EXHIBIT 10.37
AMENDED AND RESTATED PURCHASE AND LICENSE AGREEMENT
This Amended and Restated Purchase and License Agreement (the
"Agreement") is made and entered into as of January 25, 1999, and is effective
as of October 1, 1998, by and between Dura Pharmaceuticals, Inc. ("Dura"), a
Delaware corporation, DJ Pharma, Inc., a Delaware corporation ("DJ Pharma") and
Dura (Bermuda) Trading Company LTD., a Bermuda corporation ("Dura Bermuda")
(solely with respect to the Keftab Products (as hereinafter defined)) with
reference to the following facts:
RECITALS
A. WHEREAS Dura, Dura Bermuda and DJ Pharma are executing this
Agreement for the purpose of amending and restating in its entirety that certain
Purchase and License Agreement by and between the parties hereto dated October
1, 1998;
B. WHEREAS, Dura markets a line of drugs under the trademark "Rondec"
("Rondec Products") whose active ingredients are primarily carbinoxamine maleate
and pseudoephedrine hydrochloride, which products are set forth on Exhibit "A"
attached hereto and incorporated herein by this reference, and which Rondec
Products were acquired from Abbott Laboratories ("Abbott") pursuant to that
certain Purchase Agreement between Abbott Laboratories, Ross Products Division
and Dura, dated June 14, 1995 (the "Abbott Purchase Agreement") and that certain
Supply Agreement between Abbott and Dura, dated June 14, 1995 (the "Abbott
Supply Agreement");
C. WHEREAS, Dura produces certain cough, cold and allergy products
marketed by Dura under the CCA Trademarks (as hereinafter defined) (the "CCA
Products"), and Dura Bermuda has certain license rights with respect to products
sold by Dura under the trademark "Keftab" (the "Keftab Products"), which
products are set forth, together with the CCA Products, on Exhibit "B" attached
hereto and incorporated herein by this reference;
D. WHEREAS, DJ Pharma wishes to acquire certain licensing rights to the
Rondec Products and CCA Products and sublicensing rights with respect to the
Keftab Products through December 31, 2002 (the "Licensing Term") and upon the
expiration of such period to, if permitted pursuant and subject to the terms and
conditions set forth in this Agreement, (i) acquire all of Dura's assets,
rights, title and interests relating to the Rondec Products in the "Rondec
Territory," which includes the continental U.S., Hawaii, Alaska and all U.S.
military bases wherever located and specifically excludes territories,
commonwealths (including Puerto Rico) and possessions of the U.S., and to
assume, other than payment obligations under Section 5.1 of the Abbott Purchase
Agreement, all of Dura's rights and obligations under the Abbott Purchase
Agreement and the Abbott Supply Agreement (as hereinafter defined) pursuant to
an Assignment and Assumption Agreement in the form attached hereto as Exhibit
"C" and incorporated herein by this reference (the "Assignment"), (ii) acquire
all of Dura's assets, rights, title and interests relating to the CCA Products
and the CCA Trademarks, and (iii) assume and acquire all of Dura Bermuda's
assets, rights, title, interests and obligations related to the Keftab Products
(the
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"Keftab Rights"), including the Keftab trademark set forth on Exhibit "D"
attached hereto and incorporated herein by this reference (the "Keftab
Trademark") under that certain Licensing Agreement, as amended (the "Licensing
Agreement") and that certain Manufacturing Agreement, as amended (the
"Manufacturing Agreement"), each of which is by and between Eli Lilly and
Company, an Indiana corporation ("Lilly") and Dura, dated August 21, 1996,
pursuant to the Assignment; and
E. WHEREAS, Dura and Dura Bermuda wish to sell or assign their
respective assets, rights, title, interests and obligations to DJ Pharma, as the
case may be;
NOW, THEREFORE, in consideration of the foregoing premises, the
respective representations, warranties, covenants and agreements set forth
herein, and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the parties hereby agree as follows:
1. LICENSING AND PURCHASING ARRANGEMENTS WITH RESPECT TO RONDEC PRODUCTS, CCA
PRODUCTS AND KEFTAB PRODUCTS
1.1 RIGHTS GRANTED; DISCLOSURE OF KNOW-HOW WITH RESPECT TO THE RONDEC
PRODUCTS AND CCA PRODUCTS DURING LICENSING PERIOD (AS HEREINAFTER DEFINED). For
a period commencing as of the date of the Closing (as hereinafter defined) and
expiring upon the earlier of (i) a termination of this Agreement by Dura
pursuant to Section 6 below due to a breach or default by DJ Pharma and (ii) the
end of the Licensing Term (the "Licensing Period"), Dura hereby grants the
following rights and discloses the following Know-How (as hereinafter defined)
to DJ Pharma upon the following terms with respect to the Rondec Products and
CCA Products:
(a) LICENSE OF KNOW-HOW AND REGULATORY APPROVALS WITH RESPECT
TO RONDEC PRODUCTS AND CCA PRODUCTS. Subject to the terms and conditions
contained in this Agreement, Dura, as of the Closing and through the Licensing
Period, hereby grants to DJ Pharma an exclusive license (except as set forth in
Section 1.1 (d) hereof, exclusive even as to Dura) under the Know-How (as
hereinafter defined) and Regulatory Approvals (as hereinafter defined), to use,
market, distribute, promote, offer for sale and sell the Rondec Products in the
Rondec Territory and the CCA Products worldwide (the "CCA Territory"). DJ Pharma
accepts all the obligations set forth in this Agreement and agrees to use the
Know-How and Regulatory Approvals only in connection with the manufacture, sale,
distribution, offering for sale, and promotion of the Rondec Products in the
Rondec Territory and the CCA Products in the CCA Territory, only for so long as
the licenses granted in this Section 1.1(a) remain in effect.
For purposes of this Agreement, "Know-How" shall mean all
proprietary technical and clinical information, data and know-how relating to
the Rondec Products and the CCA Products, whether or not patentable, owned or
licensed by Dura with the right to grant sublicenses as of the Closing or
acquired during the Licensing Period by either party or their affiliates (with
the right to have or disclose). Know-How shall include, without limitation, all
processes, formulas, discoveries, information and inventions whether relating to
biological, chemical, pharmacological, toxicological, pharmaceutical, physical
and analytical safety, quality control and clinical data, including, without
limitation, phase IV clinical study data. Know-How shall also include relevant
medical information relating to any of the Rondec Products or CCA Products (such
as customer questions, responses thereto and adverse drug event (ADE) history)
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in Dura's possession. The term Know-How, however, shall not include (a) any
know-how, processes, information and data which is, as of the Closing or later
becomes, generally available to the public or (b) any general manufacturing
know-how not reasonably required by DJ Pharma to exercise the rights granted
under this Agreement to the Rondec Products or CCA Products.
For purposes of this Agreement, "Regulatory Approvals" shall
mean all authorizations by the appropriate domestic governmental regulatory
authorities which are required for the marketing, promotion, pricing,
distribution and sale of the Rondec Products in the Rondec Territory and the CCA
Products in the CCA Territory, each of which are owned by Dura.
(b) LICENSE OF TRADEMARKS. Subject to the terms and conditions
contained in this Agreement, Dura, as of the Closing and through the end of the
Licensing Period, hereby grants to DJ Pharma an exclusive license (exclusive
even as to Dura) to use the trademarks associated with the Rondec Products and
CCA Products, as set forth on Exhibit "D" attached hereto and incorporated
herein by this reference (the "Rondec Trademarks" and the "CCA Trademarks",
respectively) only in connection with the manufacture, sale, distribution,
offering for sale, and promotion of the Rondec Products in the Rondec Territory
and the CCA Products in the CCA Territory. DJ Pharma accepts all the obligations
set forth in this Agreement and agrees to use the Rondec Trademarks in the
Rondec Territory and the CCA Trademarks in the CCA Territory, only for so long
as the license granted under this Section 1.1(b) remains in effect.
(c) SUBLICENSING. Prior to the expiration of the Licensing
Period, DJ Pharma shall not sublicense or assign any of the rights granted to it
under this Section 1.1, without the prior written consent of Dura, which consent
may be provided or withheld in Dura's sole discretion.
(d) RETAINED RIGHTS. Notwithstanding the licenses granted to
DJ Pharma under this Section 1.1, after the Closing and through the end of the
Licensing Period (except as otherwise indicated), Dura shall retain ownership of
all rights to (a) the current NDC numbers it uses for each of the Rondec
Products and CCA Products (retained (to the extent required by applicable laws
and regulations) through and after the Second Closing (as defined below)), (b)
the real and personal property (including, without limitation, all equipment)
and general manufacturing know-how used by Dura in manufacturing the Rondec
Products or CCA Products (either before, during or after the Licensing Period)
other than Know-How (retained through and after the Second Closing), (c) all
accounts receivable from sales of the Rondec Products and CCA Products by or on
behalf of Dura prior to the Closing, and (d) all inventories of the Rondec
Products or CCA Products that have not otherwise been purchased by DJ Pharma
pursuant to the Dura Supply Agreement. In addition, Dura retains ownership of
and the right to use the Know-How to manufacture Rondec Products and CCA
Products for DJ Pharma under the Dura Supply Agreement until the end of the
Licensing Period.
(e) DURA SUPPLY AGREEMENT. By the date of Closing (as
hereinafter defined), Dura, Dura Bermuda, and DJ Pharma shall enter into a Dura
Supply Agreement (the "Dura Supply Agreement") which shall set forth the
respective rights and obligations of the parties regarding Rondec Products and
CCA Products to be supplied by Dura for DJ Pharma pursuant to the terms of the
Dura Supply Agreement.
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(f) PROMOTION, MARKETING AND SALE OF PRODUCTS.
(i) REFERRALS. As of the Closing and through the
Licensing Period, Dura shall refer to DJ Pharma any sales inquiry received from
a third party in the Rondec Territory with respect to the Rondec Products or
from a third party in the CCA Territory with respect to the CCA Products.
(ii) MATERIALS AND PROMOTIONAL CLAIMS. For so long as
the Rondec Products are sold in the Rondec Territory and the CCA Products are
sold in the CCA Territory and prior to the expiration of the Licensing Period,
DJ Pharma shall not distribute any written materials or make any promotional
claims regarding the Rondec Products or the CCA Products, respectively, unless
such written materials or promotional claims have first been reviewed and
approved by Dura, such approval not to be unreasonably withheld. Dura agrees to
provide DJ Pharma with its approval or rejection of such written materials and
promotional claims within thirty (30) days of receipt by Dura. Notwithstanding
the foregoing, DJ Pharma at all times shall be solely responsible for complying
with all applicable laws and regulations in its promotion and marketing of the
Rondec Products and CCA Products.
(g) USE OF TRADEMARKS. Prior to the expiration of the
Licensing Period, DJ Pharma agrees to use the Rondec Trademarks only in
connection with the Rondec Products and the CCA Trademarks only in connection
with the CCA Products and in the manner and style which shall have the prior
written approval of Dura, which shall not be unreasonably withheld. DJ Pharma
shall submit to Dura samples of all commercial material containing any of the
Rondec Trademarks or CCA Trademarks. Dura, within thirty (30) days of its
receipt of such materials, shall have the right to reasonably comment on the
usage of the Rondec Trademarks or CCA Trademarks in such materials and DJ
Pharma, at its own cost and expense, will promptly correct any improper usage of
the Rondec Trademarks or CCA Trademarks. Prior to the time Dura assigns such
Rondec Trademarks or CCA Trademarks to DJ Pharma pursuant to this Agreement, DJ
Pharma agrees not to claim or to assert any right of ownership in or to such
Rondec Trademarks or CCA Trademarks or the goodwill associated therewith and
shall take no action intended to destroy, damage or materially impair in any way
the ownership or rights of Dura in and to such Rondec Trademarks or CCA
Trademarks. Prior to the time Dura assigns such CCA Trademarks or Rondec
Trademarks to DJ Pharma pursuant to this Agreement, DJ Pharma shall not register
anywhere in the world in its own name or on behalf of any other person or
entity, any trademark, trade dress, brands, labeling, designs or other indicia
of ownership identical to, or confusingly similar to, the Rondec Trademarks or
CCA Trademarks, and shall not associate the Rondec Trademarks or CCA Trademarks
with any articles other than the Rondec Products or CCA Products, respectively
and shall, at the request of Dura, do all such acts and things and execute all
such documents as Dura shall in its reasonable discretion consider necessary or
proper to register or maintain the registration of the Rondec Trademarks and CCA
Trademarks in the Rondec Territory or any country of the CCA Territory,
respectively. Should usage of the Rondec Trademarks or CCA Trademarks in any
country vest title thereto in DJ Pharma prior to the time Dura assigns the
Rondec Trademarks or CCA Trademarks, respectively, pursuant to Section 1.3(a)
hereof, then DJ Pharma shall, at Dura's request, immediately assign and transfer
such title to Dura.
(h) QUALITY CONTROL. DJ Pharma will not permit the quality of
the Rondec Products or CCA Products to deteriorate while such Products are in
its possession so as to
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adversely affect the goodwill associated with the Rondec Trademarks or CCA
Trademarks, respectively. DJ Pharma shall, upon request of Dura, from time to
time furnish Dura, without charge, specifications and samples of Rondec Products
or CCA Products for quality review by Dura. Dura or an authorized representative
thereof shall have the right, at all reasonable times, to inspect the finished
goods in relation to which the Rondec Trademarks or CCA Trademarks are to be
used, as part of appropriate quality control.
(i) INFRINGEMENT OF TRADEMARKS. In the event that, during the
term of the license granted to DJ Pharma under Section 1.1 hereof, either DJ
Pharma or Dura learn that any of the Rondec Trademarks or CCA Trademarks is
being infringed in any territory by any other party, it shall promptly notify
the other of such infringement. In such event both DJ Pharma and Dura shall have
the right, but not the obligation to act jointly to terminate any such third
party infringement, including, without limitation, prosecuting a lawsuit or
other legal proceeding at both Dura's and DJ Pharma's joint expense to be shared
equally between Dura and DJ Pharma. Any recovery received as a result of such
joint action to terminate an infringement of the Rondec Trademarks or CCA
Trademarks, less the reimbursement of each Dura and DJ Pharma for the
out-of-pocket expenses incurred in taking, joining and prosecuting such action,
shall be shared equally between Dura and DJ Pharma. In the event either DJ
Pharma or Dura elects to not take any action to terminate such third party
infringement (the "Non-Acting Party") within sixty (60) days following notice
from the other of a claim of infringement, such other party (the "Acting Party")
shall have the right, but not the obligation, to act to terminate any such third
party infringement, including, without limitation, prosecuting a lawsuit or
other legal proceeding, at the Acting Party's own expense; and the Acting Party
may retain any recovery it may receive as a result of its actions to terminate
such infringement. Notwithstanding the foregoing, the Non-Acting Party shall
fully cooperate with the Acting Party in any action the Acting Party takes to
terminate such infringement and, to the extent the Acting Party recovers damages
from such third party, through settlement or otherwise, the Non-Acting Party
shall be reimbursed by the Acting Party for all reasonable expenses, if any,
incurred in connection therewith.
1.2 RIGHTS GRANTED WITH RESPECT TO THE KEFTAB PRODUCTS FOR THE
LICENSING PERIOD. For the duration of the Licensing Period and subject to the
terms and conditions set forth in this Agreement and the Licensing Agreement,
except as set forth in Section 1.2(b) hereof, Dura Bermuda hereby exclusively
(even as to Dura Bermuda) sublicenses to DJ Pharma the Keftab Rights under the
Licensing Agreement in the fifty (50) states and the District of Columbia
comprising the United States (the "Keftab Territory"). In addition to the terms
and conditions set forth in the Licensing Agreement with respect to the Keftab
Products, DJ Pharma agrees to the following terms with respect to its use of the
Keftab Products during the Licensing Period:
(a) SUBLICENSING. Prior to the expiration of the Licensing
Period, DJ Pharma shall not assign or sublicense any of the rights granted to it
under this Section 1.2, without the prior written consent of Dura Bermuda, which
consent may be provided or withheld in Dura Bermuda's sole discretion.
(b) RETAINED RIGHTS. Notwithstanding the licenses granted to
DJ Pharma under this Section 1.2, after the Closing and through the end of the
Licensing Period (except as otherwise indicated), Dura Bermuda shall retain
ownership of all rights to (a) the current NDC numbers it uses for each of the
Keftab Products (retained (to the extent required by applicable laws and
regulations) through and after the Second Closing), (b) all accounts receivable
from
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sales of the Keftab Products by or on behalf of Dura Bermuda prior to the
Closing, and (c) all inventories of the Keftab Products that have not otherwise
been purchased by DJ Pharma pursuant to the Dura Supply Agreement.
(c) REFERRALS. As of the Closing and through the Licensing
Period, Dura and Dura Bermuda shall refer to DJ Pharma any sales inquiry
received from a third party in the Keftab Territory with respect to the Keftab
Products.
(d) MATERIALS AND PROMOTIONAL CLAIMS. For so long as the
Keftab Products are sold in the Keftab Territory and prior to the expiration of
the Licensing Period, DJ Pharma shall not distribute any written materials or
make any promotional claims regarding the Keftab Products, unless such written
materials or promotional claims have first been reviewed and approved by Dura
Bermuda, such approval not to be unreasonably withheld. Dura Bermuda agrees to
provide DJ Pharma with its approval or rejection of such written materials and
promotional claims within thirty (30) days of receipt by Dura Bermuda.
Notwithstanding the foregoing, DJ Pharma at all times shall be solely
responsible for complying with all applicable laws and regulations in its
promotion and marketing of the Keftab Products.
(e) QUALITY CONTROL. DJ Pharma will not permit the quality of
the Keftab Products to deteriorate while such Products are in its possession so
as to adversely affect the goodwill associated with the Keftab Trademark. DJ
Pharma shall, upon request of Dura Bermuda, from time to time furnish Dura
Bermuda, without charge, specifications and samples of Keftab Products for
quality review by Dura Bermuda. Dura Bermuda or an authorized representative
thereof shall have the right, at all reasonable times, to inspect the finished
goods in relation to which the Keftab Trademark is to be used, as part of
appropriate quality control.
(f) DURA SUPPLY AGREEMENT. By the date of Closing, Dura, Dura
Bermuda, and DJ Pharma shall enter into the Dura Supply Agreement.
(g) USE OF TRADEMARKS. Prior to the expiration of the
Licensing Period, DJ Pharma agrees to use the Keftab Trademark only in
connection with the Keftab Products and in the manner and style which shall have
the prior written approval of Dura Bermuda, which shall not be unreasonably
withheld. DJ Pharma shall submit to Dura Bermuda samples of all commercial
material intended for use by DJ Pharma containing the Keftab Trademark. Dura
Bermuda, within thirty (30) days of its receipt of such materials, shall have
the right to reasonably comment on the usage of the Keftab Trademark in such
materials and DJ Pharma, at its own cost and expense, will promptly correct any
improper usage of the Keftab Trademark . Prior to the time Dura Bermuda assigns
such Keftab Trademark to DJ Pharma pursuant to Section 1.4 of this Agreement, DJ
Pharma agrees not to claim or to assert any right of ownership in or to such
Keftab Trademark or the goodwill associated therewith and shall take no action
which may destroy, damage or materially impair in any way the ownership or
rights of Dura in and to such Keftab Trademark. DJ Pharma shall not register at
anytime anywhere in the world, except in the Keftab Territory pursuant to the
terms of the Licensing Agreement following assignment of the Keftab Trademark
under this Agreement, in its own name or on behalf of any other person or
entity, any trademark, trade dress, brands, labeling, designs or other indicia
of ownership identical to, or confusingly similar to, the Keftab Trademark.
Prior to the time Dura Bermuda assigns such Keftab Trademark to DJ Pharma
pursuant to this Agreement, DJ Pharma shall not associate the Keftab Trademark
with any articles other than the Keftab Products and
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shall, at the request of Dura Bermuda, do all such acts and things and execute
all such documents as Dura Bermuda shall in its reasonable discretion consider
necessary or proper to register or maintain the registration of the Keftab
Trademark in the Keftab Territory. Should usage of the Keftab Trademark in any
country vest title thereto in DJ Pharma prior to the time Dura Bermuda assigns
the Keftab Trademark pursuant to this Agreement, then DJ Pharma shall, at Dura
Bermuda's request, immediately assign and transfer such title to Dura Bermuda.
Upon Dura Bermuda's assignment of Keftab Trademark to DJ Pharma pursuant to this
Agreement, DJ Pharma understands and agrees that its use of the Keftab Trademark
will be subject to the terms and conditions of the Licensing Agreement.
(h) INFRINGEMENT OF TRADEMARKS. In the event that, during the
term of the license granted to DJ Pharma under Section 1.2 hereof, either DJ
Pharma or Dura Bermuda learn that the Keftab Trademark is being infringed in any
territory by any other party, it shall promptly notify the other of such
infringement. In such event both DJ Pharma and Dura Bermuda shall have the
right, but not the obligation to act jointly to terminate any such third party
infringement, including, without limitation, prosecuting a lawsuit or other
legal proceeding at both Dura Bermuda's and DJ Pharma's joint expense to be
shared equally between Dura Bermuda and DJ Pharma. Any recovery received as a
result of such joint action to terminate an infringement of the Keftab
Trademark, less the reimbursement of each Dura Bermuda and DJ Pharma for the
out-of-pocket expenses incurred in taking, joining and prosecuting such action,
shall be shared equally between Dura Bermuda and DJ Pharma. In the event either
DJ Pharma or Dura Bermuda elects to not take any action to terminate such third
party infringement (the "Non-Acting Entity") within sixty (60) days following
notice from the other of a claim of infringement, such other party (the "Acting
Entity") shall have the right, but not the obligation, to act to terminate any
such third party infringement, including, without limitation, prosecuting a
lawsuit or other legal proceeding, at the Acting Entity's own expense; and the
Acting Entity may retain any recovery it may receive as a result of its actions
to terminate such infringement. Notwithstanding the foregoing, the Non-Acting
Entity shall fully cooperate with the Acting Entity in any action the Acting
Entity takes to terminate such infringement and, to the extent the Acting Entity
recovers damages from such third party, through settlement or otherwise, the
Non-Acting Entity shall be reimbursed by the Acting Entity for all reasonable
expenses, if any, incurred in connection therewith.
1.3 PURCHASE AND SALE OF THE RONDEC PURCHASED ASSETS (AS HEREINAFTER
DEFINED) AND THE CCA PURCHASED ASSETS (AS HEREINAFTER DEFINED).
(a) UPON EXPIRATION OF THE LICENSING PERIOD. Subject to the
terms and conditions of this Agreement, at the expiration of the Licensing Term,
(x) Dura shall, without further consideration (except as otherwise set forth
herein), transfer, assign and deliver to DJ Pharma the following assets of Dura
relating to each of the Rondec Products in the Rondec Territory (the "Rondec
Purchased Assets") and to each of the CCA Products in the CCA Territory (the
"CCA Purchased Assets") and (y) DJ Pharma shall additionally have a fully-paid,
irrevocable license and right under the rights granted in Section 1.1 above:
(i) TRADEMARKS. All of the Rondec Trademarks and CCA
Trademarks.
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(ii) REGULATORY HISTORY. A copy of all documents
pertaining to the Rondec Products' and CCA Products' regulatory history
including any existing correspondence with the FDA.
(iii) FORMULATIONS. All formulations including copies
of all documentation for the Rondec Products and CCA Products and the medical
information set forth in Exhibit "E" attached hereto and incorporated herein by
this reference.
(iv) MANUFACTURING INFORMATION; BOOKS AND RECORDS.
Copies of all relevant manufacturing information and technology for the Rondec
Products and CCA Products including, but not limited to, suppliers, production
costs and specifications. Copies of all files and records of Dura specifically
relating to the Rondec Products and CCA Products, whether in hard copy or
magnetic form including without limitation, all research and development files,
including, without limitation, FDA and other governmental agency or
instrumentality files pertaining to the Rondec Products, CCA Products or
registrations thereto, market studies, copies of consumer complaint files,
response letters, adverse event reports, manufacturing worksheets, copies of
manufacturing quality records and assurance information, packaging information,
sales histories, files, reports, operating records and quality control histories
with respect to the Rondec Products and CCA Products.
(v) MARKETING INFORMATION. All marketing and sales
material and information for the Rondec Products, CCA Products and all
copyrights and moral rights thereto.
(vi) TRADEMARK LICENSES. The Rondec Products, the CCA
Products, the Rondec Trademarks and the CCA Trademarks on the existing
respective Rondec and CCA inventory packaging, except for the trade names Dura
and Dura Pharmaceuticals, Inc., which DJ Pharma acquires from Dura under this
Section 1 and the right to continue to use such Rondec Trademarks, CCA
Trademarks and other information on Rondec Product and CCA Product labels as
used thereon by Dura prior to the Second Closing, until DJ Pharma files
appropriate drug listings with the FDA which include representative labeling,
but no later than one hundred eighty (180) days from the Second Closing or such
period of time permitted by applicable law.
(vii) KNOW-HOW AND REGULATORY APPROVALS. All of the
Know-How and Regulatory Approvals as set forth in Section 1.1(a) hereof.
(viii) OTHER RIGHTS. All other intellectual property,
proprietary or other rights owned by Dura solely with respect to the Rondec
Products or CCA Products, including without limitation such intellectual
property set forth on Exhibit "D" attached hereto and incorporated herein by
this reference.
(b) EXCLUDED ASSETS. Notwithstanding the foregoing, Dura is
not selling, and DJ Pharma is not purchasing, pursuant to this Agreement any
tangible or intangible assets, properties or rights of Dura not expressly
included in the Rondec Purchased Assets or CCA Purchased Assets. Except for the
Rondec Trademarks and CCA Trademarks set forth in Section 1.3 hereof, DJ Pharma
is not purchasing or licensing any rights to the trade names Dura or Dura
Pharmaceuticals, Inc. or any logo associated with them.
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1.4 ASSIGNMENT AND ASSUMPTION OF LICENSE AGREEMENT WITH
RESPECT TO KEFTAB PRODUCTS UPON EXPIRATION OF LICENSING PERIOD. Subject to the
terms and conditions of this Agreement and the Assignment, at the expiration of
the Licensing Term, (i) Dura Bermuda shall without further consideration (except
as otherwise provided herein), transfer, assign and deliver to DJ Pharma the
Keftab Rights and (ii) DJ Pharma shall additionally have a fully-paid,
irrevocable license and right under the Keftab Rights.
2. PAYMENTS
2.1 FOR PURCHASE AND LICENSING RIGHTS WITH RESPECT TO THE PRODUCTS. In
consideration for the purchase and licensing rights as set forth in Section 1
hereof, DJ Pharma shall (i) * hereinafter defined) and (ii) pay to Dura with
respect to the Rondec Products and CCA Products and to Dura Bermuda with respect
to the Keftab Rights the following licensing fees during the Licensing Period:
(a) for * (as hereinafter defined) * (as hereinafter defined)
of the Products during such *;
(b) for * (as hereinafter defined) * during such *;
(c) * during each * in the *;
(d) * during each * in the *; and
(e) * during each * in the * and the *.
Notwithstanding the foregoing, * under Sections 2.1(a)-(e) hereof * (all of
which are exclusive of the costs of inventory and product supply under the Dura
Supply Agreement) during the respective calendar year: (i) * (ii) * (iii) * and
(iv) *. Notwithstanding the foregoing, * (collectively, the " * ") in any way *,
including, without limitation, *.
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
For purposes of this Agreement: (A) a "Contract Quarter" shall mean each quarter
in the Contract Year commencing October 1, 1998 and ending September 30, 1999;
(B) the first "Contract Year" shall mean the period of twelve (12) consecutive
months commencing on October 1, 1998, and each subsequent Contract Year shall
begin on the respective anniversary thereof; and (C) "Net Sales" shall mean (i)
the gross amount of sales invoiced to third parties by DJ Pharma less the
reasonable and customary accrual-basis deductions from such gross amounts
including: (a) normal and customary trade and quantity discounts, allowances and
credits actually allowed or paid; (b) credits or allowances given or made for
return of previously sold products; (c) sales or excise taxes, as adjusted for
rebates and refunds; and (d) chargeback payments and rebates granted to managed
health care organizations, employer groups or to federal, state and local
governments, their agencies, purchasers and reimbursers or to trade customers,
including, but not limited to, wholesalers and chain and pharmacy buying groups,
which are specifically identified to the sale of the Products by DJ Pharma. All
amounts under this Section shall be determined from the books and records of DJ
Pharma which shall be maintained in accordance with GAAP.
2.2 REDUCTION OF PAYMENTS. Each monthly payment due under Section 2.1
of this Agreement for each Rondec Product, CCA Product and Keftab Product sold
by DJ Pharma during such month shall be reduced by the unit Supply Price (as
defined in the Dura Supply Agreement) multiplied by the number of units of each
such Product sold by DJ Pharma during such month (such reduced amount defined
herein as the "Net Royalty Payments").
2.3 PAYMENTS. For each calendar month in which DJ Pharma is obligated
to make payments to Dura with respect to sales pursuant to Section 2.1 hereof,
DJ Pharma shall, within thirty (30) days following the close of each such
calendar month, furnish to Dura a written report for the calendar month showing
(i) the number of units of each Rondec Product, CCA Product or Keftab Product,
as the case may be, sold by DJ Pharma during such calendar month, (ii) the Net
Sales of Rondec Products, CCA Products and Keftab Products sold by DJ Pharma
during such calendar month, and (iii) the amounts payable under this Section 2
for such calendar month. Simultaneously with the submission of the written
report, DJ Pharma shall pay to Dura , for the account of DJ Pharma, a sum equal
to the aggregate amount due for such calendar month calculated in accordance
with this Agreement. Payments due hereunder shall be paid by wire transfer to a
bank account as designated from time to time by Dura.
2.4 MAINTENANCE OF RECORDS BY DJ PHARMA; AUDITS.
(a) RECORDKEEPING BY DJ PHARMA. DJ Pharma shall keep accurate
books and accounts of record in connection with the sale by DJ Pharma of the
Products in sufficient detail to (i) permit accurate determination of all
figures necessary for verification of payments or refunds required to be paid
hereunder and (ii) verify compliance with Section 2.6 hereof. Records pursuant
to this Section 2.4(a) shall be maintained for a period of three (3) years after
the end of the year in which they were generated.
(b) AUDIT BY DURA. Dura, through an independent certified
public accountant, shall have the right to access such books and records of DJ
Pharma one time per year unless permitted more frequently pursuant to this
Section 2.4(b): (a) to verify the accuracy of the reports and all payments or
refunds made hereunder and (b) to verify compliance with the provisions of
Section 2.6 hereof. Notwithstanding the foregoing should an audit by Dura
pursuant to this
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Section 2.4(b) show a Material Underpayment (as hereinafter defined) by DJ
Pharma, Dura shall be permitted to conduct audits pursuant to this Section
2.4(b) as many times in any year as Dura may deem reasonably necessary. Dura's
right to have such books and records examined shall survive termination or
expiration of this Agreement for a period of six months following such
termination or expiration.
(c) UNDERPAYMENTS/OVERPAYMENTS. If such independent certified
public accountant's report shows any underpayment, DJ Pharma shall remit to Dura
within thirty (30) days after DJ Pharma's receipt of such report (i) the amount
of such underpayment to Dura and (ii) if such underpayment to Dura exceeds five
percent (5%) of the total amount owed for the calendar year then being audited
("Material Underpayment"), the reasonable fees and expenses of such independent
certified public accountant performing the audit. Any overpayments, less the
reasonable fees and expenses of such independent certified public accountant,
shall be fully creditable against amounts payable in subsequent payment periods,
if any. If no amounts are payable in subsequent periods, Dura shall credit any
overpayments, less the reasonable fees and expenses of such independent
certified public accounting firm, to principal outstanding under the
Subordinated Product Acquisition Notes.
(d) ADDITIONAL AUDIT REQUIREMENTS UNDER THE LICENSING
AGREEMENT. In addition to the audit requirements set forth above, DJ Pharma
understands and agrees that with respect to the Keftab Products it shall also be
subject to audit by Lilly and such other audit requirements as set forth in the
Licensing Agreement.
2.5 TAXES AND WITHHOLDING. All taxes, assessments and fees of any
nature levied or incurred on account of any payments from DJ Pharma to Dura
accruing under this Agreement, by national, state or local governments, will be
assumed and paid by DJ Pharma, except taxes levied thereon as income to Dura,
and if such taxes are required to be withheld by DJ Pharma they will be deducted
from payments due to Dura and will be timely paid by DJ Pharma to the proper
taxing authority for the account of Dura, and a receipt or other proof of
payment therefor secured and sent to Dura as soon as practicable.
2.6 TIMING OF SALES. DJ Pharma agrees that it shall not, by any
artifice, or unreasonable action or omission cause sales of any of the Rondec
Products, CCA Products or Keftab Products to occur later than they would
otherwise have occurred. Such actions or acts of omission may include, without
limitation, announcing or implementing changes in the price of the Products in
such a way as to delay the filling of orders from one Contract Quarter or
Contract Year to the next. If DJ Pharma has taken any such actions or committed
any such act of omission then for all purposes of payment of amounts under
Section 2 hereof such sales shall be treated as if made during the period they
would have been made were it not for the act or omission on the part of DJ
Pharma.
2.7 ADJUSTMENT OF PAYMENTS RELATED TO RONDEC PRODUCTS OR CCA PRODUCTS.
In the event of the occurrence of an * (as hereinafter defined) at any time up
to and through *, DJ Pharma's future payment obligations to Dura or Dura Bermuda
as of the * (as hereinafter defined) shall be adjusted as follows:
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
(a) * EXCEED ADJUSTED NET SALES AMOUNT. In the event that the * (as
hereinafter defined) for a * (as hereinafter defined) or * (as hereinafter
defined), as the case may be, * by DJ Pharma of such * or * (the "Adjusted Net
Sales Amount") as of the *, then DJ Pharma (i) may * for the Products as of the
* and (ii) may * (as hereinafter defined) * (x) * (such * to be determined
assuming * of the *, as the case may be, for the * immediately preceding the *
to total * (the " * ") and (y) *.
(b) ADJUSTED NET SALES EXCEED *.
(i) DURING PERIOD COMMENCING AS OF THE CLOSING AND ENDING AS
OF *. In the event that at any time in the period commencing as of the Closing
and ending *, the Adjusted Net Sales Amount exceeds the *, then DJ Pharma's *
may be * (x) * (such * to be determined assuming * and (y) the *.
(ii) DURING PERIOD COMMENCING AS OF * AND ENDING AS OF *. In
the event that at any time in the period commencing * and ending *, the Adjusted
Net Sales Amount exceeds the *, then DJ Pharma's * shall be * (i) * (x) * (such
* to be determined assuming *) and (y) * (ii) the amount by which the *.
(c) ADJUSTMENT TO *. In addition to the adjustments set forth in
Sections 2.7 (a) and (b) hereof, the * (as hereinafter defined) will be * in
effect for the respective period * of the respective *, as the case may be, for
the * immediately preceding
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
the * to total Net Sales of the Products for the * months immediately preceding
the *. Any * will * for any remaining period ratably based upon the * for such
period immediately prior to such reduction. In the event of an adjustment of
payments pursuant to this Section 2.7 *. In addition, *.
Attached as Exhibit H are examples of the calculations set forth in Sections 2.7
(a)-(c) above, based on select hypothetical scenarios.
For purposes of this Section 2.7 the " * " shall equal the * of (i) the result
of (a) the * (b) the total Net Sales of the Rondec Products and CCA Products for
the * (ii) the *.
For purposes of this Section 2.7 an " * " shall be deemed to have occurred at
such time as the *, or other * as a result of any such action by DJ Pharma, and
which (a) *, or (b) *, or (c) *. Any of the * impacted as set forth in
subsections (a)-(c) of this paragraph by the * are defined herein as the *.
For purposes of this Section 2.7 the " * " shall be, except as set forth herein,
the date upon which * of the occurrence of any or all of the foregoing events.
With respect to the * as set forth in subsection (a) of the foregoing paragraph,
the * shall be on the *.
For purposes of this Section 2.7 " * " shall * (i) the result of (a) * (b) *
-13-
*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
* (ii) * immediately follow *; in each case after giving effect to any previous
* pursuant to this Section 2.7 or Section 7.2(h).
3. CLOSING AND SECOND CLOSING
3.1 TIME AND PLACE OF THE CLOSING. The closing shall occur on January
25, 1999 (the "Closing"), and all such transactions shall be effective as of
8:00 a.m. pacific standard time on January 25, 1999.
3.2 ACTIONS TO BE TAKEN AT THE CLOSING. At the Closing, the following
actions shall be deemed to have occurred simultaneously and shall be effective
as of 8:00 a.m. pacific standard time on January 25, 1999:
(a) Except as otherwise indicated, at the Closing, Dura and
Dura Bermuda (where applicable) shall deliver to DJ Pharma the following:
(i) an executed original of this Agreement;
(ii) an executed original of the Dura Supply
Agreement;
(iii) executed originals of all investment documents
related to that certain DJ Pharma, Inc. * Agreement by and among DJ Pharma, the
* (as defined therein) and the * (as defined therein), dated January 25, 1998
(collectively, the "* Documents");
(iv) * pursuant to the * Agreement (as hereinafter
defined) in the amount of *;
(v) * by Dura and Dura Bermuda in connection with
Dura or Dura Bermuda's * pursuant to the DJ Pharma * Agreements; and
(vi) such other documents as may be required or
necessary to fully effectuate the transactions contemplated herein.
(b) At the Closing (except as otherwise indicated below), DJ
Pharma shall deliver to Dura and to Dura Bermuda (where applicable) the
following:
(i) an executed original of this Agreement;
(ii) an executed original of the Dura Supply
Agreement;
(iii) an executed original of the * and of the *,
which together with the * is collectively referred to herein as the *
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
*, both of which are attached hereto as Exhibit F and incorporated herein by
this reference;
(iv) an executed original of the * attached hereto as
Exhibit G and incorporated herein by this reference;
(v) executed originals of the * Documents;
(vi) Certificate of Incorporation and By-Laws of DJ
Pharma certified as of the date of Closing;
(vii) full payment of fees to Dura (up to an amount
not to exceed * ) as set forth in Section 7A of that certain * Agreement by and
among DJ Pharma and the * (as defined therein), dated January 25, 1998 (the "*
Agreement"), as set forth on an estimated statement provided by Dura to DJ
Pharma as of the Closing. In connection with the foregoing, DJ Pharma
understands and agrees that such amount may be increased following final
computations by Dura of * and DJ Pharma agrees to pay such increased amount (up
to an aggregate amount of * under this Section 3.2 (b)(vii) promptly following
Dura's submission to DJ Pharma of such final computation; and
(viii) full payment of all outstanding obligations
due and payable pursuant to section 2.2 of the * Agreement by and between Dura
and DJ Pharma; and
(ix) such other documents as may be required or
necessary to fully effectuate the transactions contemplated herein.
(c) At the Closing, each party shall provide to the other
party copies, certified (as appropriate) by the Secretary, Assistant Secretary
or other appropriate officer of the party, of resolutions of the party's Board
of Directors authorizing the execution, delivery and performance of this
Agreement and all other agreements, documents and instruments relating hereto,
and the consummation of the transactions contemplated hereby.
(d) Effective as of the Closing the following documents and
all exhibits thereto shall be deemed terminated and of no further force and
effect:
(i) that certain * and the * between the parties
hereto, each dated October 1, 1998;
(ii) the * by and between DJ Pharma and Dura, dated
October 1, 1998;
(iii) the * by and between DJ Pharma and Dura, dated
July 28, 1998 and October 1, 1998 (the " * ");
(iv) the * by and between Dura and DJ Pharma and all
exhibits thereto;
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
(v) the *, dated July 28, 1998, *;
(vi) the *, dated July 28, 1998, *;
(vii) the Assignment of the Abbott Purchase Agreement
and Abbott Supply Agreement; and
(viii) the * Agreement by and between Dura, Dura
Bermuda and DJ Pharma, dated December 31, 1998.
3.3 TIME AND PLACE OF THE SECOND CLOSING. The closing of the transfer
of the rights and obligations of Dura in and to the Rondec Products and CCA
Products and Dura and/or Dura Bermuda in and to the Keftab Products (the "Second
Closing") shall occur on * (or at such other date as may be mutually agreed upon
by the parties), and all such transactions shall be effective as of the close of
business on the date of the Second Closing.
3.4 ACTIONS TO BE TAKEN AT THE SECOND CLOSING. At the Second Closing,
the parties shall deliver to each other an executed original of an assignment of
the Abbott Purchase Agreement, the Abbott Supply Agreement, the Licensing
Agreement and the Manufacturing Agreement to be assigned in the form of the
Assignment and such other assignments or documents as may be required or
necessary to fully effectuate the transactions contemplated herein.
3.5 NOTIFICATION CONCERNING TRANSFER OF PRODUCTS AND RIGHTS. Promptly
after the Second Closing, DJ Pharma will, to the extent required by applicable
laws and regulations, notify customers of the Products that DJ Pharma has
purchased the Rondec Products, the CCA Products, and has licensed the Keftab
Rights.
3.6 CONDITIONS TO CLOSINGS.
(a) DJ PHARMA CONDITIONS TO CLOSINGS. The representations and
warranties of Dura and Dura Bermuda contained in this Agreement will in all
material respects be true as of the date of the Closing and the Second Closing
with the same effect as though made at the respective closing; and Dura and Dura
Bermuda will have delivered to DJ Pharma a certificate, dated as of the
respective closing thereof and signed by its President or a Vice President, to
such effect.
(b) DURA AND DURA BERMUDA CONDITIONS TO CLOSINGS. The
representations and warranties of DJ Pharma contained in this Agreement will in
all material respects be true as of the Closing and the Second Closing with the
same effect as though made at the respective closing; and DJ Pharma will have
delivered to Dura and Dura Bermuda a certificate, dated as of the respective
closing thereof and signed by its President or a Vice President, to such effect.
4. INDEMNIFICATION
4.1 INDEMNIFICATION.
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
(a) Dura and Dura Bermuda shall indemnify, defend and hold DJ
Pharma and its directors, officers, employees, agents and representatives
(collectively the "DJ Pharma Parties") harmless from and against any and all
costs, losses, claims, liabilities, fines, penalties, damages and expenses,
court costs, and reasonable fees and disbursements of counsel, consultants and
expert witnesses (including interest which may be imposed in connection with any
of the foregoing) (collectively, "Damages") incurred or suffered by the DJ
Pharma Parties excluding incidental or consequential damages suffered or
incurred by the DJ Pharma Parties directly (as opposed to incidental or
consequential Damages suffered or incurred by third parties who are, in turn,
seeking the same from the DJ Pharma Parties, which shall be covered by the
indemnity set forth herein) as a consequence of:
(i) any breach of any representation or warranty made
by Dura or Dura Bermuda in this Agreement, provided that notice of a claim based
upon any such breach is received by Dura or Dura Bermuda prior to the expiration
of such representation and warranty pursuant to Section 11.9;
(ii) any failure to perform duly and punctually any
covenant, agreement or undertaking on the part of Dura or Dura Bermuda contained
in this Agreement;
(iii) any material misrepresentation in or material
omission from any agreement, instrument or document delivered by Dura or Dura
Bermuda pursuant to the terms of this Agreement;
(iv) any activity conducted or liability incurred by
Dura or Dura Bermuda in respect to the marketing, sale, and distribution of the
Products prior to the Closing; provided, however, that such indemnity shall not
apply to the extent such liability results from any act or omission by DJ
Pharma, under that certain Co-Promotion Agreement between the parties hereto,
dated July 28, 1998, or otherwise; or
(v) any other liability of Dura not specifically
assumed by DJ Pharma pursuant to this Agreement.
(b) The DJ Pharma Parties shall indemnify, defend and hold
Dura and Dura Bermuda, and each of their respective directors, officers,
employees, agents and representatives (collectively the "Dura Parties") harmless
from and against any and all Damages incurred or suffered by the Dura Parties
(excluding incidental or consequential Damages suffered or incurred by Dura
directly (as opposed to incidental or consequential Damages suffered or incurred
by third parties who are, in turn, seeking the same from Dura, which shall be
covered by the indemnity set forth herein) as a consequence of:
(i) any breach of any representation or warranty made
by DJ Pharma in this Agreement, provided that notice of a claim based upon any
such breach is received by DJ Pharma prior to the expiration of such
representation and warranty pursuant to Section 11.9;
(ii) any failure to perform duly and punctually any
covenant, agreement or undertaking on the part of DJ Pharma contained in this
Agreement;
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(iii) any material misrepresentation in or material
omission from any agreement, instrument or document delivered by DJ Pharma
pursuant to the terms of this Agreement; or
(iv) any and all liabilities and obligations relating
to the CCA Products, the Rondec Products and the Keftab Products or Rights which
are hereby expressly assumed by DJ Pharma as set forth in Section 8.3 hereof.
4.2 NOTICE AND OPPORTUNITY TO DEFEND. Promptly after receipt by a party
hereto of notice of any claim which could give rise to a right to
indemnification pursuant to Section 4.1, such party (the "Indemnified Party")
shall give the other party (the "Indemnifying Party") written notice describing
the claim in reasonable detail. The failure of an Indemnified Party to give
notice in the manner provided herein shall not relieve the Indemnifying Party of
its obligations under this Section , except to the extent that such failure to
give notice materially prejudices the Indemnifying Party's ability to defend
such claim. The Indemnifying Party shall have the right, at its option, to
compromise or defend, at its own expense and by its own counsel, any such matter
involving the asserted liability of the party seeking such indemnification. If
the Indemnifying Party shall undertake to compromise or defend any such asserted
liability, it shall promptly (and in any event not less than ten (10) days after
receipt of the Indemnified Party's original notice) notify the Indemnified Party
in writing of its intention to do so, and the Indemnified Party agrees to
cooperate fully with the Indemnifying Party and its counsel in the compromise or
defense against any such asserted liability. All reasonable costs and expenses
incurred in connection with such cooperation shall be borne by the Indemnifying
Party. If the Indemnifying Party elects not to compromise or defend the asserted
liability, fails to notify the Indemnified Party of its election to compromise
or defend as herein provided, fails to admit its obligation to indemnify under
this Agreement with respect to the claim, or, if in the reasonable opinion of
the Indemnified Party, the claim could result in the Indemnified Party becoming
subject to injunctive relief or relief other than the payment of money damages
that could materially adversely affect the ongoing business of the Indemnified
Party in any manner, the Indemnified Party shall have the right, at its option,
to pay, compromise or defend such asserted liability by its own counsel and its
reasonable costs and expenses shall be included as part of the indemnification
obligation of the Indemnifying Party hereunder. Notwithstanding the foregoing,
neither the Indemnifying Party nor the Indemnified Party may settle or
compromise any claim over the objection of the other; provided, however, that
consent to settlement or compromise shall not be unreasonably withheld. In any
event, the Indemnified Party and the Indemnifying Party may participate, at
their own expense, in the defense of such asserted liability. If the
Indemnifying Party chooses to defend any claim, the Indemnified Party shall make
available to the Indemnifying Party any books, records or other documents within
its control that are necessary or appropriate for such defense. Notwithstanding
anything to the contrary in this Section 4.2, the party conducting the defense
of a claim shall (a) keep the other party informed on a reasonable and timely
basis as to the status of the defense of such claim (but only to the extent such
other party is not participating jointly in the defense of such claim), and (b)
conduct the defense of such claim in a prudent manner, and the Indemnifying
Party shall not cease to defend, settle or otherwise dispose of any claim
without the prior written consent of the Indemnified Party (which consent shall
not be unreasonably withheld).
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4.3 INDEMNIFICATION PAYMENT OBLIGATION. No Indemnifying Party will have
any obligations under Sections 4.l(a) or 4.1(b) until the cumulative aggregate
amount of Damages incurred or suffered by the Indemnified Party which the
Indemnifying Party is otherwise subject to under this Agreement exceeds * at
which time the entire cumulative aggregate amount of such Damages shall be
covered. The provisions of this Section 4.3 shall not limit or otherwise affect
the obligations of any Indemnifying Party under any other Section of this
Agreement.
4.4 INDEMNIFICATION PAYMENT; ADJUSTMENTS. The amount of any Damages for
which indemnification is provided under this Section 4 shall be reduced to take
account of any net tax benefit and shall be increased to take account of any net
tax detriment arising from the incurrence or payment of any such Damages or from
the receipt of any such indemnification payment and shall be reduced by the
insurance proceeds received and any other amount recovered, if any, by the
Indemnified Party with respect to any Damages; provided, however, that an
Indemnified Party shall not be subject to an obligation to pursue an insurance
claim relating to any Damages for which indemnification is sought hereunder if
pursuing such claim is reasonably likely to result in increased premiums or
materially and adversely affect a party's insurability. If any Indemnified Party
shall have received any payment pursuant to this Section 4 with respect to any
Damages and shall subsequently have received insurance proceeds or other amounts
with respect to such Damages, then such Indemnified Party shall pay to the
Indemnifying Party an amount equal to the difference (if any) between (i) the
sum of the amount of those insurance proceeds or other amounts received and the
amount of the payment by such Indemnifying Party pursuant to this Section 4 with
respect to such Damages and (ii) the amount necessary to fully and completely
indemnify and hold harmless such Indemnified Party from and against such
Damages; provided, however, in no event will such Indemnified Party have any
obligation pursuant to this sentence to pay to such Indemnifying Party an amount
greater than the amount of the payment by such Indemnifying Party pursuant to
this Section 4 with respect to such Damages.
4.5 INDEMNIFICATION PAYMENT. Upon the final determination of liability
and the amount of the indemnification payment under this Section 4, the
appropriate party shall pay to the other, as the case may be, within ten (10)
business days after such determination, the amount of any claim for
indemnification made hereunder.
4.6 INSURANCE. DJ Pharma shall obtain and maintain at all times during
the term of this Agreement, Commercial General Liability Insurance, including
Products Liability Insurance, with reputable and financially secure insurance
carriers to cover its indemnification obligations under this Section 4, with
limits of not less than * per occurrence and in the aggregate for general
liability insurance and * per occurrence and in the aggregate for products
liability insurance. DJ Pharma shall provide Dura with a Certificate of
Insurance evidencing this coverage within fifteen (15) days after the Closing.
Such products liability insurance policy shall name Dura as an additional
insured and DJ Pharma shall use its commercially reasonable efforts to ensure
that such insurance policy contains a provision requiring thirty (30) day
advance notice to Dura in the event of its cancellation or termination. During
the Licensing Period, Dura and Dura Bermuda shall each maintain insurance with
third parties sufficient to cover its obligations under Section 4.
5. DISPUTE RESOLUTION
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
5.1 GOOD FAITH DISCUSSION; ADR PROCESS. Except as set forth in Section
10, the parties shall attempt to resolve through good faith discussions any
dispute which arises under this Agreement. If they are unable to resolve the
dispute within thirty (30) calendar days after delivery of written notice of the
dispute from one party to the other, either party may seek to resolve it by
initiating an Alternative Dispute Resolution Arbitration ("ADR") in which the
American Arbitration Association (the "AAA") shall select the neutral
("Neutral") as provided herein. Notwithstanding the foregoing, the parties
hereto may seek legal channels other than ADR to the extent necessary to enforce
the terms of Section 10 herein. The ADR shall be conducted in accordance with
the Commercial Arbitration Rules of the AAA, except as otherwise provided below.
5.2 ADR ISSUES: SELECTION OF NEUTRAL. An ADR shall be initiated by a
party by sending written notice thereof to the other party and the AAA, which
notice shall state the issues to be resolved. Within ten (10) business days
after receipt of such notice, the other party may, by sending written notice to
the initiating party and the AAA, add issues to be resolved. Within twenty (20)
business days after the date of the original ADR notice, the AAA shall nominate
to the parties at least five (5) qualified nominees from the AAA's Panel of
distinguished Neutrals. The parties shall have five (5) business days after the
receipt of such nominations to agree on a Neutral or, failing to agree, to
rank-order their preferences with the most preferred being given the lowest
number, and mail the rank-order to the AAA. The AAA shall notify the parties of
their selection. If all nominees are unacceptable to a party, the procedure
shall be repeated and, if the parties cannot select a neutral the second time,
the AAA shall select the Neutral.
5.3 NEUTRAL WITH SPECIAL EXPERTISE. In the event of a dispute between
the parties relating to the calculation of any commissions or the amount of
other consideration payable under this Agreement (including, without limitation,
the results of any audit conducted on behalf of a party pursuant to this
Agreement), then, in addition to the procedure set forth in Section 5.2 above,
the Neutral shall be a partner or full member of an internationally recognized
certified public accounting firm which is not an auditing firm for either party
and has not provided material services to either party during the last two (2)
year period prior to the date of ADR initiation.
5.4 ADR HEARING. The Neutral shall hold a hearing to resolve the issues
within one hundred twenty (120) business days after selection in San Diego,
California. Each party may be represented by counsel. Prior to the hearing the
parties shall be entitled to engage in discovery under procedures of the Federal
Rules of Civil Procedure; PROVIDED, HOWEVER, that a party may not submit more
than fifty (50) written interrogatories or take more than four (4) depositions.
There shall not be any, and the Neutral shall not permit, any discovery within
thirty (30) days of the hearing. The Neutral shall have sole discretion
regarding the admissibility of evidence and conduct of the hearing. At least
five (5) business days prior to the hearing, each party shall submit to the
other party and the Neutral a copy of all exhibits on which such party intends
to rely at the hearing, a pre-hearing brief (up to 5 pages), and a proposed
disposition of the dispute (up to 5 pages). The proposed disposition shall be
limited to proposed rulings and remedies on each issue, and shall contain no
argument on or analysis of the facts or issues; PROVIDED, however, that the
parties will not present proposed monetary remedies. Within five (5) business
-20-
days after close of the hearing, each party may submit a post-hearing brief (up
to 5 pages) to the Neutral.
5.5 ADR RULING; FEES AND EXPENSES. The Neutral shall render a
disposition on the proposed rulings as expeditiously as possible after the
hearing, but not later than fifteen (15) business days after the conclusion of
the hearing. The Neutral shall rule on each issue and shall adopt in its
entirety the proposed ruling of one of the parties on each issue. In the
circumstance where the Neutral rules for a party on a claim in the form of a
claim for monetary damages, the parties will then submit a proposed remedy
within ten (10) days of notice of the ruling. The proposed remedy may be
accompanied by a brief in support of the remedy not to exceed five (5) pages.
The Neutral will rule on and adopt one of the proposed remedies within ten (10)
days of their submission. The Neutral's disposition shall be final and not
appealable, except that either party shall have the right to appeal such
disposition on the basis it was affected by fraud or bad faith in connection
with the ADR proceedings. A judgement on the Neutral's disposition may be
entered in any court having jurisdiction over the parties. The prevailing party
shall be entitled to recover from the non-prevailing party the reasonable fees
and expenses of the Neutral, as well as the standard charges of the AAA for its
assistance.
6. TERMINATION OF AGREEMENT
6.1 TERMINATION FOR CAUSE - BOTH PARTIES. Notwithstanding anything to
the contrary in this Agreement, this Agreement may be terminated prior to the
Second Closing by written notice at any time prior to the Second Closing:
(a) by Dura or Dura Bermuda for material breach by DJ Pharma
or by DJ Pharma for material breach by Dura or Dura Bermuda, which breach
remains uncured for thirty (30) days in the case of nonpayment of any amount due
and unless otherwise set forth herein, ninety (90) days for all other breaches,
each measured from the date written notice of such breach is given to the
breaching party or, if such breach is not susceptible of cure within such ninety
(90) day period and the breaching party uses diligent good faith efforts to cure
such breach, for one hundred eighty (180) days after written notice to the
breaching party. Notwithstanding the foregoing, in the event of a payment
default by DJ Pharma as a result of * (as hereinafter defined) at any one time
during the term of this Agreement, DJ Pharma shall be afforded the opportunity
to cure such payment default (as well as any other payment default occurring
within 150 days thereafter) for a period of one hundred fifty (150) days
following written notice by Dura to DJ Pharma of the initial payment breach,
provided that the following conditions have been met:
(i) DJ Pharma has not previously breached any payment
requirements under this Agreement;
(ii) During such 150 day cure period DJ Pharma uses
diligent good faith efforts to cure such breach;
(iii) any nonpayment breaches or events warranting
termination under this Agreement which occur during such 150 day cure period
shall be cured by the expiration of such 150 day cure period (or earlier if the
applicable cure period described in this Section 6 expires earlier than the 150
day cure period);
-21-
*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
(iv) During such 150 day cure period DJ Pharma does
not * ;
(v) *; and
(vi) upon termination of such cure period, DJ Pharma
agrees to pay Dura all outstanding amounts due plus interest accrued as of the
date the amounts became overdue at a rate equal to the Prime Rate in effect at
the time of default (as published by the Wall Street Journal) plus six percent
(6%) per annum (or the highest amount allowed by law, if such lawful amount is
lower than the foregoing).
(b) by Dura or Dura Bermuda or by DJ Pharma immediately upon
the filing or institution of bankruptcy, reorganization, liquidation or
receivership proceedings, or upon an assignment of a substantial portion of the
assets for the benefit of creditors by the other party, or in the event a
receiver or custodian is appointed for such party's business, or if a
substantial portion of such party's business is subject to attachment or similar
process; provided, however, in the case of any involuntary bankruptcy proceeding
such right to terminate shall only become effective if the proceedings are not
dismissed within ninety (90) days after the filing thereof.
6.2 TERMINATION FOR CAUSE - DURA AND DURA BERMUDA. Prior to Dura's
transfer to DJ Pharma of the Rondec Purchased Assets and the CCA Purchased
Assets and Dura and/or Dura Bermuda's assignment, as the case may be, of the
Keftab Rights, this Agreement may be terminated by Dura and Dura Bermuda, at
their option and discretion, if the Dura Supply Agreement is terminated prior to
its natural expiration due to a material, uncured breach by DJ Pharma.
6.3 TERMINATION FOR CAUSE - DJ PHARMA. Prior to Dura's transfer to DJ
Pharma of the Rondec Purchased Assets and the CCA Purchased Assets and Dura
and/or Dura Bermuda's assignment of the Keftab Rights, as the case may be, this
Agreement may be terminated by DJ Pharma, at its option and discretion, if the
Dura Supply Agreement is terminated prior to its natural expiration due to a
material, uncured breach by Dura or Dura Bermuda. Notwithstanding the foregoing,
DJ Pharma understands and agrees that while Dura shall use commercially
reasonable efforts to supply Products to DJ Pharma, Dura cannot guarantee
supplies from third party manufacturers and that any failure of third party
manufacturers to supply Products to or on behalf of DJ Pharma shall in no event
result in a right of termination of this Agreement by DJ Pharma.
6.4 EFFECT OF TERMINATION.
(a) In the event of termination by Dura or Dura Bermuda, DJ
Pharma shall return all Dura documents in its possession within fourteen (14)
days of any such termination.
(b) In the event of termination by DJ Pharma as a result of a
material breach by Dura or Dura Bermuda, DJ Pharma shall have any and all
remedies available at law or equity.
-22-
*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
(c) In the event of termination by Dura or Dura Bermuda as a
result of a material breach by DJ Pharma prior to the expiration of the
Licensing Term, Dura may at its option terminate the purchase and license rights
set forth in Section 1 hereof with respect to the Products. In the event of
termination by Dura or Dura Bermuda at any time as a result of material breach
by DJ Pharma, Dura or Dura Bermuda shall in addition to the remedies set forth
in this Section 6.4(c) have any and all remedies available at law or equity;
Notwithstanding the foregoing in the event Dura terminates the purchase and
license rights with respect to the Products following DJ Pharma's failure to
cure a payment default within the 150 day cure period following such default *
as of the * pursuant to Section 2 hereof * (x) the amount of * and (y) *.
(d) Expiration or termination of this Agreement shall not
relieve the parties of any obligation accruing prior to such expiration or
termination.
7. REPRESENTATIONS, WARRANTIES AND COVENANTS
7.1 REPRESENTATIONS, WARRANTIES AND COVENANTS OF DURA WITH RESPECT TO
THE CCA PRODUCTS AND THE RONDEC PRODUCTS. As of the date of this Agreement and
as of the Second Closing, Dura hereby represents, warrants and covenants to DJ
Pharma the following, all with respect to the CCA Products in the CCA Territory
and the Rondec Products in the Rondec Territory (collectively, the "CCA/Rondec
Products") only:
(a) AUTHORITY. Dura has the necessary corporate power and
authority to enter into and deliver this Agreement and to perform its
obligations hereunder and to consummate the transactions contemplated hereby.
The execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby by Dura have been duly authorized by Dura. This
Agreement constitutes the legal, valid and binding obligation of Dura,
enforceable in accordance with its terms (except as such enforcement may be
limited by applicable bankruptcy, insolvency, moratorium, or similar laws
affecting the rights of creditors generally or by general principles of equity).
Neither the execution, delivery or performance of this Agreement by Dura, nor
the consummation of the transactions contemplated hereby nor compliance by Dura
with the terms and provisions of this Agreement will result in a violation or
breach of any term or provision of Dura's Certificate of Incorporation or
By-laws, or of any statute, rule or regulation applicable to Dura, nor conflict
with or constitute a default under any agreement to which Dura is a party or to
which its assets are subject, or any instrument, judgment, decree, writ, or
other restriction to which Dura is a party or by which its assets are bound.
(b) TITLE TO ASSETS, LIENS AND ENCUMBRANCES. Except as set
forth in Schedule 7.1(b) hereof, Dura has good title to the CCA/Rondec Products
and the inventory of Rondec Products and CCA Products and any inventions,
know-how, trade secrets, intellectual property rights and technology necessary
to transfer, assign and deliver the Rondec Purchased Assets and CCA Purchased
Assets and has the right to grant the rights in connection with the CCA/Rondec
Products to DJ Pharma as set forth herein, free and clear of all security
interests, liens, claims, restrictions, royalty obligations and encumbrances
whatsoever other than any of the
-23-
*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
foregoing which will not interfere with DJ Pharma's rights to manufacture or
have manufactured, distribute, offer for sale, market and sell the CCA/Rondec
Products. Such rights licensed, assigned, transferred or delivered to DJ Pharma
represent all of the rights which Dura owns or has with respect to the
CCA/Rondec Products and constitute all of the rights necessary for DJ Pharma to
market, distribute, offer for sale, promote and sell each of the CCA/Rondec
Products (and manufacture the Rondec Products and CCA Products). Dura is the
non-exclusive licensee of the Rondec Patent in the Rondec Territory and has
exclusive rights to the U.S. trademarks RONDEC-Registered Trademark- and
RONDEC-TR-Registered Trademark- for medicine and pharmaceutical preparations in
the Rondec Territory. No other unrelated party has been granted a license or
other permission to use the trademarks RONDEC-Registered Trademark- and
RONDEC-TR-Registered Trademark- in the Rondec Territory for medicine and
pharmaceutical preparations, and upon the Closing, with the exception of the
supply and manufacture of the Rondec Products under the Abbott Supply Agreement,
DJ Pharma will have the sole right to use the trademarks RONDEC-Registered
Trademark- and RONDEC-TR-Registered Trademark- in the Rondec Territory for
medicine and pharmaceutical preparations. Dura is the sole owner of the CCA
Trademarks. No other party has been granted a license or other permission to use
the CCA Trademarks, and upon the Closing, with the exception of the supply and
manufacture of the CCA Products under the Dura Supply Agreement, DJ Pharma will
have the sole right to use the CCA Trademarks.
(c) CLAIMS; LITIGATION. Dura is not aware of any claim, suit,
action, arbitration, governmental investigation or other proceeding, nor any
order, decree or judgment pending or in effect, or threatened by, against or
relating to the CCA/Rondec Products, the CCA Trademarks, the Rondec Patent or
the trademark Rondec which if determined adversely would have an adverse effect
on DJ Pharma's rights to manufacture or have manufactured, market, distribute,
offer for sale and sell the CCA/Rondec Products.
(d) COMPLIANCE WITH LAWS. Dura is currently in compliance with
all laws, ordinances, treaties and governmental rules, orders and regulations
applicable to it with respect to the CCA/Rondec Products, the CCA Trademarks and
the trademarks RONDEC-Registered Trademark- and RONDEC-TR-Registered Trademark-.
(e) INTELLECTUAL PROPERTY. Exhibit D hereof sets forth a true
and correct list of all material patents, trademarks, service marks, trade
names, copyrights and applications for registration and registrations thereof,
owned or licensed by Dura, and used with respect to the CCA/Rondec Products
(collectively, the "Intellectual Property"). Other than the Intellectual
Property, to the best of Dura's knowledge, there are no patents, trademarks,
service marks, trade names, copyrights, applications for registration or
registrations thereof necessary for manufacture, marketing or sale of CCA
Products or the Rondec Products as currently manufactured, marketed and sold by
Dura. Dura has good and marketable title to, or other legal right to use, the
Intellectual Property, free and clear of any license, royalty arrangement, lien,
claim or encumbrance of any nature whatsoever other than any of the foregoing
which will not interfere with DJ Pharma's rights to manufacture, distribute,
offer for sale, market and sell the CCA/Rondec Products.
(f) CONTRACTS. Schedule 7.1(f) sets forth a true and complete
list of the entities with whom Dura has contracts as of the Closing relating to
the CCA/Rondec Products, and copies of such contracts or relevant portions of
contracts have been made or will be made available to DJ Pharma for inspection
prior to the Closing. Such contracts constitute the only written contracts,
arrangements, commitments and agreements, currently in force and used by
-24-
Dura with respect to the manufacture, marketing, distribution, offering for sale
or sale of the Products in the applicable territories. Such contracts are valid
and binding, enforceable by or against Dura in accordance with their respective
terms and are in full force and effect. Neither Dura nor, to Dura's best
knowledge, any other party thereto, is in breach of any provision of or in
default under any term of any such contract, and there exists no condition or
event which after lapse of time or notice (or both) would constitute any such
breach or default or result in any right to accelerate or any loss of rights.
(g) [Intentionally Omitted.]
(h) COMPLIANCE WITH CONTRACT OBLIGATIONS. Dura is in
compliance and shall at all times remain in compliance with any and all contract
obligations with DJ Pharma, including without limitation, under this Agreement,
the ongoing covenants and representations herein, any outstanding notes or
contracts currently or hereinafter in effect and with other parties to the
extent related to the subject matter hereof, including, without limitation,
obligations under the Abbott Purchase Agreement or the Abbott Supply Agreement
which are not expressly assumed by DJ Pharma. In the event of a breach of
payment terms by Dura under the Abbott Purchase Agreement or the Abbott Supply
Agreement which results in DJ Pharma's inability to acquire, market and sell the
Rondec Products as contemplated herein, DJ Pharma shall have the right to cure
such breach by making such payment and offsetting it against an equal amount of
Net Royalty Payments for the Products not yet due by DJ Pharma to Dura or under
the Subordinated Product Acquisition Notes.
(i) ACCESS TO BOOKS AND RECORDS. Subsequent to the Second
Closing (for the Rondec Products and CCA Products), each party agrees that they
will grant to each other and each other's agents reasonable access during normal
business hours upon reasonable notice to any books and records then in their
possession or in the possession of their respective affiliates to the extent of
information contained in such books or records that relates to Dura's operation
of the Rondec Purchased Assets and the CCA Purchased Assets prior to the Second
Closing, and is shown to be needed for tax, operations, regulatory or accounting
purposes.
7.2 REPRESENTATIONS, WARRANTIES AND COVENANTS OF DURA BERMUDA WITH
RESPECT TO THE KEFTAB PRODUCTS. As of the date of this Agreement and as of the
Second Closing, Dura and Dura Bermuda hereby represent, warrant and covenant to
DJ Pharma the following, all with respect to the Keftab Products in the Keftab
Territory only:
(a) AUTHORITY. Dura Bermuda has the necessary corporate power
and authority to enter into and deliver this Agreement and to perform its
obligations hereunder and to consummate the transactions contemplated hereby.
The execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby by Dura Bermuda have been duly authorized by
Dura Bermuda. This Agreement constitutes the legal, valid and binding obligation
of Dura Bermuda, enforceable in accordance with its terms (except as such
enforcement may be limited by applicable bankruptcy, insolvency, moratorium, or
similar laws affecting the rights of creditors generally or by general
principles of equity). Neither the execution, delivery or performance of this
Agreement by Dura Bermuda, nor the consummation of the transactions contemplated
hereby nor compliance by Dura Bermuda with the terms and provisions of this
Agreement will result in a violation or breach of any term or provision of Dura
Bermuda's Certificate of Incorporation and Memorandum of Association of Company
Limited
-25-
by Shares or Bye-laws, or of any statute, rule or regulation applicable to Dura
Bermuda, nor conflict with or constitute a default under any agreement to which
Dura Bermuda is a party or to which its assets are subject, or any instrument,
judgment, decree, writ, or other restriction to which Dura Bermuda is a party or
by which its assets are bound.
(b) TITLE TO ASSETS, LIENS AND ENCUMBRANCES. Except as set
forth in Schedule 7.2(b) hereof, Dura Bermuda has good title to the Keftab
Products and any inventions, know-how, trade secrets, intellectual property
rights and technology necessary to assign, transfer and deliver the Keftab
Rights, and Dura Bermuda has the right to grant the rights to the Keftab
Products to DJ Pharma as set forth herein, free and clear of all security
interests, liens, claims, restrictions, royalty obligations and encumbrances
whatsoever other than any of the foregoing which will not interfere with DJ
Pharma's rights to manufacture or have manufactured, market, distribute, offer
for sale and sell the Keftab Products. In connection with Dura's security
interest with respect to the Keftab Products pursuant to the terms of the Dura
Bermuda Security Agreement (as defined in Schedule 7.2(b) hereof), Dura hereby
covenants that should Dura exercise its rights at any time during the Licensing
Period with respect to its security interest in the Keftab Products under the
Dura Bermuda Security Agreement, Dura shall assume all of Dura Bermuda's
obligations to DJ Pharma with respect to the Keftab Products under this
Agreement. Notwithstanding the foregoing, Dura hereby covenants that should the
Keftab Rights be transferred to DJ Pharma pursant to Section 1.4 hereof, and if
as of such time Dura has not exercised its rights under the Dura Bermuda
Security Agreement with respect to the Keftab Products, Dura shall as of the
Second Closing release its security interest under the Dura Bermuda Security
Agreement with respect to the Keftab Products. Such rights licensed, assigned,
delivered or transferred to DJ Pharma under this Agreement and the Assignment
(at Second Closing) represent all of the rights which Dura Bermuda owns or has
with respect to the Keftab Products and constitute all of the rights necessary
for DJ Pharma to market, promote, distribute, offer for sale, and sell each of
the Keftab Products. Dura Bermuda has the right to grant the rights to the
Keftab Rights under the Assignment (by Second Closing) and to the Keftab
Trademark and as set forth under the Licensing Agreement.
(c) CLAIMS; LITIGATION. Neither Dura nor Dura Bermuda is aware
of any claim, suit, action, arbitration, governmental investigation or other
proceeding, nor any order, decree or judgment pending or in effect, or
threatened by, against or relating to the Keftab Products or the Keftab
Trademark in the Keftab Territory, which if determined adversely would have an
adverse effect on DJ Pharma's rights to manufacture or have manufactured, market
and sell the Keftab Products.
(d) COMPLIANCE WITH LAWS. Dura Bermuda is currently in
compliance with all material laws, ordinances, treaties and governmental rules,
orders and regulations applicable to it with respect to the Keftab Products and
the Keftab Trademark.
(e) INTELLECTUAL PROPERTY. Exhibit D hereof sets forth a true
and correct list of all material patents, trademarks, service marks, trade
names, copyrights and applications for registration and registrations thereof,
owned or licensed by Dura Bermuda subject to the terms of the License Agreement,
and used with respect to the Keftab Products in the Keftab Territory
(collectively, the "Keftab Intellectual Property"). Other than the Keftab
Intellectual Property, to the best of Dura Bermuda's knowledge, there are no
material patents, trademarks, service marks, trade names, copyrights,
applications for registration or registrations thereof necessary for
-26-
manufacture, marketing or sale of the Keftab Products as currently manufactured,
marketed and sold by Dura Bermuda. Dura Bermuda has good and marketable title
to, or other legal right to use, the Keftab Intellectual Property, free and
clear of any license, royalty arrangement, lien, claim or encumbrance of any
nature whatsoever other than any of the foregoing which will not interfere with
DJ Pharma's rights to manufacture, market, distribute, offer for sale and sell
the Keftab Products.
(f) CONTRACTS. Schedule 7.2(f) sets forth a true and complete
list of the entities with whom Dura Bermuda has contracts as of Closing relating
to the Keftab Products, and copies of such contracts or relevant portions of
contracts have been made or will be made available to DJ Pharma for inspection
prior to the Closing. Such contracts constitute the only written contracts,
arrangements, commitments and agreements, currently in force and used by Dura
Bermuda with respect to the manufacture, marketing, distribution, offering for
sale, or sale of the Keftab Products in the Keftab Territory. Such contracts are
valid and binding, enforceable by or against Dura Bermuda in accordance with
their respective terms and are in full force and effect. Neither Dura Bermuda
nor, to Dura Bermuda's best knowledge, any other party thereto, is in breach of
any provision of or in default under any term of any such contract, and there
exists no condition or event which after lapse of time or notice (or both) would
constitute any such breach or default or result in any right to accelerate or
any loss of rights.
(g) INVENTORY. [Intentionally Omitted.]
(h) COMPLIANCE WITH LICENSING AGREEMENT. Dura Bermuda shall
comply from and after the Closing and through the Second Closing in all respects
with the terms and conditions of the Licensing Agreement and the Manufacturing
Agreement. In the event * (x) *, respectively, and which is *, results in * or
(y) Dura or Dura Bermuda receive during the Licensing Period any * and are * as
a result of a * pursuant to Section 2.1 hereof will be * (Net Sales of Rondec
Products and CCA Products for the * contemplated by this Section 7.2(h) *
pursuant to this Section 7.2(h) *. Any * will * for such period immediately
prior to *. In addition, DJ Pharma's payment obligations to Dura or Dura Bermuda
* with respect to the Products may be *, with such * applying during the
Licensing Period * and upon termination of the Licensing Term *
-27-
*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
*. For purposes of applying the foregoing reduction only, * shall be
recalculated as if the *. The foregoing adjustments shall not in any way impact
or lessen any other obligations of DJ Pharma to Dura including, without
limitation, continuing obligations under the Dura Supply Agreement *. Further
upon any adjustments pursuant to this Section 7.2(h), the right, title and
interest to the Keftab Products or Keftab Rights shall immediately vest in Dura
or Dura Bermuda and DJ Pharma shall have no further right, title or interest
with respect to such Keftab Products or Keftab Rights. In addition all
documentation and materials related to the Keftab Products and Keftab Rights
shall be immediately returned by DJ Pharma to Dura Bermuda.
For purposes of this Section 7.2(h) " * " shall equal the * (i) the result of
(a) * including the * (b) * including * (ii) * remaining in the Licensing Period
which immediately follow * which includes the *; in each case after giving
effect to any previous adjustment in *.
(i) COMPLIANCE WITH DJ PHARMA CONTRACT OBLIGATIONS. Dura
Bermuda is in compliance and shall at all times remain in compliance with any
and all contract obligations with DJ Pharma, including without limitation, under
this Agreement, the ongoing covenants and representations herein, any
outstanding notes or contracts currently or hereinafter in effect.
(j) ACCESS TO BOOKS AND RECORDS. Subsequent to the Second
Closing, each party agrees that they will grant to each other and each other's
agents reasonable access during normal business hours upon reasonable notice to
any books and records then in their possession or in the possession of their
respective affiliates to the extent of information contained in such books or
records that related to Dura's or Dura Bermuda's operation of the Keftab Rights
or the Keftab Products prior to the Second Closing, respectively and is shown to
be needed for tax, operations, regulatory or accounting purposes.
8. REPRESENTATIONS, WARRANTIES AND COVENANTS OF DJ PHARMA. As of the date of
this Agreement and as of the Closing, DJ Pharma hereby represents, warrants and
covenants to Dura as follows:
8.1 AUTHORITY. DJ Pharma has the necessary corporate power and
authority to enter into and deliver this Agreement and to perform its
obligations hereunder and to consummate the transactions contemplated hereby.
The execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby by DJ Pharma has been duly authorized by DJ
Pharma. This Agreement constitutes the legal, valid and binding obligation of DJ
Pharma, enforceable in accordance with its terms (except as such enforcement may
be limited by applicable bankruptcy, insolvency, moratorium or similar laws
affecting the rights of creditors generally or by general principles of equity).
Neither the execution, delivery or performance of this Agreement by DJ Pharma,
nor the consummation of the transactions contemplated hereby nor compliance by
DJ Pharma with the terms and provisions of this Agreement will result in a
-28-
*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
violation or breach of any term or provision of DJ Pharma's Certificate of
Incorporation or by-laws, or of any statute, rule or regulation applicable to DJ
Pharma, nor conflict with or constitute a default under any agreement to which
DJ Pharma is a party or to which its asserts are subject, or any instrument,
judgment, decree, writ, or other restriction to which DJ Pharma is a party or by
which its assets are bound.
8.2 COMPLIANCE WITH LAWS. DJ Pharma is in compliance with all
governmental laws, rules and regulations applicable to its business and it shall
at all times comply with all applicable laws regulating its activities under
this Agreement.
8.3 ASSUMPTION OF LIABILITIES AND OBLIGATIONS; COMPLIANCE WITH DURA
CONTRACT OBLIGATIONS. Except as set forth herein, DJ Pharma hereby expressly
assumes all Assumed Liabilities (as defined in the Licensing Agreement) and any
and all other liabilities and obligations relating to the Products, including
without limitation all such liabilities and obligations with respect to the
Products as set forth under the Abbott Purchase Agreement, the Abbott Supply
Agreement, the Licensing Agreement and the Manufacturing Agreement
(collectively, the "Product Agreements"). In this regard, DJ Pharma hereby
assumes and agrees to bear and be responsible for and to perform and satisfy all
responsibilities, duties (including, without limitation, compliance with all
applicable laws and regulations), obligations, claims, Damages, liabilities,
burdens and problems of any nature whatsoever (collectively, the "Obligations")
associated directly or indirectly with DJ Pharma's ownership, Activities or
other use of the Products, from and after the Closing, including, without
limitation, all recalls, rebates, returns, reimbursements, chargebacks, minimum
purchase requirements under the Manufacturing Agreement or Abbott Supply
Agreement, all warranty claims and all product liability claims (without regard
to the nature of the causes of action alleged or theories of recovery asserted)
arising in connection with any of the Products sold or Keftab Rights exercised
on or after the Closing, except for those Obligations, Activities or Damages
with respect to which Dura is providing indemnification pursuant to the
provisions of Section 4 of this Agreement. Notwithstanding the foregoing, DJ
Pharma shall not be liable and does not assume (i) payment obligations under
Sections 3 and 5 of the Licensing Agreement and Abbott Purchase Agreement, (ii)
any obligations under the Product Agreements which do not relate to any of the
Products, (iii) any obligations under the Product Agreements which accrued prior
to October 1, 1998, or (iv) any obligations expressly assumed by Dura under the
Dura Supply Agreement or required in order to fulfill its obligations as a
facilitator of supplies pursuant to the terms of the Dura Supply Agreement. DJ
Pharma is in compliance and shall at all times remain in compliance with any and
all contract obligations, to the extent specified in this Section 8.3 under this
Agreement, the Licensing Agreement, the Manufacturing Agreement, the Abbott
Purchase Agreement, the Abbott Supply Agreement, the Dura Supply Agreement, and
*. In the event of an event of * during such time as *, Dura or Dura Bermuda
shall have all rights and remedies available at law or equity under the terms of
*, but such *.
8.4 PROMOTIONAL AND MARKETING EFFORTS. DJ Pharma hereby covenants to
use its commercially reasonable efforts to diligently and actively market and
promote the Products
-29-
*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
during the Licensing Period and hereby agrees to establish and spend the
following * sales and marketing budget in connection with the diligent promotion
of such Products (the "Marketing Budget") during the Licensing Period: (i) *,
the Marketing Budget must * (x) * for the respective period as set forth in
Section 2.1 hereof * in the * calendar year and (y) * for the respective period
as set forth in * hereof * (ii) From * the Marketing Budget must * (x) * in the
* calendar year and (y) *.
9. NO IMPLIED WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED IN SECTION 7 HEREOF,
NEITHER DURA NOR DURA BERMUDA MAKE ANY REPRESENTATION OR WARRANTY AS TO THE CCA
PRODUCTS, RONDEC PRODUCTS, THE KEFTAB PRODUCTS OR KEFTAB RIGHTS OR THE
MANUFACTURING, MARKETING AND SALE OF SUCH PRODUCTS OR OTHER ACTIVITIES WITH
RESPECT TO SUCH RIGHTS (COLLECTIVELY, THE "ACTIVITIES"), EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND DURA AND
DURA BERMUDA SPECIFICALLY DISCLAIM ANY AND ALL IMPLIED OR STATUTORY WARRANTIES.
WITHOUT LIMITING THE FOREGOING, DJ PHARMA ACKNOWLEDGES THAT IT HAS NO AND IS NOT
RELYING UPON AN IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR OTHERWISE, OR UPON ANY REPRESENTATION OR WARRANTY WHATSOEVER AS TO
THE PROSPECTS (FINANCIAL, REGULATORY OR OTHERWISE), OR THE VALIDITY OR
LIKELIHOOD OF SUCCESS OF THE ACTIVITIES AFTER THE CLOSING OR THE SECOND CLOSING,
AS APPLICABLE.
10. CONFIDENTIALITY
10.1 CONFIDENTIALITY. Each party (the "Receiving Party") recognizes
that certain information of the other Party (the "Disclosing Party") and its
affiliates (or other third party to whom the Disclosing Party has an obligation
of confidentiality) disclosed to the Receiving Party in connection with this
Agreement and the transactions contemplated herein, including without limitation
Know-How, is of proprietary value and is to be considered highly confidential
("Confidential Information"). The Receiving Party and its respective affiliates
agree not to disclose such Confidential Information to others, or use it for the
benefit of others, except to or for those third parties permitted under the
terms of this Agreement who reasonably require same for the purposes hereof and
who are bound to such party by a like obligation as to confidentiality, without
the express written permission of the other party. Notwithstanding the
foregoing, DJ Pharma shall not have any such obligations of confidentiality with
regard to any Rondec Purchased Assets or CCA Purchased Assets or Keftab Rights
after the Closing or Second Closing which is not addressed in any agreements
regarding such Rondec or CCA Purchased Assets or Keftab Rights, as applicable,
nor shall the Receiving Party have any obligation of confidentiality with regard
to information which:
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*Certain confidential portions of this Exhibit were omitted by means of marking
such portions with an asterisk (the "Mark"). This Exhibit has been filed with
the Secretary of the Commission without the Mark pursuant to the Company's
application requesting confidential treatment under Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
(a) can be demonstrated by written records to have been known
to the Receiving Party at the time of receipt, with the exception of certain
information transferred by Dura or Dura Bermuda to DJ Pharma upon the Second
Closing which will be deemed and shall as of the Second Closing be treated as
Confidential Information by Dura or Dura Bermuda pursuant to the terms of this
Section 10;
(b) was subsequently otherwise legally acquired by the
Receiving Party from a third party having an independent right to disclose the
information;
(c) which now or later becomes publicly known without breach
of this Agreement by the Receiving Party;
(d) which is independently developed by employees of the
Receiving Party without the aid, use or application of the Confidential
Information; or
(e) which is required by law, regulation, rule, act, or order
of any governmental authority or agency, to be disclosed by the Receiving Party;
PROVIDED, HOWEVER, that the Receiving Party shall make its best efforts to give
the Disclosing Party sufficient advance notice to permit it to seek a protective
order or other similar order with respect to such Confidential Information and
thereafter discloses only the minimum Confidential Information required to be
disclosed in order to comply.
The Receiving Party's obligation of confidentiality shall be in force
during the term of this Agreement and any extension hereof, and shall extend for
a period of ten (10) years from the expiration or termination of this Agreement
or any extension thereof.
10.2 RETURN OF INFORMATION. Upon the termination of this Agreement, DJ
Pharma shall return to Dura all documents and unused promotional materials,
including all copies, which DJ Pharma acquired from Dura or any of its related
entities under this Agreement.
10.3 EQUITABLE RELIEF. Each Party acknowledges and agrees that breach
of any of the terms of this Section 10 would cause irreparable harm and damage
to the other and that such damage may not be ascertainable in money damages and
that as a result thereof the non-breaching party would be entitled to seek
equitable or injunctive relief restraining any breach or future violation of the
terms contained herein by the breaching party without the necessity of proving
actual damages. Such right to equitable relief is in addition to whatever
remedies either party may be entitled to as a matter of law or equity, including
money damages.
11. MISCELLANEOUS
11.1 SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon and
shall inure to the benefit of the parties hereto and their respective successors
and assigns; provided, however, that DJ Pharma may not assign any of its rights,
duties, or obligations hereunder without the prior written consent of Dura,
which consent may be withheld in Dura's sole discretion.
11.2 NOTICES. All notices or other communications required or permitted
to be given hereunder shall be in writing and shall be deemed to have been duly
given if delivered by hand, prepaid telex, cable, telegram or facsimile and
confirmed in writing, or mailed first class, postage
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prepaid, by registered or certified mail, return receipt requested (mailed
notices and notices sent by telex, cable or telegram shall be deemed to have
been given on the date received) as follows:
If to DURA: Dura Pharmaceuticals, Inc.
7475 Lusk Boulevard
San Diego, CA 92121
Attention: Office of the General Counsel
Facsimile: (619) 657-0981
with a copy to: Brobeck, Phleger & Harrison, LLP
550 West "C" Street, Suite 1300
San Diego, CA 92101-3532
Attention: Faye H. Russell, Esq.
Facsimile: (619) 234-3848
If to DJ PHARMA: DJ Pharma, Inc.
12730 High Bluff Drive
San Diego, CA 92130
Attention: James W. Newman, President
Facsimile: (619) 509-8610
with a copy to: Pillsbury Madison & Sutro LLP
101 West Broadway, 18th Floor
San Diego, CA 92101
Attention: David R. Snyder, Esq.
Facsimile: (619) 236-1995
If to DURA BERMUDA: Dura (Bermuda) Trading Company LTD
102 St. James Court
Flatts, Smiths FLO4, Bermuda
Attention: Kevin Insley, President
Facsimile: (441) 292-2224
11.3 GOVERNING LAW. This Agreement shall be governed and construed in
accordance with the laws of the State of California excluding any choice of law
rules which may direct the application of the law of another state.
11.4 CAPTIONS. All section titles or captions contained in this
Agreement, in any Schedule referred to herein or in any Exhibit annexed hereto,
and the table of contents, if any, to this Agreement are for convenience only,
shall not be deemed a part of this Agreement and shall not affect the meaning or
interpretation of this Agreement.
11.5 NO THIRD-PARTY RIGHTS. No provision of this Agreement shall be
deemed or construed in any way to result in the creation of any rights or
obligation in any other individual, group, entity, or organization not a party
to this Agreement.
11.6 NO IMPLIED WAIVERS. No failure on the part of either party to
exercise and no delay in exercising any right, power, remedy or privilege under
this Agreement shall impair,
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prejudice or constitute a waiver of any such right, power, remedy or privilege
nor shall any such waiver or any single or partial exercise of any such right,
power remedy or privilege preclude any other or further exercise thereof or the
exercise of any other right, power, remedy or privilege. No waiver of either
party of any default, right, power, remedy or privilege shall be effective
unless in writing, nor shall any such waiver operate as a waiver of any other or
the same default, right, power, remedy or privilege respectively on a future
occasion.
11.7 RELATIONSHIP OF THE PARTIES. Nothing contained in this Agreement
is intended or is to be construed to constitute DJ Pharma, Dura, Dura Bermuda
(or any of their affiliates) as partners or joint venturers or either party as
an employee or agent of the other. Neither party hereto shall have any 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 other individual, entity, group or
organization, and no conduct of the parties shall be deemed to infer such right.
11.8 FURTHER ASSURANCE. Each party hereby agrees to duly execute and
deliver, or cause to be duly executed and delivered, such further instruments
and do and cause to be done such further acts and things, including, without
limitation, the filing of such additional assignments, agreements, documents and
instruments, that may be necessary or as the other party hereto may at any time
and from time to time reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes hereof or to better
assure and confirm unto such other party its rights and remedies under, this
Agreement.
11.9 SURVIVAL. The provisions of this Agreement shall survive the
closings and continue in full force and effect in accordance with their terms.
11.10 AMENDMENTS AND MODIFICATIONS. No amendment, modification,
termination or discharge of any provision of this Agreement, nor consent by DJ
Pharma or Dura to any departure therefrom, shall in any event be effective
unless the same shall be in writing specifically identifying this Agreement and
the provision intended to be amended, modified, terminated or discharged and
signed by DJ Pharma and Dura, and each amendment, modification, termination or
discharge shall be effective only in the specific instance and for the specific
purpose for which given. No provision of this Agreement shall be varied,
contradicted or explained by any other agreement, course of dealing or
performance or usage of trade or any other matter not set forth in an agreement
in writing and signed by DJ Pharma, Dura and Dura Bermuda.
11.11 SEVERABILITY. If any provision hereof should be held invalid,
illegal or unenforceable in any respect in any jurisdiction, then, to the
fullest extent permitted by law, (a) all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the parties hereto as nearly as may be
possible and (b) such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction.
11.12 CONSTRUCTION. Except as otherwise provided herein,, references to
Articles, Sections, Schedules and Exhibits are to those contained in this
Agreement. Any Schedules or Exhibits form an integral part of this Agreement and
reference to this Agreement include references thereto. Unless the context
otherwise requires, words importing the singular include
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the plural and vice versa, words importing the masculine include the feminine,
and words importing persons includes corporations. Headings used herein are for
convenience only and shall not in any way affect the construction of, or be
taken into consideration in interpreting, this Agreement.
11.13 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
11.14 ENTIRE AGREEMENT. This Agreement, together with any agreements
referenced herein, constitute the entire agreement of DJ Pharma, Dura, and Dura
Bermuda with respect to the subject matter hereof. This Agreement supersedes all
prior or contemporaneous understandings or agreements, whether written or oral,
between DJ Pharma, Dura and Dura Bermuda with respect to such subject matter.
11.15 FORCE MAJEURE
(a) EVENTS OF FORCE MAJEURE. Failure of either party to
perform its obligations under this Agreement shall not subject such party to any
liability to the other if such failure is caused by or results from causes
beyond the reasonable control of the affected party such as but not limited to
acts of God, fire, explosion, flood, drought, war, riot, sabotage, embargo,
strikes or other labor trouble, or compliance with any law, order or regulation
of any government entity acting with color of right which is promulgated after
the date hereof.
(b) CONSEQUENCES OF FORCE MAJEURE. Upon occurrence of an event
of force majeure the party affected shall promptly notify the other in writing,
setting forth the details of the occurrence, and make every attempt to resume
the performance of its obligations as soon as practicable after the force
majeure event ceases.
11.16 SALES TAX. Any and all sales or use taxes payable with respect to
the Rondec and CCA Purchased Assets, the Keftab Rights, and the transactions
contemplated under this Agreement (except for taxes levied thereon as income to
Dura) shall be borne by DJ Pharma. Any and all transfer taxes payable as a
result of the transaction shall be paid by Dura.
11.17 NO FINDERS FEE. Each party to this Agreement represents and
warrants that no broker or finder has acted for it in connection with this
Agreement or the transactions contemplated by this Agreement and that no broker
or finder is entitled to any brokerage or finders fee or other commission in
respect thereof based in any way on agreements, arrangements or understandings
made by it.
11.18 PUBLICITY. Dura and DJ Pharma agree not to disclose the existence
of this Agreement or use the name of the other in any publicity, press release,
advertising or information which is disseminated to the general public without
the other party's prior written approval, which approval shall not be
unreasonably withheld, unless such disclosure shall be required by applicable
law or regulatory agencies, in which case the other party shall have the
opportunity to review and approve the form of disclosure (such approval not to
be unreasonably withheld).
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11.19 ATTORNEYS' FEES. In the event it becomes necessary for either
party (or any of its affiliates) to institute any action at law or in equity
against the other party to enforce its rights under Section 11 hereof, the
prevailing party shall be entitled to recover from the non-prevailing party
reasonable attorneys' fees, court costs and expenses relating to such action.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the date first above
written.
DURA PHARMACEUTICALS, INC. DJ PHARMA, INC.
By: /s/ Michael Borer By: /s/ James W. Newman
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Title: Senior Vice President and CFO Title: CEO and PRESIDENT
---------------------------------- -------------------------
DURA (BERMUDA) TRADING COMPANY LTD.
By: /s/ Kevin Insley
-------------------------
Title: President
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[SIGNATURE PAGE TO AMENDED AND RESTATED
PURCHASE AND LICENSE AGREEMENT]