licensed Product directly or indirectly (i)
to any Person outside its part of the Territory or (ii) to any Person inside its
part of the Territory that (1) is reasonably likely to directly or indirectly
distribute, market, promote, offer for sale or sell the Licensed Product outside
its part of the Territory or assist another Person to do so or (2) has directly
or indirectly distributed, marketed, promoted, offered for sale or sold the
Licensed Product outside its part of the Territory or assisted another Person to
do so.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 10 of 24
5.4 REPORTING. Licensee shall in reasonable detail report to Proteo Biotech
on a country - by - country regular basis (at least once a year) relating to the
Commercialization of the Licensed Product in the Licensee Territory and
Licensee's compliance with or deviation from the Sales Plan.
5.5 COMMERCIALIZATION EFFORTS. Within [ * ] from the Effective Date, the
Parties shall meet and see on a country by country basis whether or not Licensee
has Commercialized the Licensed Product pursuant to the provisions of this
Agreement. If Licensor deems that Licensee has failed to do so in certain
countries within the Territory, then upon Licensor's request Licensee shall
enter into good faith negotiations with Licensor as to a reduction of the
Territory for such countries, if Licensee can demonstrate own economic interest
with respect to such reduction of the Territory. If [ * ] from the Effective
Date Licensee has with respect to any country within the Territory not obtained
a Regulatory Approval - if required to be obtained in such country - or if
Licensee has not started or ceased to Commercialize the Licensed Product
pursuant to the provisions of this Agreement in any country(ies), then the
exclusive license for such country will become non-exclusice.
SECTION 6
LICENSED PRODUCT RECALL
6.1 RECALL NOTIFICATION. In the event that (i) any Regulatory Authority or
any other Person or Third Person issues or requests a recall or takes similar
action in connection with the Licensed Product, (ii) any Third Party or Person
initiates Class Actions or similar law suits or (iii) in the event either Party
determines that an event, incident or circumstance has occurred that may
reasonably be determined to result in the need for a recall or market withdrawal
(collectively a "Legal Action"), the Party notified of or desiring such recall
or similar action shall, within twenty-four (24) hours, advise the other Party
thereof by telephone (and confirm by email or facsimile), email or facsimile.
Following notification of a recall in the Licensee Territory, the Parties shall
meet as soon as practical to discuss such notification or recall and Licensee
shall decide whether to conduct a recall (except in the case of a
government-mandated recall) and the manner in which any such recall shall be
conducted.
6.2 RECALL EXPENSES. Licensee shall be solely responsible for and shall
bear the cost, expenses and damages as they relate to any recall of or any Legal
Action in connection with the Licensed Product in the Licensee Territory and
shall indemnify and hold harmless Proteo Biotech respectively as provided for in
Section 9.1 hereof.
SECTION 7
CONFIDENTIALITY AND NON-DISCLOSURE
7.1 CONFIDENTIALITY OBLIGATIONS. At all times during the term of this
Agreement and for a period of three (3) years following termination or
expiration hereof, Licensee 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 Biotech, except to the extent such
disclosure or use is expressly permitted by the terms of this Agreement, is
reasonably necessary for the performance of this Agreement or is made in the
cause of the exercise of rights afforded to the Parties hereunder. "Confidential
Information" means any information provided by Proteo Biotech to the Licensee
relating to the terms of this Agreement, the remuneration payable to Proteo
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 11 of 24
Biotech under this Agreement, the Licensed Compound or the Licensed Product
(including the Regulatory Documentation, the Regulatory Approvals, and any
information or data contained in all of the aforesaid as well as any information
contained in Annexes B, C1 , C2 and D or information and data delivered or made
accessible to Licensee by Proteo Biotech pursuant to or in connection with such
Annexes), any Development or Commercialization of the Licensed Compound or the
Licensed Product or the scientific, regulatory or business affairs or other
activities of Proteo Biotech. 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 receiving Party;
(B) can be demonstrated by documentation or other competent proof to
have been in the Licensee's possession prior to disclosure by Proteo Biotech
without any obligation of confidentiality with respect to said information;
(C) is subsequently received by the receiving Party from a Third Party
who is not bound by any obligation of confidentiality with respect to said
information;
(D) has been published by a Third Party or otherwise enters the public
domain through no fault of the receiving Party in breach of this Agreement; or
7.2 PERMITTED DISCLOSURES. Licensee may disclose Confidential Information
to the extent that such disclosure is:
(A) Made in response to a valid order of a court of competent
jurisdiction, if in the reasonable opinion of the Licensee, such disclosure is
required by law; provided, however, that the receiving Party shall first have
given notice to the disclosing Party and given the disclosing Party a reasonable
opportunity to quash such order and to obtain a protective order requiring that
the Confidential Information and documents that are the subject of such order be
held in confidence by such court; or
(B) Made by Licensee to the Regulatory Authorities as required in
connection with any filing, application or request for Regulatory Approval;
provided, however, that reasonable measures, to the extent available, shall be
taken to assure confidential treatment of such information.
7.3 PRESS RELEASES. Press releases or other similar public communication by
either Party relating to this Agreement shall be approved in advance by the
other Party, 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. However, Licensee acknowledges
the right and obligation of Proteo Biotech and its Affiliates' to disclose
information relating to or in connection with this Agreement.
7.4 XXXXXXX XXXXXXX. Licensee understands and agrees that Licensee 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.
7.5 PATIENT INFORMATION. The Parties agree to abide and to take (and cause
to be taken) all reasonable and appropriate actions to ensure that all Third
Parties conducting or assisting with any clinical development activities
hereunder in accordance with, and subject to the terms of, this Agreement, shall
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 12 of 24
abide, to the extent applicable, by all Applicable Law concerning the
confidentiality or protection of patient identifiable information and/or
patient's protected health information.
7.6 PUBLICATIONS. Proteo Biotech 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 Licensed Product or other data
generated under this Agreement.
7.7 RETURN OF CONFIDENTIAL INFORMATION. Upon the effective date of the
termination of this Agreement for any reason except expiry, Proteo Biotech may
request, and Licensee shall (i) promptly destroy all copies of such Confidential
Information in the possession of Licensee and shall confirm such destruction in
writing to Proteo Biotech, or (ii) promptly deliver to Proteo Biotech all copies
of such Confidential Information in the possession of Licensee.
SECTION 8
REPRESENTATIONS AND WARRANTIES
8.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party hereby
represents, warrants and covenants to the other Party that, as of the Effective
Date, and except as set forth in Schedule 8.1:
(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) LITIGATION. Such Party is not aware of any Pending or Threatened
litigation that alleges that such Party's activities related to this Agreement
have violated or that by conducting the activities as contemplated herein such
Party would violate, any of the Patent or Intellectual Property Rights of any
other Person.
(C) 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.
(D) 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.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 13 of 24
8.2 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF LICENSEE. Licensee
represents, warrants and covenants to PROTEO Biotech that, as of the Effective
Date, unless otherwise disclosed in SCHEDULE 8.2 hereof:
(A) Licensee (i) is a corporation duly organized and in good standing
under the laws of Egypt 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.
8.3 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF PROTEO BIOTECH. PROTEO
Biotech represents, warrants and covenants to Licensee that, as of the Effective
Date unless otherwise disclosed in SCHEDULE 8.3:
(A) PROTEO Biotech 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 Biotech Controls the PROTEO Biotech Know-How, and is
entitled to grant the licenses specified herein. Except for any obligation of
PROTEO Biotech or any of its Affiliates under the German act on employees'
inventions (Gesetz uber Arbeitnehmererfindungen) or corresponding laws in other
jurisdictions, PROTEO Biotech has not - except for ordinary course of business
transactions - caused (i) any PROTEO Biotech Know-How to be subject to any liens
or encumbrances and (ii) PROTEO Biotech has not granted to any Third Party any
rights or licenses under any of the PROTEO Biotech Know-How or PROTEO Biotech
Patents that would conflict with the licenses granted to Licensee hereunder.
(C) PROTEO Biotech has no Knowledge of any actual infringement or
Threatened infringement of the PROTEO Biotech Know-How by any Person.
(D) PROTEO Biotech has not, up through and including the Effective
Date, Knowingly withheld any material information, including reports of Adverse
Event Experiences and warning letters from Regulatory Authorities, in PROTEO
Biotech's possession from Licensee in response to Licensee's reasonable
inquiries in connection with its due diligence relating to the Licensed
Compound, potential Licensed Product(s), this Agreement and the underlying
transactions contemplated thereby.
8.4 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN
THIS SECTION 8 AND SUBJECT TO THE QUANTUM LIMITATIONS CONTAINED TO THE FAVOUR OF
PROTEO BIOTECH IN SECTION 9.2 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 VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
SECTION 9
INDEMNITY
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 14 of 24
9.1 LICENSEE INDEMNIFICATION OBLIGATION. Licensee shall indemnify PROTEO
Biotech, its Affiliates and their respective directors, officers, employees,
licensors and agents, and defend and save each of them harmless, from and
against any and all losses, damages, liabilities, costs and expenses (including
reasonable attorneys' fees and expenses) in connection with any and all suits,
investigations, claims or demands of Third Parties arising from or occurring as
a result of and including: (i) the breach by Licensee of any term of this
Agreement; (ii) the negligence or willful misconduct on the part of Licensee
under this Agreement; (iii) any Third Party or Person claim under Section 6
hereof or (iv) the Exploitation by or on behalf of Licensee of the Licensed
Product. By signing this Agreement, Minapharm Pharmaceuticals S.A.E. herewith
assumes together with Licensee joint and several liability for the
indemnification obligations under this Section 9.1.
9.2 LIMITATION ON DAMAGES AND LIABILITY. EXCEPT IN CIRCUMSTANCES OF
INTENTIONAL MISCONDUCT BY PROTEO BIOTECH OR ITS AFFILIATES, NEITHER PROTEO
BIOTECH NOR ANY OF ITS RESPECTIVE AFFILIATES SHALL BE LIABLE FOR SPECIAL,
INDIRECT, OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS, WHETHER IN CONTRACT,
WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (I)
THE DEVELOPMENT, MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCT OR LICENSED
COMPOUND UNDER THIS AGREEMENT, (II) THE USE OF OR REFERENCE TO ANY PATENTS,
KNOW-HOW OR REGULATORY DOCUMENTATION, OR (III) ANY BREACH OF OR FAILURE TO
PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT.
IN ADDITION ANY WARRANTY AND LIABILITY OF PROTEO BIOTECH (INCLUDING ANY OF ITS
RESPECTIVE AFFILIATES) TO LICENSEE UNDER OR IN CONNECTION WITH THIS AGREEMENT
SHALL BE LIMITED TO THE AGGREGATE OF ANY PAYMENTS MADE BY LICENSEE TO PROTEO
BIOTECH.
SECTION 10
TERM AND TERMINATION
10.1 TERM. This Agreement shall commence upon the Effective Date and shall
automatically terminate in all countries of the Licensee Territory after a
period [ * ] years after the first commercial sales of a licensed products.
10.2 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.
10.3 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.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 15 of 24
10.4 CONSEQUENCES OF TERMINATION. In case of any termination, other than
expiry of this Agreement, Licensee shall immediately cease any activities as
concerns the Development, the Commercialization or Exploitation of Licensed
Products within or outside the Territory.
10.5 RIGHTS IN CASE OF ANY CHANGE OF STATUS AND / OR OWNERSHIP
It is agreed by both Parties that any change of status and / or ownership,
and / or shareholding of either Party shall not affect the implementation of
this Agreement in full, in any matter whatsoever, and therefore, all terms and
conditions of this Agreement shall remain binding.
SECTION 11
MISCELLANEOUS
11.1 EXPORT CONTROL. This Agreement is made subject to any restrictions
concerning the export of products or technical information under Applicable
Laws. Each Party agrees that it shall not export, directly or indirectly, any
technical information acquired from the other Party under this Agreement or any
products using such technical information to a location or in a manner that at
the time of export requires an export license or other governmental approval,
without first obtaining the written consent to do so from the appropriate agency
or other governmental entity in accordance with Applicable Law.
11.2 NON-SOLICITATION. During the term of this Agreement and for a period
[ * ] thereafter, neither Party shall actively recruit or solicit any employee
of the other Party or its Affiliates.
11.3 ASSIGNMENT. Without the prior written consent of the other Party
hereto, neither Party shall sell, transfer, assign, delegate, pledge or
otherwise dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder; provided,
however, that PROTEO Biotech may, without such consent, assign this Agreement
and its rights and obligations hereunder to an Affiliate, to the purchaser or
the licensee of the PROTEO Biotech Patents or PROTEO Biotech Know-How or to
Proteo Biotech's successor entity or acquirer in the event of a merger,
consolidation or change in control of PROTEO Biotech or any of its Affiliates.
11.4 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 here from. 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.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 16 of 24
11.5 GOVERNING LAW, JURISDICTION, ARBITRATION AND SERVICE
(A) GOVERNING LAW. This Agreement shall be governed by and construed
in accordance with the laws of France, excluding any conflicts or choice of law
rule or principle 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 / three] arbitrators appointed in accordance with
the said rules. The place of arbitration shall be Paris, the arbitration shall
be held in the English language. The aforesaid notwithstanding, either Party
shall also be entitled to initiate legal proceedings at the courts having
jurisdiction with respect to the place of incorporation of the other Party.
(C) SERVICE. Each Party further agrees that service of any process,
summons, notice or document by registered mail to its address set forth in
Section11.6 shall be effective service of process for any action, suit or
proceeding brought against it under this Agreement in any such court.
11.6 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 11.6. 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 Licensee, to: If to PROTEO Biotech, to:
Rhein Minapharm SAE PROTEO Biotech AG
Mina Street, Industrial Zone A3#2 Am-Kiel-Kanal 44
10th of Ramadan, Egypt X-00000 Xxxx, Xxxxxxx
Attention: CEO Attention: Vorstand
Facsimile: x00 00 000000 Facsimile: x00 000 0000000
with a copy to: with a copy to:
11.7 ENTIRE AGREEMENT. This Agreement, together with the 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.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 17 of 24
11.8 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 language.
11.9 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.
11.10 NO BENEFIT TO THIRD PARTIES. The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties hereto and their successors and permitted assigns, and they shall
not be construed as conferring any rights on any other Persons.
11.11 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.
11.12 RELATIONSHIP OF THE PARTIES. It is expressly agreed that PROTEO
Biotech and Licensee 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.
11.13 COUNTERPARTS. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. This Agreement may be
executed by facsimile signatures and such signatures shall be deemed to bind
each party hereto as if they were original signature.
11.14 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 (c)
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.
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 18 of 24
11.15 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 this Agreement or the intent of any provision contained in this
Agreement. The term "including" and "such as" as used herein shall mean
including, without limiting the generality of any description preceding such
term. The language of this Agreement shall be deemed to be the language mutually
chosen by the Parties and no rule of strict construction shall be applied
against either Party hereto.
Place, (Place, Date),______________
Proteo Biotech XX Xxxxx Minapharm Biogenetics S.A.E.
By: /s/ Xxxxx Xxxxxxxx By: /s/ Xxxxx Xxxxxxxx
-------------------- --------------------
Name: Xxxxx Xxxxxxxx Name: Xx. Xxxxx Xxxxxxxx
Title: Vorstand Title: CEO
We do hereby accept and assume joint and several liability with Rhein Minapharm
Biogenetics SAE pursuant to the provisions of Section 9.1 of this Agreement:
(Place, Date), ____________
Minapharm Pharmaceuticals S.A.E.
By: /s/ Xxxxx Xxxxxxxx
Name: Xx. Xxxxx Xxxxxxxx
Title: CEO
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 19 of 00
XXXXX X
XXXXXX XXXX XXXXX XXXXXX (MENA) REGION
ALL AFRICAN COUNTRIES PLUS THE FOLLOWING MIDDLE EASTERN COUNTRIES:
[ * ]
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 20 of 24
ANNEX B
LICENSED PRODUCT ELAFIN
[ * ].
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 21 of 24
ANNEX C.1
[ * ]
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 22 of 24
ANNEX C.2
PROTEO BIOTECH AG KNOW-HOW PACKAGE FOR PRODUCTION OF R-ELAFIN
[ * ]
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 23 of 24
ANNEX D
ASSISTANCE AND PROCESS TRAINING
[ * ]
[ * ] The following portion has been omitted pursuant to a Confidential
Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934 and
has been filed separately with the Securities and Exchange Commission.
Page 24 of 24
