EXHIBIT 4.21
Execution Version
SETTLEMENT AGREEMENT
This Settlement Agreement (this "Agreement") is entered into effective as
of July 28, 2004 ("Effective Date"), by and among P.N. Gerolymatos S.A., a
corporation organized under the laws of Greece ("PNG"), Xxxxxxxxx X. Gerolymatos
of Kryoneri Attikis, Greece ("Mr. Gerolymatos"), Prana Biotechnology Limited, a
corporation organized under the laws of Australia ("Prana"), The General
Hospital Corporation, a not-for-profit corporation organized under the laws of
Massachusetts, U.S.A. and doing business as Massachusetts General Hospital
("MGH"), Xxxxxx X. Xxxx of Massachusetts, U.S.A. ("Xx. Xxxx"), Xxxxxxx X. Xxxxx
of Massachusetts, U.S.A. ("Xx. Xxxxx"), and Xxxxxx Xxxxxx of Xxxxxxxx, Australia
("Xx. Xxxxxx") (each individually a "Party"; collectively, the "Parties").
WITNESSETH
1. WHEREAS, Prana, MGH, and Drs. Bush, Tanzi, and Xxxxxx filed suit against
PNG and Mr. Gerolymatos in the United States District Court for the
District of Columbia (Civil Action No. 1:00XX00000 TPJ) seeking to correct
the inventorship of U.S. Patent Nos. 6,001,852 and 5,994,323.
2. WHEREAS, PNG filed several counterclaims in such suit and thereafter filed
suit against Prana in the Multi-Judge Court of First Instance in Athens,
Greece (No. 1678-1/1).
3. WHEREAS, PNG has opposed European Patent No. 0613560 in the name of the
University of Melbourne, which is assigned to Prana, and Australian Patent
Application Nos. 29981/99 (752236) and 65484/98 (748768) in the name of
MGH, which are licensed by Prana.
4. WHEREAS, Prana has opposed Australian Patent Application No. 36324/97
(720643) in the name of PNG.
5. WHEREAS, the Parties desire to settle finally the disputes among them by
entering into this Agreement, and to further the terms of such settlement,
PNG and Prana have entered into a Patent Assignment and Settlement
Agreement of even date herewith in the form set forth in Exhibit A (the
"Patent Assignment Agreement"), a Patent Rights Security Agreement, of
even date herewith in the form set forth in Exhibit B (the "Security
Agreement"), and a Derivatives Agreement, of even date herewith in the
form set forth in Exhibit C ("the Derivatives Agreement") (collectively,
the "Transaction Documents"). Capitalized terms used but not otherwise
defined herein shall have the same meanings as in the Patent Assignment
Agreement.
NOW THEREFORE
In view of the foregoing premises and the mutual covenants set forth herein, the
Parties hereto agree as follows:
Execution Version
1. CONFIDENTIALITY
1.1 Confidential Information. Confidential Information (as hereinafter
defined) disclosed by a Party (the "disclosing Party") to another Party (the
"receiving Party") shall not be used by the receiving Party except in connection
with the activities contemplated by this Agreement, shall be maintained in
confidence by the receiving Party (except to the extent reasonably necessary for
(a) regulatory approval of products developed by either Party or its Affiliates
or for the filing, prosecution and maintenance of the Assigned Patent Rights by
Prana or the PNG Assumed Patent Rights or PNG Patent Rights by PNG, or (b)
exercise by Prana of its rights under Section 2.6 of the Patent Assignment
Agreement), and shall not otherwise be disclosed by the receiving Party to any
other person, firm, or agency, governmental or private, without the prior
written consent of the disclosing Party, except to the extent that the
Confidential Information (as determined by competent documentation):
(i) was known or used by the receiving Party prior to its date of
disclosure to the receiving Party; or
(ii) either before or after the date of the disclosure to the
receiving Party is lawfully disclosed to the receiving Party
by sources other than the disclosing Party rightfully in
possession of the Confidential Information; or
(iii) either before or after the date of the disclosure to the
receiving Party becomes published or generally known to the
public (including information known to the public through the
sale of products in the ordinary course of business) through
no fault or omission on the part of the receiving Party or its
sublicensees; or
(iv) is independently developed by or for the receiving Party
without reference to or reliance upon the Confidential
Information.
Notwithstanding anything set forth herein to the contrary, this Section 1 shall
not prohibit the receiving Party from disclosing Confidential Information of the
disclosing Party(ies) that is required to be disclosed by the receiving Party to
comply with applicable laws, governmental regulations or securities exchange
rules and regulations, or to defend or prosecute arbitration or litigation with
respect to this Agreement and the other Transaction Documents, provided that the
receiving Party provides prior written notice of such disclosure to the
disclosing Party(ies), and takes reasonable and lawful actions to avoid and/or
minimize the degree of such disclosure, including reasonably seeking
confidential treatment with respect to or a protective order covering the
information disclosed. Each Party agrees that the content of any announcements,
press releases or other formal public statements concerning the transactions
contemplated by this Agreement and the Transaction Documents will be determined
by mutual agreement and consent of all the Parties, such agreement and consent
not to be unreasonably withheld or delayed. No such approval will be necessary
to the extent disclosure may be required by applicable laws, governmental
regulations or securities exchange rules and regulations. In addition, Prana and
PNG may disclose the general terms of this Agreement and the Transaction
Documents and financial transactions thereunder, including payments and share
issuances, and financial reports
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Execution Version
thereof, to bankers, analysts and investors and other financial advisors. Prana
may disclose the existence of and terms of this Agreement and the other
Transaction Documents to third parties in connection with the grant of rights
associated with the Assigned Patent Rights and as required to comply with third
party agreements.
1.2 Employee and Advisor Obligations. The receiving Party agrees that it
shall provide Confidential Information received from the disclosing Party only
to its respective employees, consultants and advisors, and to the employees,
consultants and advisors of such Party's Affiliates, who have a need to know and
have an obligation to treat such information and materials as confidential under
terms no less restrictive than those set forth herein.
1.3 Term. All obligations of confidentiality imposed under this Section 1
shall expire upon expiration or termination of all payment obligations of the
Parties under the Patent Assignment Agreement and Derivatives Agreement;
provided that with respect to any Confidential Information identified as a trade
secret at the time of disclosure, the obligations of confidentiality imposed
under this Section 1 shall expire when such Confidential Information no longer
qualifies as a trade secret.
1.4 Definitions. For purposes of this Agreement,
(a) "Affiliate" means any corporation, company, partnership, joint
venture and/or firm that controls, is controlled by, or is under common
control with a Party. For purposes of this Section 1.4, "control" shall
mean (a) in the case of corporate entities, direct or indirect ownership
of at least fifty percent (50%) of the stock or shares having the right to
vote for the election of directors, and (b) in the case of non-corporate
entities, direct or indirect ownership of at least fifty percent (50%) of
the equity interest with the power to direct the management and policies
of such non-corporate entities. The Parties acknowledge that in the case
of certain entities organized under the laws of certain countries outside
the United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in such
case such lower percentage shall be substituted in the preceding sentence,
provided that such foreign investor has the power to direct the management
and policies of such entity.
(b) "Confidential Information" means (a) any and all materials, data
or information, including without limitation, any and all concepts,
documentation, reports, data, specifications, computer software, source
code, object code, flow charts, databases, inventions, information,
know-how, show-how and trade secrets, whether or not patentable or
copyrightable, that is (i) disclosed by the disclosing Party and (ii) if
written, is marked "CONFIDENTIAL" or with other legend indicating it is
confidential or proprietary in nature and, if orally or visually
disclosed, the disclosing party has identified the information as
confidential at the time it was disclosed and has delivered written notice
to the receiving party within thirty (30) days of such disclosure
confirming that the disclosing party considers such information to be
confidential and subject to this Agreement; (b) the terms and conditions
of this Agreement, the Patent Assignment Agreement, and the Derivatives
Agreement; and (c) the terms and conditions of the Security Agreement,
except to the extent such terms and conditions are required to be
disclosed, as reasonably determined by PNG, to permit recordation of a
form of security
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Execution Version
agreement and financing statements, sufficient to perfect the granting of
a security interest in the United States Patent and Trademark Office, the
patent offices any applicable country, or the offices of any other
applicable government entity in any applicable country.
2. DISPUTE RESOLUTION
2.1 Dismissal. The Parties agree to end all legal proceedings among them
worldwide, including but not limited to litigations and patent oppositions
regarding CQ and PQ and any related intellectual property rights (collectively,
the "Litigation"). On the Effective Date, the Parties shall execute, and shall
file within fourteen (14) days after the Effective Date, stipulations of
dismissal in such litigations and patent oppositions in the forms set forth in
Exhibits D, E, F, and G.
2.2 Release. Each of Prana, MGH, and Drs. Bush, Tanzi, and Xxxxxx hereby
releases and forever discharges PNG and Mr. Gerolymatos, and any of their past
and present officers, directors, trustees, employees, subsidiaries,
predecessors, successors, parents, assigns, agents, attorneys, heirs, and
representatives from any and all claims and/or counterclaims that (i) were
brought or could have been brought in the Litigation or (ii) relate in any
manner to the claims and/or counterclaims in the Litigation or to the
inventorship of the Assigned Patent Rights and PNG Patent Rights. Each of PNG
and Mr. Gerolymatos hereby releases and forever discharges Prana, MGH, and Drs.
Bush, Tanzi, and Xxxxxx and any of their past and present officers, directors,
trustees, employees, subsidiaries, predecessors, successors, parents, assigns,
agents, attorneys, heirs, and representatives from any and all claims and/or
counterclaims that (i) were brought or could have been brought in the Litigation
or (ii) relate in any manner to the claims and/or counterclaims in the
Litigation or to the inventorship of the Assigned Patent Rights and PNG Patent
Rights. The Parties agree that the foregoing releases shall not prohibit or in
any way limit any Party's ability to enforce the obligations created by this
Agreement or the other Transaction Documents.
2.3 Inventorship. Within thirty (30) days after the Effective Date, Prana
shall elect a neutral third party patent attorney on behalf of the Parties
(choice of attorney subject to reasonable approval by PNG) to evaluate
inventorship of the inventions of the Assigned Patent Rights covering or
relating to CQ. If, in the opinion of the third party patent attorney
inventorship correction is necessary, Prana, with cooperation from the other
Parties, shall correct such inventorship on the relevant patent records, patents
and patent applications. Each Party shall cooperate with the other Parties and
the third party patent attorney and provide reasonable assistance and
information to the other Parties and the third party patent attorney in
connection with such inventorship evaluation and correction. The cost of the
third party inventorship evaluation shall be shared equally by Prana and PNG.
The outcome of any inventorship evaluation pursuant to this Section shall not
affect the applicability or enforceability of any of the terms of this Agreement
or the Patent Assignment Agreement or Prana's ownership of the Assigned Patent
Rights or PNG's ownership of the PNG Patent Rights or MGH's rights pursuant to
the License Agreement between MGH and Prana dated January 1,2001 and any
amendments thereto.
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Execution Version
2.4 Arbitration. With respect to any dispute, controversy or claim arising
out of or relating to this Agreement or the other Transaction Documents or the
subject matters thereof, or the breach, termination or invalidity thereof, the
Parties shall first enter into good-faith negotiations to resolve such dispute,
controversy or claim at a meeting or meetings by one representative of each
Party, who shall initially be the Chairman of Prana for Prana; Avraam Manouach
for PNG and Mr. Gerolymatos; the Director of Corporate Sponsored Research and
Licensing of MGH for MGH, Xx. Xxxx and Xx. Xxxxx; and Xx. Xxxxxx for himself;
provided, that with the exception of an alleged Material Obligation Failure,
in the event of any other dispute, controversy or claim as to the breach of this
Agreement or the other Transaction Documents, prior to initiating such
negotiations, the non-breaching Party shall provide the alleged breaching Party
with written notice of such alleged breach, and the alleged breaching Party
shall be given the opportunity to cure such alleged breach within thirty (30)
days thereafter. Any participation in or initiation of such negotiations shall
not be deemed to be an admission of liability, and no statement made, provided
in or related to such negotiations shall be construed as a statement against
interest or otherwise disclosed or used in any proceeding involving any of the
Parties. Any such dispute, controversy or claim that is not fully resolved
pursuant to the foregoing process after a negotiation period of thirty (30) days
(unless such period is extended in writing by the Parties involved in such
dispute, controversy or claim) shall be finally settled by binding arbitration
conducted in the English language in New York, New York under the commercial
arbitration rules of the American Arbitration Association (the "MA"). The M A
shall appoint a panel of three arbitrators within thirty (30) days after the
initiation of the arbitration, one arbitrator to be designated by one Party or
Parties, one arbitrator to be designated by the adverse Party or Parties and the
third arbitrator to be designated by the first two arbitrators. Disputes about
arbitration procedure shall be resolved by the arbitrators or failing agreement,
by the AAA in New York, New York. The arbitrators shall be authorized to grant
interim relief, including to prevent the destruction of goods or documents
involved in the dispute, protect trade secrets and provide for security for a
prospective monetary award. Specifically, but without limitation, under no
circumstances shall the arbitrator be authorized to award punitive or multiple
damages. Any purported award of punitive or multiple of damages or of other
damages not permitted under Section 3.9 hereof or Section 11.12 of the Patent
Assignment Agreement shall be beyond the arbitrators' authority and shall be
void and unenforceable. The arbitrators shall have the authority to grant
specific performance and other forms of equitable relief as described in Section
3.2, and all costs of the arbitration, including reasonable attorneys' fees of
any prevailing party, shall be borne by the losing party. Judgment upon the
award so rendered may be entered in any court having jurisdiction or application
may be made to such court for judicial acceptance of any award and an order of
enforcement, as the case may be. The award of the arbitrators is the sole and
exclusive remedy of the Parties.
2.5 Agreements. Each of the Parties acknowledges and agrees that it or he
has read the terms and conditions of this Agreement and the other Transaction
Documents.
3. GENERAL PROVISIONS
3.1 Term. Except as provided in Section 1.3, the term of this Agreement
continues indefinitely.
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Execution Version
3.2 Equitable Relief. Each Party acknowledges that a breach by it of the
provisions of this Agreement cannot reasonably or adequately be compensated in
damages in an action at law; and that a breach by such Party of any of the
provisions contained in this Agreement shall cause the other Party irreparable
injury and damage. By reason thereof, each Party acknowledges and agrees that
the other Party shall be entitled in such cases in addition to, and not in lieu
of, any other remedies it may have under this Agreement or otherwise, under the
dispute resolution provisions of Section 2.4 to preliminary and permanent
injunctive relief and any other available equitable relief to prevent or curtail
any breach of this Agreement by the other Party or specifically to enforce the
performance of the other Party under this Agreement without the necessity of
posting any bond or other security; provided, however, that no specification in
this Agreement of a specific legal or equitable remedy shall be construed as a
waiver or prohibition against the pursuing of other legal or equitable remedies
in the event of such a breach.
3.3 Choice of Law. This Agreement will be governed by and construed in
accordance with the laws of New York and the United States.
3.4 Entire Agreement; Amendments. This Agreement constitutes the entire
agreement among the Parties with respect to the subject matter hereof except as
provided in the Patent Assignment Agreement and the other Transaction Documents,
and supersedes all previous arrangements with respect to the subject matter
hereof, whether written or oral, including, without limitation, the Base Term
Sheet, dated April 7, 2004, among PNG, Prana, and MGH and the Derivatives Term
Sheet, dated April 7, 2004, between PNG and Prana. Any amendment or modification
to this Agreement shall be made in writing signed by all Parties.
3.5 Headings. The captions or headings of the Sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
3.6 No Implied Waivers; Rights Cumulative. No failure on the part of a
Party to exercise, and no delay in exercising, any right, power, remedy or
privilege under this Agreement, or provided by statute or at law or in equity or
otherwise, shall impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege or be construed as a waiver of any breach of this
Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.
3.7 Severability. If any provision hereof should be held invalid, illegal
or unenforceable in any respect in any jurisdiction, then, to the fullest extent
permitted by law, (a) all other provisions hereof shall remain in full force and
effect in such jurisdiction and shall be liberally construed in order to carry
out the intentions of the Parties as nearly as may be possible and (b) such
invalidity, illegality or unenforceability shall not affect the validity,
legality or enforceability of such provision in any other jurisdiction.
3.8 Execution in Counterparts. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
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Execution Version
3.9 No Consequential Damages. UNLESS RESULTING FROM A PARTY'S WILLFUL
MISCONDUCT OR FROM A PARTY'S BREACH OF SECTION 1 ("CONFIDENTIALITY"), NO PARTY
WILL BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE,
MULTIPLE OR OTHER INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE
OF ITS RIGHTS HEREUNDER, OR FOR LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE
DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT WHETHER BASED
XXXX XXXXXXXX, XXXXXXXX, XXXX, XXXXXX LIABILITY OR OTHERWISE, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES.
3.10 Further Assurances. At any time and from time to time after the date
hereof, at a Party's request and sole expense, the other Party promptly shall
execute and deliver, and shall cause its Affiliates and employees, to execute
and deliver, such instruments, and take such other reasonable action, as the
requesting Party may reasonably request more effectively to carry out the
purpose and intent of this Agreement.
SIGNATURE PAGE FOLLOWS
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Execution Version
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives:
PRANA BIOTECHNOLOGY LIMITED THE GENERAL HOSPITAL CORPORATION
By: /s/ Xxxxxxxx Xxxxxxx By: /s/ Xxxxxxx Xxxxxxxxx
----------------------------- -------------------------------------
Name: Xxxxxxxx Xxxxxxx Name: Xxxxxxx Xxxxxxxxx
--------------------------- -----------------------------------
Title: Executive Chairman Title: Director Corporate
-------------------------- Sponsored Research and
Licensing
Date: July 28, 2004 ----------------------------------
Date: July 28, 2004
P.N. GEROLYMATOS S.A. Xxxxxxxxx X. Gerolymatos
By: /s/ Xxxxxxxxx X. Gerolymatos /s/ Xxxxxxxxx X. Gerolymatos
----------------------------- ----------------------------------------
Name: P. Gerolymatos Date: July 28, 2004
---------------------------
Title: President & Managing
Director
-------------------------
Date: July 28, 2004
Xxxxxx X. Xxxx Xxxxxx Xxxxxx
/s/ Xxxxxx X. Xxxx /s/ Xxxxxx Xxxxxx
-------------------------------- ----------------------------------------
Date: July 28, 2004 Date: July 28, 2004
Xxxxxxx X. Xxxxx
/s/ Xxxxxxx X. Xxxxx
--------------------------------
Date: July 28, 2004
[Signature Page to Settlement Agreement]
Execution Version
EXHIBIT A
Patent Assignment Agreement
Execution Version
EXHIBIT B
Patent Rights Security Agreement
Execution Version
EXHIBIT C
Derivatives Agreement
Execution Version
EXHIBIT D
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
-------------------------------------)
PRANA BIOTECHNOLOGY, LTD., )
THE GENERAL HOSPITAL CORPORATION, )
XXXXXX X. XXXX, XXXXXX XXXXXX, and )
XXXXXXX X. XXXXX, )
)
Plaintiffs, ) Civil Action No. 1:01CVO2052 TPJ
)
v. )
)
P.N. GEROLYMATOS S.A., and )
XXXXXXXXX X. GEROLYMATOS, )
)
Defendants. )
-------------------------------------)
STIPULATION OF DISMISSAL
Plaintiffs Prana Biotechnology, Ltd., The General Hospital Corporation,
Xxxxxx X. Xxxx, Xxxxxx Xxxxxx, and Xxxxxxx X. Xxxxx and Defendants P.N.
Gerolymatos S.A. and Xxxxxxxxx X. Gerolymatos agree and stipulate that their
claims against each other in this action, including all counterclaims, shall be
and hereby are dismissed with prejudice. Each party shall bear its own costs and
attorneys' fees.
Execution Version
PRANA BIOTECHNOLOGY, LTD., THE
GENERAL HOSPITAL CORPORATION,
P.N. GEROLYMATOS S.A. and XXXXXX X. XXXX, XXXXXX XXXXXX, and
XXXXXXXXX X. GEROLYMATOS XXXXXXX X. XXXXX
By their attorneys, By their attorneys,
__________________________________ __________________________________
Xxxxxx Xxxxxx Xxxxxxx X. XxXxxxxx (Bar#397553)
Xxx Xxxxxxxx Xxxx and Xxxx LLP
Xxxxx Day 0000 Xxxxxxxxxxxx Xxxxxx, XX
00 Xxxxxxxxx Xxxxxx, XX Xxxxxxxxxx, XX 00000
Xxxxxxxxxx, XX 00000-0000 (000) 000-0000
(000)000-0000
Xxxxxxx X. Xxx
Xxxxx X. Xxxxxx
Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
(000) 000-0000
Dated: July 28, 2004
IT IS SO ORDERED
Dated:_______________________ ______________________________________
Xxxxxxxxx Xxxxxx Xxxxxxxx Xxxxxxx
United States District Judge
Execution Version
EXHIBIT E
Form for dismissal of Greek lawsuit
BEFORE THE MULTI-MEMBER FIRST INSTANCE
COURT OF ATHENS
RESIGNATION FROM THE LAWSUIT DEED AND FROM THE RIGHT
OF
1. PN GEROLYMATOS S.A., with registered premises 00 Xxxxxxxxx Xxxxxx,
Xxxxxxxx, Xxxxxx, duly represented; and
2. PANAYOTIS GEROLYMATOS, resident of 00 Xxxxxxxxx Xxxxxx, Xxxxxxxx,
Xxxxxx, duly represented
(as Plaintiffs),
AGAINST
PRANA BIOTECHNOLOGY LIMITED, a corporation organized under the laws
of Australia, duly represented
(as Defendant),
--------------------------------------------------------------------------------
Plaintiffs have filed before the Multi-member First Instance Court of Athens, on
9.12.2001 a law suit (General Registry No. 352/2002 and law suit No. 42/2002)
against the Defendant, which was to be tried originally on 13.3.2003 and after
postponement is to be tried on 30.9.2004.
Execution Version
With this present stipulation of dismissal, Plaintiffs declare explicitly and
unequivocally that they resign from the aforementioned lawsuit and from all
their rights therefrom.
THEREFORE,
WE HEREBY RESIGN
from the law suit deed of 9.12.2001 (General Registration No. 352/2002 and law
suit No. 42/2002), against the Defendant, PRANA BIOTECHNOLOGY LIMITED, and from
all the rights that arise therefrom.
Athens,........28 July 2004
Execution Version
EXHIBIT F
Form for dismissal of European patent opposition
REGISTERED
European Patent Office
D-80298 Munchen
Tyskland
PrR/LeH/126117 28 July 2004
European Patent No. 613560
Appeal Case No. T 0264/04-338
On behalf on our client we hereby withdraw Appeal Case No. T 0264/04-338 filed
against the decision taken in the Opposition against EP 613 560 B1.
Yours sincerely,
Internationalt Patent-Bureau A/S
Xxxx Xxxxx
(Professional representative)
Encl.: EPO FORM 1037
Execution Version
EXHIBIT F continued
EPO Form 1037
[LETTERHEAD OF INTERNATIONALT PATENT-BUREAU A/S]
EPA/EPO/OEB Form 1037.1 03.99
Eingangsbestatigung fur Einsender
Acknowledgement of receipt for sender
Accuse de reseption expediteur
Bestatigung uber den Acknowledgement of Accuse de reception a
Eingang nachgereichter receipt for subsequently l'Office europeen des
Unterlagen fur Patentan- filed items relating to brevets de pieces produites
meldungen/Patente beim patent applications/patents posterieurement au depot
Europaischen Patentamt at the European Patent d'une demande de brevet/
Office a la delivrance d'un brevet
europeen
Datum und Ort des Eingangs sind Date and place of receipt are La date et le lieu de reception
aus der Perforation dieser shown by the perforation appearing sont indiques par la perforation
Eingangsbestatigung ersichtlich on this receipt du present accuse de reception
(M + Datum = Einreichungsort Munchen; (M + date = Munich as place of receipt; (M + date = pieces recues a Munich;
H + Datum = Einreichungsort Den Xxxx; H + date = The Hague as place of receipt; H + date = pieces recues a La Haye;
Datum + B = Einreichungsort Berlin) date + B = Berlin as place of receipt) date + B = pieces recues a Berlin)
Eingereichte Unterlagen Items filed Pieces envoyees
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Anmeldungs- (und Direktions-*) Nr./Patent Nr. Ihr Zeichen ggfs. Art und Datum der Unterlagen**
Application (and Directorate*) No./Patent No. Your reference Nature and date of items (optional)**
N(degree) de la demande (et de la direction*)
/n(degree) du brevet Votre reference Nature et date des pieces (facultatif)**
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* falls bereits bekannt * if already known * si deja connu
** Der Eingang der angegebenen ** The receipt of the items indicated ** La reception des pieces indiquees
Unterlagen wird bestatigt. is confirmed. est confirmee.
Enthalt diese Spalte keine If this does not contain any entries, Faute de mention dans cette
Eintragungen, so wird lediglich it is only confirmed that an item colonne, le present accuse de
bestatigt, dab eine Sendung zu dem has been received for the reception se rapporte a une piece
angegebenen Aktenzeichen eingegangen indicated file. quelconque envoyee sous la
ist. reference indiquee.
[LETTERHEAD OF INTERNATIONALT PATENT-BUREAU A/S]
EPA/EPO/OEB Form 1037.2 03.99
Kopie fur EPA
Copy fro EPO
Copie OEB
Bestatigung uber den Acknowledgement of Accuse de reception a
Eingang nachgereichter receipt for subsequently l'Office europeen des
Unterlagen fur Patentan- filed items relating to brevets de pieces produites
meldungen/Patente beim patent applications/patents posterieurement au depot
Europaischen Patentamt at the European Patent d'une demande de brevet/
Office a la delivrance d'un brevet
europeen
Datum und Ort des Eingangs sind Date and place of receipt are La date et le lieu de reception
aus der Perforation dieser shown by the perforation appearing sont indiques par la perforation
Eingangsbestatigung ersichtlich on this receipt du present accuse de reception
(M + Datum = Einreichungsort Munchen; (M + date = Munich as place of receipt; (M + date = pieces recues a Munich;
H + Datum = Einreichungsort Den Xxxx; H + date = The Hague as place of receipt; H + date = pieces recues a La Haye;
Datum + B = Einreichungsort Berlin) date + B = Berlin as place of receipt) date + B = pieces recues a Berlin)
Eingereichte Unterlagen Items filed Pieces envoyees
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Anmeldungs- (und Direktions-*) Nr./Patent Nr. Ihr Zeichen ggfs. Art und Datum der Unterlagen**
Application (and Directorate*) No./Patent No. Your reference Nature and date of items (optional)**
N(degree) de la demande (et de la direction*)
/n(degree) du brevet Votre reference Nature et date des pieces (facultatif)**
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* falls bereits bekannt * if already known * si deja connu
** Der Eingang der angegebenen ** The receipt of the items indicated ** La reception des pieces indiquees
Unterlagen wird bestatigt. is confirmed. est confirmee.
Enthalt diese Spalte keine If this does not contain any entries, Faute de mention dans cette
Eintragungen, so wird lediglich it is only confirmed that an item colonne, le present accuse de
bestatigt, dab eine Sendung zu dem has been received for the reception se rapporte a une piece
angegebenen Aktenzeichen eingegangen indicated file. quelconque envoyee sous la
ist. reference indiquee.
[LETTERHEAD OF INTERNATIONALT PATENT-BUREAU A/S]
EPA/EPO/OEB Form 1037.3 03.99
Zum Verbleib beim Einsender
For retention by sender
Copie expediteur
Bestatigung uber den Acknowledgement of Accuse de reception a
Eingang nachgereichter receipt for subsequently L'Office europeen des
Unterlagen fur Patentan- filed items relating to brevets de pieces produites
meldungen/Patente beim patent applications/patents posterieurement au depot
Europaischen Patentamt at the European Patent d'une demande de brevet/
Office a la delivrance d'un brevet
europeen
Datum und Ort des Eingangs sind Date and place of receipt are La date et le lieu de reception
aus der Perforation dieser shown by the perforation appearing sont indiques par la perforation
Eingangsbestatigung ersichtlich on this receipt du present accuse de reception
(M + Datum = Einreichungsort Munchen; (M + date = Munich as place of receipt; (M + date = pieces recues a Munich;
H + Datum = Einreichungsort Den Xxxx; H + date = The Hague as place of receipt; H + date = pieces recues a La Haye;
Datum + B = Einreichungsort Berlin) date + B = Berlin as place of receipt) date + B = pieces recues a Berlin)
Eingereichte Unterlagen Items filed Pieces envoyees
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Anmeldungs- (und Direktions-*) Nr./Patent Nr. Ihr Zeichen ggfs. Art und Datum der Unterlagen**
Application (and Directorate*) No./Patent No. Your reference Nature and date of items (optional)**
N(degree) de la demande (et de la direction*)
/n(degree) du brevet Votre reference Nature et date des pieces (facultatif)**
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1 IPB/1
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3
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4
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* falls bereits bekannt * if already known * si deja connu
** Der Eingang der angegebenen ** The receipt of the items indicated ** La reception des pieces indiquees
Unterlagen wird bestatigt. is confirmed. est confirmee.
Enthalt diese Spalte keine If this does not contain any entries, Faute de mention dans cette
Eintragungen, so wird lediglich it is only confirmed that an item colonne, le present accuse de
bestatigt, dab eine Sendung zu dem has been received for the reception se rapporte a une piece
angegebenen Aktenzeichen eingegangen indicated file. quelconque envoyee sous la
ist. reference indiquee.
Mitteilung vom 8. November 1990
uber die Xxxxxxxxxx xxx
Xxxxxxxxxxx 0000 xxx 0000
(XXX. EPA 1991, 64)
A. EPA/EPO/OEB Form 1038
1. Die nach Einreichung der europaischen Patentanmeldung einzureichenden
Schriftstucke sind, soweit es sich nicht um Anlagen handelt, vom
Verfahrensbeteiligten oder seinem zugelassenen Vertreter zu unterzeichnen (Regel
36 (3). 61a EPU). Dokumente, wie z. B. der Prioritatsbeleg oder dessen
Ubersetzung, mussen deshalb mit einem gesonderten Begleitschreiben oder
zumindest einem Vermerk auf dem Dokument selbst, dab es an das Europaische
Patentamt gerichtet ist, jeweils mit der ordnungsgemaben Unterschrift einer zum
Handeln vor dem EPA berechtigten Person (vgl. Art. 133 EPU) eingereicht werden.
Dies gilt beispielsweise auch, wenn der Vertreter eine Erfindernennung
nachreicht, die von einem Anmelder unterzeichnet xxxxxx ist, der weder Wohnsitz
noch Sitz in einem Vertragsstaat hat (s. Richtlinien fur die Prufung A-IX, 3.1).
2. ...
3. Mit Hilfe des neuen Formblatts 1038 konnen Unterlagen zu jeweils einer
europaischen Patentanmeldung/einem europaischen Patent nachgereicht werden. Da
das Original von Form 1038 das Begleitschreiben fur nachgereichte Unterlagen
darstellt und deshalb Aktenbestandteil wird, ist es nicht moglich, mit diesem
Vordruck Unterlagen zu mehreren Akten nachzureichen. Fur jede Akte mub ein
gesondertes Formblatt benutzt werden.
4. Form 1038 ist als Vierfach-Sak konzipiert. Damit erfullt es sowohl die
Funktion eines Begleitschreibens als auch die einer Eingangsbestatigung. Drei
Exemplare sollen beim Amt eingereicht werden. Das Original gelangt zur Akte, das
zweite Exemplar verbleibt bei der Sammlung der Annahmestelle des EPA, und das
dritte Exemplar geht mit einer Eingangsbestatigung versehen an den Einreicher
zuruck. Das vierte Exemplar verbleibt von vornherein als Zwischenkopie beim
Einreicher.
B. EPA/EPO/OEB Form 1037
1. Nach wie vor moglich bleibt die gleichzeitige Nachreichung von Unterlagen
(allerdings ohne Begleitschreiben und ohne Unterschriftsmoglichkeit) zu mehreren
Anmeldungsakten mit Hilfe des Form 1037. Form 1037 dient ausschlieiblich als
Eingangsbestatigung. Seine Verwendung ist wie bisher besonders dann zu
empfehlen, wenn Schriftstucke nachgereicht werden, die bereits selbst die
erforderliche Unterschrift tragen (z. B. Erwiderungen auf Bescheide und
Mitteilungen, Abbuchungsauftrage usw.).
2. Wegen der Benutzung des Formblatts 1037 wird auf die entsprechende
Veroffentlichung in ABI. EPA 1985, 289 verwiesen. ...
Notice dated 8 November 1990
concerning the introduction of
Forms 1038 and 1037
(OJ EPO 1991, 64)
A. EPA/EPO/OEB Form 1038
1. Documents, other than annexes, to be filed after filing of the European
patent application must be signed by the party concerned or his authorised
representative (Rules 36(3) and 61a EPC). Those such as the priority document or
translation thereof must consequently be filed with a separate covering letter,
or at least a note on the document itself addressing it to the European Patent
Office, in each case duly signed by a person authorised to act before the EPO
(cf. Article 133 EPC). This also applies if, for example, a representative
subsequently files the designation of the inventor signed by an applicant having
neither residence nor principal place of business in a Contracting State (see
Guidelines for Examination A-IX, 3.1).
2. ...
3. With this new Form 1038 items relating to one European patent application or
to one European patent can be subsequently filed. As the top copy of Form 1038
represents the covering letter for such items and thus becomes part of the file
it cannot be used for subsequent filing of documents relating to more than one
file. Separate forms must be used.
4. Form 1038 is in four copies, three of which are to be sent to the Office.
This allows the form to serve as both a covering letter and acknowledgement of
receipt. The top copy goes into the file, the second copy is retained by the
EPO's Receiving Section and the third is returned to the sender stamped with an
acknowledgement of receipt. In the meantime the sender retains the fourth copy.
B. EPA/EPO/OEB Form 1037
0.Xx still remains possible by using Form 1037 (but without accompanying letter
and without signature) to file subsequently items at the same time that relate
to several applications. Form 1037 is only an acknowledgement. Its use continues
to be particularly recommended for subsequent filing of documents already
bearing the required signature (e.g. replies to communications, debit orders,
etc.).
2. Please refer to the Notice on this subject published in OJ EPO 1985, 289. ...
Communique en date du
8 novembre 1990, concernant I'introduction
des formulaires 1038 et 1037
(JO OEB 1991, 64)
A. EPA/EPO/OEB Form 1038
1. A L'exclusion des pieces annexes, les documents posterieurs au depot de la
demande de brevet europeen doivent etre signes par l'interesse ou son mandataire
agree (regles 36(3) et 61 bis CBE). Il y a lieu de joindre aux documents
produits, par exemple le document de priorite ou sa traduction. une lettre
d'accompagnement separee signalant qu'ils sont adresses a l'OEB, ou tout au
moins d'en faire mention par ecrit a meme ces documents; cette lettre ou cette
mention doit etre dument signee par une personne habilitee a agir devant l'OEB
(cf. art. 133 CBE). Xxxx xxxx par exemple egalement pour le depot ulterieur, par
le mandataire, de la designation de l'inventeur lorsque celle-ci porte la
signature d'un demandeur qui n'a ni domicile ni siege sur le territoire de L'un
des Etats contractants (cf. Directives relatives a l'examen, A-IX, 3.1).
2. ...
3. Ce nouveau formulaire 1038 peut etre utilise pour produire, posterieurement
au depot, des pieces afferentes a une seule demande de brevet europeen ou a un
seul brevet europeen. Vu que l'original du formulaire 1038 constitue la lettre
d'accompagnement relative a des pieces produites posterieurement au depot et
qu'il est donc verse au dossier, il n'est pas possible d'utiliser cet imprime
pour produire, posterieurement au depot, des pieces concernant plusieurs
dossiers differents. Un formulaire separe doit etre utilise pour chaque dossier.
4. Le formulaire 1038 comporte quatre feuilles, remplissant ainsi a la fois la
fonction d'une lettre d'accompagnement et celle d'un accuse de reception. Trois
doivent etre envoyees a l'Office: l'original est verse au dossier; le deuxieme
exemplaire est conserve au bureau de reception de l'OEB et le troisieme est
renvoye a l'expediteur, accompagne d'un accuse de reception. Le quatrieme
exemplaire est conserve des le depart comme double par l'expediteur.
B. EPA/EPO/OEB Form 1037
1. Il reste possible de produire en un seul envoi, posterieurement au depot, des
pieces concernant plusieurs dossiers, en se servant du formulaire 1037
(toutefois sans lettre d'accompagnement ni possibilite de signature), formulaire
qui sert exclusivement d'accuse de reception. Comme par le passe, son
utilisation est particulierement indiquee en cas d'envoi, posterieurement au
depot, de pieces qui portent deja elles-memes la signature requise (par exemple
reponses a des avis ou des notifications, ordres de debit, etc.).
2. S'agissant de l'utilisation du formulaire 1037, priere de se reporter au
communique publie au JO OEB 1985, 289. ...
Execution Version
EXHIBITS G-1, G-2 and G-3
Forms for dismissal of Australian patent oppositions
The Commissioner of Patents
28 July 2004
Madam
IN THE MATTER OF Australian Patent No. 752236 (29981/99)
in the name of The General Hospital Corporation
and opposition thereto by
P.N. Gerolymatos S.A.
Pursuant to Regulation 5.15 of the Patent Regulations 1991, the opponent hereby
withdraws its opposition to this application.
A copy of this letter was served this day on the applicant's attorneys.
Yours faithfully
Execution Version
EXHIBITS G-1, G-2 and G-3 continued
The Commissioner of Patents
28 July 2004
Madam
IN THE MATTER OF Australian Patent No. 720643 (36324/97)
in the name of P. N. GEROLYMATOS S.A.
and opposition thereto by
PRANA BIOTECHNOLOGY LTD
Our Ref: VS:SDT:GF36365:GM29764
Pursuant to Regulation 5.15 of the Patent Regulations 1991, the opponent hereby
withdraws its opposition to this application.
A copy of this letter was served this day on the applicant's attorneys.
Yours faithfully
Execution Version
EXHIBITS G-1, G-2 and G-3 continued
The Commissioner of Patents
28 July 2004
Madam
IN THE MATTER OF Australian Patent No. 748768 (65484/98)
in the name of The General Hospital Corporation
and opposition thereto by
P.N. Gerolymatos S.A.
Pursuant to Regulation 5.15 of the Patent Regulations 1991, the opponent hereby
withdraws its opposition to this application.
A copy of this letter was served this day on the applicant's attorneys.
Yours faithfully
Execution Version
PATENT ASSIGNMENT AND SETTLEMENT AGREEMENT
This Patent Assignment and Settlement Agreement (this "Agreement") is
entered into effective as of July 28, 2004 ("Effective Date"), by and between
P.N. Gerolymatos S.A., a corporation organized under the laws of Greece ("PNG")
and Prana Biotechnology Limited, a corporation organized under the laws of
Australia ("Prana").
WITNESSETH
WHEREAS, Prana obtained a license under certain patent rights from MGH (as
hereinafter defined) covering certain pharmaceutical compositions and uses of CQ
(as hereinafter defined) to treat and prevent specified diseases;
WHEREAS, PNG is the patentee of certain patents covering certain
pharmaceutical compositions and uses of CQ and PQ (as hereinafter defined) to
treat and prevent specified diseases:
WHEREAS, Prana, MGH and certain individuals, filed suit in the United
States against PNG and Xxxxxxxxx X. Gerolymatos to correct inventorship under
certain of such patents;
WHEREAS, PNG filed several counterclaims in response to such suit, and
thereafter filed suit against Prana in Greece;
WHEREAS, PNG and Prana are also engaged in certain patent oppositions with
respect to one another's patents; and
WHEREAS, PNG, Prana and MGH desire to and have agreed to settle finally
their disputes as contemplated herein and in the Settlement Agreement (as
hereinafter defined) and effect the related assignment of certain patent rights
as contemplated herein;
NOW, THEREFORE:
in view of the foregoing premises and the mutual covenants set forth herein, and
for other good and valuable consideration, the receipt and sufficiency of which
is acknowledged by each party, the parties hereto agree as follows:
1. DEFINITIONS
1.1 Affiliate means any corporation, company, partnership, joint venture
and/or firm that controls, is controlled by, or is under common control with a
Party. For purposes of this Section 1.1, "control" shall mean (a) in the case of
corporate entities, direct or indirect ownership of at least fifty percent (50%)
of the stock or shares having the right to vote for the election of directors,
and (b) in the case of non-corporate entities, direct or indirect ownership of
at least fifty percent (50%) of the equity interest with the power to direct the
management and policies of such non-corporate entities. The Parties acknowledge
that in the case of certain entities organized under the laws of certain
countries outside the United States, the maximum percentage ownership permitted
by law for a foreign investor may be less than fifty percent (50%), and that
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in such case such lower percentage shall be substituted in the preceding
sentence, provided that such foreign investor has the power to direct the
management and policies of such entity.
1.2 Assigned Patent Rights means all Patent Rights owned by PNG as of the
Effective Date with claims covering CQ or PQ that are filed or subsisting in the
Prana Territory, as are set forth on Schedule 1.2 and as supplemented in
accordance with the terms of Section 2.2.
1.3 Clioquinol or CQ means 5-Chloro-7-iodo-8-quinolinol.
1.4 CO Milestone Payment means a payment from one or more third parties in
the form of a milestone payment associated specifically with the development of
a Product containing CQ.
1.5 Derivatives Agreement means the Derivatives Agreement, of even date
herewith, between PNG and Prana.
1.6 First Commercial Sale means, for each Product or Other Licensed
Product, the first commercial sale in the ordinary course in a country as part
of a nationwide introduction by a Party or its Affiliates, sublicensees or
distributors. Sales for test marketing, clinical trial purposes or compassionate
or similar use shall not be considered to constitute a First Commercial Sale.
1.7 FDA means the United States Food and Drug Administration, or a
successor agency thereto.
1.8 Lundbeck means X. Xxxxxxxx A/S .
1.9 Lundbeck Agreement means the License Agreement between PNG and
Lundbeck dated July 26, 1999, as amended by Addendum I, dated April 14, 2000
("Addendum I"); Addendum II, dated February 18, 2001 ("Addendum II"); Addendum
III, dated July 19, 2002 ("Addendum III"), and an additional undated Addendum
signed following the Base Term Sheet between the Parties, dated April 7, 2004
("Addendum IV"), and any successor amendments or any successor agreements
thereto to the extent affecting the rights in this Agreement.
1.10 Lundbeck Territories means those territories, if any, to which
Lundbeck exercises its option to obtain an exclusive license to market CQ and/or
PQ pursuant to the Lundbeck Agreement.
1.11 MGH means The General Hospital Corporation, a Massachusetts
not-for-profit corporation doing business as Massachusetts General Hospital.
1.12 Material Obligation Failure means (a) the failure of Prana within
eight (8) years of the Effective Date to begin a new Phase 11 Clinical Study
(excluding any such studies performed before the Effective Date) for approval by
a Regulatory Authority of CQ, PQ, or any Derivative (as defined in the
Derivatives Agreement) or (b) the failure of Prana to make any royalty or
milestone payments as provided in Article 3 hereof that are not disputed in good
faith and to cure such failure within the cure period set forth in Section 2.4.
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1.13 Net Sales means, with respect to a Product or an Other Product, the
amount received by a Party, its Affiliates and/or its licensees, sublicensees or
distributors on sales or other dispositions of such products to third parties in
arm's length transactions, less the following deductions, all determined in
accordance with United States generally accepted accounting principles (US GAAP)
consistently applied:
(a) trade, cash and/or quantity discounts actually allowed and taken
directly with respect to such sales, as reflected in the amount invoiced;
(b) tariffs, duties, excises, sales taxes or other taxes imposed
upon and paid directly by such Party with respect to the production, sale,
delivery or use of such Product or such Other Product, as applicable,
(excluding national, state or local taxes based on income), as reflected
in the amount invoiced;
(c) amounts repaid or credited by reason of rejections, defects,
recalls or returns or because of chargebacks, refunds, rebates or
retroactive price reductions; and
(d) freight, insurance and other transportation charges incurred in
shipping such Product or such Other Product to third parties, as reflected
in the amount invoiced.
1.14 Option Territories means those territories that are not Lundbeck
Territories, Prana Territories and PNG Territories.
1.15 Other Product(s) means any product containing either CQ or PQ, that,
or the use of which, is covered by the claims of the PNG Patent Rights.
1.16 Party means PNG or Prana; Parties means PNG and Prana.
1.17 Patent Right means any patent or patent application and all
substitutions, renewals, divisionals, continuations, continuations-in-part (with
respect to the Assigned Patent Rights to the extent any such
continuation-in-part was filed as of the Effective Date), resulting patents,
reissues, reexaminations, extensions, and refilings thereof and rights to xxx
for infringement thereof, past and present.
1.18 Permitted Transferee means Michel Xilinas.
1.19 Phanquinone or PQ means 4,7-Phenanthroline-5,6-dione.
1.20 PNG Patent Rights means all Patent Rights owned by PNG as of the
Effective Date with claims covering CQ or PQ that are filed or subsisting in the
Lundbeck Territories, Option Territories and PNG Territories (but excluding the
Prana Territories), as are set forth on Schedule 1.20. PNG Patent Rights include
any and all PNG Assumed Patent Rights pursuant to Section 6.2.
1.21 PNG Territories means Greece, Cyprus, Turkey, Israel, Hong Kong,
Singapore, South Korea, and any and all territories not chosen by Prana pursuant
to Section 2.2.
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1.22 PO Milestone Payment means a payment from one or more third parties
in the form of a milestone payment associated specifically with the development
of a Product containing PQ.
1.23 Phase 11 Clinical Study means a study of a Product containing either
CQ or PQ in patients to determine initial efficacy and dosing regimen.
1.24 Phase III Clinical Study means a clinical study in larger targeted
patient populations, the protocol for which is designed to ascertain efficacy
and safety of a Product containing either CQ or PQ for the purpose of preparing
and submitting an application for marketing approval to the competent Regulatory
Authorities in the applicable jurisdiction.
1.25 Prana Territories means the United States of America, Japan and
Taiwan, and any and all territories chosen by Prana pursuant to Section 2.2.
1.26 Product(s) means any product containing either CQ or PQ that, or the
use of which, is covered by the claims of the Assigned Patent Rights.
1.27 Regulatory Authority means any federal, national, multinational,
state, provincial or local regulatory agency, department, bureau or other
governmental entity with authority over the testing, manufacture, use, storage,
import, promotion, marketing and sale of therapeutic product in a country,
including the FDA.
1.28 Security Agreement means the Patent Rights Security Agreement, dated
of even date herewith, between PNG and Prana.
1.29 Settlement Agreement means the Settlement Agreement, dated of even
date herewith, among PNG, Prana, MGH, and individuals named therein.
2. ASSIGNMENT; REVERSION OF RIGHTS
2.1 Assignment. Subject to Sections 2.4 and 2.5 below, upon receipt by PNG
of the U.S. $150,000 described in Section 3.1 and the Shares described in
Section 3.2(a), PNG shall sell, transfer and assign the Assigned Patent Rights
to Prana. Thereupon, PNG shall execute and deliver to Prana a sufficient number
of original copies of the patent assignment in the form attached hereto as
Exhibit A, or such other form as required by the authorities of the applicable
country, which forms Prana shall have the right to file as necessary to perfect
such assignment.
2.2 Prana Territories Expansion. In the event Lundbeck does not elect to
exercise its option to obtain a license to market one or more Other Products in
any country within the Option Territories pursuant to Section 3 of Addendum I
and Addendum II of the Lundbeck Agreement, PNG shall notify Prana in writing of
such rejection within thirty (30) days. Prana shall have the right to elect to
include such territories in the Prana Territories by notifying PNG in writing of
its election within sixty (60) days. If Prana does not provide notice to PNG
within such 60-day period, Prana shall be deemed to have rejected such election
and such territories shall be a part of the PNG Territories. If Prana does
provide such notice within such 60-day period, such territories shall be deemed
to be part of the Prana Territories and PNG shall execute a patent assignment in
the form attached hereto as Exhibit A (or such other form as required by the
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Execution Version
applicable authorities) with respect to all Assigned Patent Rights in such
territories no later than thirty (30) days after receipt of notice from Prana.
Schedule 2.2(a) lists all Patent Rights in the Lundbeck Territories as of the
Effective Date (to be updated pursuant hereto), and Schedule 2.2(b) lists all
Patent Rights in the Option Territories as of the Effective Date (to be updated
pursuant hereto).
2.3 PNG Further Assurances. At any time and from time to time after the
date hereof, at Prana's request and sole expense, PNG promptly shall execute and
deliver, and shall cause its Affiliates and employees, to execute and deliver,
such instruments of sale, transfer, conveyance, assignment and confirmation, and
take such other reasonable action, as Prana may reasonably request to more
effectively transfer, convey and assign to Prana, and to confirm Prana's title
to, all of the Assigned Patent Rights and to carry out the purpose and intent of
this Agreement, including, without limitation, upon any expansion of the Prana
Territory pursuant to the terms hereof.
2.4 Reversion Right.
(a) The Assigned Patent Rights are subject to a reversion right as
provided in this Section 2.4 (the "Reversion Right").
(b) Prana agrees that, subject to the terms of this subsection (b),
upon the occurrence of a Material Obligation Failure hereunder that
remains uncured for thirty (30) days following written notice of such
failure, (i) subject to the Third Party Rights (as defined in Section 2.6)
and Section 2.4(d), the ownership rights in the Assigned Patent Rights
shall revert back to PNG, and (ii) effective as of the end of such thirty
(30)-day period, Prana does hereby, sell, transfer and assign to PNG such
Assigned Patent Rights, which thereafter shall be PNG Patent Rights. If
Prana disputes whether a Material Obligation Failure has occurred, it
shall institute the dispute resolution procedures set forth in Section 10
prior to the end of such thirty (30)-day cure period, and any reversions
of the Assigned Patent Rights shall be suspended pending completion of
such dispute resolution procedure; provided that the institution of such
procedures shall not in any manner extend the time period of curing any
Material Obligation Failure. Effective upon the written certification by
Prana that Prana has within the eight (8) year period after the Effective
Date begun a new Phase II Clinical Study (excluding any such studies
performed before the Effective Date) for approval by a Regulatory
Authority of CQ, PQ, or any Derivative, the Reversion Right with respect
to a Material Obligation Failure described in Section l.l2(a) will
terminate; provided that Prana will provide PNG with such additional proof
with respect of the contents of the foregoing certification as PNG may
reasonably request and any dispute as to whether Prana's beginning of such
new Phase II Clinical Study as provided above shall be resolved in
accordance with the terms of Section 10, and termination of the Reversion
Right shall be suspended pending completion of such dispute resolution
procedure.
(c) Notwithstanding anything contained herein to the contrary, in
the event a Material Obligation Failure occurs due to the failure of Prana
to make payments pursuant to Article 3 hereof, the reversion of Assigned
Patent Rights to PNG hereunder shall occur only with respect to Assigned
Patent Rights (irrespective of inventorship) in those
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territories in which the events triggering Prana's payment obligations
under such Article 3 arise and in which Prana's failure to make such
payments results in a Material Obligation Failure, and Prana shall retain
its ownership rights, subject to the Reversion Right and the Security
Interest (as defined herein), in and to the Assigned Patent Rights in all
of the remaining countries of the Prana Territory in which Prana has
complied with its payment obligations pursuant to Article 3 hereof.
(d) Upon reversion of any Assigned Patent Rights in accordance with
Section 2.4(b), all outstanding licenses out (and related sublicenses)
will survive and be assigned by Prana to PNG, subject to the prior written
consent of PNG and the affected licensees (and related sublicensees).
(e) Upon the reversion of an Assigned Patent Right to PNG pursuant
hereto, such Patent Right shall no longer be deemed an Assigned Patent
Right for purposes of this Agreement.
2.5 Security Agreement. The Assigned Patent Rights are subject to the
security interest in the Assigned Patent Rights granted to PNG pursuant to the
Security Agreement (the "Security Interest"). In no event shall the Reversion
Right or Security Interest limit Prana's ability to license the Assigned Patent
Rights to a third party in accordance with Section 2.6 below.
2.6 Grant of Rights.
(a) Transfer Restrictions. During the term of this Agreement, Prana
may transfer, sell, assign, encumber, pledge, mortgage, license,
sublicense, grant rights to prosecute and enforce and covenants not to xxx
and otherwise grant rights in and to and otherwise encumber in any way or
nature the Assigned Patent Rights (collectively, the "Third Party
Rights"), subject to the Reversion Right, Security Interest and the
obligations of this Agreement; provided, that
(i) in the event of the sale by Prana of any of the Assigned
Patent Rights or all or substantially all of Prana's
assets (including the Assigned Patent Rights) or
ownership interest of Prana, or merger of Prana, the
assignee of the Assigned Patent Rights assumes in
writing the obligations of Prana under this Agreement;
and
(ii) in the event of the mortgage, pledge or grant of a
security interest in any of the Assigned Patent Rights
by Prana, the mortgagee, pledgee or secured party
provide to PNG written acknowledgement of the priority
of the Reversion Right and Security Interest; and
(iii) in the event of the license of any of the Assigned
Patent Rights, Prana shall (A) provide in the license
agreements that the Assigned Patent Rights are subject
to the Reversion Right granted in Section 2.4 and the
Security Interest granted in the Security Agreement and
the licenses shall survive in accordance with the terms
of Section
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2.4(d); and (B) grant such licenses limited to the Prana
Territories and subject to the terms of this Agreement.
(b) Third Party Rights. Except as otherwise may occur pursuant to
Section 2.4(d), the exercise by PNG of its rights under this Agreement and
the Security Agreement will not terminate or otherwise restrict Third
Party Rights, and PNG shall take the Assigned Patent Rights subject to any
and all Third Party Rights.
(c) Review of Agreements. PNG shall have the right to review any
third party agreement entered into by Prana granting rights with respect
to the Assigned Patent Rights (whether such agreement transfers, sells,
assigns, encumbers, pledges, mortgages, licenses, sublicenses, grants
rights to prosecute or enforce and covenants not to xxx) prior to Prana
signing such an agreement, subject to written obligations of
confidentiality and non-use that are consistent with those contained in
this Agreement. The final decision on the agreement's terms and conditions
(in accordance with the foregoing), timing and the third party remains
solely at Prana's discretion. Upon execution of each agreement or any
amendment thereto, Prana shall provide PNG with a copy of such executed
agreement and any amendment thereto.
(d) Right to Cure. Each holder of a Third Party Right has the right,
but not the obligation, to perform the obligations of Prana under this
Agreement to avoid a Material Obligation Failure. PNG agrees to accept the
performance by holders of Third Party Rights of Prana obligations under
this Agreement in the place of Prana.
(e) Licenses for No Consideration. Notwithstanding anything herein
to the contrary, Prana shall not enter into any agreements to license or
sublicense for no consideration, without the prior written consent of PNG,
except if such license or sublicense is for the sole purpose of research
and development of Products.
2.7 Prana Further Assurances. At any time and from time to time after the
date hereof, at PNG's request and sole expense, Prana promptly shall execute and
deliver, and shall cause its Affiliates and employees, to execute and deliver,
such instruments of sale, transfer, conveyance, assignment and confirmation, and
take such other reasonable action, as PNG may reasonably request to more
effectively transfer, convey and assign to PNG, and to confirm PNG's title to,
any of the Assigned Patent Rights following reversion of such Assigned Patent
Rights to PNG pursuant to the Reversion Right, and to carry out the purpose and
intent of this Agreement.
3. FINANCIAL PROVISIONS
3.1 Up-front Payments. Prana shall pay to PNG the amount of U.S. $150,000
within fourteen (14) days after the Effective Date.
3.2 Equity Issuance.
(a) Prana shall issue within fourteen (14) days after the Effective
Date one million three hundred fifty thousand (1,350,000) shares of Prana
ordinary shares (the "Shares") in accordance with the terms of this
Agreement.
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(b) Prana represents and warrants that the Shares and additional
ordinary shares issued under this Agreement (the "Additional Shares") have
been duly authorized and, when issued to PNG in consideration of the terms
and conditions of this Agreement, will be validly issued, fully paid and
non-assessable.
(c) PNG agrees that, without the prior written consent of Prana, PNG
will not, directly or indirectly, sell, assign, transfer, give, donate or
otherwise dispose of, or pledge, deposit or otherwise encumber, in any
manner, the Shares or Additional Shares, for a period of one (1) year from
the date of the issuance of such shares to PNG (the "Lock-Up Period");
provided that, notwithstanding the foregoing, PNG (or any Permitted
Transferee pursuant hereto) may transfer such shares to a Permitted
Transferee so long as prior to any such transfer, such Permitted
Transferee shall execute an agreement pursuant to which such Permitted
Transferee shall agree to receive and hold such shares subject to the
provisions of this Section 3.2(c).
(d) Prana covenants and agrees that Prana shall (i) instruct its
share registry to issue the Shares within twenty-four (24) hours after
receipt of such instruction given by Prana to the share registry in
accordance with the issuance period set forth in Section 3.2(a) and the
Additional Shares within twenty-four (24) hours after receipt of such
instruction given by Prana to the share registry in accordance with the
issuance period set forth in Section 3.4(f), and (ii) apply to the
Australian Stock Exchange for the quotation of the Shares and Additional
Shares within twenty-four (24) hours after the expiration of the Lock-Up
Period. Prana will instruct its share registry to furnish statements to
PNG periodically as to PNG's ownership of such Shares and such Additional
Shares from and after the Effective Date and until all the Shares and
Additional Shares have been sold by PNG.
3.3 Milestone Payments.
(a) CQ. In the event that Prana receives CQ Milestone Payments,
Prana shall pay to PNG:
(i) the amount of US$1,750,000, either in cash or in shares
of ordinary shares of Prana, on completion of the final
clinical study report of the first successful Phase III
Clinical Study for a Product containing CQ;
(ii) the amount of US$7,000,000, either in cash or shares of
ordinary shares of Prana, on the first approval of a
Product containing CQ by the FDA allowing marketing in
the U.S.; and
(iii) ten percent (10%) of CQ Milestone Payments (not
associated with completion of Phase III Clinical Study,
as set forth in subsection (a)(i), and regulatory
approval or approval for marketing as set forth in
subsection (a)(ii)) received by Prana in excess of
US$13,000,000. If, at the first approval for marketing a
Product containing CQ in the US, the total amount of
payments to PNG
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made under this subsection (a)(iii) is less than
US$3,000,000, then Prana shall pay PNG the balance so
that the payment due under this subsection (a)(iii) is
equal to US$3,000,000 in addition to any other payment
due under subsection (a)(ii) at that time.
(b) PQ. In the event that Prana receives PQ Milestone Payments,
Prana shall pay to PNG:
(i) the amount of US$875,000, either in cash or in ordinary
shares of Prana, on completion of the final clinical
study report of the first successful Phase III Clinical
Study for a Product containing PQ;
(ii) the amount of US$3,500,000, either in cash or ordinary
shares of Prana, on the first approval of a Product
containing PQ by the FDA allowing marketing in the US.;
and
(iii) five percent (5%) of PQ Milestone Payments (not
associated with completion of the Phase III Clinical
Study as set forth in subsection (b)(i) and regulatory
approval or approval for marketing as set forth in
subsection (b)(ii)) received by Prana in excess of
US$13,000,000. If, at the first approval for marketing a
Product containing PQ in the US, the total amount of
payments to PNG made under this subsection (b)(iii) is
less than US$1,500,000, then Prana shall pay PNG the
balance so that the payment due under this subsection
(b)(iii) equals US$l,500,000 in addition to any other
payment due under subsection (b)(ii) at that time.
(c) Procedure. The election of cash payments or ordinary shares of
Prana under this Section 3.3 shall be made by Prana in its sole
discretion. The number of ordinary shares of Prana, if elected to be
issued, shall be based on the 30-day average ASX market closing price of
Prana's ordinary shares prior to the date such CQ Milestone Payment or PQ
Milestone Payment, as applicable, is payable. Ordinary shares of Prana
issued pursuant to this Section 3.3 shall be issued pursuant to the terms
of Section 3.2 hereof.
3.4 Royalty Payments.
(a) PNG.
(i) In the event that Lundbeck receives income either from
sales or royalties associated with the sale of Other
Products in any of the Lundbeck Territories, PNG shall
cause Lundbeck to pay to PNG the amounts as stipulated
in the Lundbeck Agreement as of July 19, 2002. PNG shall
then pay to Prana two percent (2%) of all income PNG
receives from net sales and royalties associated with
such marketing of Other Products in the Lundbeck
Territories.
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(ii) PNG shall pay to Prana a royalty of six percent (6%) on
Net Sales of Other Products which are sold in the PNG
Territories up to an aggregate US$20,000,000 in Net
Sales in a given calendar year and a royalty of fifteen
percent (15%) of Net Sales of Other Products which are
sold in the PNG Territories for the portion of Net Sales
in excess of US$20,000,000 in a given calendar year.
(b) Prana. (i) Prana shall pay to PNG a royalty of three percent
(3%) on Net Sales of Products which are sold in the Prana Territories.
(ii) Prana shall also pay royalties to Lundbeck as provided by the
"Licensor" obligations stated in provision 1 of Addendum III of the
Lundbeck Agreement as of July 19, 2002.
(c) Length of Royalty Payments. The royalties payable under
subsections (a) and (b)(i) shall be paid on a country-by-country basis on
each Product or Other Product, as applicable, from the First Commercial
Sale until the expiration of all Assigned Patent Rights and/or PNG Patent
Rights that cover such Product or Other Product, as applicable, in such
country.
(d) Royalties Payable Only Once. The obligation to pay royalties
pursuant to this Section 3.4 is imposed only once with respect to the same
unit of a Product or Other Product, as applicable; provided that the
foregoing shall not limit Prana's obligation to pay royalties to both PNG
and Lundbeck as required by subsection (b) above. Except as specifically
provided in this Agreement, it is understood and agreed that there shall
be no deductions from the royalties payable under this Agreement.
(e) Sales to Affiliates and Sublicensees. Sales of Products or Other
Products, as applicable, between a Party and its Affiliates, licensees,
sublicensees or distributors, or among such Affiliates, licensees,
sublicensees and distributors for resale to third parties shall not be
subject to royalties under this Section 3.4 (except to the extent such
exclusion is inconsistent with the royalty obligations to be paid by Prana
to Lundbeck as provided in the Section 3.4(b)(ii)), but in such cases the
royalties shall be calculated on the Net Sales by such Affiliates,
licensees, sublicensees or distributors to a third party.
(f) Reports and Accounting.
(i) Reports; Royalty & Milestone Payments. Each Party paying
royalties and/or making milestone payments pursuant to
Section 3.3 to the other (the "Royalty Paying Party")
shall deliver to the other Party (the "Royalty Receiving
Party"), within sixty (60) days after the end of each
calendar quarter with respect to royalties or within
thirty (30) days after receipt of CQ Milestone Payment
or PQ Milestone Payment pursuant to Section 3.3, as
applicable, reasonably detailed written accountings of
Net Sales of the Products, Other Products or milestone
payments, as applicable, that are subject to payments
due to the Royalty Receiving Party for such calendar
quarter or reasonably detailed written description of
the facts and circumstances related to any milestone
payment;
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provided that Prana shall also provide PNG such
accountings with respect to amounts payable to Lundbeck
pursuant to subsection (b)(ii) above to the extent such
disclosures to PNG are not otherwise prohibited in
writing by Lundbeck. Such royalty reports shall indicate
gross sales on a country-by-country and
product-by-product basis, the deductions from gross
sales used in calculating Net Sales and the resulting
calculation of royalties. When the Royalty Paying Party
delivers such accountings to the Royalty Receiving
Party, the Royalty Paying Party shall also deliver all
royalty payments due under this Section 3.4 and
milestone payments due under Section 3.3, as applicable,
to the Royalty Receiving Party for the relevant period.
With respect to sales of the Products or Other Products,
as applicable, invoiced in United States Dollars, the
sales and royalties payable shall be expressed in United
States Dollars. With respect to sales of the Products or
Other Products, as applicable, invoiced in a currency
other than United States Dollars, the sales and
royalties payable shall be expressed in their United
States Dollar equivalent, calculated using the
applicable conversion rates for buying United States
dollars published by The Wall Street Journal (NY
edition) on the last business day of the calendar
quarter to which the royalty report relates. Milestones
Prana elects to pay in cash shall be paid in United
States dollars; and the amount of any milestones Prana
elects to pay in ordinary shares of Prana (the total
number of which shares shall be calculated pursuant to
Section 3.3(c)) shall expressed in their Australian
Dollar equivalent, calculated using the applicable
conversion rates for buying Australian dollars published
by The Wall Street Journal (NY edition) on the last
business day of the calendar quarter to which the
milestone report relates.
(ii) Audits. The Royalty Paying Party shall keep, and shall
require its Affiliates, licensees, sublicensees and
distributors to keep, complete and accurate records of
the latest three (3) years of sales to which royalties
attach and activities to which milestone payments
attach. For the sole purpose of verifying royalties or
milestone payments payable to the Royalty Receiving
Party, the Royalty Receiving Party shall have the right
annually at its own expense (except as provided herein)
to retain an independent certified public accountant
selected by the Royalty Receiving Party and reasonably
acceptable to the Royalty Paying Party, to review such
records in the location(s) where such records are
maintained by the Royalty Paying Party, its Affiliates,
licensees, sublicensees or distributors, upon reasonable
notice and during regular business hours and under
obligations of confidence. Results of such review shall
be made available to both Parties. If the review
reflects an underpayment of royalties or milestone
payments to the Royalty
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Receiving Party, such underpayment shall be promptly
remitted to the Royalty Receiving Party, together with
interest calculated in the manner provided in Section
3.6, and the Parties shall share equally the reasonable
cost of the review. If the underpayment is equal to or
greater than five percent (5%) of the royalty and/or
milestone amount that was otherwise due, the Royalty
Paying Party shall promptly remit the underpayment with
applicable interest to the Royalty Receiving Party and
pay all of the costs of such review. If the review
reflects an overpayment of royalties or milestone
payments to the Royalty Receiving Party, the amount of
such overpayment is creditable against future royalties
or milestone payments, as applicable, owed by the
Royalty Paying Party, to the extent applicable.
3.5 Independence of Payments. As provided in the Settlement Agreement, the
payment obligations in this Article 3 are independent of, and shall be made
notwithstanding the outcome of, any inventorship evaluation conducted pursuant
to such Settlement Agreement.
3.6 Late Payments. A Party shall pay interest to the other Party on the
aggregate amount of any payments that are not paid on or before the date such
payments are due under this Agreement at a rate of twelve percent (12%) per
annum.
3.7 Blocked Payments. In the event that, by reason of applicable laws or
regulations in any country, it becomes impossible or illegal for a paying Party
or its Affiliates, licensees, sublicensees or distributors, to transfer, or have
transferred on its behalf, royalties or other payments to the receiving Party,
such royalties or other payments shall be deposited in local currency in the
relevant country to the credit of such receiving Party in a recognized banking
institution designated by such receiving Party or, if none is designated by such
receiving Party within a period of thirty (30)days, in a recognized banking
institution selected by the paying Party or its Affiliates, licensees,
sublicensees or distributors, as the case may be, and identified in a notice in
writing given to such receiving Party.
3.8 Taxes. Each Party shall be responsible for its own taxes levied on
such Party by tax authorities within any applicable territory, including all
sales, use, value added, withholding tax respecting such Party's income or other
taxes payable with respect of amounts due by the other Party to such Party. Any
such taxes which a paying Party is required to pay or withhold on behalf of the
receiving Party shall be deducted from the amount of payment due, and the paying
Party shall furnish the receiving Party with reasonable evidence of such payment
or amount withheld, in electronic or written form, as soon as practicable after
such payment is made or such amount is withheld.
4. LUNDBECK
4.1 Lundbeck Amendment. The Parties acknowledge that PNG has entered into
Addendum IV with Lundbeck, a copy of which is attached hereto as Exhibit B.
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4.2 Lundbeck Agreement. During the term of this Agreement, PNG shall not
enter into an amendment, supplement or other modification to the Lundbeck
Agreement that in any manner affects Prana's rights or obligations as provided
in this Agreement without the prior written consent of Prana.
4.3 Lundbeck Option. PNG agrees that as of the Effective Date, and at any
time prior to the exercise by Lundbeck of its option to obtain a license to
market one or more Other Products in certain territories under the Lundbeck
Agreement (the "Lundbeck Option"), Prana and Lundbeck can directly negotiate a
deal resulting in Lundbeck not exercising the Lundbeck Option in all or part of
the Option Territories as stipulated in the Lundbeck Agreement, subject to the
terms of the Lundbeck Agreement.
4.4 Reporting; Development.
(a) Reporting. Prana or its designee will provide PNG and Lundbeck
with status reports regarding the progress, if any, toward development of
the Products within forty-five (45) days after each June 30 and December
31 during the Term (as defined below). Such reports will provide a written
summary of any development progress during the past reporting period. In
addition, Prana or its designee will report to PNG and Lundbeck without
delay any results with respect to the Products deemed significant by
Prana, and any marketing registrations obtained by Prana or its agents,
collaborators or designee. Prana has no obligation to inform PNG or
Lundbeck of the existence, development or status of any product other than
the Products.
(b) Development. For purposes of the research and development of
Products, PNG hereby provides Prana and its licensees, sublicensees,
agents, collaborators and designees a covenant not to xxx on the PNG
Patent Rights which would otherwise prevent Prana and/or its licensees,
sublicensees, agents, collaborators and designees from researching and/or
developing Products in the PNG Territories, Option Territories and/or the
Lundbeck Territories.
4.5 Other Products. PNG agrees that no restrictions shall be placed by
means of the Lundbeck Agreement on Prana's ability to develop any other product
regardless of whether that product may be viewed as having the ability to
directly or indirectly compete with a CQ product or PQ product in the Prana
Territory.
5. NON-COMPETITION
For a term of ten (10) years from the Effective Date, PNG will not
directly, or indirectly through another on its behalf, research, develop, and/or
commercialize alternative treatments for neurodegenerative diseases that might
compete in the Prana Territories with the Products developed by Prana either
alone, in any partnership or through any alliance, deal or agreement.
6. INTELLECTUAL PROPERTY
6.1 Unauthorized Activities. PNG agrees to act in the PNG Territories, to
the extent allowable under applicable law, to prevent parallel or unauthorized
importation, manufacture, use or commercialization of the Other Products in the
Prana Territory. Prana agrees to act in the
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Prana Territories, to the extent allowable under applicable law, to prevent
parallel or unauthorized importation, manufacture, use or commercialization of
the Products in the PNG Territories.
6.2 Prosecution and Maintenance of Assigned Patent Rights. Prana shall
have the exclusive right and option to file and prosecute all patent
applications and to maintain all patents comprising the Assigned Patent Rights,
at Prana's sole expense. If Prana elects not to file and prosecute any such
patent applications or maintain any such patents, it shall give PNG advance
written notice to this effect reasonably sufficient to avoid any loss or
forfeiture of such patent applications or patents and thereafter PNG may, upon
written notice to Prana, file and prosecute such patent applications and
maintain such patents in PNG's name, all at PNG's expense, and furthermore, such
patent applications and patents (the "PNG Assumed Patent Rights") shall no
longer be deemed Assigned Patent Rights for purposes of this Agreement or
subject to the terms of this Agreement. Prana agrees to, and does hereby, sell,
transfer and assign the PNG Assumed Patent Rights to PNG.
6.3 Enforcement of Assigned Patent Rights. Prana shall have the exclusive
right and option to enforce, at Prana's sole expense, the Assigned Patent Rights
and to retain all damages and recoveries associated therewith in the Prana
Territories.
6.4 Cooperation. PNG agrees to reasonably cooperate with Prana, at Prana's
sole expense, in the prosecution, maintenance and enforcement of the Assigned
Patent Rights in the Prana Territories. Prana agrees to reasonably cooperate
with PNG, at PNG's sole expense, in the prosecution, maintenance and enforcement
of the PNG Assumed Patent Rights in the PNG Territories, including without
limitation, by executing an assignment of such PNG Assumed Patent Rights in a
form substantially similar to that attached hereto as Exhibit A (or such other
form as required by the applicable authorities), without reference to a
reversionary right or security interest, for recordation purposes.
6.5 Notifications. Each Party will promptly notify the other in writing of
any apparent infringement, misappropriation or other wrongful exploitation of
either the Assigned Patent Rights or the PNG Patent Rights that comes to the
attention of such Party. Furthermore, each Party will promptly notify the other
Party with respect to the actions of such Party relating to any patent term
extensions of Patent Rights.
7. WARRANTIES AND DISCLAIMERS
7.1 Representations of Authority. PNG and Prana each represents and
warrants to the others that as of the Effective Date it has full right, power
and authority to enter into this Agreement and to perform its respective
obligations under this Agreement.
7.2 Consents. PNG and Prana each represents and warrants that all
necessary consents, approvals and authorizations of all government authorities
and other persons and entities required to be obtained by such Party in
connection with execution, delivery and performance of this Agreement have been
and shall be obtained.
7.3 No Conflict. PNG and Prana each represents and warrants that the
execution and delivery of this Agreement and the performance of such Party's
obligations (a) do not conflict
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with or violate any requirement of applicable laws or regulations, and (b) do
not and will not conflict with, violate or breach or constitute a default or
require any consent under, any contractual obligations of such Party, except to
the extent waived in a written consent prior to the Effective Date.
7.4 No Encumbrances. PNG represents and warrants that, to the best of its
knowledge, (a) PNG, as of the Effective Date and as of the date of assignment of
the Assigned Patent Rights pursuant to Section 2.1 and Section 2.2, has and will
have the right to assign, and is no way encumbered in assigning, the patent
rights listed on Schedule 1.2 (and as updated pursuant to Section 2.2), and (b)
as of the Effective Date and the date of assignment of the Assigned Patent
Rights pursuant to Section 2.1 and Section 2.2, such patent rights are and will
be free and clear of any security interest or mortgage.
7.5 Lundbeck Agreement. PNG represents and warrants that a true, correct
and complete copy of the Lundbeck Agreement, including all amendments thereto,
is set forth in Exhibit C, and the Lundbeck Agreement is in full force and
effect.
7.6 No Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN OR IN
THE SECURITY AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT,
MERCHANTABILITYAND FITNESS FOR A PARTICULAR PURPOSE.
8. CONFIDENTIALITY
The terms of this Agreement are subject to the confidentiality obligations
set forth in Section 1 of the Settlement Agreement.
9. TERM AND TERMINATION
9.1 Term. This Agreement is effective as of the Effective Date, and
remains in effect until the expiration of all payment obligations set forth in
Section 3, except as set forth in Section 9.2 (the "Term").
9.2 Termination. This Agreement terminates with respect to Assigned Patent
Rights that have reverted to PNG and are no longer deemed Assigned Patent
Rights, as provided in Section 2.4. Except as described in this Section 9.2,
there is no right to terminate this Agreement.
9.3 Survival. Upon expiration or termination of this Agreement for any
reason, nothing in this Agreement shall be construed to release either Party
from any obligations that matured prior to the Effective Date or expiration or
termination; and the following provisions shall expressly survive any such
expiration or termination: 2.1 (except in the event of a termination under
Section 9.2); 3 (to the extent payment obligations remain outstanding);
3.4(f)(ii), 4.4(b) (with respect to activities of Prana performed prior to
expiration or termination hereof), 7.6, 8,9, 10, and 11 (excluding Section
11.4).
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10. ARBITRATION.
Any dispute, controversy or claim arising out of or relating to this
Agreement shall be resolved pursuant to the terms of Section 2.4 of the
Settlement Agreement.
11. GENERAL PROVISIONS
11.1 Remedies. The Parties agree and acknowledge that, effective as of the
Effective Date, except as set forth in Section 2.4 and in the Security
Agreement, the assignment of the Assigned Patent Rights pursuant to this
Agreement is final and irrevocable and shall in no way be modified, altered or
subject to any limitation, notwithstanding any alleged breach by Prana of any
provision hereunder, any alleged breach or default of any other obligation owed
to PNG, or termination of all or any portion of this Agreement for any reason.
PNG agrees and understands that PNG's sole and exclusive remedies with respect
to (a) the occurrence of a Material Obligation Failure as defined by Section
1.12(a) is the Reversion Right and the rights available under the Security
Interest as set forth in the Security Agreement and the right to receive the
costs, including reasonable legal fees, incurred by PNG in enforcing its rights,
(b) the occurrence of a Material Obligation Failure as defined by Section
1.12(b) is the Reversion Right and the rights available under the Security
Interest as set forth in the Security Agreement, the right to receive the
royalty or milestone payments (the failure of which caused the Material
Obligation Failure), interest on such payments, and the costs, including
reasonable legal fees, incurred by PNG in enforcing its rights, and (c) failure
to prosecute the Assigned Patent Rights are the rights of PNG described in
Section 6.2.
11.2 Equitable Relief. Except as set forth in Section 11.1, each Party
acknowledges that a breach by it of the provisions of this Agreement cannot
reasonably or adequately be compensated in damages in an action at law; and that
a breach by such Party of any of the provisions contained in this Agreement
shall cause the other Party irreparable injury and damage. By reason thereof,
each Party acknowledges and agrees that the other Party shall be entitled in
such cases in addition to, and not in lieu of, any other remedies it may have
under this Agreement or otherwise, under the dispute resolution provisions set
forth in Section 10 to preliminary and permanent injunctive relief and any other
available equitable relief to prevent or curtail any breach of this Agreement by
the other Party or specifically to enforce the performance of the other Party
under this Agreement without the necessity of posting any bond or other
security; provided, however, that no specification in this Agreement of a
specific legal or equitable remedy shall be construed as a waiver or prohibition
against the pursuing of other legal or equitable remedies in the event of such a
breach.
11.3 Choice of Law. This Agreement will be governed by and construed in
accordance with the laws of New York and the United States.
11.4 Assignment. No Party may assign this Agreement in whole or in part
without the consent of the other, except if such assignment occurs in connection
with the merger, sale or transfer of all or substantially all of the business
and assets of a Party. Notwithstanding the foregoing, any Party may assign its
rights (but not its obligations) pursuant to this Agreement in whole or in part
to an Affiliate of such Party. Any attempted assignment in violation of this
section shall be null and void.
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11.5 Entire Agreement; Amendments. This Agreement constitutes the entire
agreement among the Parties with respect to the subject matter hereof, and
supersedes all previous arrangements with respect to the subject matter hereof,
whether written or oral, including, without limitation, the Base Term Sheet,
dated April 7, 2004, among the Parties. Any amendment or modification to this
Agreement shall be made in writing signed by all Parties.
11.6 Notices.
Notices to Prana shall be addressed to:
Prana Biotechnology Limited
Xxxxx 0, 000 Xxxxx Xxxxxx
Xxxxxxxxx 0000, Xxxxxxxx, Xxxxxxxxx
Attention: Chairman
Facsimile No.: (00) 0 0000 0000
with a copy to:
Prana Biotechnology Limited
Xxxxx 0, 000 Xxxxx Xxxxxx
Xxxxxxxxx 0000, Xxxxxxxx, Xxxxxxxxx
Attention: Vice President, Intellectual Property
Facsimile No: (00) 0 0000 0000
Notices to PNG shall be addressed to:
P.N. Gerolymatos S.A.
00, Xxxxxxxxx xxx.
000 00 Xxxxxxxx Xxxxxx, Xxxxxx
Attention: Avraam Manouach
Facsimile No.: (+30 - 210) 81 61 956
with a copy to:
Xxxxx Day
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000 XXX
Attention: Xxxxxxx X. Antler, Esq., Ph.D.
Facsimile No: (000) 000-0000
Any Party may change its address by giving notice to the other Party in the
manner herein provided. Any notice required or provided for by the terms of this
Agreement shall be in writing and shall be (a) sent by registered or certified
mail, return receipt requested, postage prepaid, (b) sent via a reputable
overnight courier service, or (c) sent by facsimile transmission and confirmed
by regular mail, in each case properly addressed in accordance with the
paragraph above. The effective date of notice shall be the actual date of
receipt by the Party receiving the same.
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11.7 Independent Contractors. It is understood and agreed that the
relationship between the Parties hereunder is that of independent contractors
and that nothing in this Agreement shall be construed as authorization for Prana
or PNG to act as agent for the others.
11.8 Headings. The captions or headings of the Sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
11.9 No Implied Waivers: Rights Cumulative. No failure on the part of a
Party to exercise, and no delay in exercising, any right, power, remedy or
privilege under this Agreement, or provided by statute or at law or in equity or
otherwise, shall impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege or be construed as a waiver of any breach of this
Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.
11.10 Severability. If any provision hereof should be held invalid,
illegal or unenforceable in any respect in any jurisdiction, then, to the
fullest extent permitted by law, (a) all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the Parties as nearly as may be possible
and (b) such invalidity, illegality or unenforceability shall not affect the
validity, legality or enforceability of such provision in any other
jurisdiction.
11.11 Execution in Counterparts. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
11.12 No Consequential Damages. UNLESS RESULTING FROM A PARTY'S WILLFUL
MISCONDUCT OR FROM A PARTY'S BREACH OF SECTION 8 ("CONFIDENTIALITY") HEREOF,
NEITHER PARTY WILL BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY,
PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR
THE EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR LOSS OF PROFITS, LOSS OF DATA OR
LOSS OF USE DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT
WHETHER BASED XXXX XXXXXXXX, XXXXXXXX, XXXX, XXXXXX LIABILITY OR OTHERWISE,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.
11.13 Further Assurances. At any time and from time to time after the date
hereof, at a Party's request and sole expense, the other Party promptly shall
execute and deliver, and shall cause its Affiliates and employees, to execute
and deliver, such instruments, and take such other reasonable action, as the
requesting Party may reasonably request more effectively to carry out the
purpose and intent of this Agreement.
[Signature Page Follows]
18
Execution Version
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives:
P.N. GEROLYMATOS S.A. PRANA BIOTECHNOLOGY LIMITED
By: /s/ P. Gerolymatos By: /s/ Xxxxxxxx Xxxxxxx
--------------------------------- --------------------------------
Name: P. Gerolymatos Name: Xxxxxxxx Xxxxxxx
------------------------------- ------------------------------
Title: President & Managing Director Title: Executive Chairman
------------------------------ -----------------------------
Date: July 28, 2004 Date: July 28, 2004
[Signature Page to Patent Assignment and Settlement Agreement]
Execution Version
Schedule 1.2
Assigned Patent Rights
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Japan 1998-509541
--------------------------------------------------------------------------------
Japan 2000-507371
--------------------------------------------------------------------------------
USA 09/485,909 6,670,369
--------------------------------------------------------------------------------
Japan 2000-592001
--------------------------------------------------------------------------------
USA 10/098,922
--------------------------------------------------------------------------------
USA 09/023,544 6,001,852
--------------------------------------------------------------------------------
USA 09/023,543 5,980,914
--------------------------------------------------------------------------------
USA 09/023,542 5,994,323
--------------------------------------------------------------------------------
USA 10/717,182
--------------------------------------------------------------------------------
Execution Version
Schedule 1.20
PNG Patent Rights (PNG Territories, Option Territories and Lundbeck Territories)
Title: Use of the chelating agent clioquinol for the manufacture of the
pharmaceutical composition for the treatment of Alzheimer's disease
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Austria AT E 205086 T
--------------------------------------------------------------------------------
Belgium BE 959888 T
--------------------------------------------------------------------------------
Xxxxxxxxxxx/Xxxxxxxxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Germany DE 69706566 T
--------------------------------------------------------------------------------
Denmark DK 959888 T
--------------------------------------------------------------------------------
Spain ES 2192319 T
--------------------------------------------------------------------------------
Xxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Xxxxxx XX 000000 T
--------------------------------------------------------------------------------
United Kingdom GB 959888 T
--------------------------------------------------------------------------------
Xxxxxx XX 000000 T
--------------------------------------------------------------------------------
Ireland IE 959888 T
--------------------------------------------------------------------------------
Italy IT 959888 T
--------------------------------------------------------------------------------
Xxxxxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Xxxxxx XX 000000 T
--------------------------------------------------------------------------------
Netherlands NL 959888 T
--------------------------------------------------------------------------------
Xxxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Sweden SE 959888 T
--------------------------------------------------------------------------------
Xxxxxxx XX 000000
--------------------------------------------------------------------------------
Slovenia SI 959888
--------------------------------------------------------------------------------
Xxxxx xxxxxxxx XX 0000-000 XX 29244
--------------------------------------------------------------------------------
Execution Version
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Czech republic PV 2003-499
--------------------------------------------------------------------------------
Hungary P9903906
--------------------------------------------------------------------------------
Iceland 4972 IS 1907
--------------------------------------------------------------------------------
Norway 19990595
--------------------------------------------------------------------------------
Xxxxxx X00 0000
--------------------------------------------------------------------------------
Xxxxxx 99105213 RU 2193406
--------------------------------------------------------------------------------
Turkey 1999/00293
--------------------------------------------------------------------------------
Xxxxxxxxx 00000 XX 63876
--------------------------------------------------------------------------------
Israel 128416
--------------------------------------------------------------------------------
Xxxxxxxxx 00000/00 XX 000000
--------------------------------------------------------------------------------
Brazil PI97 11194-5
--------------------------------------------------------------------------------
Canada 2,264,097
--------------------------------------------------------------------------------
China 97197919.7 CN ZL 97197919.7
--------------------------------------------------------------------------------
Mexico 991466 208764
--------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 XX 334134
--------------------------------------------------------------------------------
South Korea 7001196/99
--------------------------------------------------------------------------------
Xxxxxx Xxxxxxxx XXX 000-00 SK 283117
--------------------------------------------------------------------------------
Hong Kong 00101601.9
--------------------------------------------------------------------------------
Title: Use of Phanquinone for the treatment of Alzheimer's disease
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Austria AT E 217191 T
--------------------------------------------------------------------------------
Execution Version
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Belgium BE 1007040 T
--------------------------------------------------------------------------------
Switzerland/Liechtenstein CH 1007040 T
--------------------------------------------------------------------------------
Cyprus CY 1007040 T
--------------------------------------------------------------------------------
Germany DE 69805305 T
--------------------------------------------------------------------------------
Denmark DK 1007040 T
--------------------------------------------------------------------------------
Spain ES 2177024 T
--------------------------------------------------------------------------------
Finland FI 1007040 T
--------------------------------------------------------------------------------
Xxxxxx XX 0000000 T
--------------------------------------------------------------------------------
United Kingdom GB 1007040 T
--------------------------------------------------------------------------------
Greece GR 1007040 T
--------------------------------------------------------------------------------
Ireland IE 1007040 T
--------------------------------------------------------------------------------
Italy IT 1007040 T
--------------------------------------------------------------------------------
Xxxxxxxxxx XX 0000000 T
--------------------------------------------------------------------------------
Monaco MC 1007040 T
--------------------------------------------------------------------------------
Netherlands NL 1007040 T
--------------------------------------------------------------------------------
Xxxxxxxx XX 0000000 T
--------------------------------------------------------------------------------
Sweden SE 1007040 T
--------------------------------------------------------------------------------
Xxxxxxx XX 0000000
--------------------------------------------------------------------------------
Lithuania LT 1007040
--------------------------------------------------------------------------------
Latvia LV 1007040
--------------------------------------------------------------------------------
FYROM MK 1007040
--------------------------------------------------------------------------------
Xxxxxxx XX 0000000
--------------------------------------------------------------------------------
Slovenia SI 1007040
--------------------------------------------------------------------------------
Execution Version
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Australia 81241/92 AU741782
--------------------------------------------------------------------------------
Hong Kong 01100873.1
--------------------------------------------------------------------------------
Israel 134236
--------------------------------------------------------------------------------
South Korea 2000-7001576
--------------------------------------------------------------------------------
Xxxxxxxxx 0000 00000-0 XX 70572
--------------------------------------------------------------------------------
Xxxxxx 0000/000 XX 2000 00455 B
--------------------------------------------------------------------------------
Bulgaria 107179
--------------------------------------------------------------------------------
Xxxxxx XX 0000000
--------------------------------------------------------------------------------
Canada 2,301,706
--------------------------------------------------------------------------------
China 98808292.6
--------------------------------------------------------------------------------
Czech Republic 2000-507371
--------------------------------------------------------------------------------
Eurasia 200000242 EA 002526
--------------------------------------------------------------------------------
Hungary P0004334
--------------------------------------------------------------------------------
Iceland 5356
--------------------------------------------------------------------------------
Mexico 1459
--------------------------------------------------------------------------------
Norway 200000771
--------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 XX 502565
--------------------------------------------------------------------------------
Poland P338673
--------------------------------------------------------------------------------
Xxxxxx xxxxxxxx 0000000
--------------------------------------------------------------------------------
Xxxxxxx 20000031381 UA 59412
--------------------------------------------------------------------------------
Title: Use of Phanquinone for the treatment or prevention of memory impairment
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Execution Version
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Argentina P 000100046
--------------------------------------------------------------------------------
Chile 0028-2000
--------------------------------------------------------------------------------
Hong Kong 0212678.3
--------------------------------------------------------------------------------
Israel 143903
--------------------------------------------------------------------------------
South Korea 00-0000-0000000
--------------------------------------------------------------------------------
Xxxxxxxxx 000000000-0 XX 81714
--------------------------------------------------------------------------------
Turkey 2001 01892 TR 2001 01892B
--------------------------------------------------------------------------------
EPC 00900025.8
--------------------------------------------------------------------------------
Brazil PI 0008241-4
--------------------------------------------------------------------------------
Canada 2358487
--------------------------------------------------------------------------------
Execution Version
Schedule 2.2(a)
Patent Rights in Lundbeck Territories as of the Effective Date
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
None-no countries in
Lundbeck Territories as of the
Effective Date
--------------------------------------------------------------------------------
Execution Version
Schedule 2.2(b)
Patent Rights in Option Territories as of the Effective Date
Title: Use of the chelating agent clioquinol for the manufacture of the
pharmaceutical composition for the treatment of Alzheimer's disease.
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Austria AT E 205086 T
--------------------------------------------------------------------------------
Belgium BE 959888 T
--------------------------------------------------------------------------------
Xxxxxxxxxxx/Xxxxxxxxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Germany DE 69706566 T
--------------------------------------------------------------------------------
Denmark DK 959888 T
--------------------------------------------------------------------------------
Spain ES 2192319 T
--------------------------------------------------------------------------------
Xxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Xxxxxx XX 000000 T
--------------------------------------------------------------------------------
United Kingdom GB 959888 T
--------------------------------------------------------------------------------
Ireland IE 959888 T
--------------------------------------------------------------------------------
Italy IT 959888 T
--------------------------------------------------------------------------------
Xxxxxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Xxxxxx XX 000000 T
--------------------------------------------------------------------------------
Netherlands NL 959888 T
--------------------------------------------------------------------------------
Xxxxxxxx XX 000000 T
--------------------------------------------------------------------------------
Sweden SE 959888 T
--------------------------------------------------------------------------------
Xxxxxxx XX 000000
--------------------------------------------------------------------------------
Slovenia SI 959888
--------------------------------------------------------------------------------
Xxxxx xxxxxxxx XX 0000-000 XX 29244
--------------------------------------------------------------------------------
Czech republic PV 2003-499
--------------------------------------------------------------------------------
Execution Version
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Hungary P9903906
--------------------------------------------------------------------------------
Iceland 4972 IS 1907
--------------------------------------------------------------------------------
Norway 19990595
--------------------------------------------------------------------------------
Poland P331822
--------------------------------------------------------------------------------
Russia 99105213 RU 2193406
--------------------------------------------------------------------------------
Xxxxxxxxx 00000/00 XX 000000
--------------------------------------------------------------------------------
Brazil PI9711194-5
--------------------------------------------------------------------------------
Canada 2,264,097
--------------------------------------------------------------------------------
China 97197919.7 CN ZL 97197919.7
--------------------------------------------------------------------------------
Mexico 991466 208764
--------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 XX 334134
--------------------------------------------------------------------------------
Slovak Republic PVO179-99 SK 283117
--------------------------------------------------------------------------------
Title: Use of Phanquinone for the treatment of Alzheimer's disease
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Austria AT E 217191 T
--------------------------------------------------------------------------------
Belgium BE 1007040 T
--------------------------------------------------------------------------------
Switzerland/Liechtenstein CH 1007040 T
--------------------------------------------------------------------------------
Germany DE 69805305 T
--------------------------------------------------------------------------------
Denmark DK 1007040 T
--------------------------------------------------------------------------------
Spain ES 2177024 T
--------------------------------------------------------------------------------
Finland FI 1007040 T
--------------------------------------------------------------------------------
Xxxxxx XX 0000000 T
--------------------------------------------------------------------------------
Execution Version
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
United Kingdom GB 1007040 T
--------------------------------------------------------------------------------
Ireland IE 1007040 T
--------------------------------------------------------------------------------
Italy IT 1007040 T
--------------------------------------------------------------------------------
Xxxxxxxxxx XX 0000000 T
--------------------------------------------------------------------------------
Monaco MC 1007040 T
--------------------------------------------------------------------------------
Netherlands NL 1007040 T
--------------------------------------------------------------------------------
Xxxxxxxx XX 0000000 T
--------------------------------------------------------------------------------
Sweden SE 1007040 T
--------------------------------------------------------------------------------
Xxxxxxx XX 0000000
--------------------------------------------------------------------------------
Lithuania LT 1007040
--------------------------------------------------------------------------------
Latvia LV 1007040
--------------------------------------------------------------------------------
FYROM MK 1007040
--------------------------------------------------------------------------------
Xxxxxxx XX 0000000
--------------------------------------------------------------------------------
Slovenia SI 1007040
--------------------------------------------------------------------------------
Australia 81241/92 AU741782
--------------------------------------------------------------------------------
Bulgaria 107179
--------------------------------------------------------------------------------
Xxxxxx XX 0000000
--------------------------------------------------------------------------------
Canada 2,301,706
--------------------------------------------------------------------------------
China 98808292.6
--------------------------------------------------------------------------------
Czech Republic 2000-507371
--------------------------------------------------------------------------------
Eurasia 200000242 EA 002526
--------------------------------------------------------------------------------
Hungary P0004334
--------------------------------------------------------------------------------
Iceland 5356
--------------------------------------------------------------------------------
Execution Version
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Mexico 1459
--------------------------------------------------------------------------------
Norway 200000771
--------------------------------------------------------------------------------
Xxx Xxxxxxx 000000 XX 502565
--------------------------------------------------------------------------------
Poland P338673
--------------------------------------------------------------------------------
Xxxxxx xxxxxxxx 0000000
--------------------------------------------------------------------------------
Xxxxxxx 20000031381 UA 59412
--------------------------------------------------------------------------------
Title: Use of Phanquinone for the treatment or prevention of memory impairment
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Argentina P 000100046
--------------------------------------------------------------------------------
Chile 0028-2000
--------------------------------------------------------------------------------
EPC (for countries within
Option Territories) 00900025.8
--------------------------------------------------------------------------------
Brazil PI 0008241-4
--------------------------------------------------------------------------------
Canada 2358487
--------------------------------------------------------------------------------
EXHIBIT A
PATENT ASSIGNMENT
For ten dollars ($10.00) and other good and valuable consideration, the
receipt of which is hereby acknowledged, P.N. GEROLYMATOS S.A. ("ASSIGNOR"),
hereby sells, assigns, transfers, and sets over its entire right, title, and
interest in and to the Assigned Patent Rights (as set forth below), and all
patents issuing therefrom and including all divisionals, renewals,
substitutions, continuations, continuations-in-part filed as of the date hereof,
reissues, reexaminations, extensions, refilings, any patent or reissues of any
patent of said Assigned Patent Rights and rights to xxx for infringement
thereof, past and present to Prana Biotechnology Limited ("ASSIGNEE") and its
successors and assigns; provided that such assignment is, and remains, subject
to a security interest and certain rights of reversion granted by ASSIGNEE in
favor of ASSIGNOR, the applicable provisions of which rights of reversion are
described on Exhibit A attached hereto.
Assigned Patent Rights: See Schedule 1 attached hereto.
At any time and from time to time after the date hereof, at ASSIGNEE'S
request and expense, ASSIGNOR promptly shall execute and deliver, and shall
cause its Affiliates and employees to execute and deliver, such instruments of
sale, transfer, conveyance, assignment and confirmation, and take such other
action as ASSIGNEE may reasonably request to more effectively transfer, convey
and assign to ASSIGNEE, and to confirm ASSIGNEE'S title to, all of the Assigned
Patent Rights.
IN WITNESS WHEREOF, ASSIGNOR has hereunto set its hand and seal on the date
below.
P.N. GEROLYMATOS S.A.
By:
----------------------------
Date:
--------------------------
[NOTARY]
Execution Version
Exhibit A to Patent Assignment from P.N. Gerolymatos S.A. to Prana Biotechnology
Limited
The following is a description of the security interest and reversion
rights with respect to the Assigned Patent Rights. The description shall
not in any way be deemed a modification of the actual rights granted under
the Patent Assignment Agreement or the Security Agreement (each as defined
herein). If there is any conflict between the description below and the
terms of the Patent Assignment Agreement or the Security Agreement, the
terms of the Patent Assignment Agreement and Security Agreement shall
govern.
Defined Terms
Clioquinol or CQ means 5-Chloro-7-iodo-8-quinolinol.
Derivative means those metal protein attenuating compounds other than CQ or PQ
that are claimed in a list of patent applications agreed upon by PNG and Prana.
Effective Date means July 28, 2004.
FDA means the United States Food and Drug Administration, or a successor agency
thereto.
Material Obligation Failure means (a) the failure of Prana within eight (8)
years of the Effective Date to begin a new Phase 11 Clinical Study (excluding
any such studies performed before the Effective Date) for approval by a
Regulatory Authority of CQ, PQ, or any Derivative or (b) the failure of Prana to
make any royalty or milestone payments as provided in the Patent Assignment
Agreement that are not disputed in good faith and to cure such failure within
the cure period set forth in Section 2.4.
Patent Assignment Agreement means the Patent Assignment and Settlement
Agreement, dated as of July 28, 2004, by and between P.N. Gerolymatos S.A.
("PNG") and Prana Biotechnology Limited ("Prana").
Phanquinone or PQ means 4,7-Phenanthroline-5,6-dione.
Product means any product containing either CQ or PQ, that, or the use of which,
is covered by the claims of the Assigned Patent Rights.
Phase I1 Clinical Study means a study of a Product containing either CQ or PQ in
patients to determine initial efficacy and dosing regimen.
Regulatory Authority means any federal, national, multinational, state,
provincial or local regulatory agency, department, bureau or other governmental
entity with authority over the testing, manufacture, use, storage, import,
promotion, marketing and sale of therapeutic product in a country, including the
FDA.
Execution Version
Security Agreement means the Patent Rights Security Agreement, dated as of July
28, 2004, between Prana and PNG.
Section 2.4 of the Patent Assignment Agreement: Reversion Right.
(a) The Assigned Patent Rights are subject to a reversion right as
provided in this Section 2.4 (the "Reversion Right").
(b) Prana agrees that, subject to the terms of this subsection (b), upon
the occurrence of a Material Obligation Failure hereunder that remains
uncured for thirty (30) days following written notice of such failure, (i)
subject to the Third Party Rights (as defined in Section 2.6) and Section
2.4(d), the ownership rights in the Assigned Patent Rights shall revert
back to PNG, and (ii) effective as of the end of such thirty (30)-day
period, Prana does hereby, sell, transfer and assign to PNG such Assigned
Patent Rights, which thereafter shall be PNG Patent Rights. If Prana
disputes whether a Material Obligation Failure has occurred, it shall
institute the dispute resolution procedures set forth in the Patent
Assignment Agreement prior to the end of such thirty (30)-day cure period,
and any reversions of the Assigned Patent Rights shall be suspended
pending completion of such dispute resolution procedure; provided that the
institution of such procedures shall not in any manner extend the time
period of curing any Material Obligation Failure. Effective upon the
written certification by Prana that Prana has within the eight (8) year
period after the Effective Date begun a new Phase 11 Clinical Study
(excluding any such studies performed before the Effective Date) for
approval by a Regulatory Authority of CQ, PQ, or any Derivative, the
Reversion Right with respect to a Material Obligation Failure described in
subsection (a) of the Material Obligation Failure definition will
terminate; provided that Prana will provide PNG with such additional proof
with respect of the contents of the foregoing certification as PNG may
reasonably request and any dispute as to whether Prana's beginning of such
new Phase 11 Clinical Study as provided above shall be resolved in
accordance with the dispute resolution provisions of the Patent Assignment
Agreement, and termination of the Reversion Right shall be suspended
pending completion of such dispute resolution procedure.
(c) Notwithstanding anything contained herein to the contrary, in the
event a Material Obligation Failure occurs due to the failure of Prana to
make payments pursuant to the Patent Assignment Agreement, the reversion
of Assigned Patent Rights to PNG hereunder shall occur only with respect
to Assigned Patent Rights (irrespective of inventorship) in those
territories in which the events triggering Prana's payment obligations
under the Patent Assignment Agreement arise and in which Prana's failure
to make such payments results in a Material Obligation Failure, and Prana
shall retain its ownership rights, subject to the Reversion Right and the
Security Interest (as defined herein), in and to the Assigned Patent
Rights in all of the remaining countries of the Prana Territory in which
Prana has complied with its payment obligations pursuant to the Patent
Assignment Agreement.
(d) Upon reversion of any Assigned Patent Rights in accordance with
Section 2.4(b), all outstanding licenses (and related sublicenses) will
survive and be assigned by Prana to
Execution Version
PNG, subject to the prior written consent of PNG and the affected
licensees (and related sublicensees).
(e) Upon the reversion of an Assigned Patent Right to PNG pursuant hereto,
such Patent Right shall no longer be deemed an Assigned Patent Right for
purposes of this Agreement.
Section 2.5 of the Patent Assignment Agreement: Security Agreement. The Assigned
Patent Rights are subject to the security interest in the Assigned Patent Rights
granted to PNG pursuant to the Security Agreement (the "Security Interest"). In
no event shall the Reversion Right or Security Interest limit Prana's ability to
license the Assigned Patent Rights to a third party in accordance with Section
2.6 below.
Section 2.6 of the Patent Assignment Agreement: Grant of Rights.
(a) Transfer Restrictions. During the term of this Agreement, Prana may
transfer, sell, assign, encumber, pledge, mortgage, license, sublicense,
grant rights to prosecute and enforce and covenants not to xxx and
otherwise grant rights in and to and otherwise encumber in any way or
nature the Assigned Patent Rights (collectively, the "Third Party
Rights"), subject to the Reversion Right, Security Interest and the
obligations of this Agreement; provided, that
(i) in the event of the sale by Prana of any of the Assigned Patent
Rights or all or substantially all of Prana assets (including the
Assigned Patent Rights) or ownership interest of Prana, or merger of
Prana, the assignee of the Assigned Patent Rights assumes in writing
the obligations of Prana under this Agreement; and
(ii) in the event of the mortgage, pledge or grant of a security
interest in any of the Assigned Patent Rights by Prana, the
mortgagee, pledgee or secured party provide to PNG written
acknowledgement of the priority of the Reversion Right and Security
Interest; and
(iii) in the event of the license of any of the Assigned Patent
Rights, Prana shall (A) provide in the license agreements that the
Assigned Patent Rights are subject to the Reversion Right granted in
Section 2.4 and the Security Interest granted in the Security
Agreement and the licenses shall survive in accordance with the
terms of Section 2.4(d); and (B) grant such licenses limited to the
Prana Territories and subject to the terms of this Agreement.
(b) Third Party Rights. Except as otherwise may occur pursuant to Section
2.4(d), the exercise by PNG of its rights under the Patent Assignment
Agreement and the Security Agreement will not terminate or otherwise
restrict Third Party Rights, and PNG shall take the Assigned Patent Rights
subject to any and all Third Party Rights.
(c) Review of Agreements. PNG shall have the right to review any third
party agreement entered into by Prana granting rights with respect to the
Assigned Patent Rights (whether such agreement transfers, sells, assigns,
encumbers, pledges, mortgages,
Execution Version
licenses, sublicenses, grants rights to prosecute or enforce and covenants
not to xxx) prior to Prana signing such an agreement, subject to written
obligations of confidentiality and non-use that are consistent with those
contained in the Patent Assignment Agreement. The final decision on the
agreement's terms and conditions (in accordance with the foregoing),
timing and the third party remains solely at Prana's discretion. Upon
execution of each agreement or any amendment thereto, Prana shall provide
PNG with a copy of such executed agreement and any amendment thereto.
(d) Right to Cure. Each holder of a Third Party Right has the right, but
not the obligation, to perform the obligations of Prana under this
Agreement to avoid a Material Obligation Failure. PNG agrees to accept the
performance by holders of Third Party Rights of Prana obligations under
this Agreement in the place of Prana.
(e) Licenses for No Consideration. Notwithstanding anything herein to the
contrary, Prana shall not enter into any agreements to license or
sublicense for no consideration, without the prior written consent of PNG,
except if such license or sublicense is for the sole purpose of research
and development of Products.
Section 1 of the Security Agreement: Grant of Security Interest.
a. As collateral security for the prompt and complete payment, performance
and observance of all of the Obligations (defined below), Prana hereby grants to
PNG a security interest in all of Prana's right, title and interest, whether now
owned or existing or hereafter created or acquired in, to and under all of the
following (collectively, the "Collateral"): the Assigned Patent Rights.
b. In furtherance of and without limiting the generality of foregoing, if
new patent rights are added to the Assigned Patent Rights because of the
addition of new territories in accordance with the Patent Assignment Agreement,
the provisions of the Security Agreement shall automatically apply with respect
to such new Assigned Patent Rights, and Prana hereby grants to the Secured Party
a security interest in all of Prana's right, title and interest in, to and under
such new Assigned Patent Rights, which shall be deemed to be part of the
Collateral. PNG acknowledges that Prana's rights in the Collateral are subject
to the terms of third party agreements entered into by Prana prior to the
Effective Date with respect to the Assigned Patent Rights.
c. For purposes of this Agreement, "Obligation(s)" means the obligations
of Prana (i) within eight (8) years of the Effective Date to begin a new Phase
II Clinical Study (excluding any such studies begun before the Effective Date)
for approval by a Regulatory Authority of CQ, PQ, or any Derivative and (ii) to
make royalty or milestone payments as provided in the Patent Assignment
Agreement that are not disputed in good faith. The parties hereto further agree
that the Obligations secured hereby shall also include Prana's obligations to
PNG under any arbitral award or a judgment of any court granted to PNG in
respect of Prana's breach of any of the foregoing Obligations, subject to the
limitations set forth in the Patent Assignment Agreement.
d. Notwithstanding the terms of Section l(a) or any other provision of the
Security Agreement, Prana shall not be limited in any manner in its ability to
grant rights to third parties
Execution Version
under the Assigned Patent Rights pursuant to Section 2.6 of the Patent
Assignment Agreement. All rights of the Secured Party under Sections l(a) and
(b) shall be subject to the Third Party Rights as provided in Section 2.4 of the
Patent Assignment Agreement.
e. Effective upon the written certification by Prana that Prana has within
the eight (8) year period after the Effective Date begun a new Phase II Clinical
Study (excluding any such studies performed before the Effective Date) for
approval by a Regulatory Authority of CQ, PQ, or any Derivative, the Obligations
described in Section l(c)(i) will terminate in accordance with the terms of
Section 2.4(b) of the Patent Assignment Agreement and no longer constitute an
Obligation hereunder.
Execution Version
Schedule 1
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Japan 1998-509541
--------------------------------------------------------------------------------
Japan 2000-507371
--------------------------------------------------------------------------------
USA 09/485,909 6,670,369
--------------------------------------------------------------------------------
Japan 2000-592001
--------------------------------------------------------------------------------
USA 10/098,922
--------------------------------------------------------------------------------
USA 09/023,544 6,001,852
--------------------------------------------------------------------------------
USA 09/023,543 5,980,914
--------------------------------------------------------------------------------
USA 09/023,542 5,994,323
--------------------------------------------------------------------------------
USA 10/717,182
--------------------------------------------------------------------------------
Execution Version
EXHIBIT B
Addendum IV
ADDENDUM
Pursuant to the Patent License Agreement entered into between P.N. Gerolymatos
S.A. (referred to as "Licensor") and X. Xxxxxxxx A/S (referred to as "Lundbeck")
dated 26th July 1999, as amended by Addendum I, dated April 14, 2000 ("Addendum
I"), Addendum II, dated February 18, 2002 ("Addendum II"), and Addendum III,
dated July 19, 2002 ("Addendum II") (collectively, the "Patent License
Agreement"), it is hereby irrevocably and unreservedly confirmed, that Lundbeck
agrees to the exclusion of the Territory of the United States of America from
the Territory of Lundbeck as the Territory of a license agreement concerning
marketing of pharmaceutical products containing Clioquinol or Phanquinone.
It is further understood and explicitly agreed that the exclusion of the USA
from the Territory shall be considered made on the basis of the option granted
to Licensor according to Article 3.3.1 of the Addendum I and Article 3.4.1 of
Addendum I1 to the Patent License Agreement and all other terms and arrangements
stipulated in the aforementioned Patent License Agreement and relevant Addenda,
including indicatively payment of royalties etc., will remain unaltered except
as provided below.
The Parties hereby agree that references to "Licensor" in Sections 2 and 3.1 of
Addendum I and Sections 2 and 3.2 of Addendum I1 shall be construed to mean
"Licensor or Prana Biotechnology Limited ("Prana") or the designee of Prana"
solely with respect to the USA, Japan, and Taiwan. With respect to countries
outside the USA, Japan, and Taiwan, Licensor shall remain obligated under the
terms of Sections 2 and 3.1 of Addendum I and Sections 2 and 3.2 of Addendum 11,
except as otherwise agreed in writing by Prana and Licensor, in which case
Lundbeck shall accept performance by Prana of such agreed obligations as the
designee of Licensor. Except as provided here, the Parties agree that the term
"Licensor" in the Patent License Agreement shall not include Prana.
X. XXXXXXXX A/S
By: /s/ XXXX XXXXX XXXXXXXX
-----------------------------
Name: XXXX XXXXX XXXXXXXX
Title: EVP
P.N. GEROLYMATOS S.A.
By: /s/ P.N. GEROLYMATOS
-----------------------------
Name: P.N. GEROLYMATOS
Title: President
Execution Version
EXHIBIT C
Lundbeck Agreement
PATENT LICENSE AGREEMENT
Between
P.N. Gerolymatos S.A.
00 Xxxxxxxxx Xxxxxx
00000 Xxxxxxxx Xxxxxx
Xxxxxx
(hereinafter referred to as "Licensor")
and
X. Xxxxxxxx A/S
Xxxxxxxxxx 0
XX-0000 Xxxxxxxxxx-Xxxxx
Xxxxxxx
(hereinafter referred to as "Lundbeck")
PREAMBLE:
WHEREAS Licensor is the owner of certain know how and other relevant
intellectual property rights as well as patent applications in various European
and other countries covering the use of the chemical compounds Clioquinol and
Phanquinone and possesses the right to license the rights granted herein with
regard to these compounds, both compounds anticipated to be active within
indications of Alzheimer's Disease, Xxxxxxxxx'x Disease and other indications;
WHEREAS, Lundbeck wishes to obtain from Licensor for global exploitation certain
rights relating to Clioquinol, Phanquinone and Licensed Patents, Know-how
generated and other intellectual property rights possessed;
WHEREAS, Lundbeck intends to undertake the investigations and, possibly the
further development and the subsequent possible marketing of Clioquinol and/or
Phanquinone;
WHEREAS, The Parties prior to entering into this Agreement have signed a Letter
of Intent dated 26 April 1999;
NOW THEREFORE and in consideration of the mutual covenants contained herein, the
Parties hereto have agreed to enter into this Agreement upon the following terms
and conditions:
1. DEFINITIONS
1.1 "Affiliate" shall mean corporations in which a Party, now or during the
term of this Agreement, on a permanent basis owns or controls fifty one
per cent (51%) or more of the voting stock. "Affiliate" shall also mean
any holding company owning or controlling fifty one percent (51%) or more
of the voting stock of any Party.
1.2 "Agreed Quality Standards" shall mean the at any time applicable. Good
Clinical Practice guidelines as adopted by the ICH and/or any local health
authority become competent with respect to a clinical activity to be
carried out. The "Agreed Quality Standard" shall include, but not be
limited to, the GCP criteria for protocol writing, selection of contract
research organisations, trial facility requirements, enrolment of subjects
in clinical trials, completion of case record forms and recording, storing
and reporting of results and events.
1.3 "Clioquinol" shall mean 5-Chloro-7-iodo-8-quinolinol.
1.4 "Date of Execution" shall mean the date of signature to this Agreement by
the Party last to sign.
1.5 "DKK" shall mean the official currency of Denmark, the Danish Kroner.
1.6 "Information" shall mean any information, technology (including electronic
soft- and hardware), registration data, marketing data (including customer
files), marketing material and medicinal data related to Licensed Products
that are put at a Party's disposal by the other Party and/or communicated
by one Party to the other, orally, in writing or otherwise made available,
as a result of the existence of this Agreement.
1.7 "Know-How" shall mean with respect to either Xxxxx, collectively, all
proprietary information, confidential Information, methods, products,
ideas, processes, technologies, inventions, data, information and all
intellectual property rights connected therewith, whether or not
patentable and whether oral, written or stored in any computer format,
owned, controlled or licensed to
2
either Party, now or during the term of this Agreement, to the extent
related to the research, development, manufacture, use or sale of Licensed
Products in the Territory.
1.8 "Licensed Patents" shall mean any and all present or future patents and
patent applications in the Territory or covering any part of the Territory
including but not limited to process patents, use patents and/or
formulation patents containing one or more claims covering Clioquinol
and/or Phanquinone and/or its/their formulations or use as a medicinal
product for any indication in whole or in part which are or become owned
by Licensor. Licensed Patents include the issued patents and patent
applications listed in Annex 1. forming an integral part of this
agreement, as well as any and all extensions, divisions, continuations,
continuations-in-part, re-examinations and reissues thereof and
supplementary protection certificates thereof in the Territory or covering
any part of the Territory. Licensed Patents as per Date of Execution have
been listed in Annex 1 hereto.
1.9 "Licensed Products" shall mean formulations containing Clioquinol and/or
Phanquinone.
1.10 "Licensor Technology" shall mean Licensed Patents, reference is made to
Article 1.8 above, and Know How, reference is made to Article 1.7 above,
generated by Licensor.
1.11 "Marketing Year" shall mean calendar year periods except for the first
Marketing Year. The first Marketing Year shall commence after Registration
in the first country in the Territory and on the first day of the month in
which Lundbeck makes its first commercial sale of Licensed Product (that
is, invoices its first sale of a Licensed Product to an independent third
party) in the Territory until December 31st of that year. Subsequent
Marketing Years shall be the applicable calendar years. The date on which
the first Marketing Year so commences shall be immediately confirmed by
Lundbeck to Licensor in writing. "Half of Marketing Year" shall mean six
(6) calendar month periods within the same Marketing Year. The first Half
of Marketing Year shall commence on January 1st of each calendar year and
end on June 30th of that calendar year. The second Half of Marketing Year
shall commence on July 1st of each calendar year and end on December 31st
of that calendar year.
1.12 "Net Sales" shall mean gross sales of Licensed Products to a hospital,
wholesaler or pharmacist in the Territory less (1) the total of ordinary
and customary trade discounts earned and actually taken or granted, (2)
any statutory or contractual rebates paid to any governmental or any other
public authority, agency or entity (3) cash and quantity discounts
allowed, (4) allowances and adjustments actually credited or paid to
customers for spoiled, damaged. outdated and/or returned Licensed Product,
(5) freight, insurance, transportation costs and handling charges included
by the seller in its invoices to independent third parties, (6) excise,
sales, and value added taxes included by the seller in its invoices to
independent third parties, and (7) customs duties and other compulsory
payments made by the seller to national, provincial and local government
authorities.
1.13 "Party" or "Parties" shall mean one or both of the companies listed on the
first page executing this Agreement.
1.14 "Phanquinone" shall mean 4,7-Phenanthroline-5,6-dione.
1.15 "Phase I trial" shall mean controlled clinical trials in healthy
volunteers as carried out by Lundbeck, investigating safety, tolerability
and kinetic properties of Licensed Products.
1.16 "Phase II trial" shall mean controlled clinical trials in patients as
carried out by Lundbeck investigating indication, proof of concept
(efficacy), toxicity and recommended dosages of Licensed Products.
1.17 "Phase 111 trial" shall mean controlled clinical trials in patients as
carried out by Lundbeck investigating the clinical properties of Licensed
Products, including side effects.
3
1.18 "Registration" shall mean all written governmental approvals including any
price and/or reimbursement approval required for the legal marketing of
Licensed products in any country in the Territory (e.g., approval by the
United Kingdom Medicines Control Agency or by other equivalent government
or supranational agencies in the Territory that regulates, licenses or
otherwise approves the import, manufacture, promotion and/or sale of
pharmaceutical products in that country).
1.19 "Territory" shall mean any country world-wide with the exception of
Cyprus, Greece, Turkey, Israel, Hong Kong, Singapore and South Korea.
1.20 "Trademark(s)" shall mean any and all trademarks for use in conjunction
with Licensed Products in any part of the Territory excluding any
trademark comprising the name of either Party generally used by such Party
to identify itself (a "House-Xxxx").
1.21 "Valid Claim" shall mean any claim of a patent application or of an issued
and non-expired patent including but not limited to future patents and/or
patent applications within the Licensed Patents covering or including a
Licensed Product, which has not been finally held unenforceable,
non-patentable, or invalid by a court or governmental agency of competent
jurisdiction, unappealed or unappealable within the time allowed for
appeal, nor has been admitted by the holder of the patent to be
unenforceable, non-patentable, or invalid through reissue, disclaimer, or
otherwise.
1.22 When any term defined in this Agreement in singular or plural is used in
this Agreement in plural or singular, respectively, this shall be deemed a
reference to the defined term unless the context explicitly otherwise
indicates.
2. GRANT OF LICENSED RIGHTS
2.1 Subject to the terms and conditions of this Agreement, Licensor hereby
grants to Lundbeck and Lundbeck hereby accepts the exclusive license,
including the unlimited right to grant sublicenses to any Affiliate and to
third parties, under the Licensor Technology to exploit same commercially
in any respect whatsoever, including but not limited to the right to
develop, make, offer for sale, import, export, formulate, package, use,
sell, market, promote, distribute and have sold Licensed Products for any
indication in the Territory in accordance with this Agreement. A
sublicense includes but is not limited to co-marketing and co-promotion
arrangements. Lundbeck undertakes to inform Licensor without undue delay
about sublicenses granted by Lundbeck and Affiliates.
2.2 In the event that Licensor wishes to obtain patent protection for and/or
commercialize any compound which in Licensor's view may be active within
indication of Alzheimer's Disease and/or Xxxxxxxxx'x Disease or the like,
Licensor shall give written notice to Lundbeck specifying in reasonable
detail any bona fide offer, if any, made by a third party for rights to
such compound. For sixty (60) days after receipt of such notice, Lundbeck
shall have the right of first refusal to the patent and/or
commercialisation rights concerning such compound. If this right is not
exercised by Lundbeck, then Licensor shall have the right to pursue the
patenting and/or commercialization of such compound alone or in
co-operation with any third party. If this right is exercised by Lundbeck,
then the Parties shall negotiate in good faith a license agreement
concerning the commercialization of such compound.
3. DEVELOPMENT
3.1 Lundbeck and/or its designated sublicensee, reference is made to Article
2.1, will at its own discretion decide to carry out development studies
and will, if so, prepare the relevant
4
documentation for applications for carrying out clinical trials as well as
the relevant documentation for applications for Registration with the
health authorities in those parts of the Territory where Lundbeck wishes
to pursue rights granted hereunder. Lundbeck shall apply for Registration
of Licensed Products in its own name and shall remain the sole holder of
the Registration in the Territory unless rights to the Registration are
assigned or sublicensed, reference is made to Article 2.1. All costs
and/or expenses arising or incurred in connection with preparation and
filing of the application for Registration in the Territory, including
costs and/or expenses related to Phase I, II and III trials, shall be
borne by Lundbeck.
3.2 Lundbeck shall always be responsible for all decisions on the further
investigations concerning the development of Licensed Products.
Development activities shall take place in accordance with Agreed Quality
Standards. Lundbeck may at its own discretion decide to cease any and/or
all development activities. However, Lundbeck shall decide no later than
three years after the Date of Execution whether or not Lundbeck wishes to
initiate a Phase I trial regarding Phanquinone.
3.3 Lundbeck shall report to and consult with Licensor as to results and
progress with regard to Phanquinone. Specifically, Lundbeck shall, within
the first year as of the Date of Execution, show that development work is
in progress. Furthermore, Lundbeck shall, within the second year after the
Date of Execution, show what results, if any, have been generated by such
development work. No later than three (3) years after the Date of
Execution, Lundbeck shall decide, and without delay inform so Licensor,
whether or not Lundbeck will initiate a Phase I trial regarding
Phanquinone. For such reporting and consultation each Party shall
designate a focal person for contacts between the Parties. Such reporting
and consultation shall be free of charge and each Party shall bear its own
expenditures in this connection. Reporting and consultation shall take
place two (2) to four (4) times each year.
3.4 Neither Licensor nor Lundbeck warrants that Registration of License
Products will be obtained in the Territory.
4. KNOW-HOW AND INFORMATION
4.1. Information and Know-How, both original and copy, supplied for any reason
by a Party to the other Party are the property of the supplying Party in
whatever share information and Know-How may appear.
5. MARKETING
5.1 Lundbeck agrees to use its best reasonable efforts to commercialise
Licensed Products in the parts of the Territory where Lundbeck reasonably
deems it appropriate to market such Licensed Products and will keep
Licensor continuously informed with respect to such commercialisation. If
Lundbeck explicitly decides not to apply for Registration of a specific
Licensed Product in a country within the Territory, Lundbeck shall in good
faith negotiate with Licensor a sublicense agreement on fair market terms
covering the country in question. If the Parties are unable to agree on a
sublicensing agreement, Licensor shall have the right of first refusal in
the event that Lundbeck reaches a bona fide understanding with a third
party on terms which are significantly different from the terms discussed
by the Parties.
5.2 Lundbeck shall pay for all costs related to its marketing and sale of
Licensed Products in the Territory and shall source all Licensed Products
itself.
6. MILESTONE PAYMENTS
5
6.1 Lundbeck will pay to Licensor the following amounts in accordance with the
following schedule:
(a) Within seven (7) days after the Date of Execution, the sum of nine
hundred and eighty eight thousand EUR (EUR 988,000) will be paid by
Lundbeck to Licensor.
(b) Within seven (7) days from the date of the start of the first Phase
I trial, the sum of four million nine hundred and thirty nine
thousand EUR (EUR 4,939,000) will be paid by Lundbeck to Licensor.
Such Phase I trial shall be sponsored by Lundbeck, reference is made
to Article 3.1, and shall be deemed to have started on the date of
the administering of the first dose to the first trial object. The
Parties acknowledge that Lundbeck shall decide at its own discretion
whether to start any Phase I trial, reference is made to Article
3.2.
(c) Within seven (7) days of the date of successful completion of the
first Phase II trial or start of the first Phase 111 trial,
whichever comes later, the sum of nine million eight hundred and
seventy eight thousand EUR (EUR 9,878,000). Such Phase I1 trial
shall be deemed to have been completed successfully if Lundbeck
declares the trial to have been successful and decides to initiate a
Phase 111 trial, whichever comes later, regarding the same Licensed
Product. Such Phase 111 trial shall be sponsored by Lundbeck,
reference is made to Article 3.1, and shall be deemed to have
started on the date of the administering of the first dose to the
first trial object.
6.2 Lundbeck shall only be liable to pay the amounts identified in Article 6.1
once, i.e. that Lundbeck's accumulated obligation under Article 6.1 can
under no circumstances whatsoever exceed payment of fifteen million eight
hundred and five thousand EUR (EUR 15,805,000), notwithstanding the number
of Licensed Products for which research and development activities,
including Phase I, II and III trials, have been initiated and/or
completed.
6.3 All payments to be made under Article 6.1 above shall be made to a bank
account as identified by Licensor, reference is made to Annex 2 hereto.
6.4 Any and all payments made under this Article 6 except payment made under
Article 6.1 (a) shall be repaid by Licensor to Lundbeck if Licensor has
not obtained any issued patent containing one or more claims covering a
composition containing Phanquinone and/or Clioquinol or use of Phanquinone
or Clioquinol or such a composition within three (3) years from the Date
of Execution.
Prior to the Date of Execution, Licensor shall have provided Lundbeck with
written and signed declarations from Mr P. Gerolymatos and Mr Mikis
Xilinas to the effect that Xx Xxxxx Xxxxx Xxxxxxx, Xx Xxxxxx Xxx Xxxx, Xx
Xxxxxx Xxxxxxxx Beyreuther, Xx Xxxxxx Xxxxx, Xx Xxxxx X. Xxxxxx and Xx
Xxxxxxx X. Xxxxx are not and cannot be considered as co-inventors of
Phanquinone or patents and/or patent applications covering Phanquinone,
processing of Phanquinone and/or use of Phanquinone. Such declarations
shall be included as Annex 3 hereto.
7. ROYALTIES
7.1 Each Marketing Year, Lundbeck shall pay a royalty to Licensor for the
licenses granted hereunder in accordance with the provisions of Article
7.3 hereof. Such royally shall be
- four percent (4%) of Net Sales up to one hundred million EUR (EUR
100,000,000.00),
- five percent (5%) of Net Sales between one hundred million EUR (EUR
100,000,000.00) and two hundred million EUR (EUR200,000,000.00) and
- six percent (6%) of Net Sales above two hundred million EUR (EUR
200,000,000.00)
6
of Licensed Products sold by Lundbeck and/or its Affiliates and/or its
sublicensees and distributors. Royalties shall be paid only for the term
of Licensed Patents covering the indications of the Licensed Products in
question and only to the extent such Licensed Patents are enforceable,
reference is made to Article 7.6.
Royalties for each Marketing Year, as provided hereunder, shall be paid by
Lundbeck to Licensor in two installments at the end of each Half of
Marketing Year as provided in Article 7.3 hereof.
7.2 Net Sales are to be calculated in local currencies for each of the
countries in the Territory and shall be converted into DKK based on the
average of the exchange rates of the first and the last Copenhagen banking
day of the applicable marketing quarter. The exchange rate to be used is
the purchase exchange rate for currency conversion as published by Den
Danske Bank. If Den Danske Bank has no such exchange rate, the conversion
shall be made at the average rate as calculated above for such remittances
by such other first class international bankers. Prior to being paid to
Licensor, royalty amounts shall be converted from DKK into EUR, using
exchange rates for conversion from DKK to EUR on the last banking day of
the applicable marketing quarter as quoted by Den Danske Bank.
7.3 Lundbeck shall within ninety (90) days from the last day of each Half of
Marketing Year pay to Licensor the royalties due for that Half of
Marketing Year and provide Licensor with a statement (the "Royalty
Report") showing the total Net Safes effected hereunder by Lundbeck, its
Affiliates and/or its sublicensees and distributors during the preceding
Half of Marketing Year in the Territory and all Net Sales shall be
segmented in each such report according to sales on a country-by-country
basis.
7.4 Royalty payments due to Licensor hereunder shall be made in EUR by wire
transfer to a bank account as identified by Licensor, reference is made to
Annex 2 hereto. Bank fees charged by Lundbeck's bank will be borne by
Lundbeck; bank fees charged by Licensor's bank will be borne by the
Licensor. If DKK or any other currency relevant for this Agreement is
changed to e.g. EUR the amounts shall be transformed to such new currency,
applying the official rate of exchange as per date of transformation.
7.5 All taxes assessed or imposed against or required to be withheld from all
payments due to Licensor shall be deducted from amounts payable hereunder
and shall be paid to appropriate fiscal or tax authorities by Lundbeck on
behalf of Licensor. Tax receipts received by Lundbeck evidencing payment
of such taxes shall be forwarded to Licensor.
7.6 The royalty rate pursuant to Article 7.1 will be paid on Net Sales in the
Territory on a country by country basis for the term of enforceable
Licensed Patents covering the indications of the Licensed Products in
question. If such Licensed Patents have expired in a specific country, no
Royalties shall be payable for net sales obtained in this country. If such
Licensed Patents have not been granted in a specific country, no Royalties
shall be payable for Net Sales obtained in this country. Royalties shall
only be payable on Net Sales obtained for indications covered by a
Licensed Patent covering the Licensed Products in question.
7.7 Lundbeck shall keep for a period of four (4) Marketing Years following the
year to which such records relate, full, true and accurate books of
accounts and other records containing all information and data which may
be necessary to ascertain and verify the royalties payable to Licensor
hereunder.
7.8 Licensor shall have the right to have such pertinent books and records of
Lundbeck inspected and examined biannually for the purpose of determining
the accuracy of payments made hereunder in respect of a royally report
which is not more than four (4) years old. Such inspection and examination
shall be conducted by an independent, certified public accountant
7
selected by Licensor and to whom Lundbeck shall have no reasonable
objection. Such accountant shall not disclose to Licensor any information
except for information necessary to verify the accuracy of the reports and
payments made pursuant to this Agreement. Results of such review shall be
made available to both Parties. If the review effects an underpayment,
Lundbeck shall promptly remit to Licensor any amounts due. If the
underpayment is equal to or greater than five (5) percent of the payments
made by Lundbeck to Licensor for such period under review, Lundbeck shall
pay all costs of such review and audit. If the underpayment due represents
less than five (5) percent of the payments made by Lundbeck, Licensor
shall pay all costs of such review and audit.
7.9 Licensor is entitled to charge interest on arrears for delayed payments
amounting to three (3) percent p.a. above the discount rate applied by the
Danish National Bank at the due date, provided that Licensor prior to the
due date has supplied all information necessary for effecting the transfer
of the funds (accurate address of the relevant bank, accurate bank
account, etc.)
7.10 Royalties paid under this Article 7 are non-refundable and non-creditable.
8. MARKETING RIGHTS OF LICENSOR
8.1 Licensor shall be entitled to exploit Licensor Technology commercially in
countries and territories outside the Territory. This right includes but
is not limited to the right to formulate, manufacture, package, use, sell,
market, promote and distribute such registered Licensed Product. Licensor
shall not grant sub-licenses unless Lundbeck consents in writing. Such
consent shall not be unreasonably withheld.
8.2 Licensor shall be responsible for obtaining any written governmental
approvals including any price and/or reimbursement approval required for
the marketing of products within countries and territories outside the
Territory. All costs and/or expenses incurred in connection with
preparation and filing of applications for written governmental approvals
as well as maintenance of such approvals shall be borne by Licensor.
Licensor shall be allowed to base his applications on data or registration
files prepared by Lundbeck, and Lundbeck shall use its best efforts to
assist Licensor, upon request, in connection with the filing of regulatory
applications. Licensor shall reimburse Lundbeck for any reasonably
documented expenditures connection therewith.
8.3 Products marketed in accordance with Article 8.1 shall be marketed under
trade marks registered and maintained by Licensor. Licensor shall not
actively market such products in the Territory, and Lundbeck shall not
actively market Licensed Products outside the Territory. On Licensor's
request the Parties shall discuss the possibility of using the same trade
xxxx registered and maintained by Lundbeck in said countries and
territories.
8.4 On Licensor's request, Lundbeck shall deliver supplies of compounds
covered by Licensed Patents to Licensor provided that Lundbeck and/or its
Affiliates are marketing products containing such compounds in the
Territory. Delivery of supplies shall take place in accordance with the
following terms and conditions:
(a) Before delivery takes place, the Parties shall negotiate in good
faith and agree upon reasonable specifications regarding the
formulation of the compound or compounds in question and other
quality standards. Lundbeck warrants that deliveries will comply
with such specifications and standards.
(b) Licensor shall inform Lundbeck in writing of Licensor's needs for
the following eight (8) calendar quarters ("Licensor's Order
Forecasts"). Licensor's Order Forecasts shall be binding on Licensor
in the range of eighty (80) to one hundred and ten (110) percent for
the period covered by such forecasts.
8
(c) Lundbeck shall use its best reasonable efforts to deliver according
to Licensor's orders subject to a delivery time of at least three
(3) months calculated from dispatch of order and shall promptly give
Licensor notice in case of delay or in case that Lundbeck is unable
to deliver the quantities ordered by Licensor. Lundbeck shall use
its reasonable best efforts to ensure that deliveries comply with
Licensor's orders with regard to delivery time and quantities, but
does not warrant that Lundbeck is able to deliver within the above
mentioned delivery time nor that the quantities ordered will be
delivered. Delivery of supplies shall take place CIP (Incoterms
1990) Athens or elsewhere outside the Territory as instructed by
Licensor.
(d) The price to be paid by Licensor for supplies from Lundbeck shall be
calculated as, Lundbeck's internal Cost IV Price plus ten per cent
(10%) hereof provided that such supply price adequately reflects
Lundbeck's relevant overheads and ensures that Lundbeck receives a
reasonable profit. Lundbeck's internal Cost IV Price shall be
defined as the sum of the costs of (a) the direct variable costs,
i.e. active substance, excipients, packing material, wages and
salaries, (b) allocated semi-variable costs, i.e. wages and salaries
to supervisors, laboratory technicians and service personnel, other
personnel costs, repair and maintenance of machinery, stock material
used internally, stationary and acquisitions, (c) allocated fixed
costs, i.e. salary to Director of Production, staff, head of
departments, supervisors and laboratory technicians, other personnel
costs and depreciation and (d) allocated facilities costs, i.e. rent
and energy. Lundbeck shall be entitled to amend this definition from
time to time if Lundbeck demonstrates that the aforementioned
definition of Lundbeck's relevant overheads have deviated by more
than plus/minus five per cent (5%).
(e) Licensor shall notify Lundbeck in writing of any obvious defects
within four (4) weeks of receipt of deliveries. Obvious defects
shall include without limitation defects reasonably discoverable on
visual examination of representative samples of a consignment.
Licensor shall notify Lundbeck in writing of any non-obvious defects
within four (4) weeks of discovery. Licensor shall not be obliged to
perform any chemical analysis of deliveries. Lundbeck shall be
entitled to visit and inspect the premises of Licensor used for
storing, manufacturing, distribution etc.
(f) If deliveries do not comply with agreed upon specifications or
standards, Licensor may instruct Lundbeck to refund the purchase
price or require Lundbeck to replace the consignment.
(g) Lundbeck shall invoice Licensor in DKK upon delivery of each
consignment at the prices specified in Article 8.4 (d) above. If DKK
is changed to e.g. EUR the amounts shall be transformed to such new
currency, applying the official rate of exchange as per date of
transformation.
(h) All payments to be made under Article 8.4 (g) above shall be made to
a bank account as identified by Licensor, reference is made to Annex
2 hereto.
(i) If Lundbeck due to a change of Lundbeck's production strategy wishes
to cease production of supplies to Licensor wholly or partially,
Lundbeck shall seek to secure supplies for Licensor from one or more
third parties and/or Affiliates unless Licensor is willing to
manufacture the quantities in question wholly or partially. The
terms of such production shall be discussed in good faith between
the Parties. If supplies from third parties and/or Affiliates of
Lundbeck are provided to Licensor by Lundbeck, the supply price to
be paid by Licensor shall amount to the supply price demanded by the
third party or the Affiliate plus ten per cent (10%), such ten per
cent (10%) to be paid to Lundbeck by Licensor.
9. PUBLICATION
9
9.1 If Lincensor contemplates, during the period from date of execution until
the date the first Registration has been obtained, to make any publication
or public presentation whatsoever concerning the use of Licensed Products,
it shall send any manuscript for publication or abstract for public
presentation to Lundbeck for comments at least three (3) months prior to
submission for publication or presentation. If Lundbeck fails to respond
to such request for two (2) months after receipt, then Lundbeck shall be
deemed not to have any comments. Comments made within two (2) months after
receipt by Lundbeck shall be included by Licensor in the final publication
or presentation, respectively. Lundbeck may require the modification or
deletion of parts of the manuscript of the abstract which in its opinion
might jeopardize any industrial or commercial exploitation by Lundbeck of
any of the Licensed Products. In addition Lundbeck may delay the
publication or presentation for up to thirty-six (36) months, if the
contents of such publication or presentation could in the opinion of
Lundbeck jeopardize any possible intellectual property rights of/or
licensed to Lundbeck or Lundbeck's commercial interests.
9.2 After the date of the first Registration Licensor shall not make any
publication or public presentation of the results, data or knowledge that
it has developed fully or partly pertinent to Licensed Products, unless
Lundbeck's prior written approval, which should not be unreasonably
withheld, has been obtained or unless such publication or presentation
only contains information, already published or presented pursuant to
Article 9.1.
9.3 Any publication or presentation shall mention the contribution of the
respective Parties to the publication or presentation, respectively.
9.4 All publications or public presentations and public announcements made by
Licensor and/or by Lundbeck and/or its/their Affiliates and/or its/their
sublicensees concerning the Licensed Products shall specify that Licensed
Products have been licensed to Lundbeck by Licensor.
10. CONFIDENTIALITY
10.1 Information and/or Know-How supplied by one Party (the "Supplying Party")
to the other Party (the "Receiving Party") as a result of this Agreement,
shall, regardless of whether or not it has been marked "Confidential" or
has been marked with a similar wording of the same meaning, be held in
confidence by the Receiving Party until 31 December 2010 or ten (10) years
after expiration or termination of this Agreement, whichever period is the
longer.
10.2 This confidentiality obligation should not be considered violated, if and
to the extent that Information or Know-How:
(a) was at the time of disclosure publicly known or available;
(b) has, after disclosure to the Receiving Party, become publicly known
or available through publication or otherwise, except by breach of
this Agreement by the Receiving Party;
(c) was in the possession of the Receiving Party at the time of
disclosure by the Supplying Party and was not acquired, directly or
indirectly, from the Supplying Party;
(d) was received by the Receiving Party from a third party, provided,
however, that such Information was not obtained by the said third
party directly or indirectly, from the Supplying Party; or
(e) was disclosed by the Receiving Party due to regulatory or
governmental or legal requirements or due to a court order.
10
10.3 If the Receiving Party asserts that its obligation of confidentiality
under this Article does not apply because of an exception to that
obligation, the Receiving Party shall have the burden of proving the
exception it asserts.
11. PATENT PROSECUTIONAND PATENT INFRINGEMENT
11.1 Licensor undertakes to execute national and/or international patent
applications for Licensed Products insofar as such applications have not
already been executed and filed by Licensor, reference is made to Annex 1
hereto, and insofar as Lundbeck wishes to file such applications.
Licensor shall be the applicant in all patent applications, but the
preparation and drafting of such applications shall be done by Lundbeck.
Lundbeck shall decide at its own discretion the scope and content of such
applications, the claims to be included in such applications and which
countries shall be covered by such applications. However, whenever legally
possible, Lundbeck undertakes to include countries and territories outside
the Territory in international applications.
Licensor shall assist and cooperate with Lundbeck in connection with the
preparation and drafting of the patent applications in accordance with
Lundbeck's requests. Furthermore, on receipt of final patent applications,
Licensor shall sign the applications and other necessary documents and
return the applications and other necessary documents to Lundbeck for
filing within five (5) office days from receipt of the applications. In
circumstances where Lundbeck considers such a time limit to be
insufficient, and so notifies the Licensor, Licensor shall sign the
applications and other necessary documents and return the applications and
other necessary documents to Lundbeck for filing within forty-eight (48)
hours from receipt of the applications.
Any and all costs and expenses incurred after the Date of Execution in
connection with the preparation, drafting, filing and maintenance of
Licensed Patents in the Territory shall be borne by Lundbeck with the
exception of:
(a) costs incurred by Licensor in connection with Licensor's assistance
to and co-operation with Lundbeck concerning the preparation and
drafting of patent applications as well as costs incurred by
Licensor in connection with Licensor's signing and dispatch of
patent applications, it being understood that all fees payable to
patent authorities shall be paid by Lundbeck;
(b) all costs and expenses incurred in connection with the preparation
drafting, filing and maintenance of international patent
applications covering countries and territories outside the
Territory insofar as such costs and expenses relate to such
countries and territories. Prior to the filing of international
patent applications covering countries and territories outside the
Territory, the Parties undertake to negotiate in good faith how
Licensor's contribution to such costs and expenses shall be
calculated. If no agreement is reached, Lundbeck shall be entitled
to exclude countries and territories outside the Territory from the
application in question.
When filed Lundbeck takes over the continued prosecution and maintenance
of the applications and Licensed Patents obtained, in Licensor's name and
on Licensor's behalf, but on Lundbeck's account, in said countries and in
those parts of the Territory in which, in Lundbeck's opinion, is
reasonable to conduct such prosecution and maintenance and provided that
such prosecution and maintenance, in Lundbeck's opinion, is commercially
reasonable. Licensor shall no later than seven (7) days after the Date of
Execution and continuously thereafter make available to Lundbeck all such
documents and information as is reasonably requested by Lundbeck for the
said prosecution and maintenance of the Licensed Patents. Lundbeck shall
in its reasonable opinion decide how to so prosecute and maintain the
Licensed Patents, but Lundbeck will first consult with Licensor in cases
deemed important by Lundbeck. Neither Licensor nor Lundbeck
11
warrants or represents that a Licensed Patent can be so maintained and
prosecuted that it will represent an enforceable patent covering the
indications of the Licensed Product in question. Lundbeck shall keep
Licensor informed on the status of the License Patents. If Lundbeck no
longer has interest in a patent or patent application which is part of the
Licensed Patents, Lundbeck shall notify Licensor immediately, which shall
have the right to continue to maintain the patent or application at its
expense. Any such patent or patent application shall no longer be licensed
under this Agreement.
11.2 Each Party shall notify the other Party promptly in writing of any
infringement of Licensed Patents in the Territory which becomes known to
such Party.
11.3 In order for Lundbeck to pursue infringements of the Licensed Patent in
the Territory, Licensor will supply Lundbeck with the necessary power of
attorney and will support Lundbeck in the prosecution of infringement.
Possible reimbursements from third parties resulting from the prosecution
of infringements will be due to Lundbeck. Should Lundbeck and Licensor
agree to carry on litigation together, possible reimbursements from third
parties resulting from the prosecution of infringements will be divided
between the contractual parties in proportion to the financial share in
the prosecution. If Lundbeck decides not to prosecute an infringement due
to Lundbeck estimating the chances for success being too low, Lundbeck
will inform Licensor accordingly in order for Licensor to decide whether
or not Licensor will prosecute the infringement on its own.
11.4 If Lundbeck or its Affiliates obtain one or more licenses under a patent
not licensed hereunder and agree to pay a royalty to a third party in
order to make, use or sell Licensed Product in the Territory or parts
thereof (whether as a condition of settlement of any infringement action,
or by court order or for any other reason) the obtaining of such license
must be reasonably approved by the Licensor unless required by court
order. The royalty payable to such third party shall be deducted from the
royalty payable to Licensor hereunder. However, Licensor's contribution to
the payment of royalty to the aforementioned third party shall under no
circumstances exceed an amount equaling 1/4 of Lundbeck's milestone
payments under Article 6.1. Deduction from the royalty payable to Licensor
hereunder shall be effected regardless of whether the Royalty paid to any
third party is the result of a condition of settlement of an infringement
action or a court order or takes place for any other reason.
In no case shall the current royalty payable to Licensor be less than 50%
of the royally otherwise due unless Licensed Patents have been deemed by
[ILLEGIBLE] court decision not to represent an enforceable patent covering
the indications of the Licensed Product in question in which case the
Licensed Patents shall be considered void for the country in question.
12. LIABILITY AND INDEMNIFICATION
12.1 A Party shall be liable to the other for any direct damage caused or
contributed to by any action or inaction provided that such action or
inaction was the result of gross negligence.
12.2 Neither Party including their respective directors, officers and employees
shall he held liable for any incidental, indirect or consequential
damages, including, but not limited to the loss of opportunity, loss of
the use of any data or information supplied hereunder, loss of revenue or
profit in connection with or arising out of this Agreement, the services
performed by either Party hereunder or the existence, furnishing,
functioning, or the other Parts use of any information, documentation or
services provided pursuant to this Agreement, even if the Party causing
the damage has been advised of the possibility of such damages, unless the
damage suffered is due to gross negligence or willful misconduct.
12.3 Notwithstanding the foregoing, Lundbeck agrees to indemnify, defend and
hold Licensor and each of its officers, directors, employees, agents and
consultants (and their respective heirs and
12
assignees) (each a "Licensor Indemnitee") harmless against all costs,
claims, suits, expenses (including reasonable attorneys' fees) and damages
arising from any negligence of Lundbeck or any Third Party for whom
Lundbeck is responsible in the manufacturing, distribution, promotion,
marketing and/or selling of Licensed Products in the Territory, provided
that the Licensor lndemnitee gives reasonable notice to Lundbeck of any
such claims or action, tenders the defence of such claim or action to
Lundbeck and assists Lundbeck at Lundbeck's expense in defending such
claim or action and does not compromise or settle such claim or action
without Lundbeck's prior written consent.
12.4 Notwithstanding the foregoing, Licensor agrees to indemnify, defend and
hold Lundbeck and each of its officers, directors, employees, agents and
consultants (and their respective heirs and assignees) (each a "Lundbeck
Indemnitee") harmless against all costs, claims, suits, expenses
(including reasonable attorneys' fees) and damages in countries and
territories outside the Territory arising from any negligence of Licensor,
or any third party for whom Licensor is responsible in the manufacturing,
distribution, promotion, marketing and/or selling of products containing
Licensed Products in countries and territories outside the Territory,
provided that the Lundbeck Indemnitee gives reasonable notice to Licensor
of any such claims or action, tenders the defence of such claim or action
to Licensor and assists Licensor at Licensor's expense in defending such
claim or action and does not compromise or settle such claim or action
without Licensor's prior written consent.
13. TERM AND TERMINATION
13.1 The term of this Agreement shall be for a period beginning with Date of
Execution. Unless sooner terminated pursuant to Articles 13.2, 13.3, 14.1
or 17.5, the term of this Agreement shall end at such time as Lundbeck
shall have no further obligation to make payments to Licensor on Net Sales
of Licensed Products. Upon such termination, Lundbeck shall have a
perpetual royalty-free license to such Licensor Know-How which is not or
no longer covered by a Valid Claim.
13.2 Lundbeck may at any time terminate this Agreement for any reason,
effective upon three (3) months' prior written notice.
13.3 Except as provided in Article 14, Licensor may only terminate this
Agreement, effective upon three (3) months' prior written notice, if
Lundbeck ceases all research and development activities regarding the
Licensed Products. Upon receipt of notice inaccordance with this Article
13.3, Lundbeck shall be entitled to re-start the relevant research and
development activities within thirty (30) days; if activities are
re-started within thirty (30) days the notice shall not be effective.
13.4 In the event of termination in accordance with the Article neither Party
shall compensate the other for the consequence of termination.
13.5 If the Agreement is terminated by Lundbeck pursuant to this Article all
rights and acquired Know-how will be transferred immediately to Licensor
royalty-free.
14. TERMINATION FOR CAUSE
14.1 A Party shall have the right to terminate this Agreement, if the other
Party fails to remedy any material breach within ninety (90) calendar days
of receipt by it of a written notice specifying the breach and requiring
it to be remedied. For the purposes of this sub-article, a breach shall be
considered capable of remedy if the Party in breach can comply with the
provisions in question in all respects other than as to the time of
performance.
13
14.2. Termination under this Article 14 shall be without prejudice to either
Party claiming damages to the extent warranted by applicable law.
15. RIGHTS AND PROCEDURE OF TERMINATION
15.1 Upon the effective date of termination with reference to Article 13.2 and
Article 13.3 Lundbeck shall return to Licensor Licensor Technology and
Information, original or copy, made available hereunder, and contemporary
with such return Licensor shall return Lundbeck all Lundbeck Know-How and
Information, original or copy, made available hereunder including
registration files and related material provided under Article 8.2.
15.2 If the Agreement is terminated pursuant to Article 13.3, Licensor shall
receive a royalty-free and non-exclusive license to Know-How generated by
Lundbeck in the course of Lundbeck's research and development activities.
However, such license shall be limited to Know-How which is needed by
Licensor in order for Licensor to continue the development activities
which have been seized by Lundbeck. Licensor shall not exploit the
Know-How in question for any other purpose.
16. PUBLIC ANNOUNCEMENTS
16.1 Each Party agrees that, except as may be required by law, it shall not
disclose the substance or details of this Agreement without the prior
written consent of the other Party. In cases in which disclosure is
proposed or required by law, the disclosing Party, prior to such
disclosure, will notify the non-disclosing Party of the contents of the
proposed disclosure and discuss such contents. The non-disclosing Party
shall have the right to make reasonable changes to the disclosure to
protect its interests. The disclosing Party shall not unreasonably refuse
to include such changes in its disclosure if legally proper.
16.2 All publications or public presentations and public announcements made by
Licensor and/or Lundbeck and/or its/their Affiliates and/or its/their
sublicensees concerning the Licensed Products shall specify that Licensed
Products have been licensed to Lundbeck by Licensor.
17. REPRESENTATIONS, WARRANTIES AND DUE DILIGENCE
17.1 Licensor represents and warrants to Lundbeck that:
(a) as of the Date of Execution Licensor possesses the exclusive right
for the worldwide commercial exploitation of, title and interest in
Licensed Patents and to the best of Licensor's knowledge the same
are free of any liens, encumbrances, restrictions, licenses and
other legal or equitable claims of any kind or nature;
(b) Licensor has the right to grant the licenses hereunder to Lundbeck;
(c) no license or sublicense of Licensor Technology whatsoever has been
granted;
(d) as of the Date of Execution there are to the best of Licensor's
knowledge no valid third party rights, licenses or patents, other
than the license granted to Lundbeck hereunder, which are necessary
for Lundbeck's use and enjoyment of the license granted to Lundbeck
according to Article 2.
17.2 Notwithstanding Article 17.1 (d), the Parties are aware of the existence
of European Patent EP 613 560 B1 and Patent Application WO 98/40071.
Lundbeck shall at its sole discretion decide whether or not to enter into
license agreements with relevant parties considering this Patent and
14
Patent Application, respectively. If Lundbeck decides to enter into such
agreement, any and all costs related to such agreements shall be born by
Lundbeck. If Lundbeck decides not to enter into such License Agreements
and if relevant parties initiate infringement proceedings, Lundbeck and
Licensor shall each pay fifty per cent (50%) of all costs related to such
proceedings including compensation to such parties. However, Licensor's
contribution to the payment of such costs shall under no circumstances
exceed 1/4 of Lundbeck's milestone payments under Article 6.1. Licensor's
contribution shall be set off against Lundbeck's milestone payments under
Article 6.1. If Licensor's contribution exceeds 1/4 of any milestone
payment under Article 6.1, payment of the part of the contribution
exceeding 1/4 of the milestone payment shall be postponed until a set off
against the next milestone payment may be effected. If Lundbeck decides
not to enter into the aforementioned License Agreements and if the
aforementioned relevant parties initiate infringement proceedings, the
parties shall, furthermore, share equally any and all costs related to
subsequent license agreements with such parties, including but not limited
to milestone payments and Royalties. However, Licensor's contribution to
the payment of such costs shall under no circumstances exceed 1/4 of
Lundbeck's milestone payments under Article 6.1.
17.3 Lundbeck represents and warrants to Licensor that:
(a) Lundbeck is acknowledged by the authorities in parts of the
Territory as an approved manufacturer and marketer of drugs, and is
as such under the inspection of the competent authorities in such
countries; and
(b) Lundbeck has the right and power to enter into and perform its
obligations under this Agreement.
17.4 The Parties hereto agree that here shall be no claims for indemnification
and/or warranty against Licensor out of this Agreement except those claims
identified in this Agreement.
17.5 Lundbeck shall be entitled within two (2) months from the Date of
Execution to commence due diligence investigations concerning:
(a) any and all Information, Know-How and Licensed Patents;
(b) all material agreements relating to the Licensed Products,
Information, Know-How and Licensed Patents between Licensor and
third parties, including but not limited to agreements between
Licensor and/or Mr P. Gerolymatos and Mr Mikis Xilinas.
Such due diligence investigations shall be completed no later than within
three (3) months after the commencement of the investigations. Licensor
shall make the necessary personnel and facilities available to Lundbeck on
receipt of a twenty-four (24) hour written notice. Each Party shall bear
its own costs in connection with such due diligence investigations.
Notwithstanding the provisions of Article 13, Lundbeck shall be entitled
to terminate this Agreement with immediate effect if Lundbeck's due
diligence investigations, in the opinion of Lundbeck, indicate that the
commercial potential of the Licensed Product is unsatisfactory.
18. FORCE MAJEURE
18.1 Neither Party shall be liable to the other for any delay or failure in
performing any of its obligations hereunder or for any loss or liability
which the other incurs as a result thereof provided:
(a) the delay or failure is caused by circumstances beyond its
reasonable control; and
15
(b) the non-performing Party gives prompt written notice of the reason
for the delay or failure; and
(c) the non-performing Party uses its best reasonable efforts to
overcome the cause of such delay or failure and notifies the other
Party in writing of the nature of these efforts;
and in such case (but not otherwise) the non-performing Party shall be
entitled to a reasonable extension of time for the performance of its
obligations.
19. ASSIGNABILITY
19.1 Licensor shall not be allowed to assign, transfer and/or subcontract its
obligations under this Agreement, unless specifically agreed upon in
writing by Lundbeck in advance, but shall be allowed to assign its rights
to one (1) Affiliate. Lundbeck may assign and/or, transfer its rights
and/or obligations under this Agreement (1) to a company affiliated with
Lundbeck subject to Lundbeck having obtained Licensor's prior written
approval which shall not be unreasonably withheld, or (ii) to a third
party acquiring lines of activities from Lundbeck in general, which third
party shall in all respects substitute Lundbeck as a party to this
Agreement. Lundbeck may freely sublicense any right licensed hereunder;
reference is made to Article 2.1.
20. LAW AND JURISDICTION
20.1 This Agreement and the invalidity thereof shall be governed by and
construed in accordance with the laws of Denmark.
20.2 In the event of any controversy or claim arising out of/or in relation to
any provision of this agreement or the breach or invalidity thereof, the
Parties shall try to settle the problem amicably between themselves.
Should they fail to agree, any such controversy or claim shall be settled
by arbitration in accordance with the current rules of conciliation and
arbitration of the International Chamber of Commerce. The place of
arbitration shall be London. The arbitral tribunal shall consist of three
members, one member being appointed by each of the Parties and the
chairman being appointed by the two members chosen by the Parties. If a
party has not appointed an arbitrator to the tribunal within thirty (30)
days after receiving notice of commencement of arbitration or if the two
members fail to choose a chairman within fourteen (14) days after their
appointment, the President of the International Chamber of Commerce shall
upon the request of either of the Parties appoint the member or members
required to complete the tribunal. The decision of the tribunal shall be
by majority vote and, if requested by either party, the tribunal shall
issue a written opinion. Costs shall be borne as determined by the
arbitrators. The arbitration proceeding shall be conducted in the English
language.
21. MISCELLANEOUS
21.1 The Annexes to this Agreement shall form an integral part of the Agreement
and shall be regarded as incorporated into the Agreement in every respect.
In case of inconsistency between the terms and conditions of the said
Annexes and this Agreement the latter shall prevail to the extent of such
inconsistency but no further.
21.2 All communications between the Parties and all notices made hereunder
shall be made in the English language.
21.3 Failure of either Party to Insist upon a strict performance of any of the
provisions of this Agreement or to enforce its rights under this Agreement
at any time for any period shall not be
16
construed as a waiver of such rights. The headings in this Agreement are
inserted for convenience only and do not affect the interpretation or
construction of this Agreement.
21.4 This Agreement shall supersede all previous agreements and arrangements,
written or oral, between the Patties on the subject matter hereof.
21.5 Lundbeck and Licensor agree that they are "Independent Contracts". Neither
Licensor nor any of its employees shall be employees of Lundbeck or vice
versa it being understood and agreed that Licensor, and Lundbeck are each
an independent contractor for all purposes and at all times. Nothing
contained in this Agreement shall be construed as making the Parties joint
venturers or as granting to either Party the authority to bind or contract
any obligations in the name of or on the account of the other Party or to
make any representations, guarantees or warranties on behalf of the other
Party.
21.6 This Agreement is the sole agreement with respect to the subject matter
hereof and supersedes all other agreements and understandings between the
Parties with respect to same.
21.7 Whenever possible, each provision of this Agreement will be interpreted in
such a manner as to be effective and valid under applicable law, but if
any provision is [ILLEGIBLE] to be prohibited by or invalid under
applicable law, such provision will be ineffective [ILLEGIBLE] to the
extent of such prohibition or invalidity, without invalidating the
remainder of this Agreement and the Parties shall promptly negotiate in
good faith a replacement provision to carry out the intention of the
invalid, illegal or unenforceable provision to the fullest extent
permitted by law.
21.8 All terms and provisions of this Agreement shall bind and inure to the
benefit of the parties hereto, and upon their respective successors and
assignees.
21.9 Both Parties represent and warrant that each of them has the [ILLEGIBLE]
authority to perform its respective obligations provided hereunder and
that the person [ILLEGIBLE] this Agreement has the authority to bind the
respective Party by its sole signature.
This Agreement has been made in duplicate and is signed by the duly authorised
representative of each Party hereto.
Copenhagen, 26th July 1999 Athens 26th July 1999
For X. Xxxxxxxx A/S: For Licensor:
/s/ XXXX XXXXXX-XXXXXX /s/ P.N. GEROLYMATOS
------------------------------- -------------------------------
Name: XXXX XXXXXX-XXXXXX Name: P.N. GEROLYMATOS
Title: PRESIDENT Title: PRESIDENT
[SEAL]
17
Annex 1: Licensed Patents as per Date of Execution.
Annex 2: Identification of Licensor's Bank Account.
Annex 3: Declarations by Mr P. Gerolymatas and Mr Mikis Xilinas.
18
ANNEX 1
Page 1 of 3
ANNEX:
===========================================================================================================================
Serial Filing Priority Application 1.P.-B
No. date date TITLE State No. ref.: Status
---------------------------------------------------------------------------------------------------------------------------
1 8 Aug 1997 13 Aug 1996 Use of the chelating agent PCT PCT/IB97/- 24945 National
clioquinol for the manufac- 00983 phase
ture of a pharmaceutical ---------------------------------------------
composition for the treat- EPC*) 97932969.5 26022 Pending
ment of Alzheimer's disease ---------------------------------------------
CZ PV 484-99 26023 Pending
---------------------------------------------
HU NA 26024 Pending
---------------------------------------------
IS 4972 26025 Pending
---------------------------------------------
NO 19990595 26026 Pending
---------------------------------------------
PL P 331822 26027 Pending
---------------------------------------------
RU 99105213 26028 Pending
---------------------------------------------
TR 1999/00293 26029 Pending
---------------------------------------------
SG 9900538-1 26030 Pending
---------------------------------------------
IL 128416 26031 Pending
---------------------------------------------
AU 36324/97 26032 Pending
---------------------------------------------
BR NA 26033 Pending
---------------------------------------------
CA 2,264,097 26034 Pending
---------------------------------------------
CN NA 26035 Pending
---------------------------------------------
JP 509541/1998 26036 Pending
---------------------------------------------------------------------------------------------------------------------------
ANNEX (continued)
Page 2 of 3
===========================================================================================================================
Serial Filing Priority Application 1.P.-B
No. date date TITLE State No. ref.: Status
---------------------------------------------------------------------------------------------------------------------------
MX 99 1466 26037 Pending
---------------------------------------------
NZ 334124 26038 Pending
---------------------------------------------
KR 7001196/99 26039 Pending
---------------------------------------------
SK PV 0179/99 26046 Pending
---------------------------------------------------------------------------------------------------------------
13 Feb 1998 13 Aug 1996 Clioquinol for the treat- US O9/023,544 25766 Notice of
ment of Alzheimer's disease allowance
issued
---------------------------------------------------------------------------------------------------------------------------
2 23 Dec 1998 31 Dec 1997 Pharmaceutical composition PCT PCT/098/- 25875 Pending
comprising clioquinol and 02115
vitamin B12
13 Feb 1998 31 Dec 1997 US O9/O23,542 25768 Pending
---------------------------------------------------------------------------------------------------------------------------
3 13 Feb 1998 - Clioquinol for the treat- US 09/023,543 25767 Notice of
ment of Xxxxxxxxx'x allowance
disease issued
---------------------------------------------------------------------------------------------------------------------------
4 17 Jul 1998 21 Aug 1997 Use of phanquinone for the PCT PCT/IB98/- 25380 Pending
treatment of Alzheimer's 01095
31 Aug 1997 disease
---------------------------------------------------------------------------------------------------------------------------
5 7 Jan 1999 - Use of phanquinone for the GR OR 9901- 25519 Pending
treatment of memory impair- 00005
ment
---------------------------------------------------------------------------------------------------------------------------
*) Designated states: AT, BE, CH/LI, DB, DK, ES, FI, FR, GB, GR, IE, IT, LU,
MC, NL, PT, SE; extensions: SI, RO
NA Not available
Page 3 of 3
In accordance with the Letter of Intent and Article 1.8 of the Agreement,
Licensed Patents as per Date of Execution also include
1) European patent application No. 94913779,8, publication No. 713 392.
Title: Use of clioquinol for treating Helicobacter, including H.Pylori,
infections and related diseases.
2) Greek patent application No. 970100507.
Title: Pharmaceutical composition comprising clioquinol and vitamin B12.
as well as all extensions, divisions, continuations,
continuations-in-part, reexaminations and reissues thereof and
supplementary protection certificates thereof of all Licensed Patents,
including but not limited to all international continuations of Greek
patent application GR 9901-00005 (mentioned as Serial No.5 above).
ADDENDUM
As provided in article 6.3 of the Patent License Agreement, the Parties agree
that Licensor's bank account(s) will be provided latest till 15/9/1999 and will
be the subject matter of Annex No2 to be attached and made an integral part of
the a.m Patent License Agreement.
For X. Xxxxxxxx A/S For Licensor
/s/ XXXX XXXXXX-XXXXXX /s/ P.N. GEROLYMATOS
Name: XXXX XXXXXX-XXXXXX Name: P.N. GEROLYMATOS
Title: President Title: President
Annex 3
[LETTERHEAD OF TAKIS GEROLYMATOS]
Lundbeck
9 Ottiliavej DK-2500 Valby
Copenhagen
Denmark
Kryoneri 16 July 1999
For the kind attention of Xx Xxxx Xxxxxx-Xxxxxx
In accordance with Article 6.4 of the Patent License Agreement between P.N.
Gerolymatos S.A. and X. Xxxxxxxx A/S, I the undersigned, P.N. Gerolymatos,
declare that to the best of my knowledge Xxxxx Xxxxx Xxxxxxx, Xx Xxxxxx Xxx
Xxxx, Xx Xxxxxx Xxxxxxxx Beyreuth, Xx Xxxxxx Xxxxx, Xx Xxxxx X. Xxxxxx and Xx
Xxxxxxx X. Xxxxx are not and cannot be considered as co-inventors of Phanquinone
or patents and/or patent applications covering Phanquinone, processing of
Phanquinone and/or use of Phanquinone.
Kindest regards,
/s/ P.N. Gerolymatos
P.N. Gerolymatos
19 July, 1999
To: Xxxx Xxxxx Xxxxxxxx
Senior Vice President
Corporate Affairs
Lundbeck A/S
9 Ottiliavej
XX-00 Xxxxx, Xxxxxxx
Dr. Michael Xilinas
Dexiriadis Law Xxxxxx
000 Xxxxxxxxxx Xxxxxxxx XXX Xxxxxx
Xxxxxxx Xxxxx
0000 Xxxxxxx, Xxxxxx
Dear Stig,
In accordance with the Article ___ of the Patent License Agreement between P.N.
Gerolymatos S.A. and X. Xxxxxxxx A/S, I, the undersigned Xxxxxxx Xilinas, MD,
DSc, DPH, declare that in the best of my knowledge Xxxxx Xxxxx Xxxxxxx, Xxxxxx
Xxx Xxxx, Xxxxxx Traugont Bayreuther, Xudang Xxxxx, Xxxxx X. Xxxxxx and Xxxxxxx
X. Xxxxx are not and cannot be considered as co-inventors of phanquinone or
patents and/or patent applications covering phanquinone, ___________ of
phanquinone and/or use of phanquinone.
Kind regards,
/s/ Xxxxxxx Xilinas
Xxxxxxx Xilinas
cc. Prof. C. Calavros, Xx. X. Xxxxxxxxxxxx
ADDENDUM I
TO
PATENT LICENSE AGREEMENT
by and between
P.N. Gerolymatos S.A.
00 Xxxxxxxxx Xxxxxx
00000 Xxxxxxxx Xxxxxx
Xxxxxx
(hereinafter referred to as "Licensor")
and
X.Xxxxxxxx A/S
Xxxxxxxxxx 0
XX-0000 Xxxxxxxxxx-Xxxxx
Xxxxxxx
(hereinafter referred to as "Lundbeck")
Dated 26 July 1999
This Addendum forms an integral part of the Patent License Agreement of 26 July
1999 between P.N. Gerolymatos S.A. and X. Xxxxxxxx A/S (the "Patent License
Agreement") and is to be deemed as fully incorporated within it.
1. AMENDMENTS OF THE PATENT LICENSE AGREEMENT
1.1 The Parties agree that Article 1.8 of the Patent License Agreement shall
be amended as follows:
"1.8 "Licensed Patents" shall mean any and all present or future patents
and patent applications in the Territory or covering any part of the
Territory including but not limited to process patents, use patents and/or
formulation patents containing one or more claims covering Phanquinone
and/or its formulations or use as a medicinal product for any indication
in whole or in part which are or become owned by Licensor. Licensed
Patents include, without limitation, the issued patents and patent
applications listed in Annex A, forming an integral part of this Agreement
as well as any and all extensions, divisions, continuations,
continuations-in-part, re-examinations and reissues thereof and
supplementary protection certificates thereof in the Territory or covering
any part of the Territory. Licensed Patents as per Date of Execution have
been listed in Annex A hereto."
1.2 The Parties agree that Article 1.9 of the Patent License Agreement shall
be amended as follows:
"1.9 "Licensed Products" shall mean formulations containing Phanquinone."
1.3 The Parties agree that Annex 1 of the Patent License Agreement shall be
replaced by Annex A hereto.
1.4 The Parties agree that the following Article 2.3 shall be added to the
Patent License Agreement:
"2.3 Trademark(s) shall be chosen by, registered to and owned by
Lundbeck."
2. DEVELOPMENT OF CLIOQUINOL
2.1 Licensor and/or its designated sub-licensees will at its own discretion
decide to carry out development studies of Clioquinol and will, if so,
prepare the relevant documentation for applications for carrying out
clinical trials as well as the relevant documentation for applications for
registration with the health authorities in those parts of the world where
Licensor is to market pharmaceutical products containing Clioquinol.
Licensor shall apply for registration of pharmaceutical products
containing Clioquinol in its own name and shall remain the sole holder of
the registrations. All costs and/or expenses arising or incurred in
connection with preparation and filing of the applications for
registration including costs and/or expenses related to Phase I, II and
III trials shall be borne by Licensor. For the purposes of this Addendum,
"registration" shall mean all written governmental approvals including any
price and/or reimbursement approval required for the legal marketing of
pharmaceutical products containing Clioquinol in any country in the world.
2.2 Licensor shall report to Lundbeck as to results and progress with regard
to Licensor's development of Clioquinol. Specifically, Licensor shall
every six (6) month during the term of the Patent License Agreement submit
to Lundbeck a written summary stating the results, findings and
conclusions reached by Licensor concerning development of Clioquinol in
the past six (6)
-2-
months. Such summaries shall include, without limitation, information as
to whether or not Licensor expects to file any application for
registration in any country worldwide and, if so, the content of such
application and information on when and where such application may be
filed. In addition, Licensor shall report all significant results and/or
events to Lundbeck without delay.
2.3 Licensor does not warrant that registration of pharmaceutical products
containing Clioquinol will be obtained in any country.
2.4 Any and all costs and expenses arising or incurred in connection with the
preparation, drafting, filing and maintenance of patents covering
Clioquinol shall be borne by Licensor.
3. MARKETING OF CLIOQUINOL
3.1 When the first registration of a pharmaceutical product containing
Clioquinol covering the indication of Alzheimer's Disease, Xxxxxxxxx'x
Disease or other indications within the CNS area is obtained by Licensor,
Licensor shall immediately notify Lundbeck in writing (the "the
Registration Notification"). Furthermore, Licensor shall, on request from
Lundbeck, provide Lundbeck with all necessary information concerning such
registration (the "the Registration Information").
3.2 For ninety (90) days after receipt of the Registration Notification or
receipt of the Registration Information, which ever comes later, Lundbeck
shall have the option to enter into a license agreement with Licensor
which shall xxxxx Xxxxxxxx exclusive marketing rights to any and all
pharmaceutical products containing Clioquinol and registered to Licensor
("the Lundbeck Option").
3.3 If the Lundbeck Option is exercised by Lundbeck, the license agreement
concerning marketing of pharmaceutical products containing Clioquinol
shall reflect, mutatis mutandis, the provisions of the Patent License
Agreement. However, the Parties agree that the license agreement
concerning marketing of pharmaceutical products containing Clioquinol
shall include separate provisions concerning territory, royalties and
minimum sales.
3.3.1 The territory of the license agreement concerning marketing of
pharmaceutical products containing Clioquinol shall be defined as any
country worldwide with the exception of Cyprus, Greece, Turkey, Israel,
Hong Kong, Singapore, South Korea, Japan and Taiwan. However, Licensor
shall have the option to exclude the United States of America from the
definition of the territory. If this option is exercised Licensor shall be
obligated to pay a royalty to Lundbeck of Net Sales in the United States
of America. Such royalty shall be four per cent (4%) of Net sales up to
one hundred million EUR (EUR 100,000,000.00), five per cent (5%) of Net
sales up between one hundred million EUR (EUR 100,000,000.00) and two
hundred million EUR (EUR 200,000,000.00), and 6 per cent of Net sales up
above two hundred million EUR (EUR 200,000,000.00).
3.3.2 The royalties payable by Lundbeck to Licensor under the licence agreement
concerning marketing of pharmaceutical products containing Clioquinol
shall be calculated as follows:
- nineteen per cent (19%) of Net sales up to fifty million EUR (EUR
50,000,000.00),
- twenty per cent (20%) of Net sales between fifty million EUR (EUR
50,000,000.00) and one hundred million EUR (EUR 100,000,000.00), and
- twenty one per cent (21%) of Net sales above one hundred million EUR
(EUR 100,000,000.00).
-3-
3.3.3 The license agreement concerning marketing of pharmaceutical products
containing Clioquinol shall include provisions which require Lundbeck to
guarantee minimum combined annual sales in Denmark, France, Germany,
Sweden and the UK in the amount of fifty million EUR (EUR 50,000,000.00)
in the fifth calendar year after a registration covering Denmark, France,
Germany, Sweden and the UK has been obtained by Licensor. Failure to
achieve such minimum sales shall entitle Licensor to terminate the license
agreement with six (6) months' written notice.
3.4 If the Lundbeck Option is not exercised by Lundbeck, the Parties shall
enter into a royalty agreement concerning payments of royalty from
Licensor to Lundbeck. Such agreement shall include provisions which shall
require Licensor to pay Lundbeck a royalty of four per cent (4%) of Net
Sales up to one hundred million EUR (EUR 100,000,000.00), five per cent
(5%) of Net sales up between one hundred million EUR (EUR 100,000,000.00)
and two hundred million EUR (EUR 200,000,000.00), and 6 per cent of Net
sales up above two hundred million EUR (EUR 200,000,000.00) by Licensor,
its Affiliates or sub-licensees of pharmaceutical products containing
Clioquinol; provided, however, that such Net Sales are obtained in the
territory excluding the United States of America. On Net Sales obtained in
the United States of America and in countries outside the territory,
Licensor shall be required to pay Lundbeck a royalty of two per cent (2%)
of Net Sales. For the purposes of this Article 3.4, "territory" shall have
the meaning set out in Article 1.19 of the Patent License Agreement.
4. MISCELLANEOUS
4.1 In this Addendum the terms "Affiliates", "Clioquinol", "Licensor",
"Lundbeck", "Parties" and "Phase I, II and III Trials" shall be construed
in accordance with Article 1 of the Patent License Agreement.
4.2 In this Addendum the term "Net Sales" shall be gross sales of
pharmaceutical products containing Clioquinol to a hospital, wholesaler or
pharmacist less (1) the total of ordinary and customary trade discounts
earned and actually taken or granted, (2) any statutory or contractual
rebates paid to any governmental or any other public authority, agency or
entity, (3) cash and quantity discounts allowed, (4) allowances and
adjustments actually credited or paid to customers for spoiled, damaged,
outdated and/or returned pharmaceutical products containing Clioquinol,
(5) freight, insurance, transportation costs and handling charges included
by the seller in its invoices to independent third parties, (6) excise,
sales, and value added taxes included by the seller in its invoices to
independent third parties, and (7) customs duties and other compulsory
payments made by the seller to national, provincial and local government
authorities.
IN WITNESS HEREOF the Parties have caused this Addendum to be executed by their
duly authorized representatives.
Athens, Copenhagen,
For P.N. Gerolymatos S.A.: for X. Xxxxxxxx A/S:
/s/ Xxxxxxx Manouach /s/ Xxxx Xxxxx Xxxxxxxx
----------------------------- -----------------------------
Name: Xxxxxxx Manouach Name: Xxxx Xxxxx Xxxxxxxx
Title: Executive Vice President Title: Senior Vice President
International Division
-4-
/s/ P.N. Gerolymatos /s/ Xxxx Xxxxxx-Xxxxxx
----------------------------- -----------------------------
Name: P.N. Gerolymatos Name: Xxxx Xxxxxx-Xxxxxx
Title: President Title: President
-5-
Annex A
Patents relating to Phanquinone
------------------------------------------------------------------------------------------------------------------------------
Filing Date Priority Date Title State Application Status
No.
------------------------------------------------------------------------------------------------------------------------------
17 July 1998 21 Aug 1997 Use of phanquinone for the PCT PCT/IB98/01 Has entered
31 Dec 1997 treatment of Alzheimer's 095 national phase
Disease
------------------------------------------------------------------------------------------------------------------------------
EPC1 NA Pending
------------------------------------------------------------------------------------------------------------------------------
AU 81241/98 Pending
------------------------------------------------------------------------------------------------------------------------------
BG NA Pending
------------------------------------------------------------------------------------------------------------------------------
BR NA Pending
------------------------------------------------------------------------------------------------------------------------------
CA NA Pending
------------------------------------------------------------------------------------------------------------------------------
CN NA Pending
------------------------------------------------------------------------------------------------------------------------------
CZ PV2000611 Pending
------------------------------------------------------------------------------------------------------------------------------
EA NA Pending
------------------------------------------------------------------------------------------------------------------------------
HK NA Pending
------------------------------------------------------------------------------------------------------------------------------
XX XX Xxxxxxx
------------------------------------------------------------------------------------------------------------------------------
XX 000000 Pending
------------------------------------------------------------------------------------------------------------------------------
IS 5366 Pending
------------------------------------------------------------------------------------------------------------------------------
JP NA Pending
------------------------------------------------------------------------------------------------------------------------------
KR 20007001576 Pending
------------------------------------------------------------------------------------------------------------------------------
XX 000000 Pending
------------------------------------------------------------------------------------------------------------------------------
NO 20000771 Pending
------------------------------------------------------------------------------------------------------------------------------
NZ 502565 Pending
------------------------------------------------------------------------------------------------------------------------------
PL P338673 Pending
------------------------------------------------------------------------------------------------------------------------------
SG 2000004838 Pending
------------------------------------------------------------------------------------------------------------------------------
SK PV02062000 Pending
------------------------------------------------------------------------------------------------------------------------------
TR NA Pending
------------------------------------------------------------------------------------------------------------------------------
UA NA Pending
------------------------------------------------------------------------------------------------------------------------------
US NA Pending
------------------------------------------------------------------------------------------------------------------------------
7 Jan 1999 Use of phanquinone for the XX XX 0000- Xxxxxxxxx
treatment of memory 00005
impairment
------------------------------------------------------------------------------------------------------------------------------
6 Jan 2000 7 Jan 1999 PCT PCT/IB00/00 Pending
011
------------------------------------------------------------------------------------------------------------------------------
6 Jan 2000 7 Jan 1999 AR P 00 0100046 Pending
------------------------------------------------------------------------------------------------------------------------------
6 Jan 2000 7 Jan 1999 CL 00282000 Pending
------------------------------------------------------------------------------------------------------------------------------
1) Designates states: AT, BE, CH/LI, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU,
MC, NL, PT, SE, extension states: SI, LT, LV, AL, RO, MK
/s/ Xxxxxxx Manouach /s/ Xxxx Xxxxx Xxxxxxxx
Xxxxxxx Manouach Xxxx Xxxxx Xxxxxxxx
Executive Vice President Senior Vice President
International Division
/s/ P.N. Gerolymatos /s/ Xxxx Xxxxxx-Xxxxxx
P.N. Gerolymatos Xxxx Xxxxxx-Xxxxxx
President President
-6-
ADDENDUM II
To Agreement dated July 26, 1999
by and between
P.N. GEROLYMATOS S.A.
00 Xxxxxxxxx Xxxxxx
00000 Xxxxxxxx Xxxxxx
Xxxxxx
(hereinafter referred to as "Licensor")
and
X. Xxxxxxxx A/S
Xxxxxxxxxx 0
XX-0000 Xxxxxxxxxx-Xxxxx
Xxxxxxx
(hereinafter referred to as "Lundbeck")
WHEREAS the Parties have entered into an agreement dated July 26, 1999 and an
Addendum I dated April 14, 2000 (collectively the "Agreement");
WHEREAS the Agreement contains provisions regarding development and
commercialisation of compounds containing Clioquinol and separate provisions
regarding development and commercialisation of compounds containing Phanquinone;
and
WHEREAS the Parties have agreed that development and commercialisation of
compounds containing Phanquinone shall be governed by terms similar to the terms
governing development and commercialisation of compounds containing Clioquinol;
NOW, THEREFORE, the Parties have entered into this Addendum upon the following
terms and conditions:
1. Definitions
1.1 The terms "Affiliate", "Clioquinol", "Net Sales", "Parties", "Party",
"Patent License Agreement", "Phanquinone" and "Registration" shall have
the meaning set forth in Article 1 and the preamble of the Agreement.
1
2. Development of Phanquinone
2.1 Article 5.1-5.4 of the Agreement shall with respect to Phanquinone be
replaced by the provisions in Article 2.2-2.5 hereof.
2.2 Licensor and/or its designated sub-licensees will at its own discretion
decide to carry out development studies of Phanquinone and will, if so,
prepare the relevant documentation for applications for carrying out
clinical trials as well as the relevant documentation for applications for
Registration with the health authorities in those parts of the world where
Licensor is to market pharmaceutical products containing Phanquinone.
Licensor shall apply for Registration of pharmaceutical products
containing Phanquinone in its own name and shall remain the sole holder of
the Registrations. All costs and/or expenses arising or incurred in
connection with preparation and filing of the applications for
Registration including costs and/or expenses related to phase I, II and
III trials shall be borne by Licensor.
2.3 Licensor shall report to Lundbeck as to results and progress with regard
to Licensor's development of Phanquinone. Specifically, Licensor shall
every six (6) months submit to Lundbeck a written summary stating the
results, findings and conclusions reached by Licensor concerning
development of Phanquinone in the past six (6) months. The first such
summary shall be sent to Lundbeck no later than 1 May 2002. Such summaries
shall include, without limitation, information as to whether or not
Licensor expects to file any application for Registration in any country
worldwide and, if so, the content of such application and information on
when and where such application may be filed. In addition, Licensor shall
report all significant results and/or events to Lundbeck without delay.
2.4 Licensor does not warrant that Registration of pharmaceutical products
containing Phanquinone will be obtained in any country.
2.5 Any and all costs and expenses arising or incurred in connection with the
preparation, drafting, filing and maintenance of patents covering
Phanquinone shall be borne by Licensor.
3. Marketing of Phanquinone
3.1 Article 6.1-6.4 of the Agreement shall with respect to Phanquinone be
replaced by the provisions in Article 3.2-3.5 hereof.
3.2 When the first Registration of a pharmaceutical product containing
Phanquinone covering the indication of Alzheimer's Disease, Xxxxxxxxx'x
Disease or other indications within the CNS area is obtained by Licensor,
Licensor shall immediately notify Lundbeck in writing (the "Registration
Notification"). Furthermore, Licensor shall, on request from Lundbeck,
provide Lundbeck with all necessary information concerning such
Registration (the "Registration Information").
3.3 For ninety (90) days after receipt of the Registration Notification or
receipt of the Registration Information, which ever comes later, Lundbeck
shall have the option to enter into a license agreement with Licensor
which shall xxxxx Xxxxxxxx exclusive marketing rights to any and all
pharmaceutical products containing Phanquinone and registered to Licensor
("the Lundbeck Option").
3.4 If the Lundbeck Option is exercised by Lundbeck, the license agreement
concerning marketing of pharmaceutical products containing Phanquinone
shall reflect, mutatis mutandis, the
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provisions of the Patent License Agreement. However, the Parties agree
that the license agreement concerning marketing of pharmaceutical products
containing Phanquinone shall include separate provisions concerning
territory, royalties and minimum sales.
3.4.1 The territory of the license agreement concerning marketing of
pharmaceutical products containing Phanquinone shall be defined as
any country worldwide with the exception of Cyprus, Greece, Turkey,
Israel, Hong Kong, Singapore, South Korea, Japan and Taiwan.
However, Licensor shall have the option to exclude the United States
of America from the definition of the territory. If this option is
exercised Licensor shall be obligated to pay a royalty to Lundbeck
of Net Sales in the United States of America. Such royalty shall be
four per cent (4%) of Net Sales up to one hundred million EUR (EUR
100,000,000.00), five per cent (5%) of Net Sales between one
hundred million EUR (EUR 100,000,000.00) and two hundred million EUR
(EUR 200,000,000.00), and 6 per cent of Net Sales above two hundred
million EUR (EUR 200,000,000.00).
3.4.2 The royalties payable by Lundbeck to Licensor under the licence
agreement concerning marketing of pharmaceutical products containing
Phanquinone shall be calculated as follows:
- nineteen per cent (1ing%) of Net Sales up to fifty million EUR
(EUR 50,000,000.00),
- twenty per cent (20%) of Net Sales between fifty million EUR
(EUR 50,000,000.00) and one hundred million EUR (EUR
100,000,000.00), and
- twenty one per cent (21%) of Net Sales above one hundred
million EUR (EUR 100,000,000.00).
3.4.3 The license agreement concerning marketing of pharmaceutical
products containing Phanquinone shall include provisions which
require Lundbeck to guarantee minimum combined annual sales in
Denmark, France, Germany, Sweden and the UK in the amount of fifty
million EUR (EUR 50,000,000.00) in the fifth calendar year after a
Registration covering Denmark, France, Germany, Sweden and the UK
has been obtained by Licensor. Failure to achieve such minimum sales
shall entitle Licensor to terminate the license agreement with six
(6) months' written notice.
3.5 If the Lundbeck Option is not exercised by Lundbeck, the Parties shall
enter into a royalty agreement concerning payments of royalty from
Licensor to Lundbeck. Such agreement shall include provisions which shall
require Licensor to pay Lundbeck a royalty of four per cent (4%) of Net
Sales up to one hundred million EUR (EUR 100,000,000.00), five per cent
(5%) of Net Sales between one hundred million EUR (EUR 100,000,000.00)
and two hundred million EUR (EUR 200,000,000.00), and 6 per cent of Net
Sales above two hundred million EUR (EUR 200,000,000.00) by Licensor, its
Affiliates or sub-licensees of pharmaceutical products containing
Phanquinone; provided, however, that such Net Sales are obtained in the
territory excluding the United States of America. On Net Sales obtained in
the United States of America and in countries outside the territory,
Licensor shall be required to pay Lundbeck a royalty of two per cent (2%
of Net Sales. For the purposes of this Article 3.5, "territory" shall mean
any country worldwide with the exception of Cyprus, Greece, Turkey,
Israel, Hong Kong, Singapore and South Korea.
4. Effective Date and Governing Law
-3-
4.1 This Addendum shall take effect on the date of the last signature on this
Agreement. The Addendum shall be governed by and construed in accordance
with the laws of Denmark.
IN WITNESS HEREOF the Parties have caused this Addendum to be executed by their
duly authorized representatives.
Athens, February 18, 2002 Copenhagen,
For P.N. Gerolymatos S.A.: for X. Xxxxxxxx A/S:
/s/ P.N. Gerolymatos /s/ Xxxx Xxxxxx-Xxxxxx
----------------------------- -----------------------------
Name: P.N. GEROLYMATOS Name: XXXX XXXXXX-XXXXXX
Title: President Title: PRESIDENT
-4-
ADDENDUM III
To
Patent License Agreement dated July 26, 1999
and to subsequent Addenda I and II thereto
By and Between
P.N. GEROLYMATOS S.A.
00 Xxxxxxxxx Xxxxxx
000 00 Xxxxxxxx Xxxxxx
Xxxxxx
(hereinafter referred to as "Licensor")
and
X. XXXXXXXX A/S
Xxxxxxxxxx 0
XX-0000 Xxxxxxxxxx-Xxxxx
Xxxxxxx
(hereinafter referred to as "Lundbeck")
Dated July 19, 2002
Whereas the Parties have entered into an Agreement dated July 26, 1999 and,
Addendum I dated April 14, 2000 and an Addendum II dated February 18, 2002
(collectively the "Agreement");
This Addendum forms an integral part of the Patent License Agreement of July 26,
1999 between P.N. Gerolymatos S.A. and X. Xxxxxxxx A/S (the "Patent License
Agreement") and is to be deemed as fully incorporated within it.
Now, the Parties have entered into this Addendum III upon the following terms
and conditions:
1. AMENDMENTS OF THE PATENT LICENSE AGREEMENT AND ADDENDA I AND II.
With respect to Article 3 "Marketing of Clioquinol" of Addendum I and Article 3
"Marketing of Phanquinone" of Addendum II and with specific reference to the
case in which Licensor shall be obliged to pay royalties to Lundbeck as provided
therein as per Article 3.3.1 and 3.4 of Addendum I and Article 3.4.1 and 3.5 of
Addendum II respectively, the Parties hereby agree that the percentages of
royalties which Licensor shall be obliged to pay to Lundbeck are reduced by 50%.
2. EFFECTIVE DATE AND GOVERNING LAW
This Addendum shall take effect on the date of July 19, 2002. The Addendum shall
be governed by and construed in accordance with the laws of Denmark.
IN WITNESS WHEREOF the Parties have caused this Addendum to be executed by their
duly authorized representatives.
Athens, July 19, 2002 Copenhagen, July 19, 2002
For P.N. Gerolymatos S.A.: for X. Xxxxxxxx A/S:
/s/ Xxxx Xxxxxx-Xxxxxx
----------------------------- -----------------------------
Name: P.N. Gerolymatos Name: Xxxx Xxxxxx-Xxxxxx
Title: President Title: President
ADDENDUM
Pursuant to the Patent License Agreement entered into between P.N. Gerolymatos
S.A. (referred to as "Licensor") and X. Xxxxxxxx A/S (referred to as "Lundbeck")
dated 26th July 1999, as amended by Addendum I, dated April 14, 2000 ("Addendum
I"), Addendum II, dated February 18, 2002 ("Addendum II"), and Addendum III,
dated July 19, 2002 ("Addendum III") (collectively the "Patent License
Agreement"), it is hereby irrevocably and unreservedly confirmed, that Lundbeck
agrees to the exclusion of the Territory of the United States of America from
the Territory of Lundbeck as the Territory of a license agreement concerning
marketing of pharmaceutical products containing Clioquinol or Phanquinone.
It is further understood and explicitly agreed that the exclusion of the USA
from the Territory shall be considered made on the basis of the option granted
to Licensor according to Article 3.3.1 of the Addendum I and Article 3.4.1 of
Addendum II to the Patent License Agreement and all other terms and arrangements
stipulated in the aforementioned Patent License Agreement and relevant Addenda,
including indicatively payment of royalties etc., will remain unaltered except
as provided below.
The Parties hereby agree that references to "Licensor" in Sections 2 and 3.1 of
Addendum I and Sections 2 and 3.2 of Addendum II shall be construed to mean
"Licensor or Prana Biotechnology Limited ("Prana") or the designee of Prana"
solely with respect to the USA, Japan, and Taiwan. With respect to countries
outside the USA, Japan, and Taiwan, Licensor shall remain obligated under
Sections 2 and 3.1 of Addendum I and Sections 2 and 3.2 of Addendum II, except
as otherwise agreed in writing by Prana and Licensor, in which case Lundbeck
shall accept performance by Prana of such agreed obligations as the designee of
Licensor. Except as provided here, the Parties agree that the term "Licensor" in
the Patent License Agreement shall not include Prana.
X. XXXXXXXX A/S
By: /s/ Xxxx Xxxxx Xxxxxxxx
--------------------------------------------------
Name: XXXX XXXXX XXXXXXXX
Title: EVP
P.N. GEROLYMATOS S.A.
By: /s/ P.N. Gerolymatos
--------------------------------------------------
Name: P.N. GEROLYMATOS
Title: President
Execution Version
PATENT RIGHTS SECURITY AGREEMENT
THIS PATENT RIGHTS SECURITY AGREEMENT (this "Agreement") dated as of July
28, 2004 is made by PRANA BIOTECHNOLOGY LIMITED, a corporation organized under
the laws of Australia ("Prana"), in favor of P.N. GEROLYMATOS S.A., a
corporation organized under the laws of Greece (the "Secured Party").
RECITALS
WHEREAS, the parties hereto and Xxxxxxxxx X. Gerolymatos, The General
Hospital Corporation, Xxxxxx X. Xxxx, Xxxxxxx Xxxxx and Xxxxxx Xxxxxxx have
entered into that certain Settlement Agreement, of even date herewith.
WHEREAS, further to such settlement, the parties hereto have entered into
that certain Patent Assignment and Settlement Agreement dated as of even date
herewith (the "Patent Assignment Agreement") whereby the Secured Party sold,
transferred and assigned the Assigned Patent Rights (as defined in the Patent
Assignment Agreement) to Prana. In connection with such transfer, Prana is
hereby granting to the Secured Party a first priority security interest in and
continuing lien on the Assigned Patent Rights and the other Collateral (as
defined below) to secure Obligations (as defined below) of Prana under the
Patent Assignment Agreement. Capitalized terms used but not otherwise defied
herein shall have the same meanings as in the Patent Assignment Agreement.
NOW, THEREFORE, for good and valuable consideration, receipt of which is
hereby acknowledged and intending to be legally bound, as collateral security
for the prompt and complete payment and performance when due of Obligations,
Prana hereby represents, warrants, covenants and agrees as follows:
1. Grant of Security Interest.
a. As collateral security for the prompt and complete payment,
performance and observance of all of the Obligations, Prana hereby grants to the
Secured Party a security interest in all of Prana's right, title and interest,
whether now owned or existing or hereafter created or acquired in, to and under
all of the following (collectively, the "Collateral"): the Assigned Patent
Rights set forth on Exhibit A attached hereto, as amended from time to time.
b. In furtherance of and without limiting the generality of
foregoing, if new Patent Rights are added to the Assigned Patent Rights because
of the addition of new territories in accordance with Section 2.2 of the Patent
Assignment Agreement, the provisions of this Agreement shall automatically apply
with respect to such new Assigned Patent Rights, and Prana hereby grants to the
Secured Party a security interest in all of Prana's right, title and interest
in, to and under such new Assigned Patent Rights, which shall be deemed to be
part of the Collateral. The Secured Party acknowledges that Prana's rights in
the Collateral are subject to the terms of third party agreements entered into
by Prana prior to the Effective Date with respect to the Assigned Patent Rights.
c. For purposes of this Agreement, "Obligation(s)" means the
obligations of Prana (i) within eight (8) years of the Effective Date to begin a
new Phase II Clinical Study (excluding any such studies begun before the
Effective Date) for approval by a Regulatory Authority of CQ, PQ, or any
Execution Version
Derivative (as defined in the Derivative Agreement) and (ii) to make royalty or
milestone payments as provided in Article 3 of the Patent Assignment Agreement
that are not disputed in good faith. The parties hereto further agree that the
Obligations secured hereby shall also include Prana's obligations to the Secured
Party under any arbitral award or a judgment of any court granted to the Secured
Party in respect of Prana's breach of any of the foregoing Obligations, subject
to the limitations set forth in Section 11.1 of the Patent Assignment Agreement.
d. Notwithstanding the terms of Section 1(a) or any other provision
of this Agreement, Prana shall not be limited in any manner in its ability to
grant rights to third parties under the Assigned Patent Rights pursuant to
Section 2.6 of the Patent Assignment Agreement. All rights of the Secured Party
under Sections 1(a) and (b) shall be subject to the Third Party Rights as
provided in Section 2.4 of the Patent Assignment Agreement.
e. Effective upon the written certification by Prana that Prana has
within the eight (8) year period after the Effective Date begun a new Phase II
Clinical Study (excluding any such studies performed before the Effective Date)
for approval by a Regulatory Authority of CQ, PQ, or any Derivative, the
Obligations described in Section l(c)(i) will terminate in accordance with the
terms of Section 2.4(b) of the Patent Assignment Agreement and no longer
constitute an Obligation hereunder.
f. The grant of the Security Interest is not effective until
assignment of the Assigned Patent Rights pursuant to the Patent Assignment
Agreement.
2. Authorization and Request. Prana hereby authorizes the Secured Party to
file one or more financing or continuation statements, and amendments thereto,
including, without limitation, one or more financing statements under the
Uniform Commercial Code, as in effect from time to time in any relevant
jurisdiction, indicating that such financing statements cover all Collateral or
any part thereof. A photocopy or other reproduction of this Agreement or any
financing statement covering the Collateral or any part thereof shall be
sufficient as a financing statement where permitted by law. Prana authorizes and
requests the applicable authorities in the Prana Territories to record this
Agreement. Prana hereby authorizes and consents to the Secured Party filing, at
the expense of Prana, a copy this Agreement with the United States Patent and
Trademark Office (the "PTO").In addition, Prana hereby agrees that it shall so
record this Agreement in the Prana Territories and provide to the Secured Party
written evidence of such recordation. If Prana fails to do so within ninety (90)
days after the execution hereof, PNG shall have the right to so record this
Agreement at Prana's expense.
3. Covenants and Warranties. Prana represents, warrants, covenants and
agrees as follows:
a. Performance of this Agreement does not conflict with or result in
a breach of any other written agreement to which Prana is bound, except for such
conflicts or breaches that would not result in a material impairment of the
ability of Prana to perform its obligations hereunder or to grant the security
interest provided for hereunder, a material impairment of the rights of or
remedies available to the Secured Party hereunder, or a material adverse effect
on the Collateral or the security interest in favor of the Secured Party in the
Collateral or the priority thereof.
b. During the term of this Agreement, Prana will not transfer, sell,
assign, encumber, mortgage, license, sublicense, grant rights to prosecute and
enforce and covenants not to xxx
-2-
Execution Version
and otherwise grant rights in and to and otherwise encumber in any kind or
nature any interest in the Collateral except as otherwise permitted under
Section 2.6 of the Patent Assignment Agreement.
C. This Agreement creates, in favor of the Secured Party, a valid
and perfected security interest in the Collateral in the Prana Territories,
securing the performance of the Obligations upon making the appropriate filings
with the appropriate authorities with respect to the Collateral. Such security
interest is of a first priority.
4. Further Assurances. On a continuing basis and from time to time, as
additional Assigned Patent Rights become subject to this Agreement as a result
of the addition of additional territories in accordance with Section 2.2 of the
Patent Assignment Agreement, at the Secured Party's request, Prana will, subject
to any prior licenses, encumbrances and restrictions and Third Party Rights,
make, execute, acknowledge and deliver, and file and record in the proper filing
and recording places in the Prana Territories, all such instruments, including
appropriate financing and continuation statements and collateral agreements and
filings with the PTO and other applicable authorities, and take all such action
as may reasonably be deemed necessary or advisable, or as reasonably requested
by the Secured Party, to perfect the Secured Party's security interest in the
Collateral, or for assuring and confirming to the Secured Party the grant or
perfection or priority of a security interest in the Collateral. Prana will
furnish to the Secured Party from time to time statements and schedules further
identifying and describing the Collateral and such other reports in connection
with such Collateral as the Secured Party may reasonably request, all in
reasonable detail.
5. Events of Default. The parties confirm and acknowledge that this
Agreement is subject to the provisions of Section 10 of the Patent Assignment
Agreement regarding binding arbitration. An Event of Default under this
Agreement shall mean that both of the following events have occurred: (i) the
failure to perform or observe any of the Obligations, which failure remains
uncured for thirty (30) days following written notice of such failure, and (ii)
if Prana disputes whether a failure to perform or observe any of the Obligations
has occurred and institutes a dispute resolution procedure in accordance with
Section 10 of the Patent Assignment Agreement prior to the end of the foregoing
thirty (30)-day period, the completion of any dispute resolution procedure
pursuant to such Section 10 with a determination by the arbitrators that such a
failure has occurred; provided that the institution of such procedures shall not
in any manner extend the foregoing thirty (30)-day cure period.
6. Remedies. Upon the occurrence of an Event of Default, subject to the
provisions of Section 1(d) of this Agreement, the Secured Party shall have all
rights and remedies available to it under applicable law, including under the
Uniform Commercial Code as in effect from time to time in the State of New York.
Notwithstanding anything contained herein to the contrary, in the event an Event
of Default occurs due to the failure of Prana to make payments pursuant to
Article 3 of the Patent Assignment Agreement, the remedies available to the
Secured Party hereunder shall occur only with respect to the Collateral in those
territories in which the events triggering Prana's payment obligations under
such Article 3 arise and in which Prana's failure to make such payments results
in an Event of Default. This Agreement terminates upon the satisfaction and
payment in full of the Obligations.
7. Expenses. In the event of an occurrence of an Event of Default, Prana
agrees to pay, on demand, all of the Secured Party's out-of-pocket expenses
(including reasonable attorneys' fees and disbursements) incurred in connection
with the enforcement of this Agreement and the rights and remedies in connection
herewith including, without limitation, all reasonable attorneys' fees and
disbursements, and all reasonable costs incurred by Secured Party in connection
with the enforcement of
-3-
Execution Version
any such rights or remedies in connection with any proceeding commenced by or
against Prana under Title 11 of the U.S. Code or any similar law in any other
country.
8. Cumulative Remedies: No Deficiency. Subject to the provisions of
Sections 5 and 6 of this Agreement, Prana hereby acknowledges and affirms that
the rights and remedies with respect to the Collateral, whether established
hereby or by the Patent Assignment Agreement or by any other agreements or by
law, shall be cumulative and may be exercised singularly or concurrently,
provided, however, upon the Secured Party's exercise of its remedies under
either Section 6 of this Agreement or Section 2.4 of the Patent Assignment
Agreement, any further claims or recourse against Prana, including, without
limitation, any deficiency claim, with respect to any Obligations as to which
such remedies have been exercised shall be subject to the limitations set forth
in Section 11.1 of the Patent Assignment Agreement.
9. Amendments. This Agreement may be amended only by a written instrument
signed by both parties hereto.
10. Counterparts. This Agreement may be executed in any number of
counterparts, all of which taken together shall constitute one agreement, and
any of the parties hereto may execute this Agreement by signing any such
counterpart. This Agreement shall be effective when it has been executed by
Prana and the Secured Party.
11. Choice Of Law. THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN
ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK, INCLUDING, WITHOUT
LIMITATION, SECTION 5-1401 OF THE NEW YORK GENERAL OBLIGATIONS LAW. SUBJECT TO
THE PROVISIONS OF SECTION 5 OF THIS AGREEMENT REGARDING BINDING ARBITRATION, THE
PARTIES AGREE THAT THE SECURED PARTY MAY BRING AN ACTION TO ENFORCE ANY
ARBITRATION AWARD IN THE NEW YORK STATE COURTS AND THE UNITED STATES FEDERAL
COURTS LOCATED IN THE SOUTHERN DISTRICT OF NEW YORK, AND THE PARTIES HERETO
HEREBY CONSENT TO THE NON-EXCLUSIVE PERSONAL JURISDICTION AND VENUE OF THE
COURTS.
12. Conflict. To the extent of any conflict between the provisions of this
Agreement and the provisions of the Patent Assignment Agreement, the provisions
of the Patent Assignment Agreement shall govern and control.
13. Confidentiality. The confidentiality obligations set forth in Section
1 of the Settlement Agreement are incorporated herein in their entirety.
[Signature Page Follows]
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Execution Version
IN WITNESS WHEREOF, the parties have caused the Agreement to be duly executed as
of the date written above.
PRANA BIOTECHNOLOGY LIMITED
By: /s/ Xxxxxxxx Xxxxxxx
--------------------------------
Name: Xxxxxxxx Xxxxxxx
Title: Executive Chairman
Date: July 28, 2004
P.N. GEROLYMATOS S.A.
By: /s/ P. Gerolymatos
--------------------------------
Name: P. Gerolymatos
Title: President & Managing Director
Date: July 28, 2004
[Signature Page to Patent Rights Security Agreement]
Execution Version
Exhibit "A"
attached to that certain
Patent Rights Security Agreement dated July 28, 2004.
Assigned Patent Rights
--------------------------------------------------------------------------------
Country Application No. Patent No.
--------------------------------------------------------------------------------
Japan 1998-509541
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Japan 2000-507371
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USA 09/485,909 6,670,369
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Japan 2000-592001
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USA 10/098,922
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USA 09/023,544 6,001,852
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USA 09/023,543 5,980,914
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USA 09/023,542 5,994,323
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USA 10/7 17,182
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Execution Version
DERIVATIVES AGREEMENT
This Derivatives Agreement (this "Agreement") is entered into effective as
of July 28, 2004 ("Effective Date"), by and among P.N. Gerolymatos S.A., a
corporation organized under the laws of Greece ("PNG") and Prana Biotechnology
Limited, a corporation organized under the laws of Australia ("Prana").
WITNESSETH
WHEREAS, Prana obtained a license under certain patents from MGH covering
certain pharmaceutical compositions and uses of CQ (as hereinafter defined) to
treat and prevent specified diseases;
WHEREAS, PNG is the patentee of certain patents covering certain
pharmaceutical compositions and uses of CQ and PQ (as hereinafter defined) to
treat and prevent specified diseases;
WHEREAS, Prana, MGH and certain individuals, filed suit in the United
States against PNG and Xxxxxxxxx X. Gerolymatos to correct inventorship under
certain of such patents;
WHEREAS, PNG filed several counterclaims in response to such suit, and
thereafter filed suit against Prana in Greece;
WHEREAS, PNG and Prana are also engaged in certain patent oppositions with
respect to each other's patents;
WHEREAS, PNG and Prana desire to and have agreed to settle finally their
disputes as contemplated in the Patent Assignment and Settlement Agreement, of
even date herewith, entered into by the parties hereto (the "Patent Assignment
Agreement"); and
WHEREAS, PNG and Prana desire to enter into this Agreement to provide PNG
with additional compensation with respect to the Patent Assignment Agreement.
NOW, THEREFORE:
in view of the foregoing premises and the mutual covenants set forth herein, and
for other good and valuable consideration, the receipt and sufficiency of which
is acknowledged by each party, the parties hereto agree as follows.
1. DEFINITIONS
1.1 Affiliate means any corporation, company, partnership, joint venture
and/or firm that controls, is controlled by, or is under common control with a
Party. For purposes of this Section 1.1,"control" shall mean (a) in the case of
corporate entities, direct or indirect ownership of at least fifty percent (50%)
of the stock or shares having the right to vote for the election of directors,
and (b) in the case of non-corporate entities, direct or indirect ownership of
at least fifty percent (50%) of the equity interest with the power to direct the
management and policies of
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such non-corporate entities. The Parties acknowledge that in the case of certain
entities organized under the laws of certain countries outside the United
States, the maximum percentage ownership permitted by law for a foreign investor
may be less than fifty percent (50%), and that in such case such lower
percentage shall be substituted in the preceding sentence, provided that such
foreign investor has the power to direct the management and policies of such
entity.
1.2 Clioquinol or CQ means 5-Chloro-7-iodo-8-quinolinol.
1.3 Derivative means the metal protein attenuating compounds other than CQ
or PQ that are claimed in the patent applications listed in Schedule 1.4.
Schedule 1.4 will be updated from time to time by the Parties to include any
future patent applications filed within eight (8) years after the Effective Date
that claim additional metal protein attenuating compounds invented by Prana
directed to related chemical structural derivatives of CQ or PQ for the
treatment of Alzheimer's Disease and Xxxxxxxxx'x Disease.
1.4 Derivative Milestone Payment means a payment from one or more third
parties in the form of a milestone payment (including any up-front or cash-down
payment) associated specifically with the development of a Derivative.
1.5 Income means (a) royalties and other income received by Prana from
licensees and sublicensees as a result of such licensees' and sublicensees' sale
of Derivatives; and (b) income (net income prior to taxes) earned by Prana from
the sale of Derivatives by Prana.
1.6 Party means PNG or Prana; Parties means PNG and Prana.
1.7 Patent Right means any patent or patent application and all
substitutions, renewals, divisionals, continuations, continuations-in-part (with
respect to the applications set forth on Schedule 1.4 to the extent any such
continuation-in-part was filed within eight (8) years after the Effective Date)
resulting patents, reissues, reexaminations, extensions, and refilings thereof.
1.8 Phanquinone or means 4,7-Phenanthroline-5,6-dione.
2. DERIVATIVES
2.1 No Obligation. Prana is not obligated to research, develop,
manufacture, commercialize or otherwise invest in any compound or any
derivatives of CQ or PQ, including the Derivatives.
2.2 Right to Review. PNG shall have the right to review any third party
agreement entered into by Prana granting a license of rights to Derivatives
prior to Prana signing such an agreement, subject to written obligations of
confidentiality and non-use that are consistent with those contained in this
Agreement. The final decision on the license terms and conditions (in accordance
with the foregoing), timing and the licensee remains solely at Prana's
discretion. Upon execution of each license agreement or any amendment thereto,
Prana shall provide PNG with a copy of such executed agreement and any amendment
thereto.
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3. FINANCIAL PROVISIONS
3.1 Milestone Payments.
(a) In the event that Prana receives Derivative Milestone Payments,
Prana shall pay to PNG two percent (2%) of Derivative Milestone Payments
received by Prana.
(b) Milestone Payments Payable Only Once. For purposes of clarity,
the milestone obligations pursuant to this Section 3.1 are not to
duplicate the milestone obligations of the Patent Assignment Agreement,
and, in all cases, the maximum milestone obligations associated with the
development of Derivatives is two percent (2%).
3.2 Royalty Payments.
(a) Prana. Prana shall pay to PNG a royalty of two percent (2%) on
all Income.
(b) Length of Royalty Payments. The royalties payable under
subsection (a) shall be paid until the expiration of all Patent Rights
listed on Schedule 1.4 (as updated pursuant hereto) that cover such
Derivative.
(c) Royalties Payable Only Once. The obligation to pay royalties
pursuant to this subsection (c) is imposed only once with respect to the
same unit of a Derivative. Except as specifically provided in this
Agreement, it is understood and agreed that there shall be no deductions
from the royalties payable under this Agreement. For purposes of clarity,
the royalty obligations pursuant to this Section 3.2 are not to duplicate
the royalty obligations of the Patent Assignment Agreement, and, in all
cases, the maximum royalty obligations associated with the development of
Derivatives is two percent (2%).
(d) Reports and Accounting.
(i) Reports: Royalty Payments. Prana shall deliver to PNG,
within sixty (60) days after the end of each calendar
quarter with respect to royalties payable pursuant to
Section 3.2 or within thirty (30) days after receipt of
Derivative Milestone Payments pursuant to Section 3.1,
as applicable, reasonably detailed written accountings
of Income of the Derivatives or milestone payments, as
applicable, that are subject to payments due to PNG for
such calendar quarter or reasonably detailed written
description of the facts and circumstances related to
any milestone payment. Such royalty reports shall
indicate gross Income and the resulting calculation of
royalties. When Prana delivers such accountings to PNG,
Prana shall also deliver all royalty payments due under
Section 3.2 and milestone payments due under Section
3.1, as applicable, to PNG for the relevant period. With
respect to sales of Derivatives invoiced in United
States Dollars, the sales and royalties payable shall be
expressed in United States Dollars. With respect to
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Income of the Derivatives invoiced in a currency other
than United States Dollars, the royalties payable shall
be expressed in their United States Dollar equivalent,
calculated using the applicable conversion rates for
buying United States dollars published by The Wall
Street Journal (NY edition) on the last business day of
the calendar quarter to which the royalty report
relates. Prana shall pay milestone payments in United
States dollars.
(ii) Audits. Prana shall keep complete and accurate records
of the latest three (3) years of Income to which
royalties attach and activities to which milestone
payments attach. For the sole purpose of verifying
royalties or milestone payments payable to PNG, PNG
shall have the right annually at its own expense (except
as provided herein) to retain an independent certified
public accountant selected by PNG and reasonably
acceptable to Prana, to review such records in the
location(s) where such records are maintained by Prana,
upon reasonable notice and during regular business hours
and under obligations of confidence. Results of such
review shall be made available to both Parties. If the
review reflects an underpayment of royalties or
milestone payments to PNG, such underpayment shall be
promptly remitted to PNG, together with interest
calculated in the manner provided in Section 3.3, and
the Parties shall share equally the reasonable cost of
the review. If the underpayment is equal to or greater
than five percent (5%) of the royalty and/or milestone
amount that was otherwise due, Prana shall promptly
remit the underpayment with applicable interest to PNG
and pay all of the costs of such review. If the review
reflects an overpayment of royalties or milestone
payments to PNG, the amount of such overpayment is
creditable against future royalties or milestone
payments, as applicable, owed by Prana, to the extent
applicable.
3.3 Late Payments. Prana shall pay interest to PNG on the aggregate amount
of any payments that are not paid on or before the date such payments are due
under this Agreement at a rate of twelve percent (12%) per annum.
3.4 Blocked Payments. In the event that, by reason of applicable laws or
regulations in any country, it becomes impossible or illegal for Prana to
transfer, or have transferred on its behalf, royalties or other payments to PNG,
such royalties or other payments shall be deposited in local currency in the
relevant country to the credit of PNG in a recognized banking institution
designated by PNG or, if none is designated by PNG within a period of thirty
(30) days, in a recognized banking institution selected by Prana as the case may
be, and identified in a notice in writing given to such other Party.
3.5 Taxes. Prana shall be responsible for its own taxes levied on Prana by
tax authorities within any applicable territory, including all sales, use, value
added, withholding tax respecting Prana's income or other taxes payable with
respect of amounts due by Prana to PNG.
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Any such taxes which Prana is required to pay or withhold on behalf of PNG shall
be deducted from the amount of payment due, and Prana shall furnish PNG with
reasonable evidence of such payment or amount withheld, in electronic or written
form, as soon as practicable after such payment is made or such amount is
withheld.
4. NON-COMPETITION
For a term of eight (8) years from the Effective Date, PNG will not directly, or
indirectly through another on its behalf, research, develop, and/or
commercialize alternative treatments for Alzheimer's disease and/or Xxxxxxxxx'x
disease that might compete with any Derivative developed by Prana either alone,
in any partnership or through any alliance, deal or agreement; provided that the
foregoing prohibition shall not apply to PNG's commercialization or marketing of
any such alternative treatments in the PNG Territories.
5. NO WARRANTIES.
PRANA MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, HEREUNDER, INCLUDING, WITHOUT LIMITATION, ALL IMPLIED
WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE
6. TERM.
This Agreement shall become effective as of the Effective Date and remain in
effect until the expiration of all payment obligations set forth in Section 3
(the "Term"). The terms of Sections 3.1 and 3.2 (to the extent payment
obligations remain outstanding), 3.2(d)(ii), 3.4, 3.5, 5, 6 and 7 (excluding
7.3) survive termination of this Agreement.
7. GENERAL PROVISIONS
7.1 Arbitration: Equitable Relief. The Parties agree to resolve all
disputes under this Agreement in accordance with the arbitration provisions set
forth in Section 2.4 of the Settlement Agreement, of even date herewith, entered
into by the Parties, The General Hospital Corporation and certain individuals
(the "Settlement Agreement"). Each Party acknowledges that a breach by it of the
provisions of this Agreement cannot reasonably or adequately be compensated in
damages in an action at law; and that a breach by such Party of any of the
provisions contained in this Agreement shall cause the other Party irreparable
injury and damage. By reason thereof, each Party acknowledges and agrees that
the other Party shall be entitled in such cases in addition to, and not in lieu
of, any other remedies it may have under this Agreement or otherwise, under the
dispute resolution provisions set forth in Section 2.4 of the Settlement
Agreement to preliminary and permanent injunctive relief and any other available
equitable relief to prevent or curtail any breach of this Agreement by the other
Party or specifically to enforce the performance of the other Party under this
Agreement without the necessity of posting any bond or other security; provided,
however, that no specification in this Agreement of a specific legal or
equitable remedy shall be construed as a waiver or prohibition against the
pursuing of other legal or equitable remedies in the event of such a breach.
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7.2 Choice of Law. This Agreement will be governed by and construed in
accordance with the laws of New York and the United States.
7.3 Assignment. No Party may assign this Agreement in whole or in part
without the consent of the other, except if such assignment occurs in connection
with the merger, sale or transfer of all or substantially all of the business
and assets of a Party. Notwithstanding the foregoing, any Party may assign its
rights (but not its obligations) pursuant to this Agreement in whole or in part
to an Affiliate of such Party. Any attempted assignment in violation of this
section shall be null and void.
7.4 Entire Agreement; Amendments. This Agreement constitutes the entire
agreement among the Parties with respect to the subject matter hereof, and
supersedes all previous arrangements with respect to the subject matter hereof,
whether written or oral, including, without limitation, the Derivatives Term
Sheet, dated April 7, 2004, between the Parties. Any amendment or modification
to this Agreement shall be made in writing signed by all Parties.
7.5 Notices.
Notices to Prana shall be addressed to:
Prana Biotechnology Limited
Xxxxx 0, 000 Xxxxx Xxxxxx
Xxxxxxxxx 0000, Xxxxxxxx, Xxxxxxxxx
Attention: Chairman
Facsimile No.: (00) 0 0000 0000
with a copy to:
Prana Biotechnology Limited
Xxxxx 0, 000 Xxxxx Xxxxxx
Xxxxxxxxx 0000, Xxxxxxxx, Xxxxxxxxx
Attention: Vice President, Intellectual Property
Facsimile No: (00) 0 0000 0000
Notices to PNG shall be addressed to:
P.N. Gerolymatos S.A.
00, Xxxxxxxxx xxx.
000 00 Xxxxxxxx Xxxxxx, Xxxxxx
Attention: Avraam Manouach
Facsimile No.: (+30 - 210) 81 61 956
with a copy to:
Xxxxx Day
000 Xxxx 00xx Xxxxxx
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Xxx Xxxx, Xxx Xxxx 00000 XXX
Attention: Xxxxxxx X. Antler, Esq., Ph.D.
Facsimile No: (000) 000-0000
Any Party may change its address by giving notice to the other Party in the
manner herein provided. Any notice required or provided for by the terms of this
Agreement shall be in writing and shall be (a) sent by registered or certified
mail, return receipt requested, postage prepaid, (b) sent via a reputable
overnight courier service, or (c) sent by facsimile transmission and confirmed
by regular mail, in each case properly addressed in accordance with the
paragraph above. The effective date of notice shall be the actual date of
receipt by the Party receiving the same.
7.6 Independent Contractors. It is understood and agreed that the
relationship between the Parties hereunder is that of independent contractors
and that nothing in this Agreement shall be construed as authorization for Prana
or PNG to act as agent for the others.
7.7 Headings. The captions or headings of the Sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
7.8 No Implied Waivers; Rights Cumulative. No failure on the part of a
Party to exercise, and no delay in exercising, any right, power, remedy or
privilege under this Agreement, or provided by statute or at law or in equity or
otherwise, shall impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege or be construed as a waiver of any breach of this
Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.
7.9 Severability. If any provision hereof should be held invalid, illegal
or unenforceable in any respect in any jurisdiction, then, to the fullest extent
permitted by law, (a) all other provisions hereof shall remain in full force and
effect in such jurisdiction and shall be liberally construed in order to carry
out the intentions of the Parties as nearly as may be possible and (b) such
invalidity, illegality or unenforceability shall not affect the validity,
legality or enforceability of such provision in any other jurisdiction.
7.10 Execution in Counterparts. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
7.11 No Consequential Damages. UNLESS RESULTING FROM A PARTY'S WILLFUL
MISCONDUCT OR FROM A PARTY'S BREACH OF SECTION 7.12 ("CONFIDENTIALITY"), NEITHER
PARTY WILL BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY,
PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR
THE EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR LOSS OF PROFITS, LOSS OF DATA OR
LOSS OF USE DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS
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AGREEMENT WHETHER BASED XXXX XXXXXXXX, XXXXXXXX, XXXX, XXXXXX LIABILITY OR
OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.
7.12 Confidentiality. The confidentiality obligations set forth in Section
1 of the Settlement Agreement are incorporated herein in their entirety.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives:
P.N. GEROLYMATOS S.A. PRANA BIOTECHNOLOGY LIMITED
By: /s/ P. Gerolymatos By: /s/ Xxxxxxxx Xxxxxxx
--------------------------------- --------------------------------
Name: P. Gerolymatos Name: Xxxxxxxx Xxxxxxx
------------------------------- ------------------------------
Title: President & Managing Director Title: Executive Chairman
------------------------------ -----------------------------
Date: July 28, 2004 Date: July 28, 2004
[Signature Page to Derivatives Agreement]
Execution Version
Schedule 1.4
Derivative Patent Applications
1. Title: "8-Hydroxyquinoline Derivatives"
International Patent Application No. PCT/AUO3/00914
International Filing Date: 16 July 2003
2. Title: "Neurologically-Active Compounds"
International Patent Application No. PCT/AUO3/01303
International Filing Date: 3 October 2003.
3. Title: "Compound V"
Australian Provisional Patent Application No. 0000000000
Filing Date: 7 October 2003
4. Title: "Compound VI"
Australian Provisional Patent Application No. 2003905936
Filing Date: 7 October 2003
