Exhibit
10.15
RESEARCH
AGREEMENT
THIS
RESEARCH AGREEMENT (this “Agreement”), dated as of September 15th, 2015 (the “Effective Date”),
between Fortress Biotech, Inc. (f/k/a Coronado Biosciences, Inc.), a Delaware Corporation (the “Company”) having
an address 0 Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, XX 00000, and NeuPharma, Inc., a Delaware corporation
(“NeuPharma”) having an address of 0000 Xxxxx Xxxxx, Xxx 000, Xxxxxx Xxxx, XX 00000.
PRELIMINARY
STATEMENT
On
March 17, 2015, NeuPharma and the Company entered into a license agreement pursuant to which, inter
alia, NeuPharma granted the Company an exclusive royalty-bearing right and license under the Licensor Technology to
research, Develop, have Developed, manufacture, have manufactured, use, import and Commercialize and have Commercialized the Licensed
Products (the “License Agreement”).
Pursuant
to the License Agreement, the Parties contemplated the possibility entering into a sponsored research agreement to identify additional
inhibitors of EGFR and/or BTK, with differing kinase profile from the current lead Licensed Products.
Accordingly,
the Parties have agreed as to the terms and conditions on which NeuPharma shall conduct the research required to identify additional
Compounds and Licensed Products as follows:
TERMS
AND CONDITIONS
In
consideration of their mutual covenants set forth in this Agreement, Company and NeuPharma agree as set forth herein.
The
following initially capitalized terms have the meanings set forth herein, unless otherwise expressly provided. Each meaning shall
apply to both singular and plural forms of such capitalized terms as the context may require. Capitalized terms used herein but
not defined herein shall have the meaning ascribed to such term in the License Agreement.
“Force
Majeure” means, as to any person, any act of God, fire, act of government or state, war, civil commotion, insurrection,
embargo, prevention from or hindrance in obtaining energy or other utilities, labor disputes of whatever nature or any other reason
beyond the reasonable control of the person in question.
“Party”
means NeuPharma or Company, and “Parties” means NeuPharma and Company.
“Research”
means the work to be performed by NeuPharma pursuant to this Research Agreement as set forth in one or more Research Work Orders.
“Research
Work Order” means any plan of work to be conducted by NeuPharma pursuant to this Agreement executed by the Parties
and attached hereto a form as Exhibit A,
as amended from time to time by the Parties.
“Results”
has the meaning provided in Section 5.4.
“Subject
Inventions” shall mean patentable inventions or discoveries conceived and reduced to practice in the course of
the Research by one or more employees or agents of NeuPharma, or by one or more employees or agents of Company, or jointly by one
or more employees or agents of NeuPharma and one or more employees or agents of Company, including all intellectual property rights
therein and thereto.
“Term”
has the meaning provided in Section 11.1 below.
2.1 Research;
Additional Research Work Orders. Commencing on the Effective Date, NeuPharma shall use reasonable efforts to conduct
the Research in a professional manner, consistent with the applicable Research Work Orders. Company shall identify a designated
representative in the Research Work Order (“Designated
Representative”) to be Company’s contact person with respect to the conduct of the Research.
NeuPharma shall consider in good faith the advice and guidance of the Designated Representative with respect to the conduct of
the Research. Any disputes as to the conduct of the Research shall be settled by agreement of the CEO’s of each of the Parties.
At the request of the Company, NeuPharma shall prepare a proposal for additional Research Work Orders. Additionally, if during
the conduct of the Research, either Party believes a modification to Research Work Order is necessary, the Parties shall discuss
in good faith any modifications to a Research Plan that may be proposed by Company or NeuPharma. Such proposed modifications shall
not become effective until agreed to in writing by Company and NeuPharma; provided, however, that for items in the budget that
require discussion among the parties, NeuPharma will not move forward without the agreement of the Designated Representative. NeuPharma
shall have the right to subcontract any of its obligations under this Agreement, provided that NeuPharma shall be responsible for
the activities of its subcontractors performing NeuPharma’s obligations under this Agreement.
2.2 Cooperation.
To the extent reasonably required to perform the Research, NeuPharma shall permit personnel of Company, upon reasonable prior notice
to NeuPharma and conditioned upon appropriate assurances of confidentiality and compliance with NeuPharma restrictions applicable
to such facilities, to visit the NeuPharma facilities where the Research is being conducted.
3.1 Personnel.
Following the Effective Date as it relates to the initial Research Work Order and once additional Research Work Orders are finalized,
NeuPharma will take reasonable steps to make available suitably qualified personnel for the conduct of the Research. NeuPharma
shall be responsible for all compensation, fringe benefits, reimbursement of expenses and withholding of governmental taxes and
charges with respect to its personnel, and NeuPharma shall have the right to terminate or replace any of its personnel involved
in the Research in its discretion.
3.2 Equipment
and Facilities. All equipment and facilities necessary to perform the Research shall be the responsibility of NeuPharma.
4.1 Payments.
Company shall not be obligated to pay any amount for Research other than as specifically stated in a Research Work Order. Except
as set forth in a Research Work Order, this Agreement or the License Agreement, including with respect to prosecution of any Licensor
Patents, NeuPharma shall be responsible for all costs and expenses it incurs in connection with this Agreement. Company shall make
the payments to NeuPharma for the Research as set forth in each Research Work Order. All such payments shall be made by bank wire
transfer in accordance with the instructions agreed to by the Parties.
5.1 Records.
NeuPharma will maintain complete and accurate records of the conduct, status and progress of the Research in compliance with its
standard internal practices as in effect during the term of the Agreement and make such records available to Company during mutually
convenient times during normal business hours upon reasonable advanced written notice.
5.2 Reports.
On quarterly basis following the Effective Date, NeuPharma will provide a written report to Company with respect to the Research.
Such reports will be prepared in the standard format of NeuPharma, and will summarize the work performed on the Research during
the prior quarter and results obtained to date. Additionally, between quarterly reports NeuPharma shall communicate with the Designated
Representative on a regular basis, including weekly or bi-monthly calls, or other agreed upon frequency of calls as the Parties
may agree, to review the Research and troubleshoot any issues and/or suggest modifications. A final written report shall be delivered
by NeuPharma to Company within 30 days after the completion of the Research or the termination of this Agreement, whichever is
earlier. Company shall, upon NeuPharma’s request, provide a written report of any Results prepared or generated by Company,
conducted in connection with the Research.
5.3 Personnel.
Each Party shall obtain, or shall have obtained, from each of its personnel involved in the Research an agreement by which each
of them assigns to such Party all of his or her right, title and interest in and to (a) any invention or discovery conceived or
reduced to practice in the performance of the Research, and (b) all rights, including copyright rights, in and to any original
work of authorship prepared in connection with the Research.
5.4 Ownership
of Data and Documents. All reports, findings, data and supporting documentation, in whatever form (e.g.,
laboratory notebooks, original data, slides, photographs or computer records), that are prepared or generated by NeuPharma or Company
pursuant to this Agreement and that do not constitute Subject Inventions (collectively, the “Results”)
shall be the property of the preparing or generating Party. Results prepared or generated by NeuPharma that pertain directly to
SRA Compounds shall be deemed to be included in Licensor Know-How licensed to Company under the License Agreement. Results prepared
or generated by Company that pertain directly to SRA Compounds shall be deemed to be included in Company Technology licensed to
NeuPharma under the License Agreement.
5.5 Subject
Inventions. Each Party shall promptly report to the other Party any Subject Invention, which report shall be accompanied
by an invention disclosure that describes in reasonable detail the substance of the discovery or invention (a “Disclosure
Report”). All rights to Subject Inventions conceived solely by employees, contractors, representatives or agents
of NeuPharma will belong solely to NeuPharma (“NeuPharma
Inventions”). All rights to Subject Inventions conceived solely by employees, contractors, representatives or
agents of Company will belong solely to Company (“Company
Inventions”‘). All rights to Subject Inventions conceived jointly by employees, contractors, representatives
or agents of NeuPharma and employees or agents of Company will belong jointly to NeuPharma and Company (“Joint
Inventions”). All NeuPharma Inventions Covering SRA Compounds shall be deemed included in Licensor Patents licensed
to Company under the License Agreement. All Company Inventions outside the Territory Covering SRA Compounds shall be deemed included
in Coronado Technology licensed to NeuPharma under the License Agreement. Except as expressly provided in this Agreement, it is
understood that neither Party shall have any obligation to account to the other for profits, or to obtain any approval of the other
Party to license, assign or otherwise exploit such jointly owned inventions or intellectual property, by reason of joint ownership
thereof, and each Party hereby waives any right it may have under the laws of any jurisdiction to require any such approval or
accounting.
5.6 Compounds.
Any inhibitor(s) primarily targeting EGFR or BTK that are discovered in performance of the Research at any time during the term
of this Agreement (“SRA Compounds”)
shall be deemed Compounds under the License Agreement. To the extent that NeuPharma provides company with any information or materials
pertaining to inhibitors that are not SRA Compounds, Company agrees to use such information and materials only for the purpose
of internal evaluation of the structure-activity relationships of SRA Compounds by Company and for no other purposes.
All
notices under this Agreement shall be sent by registered or certified mail, postage prepaid, or by overnight courier service. Notices
pertaining to this Agreement shall be sent to:
If
to NeuPharma:
Address:
NeuPharma,
Inc.
0000 Xxxxx
Xx., Xxx 000
Xxxxxx Xxxx,
XX 00000
Attention:
Xxxxx Xxxx
If
to the Company:
Fortress Biotech,
Inc.
0 Xxxxxxxx
Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxx Xxxxxxx
7.1 Company.
Company hereby represents and warrants that: (a) it has full power and authority to enter into this Agreement, and (b) it is bound
by this Agreement in accordance with its terms.
7.2 NeuPharma.
NeuPharma hereby represents and warrants that it (a) has full power and authority to enter into this Agreement, and (b) is bound
by this Agreement in accordance with its terms.
8.1 Warranties
Disclaimed. EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES PROVIDED IN SECTION 7, EACH PARTY DISCLAIMS ALL WARRANTIES
OF WHATEVER NATURE, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF QUALITY, MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE, OR AS TO THE SUCCESS OR LIKELIHOOD OF SUCCESS OF THE RESEARCH, DEVELOPMENT OR COMMERCIALIZATION OF A COMPOUND,
INCLUDING ANY SRA COMPOUND.
8.2 Indemnification.
(a) Company
shall indemnify, defend and hold harmless NeuPharma and its officers, directors, medical and professional staff, employees, affiliates
and representatives and their respective successors, heirs and assigns (the “NeuPharma
Indemnitees”), against any liability, damage, loss or expense incurred by or imposed upon them in connection with
any claims, suits, actions, demands or judgments (“Claim”)
by a third party arising out of the manufacture, use or sale of any material or product by or on behalf of Company as a result
of the Research and/or embodying Subject Inventions and/or based on any theory of product liability (including, but not limited
to, actions in the form of tort, warranty, or strict liability) concerning any process or service made, used or sold by Company
pursuant to any right or license granted under this Agreement. Company shall not have any obligations under this paragraph with
respect to Claims arising out of the negligence or intentional misconduct of the NeuPharma Indemnitees.
(b) NeuPharma
shall indemnify, defend and hold harmless the Company and its officers, directors, medical and professional staff, employees, affiliates
and representatives and their respective successors, heirs and assigns (“Company
Indemnitees”‘), against any liability, damage, loss or expense incurred by or imposed upon them in connection
with any Claim by a third party arising out of NeuPharma’s negligence, bad faith, willful misconduct or material breach of
this Agreement. NeuPharma shall not have any obligation under this paragraph with respect to Claims arising out of the negligence
or intentional misconduct of the Company Indemnitees.
(c) The
procedure and expenses for a Party or other Person intending to claim indemnification under this Section 8.2 shall be as set forth
in Sections 9.3 and 9.4 of the License Agreement, mutatis
mutandis.
9.1 Mutual
Confidentiality. Neither Party shall disclose the other Party’s Confidential Information to any person other than
its employees, officers, directors, affiliates, agents and representatives who are bound by obligations of confidentiality and
who have a need to know such information in order to perform their obligations in connection with the Research. Each Party may
only use the other Party’s Confidential Information as permitted to perform its respective obligations under this Agreement.
“Confidential Information”
means any information disclosed by a Party to the other Party that is reasonably expected to be treated in a confidential manner
under the circumstances of disclosure under this Agreement or by the nature of the information itself.
9.2 Exceptions.
The obligations of confidentiality applicable to Confidential Information of the other Party shall not apply to any information
that is (a) known publicly or becomes known publicly through no fault of the recipient; (b) learned by the recipient on a non-confidential
basis from a third party entitled to disclose it without obligation of confidentiality; (c) developed by the recipient independently
of and without use of or reference to Confidential Information of the other Party as evidenced by prior written records of the
recipient; (d) already known to the recipient without obligations of confidentiality before receipt from the disclosing party,
as shown by its prior written records; or (e) is disclosed to the public to the extent required by law, regulation or the order
of a judicial or administrative authority, provided that the recipient notifies the disclosing party promptly upon receipt at any
such order or becoming aware of any such law or regulation. If a Party becomes legally compelled to disclose any Confidential Information
of the other Party, such Party will (1) provide the other Party prompt written notice, if legally permissible, and will use its
best efforts to assist such other Party in seeking a protective order or another appropriate remedy and (2) furnish only that portion
of the Confidential Information that is legally required to be disclosed. Any Confidential Information legally compelled to be
disclosed shall maintain its confidentiality protection for all purposes other than such legally compelled disclosure.
9.3 Publicity.
Neither Party may issue a press releases or otherwise disclose the existence or terms of this Agreement without the prior written
consent of the other Party; provided, however, that once the existence or any terms or conditions of this Agreement has been publicly
disclosed in a manner mutually and reasonably agreed-to by the Parties, either Party may republish the facts previously disclosed
without the prior consent of the other Party.
10.1 Term.
The term of this Agreement shall commence
on the Effective Date, and, unless terminated earlier as provided herein, shall expire on the earlier of (i) the completion of
the Research or (ii) the second anniversary of the Effective Date.
10.2 Right
to Terminate. Company shall have the right to terminate this Agreement at any time upon thirty (30) days written notice
to NeuPharma. Either Company or NeuPharma may terminate this Agreement effective upon notice to the other:
(a) the
other Party commits a material breach of this Agreement and the breach is not remedied within 30 days after the receipt of notice
identifying the breach, requiring its remedy and stating the intent of the Party giving notice to terminate in the absence of remedy,
or
(b) the
other Party (i) becomes unable to pay its debts as they become due, (ii) suspends payment of its debts, (iii) enters into or becomes
subject to corporate rehabilitation or bankruptcy proceedings or liquidation or dissolution that is not dismissed within 60 days
of filing, (iv) makes an assignment for the benefit of its creditors or (v) seeks relief under any similar laws for debtor’s
relief.
10.3 Effect
of Expiration or Termination. Upon the termination of this Agreement, NeuPharma shall cease all Research. Within 30
days following the expiration or termination of this Agreement, each Party shall promptly deliver to the other party all of its
Confidential Information (save one copy for purposes of determining compliance with its obligations of confidentiality hereunder).
This Section 10.3 and Sections 1, 5.4, 5.5, 5.6, 6, 8, 9 and 11 shall survive expiration or termination of this Agreement. Termination
or expiration of this Agreement shall not relieve the Parties of any liability that accrued hereunder before the effective date
of such termination or expiration. In addition, termination
or expiration of this Agreement shall not preclude either Party from pursuing all rights and remedies it may have hereunder or
at Law or in equity with respect to any breach of this Agreement nor prejudice either Party’s right to obtain performance
of any obligation.
(a) Neither
this Agreement nor any right or obligation hereunder shall be assignable in whole or in part, whether by operation of law, or otherwise
by one party without the other prior written permission. Notwithstanding the foregoing, either Party may assign or transfer all
of its rights and obligations under this Agreement without the consent of the other Party to an Affiliate of such assigning Party
or a person that succeeds to all or substantially all of that Party’s business or assets to which this Agreement pertains
whether by sale, merger, operation of law or otherwise. This Agreement shall be binding upon and inure to the benefit of and be
enforceable by the Parties hereto and their respective successors and permitted assignees. Any transfer or assignment of this Agreement
in violation of this Section 11(a) shall be null and void.
(b) This
Agreement and the License Agreement contains the entire agreement between the Parties relating to the subject matter hereof, and
all prior understandings, representations and warranties between the Parties are superseded by this Agreement and the License Agreement.
(c) Changes
and additional provisions to this Agreement shall be binding on the Parties only if agreed upon in writing and signed by the Parties.
(d) This
Agreement shall be construed and interpreted in accordance with the laws of the State of New York and all rights and remedies shall
be governed by such laws without regard to principles of conflicts of law. Any dispute arising under or with respect to this Agreement
may be brought and maintained solely in the state or federal courts located in New York, NY, and the Parties expressly consent
to the exclusive jurisdiction of such courts for such purpose.
(e) The
Parties do not intend to violate any public policy or statutory common law. However, if any sentence, paragraph, clause or combination
of this Agreement is in violation of any law or is found to be otherwise unenforceable, such sentence, paragraph, clause or combination
of the same shall be deleted and the remainder of this Agreement shall remain binding, provided that such deletion does not alter
the basic purpose and structure of this Agreement.
(f) Nothing
herein shall create any association, partnership, joint venture, fiduciary duty or the relation of principal and agent between
the Parties hereto, it being understood that each Party is acting as an independent contractor, and neither Party shall have the
authority to bind the other or the other’s representatives in any way.
(g) No
delay on the part of either Party hereto in exercising any power or right hereunder shall operate as a waiver thereof, nor shall
any single or partial exercise of any power or right hereunder preclude other or further exercise thereof or the exercise of any
other power or right. No waiver of this Agreement or any provision hereof shall be enforceable against any Party hereto unless
in writing, signed by the Party against whom such waiver is claimed, and shall be limited solely to the one event.
(h) This
Agreement has been prepared jointly and no rule of strict construction shall be applied against either Party. In this Agreement,
the singular shall include the plural and vice versa and the word “including” shall be deemed to be followed by the
phrase “without limitation.” The section headings contained in this Agreement are inserted for convenience only and
shall not affect in any way the meaning or interpretation of this Agreement.
(i) This
Agreement may be executed in counterparts, each of which together shall constitute one and the same Agreement. For purposes of
executing this agreement, a facsimile copy of this Agreement, including the signature pages, will be deemed an original.
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remainder of this page intentionally left blank.]
IN WITNESS
WHEREOF, Company and NeuPharma have caused this Agreement to be executed and delivered as of the date hereof.
| FORTRESS BIOTECH, INC. |
|
NEUPHARMA, INC. |
| |
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| By |
/s/
Xxxxxxx Xxxxx |
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By |
/s/ Xxxxx
Xxxx |
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| Name: Xxxxxxx Xxxxx |
|
Name: Xxxxx Xxxx |
| |
|
|
| Title: Executive Vice Chairman |
|
Title: President & CEO |
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EXHIBIT A
Research Work Order #1
| Scope of Research to be Conducted: |
Identify selective compounds with more potent BTK inhibition: BTK IC50 <10 nM; IC50 wtEGFR/BTK >10; selectivity against majority of the kinome. |
| |
|
| Company’s Designated Representative |
Xxxxxx Xxxxxxx |
| |
|
| Budget/Payment Obligations: |
The projected
12-month budget is totaled $1,300,000 to $1,533,000.
The non-refundable
down payment of $260,000 is due within 7 days after the agreement is signed.
NeuPharma shall
raise quarterly invoices to Company for the work conducted and expenses incurred for that particular quarter. Payment by Company
on any invoice issued by NeuPharma shall be due within thirty (30) days of the receipt date of such invoice.
If NeuPharma
does not receive payment of any sum due to it on or before the due date therefor, simple interest shall thereafter accrue on the
sum due to Company from the due date until the date of payment at a rate equal to the lesser of (a) US dollar one-month LIBOR plus
500 basis points, or (b) the maximum rate permissible under applicable Law. |
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| Projected Start Date: |
October 1, 2015 |
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| Projected End Date: |
October 1, 2016 |
