CHINA RIGHTS AGREEMENT
Exhibit
10.2
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL
TREATMENT REQUEST PURSUANT TO RULE 24b-2.
REDACTED
MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH
THE
SECURITIES AND EXCHANGE COMMISSION.
This
CHINA RIGHTS AGREEMENT (“Agreement”) is made and entered into as of September 7,
2010 (the “Effective Date”), by and between Selected Value Therapeutics I, LLC,
a Delaware limited liability company (“SVT”), and ENTREMED, INC., a Delaware
corporation (“ENMD”).
Recitals
A. As
of the Effective Date, ENMD has agreed to issue units of common stock and
warrants to SVT pursuant to a Securities Purchase Agreement dated as of the date
hereof.
B. ENMD
now desires to grant to SVT a right to acquire an exclusive license to develop
and commercialize ENMD’s proprietary drug product, ENMD-2076, in China, on the
terms and conditions contained herein.
Agreement
Now,
Therefore, in consideration of the foregoing recitals and the mutual
promises, representations, warranties, and covenants hereinafter set forth and
for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties hereto agree as set forth
herein.
ARTICLE
1
RIGHT TO
LICENSE
1.1
Issuance of the
Right.
(a) As
consideration for the transactions agreed to by SVT herein, ENMD hereby grants
to SVT a Right, exercisable at any time until December 31, 2011, to acquire an
exclusive license to develop and commercialize ENMD’s proprietary drug product,
ENMD-2076, in China (the “Right”). The Right shall be exercisable by written
notice by SVT to ENMD.
(b) Upon
exercise of the Right, ENMD and SVT shall negotiate in good faith the terms and
conditions for an exclusive license agreement to develop and commercialize
ENMD-2076 in China, which terms shall, except as the parties otherwise
agree:
(i)
be consistent with the terms described in the material
terms attached hereto as Exhibit
A (“Material Terms”);
(ii) be
commercially reasonable, except to the extent that the Material Terms otherwise
provides; and
(iii) be
consistent with comparable transactions, except as the Material Terms otherwise
provides.
(c) If
after ninety (90) days of such negotiation, ENMD and SVT are unable to agree on
the terms and conditions of such a license, either Party may send the other
Party a written notice that such Party wishes to appoint an expert panel made up
of three members to establish any unresolved terms for a license agreement
consistent with this Section 1.1.
(i) In
furtherance of the foregoing, each Party shall, within seven (7) days of receipt
of the notice seeking to establish such a panel, appoint one member of the panel
who is not affiliated with either Party, and the two appointed members shall,
within fourteen (14) days of such notice, appoint the third member of the panel,
who also shall not be affiliated with either Party. Each appointed member shall
also have demonstrated expertise in licensing oncology products at the clinical
stage of development, including at least seven (7) years of experience in the
pharmaceutical industry.
(ii) Each
appointed member shall enter into a written agreement providing for such
member’s compensation, and binding such member to confidentiality and non-use
provisions no less stringent than those contained in this Agreement. Each panel
member shall be compensated at a rate to be agreed to by the Parties, and the
fees and disbursements of the panel shall be shared equally by the
Parties.
(iii) The
Parties may submit such materials and arguments to the panel at a hearing to be
held within fifteen (15) days of the appointment of the third member of the
panel, and the panel shall render its judgment establishing terms as described
in this Section 1.1, by majority vote, within fifteen (15) days of such
hearing.
(iv) The
majority decision of the panel shall be binding upon the Parties, and the
Parties shall negotiate in good faith the final version of the license agreement
containing the terms established by the panel.
ARTICLE
2
TERMINATION
2.1 Right to Terminate.
This Agreement and the Right shall terminate at any time upon the occurrence of
the earlier of the following:
(a) by
mutual written consent of ENMD and SVT; or
(b) December
31, 2011.
2.2 Effect of
Termination. In the event of this Agreement as provided in Section 2.1,
this Agreement shall become void and have no further force or effect, provided
that no such termination shall release any Party of liability to any other Party
for damages or otherwise by reason of the breach of any of the provisions of
this Agreement and provided further that Article 3 shall survive termination of
this Agreement.
ARTICLE
3
GENERAL
PROVISIONS
3.1 Expenses. Whether or
not the Right is consummated, each Party will pay its own fees and expenses
incident to the negotiation, preparation and execution of this Agreement and any
resulting license agreement, including all legal, accounting and advisory fees.
Should any suit or other action be brought hereunder, the attorneys’ fees and
expenses of the prevailing Party(ies) shall be paid by the losing Party(ies) to
such action.
3.2 Notices. Any notice
or other communication required or permitted to be delivered to any Party under
this Agreement shall be in writing and shall be deemed properly delivered, given
and received when delivered (by hand, by registered mail, by courier or express
delivery service or by facsimile) to the address or facsimile telephone number
set forth beneath the name of such Party below (or to such other address or
facsimile telephone number as such Party shall have specified in a written
notice given to the other Parties).
If to
SVT:
c/o Selected Value Therapeutics I,
LLC
******************************
******************************
Attention: ******
If to
ENMD:
0000
Xxxxxxx Xxxxxx Xxxxx
Xxxxxxxxx,
XX 00000
Fax:
(000) 000-0000
Attention:
Executive Chairman
with a
copy to:
Xxxxxx & Xxxxxx LLP
000 00xx Xx.,
X.X.
Xxxxxxxxxx, X.X. 00000
Fax: (000) 000-0000
Attention: Xxxxxxx X.
Xxxxx
3.3 Publicity. The
Parties agree that, except as may otherwise be required by applicable laws or
orders, and except as may be authorized in this Section 3.3, no information
concerning this Agreement and the transactions contemplated herein shall be made
public by the Parties without the prior written consent of the other Party.
Neither Party shall issue or release any media release or public announcement
(including any announcements made via any posting on the World Wide Web or
Internet) regarding this Agreement or disclosing any term or condition herein
without the prior written consent of the other Party. Notwithstanding the
foregoing, each Party shall have the right to issue media releases and other
statements, immediately and without the prior consent of the other Party that
disclose any information required by the rules and regulations of the Securities
and Exchange Commission, or applicable law.
3.4 Severability. If any
term or other provision of this Agreement is held to be invalid, illegal or
incapable of being enforced by any rule of law, or public policy, all other
conditions and provisions of this Agreement shall nevertheless remain in full
force and effect. If the final judgment of a court of competent jurisdiction
declares that any term or provision hereof is invalid or unenforceable, the
Parties agree that the court making such determination shall have the power to
limit the term or provision, to delete specific words or phrases, or to replace
any invalid or unenforceable term or provision with a term or provision that is
valid and enforceable and that comes closest to expressing the intention of the
invalid or unenforceable term or provision, and this Agreement shall be
enforceable as so modified. In the event such court does not exercise the power
granted to it in the prior sentence, the Parties agree to replace such invalid
or unenforceable term or provision with a valid and enforceable term or
provision that will achieve, to the extent possible, the economic, business and
other purposes of such invalid or unenforceable term.
3.5 Entire Agreement.
This Agreement constitutes the entire agreement between the Parties with respect
to the subject matter hereof and supersedes all prior agreements and
undertakings, both written and oral, among the Parties with respect to the
subject matter hereof and thereof.
[***]
Represents confidential material which has been redacted and filed separately
with the Commission pursuant to a request for confidential treatment in
accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A
complete version of this exhibit has been filed separately with the Securities
and Exchange Commission.
3.6 Successors and Assigns;
Assignment. This Agreement shall be binding upon ENMD and its successors
and permitted assigns (if any), and SVT and its successors and permitted assigns
(if any). This Agreement shall inure to the benefit of ENMD and SVT and the
respective successors and assigns (if any) of the foregoing. This Agreement
shall not be assigned by any Party (other than to an affiliate of SVT) whether
by operation of law or otherwise without the prior written consent of the other
party, which consent will not be unreasonably withheld or delayed; provided,
however, that SVT may freely assign any or all of its rights under this
Agreement, in whole or in part, to any successor to all or substantially all of
the business of SVT to which the Agreement relates, whether by merger,
acquisition of assets or otherwise, without obtaining the consent or approval of
ENMD or of any other Person.
3.7 Parties in Interest.
Nothing in this Agreement, express or implied, is intended to or shall confer
upon any other Person any right, benefit or remedy of any nature whatsoever
under or by reason of this Agreement.
3.8 Governing
Law.
(a) This
Agreement shall be governed by, and construed in accordance with, the laws of
the State of New York, regardless of the laws that might otherwise govern under
applicable principles of conflicts of laws thereof.
(b) The
Parties hereto hereby submit to the jurisdiction of the courts of New York or
the courts of the United States District Court located in the New York City, New
York in respect of the interpretation and enforcement of the provisions of this
Agreement and any related agreement, certificate or other document delivered in
connection herewith and hereby waive, and agree not to assert, any defense in
any action, suit or proceeding for the interpretation or enforcement of this
Agreement and any related agreement, certificate or other document delivered in
connection herewith, that they are not subject thereto or that such action, suit
or proceeding may not be brought or is not maintainable in such courts or that
this Agreement may not be enforced in or by such courts or that their property
is exempt or immune from execution, that the suit, action or proceeding is
brought in an inconvenient forum, or that the venue of the suit, action or
proceeding is improper.
3.9 Enforcement of
Agreement. The Parties hereto agree that irreparable damage would occur
to the Parties if any of the provisions of this Agreement were not performed in
accordance with its specific terms or were otherwise breached. It is accordingly
agreed that the Parties would not have an adequate remedy at law and therefore
will be entitled to seek an injunction or injunctions to prevent breaches of
this Agreement and to enforce specifically the terms and provisions hereof, this
being in addition to any other remedy to which the Parties are entitled
hereunder, at law or in equity.
3.10 Headings. The
descriptive headings contained in this Agreement are included for convenience of
reference only and shall not affect in any way the meaning or interpretation of
this Agreement.
3.11 Counterparts. This
Agreement may be executed and delivered (including by facsimile transmission) in
one or more counterparts, and by the different Parties in separate counterparts,
each of which when executed and delivered shall be deemed to be an original but
all of which taken together shall constitute one and the same
agreement.
3.12 Waiver. No failure on
the part of either Party to exercise any power, right, privilege or remedy under
this Agreement, and no delay on the part of either Party in exercising any
power, right, privilege or remedy under this Agreement, shall operate as a
waiver of such power, right, privilege or remedy; and no single or partial
exercise of any such power, right, privilege or remedy shall preclude any other
or further exercise thereof or of any other power, right, privilege or remedy.
No Party shall be deemed to have waived any claim arising out of this Agreement,
or any power, right, privilege or remedy under this Agreement, unless the waiver
of such claim, power, right, privilege or remedy is expressly set forth in a
written instrument duly executed and delivered on behalf of such Party; and any
such waiver shall not be applicable or have any effect except in the specific
instance in which it is given.
3.13 Further Assurances.
Each Party hereto shall execute and cause to be delivered to the other Parties
hereto such instruments and other documents, and shall take such other actions,
as such other Party may reasonably request for the purpose of carrying out or
evidencing any of the transactions and other matters contemplated by this
Agreement.
3.14 Amendment and Waiver.
This Agreement may not be amended, modified, altered or supplemented other than
by means of a written instrument duly executed and delivered on behalf of SVT
and ENMD.
end
of page
[signatures
appear on following page]
IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed and
delivered as of the date first set forth above.
Selected
Value Therapeutics I, LLC
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By:
Selected Value Therapeutics GP, LLC, its managing
member
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By:
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/s/ ******
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Name: ******
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Title: Managing
Member
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By:
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/s/ Xxxxxxx Xxxxxx
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Name: Xxxxxxx
X. Xxxxxx
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Title:
Executive Chairman
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[***] Represents confidential material
which has been redacted and filed separately with the Commission pursuant to a
request for confidential treatment in accordance with Rule 24b-2 of the
Securities Exchange Act of 1934, as amended. A complete version of this exhibit
has been filed separately with the Securities and Exchange
Commission.
Exhibit
A
China Rights Material
Terms
Selected
Value Therapeutics and EntreMed
Material
Terms
September
7, 2010
These
“Material Terms” outline the terms of an agreement under negotiation by Selected
Value Therapeutics I, LLC (“SVT”) and EntreMed Inc. (“ENMD”). Subject to the
provisions hereof, as contemplated by a China Rights Agreement between the
parties dated September 7, 2010, the parties intend to negotiate a potential
license and supply agreement for the commercialization of ENMD’s proprietary
product, ENMD-2076 (the “Product”) in specified jurisdictions (collectively, the
“Territory”), on substantially the terms set forth below. These Material Terms
are key terms and conditions which, in the event that SVT exercises its Right
(as defined in the China Rights Agreement), shall be included in a mutually
acceptable and fully-integrated license and supply agreement (“License
Agreement”) in accordance with the China Rights Agreement.
I.
Product
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ENMD’s
proprietary drug product, ENMD-2076 (the “Product”)
***********.
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II.
Licensed Rights
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ENMD
will grant SVT an exclusive license (to the exclusion of all third
parties, including ENMD and its affiliates) to use, develop, import, offer
for sale, market, commercialize, distribute and sell Product for use in
the Field throughout the Territory under the following Licensed
Rights:
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(I)
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Patents:
Existing Chinese Patent Application No. 200680044656.7, filed September
29, 2006, and Hong Kong Patent Application No. 081129878.4 filed November
17, 2008; together with all other ENMD patent applications (divisionals,
continuations-in-part, reissues, renewals, etc.) pending in respect of the
Product for use in the Field in any jurisdiction in the Territory;
and
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(II)
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Know-How:
All information and data provided by ENMD to SVT and related to ENMD-2076
in the Territory under the License Agreement.
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The
License Agreement shall provide that the Patents and Know-How shall be and
remain the property of ENMD, subject to the exclusive Licensed Rights
granted to SVT thereunder.
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III.
Improvements
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Any
Improvements to the Patents and Know-How shall be and remain the property
of ENMD.
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IV.
Field
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ENMD-2076
as a single ingredient Product for treatment of cancer in humans (the
“Field”). Combination of the Product with other active drug ingredients
will result in a new product from a regulatory point of view and will be
made part of the license to SVT on terms to be included in the License
Agreement.
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V.
Territory
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People’s
Republic of China, including Hong Kong and Macau; and
Taiwan.
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[***]
Represents confidential material which has been redacted and filed separately
with the Commission pursuant to a request for confidential treatment in
accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A
complete version of this exhibit has been filed separately with the Securities
and Exchange Commission.
VI.
Sublicensing, Subcontracting and Distribution
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SVT
may not sublicense or subcontract to any third party, or appoint any
distributor, except with the prior written consent of ENMD, which may not
be unreasonably withheld or delayed. For any sublicense granted, SVT will
pay to ENMD ********.
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VII.
Agreement Payments
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SVT
will make the following payments to ENMD under the License
Agreement:
******************************************************************
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VIII.
Reports
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The
License Agreement will contain reporting requirements for SVT,
including:
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(I)
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Quarterly
clinical trial and other development cost reports;
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(II)
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Quarterly
clinical trial progress reports;
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(III)
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Monthly
sales reports vs. forecast and budget;
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(IV)
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Quarterly
royalty reports including payments; and
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(V)
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Periodic
progress reports in respect of applications for marketing approvals
throughout the Territory;
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in
each case, broken down on a jurisdiction-by-jurisdiction basis. All
reports will be subject to audit or review by ENMD or an
appointee.
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IX.
Clinical development
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SVT
will be responsible for all clinical development and regulatory costs
related to obtaining regulatory approval in the Territory, pursuant to a
Development Plan to be agreed upon by the parties and attached to the
License Agreement, with such changes as the parties agree to make from
time to time. It is understood that SVT will have control of the necessary
regulatory submissions to the SFDA. Any clinical trial will be carried out
by a CRO mutually acceptable to SVT and ENMD, each acting reasonably, and
selection of sites for clinical trials will be mutually agreed upon by SVT
and ENMD, each acting reasonably.
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X.
Product registrations
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SVT
will be responsible for obtaining and maintaining product registrations in
the Territory and will carry the administrative costs and SVT personnel
costs associated with this responsibility. SVT will own the product
registrations in the Territory subject to reversion to ENMD upon
termination of the license.
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XI.
Sales and Marketing
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SVT
will be responsible for all selling costs associated with the Product
under the License Agreement (sales, marketing, advertising, promotion,
etc). SVT will ensure that in each jurisdiction of the Territory at the
time of Product launch sales representatives will be trained and ready.
Sales and marketing plans will be presented once yearly to joint marketing
committee meetings.
The
License Agreement will provide for standard diligence requirements
including but not limited to objectively measurable performance criteria
for SVT.
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XII.
Supply of Product
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ENMD
will be the exclusive manufacturer and supplier (either directly or
through an Affiliate or contract manufacturer of its choice) of the
Product under the License Agreement. Backup manufacturing capability to be
discussed in the event ENMD cannot
supply.
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[***]
Represents confidential material which has been redacted and filed separately
with the Commission pursuant to a request for confidential treatment in
accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A
complete version of this exhibit has been filed separately with the Securities
and Exchange Commission.
XIII.
Supply Price
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The
supply price for ENMD-2076 will be finalized as a part of the License
Agreement, and be based on
********************************************************.
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XIV.
Committee(s)
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The
parties will form a Joint Steering Committee to govern the activities of
the parties as they relate to the Product. Specifically, the Joint
Steering Committee will have oversight of development of the Product in
the Territory. The Joint Steering Committee will oversee the development
and obtaining regulatory approval of the Product in the Territory pursuant
to a Development Plan approved by the Joint Steering Committee and
EntreMed. Any amendments to the Development Plan would require approval of
the Joint Steering Committee and EntreMed. The Joint Steering Committee
and EntreMed will oversee the supply and manufacture of API and Licensed
Product formulations for the Territory as part of the Development Plan.
The Joint Steering Committee will meet on a regular basis, but at least
every 6 months until the last marketing approval of the Product in the
Territory. In the event of a dispute which cannot be resolved by the
senior executives of both parties acting in good faith, ENMD will make the
final decision.
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XV.
Rights of First Refusal
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*************************
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XVI.
Non-competition
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Throughout
the term of the License Agreement, subject to applicable law in the
Territory, SVT will not commercialize any competing cancer products for
use in humans in the Territory; it being understood that, in consideration
for the exclusive rights to be granted under the License Agreement, ENMD
will be entitled to the broadest non-competition protection legally
available in specific jurisdictions throughout the Territory. SVT and its
sublicensees shall use a level of effort in developing and commercializing
the Product that is equal to or greater than that of any other product
that it is then developing or commercializing, and SVT and its
sublicensees may not reduce its level of such effort as a result of any
other cancer product that it is then developing or
commercializing.
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XVII.
Standstill Agreement
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A
standstill agreement, pursuant to which SVT undertakes not to attempt,
directly or indirectly, to obtain control of ENMD during the term of the
License Agreement, will be negotiated.
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XVIII.
Term; Termination
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The
Licenses granted under the License Agreement will remain in force for as
long as SVT or its affiliates, distributors and/or sublicensees sell
Product subject always to normal course termination rights of the Parties
in respect of breach, insolvency, etc. ENMD will have the right to
terminate the License Agreement if SVT has not commenced clinical
development of the Product within six months of the submission by ENMD of
an NDA filing in the US.
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XIX.
Governing Law; Dispute Resolution
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These
Material Terms and the License Agreement will be governed by and
interpreted in accordance with the laws of the State of New York. The
License Agreement will also contain an alternative dispute resolution
clause.
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[***]
Represents confidential material which has been redacted and filed separately
with the Commission pursuant to a request for confidential treatment in
accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A
complete version of this exhibit has been filed separately with the Securities
and Exchange Commission.
XX.
Miscellaneous
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The
License Agreement will contain normal course provisions relating to, among
other things, diligence requirements with respect to Product development
and marketing activities, amendment of royalty rate due to post grant
events such as loss of patent protection or other competition,
representations and warranties, early termination, indemnification,
assignment, change of control and confidentiality.
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XXI.Confidentiality
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No
disclosure or announcement, public or otherwise, in respect of the matters
contained in these Material Terms, will be made by any other party hereto
without the prior agreement of the other party as to timing, content, and
methods, provided that the obligations herein will not prevent any party
from making, after consultation with the other party, such disclosure as
its counsel advises is required by any applicable laws or
regulations.
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XXII.
Assignment
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The
License Agreement will not be assignable by SVT without the prior written
consent of ENMD, which consent will not be unreasonably withheld or
delayed. Notwithstanding the foregoing, SVT may make such an assignment
without ENMD consent to its affiliates or to a successor to substantially
all of the business of SVT to which the License Agreement relates, whether
pursuant to a merger, sale of stock, sale of assets or other
transaction.
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XXIII.
Currency; Inflation
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All
references to Dollars and to $ herein shall be to the currency of the
United States Dollar. Milestone payments referred to herein shall be
indexed to an inflationary measure to be agreed between the
parties.
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XXIV.
Expenses
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Each
party will be responsible for its and its financial and legal advisors’
expenses associated with the transactions referred to
herein.
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XXV.
Binding Terms
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The
provisions entitled “Confidentiality” and “Expenses” in these Material
Terms shall be binding on the parties hereto. No other portion of these
Material Terms are intended at the date hereof to represent enforceable
provisions, unless and until the parties negotiate a License Agreement if
and when SVT exercises its Right as set forth in the China Rights
Agreement. The terms of this Material Terms document will be binding at
such time to the extent that the parties agree to such terms as part of a
License Agreement.
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