Exhibit 10.10


 


ASSIGNMENT
AND TERMINATION AGREEMENT


 


by and between


 


PALIGENT
INC.


 


and


 


INDEVUS
PHARMACEUTICALS, INC.


 





















 


THIS ASSIGNMENT AND TERMINATION AGREEMENT (“Agreement”) is entered into
as of December 14, 2004 but is effective as of September 27, 2004 (“Effective
Date”), by and between PALIGENT INC.
(formerly Heavenlydoor.com, Inc.), a corporation organized and existing
under the laws of the State of Delaware and having its principal office at 10
East 53rd Street, 33rd Floor, New York, New York 10022 (“PALIGENT”)
and INDEVUS PHARMACEUTICALS INC. (formerly
Interneuron Pharmaceuticals, Inc.), a corporation organized and existing
under the laws of the State of Delaware and having its principal office at 99
Hayden Avenue, Suite 200, Lexington, Massachusetts 02421 (“INDEVUS”).


 


W I T N E
S S E T H:


 


WHEREAS, pursuant to the License Agreement (as defined herein),
PALIGENT granted INDEVUS an exclusive license in the Territory under the
PALIGENT Intellectual Property (each as defined herein) and, pursuant to an
amendment to the License Agreement, granted INDEVUS an option to buy out future
payment obligations, terminate the License Agreement and obtain an assignment
of the PALIGENT Intellectual Property;


 


WHEREAS, PALIGENT is the owner of the PALIGENT Intellectual Property;


 


WHEREAS, the Parties desire to terminate the License Agreement and
INDEVUS desires to obtain from PALIGENT an assignment of the PALIGENT
Intellectual Property and the Third Party Agreements, and PALIGENT desires to
grant such assignment to INDEVUS, all upon the terms and conditions set forth
herein.


 


NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the Parties intending to be legally bound, hereby agree as follows:


 


ARTICLE I


 


DEFINITIONS


 


Unless specifically set forth to the contrary herein, the following
terms, where used in the singular or plural, shall have the respective meanings
set forth below:


 


1.1.                              “Affiliate” shall mean (i) any
corporation or business entity of which more than fifty percent (50%) of the
securities or other ownership interests representing the equity, the voting
stock or general partnership interest are owned, controlled or held, directly
or indirectly, by a Party; (ii) any corporation or business entity which,
directly or indirectly, owns, controls or holds more than fifty percent (50%)
(or the maximum ownership interest permitted by law) of the securities or other
ownership interests representing the equity, voting stock or general
partnership interest of a Party or (iii) any corporation or business
entity of which a Party has the right to acquire, directly or indirectly, at
least fifty percent (50%) of the securities or other ownership interests
representing the equity, voting stock or general partnership interest thereof.


 


1.2.                              “Business Day(s)” shall
mean any day that is not a Saturday or a Sunday or a day on which the New York
Stock Exchange is closed.


 





















 


1.3.                              “Compound” shall mean a
condensation polymer of an aromatic sulfonic acid and an aldehyde, any other
compounds disclosed or covered in the PALIGENT Patent Assets, and any
derivative, homolog, or analog of any of the foregoing, and any isomer, salt, hydrate,
solvate, amide, ester, metabolite, or prodrug of any of the foregoing.


 


1.4.                              “Improvement” shall mean
any improvement or enhancement relating to Compound or Product including,
without limitation, any change or modification to any method, process, composition,
or any enhancement in the manufacture, formulation, ingredients, preparation,
presentation, means of delivery, dosage, administration, use, indication or
packaging as well as the addition of other active ingredients.


 


1.5.                              “IND” shall mean an investigational
new drug application, as defined in 21 CFR Section 312.3, and any
amendments thereto, filed with any regulatory authority, the filing of which is
necessary to commence clinical testing of Product in such regulatory
jurisdiction, including IND number 56,962.


 


1.6.                              “Inventory” shall mean any
inventory of Compound or Product owned or controlled by PALIGENT or any
Affiliate as of the Effective Date, including all inventory of finished Product
or Compound, whether held at a location or facility of PALIGENT or any
Affiliate (or of any other person on behalf of PALIGENT or any Affiliate) including any such materials
held by Pharm-Eco Laboratories, Inc. and/or Dow Pharmaceutical Sciences.


 


1.7.                              “License Agreement” shall
mean the License Agreement by and between PALIGENT and INDEVUS effective as of June 14,
2000, as amended on April 10, 2003.


 


1.8.                              “PALIGENT Intellectual
Property” shall mean the PALIGENT Patent Assets, the PALIGENT Know-How and
the Trademarks.


 


1.9.                              “PALIGENT Know-How” shall
mean any and all information and materials, including but not limited to,
discoveries, information, Improvements, processes, formulas, data, inventions,
know-how and trade secrets, patentable or otherwise, which


 


(i)                                     relate
to Compound, Product or any Improvement; and


 


(ii)                                  are
owned by PALIGENT or any PALIGENT Affiliate or are in the possession or control
of PALIGENT or any PALIGENT Affiliate.


 


Such Know-How shall include, without limitation, all chemical,
pharmaceutical, toxicological, preclinical, clinical, assay control,
manufacturing, regulatory, and any other information used or useful for the
development, manufacturing and/or regulatory approval of Compound or Product,
including such rights which PALIGENT or any PALIGENT Affiliate has to
information developed by Third Parties, including, without limitation any IND
or other regulatory filing or data included in or generated as a result of or
under an IND or other regulatory filing, including data or results from the
clinical trials listed on Schedule 1.9.


 


1.10.                        “PALIGENT Patent Assets”
shall mean any and all patents and patent applications, including provisionals
and priority filings, utility models and their applications (which shall be


 


2





















 


deemed to include certificates of invention
and applications for certificates of invention and supplementary protection
certificates, together in all cases with any continuations,
continuations-in-part, divisions, patents of addition, reexaminations,
reissues, renewals as well as extensions, supplementary protection certificates
and any other patent term extensions of any of the foregoing which as of the
Effective Date


 


(a)                                  are owned or controlled by
PALIGENT or any PALIGENT Affiliate in whole or in part, and


 


(b)                                 relate to Compound, Product or
any Improvement, including but not limited to methods of their development,
manufacture, or use, or otherwise relate to PALIGENT Know-How,


 


including but not limited to the patents and patent applications listed
on Schedule 1.10 and any counterparts
thereof which have been or may be filed in other countries.


 


1.11.                        “Party” shall mean
PALIGENT or INDEVUS.


 


1.12.                        “Patent Assignment” shall
mean the assignment of the PALIGENT Patent Assets in the form attached hereto
as Exhibit 1.12 to be executed
by PALIGENT on the Effective Date and thereafter recorded in the United States
Patent and Trademark Office and in any foreign national patent granting
authority.


 


1.13.                        “Product” shall mean any
pharmaceutical composition which contains Compound as at least one of the
therapeutically active ingredients, in any and all formulations, delivery
systems or package configurations for any indication.


 


1.14.                        “Territory” shall mean
all of the countries in the world.


 


1.15.                        “Third Party(ies)” shall
mean a person or entity who or which is neither a Party nor an Affiliate of a
Party.


 


1.16.                        “Third Party Agreements”
shall mean any and all agreements between PALIGENT and any Third Party relating
to the development of Compound or Product, including the agreements listed on Schedule 1.16.


 


1.17.                        “Trademarks” shall mean
the trademarks listed on Schedule 1.17, all
related domain names and other trademark related rights relating to Compound or
Product.


 


1.18.                        “Trademark Assignment”
shall mean the assignment of the Trademarks in the form attached hereto as Exhibit 1.18, to be executed by
PALIGENT on the Effective Date and thereafter recorded in the United States
Patent and Trademark Office and in any foreign national trademark granting
authority.


 


3





















 


ARTICLE II


 


TERMINATION OF LICENSE AGREEMENT;
ASSIGNMENT


 


2.1.                              In consideration of the payment
of US$500,000 by INDEVUS to PALIGENT, the receipt of which is hereby
acknowledged by PALIGENT, the following shall occur with effect on, from and as
of the Effective Date:


 


(a)                                  Termination.  The License Agreement shall be and is hereby
cancelled and terminated in its entirety. 
Notwithstanding any provision contained in the License Agreement,
neither Party shall have any obligation or liability to the other Party under
the License Agreement or in connection with the termination thereof, except
that the provisions of Article IV of the License Agreement shall survive
the termination thereof on the terms set forth in the License Agreement.


 


(b)                                 Assignments.  PALIGENT, on behalf of itself and any
PALIGENT Affiliate, shall, and hereby irrevocably, absolutely and
unconditionally assigns, transfers and conveys to INDEVUS, and INDEVUS hereby
accepts from PALIGENT, (i) all of PALIGENT’S rights, title and interest
throughout the Territory in and to the PALIGENT Intellectual Property,
including the right to bring an action for past patent or trademark
infringement; (ii) the Third Party Agreements and all of PALIGENT’s rights
and interest throughout the Territory in and under the Third Party Agreements;
and (iii) all of PALIGENT’S rights, title and interest in and to any
Inventory.  The foregoing assets are
sometimes referred to collectively herein as the “Assigned Assets” and the
foregoing assignments are sometimes referred to herein as the “Assignment.”


 


2.2.                              PALIGENT shall not execute any
writing or do any act whatsoever conflicting with the Assignment, and shall, at
any time upon request without further or additional consideration, execute and
perform such additional assignments, instruments and other writings, each of
which shall be prepared by, and at the sole cost and expense of, INDEVUS and do
such additional acts as INDEVUS may deem necessary or desirable to perfect
INDEVUS’ enjoyment of the grant of the Assignment; provided such acts do not
require the expenditure of any funds by PALIGENT or any Affiliate thereof (in
all cases other than fees or expenses that were paid or incurred by PALIGENT
prior to or as of the Effective Date or legal fees and expenses of PALIGENT
relating to the execution of this Agreement, all of which shall be the
responsibility of PALIGENT), it being understood that the foregoing covenant
and agreement shall bind assigns and legal representatives of PALIGENT and
inure to the benefit of the assigns and legal representatives of INDEVUS.  Without limiting the generality of the
foregoing, (i) PALIGENT shall execute and deliver to INDEVUS the Patent
Assignment and the Trademark Assignment simultaneously with the execution and
delivery of this Agreement; and any foreign counterparts thereof promptly
thereafter (ii) the Assignmentof the Assigned Assets shall be subject to
the provisions of Section 2.4; and (iii) neither PALIGENT nor any of
its Affiliates shall directly or indirectly market, promote, sell and/or
distribute in the Territory, any product under any trademark that is
confusingly similar to the Trademarks.


 


2.3.                              As promptly as practicable after
the Effective Date, PALIGENT shall transfer to INDEVUS all PALIGENT
Intellectual Property not previously made available to INDEVUS, in electronic
format, where available, and hard copies (or, upon INDEVUS’ request,
originals), all


 


4





















 


of which shall be subject to the Assignment;
it being understood that PALIGENT, to its knowledge, has previously delivered
to INDEVUS or its agents or employees all files, documents and other materials
relating to the PALIGENT Intellectual Property. 
The Parties acknowledge and agree that, pursuant to the License
Agreement, IND number 56,962 has previously been transferred by PALIGENT to
INDEVUS and is held by and in the name of INDEVUS.


 


2.4.                              Notwithstanding anything to the
contrary contained in this Agreement, no Third Party Agreement shall be deemed
assigned to INDEVUS pursuant to this Agreement if the attempted assignment of
the same to INDEVUS without the consent or approval of the other party thereto
or of any governmental entity, including but not limited to any regulatory
authority, would be prohibited by law, would be ineffective or would constitute
a material breach thereof. If any such consent or approval is required but not
obtained on or prior to the Effective Date, PALIGENT covenants and agrees that:


 


(a)                                  the economic (beneficial)
interest in or to such Third Party Agreement shall in any event pass to
INDEVUS, and any and all liabilities, obligations and responsibilities
pertaining to such Third Party Agreements shall be assumed (and PALIGENT shall
be indemnified and held harmless from the same, except for liabilities arising
or resulting from acts or omissions by PALIGENT) by INDEVUS, in each case as of
the Effective Date hereunder;


 


(b)                                 from and after the Effective
Date, PALIGENT shall hold and declare that they hold any and all such Third
Party Agreement for the benefit of INDEVUS;


 


(c)                                  At the request of Indevus,
PALIGENT shall use commercially reasonable efforts to obtain and secure any and
all consents and approvals that may be necessary to effect the valid transfer,
conveyance or assignment of the same to INDEVUS without adversely changing any
of the material terms or conditions thereof (including, without limitation, the
formal assignment or novation of any of the same, if so required), designed to
provide to INDEVUS the benefits of such Third Party Agreement that it would
have obtained had the Third Party Agreement been deemed assigned to INDEVUS
under this Agreement and, once approval or consent for the assignment of any
such Third Party Agreement is obtained, PALIGENT shall assign such Third Party
Agreement to INDEVUS at no additional cost to INDEVUS; and


 


(d)                                 PALIGENT shall cooperate with
INDEVUS in any other reasonable arrangement designed to provide for INDEVUS the
benefits of and to such Assigned Assets.


 


ARTICLE III


 


REPRESENTATION AND WARRANTIES


 


3.1.                              PALIGENT Representations and
Warranties.  PALIGENT represents and warrants to INDEVUS
that as of the Effective Date:


 


(a)                                  this Agreement has been duly
executed and delivered by PALIGENT and constitutes legal, valid, and binding
obligations enforceable against PALIGENT in accordance


 


5





















 


with its terms, except as enforceability is limited by (i) any
applicable bankruptcy, insolvency, reorganization, moratorium or similar law
affecting creditor’s rights generally, or (ii) general principles of
equity, whether considered in a proceeding in equity or at law;


 


(b)                                 no approval, authorization,
consent, or other order or action of or filing with any court, administrative
agency or other governmental authority is required for the execution and
delivery by PALIGENT of this Agreement or the consummation by PALIGENT of the
transactions contemplated hereby; the execution, delivery, and performance by
PALIGENT of this Agreement and each such agreement, document and instrument
contemplated by this Agreement to which PALIGENT is a party (i) do not
violate any provision of the certificate or articles of incorporation or other
similar governing instruments or by-laws of PALIGENT; and (ii) do not and
will not result in a breach of, constitute a default under any material
agreement, order, writ, judgment, or award to which PALIGENT is a party or by
which any property of PALIGENT is bound or affected;


 


(c)                                  PALIGENT has the full corporate
power and authority to enter into and deliver this Agreement, to grant the
Assignment and to consummate the transactions contemplated hereby; all
corporate acts and other proceedings required to be taken to authorize such
execution, delivery, and consummation have been duly and properly taken and
obtained;


 


(d)                                 Schedule 1.10 is a complete and accurate list
of all patents and patent applications in the Territory relating to Compound or
Product owned or controlled by PALIGENT; to PALIGENT’S knowledge, the issued
patents included in the PALIGENT Patent Assets are valid and enforceable over
any references or prior art; PALIGENT is the sole and exclusive owner of the
PALIGENT Intellectual Property, all of which are free and clear of any liens,
charges and encumbrances, and, to PALIGENT’S knowledge, no other person,
corporate or other private entity, or governmental or university entity or
subdivision thereof has any claim of ownership or rights therein, whatsoever
(other than, prior to the Effective Date, pursuant to the License Agreement);
PALIGENT has not previously assigned, transferred, conveyed, licensed or
otherwise encumbered its right, title and interest in or to any of the PALIGENT
Intellectual Property or the Third Party Agreements or entered into any
agreement with any Third Party which is in conflict with the rights granted to
INDEVUS pursuant to this Agreement;


 


(e)                                  PALIGENT has transferred to
INDEVUS the files for the PALIGENT Patent Assets as well as all information
received by PALIGENT as of the Effective Date relating to the PALIGENT Patent
Assets as well as all information received by PALIGENT concerning the
institution or possible institution of any interference, opposition,
reexamination, reissue, revocation, nullification, or any official proceeding
involving a PALIGENT Patent Asset, and will continue to make all such
disclosures to INDEVUS regarding any new significant event of which PALIGENT
becomes aware relating to the PALIGENT Patent Assets;


 


(f)                                    there are no claims, judgments
or settlements against or owed by PALIGENT relating to the PALIGENT Patent
Assets or the Trademarks or pending or, to the best of PALIGENT’s knowledge,
threatened claims or litigation against PALIGENT relating to the PALIGENT
Patent Assets or the Trademarks;


 


6





















 


(g)                                 PALIGENT has disclosed to
INDEVUS all relevant information known by it regarding the PALIGENT
Intellectual Property reasonably related to the development and
commercialization of Product.;


 


(h)                                 prior to and as of the Effective
Date, no regulatory filings relating to regulatory review or approval of
Compound or Product have been filed by PALIGENT or any PALIGENT Affiliate with
any government authority in any part of the world for any product relating to
Compound or Product, except for IND number 56,962, which has been transferred
to INDEVUS;


 


(i)                                     Except for any royalty payments
that may be owed pursuant to the Third Party Agreements listed on Schedule 1.16, no royalty payments are
owed by PALIGENT to any Third Party with respect to the Compound or Product;
PALIGENT has furnished INDEVUS with a true and complete copy of the Third Party
Agreements, each of which, to PALIGENT’S knowledge, is in full force and effect
in accordance with its terms and Paligent is not in default or breach of any of
the Third Party Agreements, nor has it received any notice of any defaults,
breaches or violation thereunder; and, to PALIGENT’S knowledge, no other party
to the Third Party Agreements is in default or breach of such agreement; and


 


3.2.                              INDEVUS Representations, Warranties.  INDEVUS represents and warrants to PALIGENT
that as of the Effective Date:


 


(a)                                  this Agreement has been duly
executed and delivered by INDEVUS and constitutes legal, valid, and binding
obligations enforceable against it in accordance with their respective terms
except as enforceability is limited by (i) any applicable bankruptcy,
insolvency, reorganization, moratorium or similar law affecting creditor’s
rights generally, or (ii) general principles of equity, whether considered
in a proceeding in equity or at law;


 


(b)                                 it has full corporate power and
authority to execute and deliver this Agreement and to consummate the
transactions contemplated hereby.  All
corporate acts and other proceedings required to be taken to authorize such
execution, delivery, and consummation have been duly and properly taken and
obtained; and


 


(c)                                  no approval, authorization,
consent, or other order or action of or filing with any court, administrative
agency or other governmental authority is required for the execution and
delivery by INDEVUS of this Agreement.


 


ARTICLE IV


 


MISCELLANEOUS


 


4.1.                              Notices.  All notices or other communications which are
required or permitted hereunder shall be in writing and sufficient if delivered
personally, sent by facsimile (and promptly confirmed by personal delivery,
registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified
mail, postage prepaid, return receipt requested, addressed as follows:


 


7





















 


if to INDEVUS to:


 


INDEVUS PHARMACEUTICALS, INC.

99 Hayden Avenue

Lexington, MA 02421

Attention:  President

Fax No.: 781-862-3859


 


if to PALIGENT to:


 


PALIGENT, INC.

10 East 53rd Street, 33rd Floor

New York, NY 10022

Attention:  President

Fax No.: (212) 755-5463


 


or to such other address as the Party to whom notice is to be given may
have furnished to the other Parties in writing in accordance herewith.  Any such communication shall be deemed to
have been given when delivered if personally delivered or sent by facsimile on
a Business Day, upon confirmed delivery by nationally-recognized overnight
courier if so delivered and on the third Business Day following the date of
mailing if sent by registered or certified mail.


 


4.2.                              Applicable Law.  The Agreement shall be governed by and
construed in accordance with the laws of the United States of America and State
of New York without reference to any rules of conflict of laws.


 


4.3.                              Entire Agreement.  This Agreement, including the exhibits and
schedules hereto, contain the entire agreement and understanding of the Parties
with respect to the subject matter hereof and supersedes all previous
agreements, writings and understandings, including without limitation, the
License Agreement (except as specifically set forth herein).  This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by all Parties
hereto.


 


4.4.                              Headings.  The captions to the several Articles and
Sections hereof are not a part of the Agreement, but are merely guides or
labels to assist in locating and reading the several Articles and Sections
hereof.


 


4.5.                              Counterparts.  The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.


 


4.6.                              Use of Names.  Except as otherwise provided in this
Agreement, neither Party shall use the name of the other Party in relation to
this transaction in any public announcement, press release or other public
document without the consent of such other Party, which consent shall not be
unreasonably withheld or delayed; provided, however, that either Party may use
the name of the other Party in any document required to comply with applicable
laws, rules or regulations.


 


4.7.                              Successors and Assigns.  This Agreement shall inure to the benefit of
and be binding on the parties hereto and their respective successors and
permitted assigns.


 


8





















 


4.8.                              Third Parties.  This Agreement does not create any rights,
claims or benefits inuring to any person that is not a party hereto nor create
or establish any third party beneficiary hereto.


 


IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.


 


PALIGENT INC.


 


 


	
  By:

  	
  /s/ Salvatore A. Bucci

  	
   

  
	
   

  	
  Name:

  	
  Salvatore A. Bucci

  
	
   

  	
  Title:

  	
  President and Chief Executive Officer

  
	
   

  	
   

  
	
   

  	
   

  
	
  INDEVUS PHARMACEUTICALS, INC.

  
	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Glenn L. Cooper

  	
   

  
	
   

  	
  Name:

  	
  Glenn L. Cooper, M.D.

  
	
   

  	
  Title:

  	
  President and Chief Executive Officer

  
				



 


9





















 


SCHEDULE 1.9


 


CLINICAL
TRIALS


 


•                                          Protocol
RD 499/20914:  A Rising Single Dose
Tolerance Study of PRO 2000/5 in Adult Healthy Volunteers


 


•                                          Protocol
PRO 2000/5-01:  A Multi-center Phase
I/II Randomized, Controlled, Open-label Study to Determine the Safety and
Anti-HIV-1 Activity of a Continuous Infusion of PRO 2000/5 in HIV-1 Positive
Patients


 


•                                          Protocol
PRO 2000/5-02:  A Single Center
Phase I/II Open-label Study to Determine the Safety and Anti-HIV-1 Activity of
Multiple Single-dose Infusions of PRO 2000/5 in HIV Seropositive Patients


 


•                                          Protocol
PRO 2000/5-03:  A Phase I Study to
Assess the Safety and Tolerance of PRO 2000/5 Gel in Healthy Volunteers


 


•                                          Protocol
PRO 2000/5-04:  A Phase I Study to
Assess the Safety and Tolerance of PRO 2000/5 Gel in Healthy Volunteers


 


•                                          Protocol
HIVNET 020:  A Phase I Multicenter Dose
Escalation Safety and Acceptability Study of the Investigational Vaginal
Microbicide Agent PRO 2000/5 Gel (P)


 





















 


SCHEDULE 1.10


 


PALIGENT
PATENT ASSETS


 


1)  Compound for inhibiting
HIV infectivity.


Inventors:  S. K. Singh, R. J.
Patch, P. V. Pallai, E. A. Neidhardt, G. P. Pallace, K. J. Willis, T. M. Sampo,
K. W. McDonald, Z. Shi


 


Issued U.S. Patents:


 


	
  Patent No.

  	
  US 5,614,559

  
	
  Issue Date:

  	
  25 March 1997

  
	
   

  	
   

  
	
  Patent No.

  	
  US 5,677,343

  
	
  Issue Date:

  	
  14 October 1997

  
	
   

  	
   

  
	
  Patent No.

  	
  US 6,075,050

  
	
  Issue Date:

  	
  13 June 2000

  
	
   

  	
   

  
	
  Patent No.

  	
  US 6,365,625

  
	
  Issue Date:

  	
  2 April 2002

  
	
   

  	
   

  
	
   

  	
   

  
	
  Patent Family:

  	
   

  
	
   

  	
   

  
	
  PCT:

  	
   

  
	
  Application No.:

  	
  PCT/US94/13335

  
	
  Application Date:

  	
  17 November 1994

  
	
  Publication No.:

  	
  WO 9514479

  
	
  Publication Date:

  	
  01 June 1995

  
	
  Title:

  	
  Condensation Polymer of an Aromatic Sulfonic Acid and an Aldehyde for
  inhibiting HIV Infectivity

  
	
  Status:

  	
  Inactive

  
	
   

  	
   

  
	
   

  	
   

  
	
  Canada:

  	
   

  
	
  Application No.:

  	
  2,177,257

  
	
  Application Date:

  	
  17 November 1994

  
	
  Language:

  	
  English

  
	
   

  	
   

  
	
  EPC:

  	
   

  
	
  Application No.:

  	
  95 902 606

  
	
  Application Date:

  	
  17 November 1994

  



 


2





















 


	
  Language:

  	
  English

  
	
  Designated States: (National)  AT; BE; CH; DE; DK; ES; FR; GB; GR; IE; IT;
  LI; LU; MC; NL; PT; SE

  
	
   

  	
   

  
	
   

  	
   

  
	
  Japan:

  	
   

  
	
  Application No.:

  	
  7-515151

  
	
  Application Date:

  	
  17 November 1994

  
	
  Language:

  	
  Japanese

  
	
   

  	
   

  
	
   

  	
   

  
	
  U.S.:

  	
   

  
	
  Application No.:

  	
  08/156,443

  
	
  Application Date:

  	
  23 November 1993

  
	
  Inactive:

  	
  Abandoned

  
	
   

  	
   

  
	
   

  	
   

  
	
  U.S.:

  	
   

  
	
  Application No.:

  	
  08/468,877

  
	
  Application Date:

  	
  05 July 1995

  
	
  Inactive:

  	
  Abandoned

  
	
  CIP of 08/245,619

  	
   

  



 


 


(2)  Sulfonic acid and aldehyde condensation polymers for
preventing pregnancy.


Inventors:  A.J. Sonderfan, A. T.
Profy, T. Chancellor, M. McKinlay


 


 


	
  Issued U.S. Patent:

  	
   

  
	
   

  	
   

  
	
  Patent No.

  	
  US 5,958,399

  
	
  Issue Date:

  	
  28 September 1999

  
	
  Title:

  	
  Sulfonic Acid and Aldehyde Condensation
  Polymers for Preventing Pregnancy

  
	
   

  	
   

  
	
   

  	
   

  
	
  Patent Family:

  	
   

  
	
   

  	
   

  
	
  PCT:

  	
   

  
	
  Application No.:

  	
  PCT/US98/08440

  
	
  Application Date:

  	
  27 April 1998

  
	
  Publication No:

  	
  WO 9848819

  
	
  Publication Date:

  	
  05 November 1998

  
	
  Status:

  	
  Inactive

  
	
   

  	
   

  
	
  Designated
  States: (National)  AL; AM; AT; AU; AZ;
  BA; BB; BG; BR; BY; CA; CH; CN; CU; CZ; DE; DK; EE; ES; FI; GB; GE; GH; GM;
  GW; HU; ID;

  



 


3





















 


IL; IS; JP; KE; KG; KP; KR; KZ; LC; LK; LR;
LS; LT; LU; LV; MD; MG; MK; MN; MW; MX; NO; NZ; PL; PT; RO; RU; SD; SE; SG; SI;
SK; SL; TJ; TM; TR; TT; UA; UG; UZ; VN; YU; ZW (Regional) GH; GM; KE; LS; MW; SD;
SZ; UG; ZW; AM; AZ; BY; KG; KZ; MD; RU; TJ; TM; AT; BE; CH; CY; DE; DK; ES; FI;
FR; GB; GR; IE; IT; LU; MC; NL; PT; SE; BF; BJ; CF; CG; CI; CM; GA; GN; ML; MR;
NE; SN; TD; TG


 


 


	
  Australia:

  	
   

  
	
  Patent No.

  	
  AU 732693

  
	
  Issue Date:

  	
  9 August 2001

  
	
   

  	
   

  
	
   

  	
   

  
	
  Brazil:

  	
   

  
	
  Application No.:

  	
  P19809378-9

  
	
  Application Date:

  	
  27 April 1998

  
	
  Language:

  	
  Portuguese

  
	
   

  	
   

  
	
   

  	
   

  
	
  Canada:

  	
   

  
	
  Application No.:

  	
  CA 2,288,024

  
	
  Application Date:

  	
  27 April 1998

  
	
  Language:

  	
  English

  
	
   

  	
   

  
	
   

  	
   

  
	
  China:

  	
   

  
	
  Patent No.

  	
  ZL98804711.X

  
	
  Issue Date:

  	
  15 October 2003

  
	
  Language:

  	
  Chinese

  
	
   

  	
   

  
	
   

  	
   

  
	
  Hong Kong:

  	
   

  
	
  Patent No.

  	
  HK 1027981

  
	
  Issue Date:

  	
  18 June 2004

  
	
  Language:

  	
  English

  
	
   

  	
   

  
	
   

  	
   

  
	
  Japan:

  	
   

  
	
  Application No:

  	
  10547245

  
	
  Application Date:

  	
  27 April 1998

  
	
  Publication No.:

  	
  JP 2001523251

  
	
  Publication Date:

  	
  20 November 2001

  
	
  Language:

  	
  Japanese

  



 


4





















 


	
  Mexico:

  	
   

  
	
  Application No.:

  	
  999985

  
	
  Application Date:

  	
  27 April 1998

  
	
  Title:

  	
  Condensation Polymer Composition for Preventing Pregnancy

  
	
   

  	
   

  
	
   

  	
   

  
	
  New Zealand:

  	
   

  
	
  Patent No.

  	
  NZ 500640

  
	
  Issue Date:

  	
  10 May 2001

  
	
  Language:

  	
  English

  
	
   

  	
   

  
	
   

  	
   

  
	
  Russia:

  	
   

  
	
  Publication No.

  	
  RU 2203672

  
	
  Publication Date:

  	
  10 May 2003

  
	
  Language:

  	
  Russian

  
	
   

  	
   

  
	
   

  	
   

  
	
  South Africa:

  	
   

  
	
  Patent No.:

  	
  ZA 9803655

  
	
  Issue Date:

  	
  24 February 1999

  
	
  Language:

  	
  English

  
	
   

  	
   

  
	
   

  	
   

  
	
  South Korea:

  	
   

  
	
  Application No.:

  	
  1999-7010094

  
	
  Application Date:

  	
  27 April 1998

  
	
  Request for exam:

  	
  25 April 2003

  
	
  Title:

  	
  Condensation Polymer Composition for Preventing Pregnancy

  
	
   

  	
   

  
	
   

  	
   

  
	
  EPC:

  	
   

  
	
  Patent No.

  	
  0 981 354

  
	
  Grant Date:

  	
  16 June 2004

  
	
  Application No.

  	
  98 91 9920

  
	
  Title:

  	
  Condensation Polymer Composition for Preventing Pregnancy

  
	
   

  	
   

  
	
   

  	
   

  
	
  Austria:

  	
   

  
	
  Patent No.

  	
  E269092

  
	
  Issue Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Belgium:

  	
   

  
	
  Application No.:

  	
  0981354

  
	
  Application Date:

  	
  27 April 1998

  



 


5





















 


	
  Publication No:

  	
  0981354

  
	
   

  	
   

  
	
   

  	
   

  
	
  Cyprus:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Anticipated Patent Date: 

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Denmark:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Anticipated Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Finland:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  France:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Germany:

  	
   

  
	
  Patent No.:

  	
  DE 69824580.6-08

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Great Britain

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Greece:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Anticipated Patent Date:

  	
  01 March 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Ireland:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Italy:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Luxembourg:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Monaco:

  	
   

  
	
  Patent No.:

  	
  0981354

  



 


6





















 


	
  Anticipated  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
  Netherlands:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Portugal:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Spain:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Anticipated Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Sweden:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Switzerland/Liechtenstein:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Albania:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Anticipated Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Lithuania:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Anticipated Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Latvia:

  	
   

  
	
  Patent No.:

  	
  P04448

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Romania:

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Anticipated Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Slovenia:

  	
   

  
	
  Patent No.:

  	
  P9830686

  
	
  Patent Date:

  	
  16 June 2004

  
	
   

  	
   

  
	
   

  	
   

  
	
  Yugoslavia (Macedonia):

  	
   

  
	
  Patent No.:

  	
  0981354

  
	
  Patent Date:

  	
  16 June 2004

  



 


7





















 


EXHIBIT 1.12


 


PATENT
ASSIGNMENT


 


WHEREAS PALIGENT INC., formerly HeavenlyDoor.com Inc., a corporation
organized and existing under the laws of the State of Delaware and having its
principal office at 10 East 53rd Street, 33rd Floor, New
York, New York 10022 (“Assignor”), is the sole owner of the entire right, title
and interest in the patents and patent applications listed in Schedule A,
attached hereto; and


 


WHEREAS, Indevus Pharmaceuticals, Inc., a corporation organized
and existing under the laws of the State of Delaware and having its principal
office at 99 Hayden Avenue, Suite 200, Lexington, Massachusetts 02421 (“Assignee”),
is desirous of acquiring the entire right, title and interest in and to the
inventions disclosed or claimed in said patents and patent applications, and in
and to any and all Letters Patent of the United States and any foreign countries
which may be obtained therefore;


 


NOW, THEREFORE, for good and valuable consideration, the receipt for
and sufficiency of which is hereby acknowledged, Assignor does hereby sell,
assign, transfer and set over unto the Assignee, its legal representatives,
successors, and assigns, the entire right, title and interest in and to said
patents and patent applications, including the right to sue for past
infringement, as set forth in the above-mentioned Exhibit A and the
inventions disclosed or claimed therein, including any continuations,
continuations-in-part, divisions, reissues, re-examinations or extensions
thereof, and to any and all Letters Patents of the United States and any
foreign countries which may be issued for said inventions;


 


Assignor also hereby agrees with the said Assignee that Assignor will
not execute any writing or do any act whatsoever conflicting with these
presents, and that it will, at any time upon request without further or
additional consideration but at the expense of said Assignee, execute such
additional assignments and other writing and do such additional acts as said
Assignee may deem necessary or desirable to perfect said Assignee’s enjoyment
of this grant, and render all necessary assistance in making application for
and obtaining original, divisional, continuations, continuations-in-part,
reexamined, reissued, or extended Letters Patent of the United States or of any
and all foreign countries on said inventions, and in enforcing any rights or
causes in action accruing as a result of such applications or patents, by
giving testimony in any proceeding or transactions involving such applications
or patents, and by executing preliminary statements and other affidavits, it
being understood that the foregoing covenant and agreement shall bind assigns
and legal representatives of Assignor and inure to the benefit of the assigns
and legal representatives of Assignee;


 


Assignor requests the Director of Patents and Trademarks to issue
Letters Patents of the United States (or, for any and all foreign countries,
any foreign national patent granting authority) which may be granted for said
inventions to said Assignee, its legal representatives, successors or assigns,
as the sole owner of the entire right, title and interest in and to said patents
and the inventions covered thereby.


 


8





















 


IN TESTIMONY WHEREOF, We have hereunto set our hands.


 


	
   

  	
  PALIGENT INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
  Date: 

  	
  December 14, 2004

  	
   

  	
  By :

  	
  /s/ Salvatore A. Bucci

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
  President & CEO

  	
   

  
						



 


 


	
  STATE OF New York

  	
  )

  	
   

  
	
   

  	
  )

  	
  SS.

  
	
  COUNTY OF New York

  	
  )

  	
   

  



 


On this 14th day of December, 2004, before me,
Notary Public, personally appeared to me known to be the individual whose name
is subscribed to this instrument, and acknowledged that he/she executed it as
his/her free and voluntary act and deed for the uses and purposes mentioned
therein.


 


WITNESS my hand and official seal.


 


	
   

  	
  /s/ Carmel T. McDonald

  	
   

  
	
   

  	
  Notary Public

  
	
   

  	
  My Commission Expires: 9/29/2005

  



 




	
   

  	
  CARMEL T.
  MCDONALD

  
	
   

  	
  Notary
  Public, State of New York

  
	
   

  	
  No.
  01MC5085770

  
	
   

  	
  Qualified in
  Orange County

  
	
   

  	
  Commission
  Expires September 29, 2005

  






 


9





















 


SCHEDULE A
TO PATENT ASSIGNMENT (UNITED STATES)


 


1)  Compound for inhibiting
HIV infectivity.


Inventors:  S. K. Singh, R. J.
Patch, P. V. Pallai, E. A. Neidhardt, G. P. Pallace, K. J. Willis, T. M. Sampo,
K. W. McDonald, Z. Shi


 


Issued U.S. Patents:


 


	
  Patent No.

  	
  US 5,614,559

  
	
  Issue Date:

  	
  25 March 1997

  
	
   

  	
   

  
	
  Patent No.

  	
  US 5,677,343

  
	
  Issue Date:

  	
  14 October 1997

  
	
   

  	
   

  
	
  Patent No.

  	
  US 6,075,050

  
	
  Issue Date:

  	
  13 June 2000

  
	
   

  	
   

  
	
  Patent No.

  	
  US 6,365,625

  
	
  Issue Date:

  	
  2 April 2002

  



 


 


(2)  Sulfonic acid and aldehyde condensation polymers for
preventing pregnancy.


Inventors:  A.J. Sonderfan, A. T.
Profy, T. Chancellor, M. McKinlay


 


Issued U.S. Patent:


 


	
  Patent No.

  	
  US 5,958,399

  
	
  Issue Date:

  	
  28 September 1999

  
	
  Title:

  	
  Sulfonic Acid and Aldehyde Condensation Polymers for Preventing
  Pregnancy

  



 


10





















 


SCHEDULE 1.16


 


THIRD
PARTY AGREEMENTS


 


Agreement dated as of October 7, 1996 by and between Procept, Inc.
(a predecessor of PALIGENT) and the Medical Research Council.


 


Agreement dated as of February 25, 1999 by and between Procept, Inc.
and the Medical Research Council.


 


Reseach and Manufacturing Contract dated as of March 14, 1994
between Pharm-Eco Laboratories and Procept, Inc.


 


Proposal for Formulation of an Intravaginal Virucide (PRO 2000/5) dated
December 19, 1995 between Dow Dermatologics, Inc. and Procept, Inc.


 


The Proposal ‘Reformulation of PRO 2000/5 Vaginal Gel to Contain a
Preservative System’ dated January 10, 1997 between Dow Pharmaceutical
Sciences, Inc. and Procept, Inc.


 


The Quotation dated December 19, 1994 executed by Simbec Research
Limited and Procept, Inc.


 


Clinical Study Agreement dated June 27, 1995 among Academisch
Ziekenhuis bij de Universiteit van Amsterdam (“AMC-UvA”), Joep M. A. Lange,
M.D., Ph.D., and Procept, Inc.


 


Clinical Study Agreement dated March 19, 1996 among the non-profit
association LABREFIP, Dr. S. Sprecher, and Procept, Inc.


 


Clinical Study Agreement dated November 15, 1996 among the Prince
Leopold Institute of Tropical Medicine, Dr. Marie Laga, and Procept, Inc.


 


Clinical Study Agreement dated January 10, 1997 among Imperial
College of Science, Technology and Medicine, Professor Jonathan Weber, Dr. Valerie
Kitchen, and Procept, Inc.


 


Clinical Trial Agreement dated March 3, 1999 between the Division
of AIDS, National Institute of Allergy and Infectious Diseases (NIAID) and
Procept, Inc.


 


Screening Agreement dated May 14, 1996 between the Division of
Microbiology and Infectious Diseases (DMID), National Institute for Allergy and
Infectious Diseases and Procept, Inc.


 


Material Transfer Agreement dated December 15, 1999 among the
National Institute of Child Health and Human Development, Dr. Richard
Blye, Dr. Albert Profy and Procept, Inc.


 


Material Transfer Agreement dated May 3, 2000 among the Centers
for Disease Control and Prevention, Dr. Clyde E. Hart, Dr. Albert T.
Profy and Procept, Inc.


 


Materials Transfer Agreement dated January 7, 1997 among CONRAD, Dr. Lee
Claypool, and Procept, Inc.


 





















 


Materials Transfer Agreement dated January 27,
1998 among Duke University, Professor David Katz, and Procept, Inc.


 


Consulting and Confidentiality Agreement
dated June 15, 1998 among Duke University, Professor David Katz, and
Procept, Inc.


 


Materials Transfer Agreement dated October 3,
1996 among Magee-Womens Hospital, Dr. Sharon Hillier, and Procept, Inc.


 


Research Evaluation Agreement dated December 21,1998
between Zonagen, Inc. and Procept, Inc.


 


Agreement dated April 30, 1997 between
Medical and Technical Research Associates, Inc. and Procept, Inc.


 


2





















 


SCHEDULE 1.17


 


TRADEMARKS


 


PRO 2000/5                                   Registration
No. 2082174


PRO 2000                                             Registration
No. 2292972


 


3





















 


EXHIBIT 1.18


 


TRADEMARK
ASSIGNMENT


 


WHEREAS PALIGENT INC., formerly
HeavenlyDoor.com Inc., a corporation organized and existing under the laws of
the State of Delaware and having its principal office at 10 East 53rd
Street, 33rd Floor, , New York, New York 10022 (“Assignor”), is the
sole owner of the entire right, title and interest in the trademark
registrations listed on Schedule A,
attached hereto (“the Marks”); and


 


Whereas, Indevus Pharmaceuticals, Inc.,
a corporation organized and existing under the laws of the State of Delaware
and having its principal office at 99 Hayden Avenue, Suite 200, Lexington,
Massachusetts 02421 (“Assignee”), is desirous of acquiring the entire right,
title and interest in and to the said Marks, in the United States and
throughout the world, including the good will represented by the Marks;


 


NOW, THEREFORE, for good and valuable
consideration, the receipt for and sufficiency of which is hereby acknowledged,
Assignor does hereby sell, assign, transfer and set over unto the Assignee, its
legal representatives, successors, and assigns, the entire right, title and
interest in and to said Marks, together with the entire goodwill associated
with and symbolized by the Marks, together with all common law rights,
together with all rights and privileges granted and secured thereby,
including the right to sue for all
causes of action related to the Marks, and the right to sue in Assignee’s own
name and to recover for any damages and profits for past infringement, unfair
competition or passing off, said rights to be held and enjoyed by said
Assignee, for its own use and benefit and for the use and benefit of its
successors, assigns or other legal representatives as fully and entirely as the
same would have been held and enjoyed by said Assignor if this Assignment and
sale had not been made;


 


Assignor also hereby agrees with the said
Assignee that Assignor will not execute any writing or do any act whatsoever
conflicting with these covenants and agreements, and that it will, at any time
upon request without further or additional consideration but at the expense of
said Assignee, execute such additional assignments and other writing and do
such additional acts as said Assignee may deem necessary or desirable to
perfect, secure, record, and register said Assignee’s enjoyment of this grant,
it being understood that the foregoing covenant and agreement shall bind
assigns and legal representatives of Assignor and inure to the benefit of the
assigns and legal representatives of Assignee;


 


4





















 


IN TESTIMONY
WHEREOF, We have hereunto set our hands.


 


 


	
   

  	
   

  	
   

  	
  PALIGENT INC.

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  December 14, 2004

  	
   

  	
  By:

  	
  /s/ Salvatore A. Bucci

  	
   

  
	
   

  	
   

  
	
   

  	
  Title: 

  	
  President & CEO

  	
   

  



 


	
  STATE OF New York  

  	
  )

  	
   

  
	
   

  	
  )

  	
  SS.

  
	
  COUNTY OF New York

  	
  )

  	
   

  



 


 


On this 14th day of December,
2004, before me,                                                Notary
Public, personally appeared to me known to be the individual whose name is
subscribed to this instrument, and acknowledged that he/she executed it as
his/her free and voluntary act and deed for the uses and purposes mentioned
therein.


 


 


WITNESS my hand and official seal.


 


	
   

  	
  /s/ Carmel T. McDonald

  	
   

  
	
   

  	
  Notary Public

  
	
   

  	
  My Commission Expires: 9/29/2005

  



 




	
   

  	
  CARMEL T.
  MCDONALD

  
	
   

  	
  Notary
  Public, State of New York

  
	
   

  	
  No.
  01MC5085770

  
	
   

  	
  Qualified in
  Orange County

  
	
   

  	
  Commission
  Expires September 29, 2005

  






 


5





















 


SCHEDULE A
TO TRADEMARK ASSIGNMENT


 




	
  Trademark

  	
   

  	
  U.S. Registration No.

  	
   

  
	
  PRO 2000/5

  	
   

  	
  2,082,174

  	
   

  
	
  PRO 2000

  	
   

  	
  2,292,972

  	
   

  






 


6