Exhibit 10.1   




Confidential treatment has been
requested for portions of this exhibit. The copy filed herewith omits the information
subject to the confidentiality request. Omissions are designated as [*]. A complete
version of this exhibit has been filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 



LICENSING AND
DISTRIBUTION AGREEMENT  



by and between  



BRADLEY
PHARMACEUTICALS, INC.  



and  



PAR PHARMACEUTICAL,
INC.  







* * *  



DOXYCYCLINE
MONOHYDRATE  




* * *  



DECEMBER 13, 2005  





 
	 	 
	 
















TABLE OF CONTENTS  



	  	  	  	 Page
        

	 1.	 DEFINITIONS	 2
	  	  	  	  
	 2.	 LICENSE GRANT	 4
	  	 2.1	 License Grant	 4
	  	  	  	  
	 3.	 GENERIC PRODUCT DEVELOPMENT,
        MANUFACTURING AND DISTRIBUTION	 4
	  	 3.1	 Change of Tablet and Capsule Imprint	 4
	  	 3.2	 Appointment; Commercial Launch; Supply and
        Distribution	 4
	  	 3.3	 Packaging	 5
	  	  	  	  
	 4.	 FINANCIAL TERMS	 6
	  	 4.1	 Cost of Tablet and Capsule Imprint Change	 6
	  	 4.2	 Cost of Obsolete Inventory	 6
	  	 4.3	 Net Profit Split	 6
	  	 4.4	 Late Payments	 6
	  	 4.5	 Change in Circumstances	 7
	  	  	  	  
	 5.	 CERTAIN UNDERTAKINGS	 7
	  	 5.1	 Generic Product Complaints and Adverse Drug
        Experiences	 7
	  	 5.2	 Generic Product Recall	 7
	  	 5.3	 Facility Maintenance; Inspection; Reports	 8
	  	 5.4	 Filing Requirements and Maintenance	 9
	  	 5.5	 Insurance	 9
	  	 5.6	 Audit Right	 9
	  	 5.7	 Publicity	 9
	  	  	  	  
	 6.	 WARRANTIES; INDEMNIFICATION; AND
        LIMITATION OF LIABILITY	 10
	  	 6.1	 Certain Representations, Warranties and Covenants
        of Par	 10
	  	 6.2	 Certain Representations, Warranties and Covenants
        of Bradley	 11
	  	 6.3	 Representation and Warranties with Regard
        to Status	 11
	  	 6.4	 Par’s Indemnification Obligations	 11
	  	 6.5	 Bradley’s Indemnification Obligations	 12
	  	 6.6	 Indemnification Procedures	 12
	  	  	  	  
	 7.	 TERM AND TERMINATION	 13
	  	 7.1	 Term	 13
	  	 7.2	 Termination for Breach	 13
	  	 7.3	 Termination for Bankruptcy	 13
	  	 7.4	 Termination for Change in Circumstances	 13
	  	 7.5	 Post-Termination	 13
	  	  	  	  





 
	 	 
	 














TABLE OF CONTENTS 
(continued) 





	  	  	  	 Page
        

	 8.	 CONFIDENTIALITY	 14
	  	 8.1	 Treatment of Confidential Information	 14
	  	 8.2	 Limits on Disclosure	 14
	  	  	  	  
	 9.	 FORCE MAJEURE	 15
	  	 9.1	 Effects of Force Majeure	 15
	  	 9.2	 Notice of Force Majeure	 15
	  	  	  	  
	 10.	 MISCELLANEOUS	 15
	  	 10.1	 Dispute Resolution	 15
	  	 10.2	 Independent Contractors	 15
	  	 10.3	 Assignment	 16
	  	 10.4	 Governing Law; Waiver of Jury Trial	 16
	  	 10.5	 No Implied Waiver	 16
	  	 10.6	 Notice	 16
	  	 10.7	 Amendments	 17
	  	 10.8	 Counterparts	 17
	  	 10.9	 Interpretation	 17
	  	 10.10	 Entire Agreement	 17
	  	 10.11	 Benefit; Binding Effect	 18
	  	 10.12	 Survival	 18
	  	 10.13	 Further Assurances	 18
	  	 10.14	 Severability	 18







 
	 	
ii	 















LICENSING AND
DISTRIBUTION AGREEMENT  



        This
LICENSING AND DISTRIBUTION AGREEMENT (this “Agreement”), dated December
13, 2005, by and between BRADLEY PHARMACEUTICALS, INC., a Delaware corporation with an
address at 383 Route 46 West, Fairfield, New Jersey (“Bradley”), and PAR
PHARMACEUTICAL, INC., a Delaware corporation with an address at One Ram Ridge Road, Spring
Valley, New York (“Par”). 



        WHEREAS,
Par has developed certain intellectual property, including its rights under the ANDAs (as
defined below), necessary or useful to make, use and sell the pharmaceutical product
identified on Exhibit A hereto (the “Product”); 



        WHEREAS,
  Par and Bioglan Pharma, Inc. (now known as BPI Corp.), a Delaware corporation
  (“Bioglan”), have entered into that certain Distribution Agreement,
  dated as of December 27, 2000 (the “Original Agreement”),
  relating to the supply and distribution of doxycycline monohydrate tablets and
  capsules; 



        WHEREAS,
Par, Bioglan and Quintiles Ireland Limited, a company incorporated in the Republic of
Ireland (“Quintiles”), have entered into that certain Assignment of
Distribution Agreement (the “Assignment”), pursuant to which, among other
matters, (i) Bioglan assigned all of its right, title and interest in and to the
Original Agreement to Quintiles, (ii) Quintiles assumed certain obligations of
Bioglan under the Original Agreement, (iii) Par consented to the foregoing assignment
and assumption and (iv) the parties amended certain provisions of the Original
Agreement, all as set forth therein; 



        WHEREAS,
Par and Quintiles have entered into that certain Second Amendment to Distribution
Agreement and First Amendment to Assignment of Distribution Agreement, dated as of
September 11, 2003, pursuant to which Par and Quintiles amended the Assignment and
further amended the Original Agreement, as amended, all as set forth therein; 



        WHEREAS,
Par and Quintiles have entered into that certain Third Amendment to Distribution
Agreement, dated as of April 13, 2004, pursuant to which Par and Quintiles further
amended the Original Agreement, as amended, all as set forth therein; and 



        WHEREAS,
  pursuant to that certain Consent and Agreement, dated as of July 9, 2004,
  Quintiles assigned all of its right, title and interest in and to the Original
  Agreement, as amended, to Bradley (the Original Agreement, as amended by the
  Assignment, the Second Amendment, the Third Amendment and the Consent and Agreement,
  and as may hereafter be amended from time to time, is hereinafter referred to
  as the “Amended Agreement”); 



        WHEREAS,
pursuant to the Amended Agreement, Bradley is having made, selling and distributing the
Product under the brand name Adoxa® (the “Branded Product”); and 



        WHEREAS,
Par desires to license from Bradley certain rights licensed to Bradley under the Amended
Agreement, and Bradley desires to grant Par such rights, to enable Par and its Affiliates
and designee(s) to manufacture and distribute in the Territory a generic (non-branded) 





 
	 	
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version of the Product in all strengths and dosage forms under the ANDA except 50 mg
and 100 mg capsules (the “Generic Product”), all upon the terms and
conditions set forth herein. 



        NOW,
THEREFORE, in consideration of the foregoing premises and the mutual covenants and
obligations contained herein, Par and Bradley hereby agree as follows: 


       1.
  DEFINITIONS


        “Act”
means the Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the
rules and regulations promulgated thereunder. 



        “Affiliate”
means, with respect to any Person, any other Person controlled by, controlling or under
common control with such Person, where control means more than 50% ownership or voting
rights and/or the power to direct management or policy. 



        “Amended
  Agreement” has the meaning set forth in the recitals hereto. 



        “ANDA”
means either, and “ANDAs” means both, of the abbreviated new drug
applications numbers 065055 and 065070 filed by Par and maintained by the ANDA Holder with
the FDA for the manufacture and sale of the Product in the Territory, as the same may be
supplemented and/or amended from time to time. 



        “ANDA
Holder” means Par, unless and until such time as the applicable ANDA is purchased
by Bradley, at which time the ANDA Holder with respect to such ANDA for purposes hereof
shall mean Bradley. 



        “Branded
Product” has the meaning set forth in the recitals hereto. 



        “cGMP”
means the current Good Manufacturing Practices regulations of the FDA (as in effect from
time to time) contained in 21 C.F.R. pts. 210 and 211. 



        “Commercial
Launch” has the meaning set forth in Section 3.2(b) hereof. 



        “Confidential
Information” means any information that in any way shall relate to a party hereto
or an Affiliate thereof, including its products, business, know-how, methods, trade
secrets, business and marketing strategies, customer lists and technology, that shall be
furnished or disclosed to the other party, on a confidential basis, in connection with
this Agreement, and any other information that would be reasonably recognized as
confidential or proprietary information; provided, however, that
Confidential Information shall not include any information: 



        (i)
  that, at the time of its disclosure, is generally available to the general industry;
  



        (ii)
  that, after its disclosure in connection herewith, becomes generally available
  to the general industry, except as a result of a breach of this Agreement by
  the recipient of such information; 





 
	 	
2	 
















        (iii)
  that becomes available to the recipient of such information from a third party
  that is not legally or contractually prohibited from disclosing such Confidential
  Information; or 



        (iv)
  that the recipient of which can demonstrate was developed by or for such recipient
  independently of, and without the use of, the Confidential Information disclosed
  to the recipient by the disclosing party or its Affiliates in connection herewith.
  



        “Cost
of Goods” means Par’s fully-allocated cost of goods of manufacturing,
packaging and labeling the Generic Product, including a proportionate share of overhead
but excluding marketing expenses, all calculated in accordance with GAAP. The Cost of
Goods shall include the price paid by Par to any third-party subcontractor (if any) for
manufacturing, packaging and/or labeling of the Generic Product. 



        “Effective
Date” means the date of this Agreement as written above. 



        “FDA”
means the United States Food and Drug Administration or any successor government agency. 



        “First
Commercial Sale” means the first sale of the Generic Product under this Agreement
by Par or its Affiliate in an arms’ length transaction to an unaffiliated third
party, which shall constitute commencement of the Commercial Launch. 



        “Force
Majeure Event” has the meaning set forth in Section 9.1 hereof. 



        “GAAP”
means U.S. generally accepted accounting principles. 



        “Generic
Product” has the meaning set forth in the recitals hereto. 



        “Gross
Margin” means Net Profit divided by Net Sales, expressed as a percentage (i.e.,
multiplied by 100). 



        “Ineligible
Person” has the meaning set forth in Section 6.3(a) hereof. 



        “Initial
Term” has the meaning set forth in Section 7.1 hereof. 



        “Intellectual
Property” has the meaning set forth in the recitals hereto. 



        “Launch
Quantities” has the meaning set forth in Section 4.2 hereof. 



        “Losses”
has the meaning set forth in Section 6.4 hereof. 



        “Net
Profit” means Net Sales less Cost of Goods. 



        “Net Profit
Split” has the meaning set forth in Section 4.3 hereof. 



        “Net
Sales” means the gross revenues invoiced by Par and derived from sales of the
Generic Product in the Territory by Par and its Affiliates, less (a) all customary
discounts, including cash and volume discounts, chargebacks, allowances, shelf stock
adjustments, rebates  




 
	 	
3	 














(including Medicaid, Medicare and similar rebates), returns, credits,
sales rejections and price protection adjustments, and (b) all customary freight,
shipping, insurance costs, duties and taxes; all of the foregoing calculated in accordance
with GAAP. 



        “Obsolete
Inventory” means inventory of the Generic Product having expiry dating of twelve
(12) months or less. 



        “Product”
has the meaning set forth in the recitals hereto. 



        “Person”
means a natural person, corporation, partnership, company or other entity. 



        “Renewal
Term” has the meaning set forth in Section 7.1 hereof. 



        “Specifications”
means the terms, requirements and conditions applicable to the Product and described in
the applicable ANDA, as the same may be supplemented and/or amended from time to time, and
as required by United States Pharmacopeia. 



        “Term”
has the meaning set forth in Section 7.1 hereof. 



        “Territory”
means the United States of America, together with its territories, possessions and
protectorates. 



        “Trademarks
and Copyrights” shall have the meaning set forth in Section 3.3(c) hereof. 



        2.
LICENSE GRANT 



        2.1
License Grant. Bradley hereby grants to Par and its Affiliates an exclusive,
royalty-bearing license of its rights under the Amended Agreement to make, have made, use,
import, offer for sale, sell and distribute the Generic Product in the Territory during
the Term. 



        3.
GENERIC PRODUCT DEVELOPMENT, MANUFACTURING AND DISTRIBUTION 



        3.1
Change of Tablet and Capsule Imprint. Par shall, subject to FDA approval, change
the tablet and capsule imprint of the Generic Product to differentiate the Generic Product
from the Branded Product. The tablet and capsule imprint of the Generic Product shall be
determined by Par, subject to Bradley’s consent, which shall not be unreasonably
withheld, conditioned or delayed. 



        3.2
Appointment; Commercial Launch; Supply and Distribution. (a) Bradley hereby
appoints Par as its sole and exclusive distributor for the Generic Product in the
Territory, and Par hereby accepts such appointment and agrees to act as such sole and
exclusive distributor, all upon the terms and conditions set forth herein. During the
Term, Bradley shall not market, promote, encourage, exploit, offer to sell, sell or
otherwise dispose of any generic (non-branded) doxycycline monohydrate tablet or capsule
product that is A/B rated to the Product, except in any dosage form and strength not
covered by this Agreement, (i) within the Territory or (ii) outside the 





 
	 	
4	 















Territory where it knows such product will be distributed within the Territory. During the
Term, Par shall not market, promote, encourage, exploit, offer to sell, sell or otherwise
dispose of any generic (non-branded) doxycycline monohydrate tablet or capsule product
that is A/B rated to the Product, except in any dosage form and strength not covered by
this Agreement, (i) within the Territory or (ii) outside the Territory where it
knows such product will be distributed within the Territory. 



        (b)
  Par shall have the discretion to launch such combinations of Generic Product
  strengths and dosage forms as it chooses, subject to Bradley’s prior approval.
  Par and Bradley shall confer and mutually agree upon the timing of the commercial
  launch of the Generic Product (the “Commercial Launch”), taking
  into account the actions required to be undertaken by Par and Bradley pursuant
  to Section 3.1 hereof and current and anticipated market conditions. Manufacturing,
  sales and marketing of the Generic Product in the Territory will be the sole
  responsibility of Par, which shall have the sole right and discretion to make
  all marketing and pricing strategies and decisions. 



        (c)
  Par shall, directly or through its Affiliates and designees, manufacture and
  maintain in inventory Generic Product to meet its forecasted requirements for
  the Commercial Launch in the Territory. Par may, in its discretion and at its
  expense, subcontract to a third party the manufacturing, packaging and/or labeling
  of the Generic Product, and at Par’s request, the ANDA Holder shall, at
  its own expense, file a supplement to the ANDA, based upon the information provided
  by Par, to obtain all FDA and other regulatory approval necessary for the manufacturing,
  packaging and/or labeling of the Generic Product by such subcontractor. 



        (d)
  Following the First Commercial Sale, Par shall use commercially reasonable efforts
  to market and promote sales of the Generic Product in the Territory in a manner
  generally consistent with Par’s marketing and sales of its other similarly-situated
  generic products in the Territory; provided, that Par shall not advertise
  the Generic Product in any trade journal without Bradley’s prior consent.
  



        3.3
Packaging. (a) Par shall package and label the Generic Product for sale in the
Territory with packaging and labels conforming with FDA requirements under the applicable
ANDA and shall determine the contents of the labels and artwork on all finished labeled
units, subject to the prior approval of Bradley, which approval shall not be unreasonably
withheld, conditioned or delayed; provided, that Bradley may, in its sole
discretion, withhold its approval for Par to market or sell the Generic Product in blister
or unit-dose packaging. Par shall be responsible for the cost of the initial inventory of
labels for the Generic Product. 



        (b)
  Thereafter, each of Par and Bradley may make changes to the labels, product
  inserts and other labeling for the Generic Product, subject to the requirements
  of applicable laws and regulations and the prior approval of the other party
  hereto, which shall not be unreasonably withheld, conditioned or delayed; provided,
  that Bradley may, in its sole discretion, withhold its approval to sell the
  Generic Product in blister or unit-dose packaging. Any such changes shall be
  promptly submitted by the applicable ANDA Holder (with the cooperation of the
  other party hereto) to all applicable governmental agencies and other third
  parties responsible for the reviewing and/or approval of the labels, product
  inserts and other labeling, if required. Par will not implement packaging or
  labeling changes until the applicable ANDA Holder obtains any 





 
	 	
5	 














required FDA
approval or makes the required FDA notification, as applicable. The           parties
shall share equally the actual cost incurred by Par of any such labels,
          packaging and product inserts rendered obsolete due to a change precipitated by
          the FDA or other regulatory requirements. Subject to the foregoing, Par shall
be           responsible for the actual cost incurred by Par of any labels, product
inserts           and other labeling rendered obsolete due to a change directly
precipitated by           Par, and Bradley shall be responsible for the actual cost
incurred by Par of any           labels, product inserts and other labeling rendered
obsolete due to a change           directly precipitated by Bradley.  



        (c)
  Subject to the foregoing, Par shall be responsible for selecting, maintaining,
  and enforcing trademarks, logos, slogans, designs, copyrights, emblems, insignias,
  trade dress and other protectable intellectual property rights (“Trademarks
  and Copyrights”) to be used in connection with the manufacture and
  sale of the Generic Product. Par shall own the entire right, title and interest
  in and to such Trademarks and Copyrights. Notwithstanding the foregoing, Par
  shall not knowingly adopt or use any Trademarks and Copyrights owned by Bradley
  and used by Bradley in connection with the manufacture and sale of the Branded
  Product. Bradley shall not use the Trademarks and Copyrights of Par without
  the prior written authorization of Par. 



        4.
  FINANCIAL TERMS. 



        4.1
Cost of Tablet and Capsule Imprint Change. The costs and expenses incurred by Par
or its Affiliates in the performance of its obligations set forth in Section 3.1 hereof
shall be borne solely by Par, except that Par and Bradley shall each bear one-half of the
cost of tooling associated with the manufacture of the Generic Product. Bradley shall
promptly pay Par upon Par’s submission of any invoice detailing such costs and
expenses. 



        4.2
Cost of Obsolete Inventory. Schedule 4.2 hereto sets forth the parties’
forecasted requirements of the Generic Product for the Commercial Launch (the
“Launch Quantities”). Par shall use commercially reasonable efforts,
after completing its obligations under Section 3.1 hereof, to manufacture and maintain in
inventory the Launch Quantities in preparation for the Commercial Launch. Par and Bradley
from time to time may amend the volume of Launch Quantities set forth on
Schedule 4.2 by mutual written agreement. Bradley shall be responsible for
Par’s Cost of Goods associated with any portion of the Launch Quantities that
constitutes Obsolete Inventory. Bradley shall promptly pay Par upon remittance of an
invoice detailing such costs. Such invoicing shall be in accordance with Par’s policy
and practice in expensing obsolete inventory. Except as set forth herein, Bradley shall
not be responsible for reimbursing Par for the cost of Obsolete Inventory. 



        4.3
Net Profit Split. Par shall pay to Bradley an amount equal to 50% of the Net
Profit, and Par shall retain an amount equal to 50% of the Net Profit (such allocation of
Net Profit being referred to herein the “Net Profit Split”). Par shall
pay Bradley’s share of the Net Profit Split to Bradley quarterly, within forty-five
(45) days after the close each calendar quarter, accompanied by a reasonably-detailed
calculation of such Net Profit Split. Par shall keep true and accurate books of account
and shall keep and maintain all records and documents necessary for Bradley to ascertain
its share of the Net Profit Split due under this Agreement. 



        4.4
Late Payments. In the event of a late payment under this Article 4, the payor shall
pay to the payee interest calculated on a daily basis on the overdue payment from the 





 
	 	
6	 














date
such payment was due to the date such payment is received by the payee at a rate of 1.0%
per calendar month. 



        4.5
Change in Circumstances. If, at any time during the Term following the First
Commercial Sale, either party’s share of the Net Profit Split is less than
(a) five (5%) percent of Net Sales over the course of any two (2) consecutive
calendar years (not including any partial calendar year) or (b) $500,000 in any full
calendar year; then, upon written notice by either party to the other, the parties shall
in good faith attempt to negotiate (i) early termination of the Agreement or
(ii) a sublicense to a third party of the distribution and marketing of the Generic
Product in the Territory. 



        5.
CERTAIN UNDERTAKINGS 



        5.1
Generic Product Complaints and Adverse Drug Experiences. Par shall be responsible
for handling all Generic Product complaints and for notifying Bradley within thirty (30)
days of receipt of any such complaint where such notification is required by FDA
regulation. Par shall notify Bradley of any report of serious and unexpected adverse drug
experience concerning the Generic Product within five (5) business days of its receipt of
the report, or earlier if required by applicable law and regulations and so requested by
Bradley, and provide Bradley with information as required by applicable law and
regulations and so requested by Bradley in order for Bradley to comply with the
post-marketing reporting requirements in accordance with 21 C.F.R. § 314.80
and 21 C.F.R. § 314.81. 



        5.2
Generic Product Recall. (a) In the event of any recall or seizure of any Generic
Product, Bradley shall be responsible for one-half, and Par shall be responsible for
one-half, of the aggregate transportation costs, taxes, freight insurance, handling and
reasonable and verifiable out-of-pocket costs incurred in respect of such recalled or
seized Generic Product (collectively, the “Recall Expenses”);
provided, that, (i) in the event and to the extent that any recall or seizure
of any Generic Product arises out of any improper act or omission by Par, its Affiliates
or any third party subcontractor engaged by Par, Par shall be responsible (as between
Bradley and Par) for the Recall Expenses associated with such recall or seized Generic
Product, and (ii) if, and after such time as, Bradley becomes the ANDA Holder of the
applicable ANDA, in the event and to the extent that any recall or seizure of any Generic
Product arises out of any improper act or omission by Bradley, its Affiliates or any third
party subcontractor engaged by Bradley, Bradley shall be responsible (as between Par and
Bradley) for the Recall Expenses associated with such recall or seized Generic Product. 



        (b)
  For purposes of this Section 5.2, “recall” means (i) any
  action by Par, Bradley or any Affiliate of either to recover title to or possession
  of any Generic Product sold or shipped (including, but not limited to, market
  withdrawal) and/or (ii) any decision by Par not to sell or ship Generic
  Product to third parties that would have been subject to recall if it had been
  sold or shipped, in each case taken in the good faith belief that such action
  was appropriate under the circumstances. For purposes of this Section 5.2,
  "seizure” means any action by any governmental agency to detain or
  destroy any Generic Product. 



        (c)
  Par shall control all recall activities, and Bradley shall cooperate with Par
  and provide such assistance as Par reasonably requests with respect thereto.
  Par and Bradley shall 





 
	 	
7	 















keep the other fully informed
  in writing of any notification or other information, whether received directly
  or indirectly, that could reasonably be expected to (i) affect the safety
  or effectiveness of the Generic Product, (ii) result in liability issues
  or otherwise necessitate recall action on the part of either party or (iii)
  result in recall or seizure of any Generic Product. Par shall be responsible,
  in its good-faith discretion, for determining whether or not such circumstances
  necessitate a recall of the Generic Product and shall carry out any recall activities
  that it deems appropriate with respect thereto; provided, that, if Par
  determines not to undertake a recall and Bradley reasonably believes that a
  recall is required under applicable law, then Bradley may undertake and carry
  out such recall. Par and Bradley shall reasonably cooperate with each other
  in carrying out any such recall or seizure. The applicable ANDA Holder will
  be responsible for assuring that any such recall is closed-out with the FDA,
  unless the FDA shall otherwise require. 



        5.3
Facility Maintenance; Inspection; Reports. (a) Par shall (or shall obtain the
agreement of its third-party manufacturer and/or packager, if applicable, to) use
commercially reasonable efforts to maintain and operate the manufacturing and packaging
facility designated in the ANDAs and implement such quality control procedures required so
as to meet the requirements of FDA regulations and so as to be able to perform timely its
obligations hereunder. Par shall (and shall obtain the agreement of any third-party
manufacturer and/or packager, if applicable, to) permit quality assurance representatives
of Bradley reasonably acceptable to Par to inspect such facilities not more than once per
calendar year upon reasonable notice, during normal business hours and on a confidential
basis. Bradley shall cause its quality assurance representatives to provide Par with a
written report of the results of any such inspection simultaneously with the provision of
such report to Bradley. If such inspecting party finds any non-compliance during any such
inspection with respect to the Generic Product, Par shall (and shall obtain the agreement
of any third-party manufacturer and/or packager, if applicable, to) diligently rectify
such non-compliance and implement appropriate procedures with a view to avoiding
repetition of such non-compliance; provided, that, if Par disagrees with the
conclusions of such inspecting party, it shall so notify Bradley in writing, and the
parties shall cooperate in good faith to resolve such dispute and, in the event that the
parties shall be unable to resolve such dispute within thirty (30) calendar days from the
date of Par’s notice pursuant to this Section 5.3 or such other time period mutually
agreeable to the parties, the parties shall submit such dispute to a mutually
satisfactory, non-Affiliated third-party consultant. The determination of such consultant
shall be final and binding on the parties, and the costs therefor shall be borne by the
parties in proportion to the percentage of fault attributed to each party by such
consultant. 



        (b)
  If Par or any third-party manufacturer and/or packager of the Generic Product
  receives an FDA Form 483 (“Notice of Observations”) evidencing
  any non-compliance with respect to the Generic Product, Par shall (and shall
  obtain the agreement of any third-party manufacturer and/or packager, if applicable,
  to) diligently rectify such non-compliance and implement appropriate procedures
  with a view to avoiding repetition of such non-compliance. Par shall provide
  Bradley with a copy of any FDA Form 483 (which may be redacted with respect
  to information unrelated to the Generic Product and as otherwise necessary to
  preserve the confidentiality of sensitive information) received at the conclusion
  of an FDA inspection relating to the Generic Product. 



        (c)
  If, for supply reasons or compliance reasons, Par subcontract to a third party
  the manufacturing, packaging and/or labeling of the Generic Product, such subcontracting
  shall be 




 
	 	
8	 
















in Par’s discretion and at Par’s expense, and
          the applicable ANDA Holder shall, at its own expense, file a supplement to the
          ANDA, based upon the information provided by Par, to obtain all FDA and other
          regulatory approval necessary for the manufacturing, packaging and/or labeling
          of the Generic Product by such subcontractor.  



        5.4
Filing Requirements and Maintenance. The ANDA Holder shall promptly comply with all
FDA requirements with respect to the Generic Product, including all filing and reporting
requirements necessary to keep such ANDA current with the FDA and all payment obligations
with respect to required fees and costs associated with such ANDA and any other regulatory
approvals; provided, that Par shall be responsible for (a) drug listings,
formulary submissions and Par’s NDC number and (b) such compliance with other
FDA, DEA and all other regulations applicable only to a distributor of the Generic Product
as can be achieved by Par, given regulatory requirements. As reasonably requested by
Bradley, if Bradley is the ANDA Holder, Par shall supply to Bradley samples of finished
labeled units of the Generic Product and otherwise reasonably assist Bradley with such
filing and reporting requirements. Par shall be responsible for all stability studies that
may be required for ongoing marketing and sale of the Generic Product and shall conduct
such stability studies in compliance with the ANDAs. 



        5.5
Insurance. Each of Bradley and Par shall (and shall cause their respective
Affiliates, as required, to), promptly after the Effective Date and extending through the
remaining term of this Agreement and for a period of not less than 36 months following the
termination or expiration of this Agreement, carry or be subject to coverage under (as a
named insured), product liability insurance in an amount of not less than Ten
Million Dollars ($10,000,000) combined single limit, which insurance will be written
on a "claims-made” policy basis with an insurance carrier rated at least
‘A’ by Bests Rating Service or a comparable rating by a comparable rating
service. Each party shall provide the other party with evidence of coverage contemplated
hereby, in the form of certificates of insurance, as reasonably requested. 



        5.6
Audit Right. Par shall maintain true and complete books of account containing an
accurate record of all data necessary for proper assessment of the Net Profit Split
(including Cost of Goods, Net Sales and Net Profit). Bradley shall have the right, through
an independent certified public accountant, to examine Par’s books of account related
to such matters during regular business hours, on reasonable prior notice (but not more
than once in any calendar year), within three (3) years after the end of the calendar year
in which Bradley’s share of the Net Profit Split was paid by Par for the purpose of
verifying the accuracy of such matters. The parties agree that information furnished to
Bradley as a result of any such examination shall be limited to a written statement by
such certified public accountant to the effect that it has reviewed the books of account
of Par and either (i) Par’s calculations are correct or (ii) setting forth
any required adjustments thereto; and Bradley shall ensure that any such written statement
is provided concurrently to Par. If any such audit shows any underpayment or overpayment
by Par, a correcting payment shall be made within thirty (30) days after receipt of the
written statement described above. The costs and expenses of such audit shall be borne by
Bradley; provided, however, if such audit shows an underpayment by Par
exceeding $10,000 in any calendar year, Par shall reimburse Bradley for its reasonable
third-party costs of such audit. 



        5.7
Publicity. Neither party shall issue or release any media release or public
announcement (including, without limitation, any announcements made via any posting on the 





 
	 	
9	 















World Wide Web or Internet) or other similar publicity in any country announcing the
existence of this Agreement or any term or condition of this Agreement or the
relationships created by this Agreement without prior written consent of the other party
and the prior agreement of the other party on the relevant wording relating to the
Agreement or term or condition of the Agreement. The parties shall not issue or release
any joint statement utilizing Bradley’s or its Affiliate’s or Par’s or its
Affiliate’s corporate identifiers, including, without limitation, any public
announcement or advertisement, without the prior written approval of Bradley or Par, as
applicable. Notwithstanding the foregoing, each party shall have the right to issue media
releases, immediately and without prior consent of the other party, that disclose any
information required by the rules and regulations of the Securities and Exchange
Commission, any securities exchange on which a party’s or its Affiliate’s
capital stock may be traded, or any federal, state or foreign law or regulation;
provided, that the disclosing party shall use commercially reasonable efforts to
(a) notify the other party prior to such disclosure, (b) provide the other party
with a copy of the relevant wording relating to the Agreement or term or condition of the
Agreement, and (c) seek confidential treatment of any information that the other
party reasonably requests to be maintained as confidential. 



        6.
WARRANTIES; INDEMNIFICATION; AND LIMITATION OF LIABILITY. 



        6.1
Certain Representations, Warranties and Covenants of Par. (a) Par hereby
represents and warrants to Bradley that (i) Par has the requisite power and authority
to enter into this Agreement and to perform its obligations hereunder; (ii) the
execution, delivery and performance of this Agreement have been duly authorized by all
necessary action on the part of Par; and (iii) the terms of this Agreement do not
conflict with or breach any agreement to which Par or any Affiliate is a party or by which
Par or any Affiliate is otherwise bound or violate any applicable law. 



        (b)
  Par hereby warrants and covenants to Bradley that (i) any trademarks of
  Par that are to be utilized in connection with the labeling and packaging of
  the Generic Product are (or will be) the property of Par and may be lawfully
  used as directed by Par; and (ii) all Generic Product distributed by it
  hereunder shall be manufactured, tested, packaged, labeled, stored and handled
  in accordance with the Specifications most recently provided by Bradley to Par
  and cGMP in effect at the time of manufacturing and testing and that, at the
  time of distribution, such Generic Product: (A) will meet the Specifications
  or, if Bradley is the ANDA Holder, will meet the Specifications most recently
  provided by Bradley to Par, and will not be adulterated or misbranded within
  the meaning of the Act, as in effect at the time of delivery; and (B) will
  not be an article which may not be introduced into interstate commerce under
  the provisions of Sections 404 and 505 of the Act. 



        (c)
  Par hereby further represents, warrants and covenants to Bradley that, for so
  long as Par is the ANDA Holder, (i) any filings to be made by Par or its
  Affiliates with the FDA in connection with the Product shall be accurate, complete
  and truthful when filed and made in good faith upon the best information available
  to Par and its Affiliates at such time; and (ii) the ANDA and all other
  such regulatory filings with the FDA in connection with the Product will be
  amended, supplemented or otherwise updated in a timely manner whenever the information
  contained in any of them is no longer accurate, complete and truthful. 





 
	 	
10	 
















THE FOREGOING WARRANTIES IN THIS
SECTION 6.1 ARE MADE BY PAR EXPRESSLY IN LIEU OF ANY OTHER EXPRESS OR IMPLIED WARRANTIES,
INCLUDING, BUT NOT BY WAY OF LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR
A PARTICULAR PURPOSE. 



        6.2
Certain Representations, Warranties and Covenants of Bradley. (a) Bradley
hereby represents and warrants to Par that (i) Bradley has the requisite corporate
power and authority to enter into this Agreement and to perform it obligations hereunder;
(ii) the execution, delivery and performance of this Agreement have been duly
authorized by all necessary action on the part of Bradley; and (iii) the terms of
this Agreement do not conflict with or breach any agreement to which Bradley or any
Affiliate is a party or by which Bradley or any Affiliate is otherwise bound or violate
any applicable law. 



        (b)
  Bradley hereby further represents, warrants and covenants to Par that, during
  such time (if any) that Bradley is the ANDA Holder, (i) any filings to
  be made by Bradley or its Affiliates with the FDA in connection with the Product
  shall be accurate, complete and truthful when filed and made in good faith upon
  the best information available to Bradley and its Affiliates at such time; and
  (ii) the ANDA and all other such regulatory filings with the FDA in connection
  with the Product will be amended, supplemented or otherwise updated in a timely
  manner whenever the information contained in any of them is no longer accurate,
  complete and truthful. 



THE FOREGOING WARRANTIES IN THIS
SECTION 6.2 ARE MADE BY BRADLEY EXPRESSLY IN LIEU OF ANY OTHER EXPRESS OR IMPLIED
WARRANTIES, INCLUDING, BUT NOT BY WAY OF LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE. 



        6.3
Representation and Warranties with Regard to Status.  



        (a)
  Bradley hereby represents and warrants to Par that neither it nor any of its
  Affiliates is prohibited by any law, rule or regulation or by any order, directive
  or policy from selling the Generic Product or other pharmaceutical products
  within the Territory and that neither Bradley nor any of its Affiliates is a
  Person that is listed by a United States federal agency as debarred, suspended,
  or otherwise ineligible for federal programs in the United States, its territories
  and protectorates (an “Ineligible Person”) or listed by a United
  States federal agency as proposed for debarment or suspension. 



        (b)
  Par hereby represents and warrants to Bradley that neither it nor any of its
  Affiliates that is or will be a manufacturer of the Generic Product is prohibited
  by any law, rule or regulation or by any order, directive or policy from selling
  the Generic Product or other pharmaceutical products and that neither Par nor
  any such Affiliate is an Ineligible Person or listed by a United States federal
  agency as proposed for debarment or suspension. 



        6.4
Par’s Indemnification Obligations. Par shall indemnify and hold Bradley and
its Affiliates and their respective officers, directors, stockholders, employees and
agents harmless from and against, and pay or reimburse, any claim, action, suit,
proceeding, loss, liability, damage or expense (including reasonable attorneys’ fees)
(“Losses”) arising, directly or indirectly, 





 
	 	
11	 















as a result of Par’s or
its Affiliates’ negligent acts or omissions, willful wrongful acts, or breach of any
of its representations, warranties, covenants or other obligations hereunder;
provided, however, that Par shall not be required to indemnify Bradley with
respect to any Losses to the extent arising from or related to Bradley’s or its
Affiliates’ negligent acts or omissions, willful wrongful acts or Bradley’s
breach of its representations, warranties, covenants or other obligations hereunder, or
from information supplied by Bradley or its Affiliates to Par or contained in regulatory
filings or correspondence prepared or delivered by Bradley or its Affiliates. 



        6.5
Bradley’s Indemnification Obligations. Bradley shall indemnify and hold Par
and its Affiliates and their respective officers, directors, stockholders, employees and
agents harmless from and against, and pay or reimburse, any Losses arising, directly or
indirectly, as a result of Bradley’s or its Affiliates’ negligent acts or
omissions, willful wrongful acts or breach of any of its representations, warranties,
covenants or other obligations hereunder; provided, however, that Bradley
shall not be required to indemnify Par with respect to any Losses to the extent arising
from or related to Par’s or its Affiliates’ negligent acts or omissions, willful
wrongful acts or Par’s breach of its representations, warranties, covenants or other
obligations hereunder, or from information supplied by Par or its Affiliates to Bradley or
contained in regulatory filings or correspondence prepared or delivered by Par or its
Affiliates. 



        6.6
  Indemnification Procedures. With respect to indemnification for a third-party
  action, claim or liability under this Article 6, a party that intends to claim
  indemnification hereunder (the “indemnitee”) shall notify the
  other party (the “indemnitor”) promptly in writing of such
  third-party action, claim or liability in respect of which the indemnitee believes
  it is entitled to claim indemnification; provided, that the failure to
  give timely notice to the indemnitor shall not release the indemnitor from any
  liability to the indemnitee except to the extent the indemnitor is materially
  prejudiced thereby. The indemnitor shall have the right, by written notice to
  the indemnitee, to assume the defense of any such action or claim, within the
  fifteen (15)-day period after the indemnitor’s receipt of written notice
  of any action or claim, with counsel of the indemnitor’s choice and at
  the sole cost of the indemnitor. If the indemnitor so assumes such defense,
  the indemnitee may participate therein through counsel of its choice, but at
  the sole cost of the indemnitee. If the indemnitor fails to assume such defense
  and/or to diligently prosecute the same, the indemnitee may assume such defense
  at the indemnitor’s sole expense. The party not assuming the defense of
  any such claim shall render all reasonable assistance to the party assuming
  such defense, and all reasonable out-of-pocket costs of such assistance shall
  be for the account of the indemnitor. No such claim shall be settled other than
  by the party defending the same, and then only with the prior written consent
  of the other party, which consent shall not be unreasonably withheld or delayed;
  provided, however, that the indemnitee shall have (a) no
  obligation to consent to any settlement of any such action or claim that (i) imposes
  on the indemnitee any monetary or other liability or obligation that cannot
  be assumed and performed in full by the indemnitor or (ii) adversely affects
  the indemnitee’s rights hereunder or damages its reputation or business,
  and (b) no right to withhold its consent to any settlement of any such
  action or claim if the settlement involves only the payment of money by the
  indemnitor or its insurer and the indemnitor or its insurer agrees in writing
  to make such payment. EXCEPT WITH RESPECT TO INDEMNIFICATION FOR THIRD-PARTY
  CLAIMS OR DAMAGES RESULTING FROM PAR’S COMMERCIAL LAUNCH OF THE GENERIC
  PRODUCT WITHOUT BRADLEY’S CONSENT, IN NO EVENT WILL EITHER PARTY BE LIABLE
  FOR ANY SPECIAL, INCIDENTAL OR INDIRECT DAMAGES, INCLUDING ANY LOSS OF INCOME,
  LOSS OF 




 
	 	
12	 
















PROFITS, COSTS OF
SUBSTITUTION, COSTS OF COVER OR INCREASED CAPITAL COSTS, REGARDLESS OF THE FORM OR NATURE
OF ACTION, WHETHER IN CONTRACT, BREACH OF WARRANTY, STRICT LIABILITY, EQUITY, INDEMNITY,
NEGLIGENCE, INTENTIONAL CONDUCT, TORT OR OTHERWISE, EVEN IF SUCH DAMAGES WERE FORESEEABLE
OR IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 



        7.
TERM AND TERMINATION. 



        7.1
Term. This Agreement shall commence on the Effective Date and continue, unless
otherwise earlier terminated in accordance herewith, for a period that shall extend ten
(10) years from the date of the First Commercial Sale of the Generic Product (the
“Initial Term”). Thereafter, this Agreement shall be automatically
renewed for successive one-year periods (each, a “Renewal Term”
and collectively with the Initial Term, the “Term”), unless a party
shall otherwise notify the other in writing at least ninety (90) days prior to the
expiration of the Initial Term or any Renewal Term. 



        7.2
Termination for Breach. (a) If either party commits a breach or default in the
performance or observance of any of its material obligations under this Agreement, and
such breach or default continues for a period of sixty (60) days after delivery by the
other party of written notice reasonably detailing such nonperformance, then the
non-breaching or non-defaulting party shall have the right to terminate this Agreement,
with immediate effect, by giving written notice to the breaching or defaulting party. If
the nonperforming party disputes the asserted nonperformance in writing within thirty (30)
days after notice of nonperformance, the matter shall be referred to the dispute
resolution procedures set forth in Section 10.1 hereof. 



        (b)
  Either party may terminate this Agreement upon thirty (30) days’ prior
  written notice if the other party is legally prohibited from performing its
  obligations hereunder or becomes (or its Affiliate becomes) an Ineligible Person
  in respect of the Generic Product. 



        7.3
Termination for Bankruptcy. This Agreement shall automatically terminate upon
(i) either party’s initiation of any proceeding in bankruptcy, reorganization or
arrangement for the appointment of a receiver or trustee to take possession of its assets
or similar proceeding under the law for release of creditors, (ii) either
party’s making a general assignment for the benefit of its creditors, or (iii) a
third party’s initiation of any proceeding in bankruptcy, reorganization or
arrangement for the appointment of a receiver or trustee to take possession of the assets
of a party hereto or similar proceeding under the law for release of creditors by or
against a party hereto, and such proceeding continues unstayed for more than sixty (60)
days. 



        7.4
Termination for Change in Circumstances. This Agreement may be terminated by either
party upon written notice to the other if, despite good faith negotiations pursuant to
Section 4.5 hereof, the parties are unable to reach agreement pursuant to Section 4.5
hereof within thirty (30) days after the provision of notice thereunder. 



        7.5
Post-Termination. (a)  If this Agreement is terminated by Bradley pursuant to
Section 7.4 or by Par pursuant to Section 7.2 or 7.3 hereof, Par shall have the
right to sell its existing inventory of Generic Product and Bradley shall reimburse Par
for the cost of its raw  




 
	 	
13	 














materials ordered prior to such termination for the manufacture of
the Generic Product. If this Agreement expires at the end of the Term pursuant to Section
7.1 hereof, Par shall have the right to sell its existing inventory of Generic Product. 



        (b)
  The termination or expiration of this Agreement shall not affect any payment
  or other obligations or liabilities that have accrued prior to the date of such
  termination or expiration, and the parties shall retain all rights and remedies
  (at law or in equity) in respect of any breach thereof. In the event that Par
  disposes of existing inventory of Generic Product pursuant to Section 7.5(a)
  after termination of this Agreement pursuant to Section 7.2, 7.3 or 7.4,
  such termination shall not relieve Par of its obligation under Section 4.3
  to pay Bradley’s share of the Net Profit Split with respect to sales in
  the Territory of the Generic Product hereunder after the date of termination.
  



        8.
CONFIDENTIALITY. 



        8.1
Treatment of Confidential Information. Except as required by applicable laws and
regulations (including rules or regulations of any exchange upon which a party’s
capital stock may be traded) or as otherwise provided in this Article 8, during the Term,
and for three (3) years thereafter, each party shall hold in confidence, and may not use
for purposes other than those contemplated by this Agreement or disclose to a third party
(except as specifically set forth herein or with the express prior written consent of the
other party) any and all Confidential Information. 



        8.2
Limits on Disclosure. (a) Without limiting the generality of the foregoing, each
party may disclose Confidential Information to those employees or agents who need to
receive the Confidential Information in order to further the activities contemplated by
this Agreement. Each party shall take reasonable precautions to safeguard the Confidential
Information, including obtaining appropriate commitments and enforceable confidentiality
agreements. Each party understands and agrees that the wrongful disclosure of Confidential
Information may result in serious and irreparable damage to the other party, that the
remedy at law for any breach of this covenant may be inadequate, and that the party
seeking redress hereunder shall be entitled to injunctive relief, without prejudice to any
other rights and remedies to which such party may be entitled. 



        (b)
  It is acknowledged that Confidential Information may be obtained by a party
  from the other party not only in writing or other tangible form (including electronic),
  but also through discussions between each party’s respective representatives,
  demonstrations, observations and other intangible methods. Any verbal disclosure
  of Confidential Information by a party shall be reduced to writing and provided
  to the other party within forty-five (45) days. 



        (c)
  Notwithstanding the foregoing, each party shall have the right with the exercise
  of reasonable discretion, and insofar as practical under written confidentiality
  agreements having provisions no less stringent than those contained herein,
  to make disclosures of such portions of Confidential Information to third party
  consultants, attorneys, contractors, advisors, Affiliates and governmental agencies
  where, in the recipient’s judgment, such disclosure is beneficial to the
  development, approval or marketing of the Generic Product pursuant to this Agreement.
  






 
	 	
14	 















        (d)
  Except as otherwise set forth in this Agreement, upon the termination or expiration
  of this Agreement and at the written request of the disclosing party, the receiving
  party shall return all Confidential Information of the disclosing party (including
  all copies, excerpts and summaries thereof contained on any media) or destroy
  such Confidential Information at the option of the disclosing party; provided,
  that the receiving party may retain one copy of all Confidential Information
  of the disclosing party for its legal records. 




        9.
  FORCE MAJEURE. 



        9.1
Effects of Force Majeure. No party hereto shall be held liable or responsible for
failure or delay in fulfilling or performing any of its obligations under this Agreement
(other than the payment of money) if such failure or delay is caused by, without
limitation, acts of God, acts of the public enemy, fire, explosion, flood, drought, war,
terrorists, riot, sabotage, embargo, strikes or other labor disputes, intervention of
governmental agency (subject to Section 7.2(b)), or by any other event or circumstance of
like or different character to the foregoing beyond the reasonable control and without the
fault or negligence of the affected party (a “Force Majeure Event”). Such
excuse shall continue as long as the Force Majeure Event continues. Upon cessation of such
Force Majeure Event, such party shall promptly resume performance hereunder. 



        9.2
Notice of Force Majeure. Each party agrees to give the other party prompt written
notice of the occurrence of any Force Majeure Event, the nature thereof and the extent to
which the affected party will be unable to perform its obligations hereunder. Each party
further agrees to use reasonable efforts to correct or otherwise address the Force Majeure
Event as soon as practicable and to give the other parties prompt written notice when it
is again fully able to perform such obligations. 



        10.
MISCELLANEOUS. 



        10.1
Dispute Resolution. The parties recognize that a bona fide dispute as
to certain matters may, from time to time, arise during the Term that relates to a
party’s rights and/or obligations hereunder. In the event of the occurrence of such a
dispute, either party may, by written notice to the other party, have such dispute
referred to their respective officers, designated below, or their successors, for
attempted resolution by good faith negotiation within thirty (30) days after such notice
is received. Such designated officers are as follows: 



	        For
      Par:	  	Scott Tarriff,
      President and Chief Executive Officer




	        For Bradley:
      	  	Daniel Glassman,
      President and Chief Executive Officer 


  

In the event that the designated
officers are not able to resolve the dispute within such thirty (30)-day period, or such
other period of time as the parties may mutually agree to in writing, each party shall
have the right to pursue any and all remedies available at law or in equity. 



        10.2
Independent Contractors. The relationship between Par, on the one hand, and
Bradley, on the other hand, is that of independent contractors and nothing herein shall
be deemed to constitute or create the relationship of partners, joint venturers nor of
principal and agent between Par on the one hand and Bradley on the other hand. Neither
party shall have any  




 
	 	
15	 















express or implied right or
authority to assume or create any obligations on behalf of or in the name of the other
party or to bind the other party to any contract, agreement or undertaking with any third
party.  



        10.3
Assignment. This Agreement may be assigned and delegated by either party
(a) to an Affiliate of such party or (b) in connection with any sale, merger or
other business combination involving all or substantially all of such party’s assets
or capital stock. Except as set forth in the preceding sentence, neither this Agreement
nor any other rights or obligations hereunder shall be assigned or delegated by either
party without the prior written consent of the other party. 



        10.4
Governing Law; Waiver of Jury Trial. This Agreement shall be governed by, and
construed in accordance with, the laws of the State of New Jersey. Each party hereby
consents to the exclusive jurisdiction of Federal and New York State courts located in
Manhattan, New York, and hereby waives any objection to venue or forum laid therein. Each
party hereby agrees that service of process by certified mail, return receipt requested,
shall constitute personal service for all purposes hereof. EACH PARTY HEREBY WAIVES ITS
RIGHT TO A TRIAL BY JURY OF ANY CLAIM OR CAUSE OF ACTION BASED UPON, ARISING OUT OF OR
RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, IN ANY ACTION,
PROCEEDING OR OTHER LITIGATION OF ANY TYPE BROUGHT BY ANY PARTY AGAINST THE OTHER, WHETHER
WITH RESPECT TO CONTRACT CLAIMS, TORT CLAIMS OR OTHERWISE. THIS WAIVER SHALL APPLY TO ANY
SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT. 



        10.5
No Implied Waiver. No failure or delay on the part of either party hereto to
exercise any right, power or privilege hereunder or under any instrument executed pursuant
hereto shall, in itself, operate as a waiver; nor shall any single or partial exercise of
any right, power or privilege preclude any other or further exercise thereof or the
exercise of any other right, power or privilege. 



        10.6
Notice. All notices required to be given hereunder shall be in writing and shall be
given by personal delivery, via facsimile transmission followed by U.S. mail, by a
nationally recognized overnight carrier or by registered or certified mail, postage
prepaid with return receipt requested. Notices shall be addressed to the parties as
follows: 



	 If to Bradley:	 Bradley Pharmaceuticals, Inc.
	  	 383 Route 46 West
	  	 Fairfield, NJ 07004-2402
	  	 Attn:	 Daniel Glassman, President and
        Chief Executive Officer
	  	 Facsimile No.: (973) 575-5366
	  	  	  
	 If to Par:	 Par Pharmaceutical, Inc.
	  	 300 Tice Boulevard
	  	 Woodcliff Lake, NJ 07677
	  	 Attn:	 Scott Tarriff, President and Chief Executive
        Officer
	  	  	 Thomas Haughey, General Counsel





 
	 	
16	 















	 	 	Michael Graves, Vice
      President, Strategic Planning and
	 	 	Corporate Development
	 	Facsimile
      No.: (201) 802-4622
	  	  	  
	 With a copy	 Kirkpatrick & Lockhart
      Nicholson Graham LLP
	 (which shall	 599 Lexington Ave.
	 not constitute	 New York, NY 10022
	 notice) to:	 Attn:	 Stephen R. Connoni, Esq.
	  	  	 Barry J. Gilman, Esq.
	  	 Facsimile No.: (212)
      536-3901




Notices delivered personally shall be
deemed communicated as of actual receipt; notices sent via facsimile transmission shall be
deemed communicated as of receipt by the sender of written confirmation of transmission
thereof; notices sent via overnight courier shall be deemed received as of one business
day following sending; and notices mailed shall be deemed communicated as of three (3)
business days after proper mailing. A party may change its address by written notice sent
in accordance with this Section 10.6. 



        10.7
Amendments. Any amendment or modification of this Agreement shall be valid
only if made in writing and signed by the parties hereto. 



        10.8
Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed an original and both of which shall constitute a single document. A
facsimile signature of an authorized signatory of either party shall be valid and binding
and constitute due execution and delivery of this Agreement by such party. 



        10.9
Interpretation. The Section headings contained in this Agreement are for the
convenience of reference only and shall not affect the meaning or interpretation of this
Agreement. As used in this Agreement, any reference to the masculine, feminine or neuter
gender shall include all genders, the plural shall include the singular, and the singular
shall include the plural. Unless the context otherwise requires, the term
“party” when used herein means a party hereto. References herein to a party or
other Person include their respective successors and assigns. The words
“includes” and “including” when used herein shall be deemed to
followed by the phrase “without limitation” unless such phrase otherwise
appears. Unless the context otherwise requires, references herein to Articles, Sections,
Exhibits and Schedules shall be deemed references to Articles and Sections of, and
Exhibits and Schedules to, this Agreement. Unless the context otherwise requires, the
words “hereof,” “hereby” and “herein” and words of similar
meaning when used in this Agreement refer to this Agreement in its entirety and not to any
particular Section or provision hereof. With regard to each and every term and condition
of this Agreement, the parties understand and agree that the same has or have been
mutually negotiated, prepared and drafted, and that, if, at any time, the parties desire
or are required to interpret or construe any such term or condition or any agreement or
instrument subject thereto, no consideration shall be given to the issue of which party
actually prepared, drafted or requested any term or condition of this Agreement. 



        10.10
Entire Agreement. This Agreement constitutes the entire understanding between the
parties with respect to the subject matter hereof and supersedes all prior contracts, 





 
	 	
17	 















agreements and understandings
related to the same subject matter between the parties. The parties intend this Agreement
to be a complete statement of the terms of their understanding.  



        10.11
Benefit; Binding Effect. This Agreement shall be binding upon and shall inure to
the benefit of the parties hereto and their respective successors and permitted assigns. 



        10.12
Survival. Notwithstanding anything to the contrary contained in this Agreement, the
provisions of Sections 5.1 (to the extent of post-termination complaints and reporting
obligations), 5.2 (to the extent of post-termination recall activities), 5.4 (to the
extent of post-termination distribution of Generic Product), 5.5, 5.6, 7.5 and Articles 1,
6, 8 and 10 shall survive, in accordance with their respective terms, any termination of
this Agreement. 



        10.13
Further Assurances. The parties agree that they shall take all appropriate actions,
including the execution or filing of any documents or instruments, that may be reasonably
necessary or advisable to carry out the intent and accomplish the purposes of any of the
provisions hereof. 



        10.14
Severability. In the event that any provision of this Agreement shall be held
invalid or unenforceable for any reason by a court of competent jurisdiction, such
provision or part thereof shall be considered separate from the remaining provisions of
this Agreement, which shall remain in full force and effect. Such invalid or unenforceable
provision shall be deemed revised to effect, to the fullest extent permitted by applicable
law, the intent of the parties as set forth herein. 



[SIGNATURE PAGE
FOLLOWS]  





 
	 	
18	 

















        IN
WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date
first above written by their duly authorized representatives. 



	 	 BRADLEY PHARMACEUTICALS,
      INC.
	 	  	  	  
	 	By: 	       /s/
        Daniel Glassman
        

	 	  	 Name:	 Daniel Glassman
	 	  	 Title:	 President and Chief Executive Officer
	 	  	  	  
	 	PAR PHARMACEUTICAL,
      INC.
	 	  	  	  
	 	By: 	       /s/
        Michael Graves
        

	 	  	 Name:	 Michael Graves
	 	  	 Title:	 Vice President, Strategic Planning and Corporate
        Development





 
	 	
19	 















Schedule
  4.2 



Launch Quantity 







	

	Description

      (Strength) 	 	Bottle

      Size (Tabs

      per Bottle) 	 	Number of

      Batches 	 	Batch Size

      (Tabs) 	 	Tablets

      per Bottle

      Size 	 	Number of

      Bottles 
	

	50 mg	 	[*]’s	 	[*]	 	[*]	 	[*]	 	[*]
	

	 	 	 	 	 	 	 	 	 	 	 
	

	75 mg	 	[*]’s	 	[*]	 	[*]	 	[*]	 	[*]
	75 mg	 	[*]’s	 	 	 	[*]	 	[*]
	

	 	 	 	 	 	 	 	 	 	 	 
	

	100 mg	 	[*]’s	 	[*]	 	[*]	 	[*]	 	[*]
	100 mg	 	[*]’s	 	 	 	[*]	 	[*]
	







	[*] 	 Certain information on this page has been omitted
      and filed separately with the Securities and Exchange Commission. Confidential
      treatment has been requested with respect to the omitted portions. 


          





 
	 	
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EXHIBIT A  



Product 



The pharmaceutical product
doxycycline monohydrate tablets and capsules in all strengths under the ANDAs. 





 
	 	
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