Exhibit 10.55
Product Development and Patent License Agreement - Page 1
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
EXECUTION COPY
PRODUCT DEVELOPMENT AND
PATENT LICENSE AGREEMENT
BETWEEN
PAR PHARMACEUTICAL, INC.
AND
NORTEC DEVELOPMENT ASSOCIATES, INC.
Dated: As of October 22, 2003
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Product Development and Patent License Agreement - Page 2
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PRODUCT DEVELOPMENT AND PATENT LICENSE AGREEMENT
TABLE OF CONTENTS
1. Definitions.
1
2. Development of
New Products.
4
3. Par's
Exclusivity.
5
4. Patent and
Know-How License.
6
5. Compensation to
Nortec - Advance Payments and Royalties.
8
6. Additional
Obligations Relating to Product Development and Marketing. 9
7. Manufacture of
New Products.
10
8. Termination of
Development Rights.
12
9. Terminination of
License or Individual Product.
15
10. Confidentiality.
16
11. Representations and
Warranties.
16
12. Indemnification.
18
13. Limitation on Liability.
19
14. Ownership of Inventions.
19
15. Stock Options.
20
16. Publicity.
21
17. Force Majeure.
21
18. Arbitration.
22
19. Notices.
22
20. Miscellaneous.
23
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Product Development and Patent License Agreement - Page 3
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PRODUCT DEVELOPMENT AND PATENT LICENSE AGREEMENT
This
PRODUCT DEVELOPMENT
AND PATENT LICENSE
AGREEMENT (the "AGREEMENT")
is dated as of October 22, 2003 (the "Effective Date")and is between NORTEC
DEVELOPMENT ASSOCIATES, INC. ("NORTEC"), a
New Jersey corporation with an office
at 100 Spear Road, Ramsey, NJ 07446, and PAR
PHARMACEUTICAL,
INC. ("PAR"),
a
Delaware corporation with an office at 300
Tice Boulevard,
Woodcliff Lake, New
Jersey 07677.
BACKGROUND OF THIS AGREEMENT
Par
is in the business of manufacturing and selling generic
pharmaceutical products. Nortec is in the business of
developing pharmaceutical
products, including products utilizing the proprietary so-called "CPS
Technology". Par is interested in having Nortec develop a number of
pharmaceutical products for Par, and Nortec
desires to do so. Par and Nortec are
entering into this Agreement to set forth
the terms and
conditions under
which
Nortec will develop various pharmaceutical products for Par and arrange to
manufacture those products for clinical
testing and biostudies. In consideration
of the mutual promises set forth in this
Agreement, Nortec and
Par hereby agree
to the provisions of this Agreement.
1.
DEFINITIONS.
The
following terms shall
have the following
meanings when used in this
Agreement.
(a)
"ACTIVE MOIETY" means, with respect to any New Product, the
molecules
or ions having the chemical structure (the "Base Chemical
Structure") which
is
contained in and is responsible for the
physiological or pharmacological action
of that New Product. All salts (including salts with hydrogen or
coordination
bonds), esters, complexes, chelates, clathrates or other such
structures which
involve the Base Chemical Structure shall be understood to contain
such Active
Moiety, but such appended portions are not
part of the Active Moiety.
(b)
"ADVANCE PAYMENTS" is defined in Section 5(b) below.
(c)
"AFFILIATE"
with respect to any party means any
person, entity or
organization which either directly or
indirectly controls,
is controlled by, or
is under common control with that party.
For these purposes,
the term "control"
by a person, entity or organization means
possession by that person, entity or
organization of the power to direct, or
cause the direction of, any other entity
or organization.
(d)
"BULK PRODUCT" means
with respect to any New Product that product in
an oral solid dosage form, bulk packaged
for intermediate use in bulk containers
which will subsequently be packaged in its
final packaging form by Par for Par's
analytical stability studies and pilot and
pivotal bio equivalency studies.
(e)
"CONTRACT YEAR" means each consecutive 12-month period beginning on
the Effective Date of this Agreement.
(f)
"CPS OROCEL"
means CPS Orocel
LLC, a Delaware limited liability
company.
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(g)
"CPS PATENT RIGHTS" means collectively all rights licensed
by Nortec
from CPS Orocel under (1) United States
Patent Number 6,354,728 entitled "Device
for producing a pourable product with a
guide vane therein", issued on March 12,
2002; (2) United States Patent Number
6,449,869 entitled
"Device and Method for
Drying Pourable Products", issued September 17, 2002, (3)
Patent
Application,
entitled "Method of Preparing Biologically Active Formulations" filed with the
USPTO on December 12, 2002, and (4) application for a United States Patent
entitled "Method of Preparing Biologically
Active Formulations",
filed December
12, 2002, and reissues, extensions, continuations, continuations-in-part or
divisions of any of the foregoing.
(h)
"CPS TECHNOLOGY"
means the mechanism
and technique for
developing
pharmaceutical products utilizing what is termed "complex perfect sphere"
technology and which is currently the
subject of the CPS Patent Rights.
(i)
"DEVELOPMENT FEES" is defined in Section 8(c)(1) below.
(j)
"DEVELOPMENT WORK" is defined in Section 2(c)(ii) below.
(k)
"FDA" means the United States Food and Drug Administration.
(l)
"GAT" means Glatt Air Techniques, Inc., a New York corporation.
(m)
"KNOW-HOW" means any
idea, invention,
information,
data and other
know-how, whether or not patentable,
except that which is
otherwise claimed in
the CPS Patent Rights, which are owned by or to which
Nortec has rights to
or
develops or possesses on or after the date of this Agreement and which are
necessary or useful in the evaluation,
development,
registration,
manufacture,
use or sale of any of the New Products, including, but not limited to, the
following:
(1) copies of all
papers relating to patents applied for in the
Territory which relate in any way to any of the New Products;
(2) all data and/or information regarding the procedures for
manufacturing any of the New Products;
(3) all data and/or
information,
including summaries
and completed
case reporting
forms, concerning the testing, manufacture,
pharmacology and clinical use of any of the New Products; and
(4) the CPS
Technology
to the extent that it
is not claimed in the
CPS Patent Rights.
(n)
"MODIFIED ROYALTIES" is defined in Section 8(c)(2) below.
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(o)
"NET SALES"
with respect to any New Product means the amounts
invoiced in the first bona fide arm's-length sales of that New Product to
independent unaffiliated third parties by PAR and or by any affiliate or
designee of Par, less the following deductions in each case to the extent
related specifically to that New Product: (i) any sales, use or excise taxes
included in such amount, (ii) discounts allowed and taken, (iii) amounts
refunded or credited by reason of returns,
allowances
for retroactive price
adjustments, or payments made by Par to
independent
unaffiliated third parties
as part of rebate arrangements, (iv) charges for freight, handling and
transportation separately itemized on the
invoice; and (v)
charge-back rebates
and state or federal Medicare or Medicaid rebates. In the event that a New
Product is sold to a customer at a discount
which exceeds the discounts afforded
such customer for other Par pharmaceutical
products, the Net Sales of that New
Product to such customer shall be deemed to be the
average undiscounted Net
Sales of that New Product to all customers
for the period in question discounted
to a level consistent with the average discount afforded to such customer on
other pharmaceutical products.
(p)
"NEW PRODUCT" means any bulk or finished pharmaceutical product
which
is developed or manufactured by Nortec and/or its Affiliates
pursuant to this
Agreement.
(q)
"NORTEC HOLDING" means Nortec Holding LLC, a Delaware limited
liability company that, as of the date of this Agreement, is the sole
shareholder of Nortec.
(r)
"PRIORITY LIST" is defined in Section 3(b) below.
(s)
"RIGHTS TERMINATION" is defined in Section 8(a) below.
(t)
"ROYALTIES" is defined in Section 5(c) below.
(u)
"STOCK PURCHASE
AGREEMENT" means the Stock Purchase and Shareholders
Agreement, dated as of the date of this
Agreement, among Par, Nortec Holding and
Nortec.
(v)
"THIRD PARTY CONTRACT" is defined in Section 4(e) below.
(w)
"TWO EXISTING
AGREEMENTS" means collectively (1) the Patent and Know
How License Agreement, dated as of May 24,
2002, between Par and Nortec relating
to the development, manufacture and sale of a ********* ******* **********
product and (2) the Patent and Know How
License Agreement,
dated as of June 14,
2002, between Par and Nortec relating to
the development,
manufacture and sale
of a ********* ******* ***********
product.
(x)
"TERRITORY" means Canada and the United States of America,
including
its territories and possessions, and the
Commonwealth of Puerto Rico.
2.
DEVELOPMENT OF NEW PRODUCTS.
(a)
During each Contract Year, Par shall have right to ask Nortec
to
start Development Work on up to three New
Products selected by Par in Par's
reasonable discretion. Par shall make a
good faith effort to ask Nortec to start
Development Work on at least one New
Product each year during the first four
Contract Years. Nortec agrees that it will
develop such New Products for Par, up
to a maximum of twelve New Products, and Nortec shall begin that Development
Work on such New Products reasonably promptly after being
requested to do so by
Par.
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(b)
Par shall supply to Nortec all active pharmaceutical ingredients and
inactive raw material ingredients reasonably required for Nortec's
Development
Work in connection with each New Product and for
Nortec's manufacture
of Bulk
Product for Par's pilot and pivotal bio
equivalency studies (referred to here as
"CLINICAL SUPPLIES MANUFACTURING") under this Agreement. Par shall use
reasonable commercial efforts to provide in a timely manner all analytical
testing services that are required to
support Nortec's
development and Clinical
Supplies Manufacturing activities under this Agreement.
Nortec will notify
Par
in writing of its requirement for materials, and Par will furnish those
materials in a timely manner. Nortec will not charge any
additional
fee for
manufacturing Bulk Product for the pilot
and pivotal biostudies, other than the
amounts otherwise set forth in this
Agreement.
(c)
Nortec shall develop each New Product in accordance with a
development plan, as follows:
(1) As soon as reasonably practicable following identification of
each New Product for development by Nortec, Par and Nortec shall prepare a
mutually acceptable plan for the
development of such
New Product (referred
to
here as the "DEVELOPMENT PLAN"). Each Development Plan shall set forth in
writing in reasonable detail the
responsibilities
of Nortec in
developing such
New Product which shall be responsibilities typical in pharmaceutical
product
development, including relevant
deliverables and timelines. Nortec and Par shall
work together to mutually work out the
details of each Development Plan.
(2) Nortec shall
develop each New
Product in accordance
with the
Development Plan for that New Product; such work by Nortec is
referred to in
this Agreement as the "DEVELOPMENT
WORK".
(3) Nortec shall use its commercially reasonable efforts to perform
the Development Work for each New Product in accordance with the timelines
provided in the Development Plan for that New Product and deliver the
deliverables to Par as provided in that
Development Plan.
(4) Nortec shall keep Par fully informed of its progress
toward the
completion of the Development Work for each New Product and Par shall keep
Nortec informed regarding its supply of
materials and its regulatory activities.
(5) Nortec
shall maintain complete and proper records of its
Development Work for each New Product.
(d)
Nortec shall provide all documents and information in its possession
that are reasonably required by Par to support Par's
filing and prosecution
of
an ANDA or other application with the FDA
to register any New Product. Any such
application shall be owned by Par and
submitted in its name, and Par shall have
the final authority with respect to all decisions concerning the content,
compilation, prosecution, amendment or
supplementation of any such ANDA. Nortec
shall not have any obligation to carry out
any analytical, stability or clinical
studies in connection with its duty to provide
information
to Par that Nortec
has in its possession. Nortec shall exercise diligent efforts to assist Par
in
the review and compilation of reports to be included in any such ANDA
application. Nortec shall have the right to
consult with Par with respect to the
preparation of any such ANDA for any New
Product to be filed with the FDA.
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(e)
Each party shall provide the other party with all information in its
possession or control that is necessary
for the other party to
comply with any
applicable reporting requirements. Each party shall promptly notify
the other
party of any comments, responses or notices received from, or inspections
by,
the FDA or other applicable competent
authorities which
relate to or may impact
a New Product. Each party shall promptly
inform the other party of any responses
to such comments, responses, notices or inspections
and the resolution of
any
issue raised by the FDA or other competent
authorities.
3.
PAR'S
EXCLUSIVITY.
(a)
Commencing on the date that Par asks Nortec to begin development
work
on any New Product, Nortec shall not, and shall cause its Affiliates not to,
develop, make, have made, sell, offer for sale, distribute or otherwise make
available (or contract with any third party
to do any of the foregoing) that New
Product or any other pharmaceutical product that has the same Active
Moiety as
that New Product in the Territory for its
own (or such
Affiliates own)
benefit
or for any other party. The prohibition in the preceding sentence shall
automatically end, however, with respect to any New Product
(i) immediately if
and when Par abandons all work involving that New Product under this
Agreement
pursuant to Section 9(b) below or (ii) one year
following the expiration or
termination of this Agreement with respect to that New Product for
any other
reason. For the avoidance of doubt, nothing in this Section 3(a) shall
in any
way limit or prohibit Nortec or any Affiliate of Nortec from (1) developing,
making, having made, selling, offering for sale, distributing or otherwise
making available (or contracting with any third party to do any of the
foregoing) any pharmaceutical product that competes with that
New Product, as
long as that pharmaceutical product does not contain the same
Active Moiety as
that New Product, and (2) manufacturing,
developing,
selling, distributing or
servicing any Non-CPS Equipment, or providing technical support for any such
equipment, even if that equipment is utilized
by any other party to manufacture
any pharmaceutical product that is the same as that
New Product or has the same
Active Moiety as that New Product.
Non-CPS Equipment is equipment
that is not
being provided specifically to a customer for the manufacture of products
embodying the CPS Technology
(b)
Within 90 days after the date of this Agreement, Par shall provide
to
Nortec a written list (referred to here as
the "PRIORITY LIST")
that identifies
up to twelve drugs. Within 45 days after receiving the Priority
List, Nortec
will notify Par if Nortec or any of its
Affiliates have
previously granted
any
option, right or license to any third
person or entity with
respect to any of
CPS Patent Rights or Know-How relating to the manufacture, use or sale within
the Territory of any drugs identified in that Priority List;
in that event, any
such drug shall be removed from the
Priority List, and Par shall have the right,
within 45 days thereafter, to substitute a different drug for
the drug that is
so removed from the Priority List. In the event that any third party
requests
that GAT or any Affiliate of GAT (including
CPS Orocel) begin
discussions which
would involve GAT or that Affiliate developing or producing any drug that is
identified on the Priority List utilizing the CPS Technology, Nortec shall
promptly notify Par of that request. That notice will identify only the drug
involved; that notice will not identify the
third party. Par shall have fifteen
business days after receiving that notice to provide a notice to
Nortec which
sets forth a request for Nortec to begin
development
work (pursuant to
Section
2(a) above) on a New Product that
utilizes that drug. If Par provides such a
notice within that 15-business day period,
then Nortec shall
begin development
work on that New Product for Par
(pursuant to Section
2(a) above), and
Nortec,
GAT and their respective Affiliates shall not perform or
permit to be performed
by their Affiliates any development work or production of any product that
utilizes the drug for that third party or
for any other party.
If Par does not
provide such a notice within that
15-business day period, then that drug will be
automatically and permanently be removed from
the Priority List, and thereafter
Nortec, GAT and their Affiliates may
conduct development
work and production of
any product utilizing the CPS technology involving that drug for that third
party or for any other party. The
restriction set forth in the fifth sentence of
this Section 3(b) shall automatically end,
however, with respect
to any drug if
and when Par abandons all work under this
Agreement involving the New Product
that utilizes that drug.
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4.
PATENT AND
KNOW-HOW LICENSE.
(a)
Subject to the terms and conditions of this Agreement, Nortec hereby
grants to Par, and Par hereby accepts, a license of the CPS Patent
Rights and
the Know-How to make, import, use and sell each of the New
Products in the
Territory. No license is granted for any
other product
than the New
Products
that are developed by Nortec pursuant to Section 2 above. No
license is granted
for any New Product anywhere outside the
Territory. Except as otherwise provided
in Sections 8 or 9 below, this license with respect to any New Product
shall
remain in effect (1) with respect to any
patent, until the
expiration
of that
patent, including any reissues, extensions,
continuations, continuations-in-part
or divisions of that patent, and (2) with respect to any
Know-How, for as
long
as Par is manufacturing and marketing that
New Product.
(b)
Except as provided
in the next
sentence, the license set forth in
Section 4(a) above is exclusive; in other words, for as long as that license
remains in effect under Section 4(a) above with respect to any New Product,
Nortec and its Affiliates shall not grant to any other
person or entity
any
license to use the CPS Patent Rights or the Know-How anywhere within the
Territory for the purpose of making,
using or selling
that New Product or
any
other pharmaceutical product that contains the same Active Moiety as
that New
Product; provided, however, that nothing herein shall prevent Nortec and
its
Affiliates from generally selling, distributing or servicing any Non-CPS
Equipment, or providing technical support for
any such equipment,
even if that
equipment is utilized by any other party to manufacture any pharmaceutical
product that is the same as that New
Product or has the same Active Moiety as
that New Product. The license set forth in Section
4(a) above
shall become
non-exclusive with respect to any New Product if at
any time after three years
from the date of the launch of that New Product, the Net Sales of that New
Product fall below *** of the total
generic solid dosage market for the drug
that is contained in that New Product; in that event, Nortec shall have the
right to grant to third parties
non-exclusive licenses
to the CPS Patent Rights
and Know-How in the Territory relating to that New Product under
such terms and
conditions as Nortec deems appropriate.
(c)
Within 14 days after Par asks Nortec to start development work on a
New Product (pursuant to Section 2(a) above), Nortec will disclose to Par,
subject to the confidentiality provisions
of Section 10 below, all then-existing
Know-How not previously disclosed to PAR to the extent
necessary for Par to
describe the manufacture of that New Product in
connection
with any ANDA or
equivalent document. Thereafter, Nortec shall promptly
identify and disclose to
PAR, to the extent PAR requests disclosure,
any new or additional Know-How which
comes into the possession or control of
Nortec or any of its
Affiliates, again
subject to Section 10 below and to the
extent necessary for
Par to describe the
manufacture of that New Product in connection with any ANDA or equivalent
document. Nortec shall provide to Par, at no additional cost to Par, such
assistance as Nortec deems necessary for
Par to describe the manufacture of that
New Product under this Agreement.
(d)
Par hereby acknowledges that it does not have, and shall not
acquire,
any interest in any trademarks or trade names owned or
licensed by Nortec,
GAT
or any of their Affiliates that may appear
on the labels or packaging materials
for any New Product.
(e)
Except as expressly
provided in this
Section 4(e), Par shall not
assign or sublicense all or any portion of this
Agreement or all or any portion
of the license set forth in Section 4(a)
above without the prior written consent
of Nortec, which consent shall not be
unreasonably withheld.
Par may, however,
enter into one or more contracts with third
parties (referred to
here as "THIRD
PARTY CONTRACTS") pursuant to which those third
parties have the right to sell
one or more New Products, subject to the limitations set
forth in subparagraphs
(1) through (5) below, inclusive.
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If those limitations
are satisfied with
respect to any Third Party
Contract, then Par shall have the right to
sublicense the CPS Patent Rights and
the Know-How to the third party under that
Third Party Contract
solely for the
purpose of enabling that third party to sell any New
Product that is covered by
such Third Party Contract. The applicable
limitations are as follows:
(1) Any such sublicense of the CPS Patent Rights and Know-How to
any
such third party is subject to the prior written consent of Nortec for each
subject New Product, which consent shall not be unreasonably withheld or
delayed;
(2) Prior to entering into any such Third Party Contract,
Par shall
consult with Nortec regarding the proposed Third Party Contract and shall
provide Nortec with such information as Nortec may
reasonably request
relating
to that proposed Third Party Contract;
(4) Par shall remain
fully liable for all
obligations
under this
Agreement, notwithstanding any sublicense
set forth in any Third Party Contract;
and
(5) Par shall not, and
shall not have any right to, sublicense or
assign any other rights under this Agreement, including without limitation
providing a sublicense to develop or
manufacture any products utilizing the CPS
Patent Rights or the Know-How, sublicensing
or assigning any right under Section
7(c) below to purchase any equipment that embodies the CPS Technology, or
assigning any right to utilize any equipment purchased by Par pursuant to
Section 7(c) below.
5.
COMPENSATION TO NORTEC - ADVANCE PAYMENTS AND ROYALTIES.
(a)
In consideration for the services to be provided by Nortec under
this
Agreement and the license of the CPS Patent
Rights and
Know-How set forth in
this Agreement, Nortec hereby acknowledges that Par has paid to Nortec
the
amount of Five Hundred Thousand Dollars ($500,000) and Par shall
additionally
pay to Nortec the Advance Payments set forth in Section 5(b) below and the
Royalties set forth in Section 5(c)
below.
(b)
Par shall pay to Nortec payments (referred to here as "ADVANCE
PAYMENTS") totaling Two Million Five Hundred
Thousand Dollars
(US$2,500,000).
Par will pay the Advance Payments as follows: $500,000 on each of October
15,
2003, December 15, 2003, June 15, 2004,
September 15, 2004,
January 15, 2005.
[In economic terms, the Advance Payments
represent advance payments of royalties
that would otherwise have been payable with
respect to the New Products.]1
(c)
Par shall pay to Nortec a royalty
(individually
a "ROYALTY" and
collectively the "ROYALTIES") with respect to each New Product
based on the Net
Sales and the market share of that New
Product, as shown in the following table:
------------------------------------------------------------------------------
ROYALTY AMOUNT FOR EACH
PAR'S MARKET SHARE (MS) OF THE TOTAL
NEW PRODUCT
SUSTAINED RELEASE SOLID DOSAGE MARKET FOR
(% OF NET SALES)
THAT NEW PRODUCT
------------------------------------------------------------------------------
**%
MS > **%
-
------------------------------------------------------------------------------
****%
**% > MS > **%
-
------------------------------------------------------------------------------
*%
**% > MS > **%
-
------------------------------------------------------------------------------
***%
**% > MS > **%
-
------------------------------------------------------------------------------
***%
MS < **%
------------------------------------------------------------------------------
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For
these purposes,
the market share of
each New Product shall be based
on the total sales reported for that New Product
divided by the total
sales of
the branded and generic products in all dosage forms, as
reported by IMS at the
end of each calendar year
(d)
In the event
that Par enters into any Third Party Contract as
permitted pursuant to Section 4(e) above, then solely for purposes of
calculating the Royalty applicable to sales
of New Product made by a third party
under that Third Party Contract, Par shall pay to Nortec the
Royalty shown in
the table in Section 5(c) above,
with the "Net Sales"
in that case equal to the
total consideration (both cash and non-cash)
received by Par under
that Third
Party Contract.
(e)
Par shall pay
Royalties to Nortec
with respect to each
New Product
during such time as Par (or its
subcontractor)
offers the New Product
for sale
in the Territory until the date that is
fifteen (15) years from the date of
final FDA approval to market such New
Product in the
Territory. Par shall
pay
the Royalty to Nortec with respect to each
New Product within 45
days after the
end of each calendar quarter based on the Net Sales of that New
Product made
within that calendar quarter and based on
Par's reasonable estimate at that time
of the market share of that New Product. If at any time after making any
quarterly payment Par or Nortec determines
that the actual market share of that
New Product is different than the market share that was used by Par in
determining the amount of that payment,
Par and Nortec shall
promptly make an
appropriate payment to the other to account for that difference. Any other
discrepancies in the calculation and payment of
the Royalty shall be reconciled
promptly after the delivery of each
quarterly sales report
pursuant to
Section
6(e) below.
(f)
While this Agreement
is in effect and for a period of six (6) months
thereafter, Nortec shall have the right at its
expense to have an
independent
certified public accounting firm reasonably acceptable to Par examine the
records described in Section 6(e) below
(excluding those records, if any, which
relate to the qualitative commentary of Section 6(e) below)
and Section 5.2(c)
above. Nortec may have those records
examined during reasonable business hours,
not more often than once each calendar year for then-current year and for
then-preceding three (3) years. That examination shall be made for the sole
purpose of determining whether the amount of the
Royalties has been
correctly
calculated and paid. That independent
certified public
accounting firm shall be
required to treat as confidential,
and not disclose to
Nortec, any
information
that it has obtained, except such information which
would properly be contained
in a sales report provided by Par to Nortec
under this Agreement.
In addition,
that independent certified public accounting firm shall not disclose to any
other party any information obtained as a
result of such examination, except as
may be required by binding legal process or
government
requirements,
and then
only on reasonable prior notice and in
consultation with Par.
6.
ADDITIONAL OBLIGATIONS
RELATING TO PRODUCT DEVELOPMENT AND MARKETING.
The
provisions
of this Section 6 shall apply with
respect to each
New
Product starting on the date that Par asks
Nortec to start
development work on
that New Product until such time that Par
abandons all work
involving that New
Product under this Agreement.
(a)
PROCEDURES
FOR FILING AN ANDA. (1) Par shall use reasonable
commercial efforts to prepare, compile and submit an ANDA for
each New Product
in the Territory and, following such
submission, Par shall
diligently prosecute
that ANDA with the FDA with a view to
obtaining timely approval for that New
Product.
<PAGE>
Product Development and Patent License Agreement - Page 11
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH SECURITIES AND EXCHANGE COMMISSION
ASTERISKS DENOTE SUCH OMISSION
(2)
At such time or times as may be reasonably requested by Nortec, Par
shall provide Nortec with written
reports on its efforts
to obtain from the FDA
marketing approval in the Territory for
that New Product,
including
supporting
documentation reasonably requested by Nortec. Nortec shall have the right to
inspect the ANDA and associated
correspondence for
each New Product at any time
on prior notice during normal business
hours during the term of this Agreement.
(b)
MARKETING EFFORTS.
Par will use
reasonable
commercial
efforts to
market each New Product in the Territory
during the term of the
Agreement. Par
shall furnish and label each New Product in
compliance with the
specifications
and requirements set forth in the FDA's
marketing approval documents.
(c)
ADVERSE DRUG REACTIONS. Par and Nortec shall promptly, after
learning
thereof, notify the other in writing of any
report of adverse,
or possible or
suspected adverse, effects of any New
Product. Whenever
either party intends to
report th
