LICENSE, RESEARCH AND COLLABORATION AGREEMENT
This License, Research and Collaboration Agreement is entered into as of
the 13th day of December, 1996 by and between Apollo Genetics, Inc., a Delaware
corporation ("Apollo"), and Endocon, Inc., a Maryland corporation ("Endocon").
WHEREAS, Apollo has certain intellectual property rights in the form of an
issued U.S. Patent and various pending patent applications dealing with the use
of certain estrogen compounds for neuroprotection; and
WHEREAS, Endocon owns intellectual property rights under certain issued
U.S. Patents and various pending patent applications dealing with products and
processes in the field of controlled-release drug delivery, especially
bioerodible subcutaneous implants for use with steroidal compounds;
NOW, THEREFORE, the parties hereto agree as follows:
1. DEFINITIONS
When used herein, the following words shall have the following meanings:
(a) "Affiliate" shall mean any individual, trust, business trust, joint
venture, partnership, corporation, division of a corporation, association or any
other entity that (directly or indirectly) is controlled by, controls or is
under common control with a party to this Agreement. For purposes of this
definition, the term "control" shall mean the possession (directly or
indirectly) of the power to direct or cause the direction of the management or
policies of such party.
(b) "Apollo Proprietary Technology" shall mean all inventions, biological
or biochemical materials, works of authorship, technical information, know-how,
and data, which is applicable to the Field, in existence on the date of this
Agreement and owned by, licensed to or known to Apollo or an Affiliate of Apollo
and with respect to which Apollo has the right to disclose and use in connection
with this Agreement, now or in the future, including all rights of Apollo under
the patents and patent applications set forth on Exhibit A hereto.
(c) "Commercialize" or "Commercialization" shall mean registration,
regulatory approval, marketing, distribution and sale of the Products.
(d) "Endocon Proprietary Technology" shall mean all inventions, biological
or biochemical materials, works of authorship, technical information, know-how,
and data, which is applicable to the Field, in existence on the date of this
Agreement and owned by, licensed to or known to Endocon or an Affiliate of
Endocon and with respect to which Endocon has the right to disclose and use in
connection with this Agreement, now or in the future, including all rights of
Endocon under the patents and patent applications set forth on Exhibit B hereto.
(e) "Field" shall mean Formulations for the treatment of Neurodegenerative
Diseases.
(f) "Formulation" shall mean estradiol or other estrogen compounds in a
subdermal implant employing Endocon Proprietary Technology.
(g) "Improvements" shall mean any improvements or developments, within the
Field, upon any of the Proprietary Technology that Endocon (or an Affiliate of
Endocon) or Apollo (or an Affiliate of Apollo), either solely or jointly with
any third party that is not an Affiliate of the other party, may acquire,
discover, invent, originate, make, conceive or have a right to, in whole or in
part, during the term of this Agreement, whether or not such improvement or
development is patentable, commercially useful or reducible to writing or
practice. "Endocon Improvements" shall mean any Improvements acquired,
discovered, invented, originated, made or conceived by Endocon (or an Affiliate
of Endocon) or to which Endocon (or an Affiliate of Endocon) has a right, either
solely or jointly with any third party that is not an Affiliate of Apollo, with
respect to which Endocon has the right to disclose and use in connection with
this Agreement. "Apollo Improvements" shall mean any Improvements acquired,
discovered, invented, originated, made or conceived by Apollo (or an Affiliate
of Apollo) or to which Apollo (or an Affiliate of Apollo) has a right, either
solely or jointly with any third party that is not an Affiliate of Endocon, with
respect to which Apollo has the rights to disclose and use in connection with
this Agreement. "Joint Improvements" shall mean any improvements or developments
in the Field upon any of the Proprietary Technology, which Endocon (or an
Affiliate of Endocon) and Apollo (or an Affiliate of Apollo) jointly acquire,
discover, invent, originate, make, conceive or have a right to during the term
of this Agreement, whether or not such improvement or development is patentable,
commercially useful or reducible to writing or practice.
(h) "Net Proceeds" shall mean the aggregate amount of proceeds (including,
without limitation, license fees, milestone payments and royalties) received
from third parties by Apollo and/or Endocon in connection with the development
of the Products and Commercialization, after deduction and reimbursement of
expenses previsously incurred by Apollo and/or Endocon in connection with the
development of the Products and Commercialization and not previously reimbursed.
(i) "Neurodegenerative Diseases" shall mean diseases caused or
characterized by the impairment of neurons, including, without limitation,
Alzheimer's disease, Huntington's disease and Parkinson's disease.
(j) "Proprietary Technology" shall mean any of the Apollo Proprietary
Technology and the Endocon Proprietary Technology.
2. COLLABORATION; LICENSE
From the date hereof, the parties agree to collaborate in the joint
development of Formulations in the Field (collectively, the "Products").
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Each of the parties hereby grants to the other party, under its present
and future intellectual property rights, an exclusive, worldwide, royalty-free
license to make and use the Products for research and development purposes only.
Endocon hereby further grants to Apollo an exclusive, worldwide, royalty-free
license to distribute for sale and sell the Products; provided, however that (i)
the parties agree, prior to Apollo's commercialization of any Products, to enter
into good faith negotiations regarding the alternative financial terms and
conditions of said license and further agree to negotiate license fee rates and
royalties which are fair and reasonable to both parties and (ii) Apollo hereby
agrees, in connection with the grant of such license, that Endocon shall have
the exclusive right to manufacture the Products. Subject to the foregoing,
Apollo shall have full power and authority under such license to negotiate
sublicensing agreements with third parties with respect to the Products and to
obtain financing from third parties to assist Commercialization.
3. MANAGEMENT OF COLLABORATION
The parties hereby create a committee (the "Research Committee"), which
shall consist of two (2) members, one of which shall be designated by Apollo and
one of which shall be designated by Endocon. If any member of the Research
Committee dies, resigns or becomes incapacitated, the party which designated
such member shall designate his or her successor (whose term shall commence
immediately), and any party may withdraw the designation of its member of the
Research Committee and designate a replacement (whose term shall commence
immediately) at any time by giving notice of the withdrawal and replacement to
the other party.
Pursuant to no less than 5 days' notice, meetings of the Research
Committee shall be held at such times and places as the members of the Research
Committee shall from time to time agree. In the event a Research Committee
member is unable to attend a meeting or wishes a scientific, business or other
expert to represent his or her party at such meeting, such Committee member may
designate an alternate member to serve in such member's stead, solely for such
Research Committee meeting.
All management of the contractual relationships created by this Agreement
shall be taken by the Research Committee, acting in accordance with this
Agreement, or by agents duly authorized in writing by the Research Committee.
Only a determination or other action agreed to by all of the members of the
Research Committee (or the designee or agent of all of the members) shall bind
the parties.
If the Research Committee fails to reach agreement upon any matter, either
party may request, upon fifteen (15) days' notice, that the dispute be resolved
in accordance with the procedures set forth in Section 10 below.
4. DEVELOPMENT COSTS; INTERESTS IN PROCEEDS
Each party shall bear the costs and expenses of its respective activities
in connection with the collaboration established hereby and shall promptly make
payments to third parties arising therefrom; provided, however, that neither
party has any obligation hereunder to finance development of the Products. The
parties anticipate that development costs will be
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borne primarily by a third party marketing partner under a license agreement
among such third party and the parties hereto.
All Net Proceeds received by either of the parties from the development of
the Products shall be allocated 60% to Apollo and 40% to Endocon. From time to
time, the Research Committee shall determine the amount of proceeds available
for distribution as Net Proceeds.
Notwithstanding the foregoing, the parties acknowledge that there may be
future events affecting the equitable distribution of Net Proceeds and agree
that they will act, by amendment of this Agreement if necessary, in a
commercially reasonable manner with respect to the division of Net Proceeds, the
establishment of manufacturing fees, the recovery of development costs and other
commercial terms hereof. If the parties fail to reach agreement upon any such
matter, either party may request, upon fifteen (15) days' notice, that the
dispute be resolved in accordance with the procedures set forth in Section 10
below.
5. TERMINATION; SURVIVING RIGHTS
The term of this Agreement shall be perpetual; provided, however, that
either party may terminate this Agreement upon sixty (60) days' notice to the
other party. Upon termination pursuant to this Section 5, the non-terminating
party shall receive from the terminating party an exclusive, worldwide,
royalty-free license (with the right to sublicense) to develop, make, have made,
use, distribute for sale and sell the Products.
6. CONFIDENTIAL INFORMATION; PUBLIC ANNOUNCEMENTS
The parties contemplate that, during the term of this Agreement, each
party (as such, a "Disclosing Party") will disclose to the other party (as such,
a "Receiving Party") Proprietary Technology of the Disclosing Party that is
marked or otherwise reasonably identifiable as such. A Receiving Party shall
hold in confidence and shall not, directly or indirectly, at any time during or
subsequent to the term of this Agreement, unless otherwise agreed to in writing
by the Disclosing Party, disclose, publish, transfer or use (other than in
accordance with the terms of this Agreement) any Proprietary Technology of the
Disclosing Party; provided, however, that the foregoing restrictions shall not
apply to any Proprietary Technology that:
(a) becomes part of the public domain through no wrongful act of the
Receiving Party;
(b) is lawfully received by the Receiving Party from a third party
without contravention of this Agreement;
(c) prior to the time of receiving such Proprietary Technology from
the Disclosing Party, is known by the Receiving Party and may
lawfully be used by it without restriction; or
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(d) is independently developed by the Receiving Party, provided that
the person or persons developing the same have not had any access to
the Disclosing Party's Proprietary Technology.
Proprietary Technology specific to the use of certain compounds, methods,
conditions or features shall not be deemed to be within the foregoing exceptions
merely because such Proprietary Technology is embraced by general disclosures in
the public domain or in the possession of the Receiving Party; in addition, a
combination of Proprietary Technology will not be deemed to fall within the
foregoing exceptions, even if all of the components fall within an exception,
unless the combination itself and its significance are in the public domain or
in the possession of the Receiving Party prior to the disclosure thereof by the
Disclosing Party.
Except as shall be necessary to comply with applicable laws and
regulations, and except as otherwise agreed to by the parties hereto, the
parties each agree to keep the existence of this Agreement, and the transactions
contemplated hereby, strictly confidential. Any press release or similar public
announcements regarding this Agreement or the transactions contemplated herein
shall be agreed upon in writing between the parties prior to publication.
7. PROPRIETARY MATERIALS
In the course of the collaboration established hereby, one party (the
"Provider") may transfer to the other party (the "Recipient") certain of its
materials that were developed by the Provider prior to or outside the
performance of this Agreement ("Proprietary Materials"). In such event, the
Recipient acknowledges and agrees that such Proprietary Materials are and shall
be owned by the Provider. The Recipient agrees to execute and deliver any
documents of assignment or conveyance to effectuate or document the ownership
rights of the Provider in such Proprietary Materials.
The Recipient further agrees to use Proprietary Materials provided by the
Provider sale for purposes set forth in this Agreement or a subsequent writing.
The Recipient shall use such Proprietary Materials only in compliance with all
applicable federal, state, and local laws and regulations.
The Recipient shall not distribute any Proprietary Materials to any third
party other than its employees who are working on the collaboration established
hereby.
8. RIGHTS TO IMPROVEMENTS
All right, title and interest in (i) all Apollo Improvements shall be
solely in Apollo, (ii) all Endocon Improvements shall be solely in Endocon and
(iii) all Joint Improvements shall be 50% in Apollo and 50% in Endocon.
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Each party shall use its best efforts to ensure that its employees,
consultants, agents, and representatives are contractually required to assign
all Improvements to such party and that such employees, consultants, agents, and
representatives promptly disclose any Improvements to such party.
Each party shall promptly disclose to the other party all Improvements
made or conceived by its employees, consultants, agents, and representatives.
9. PATENTS
Apollo shall be responsible for and shall control, at its expense, the
preparation, filing, prosecution, grant and maintenance of any patent
applications covering Apollo Improvements and shall consult with Endocon on, and
give Endocon a reasonable opportunity to review, all such filings to the extent
they relate to the collaboration established hereby. Endocon shall be
responsible for and shall control, at is expense, the preparation, filing,
prosecution, grant and maintenance of all patent applications covering Endocon
Improvements and shall consult with Apollo on, and give Apollo a reasonable
opportunity to review all such filings to the extent such applications relate to
the collaboration established hereby. Patent applications covering Joint
Improvements shall be filed, prosecuted and maintained jointly under each
party's name and under the direction of both parties, and all expenses relating
thereto will be borne equally by the parties.
Each party agrees to cooperate with the other party fully in the
preparation, filing and prosecution of any patent applications covering Joint
Improvements or any use patent applications.
10. DISPUTE RESOLUTION
(a) The parties hereby agree that the Research Committee will attempt in
good faith to resolve any controversy, claim or dispute (a "Dispute"), arising
out of or relating to this Agreement, through negotiations. Any such Dispute,
which is not settled by the Research Committee within fifteen (15) days after
notice of such Dispute is given by one party to the other in writing, shall be
referred to the Presidents of the parties hereto (the "Senior Executives"). The
Senior Executives shall then meet for negotiations within fifteen (15) days of
the end of the 15-day negotiation period referred to above, at a time and place
mutually acceptable to both Senior Executives. If the Dispute has not been
resolved within thirty (30) days after the end of the commencement of
negotiations between the Senior Executives (which 30-day period may be extended
by mutual agreement of the Senior Executives), subject to any rights to
injunctive relief, and unless otherwise specifically provided for herein, any
Dispute will be settled in accordance with subsections (b) and (c) below.
(b) Any Dispute which is not resolved by the parties within the time
period described in subsection (a) shall be submitted to an alternative dispute
resolution process ("ADR"). Within five (5) business days after the expiration
of the negotiating periods established in accordance with subsection (a) of this
Section, each party shall select for itself a representative with the authority
to bind such party and shall notify the other party in
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writing of the name of such representative. Within ten (10) business days after
the date of delivery of such notice, the representatives shall schedule a date
for engaging in non-binding ADR with a neutral mediator or dispute resolution
firm mutually acceptable to both representatives. Any such mediation shall be
held in Boston, Massachusetts. Thereafter, the representatives of the parties
shall engage in good faith in an ADR process under the auspices of such
individual or firm. If the representatives of the parties have not been able to
resolve a Dispute within thirty (30) business days after the commencement of the
ADR process, or if the representatives of the parties fail to schedule a date
for engaging in non-binding ADR within the ten- (10-) day period set forth
above, the Dispute shall be settled by binding arbitration as set forth in
subsection (c) below. If the representatives of the parties resolve the dispute
within the thirty- (30-) day period set forth above, then such resolution shall
be binding upon the parties.
(c) If the parties have not been able to resolve the Dispute as provided
in subsections (a) and (b) above, the Dispute shall be finally settled by
binding arbitration. Any arbitration hereunder shall be conducted under rules of
the American Arbitration Association. The arbitration shall be conducted before
three arbitrators chosen according to the following procedure: each of the
parties shall appoint one arbitrator and the two so nominated shall chose the
third arbitrator. If the arbitrators chosen by the parties cannot agree on the
choice of the third arbitrator within a period of thirty (30) days after their
appointment, then the third arbitrator shall be appointed by the Court of
Arbitration of the American Arbitration Association. Any such arbitration shall
be held in Boston, Massachusetts or such other location as the arbitrators may
agree. The arbitrators shall have the authority to grant specific performance,
and to allocate between the parties the costs of arbitration in such equitable
manner as they determine. The arbitral award (i) shall be final and binding upon
the parties; and (ii) may be entered in any court of competent jurisdiction.
(d) Nothing contained in this Section or any other provisions of this
Agreement shall be construed to limit or preclude a party from bringing any
court action for injunctive or other provisional relief to compel the other
party to comply with its obligations hereunder before or during the pendency of
mediation or arbitration proceedings. The parties hereby irrevocably consent to
submit to the jurisdiction of the federal courts located within the Commonwealth
of Massachusetts and agree that such venue is proper and will not seek to alter
or contest such venue.
11. MISCELLANEOUS
Neither party shall have authority to make any statements, representations
or commitments of any kind, or to take any action which shall be binding on the
other party, except as may be explicitly provided for herein or authorized in
writing.
This Agreement may be executed in one or more counterparts, each of which
shall be deemed an original, and all of which together shall be deemed to be one
and the same instrument.
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This Agreement shall inure to the benefit of and be binding upon the
parties and their respective lawful successors and assigns. This Agreement may
not be assigned by either party without the prior written consent of the other
party, except that either of the parties may assign this Agreement to a
successor in connection with the merger, consolidation, or sale of all or
substantially all of its assets or that portion of its business pertaining to
the subject matter of this Agreement.
This Agreement may be amended, supplemented, otherwise modified at any
time (including, without limitation, to broaden this Agreement with respect to
additional compounds, delivery systems and product indications), but only by
means of a written instrument signed by both parties. Any waiver of any rights
or failure to act in a specific instance shall relate only to such instance and
shall not be construed as an agreement to waive any rights or fail to act in any
other instance.
In the event that any provision of this Agreement shall, for any reason,
be held to be invalid or unenforceable in any respect, such invalidity or
unenforceability shall not affect any other provision hereof, and this Agreement
shall be construed as if such invalid or unenforceable provision had not been
included herein.
This Agreement supersedes any and all prior understandings of the parties,
oral or written, relating to the subject matter hereof and constitutes the
entire agreement of the parties relating to the subject matter hereof.
This Agreement shall be governed by and construed in accordance with the
internal laws of the Commonwealth of Massachusetts.
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first written above by their duly authorized officers.
APOLLO GENETICS, INC.
By: /s/ Xxxxxxxxx Xxxxxx
__________________________
Xxxxxxxxx Xxxxxx, Ph.D.
ENDOCON, INC.
By: /s/ Xxxxx X. Xxxxxx
__________________________
Xxxxx X. Xxxxxx
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Exhibit A
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APOLLO PATENTS AND PATENT APPLICATIONS
Patent/
Country/region Serial Number Filing Date Title Status
-------------- ------------- ----------- ----- ------
United States 08/149,175 11/6/93 Compositions and Methods Abandoned
for Neuroprotection
United States(1) 5,554,601 10/4/94 Methods for Issued 9/10/96
(CIP of 08/149,175) Neuroprotection
[*]
----------
(1) Priority of US 08/149,175, which is now abandoned
* Confidential treatment is being requested for marked portion.
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Exhibit B
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ENDOCON PATENTS AND PATENT APPLICATIONS
Patent/
Country/region Serial Number Filing Date Title Status
-------------- ------------- ----------- ----- ------
United States 4,748,024 4/6/87 Flash Flow Fused* Issued (5/31/88)
Medicinal Implants
United States 4,892,734 3/30/88 Dispensing Paste for* Issued (1/9/90)
Forming Medicinal Pellets
[**]
Austria E109941 4/4/88 * Issued (8/17/94)
Belgium 357644 4/4/88 * Issued (8/17/94)
Canada 1330939 4/5/88 Flash Flow Fused Issued (7/26/94)
Medicinal Implants
Canada 1330940 4/5/88 Dispensing Paste for Issued (7/26/94)
Forming Medicinal Implants
Switzerland 357644 4/4/88 * Issued (8/17/94)
Germany 357644 4/4/88 * Issued (8/17/94)
France 357644 4/4/88 * Issued (8/17/94)
Italy 357644 4/4/88 * Issued (8/17/94)
Netherlands 357644 4/4/88 * Issued (8/17/94)
Sweden 357644 4/4/88 Issued (8/17/94)
Norway 178783 4/4/88 Issued (6/5/96)
Xxxxxx Xxxxxx 0000000 5/24/91 Manufacture of Partially Issued (8/11/92)
Fused Peptide Pellets
* These patents were combined into one called Flash Flow Medicinal Implants
** Confidential treatment is being requested for marked portion.
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