JOINT VENTURE FRAMEWORK AGREEMENT
between
Biofrontera Pharmaceuticals GmbH, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇
including its affiliated companies Biofrontera AG and Biofrontera Discovery GmbH
- Biofrontera -
and
DNAPrint genomics Inc., ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇. Sarasota, FL 34236, USA
- DNAPrint -
Preamble:
DNAPrint and Biofrontera AG have agreed that DNAPrint will invest EUR 20,000,000
in Biofrontera AG in return for shares in Biofrontera AG created via a share
capital increase pursuant to the investment agreement dated the same date as
this Agreement (the DNAPrint Investment Agreement).
DNAPrint and Biofrontera both own technologies that provide an ideal fit to
discover new drugs and develop them to market. To make optimal use of the
combined resources, they have agreed to set out Joint Ventures with the
objective to develop medications for sale.
1. Definitions
1.1 Agreement means this joint venture framework agreement;
Know-how means all technical information, experience and data (including
drawings, specifications, computer programs and documentation) relating to
the Agreement, in particular all results of research and development work
in relation to this Agreement, including the results of the pre-clinical
and clinical developments (including phase II and phase III), all public
and non-public dossiers, synthesis descriptions and documentation, and any
formulations.
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SEC Approval means the approval as defined in Clause 12 of the DNAPrint
Investment Agreement.
Joint Venture means a contractual or corporate joint venture formed on the
basis of this Agreement.
1.2 Unless otherwise specified, any reference to Clauses and Subclauses are
references to clauses and Subclauses of this Agreement.
1.3 Defined terms importing the singular shall include the plural and vice
versa.
1.4 Unless otherwise specified, temporal limits and events expressed in this
Agreement are inclusive.
1.5 Unless otherwise specified the terms "in particular" and "including" shall
mean respectively, "including but without limitation" and "in particular
but without limitation".
2. intention to create joint ventures
2.1 DNAPrint and Biofrontera both own technologies that provide an ideal fit
to discover new drugs and develop them to market. To make optimal use of
the combined resources, they have agreed to set out Joint Ventures with
the objective to develop medications for sale. The parties will openly
exchange confidential information about their respective technologies, and
agree to undertake commercially reasonable practices to within 90 days or
sooner enter into a definitive agreement upon the formation of mutually
beneficial Joint Ventures for the joint development of selected projects.
Each Joint Venture shall be formed under a separate agreement, the general
principles of which are set out in Clause 3.
The parties or their affiliated companies have the following compounds and
technologies under development:
Biofontera's projects at the preclinical research stage include
Cathepsin inhibitors
Inhibitors for protease activated receptors
Inhibitors for sphingomyelinase
Kinase inhibitors
Biofrontera's projects at the preclinical development stage include
- 5-HT2B receptor inhibitor for migraine prophylaxis
Biofrontera's projects at the clinical development stage include
Histidine decarboxylase inhibitor (Phase II)
Skin cancer drug (Phase II, inlicensing deal currently closed)
DNAPrint's projects include
Ovanome - Taxol/Carboplatin efficacy
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Statnome - Lipitor, Zocor, efficacy
Statnome Muscle - Lipitor, Zocor adverse myalgia response
Acenome - Enalapril, Lisinopril efficacy
Acenome Musc - Enalapril, Lisinopril adverse cough
Immunosuppressants - Sirolimus, Tacrolimus, Mycophenolate
mofetil efficacy in transplant patients
▇▇▇▇▇▇▇ projects
1) Response of Metastatic Colorectal Cancer to
Irinotecan/Capecitabine (Xeliri) and Oxaliplatin/Capecitabine
(Xelox)
2) Melphalan and Topotecan (MT) efficacy for treatment of
Multiple Myeloma
3) Cyclophosphamide efficacy
4) Organistron adverse events - post operative nausea and
vomiting
5) Esophageal malignancy chemotherapy response - standard FDA
treatment
3. GENERAL TERMS OF EACH JOINT VENTURE
3.1 Biofrontera's contribution to the Joint Venture will consist in a licence
to the Joint Venture to use selected technology related Know-how and
related intellectual property relevant to the business objective of the
Joint Venture. DNAPrint's contribution to the Joint Venture shall consist
either in kind i.e. research and development or cash and selected
technology related Know-how and related intellectual property relevant to
the business objective of the Joint Venture.
3.2 The parties agree that the relative values of the inputs of both parties
defined in Subclause 3.1 will be reflected by the equity ownership in the
Joint Venture, or otherwise as mutually agreed.
3.3 No party shall be obliged to assign any of its intellectual property
rights to the Joint Venture. Each invention made by or on behalf of a
party shall vest in that party. Each party will protect its inventions
relevant to the business objective of the Joint Venture, and license them
and relevant Know how to the Joint Venture. Depending on the relevant
business objective of the Joint Venture, the grant of licences to the
Joint Venture shall have the objective to put the Joint Venture into the
position of exclusive worldwide marketing rights for the development and
exploitation of selected drug candidates.
3.4 The term of the Joint Venture shall be until either expiration of last
patent protecting the relevant product marketed by the Joint Venture or 10
years from first sales, whichever event is later.
3.5 Profits shall be shared according to participation in the Joint Venture.
3.6 The parties shall establish and mutually agree upon (i) an overall plan to
develop the product to market and (ii) rolling annual development plans.
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3.7 In case of non-performance or late performance by either party (including
delay of more than six months compared to the yearly development plan
unless caused by project-related unforeseen events):
(a) the party in default looses its right to develop the product and will
agree to transfer to the other party a percentage in its ownership in the
Joint Venture that corresponds to the percentage of the total development
cost that has not been spent up to this point, or
(b) each party has the right to offer its part to the other party in exchange
for royalties or outright sale of its ownership.
4. Term
4.1 This Agreement shall commence on signing and is valid for four years. This
Agreement will be automatically renewed for further two years if not
terminated by one of the Parties with six month's prior written notice.
4.2 The right to terminate this Agreement without notice for cause shall
remain unaffected.
5. Condition SUBSEQUENT
This Agreement shall cease to be binding if the SEC Approval is not granted
within 120 days after the signing of this Agreement unless agreed
otherwise.
6. Confidentiality
6.1 Each party undertakes to keep strictly confidential any and all secret
Know-how and other proprietary information received from the other party
prior to and during the term of this Agreement or any Joint Venture
agreement (Information). Each party shall use such Information only for
the purposes of the evaluation of the possibility of entering into a Joint
Venture and may not make available Information to any third party. The
obligation not to disclose Information shall not apply to any part of such
Information that: (i) is or becomes part of the public domain other than
by unauthorized acts of the party obligated not to disclose such
Information or sublicensees; (ii) can be shown by written documents to
have been disclosed to the receiving party or sublicensees by a third
party, provided such Information was not obtained by such third party in
violation of a confidentiality obligation vis-a-vis the disclosing party;
(iii) prior to disclosure under this Agreement, was already in the lawful
possession of the receiving party or its sublicensees; (iv) can be shown
by written documents to have been independently developed by the receiving
party without breach of any of the provisions of this Agreement; or (v) is
or must be disclosed by the receiving party pursuant to interrogatories,
requests for information or documents, subpoena, civil investigative
demand issued by a court or governmental agency or as otherwise required
by federal or state law or regulation (including, for the sake of
clarification, under FDA rules and regulations), provided that the
receiving party notifies the other party immediately upon receipt of a
request, interrogatory, court decree etc under which information must be
disclosed and grants the disclosing party the possibility to seek legal
protection against such disclosure and limits the scope of disclosure to
that portion of the Information that is legally required to be disclosed.
Each party undertakes to allow only access to Information to employees on
a need to know basis and to impose the above duty of confidentiality on
all of its employees who could acquire Information. To the extent
reasonably possible, employees shall be made subject to the duty of
confidentiality even after expiry or termination of their employment.
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6.2 On expiry or termination of this Agreement each party shall return to the
other all documents containing Information of the other, unless this
Information may be used under a Joint Venture agreement.
6.3 The parties' obligations under this Clause 6 shall survive the term of
this Agreement.
7. WARRANTY
Each party warrants that it is not prevented from entering into this
agreement or to assume any of its obligations under this Agreement by
virtue of agreements with third parties, by law or otherwise.
8. General Provisions
8.1 This agreement is binding on both parties, which will use commercially
reasonable efforts to exploit mutually beneficial opportunities and
technologies.
8.2 This Agreement may not be assigned or otherwise transferred by either
party to a third party without the prior written consent of the other
party; provided however, that either party may, without such consent,
assign its position under the Agreement as a whole in connection with a
merger, consolidation or sale of substantially all of such party's assets
to an unrelated third party or a sale to an unrelated third party of all
or a substantial portion of its business of which the transaction
contemplated hereby is a part unless where the third party is a competitor
of the other party, in which case the merger, consolidation or sale shall
require the prior written consent of the other party, which consent shall
not be unreasonably withheld or delayed. The assigning party's rights and
obligations under this Agreement shall be assumed in writing by the
assignee and the assigning party shall inform the other party of the
assignment without undue delay after the assignment.
8.3 This Agreement contains the whole agreement between the parties relating
to its subject matter and supersedes all previous agreements of the
parties relating to the subject matter, in particular the letter of intent
between DNAPrint and Biofrontera dated 23 July 2004.
8.4 Amendments or supplements to this Agreement must be in written form in
order to be legally valid. The foregoing applies also to any waivers of
this written form requirement. To the extent to which this Agreement
stipulates that declarations shall be effected in written form, the
submission by fax or email shall suffice.
8.5 If any current or future term of this Agreement is wholly or partially
invalid or unenforceable or subsequently becomes invalid or unenforceable,
this shall not affect the validity of the remaining terms of the
Agreement. The same applies if it is ascertained that this Agreement
contains a gap. In place of the gap, an appropriate term will apply which,
to the extent permitted by law, most closely reflects that which the
parties intended or would have intended given the spirit and purpose of
this Agreement if they had considered the issue upon execution of this
Agreement. The foregoing shall apply even if the invalidity of a term is
based on a measurement of performance or time (period/deadline) set forth
in this Agreement. In such a situation, a legally permitted measurement of
performance or time (period/deadline) which most closely reflects that
which was intended shall replace the agreed term.
8.6 This Agreement shall be executed in two or more counterparts, each of
which shall be deemed to be an original but all of which together shall
constitute one and the same instrument.
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9. Costs
Each party shall bear its own costs and expenses in connection with this
Agreement including legal, accounting and other advisory fees and costs
for any regulatory filings unless this Agreement provides otherwise.
10. Governing Law and Jurisdictions
10.1 This Agreement is governed by and shall be constituted in accordance with
the laws of the Federal Republic of Germany with the exclusion of the
United Nations convention on contracts for the international sale of
goods.
10.2 To the extent legally permissible each party submits to the exclusive
jurisdiction of the courts of Frankfurt am Main, Germany for all purposes
relating to this Agreement. The parties waive any objection to the German
courts on grounds that they are an inconvenient or inappropriate forum to
settle any such dispute. DNAPrint shall at any time have appointed an
agent for service of process domiciled in Germany and undertakes to inform
the Biofrontera of any change within a period of ten (10) days after the
change has been effected. ss. 170 of the BGB shall remain unaffected.
DNAPrint herewith appoints ▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇ & Maw LLP, Bockenheimer
▇▇▇▇▇▇▇▇(beta)e 98-100, 60323 Frankfurt am Main as its agent in Germany
for service of process.
Date/Place:
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DNAPrint genomics Inc.
Date/Place:
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Biofrontera Pharmaceuticals GmbH
also for and on behalf of Biofrontera AG and Biofrontera Discovery GmbH
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