Document:

exv10w2

 

Exhibit 10.2

AMENDMENT NO. 1 TO JPPLP INTELLECTUAL PROPERTY TRANSFER AND LICENSE AGREEMENT

This Amendment No. 1 (the “JPPLP Amendment”) is made and entered into as of
September 7, 2004 by and between Janssen Pharmaceutica Products, L.P., a New
Jersey limited partnership having a principal place of business at 1123
Trenton-Harbourton Road, Titusville, New Jersey 08628 (hereinafter referred to
as “JPPLP”) and Barrier Therapeutics, Inc., a Delaware corporation having an
address at 600 College Road East, Suite 3200, Princeton, New Jersey 08540
(hereinafter referred to as “Barrier”).

WHEREAS, JPPLP and Barrier are parties to that certain Intellectual Property
Transfer and License Agreement dated May 6, 2002 (the “Original JPPLP
Agreement”);

WHEREAS, JPPLP and Barrier desire to make certain amendments to the Original
JPPLP Agreement pursuant to the terms of this JPPLP Amendment; and

WHEREAS, contemporaneously with the execution and delivery hereof, Barrier and
Johnson & Johnson Consumer Companies, Inc., an Affiliate of JPPLP (“JJCC”), are
entering into an amendment to that certain Intellectual Property Transfer and
License Agreement between Barrier and JJCC dated May 6, 2002.

NOW, THEREFORE, in consideration of the above premises and the covenants
contained herein, the parties agree as follows:

	1.	 	The Original JPPLP Agreement is hereby amended as follows:

	 	1.1.	 	The following new definitions are hereby added to Article I
of the Original JPPLP Agreement as Sections 1.55 to 1.59 to read in
their entirety as follows:

     “1.55 ‘Ketanserin Semi-exclusive Countries’ shall mean Argentina,
Bolivia, Brazil, Chile, Colombia, Ecquador, French Guiana, Guyana,
Paraguay, Peru, Suriname, Uruguay and Venezuela.”

     “1.56 ‘Ketanserin Exclusive Territory’ shall mean the entire world,
with the exception of the JPPLP Ketanserin Countries and the Ketanserin
Semi-exclusive Countries.”

     “1.57 ‘Caribbean’ shall mean Antigua and Barbuda, Aruba, Bahamas,
Barbados, Cayman Islands, Dominica, Dominican Republic, Grenada,
Guadeloupe, Haiti, Jamaica, Martinique, Puerto Rico, St. Kitts and Nevis,
St. Lucia, St. Vincent and the Grenadines, Trinidad and Tobago, Turks and
Caicos Islands and the Virgin Islands.”

 

 

     “1.58 ‘Cental America’ shall mean Belize, Costa Rica, El Salvador,
Guatemala, Honduras, Nicaragua and Panama.”

     “1.59 ‘Ketanserin Field’ shall mean applications for treatment or
prevention of diseases of the human skin, hair, nails and/or the oral or
genital mucosa customarily diagnosed and treated by dermatologists,
excluding skin cancer, but including without limitation, actinic
keratosis and anal fissures.

	 	1.2	 	The definition of “Field” in Section 1.14 of the Original
JPPLP Agreement is hereby replaced in its entirety with the
following:

          “Field shall mean applications for treatment or prevention of diseases of
the human skin, hair, nails and/or the oral or genital mucosa customarily
diagnosed and treated by dermatologists, excluding skin cancer and anal
fissures, but including without limitation, actinic keratosis.”

	 	1.3	 	The definition of “JPPLP Ketanserin Countries” in Section
1.21 of the Original JPPLP Agreement is hereby replaced in its
entirety with the following:

          “JPPLP Ketanserin Countries” shall mean Mexico, Central America and the
Caribbean.”

	 	1.4	 	The definition of “Ketanserin Territory” in Section 1.30 of
the Original JPPLP Agreement is hereby replaced in its entirety with
the following:

     “Ketanserin Territory” shall mean the Ketanserin Semi-exclusive
Countries and the Ketanserin Exclusive Territory.

	 	1.5	 	Section 2.3(a) of the Original JPPLP Agreement is hereby
replaced in its entirety with the following:

     JPPLP hereby grants to Barrier the exclusive (even as to JPPLP and
its Affiliates), royalty-free license, with the unrestricted right to
grant sublicenses (subject to Section 2.6 and Article 7), under the
Ketanserin Patent Rights to (i) import, use, sell, offer for sale, and
have sold, Ketanserin Products in the Ketanserin Exclusive Territory in
the Ketanserin Field, and (ii) make and have made Ketanserin Products
anywhere in the world in order to import, use, sell, offer for sale, and
have sold Ketanserin Products in the Ketanserin Exclusive Territory in
the Ketanserin Field.

     JPPLP hereby grants to Barrier (i) the Semi-exclusive (along with
JPPLP and its Affiliates), royalty-free license, under the Ketanserin
Patent Rights to import, use, sell, offer for sale, and have sold,
Ketanserin Products in the Ketanserin Semi-exclusive Countries in the
Field, and (ii) the non-exclusive,

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royalty-free license under the Ketanserin Patent Rights to make and have
made Ketanserin Products anywhere in the world in order to import, use,
sell, offer for sale, and have sold Ketanserin Products in the Ketanserin
Semi-exclusive Countries in the Field.

     For purposes of this Agreement, the term “Semi-exclusive” shall mean with,
respect to a product, that at any given time only two entities may
commercialize such product in the country at issue, with such two entities
being (x) either JPPLP, or a single Affiliate of JPPLP, or a single third party
designated by JPPLP, on the one hand, and (y) either Barrier, or a single
Barrier Affiliate, or a single third party designated by Barrier, on the other
hand.

	 	1.6	 	Section 2.3(b) of the Original JPPLP Agreement is hereby
replaced in its entirety with the following:

JPPLP retains under the Ketanserin Patent Rights, (i) all rights to
import, use, sell, offer for sale, and have sold Ketanserin Products in
the JPPLP Ketanserin Countries, (ii) all rights to import, use, sell,
offer for sale, and have sold Ketanserin Products for anal fissures in
the Ketanserin Semi-exclusive Countries, (iii) the Semi-exclusive right
to import, use, sell, offer for sale, and have sold Ketanserin Products
in the Ketanserin Semi-exclusive Countries, (iv) all right to make and
have made the Ketanserin Products anywhere in the world in order to
import, use, sell, offer for sale, and have sold such Ketanserin Products
in the JPPLP Ketanserin Countries, and (v) the non-exclusive right to
make and have made the Ketanserin Products anywhere in the world in order
to import, use, sell, offer for sale, and have sold such Ketanserin
Products in the Ketanserin Semi-exclusive Countries.

	 	1.7	 	Section 2.5(c) of the Original JPPLP Agreement is hereby
replaced in its entirety with the following:

          (c) To the extent JPPLP owns or otherwise Controls any patents or patent
applications as of the Execution Date, other than those listed in Schedule
1.28, that generally or specifically claim a Ketanserin Product provided such
patents or patent applications contain composition of matter claims or methods
of manufacturing a Ketanserin Product, JPPLP hereby grants (if and to the
extent JPPLP has the right to do so) to Barrier a non-exclusive, royalty-free
license or sublicense, with the right to grant sublicenses (subject to Section
2.6 and Article 7) under such patents and patent applications, (i) to make,
have made, import, use, sell, offer for sale, and have sold Ketanserin Products
in the Ketanserin Exclusive Territory in the Ketanserin Field, and (ii) to
make, have made, import, use, sell, offer for sale, and have sold Ketanserin
Products in the Ketanserin Semi-exclusive Countries in the Field. Where JPPLP’s
rights are subject to a license with a third party, Barrier’s rights under such
license are subject to Barrier negotiating with JPPLP and/or the applicable
holder of the license and entering into an appropriate sublicense arrangement.

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	 	1.8	 	Sections 3.3 (c) and (d) of the Original JPPLP Agreement are
hereby replaced in their entirety with the following:

          (c) Subject to Section 3.3(d), at any time, and from time to time,
following the Execution Date, upon Barrier’s reasonable request, (i) JPPLP
shall provide Barrier with copies of specifically identified materials,
information and/or reports in its Control with regards to the Oxatomide Product
or the Itraconazole Product (including without limitation, correspondence with
Regulatory Authorities, side effect reports, internal question and answer and
audit reports, and post marketing surveillance reports) (collectively,
“Materials”) which Barrier needs in connection with Barrier’s submissions to a
Regulatory Authority for Products and (ii) JPPLP shall grant Barrier a “Right
of Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b) to any
requested Materials.

          (d) Notwithstanding Section 3.3(c), JPPLP shall be entitled to deny any
request for copies of Materials and/or deny any request for a “Right of
Reference or Use” to such Materials if JPPLP has a reasonable reason for doing
so and such reason is communicated to Barrier in writing within a reasonable
period of time following JPPLP’s receipt of such request.

	 	1.9	 	A new Section 3.3(e) is hereby added to the Original JPPLP
Agreement to read in its entirety as follows:

“At any time and from time to time, upon Barrier’s reasonable request,
JPPLP shall (i) provide to Barrier, without additional consideration,
copies of all data, materials, information and reports regarding a
Ketanserin Product generated by JPPLP or its Affiliates to support a
filing with a Regulatory Authority in a JPPLP Ketanserin Country or a
Ketanserin Semi-exclusive Country (collectively, “JPPLP Ketanserin
Know-How”) for Barrier’s use in connection with Barrier’s submissions to
a Regulatory Authority (a) for indications within the Ketanserin Field in
the Ketanserin Exclusive Territory and (b) for indications within the
Field for the Ketanserin Semi-exclusive Countries and (ii) grant to
Barrier all necessary “rights of reference” or similar documentation for
submission to a Regulatory Authority in connection therewith. For
clarity, JPPLP Ketanserin Know-How shall be included within the
definition of “JPPLP Know-How”. Barrier’s right to request (and “right
of reference” to), and JPPLP’s obligation to provide, JPPLP Ketanserin
Know-How shall terminate upon the first Regulatory Approval by a
Regulatory Authority of a Barrier Drug Approval Application for a
Ketanserin Product in a country within the Ketanserin Territory. Barrier
shall provide written notice to JPPLP of such first Regulatory Approval
within ten (10) days of its receiving such Regulatory Approval.

It is understood and agreed that the rights set forth in this Section
3.3(e) are in addition to and not a limitation of any rights of JPPLP or
Barrier set forth elsewhere in this Agreement.”

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	 	1.10	 	A new Section 3.3(f) is hereby added to the Original JPPLP
Agreement to read in its entirety as follows:

     “The parties acknowledge that Barrier may want JPPLP or its Affiliate to
manufacture Ketanserin Product for Barrier’s sale within the Ketanserin
Territory, other than the United States and Europe. If, within sixty (60)
days following JPPLP’s reciept of a written request from Barrier for JPPLP or
its Affiliate to manufacture Ketanserin Product for Barrier, Barrier and JPPLP
or its Affiliate are not able to agree to the terms of a defintive supply
agreement for such manufacturing of a Ketanserin Product, then JPPLP shall
promptly, and in any event within sixty (60) days following the end of such
sixty day period, deliver to Barrier all formulation and manufacturing
procedures and any analytical methods that have been developed that are
necessary for Barrier to manufacture Ketanserin Product. It is understood and
agreed that the rights set forth in this Section 3.3(f) are in addition to and
not a limitation of any rights of Barrier set forth elsewhere in this
Agreement.

2. Capitalized terms used herein and not otherwise defined shall have the
meanings given to them in the Original JPPLP Agreement.

3. Except as expressly amended herein, all terms and conditions of the Original
JPPLP Agreement shall remain in full force and effect.

4. All matters affecting the interpretation, validity, and performance of this
JPPLP Amendment shall be governed by the laws of the State of New York, USA,
without regard to its choice or conflict of law principles.

5. This JPPLP Amendment may be executed in one or more counterparts, each of
which shall for all purposes be deemed to be an original and all of which shall
constitute the same instrument. This JPPLP Amendment may be executed by
facsimile signature which shall have the same force and effect as the original
signatures.

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     IN WITNESS WHEREOF, and intending to be legally bound, the parties hereto
have caused this JPPLP Amendment to be executed by their duly authorized
representatives as of the date first set forth above.

	 	 	 	 	 
	JANSSEN PHARMACEUTICA PRODUCTS, L.P.	 	 
	 
	 	 	 	 
	By:

	 	JANET VERGIS	 	 
	

	 	
 	 	 
	 
	 	 	 	 
	Print Name:

	 	Janet Vergis	 	 
	 
	 	 	 	 
	Print Title:

	 	President	 	 
	 
	 	 	 	 
	 
	 	 	 	 
	BARRIER THERAPEUTICS, INC.	 	 
	 
	 	 	 	 
	By:

	 	AL ALTOMARI	 	 
	

	 	
 	 	 
	 
	 	 	 	 
	Print Name:

	 	Al Altomari	 	 
	 
	 	 	 	 
	Print Title:

	 	Chief Commercial Officer	 	 

6Exhibit 10.1
                                                                     -----------
  AMENDMENT TO THE AMENDED AND RESTATED EMPLOYMENT AGREEMENT DATED JUNE 6, 2003
  -----------------------------------------------------------------------------

          This  Amendment  to the Amended and Restated Employment Agreement (the
"2004  Amendment") is made and entered into as of the 9th day of September, 2004
                                                      --------------------------
(the  "Execution  Date"),  by  and  between  N-Viro International Corporation, a
Delaware  corporation  (the  "Company"), and Michael G. Nicholson, an individual
("Employee").
N-Viro
     W  I  T  N  E  S  S  E  T  H:
     -  -  -  -  -  -  -  -  -  -

          WHEREAS, the Company and Employee entered into an Amended and Restated
Employment  Agreement as of June 6, 2003 (the "2003 Employment Agreement"); and,
          WHEREAS,  the Company and Employee desire to amend the 2003 Employment
Agreement  upon  the  terms and subject to the terms and conditions set forth in
this  Amendment.
          NOW, THEREFORE, in consideration of the premises, the mutual promises,
covenants  and  conditions herein contained and in the 2003 Employment Agreement
and  for  other good and valuable considerations, the receipt and sufficiency of
which  are hereby acknowledged, the parties hereto intending to be legally bound
hereby  agree  as  follows:

SECTION  1.     Section  3 of the 2003 Employment Agreement is hereby deleted in
-----------
its  entirety  and  replaced  as  follows:
Section  3.     Capacity and Duties.  Employee shall be employed in the capacity
of Vice President of Sales (VP Sales) and Chief Development Officer (CDO) of the
Company  and  its  subsidiaries and affiliates and shall have such other duties,
responsibilities  and  authorities  as  are  assigned  to  him by the CEO of the
Company  so long as such additional duties, responsibilities and authorities are
consistent  with  Employee's position and level of authority as VP Sales and CDO
of  the  Company.  Employee shall report directly to the Chief Executive Officer
of  the  Company.  Subject  to  the  control and general directions of the Chief
Executive  Officer  of  the  Company  and  the  general  policies and guidelines
established by the Board and except as otherwise herein provided, Employee shall
devote  all  of  his  business  time,  best efforts and attention to promote and
advance  the  business of the Company and its subsidiaries and affiliates and to
perform  diligently  and  faithfully  all  the  duties,  responsibilities  and
obligations  set forth under this Employment Agreement.  Employee's duties shall
include  the  on-going  management  and  oversight  of  the  sales  and business
development  functions  for  the Company and its subsidiaries and affiliates and
shall  include,  but  not be limited to sales and marketing of both products and
processes,  business  development  of  same,  and  general  promotion,  all  in
accordance  with  national,  regional  and  local  policies  and  governmental
regulations  relating  to  water, wastewater management and the environment.  So
long  as  Employee  is  employed  by the Company, the Company shall use its best
efforts to cause the Nominating Committee of the Board or the Board, if there is
no  Nominating  Committee of the Board, to nominate Employee for reelection as a
director  of the Company for a two year term upon expiration of his current term
as  a  director  of  the Company and, if so nominated, Employee shall consent to
serve  as  a  director  if elected so long as that the company provides adequate
directors  and  officers  insurance.  If  the  company  chooses to eliminate the
directors  and  officers  insurance  the  employee may serve on the board at the
Employee's option.  During the Employment Period, Employee shall not be employed
in  any  other  business  activity,  whether or not such activity is pursued for
gain,  profit  or  other  pecuniary  advantage;  provided,  however,  that  this
restriction shall not be construed as preventing Employee from (i) investing his
personal  assets  in  a business that is not engaged in any Business Activities,
where  the  form  or  manner of such investment will not require services of any
significance  on  the  part  of  Employee in the operation of the affairs of the
business  in  which  such  investment  is made and in which his participation is
solely  that  of  a  passive  investor or advisor or (ii) being engaged in those
activities  listed on Exhibit 2 attached hereto; provided further, however, that
the  activities described in clause (ii) of this sentence shall not unreasonably
interfere  with  Employee's performance of his obligations under this Employment
Agreement.

SECTION  2.     The  parties  hereto  acknowledge that under the 2003 Employment
-----------
Agreement,  the  Company  granted  Employee options pursuant to Section 6.04 and
---
further  pursuant  to Exhibit 6.04 of such agreement, the Stock Option Agreement
---
(the  "2003  Option Agreement").  By circumstances beyond the reasonable control
of  either  party, the grant of options to Employee could not be fully completed
and expired until after the acceptance by the shareholders of the Company of the
N-Viro  International  2004  Stock Option Plan on May 12, 2004.  Accordingly, to
effectuate  the  intent of the parties at the time the 2003 Employment Agreement
was executed, the Company and Employee have now agreed to revise Section 6.04 of
the  2003  Employment Agreement, by deleting the first sentence of Section 6.04,
and  replacing  it  as  follows:
The  Company  shall grant to Employee the sole and exclusive right and option to
purchase Thirty Thousand (30,000) shares of the Common Stock, par value $.01 per
share, of the Company (the "Company Common Stock") at a price per share equal to
Ninety  Cents ($0.90), the closing sale price of the Company Common Stock on the
execution  date  of the 2003 Employment Agreement and upon the terms and subject
to  the  conditions  set forth in the form of the Amended Stock Option Agreement
attached hereto as Exhibit 2.1 (the "Amended Stock Option Agreement"), which the
Company  and  Employee  shall  each  execute  and deliver to the other as of the
execution  hereof.  Additionally,  the  Company shall grant to Employee the sole
and  exclusive  right  and option to purchase Twenty Thousand (20,000) shares of
the  Company  Common  Stock at a price per share equal to One Dollar Ninety-five
Cents  ($1.95), the closing sale price of the Company Common Stock on August 12,
2004  and  upon the terms and subject to the conditions set forth in the form of
the  Amended Stock Option Agreement.  Upon the vesting of such options, Employee
may  execute  such  options  at any time prior to or within two (2) years of the
termination  of  the  2003  Employment  Agreement or two years of the employee's
termination  of  employment  with  the  Company,  whichever  is  the later date.

SECTION  3.     Except  as otherwise amended specifically in Section and Section
-----------
2,  herein, and in the Amended Stock Option Agreement attached hereto and made a
part  hereof,  all sections of the 2003 Employment Agreement are affirmed by the
Company  and  Employee.

IN  WITNESS  WHEREOF,  this  2004 Amendment to the 2003 Employment Agreement has
been  duly  executed  by the Company and Employee in four (4) counterparts as of
the  date  first  above  written.

                              N-VIRO  INTERNATIONAL  CORPORATION

                              By     /s/  Phillip  Levin
                                     -------------------
                                   Phillip  Levin
                              Its     Chief  Executive  Officer
                                      -------------------------

                                By     /s/  Michael  G.  Nicholson
                                         -------------------------
                                   Michael  G.  Nicholson

<PAGE>
                                     ------
                                  EXHIBIT 6.04
                                  ------------

AMENDED  STOCK  OPTION  AGREEMENT

Pursuant  to  the  N-Viro  International  2004 Stock Option Plan, Mr. Michael G.
Nicholson  is  hereby  granted  30,000  options to purchase N-Viro International
Corporation Common Stock, at Ninety Cents ($0.90).  Such 30,000 options shall be
fully  vested in Employee as of August 12, 2004.  Further pursuant to the N-Viro
International 2004 Stock Option Plan, Mr. Michael G. Nicholson is hereby granted
20,000  options  to purchase N-Viro International Corporation Common Stock, at a
closing  price  determined  by  the  OTC on August 12, 2004, with 10,000 of such
options vesting on June 6, 2005 and the remaining 10,000 options vesting on June
6,  2006.

          IN  WITNESS  WHEREOF  the  parties have set their hands as of the date
first  above  written.

                              N-VIRO  INTERNATIONAL  CORPORATION

                              By     /s/  Phillip  Levin
                                     -------------------
                                   Phillip  Levin
                              Its    Chief  Executive  Officer
                                   ---------------------------

                                By     /s/Michael  G.  Nicholson
                                       -------------------------
                                   Michael  G.  Nicholson

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