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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K/A-1
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
September 5, 1996
(Date of Report - earliest event reported)
DURA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
CALIFORNIA 000-19809 95-3645543
(State or other jurisdiction (Commission (I.R.S. Employer
of incorporation) File Number) Identification No.)
5880 PACIFIC CENTER BLVD., SAN DIEGO, CALIFORNIA 92121
(Address of principal executive offices) (Zip Code)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE IS (619) 457-2553
Page 1
Exhibit Index on Page 4
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Item 2. Acquisition or Disposition of Assets
a. On August 21, 1996, Dura Pharmaceuticals, Inc. (the "Company")
signed a Licensing Agreement (the "Licensing Agreement") with Eli Lilly
and Company ("Lilly") to acquire exclusive U.S. marketing rights to
the patented antibiotics Keftab-Registered Trademark- (cephalexin
hydrochloride) and Ceclor-Registered Trademark- CD (cefaclor extended release
tablets). The acquisition closed on September 5, 1996. The purchase price
consisted of $100.0 million paid in cash at closing. Additional
future contingent payments of an aggregate of $75.0 million starting
in the year 1999 are subject to Ceclor-Registered Trademark- CD remaining
available by prescription only with no competitive products, as defined
in the Licensing Agreement. The Company and Lilly determined the purchase
price in arms' -length negotiations prior to August 21, 1996.
The Keftab-Registered Trademark- product generated U.S. sales revenues
for Lilly in 1993, 1994, and 1995 of approximately $13.0 million, $18.0
million, and $19.0 million respectively, and direct product cost of sales in
1993, 1994, and 1995 of approximately $2.5 million, $3.5 million, and $3.8
million, respectively. Ceclor-Registered Trademark- CD received marketing
approval from the U.S. FDA in June 1996; therefore, there is no historical
financial information available for Ceclor-Registered Trademark- CD. The
Company expects to launch Ceclor-Registered Trademark- CD this fall.
Lilly will manufacture Keftab-Registered Trademark- and
Ceclor-Registered Trademark- CD products for the Company under a separate
Manufacturing Agreement executed on August 21, 1996 (the "Manufacturing
Agreement"). The Company does not expect the Manufacturing Agreement with
Lilly to significantly impact the products' future cost of sales as a percent
of sales revenue as compared to its historical percentages.
The Licensing Agreement provides that Dura can recover a portion,
declining over time, of the purchase price and future annual contingent
payments upon the occurrence of a breach by Lilly of either the Licensing
Agreement or the Manufacturing Agreement, or a force majeure event occurs to
Lilly that would permit Dura to terminate the Manufacturing Agreement.
The Keftab-Registered Trademark- products are being marketed by the
Company primarily to the same respiratory physician specialists currently
targeted by the Company's national sales force. The Company expects to
increase the number of field sales force personnel to support the
Ceclor-Registered Trademark- CD product launch in time for the upcoming
respiratory season (which traditionally begins in October), and expects to
continue sales force growth in 1997.
Item 7. Financial Statements and Exhibits
c. Exhibits:
2.1 Licensing Agreement dated August 21, 1996 between the
Company and Lilly.* The exhibits referenced in the Licensing Agreement have
not been included because they are either disclosed in the agreement or would
not be material to an investment decision; they will be provided to the
Commission upon request.
*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.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report on Form 8-K/A-1 to be signed on its
behalf by the undersigned hereunto duly authorized.
DURA PHARMACEUTICALS, INC.
Date: December 20, 1996 /s/ MITCHELL R. WOODBURY
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Mitchell R. Woodbury
Vice President and General Counsel
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DURA PHARMACEUTICALS, INC.
FORM 8-K/A-1
EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
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2.1 Licensing Agreement dated August 21, 1996 between
the Company and Lilly.*
*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.
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EXHIBIT 2.1*
LICENSING AGREEMENT
This LICENSING AGREEMENT ("Agreement"), dated as of August 21, 1996, by
and between ELI LILLY AND COMPANY, an Indiana corporation with offices
located at Lilly Corporate Center, Indianapolis, Indiana 46285 ("Lilly"), and
DURA PHARMACEUTICALS, INC., a California corporation with offices located at
5880 Pacific Center Boulevard, San Diego, California 92121-4204 ("Dura").
RECITALS
1. Lilly is engaged, among other things, in the business of
manufacturing, marketing and selling anti-infective pharmaceutical products;
and
2. Subject to the terms and conditions set forth in this Agreement,
Lilly wishes to license to Dura and Dura wishes to license from Lilly certain
rights under certain of the assets which Lilly uses in the conduct of its
anti-infective pharmaceutical business.
NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby
agree as follows:
SECTION 1
DEFINITIONS
For purposes of this Agreement, the following terms shall have the meanings
set forth below:
"ACTIVITIES" shall mean the manufacturing, marketing and selling of the
Products in the United States as conducted on the Closing Date by Lilly.
"AFFILIATES" shall mean, with respect to any Person, any Persons directly
or indirectly controlling, controlled by, or under common control with, such
other Person. For purposes hereof, the term "controlled" (including the terms
"controlled by" and "under common control with"), as used with respect to any
*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.
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Person, shall mean the direct or indirect ability or power to direct or cause
the direction of management policies of such Person or otherwise direct the
affairs of such Person, whether through ownership of voting securities or
otherwise.
"ASSUMED LIABILITIES" shall have the meaning set forth in Section 2.5
hereof.
"BULK PATENTS" shall include those United States patent applications
pending or filed by Lilly or its Affiliates (or the rights to which have been
assigned to Lilly) as of the date hereof relating to bulk cefaclor and bulk
cephalexin and those patents set forth on Schedule 5.4 hereto, including any
patent application or patent which constitutes an extension, registration,
confirmation, reissue, renewal, reexamination or continuation-in-part of such
patent application or patent. Notwithstanding anything herein to the
contrary, "Bulk Patents" shall not include any Product Patents whatsoever.
"BULK TECHNOLOGY" shall mean all of Lilly's Bulk Patents, technology,
know-how and all other information necessary to the manufacture of bulk
cefaclor and bulk cephalexin. Notwithstanding anything herein to the
contrary, "Bulk Technology" shall not include any Product Technology
whatsoever.
"CECLOR-Registered Trademark- CD" shall mean cefaclor extended release
tablets in 375 mg and 500 mg presentations and all other dosage strengths and
sizes that may, pursuant to applicable laws and regulations, be manufactured,
marketed and sold in the United States under the approved NDA, together with
all expansions and improvements to Ceclor CD which may be included in any
supplement, modification or addition to the NDA.
"CLOSING DATE" shall have the meaning given in Section 4.3 hereof.
"COPYRIGHTS" shall mean all of Lilly's copyright rights in the United
States that are used or exercised by Lilly solely in connection with the
Activities, including, without limitation, Lilly's copyright rights in the
Marketing and Pricing Data and the Marketing Materials.
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"DAMAGES" shall mean 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 incurred by a
party hereto (including interest which may be imposed in connection
therewith).
"FDA" shall mean the United States Food and Drug Administration.
"INDEMNIFIED PARTY" shall have the meaning given in Section 8.2 hereof.
"INDEMNIFYING PARTY" shall have the meaning given in Section 8.2 hereof.
"INTELLECTUAL PROPERTY" shall mean, collectively, (i) the Copyrights,
(ii) the Trademarks, and (iii) the Marketing Materials.
"KEFTAB" shall mean cephalexin hydrochloride in a 500 mg presentation and
all other dosage strengths and sizes that may, pursuant to applicable laws
and regulations, be manufactured, marketed and sold in the United States
under the approved NDA, together with all expansions and improvements to
Keftab which may be included in any supplement, modification or addition to
the NDA.
"LICENSED ASSETS" shall have the meaning set forth in Section 2.1 hereof.
"MANUFACTURING AGREEMENT" shall mean the Manufacturing Agreement, dated
as of the date of this Agreement, between Lilly and Dura, which provides for
the manufacture by Lilly of the Products for Dura for the period specified
therein.
"MARKETING AND PRICING DATA" shall mean, with respect to Keftab, all
Lilly customer lists, sales data, price lists and, subject to confidentiality
obligations to third parties, all other pricing information in the possession
or control of Lilly relating solely to sales of Keftab occurring in the most
recent 12-month period prior to the date of this Agreement for which such
information is available.
"MARKETING MATERIALS" shall mean all labeling, marketing and promotional
materials and inserts currently used by Lilly solely in connection with the
Activities.
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"NDAS" shall have the meaning set forth in Section 2.1(a).
"NET SALES" shall mean, with respect to the Products, the gross amount
invoiced to unrelated third parties for the Products in the United States,
less:
(a) Trade, quantity and cash discounts allowed;
(b) Commissions, discounts, refunds, rebates, chargebacks,
retroactive price adjustments and any other allowances which
effectively reduce the net selling price; and
(c) Product returns, credits and allowances.
Such amounts shall be determined from books and records maintained in
accordance with GAAP, consistently applied.
"PDMA" shall mean the Prescription Drug Marketing Act of 1987, as amended
from time to time, together with any rules or regulations promulgated
thereunder.
"PERSON" shall mean a natural person, a corporation, a partnership, a
trust, a joint venture, a limited liability company, any governmental
authority or any other entity or organization.
"PRODUCT PATENTS" shall include those United States patent applications
pending or filed by Lilly or its Affiliates (or the rights to which have been
assigned to Lilly) as of the date hereof relating to the Products and those
patents set forth on Schedule 5.4 hereto including any patent application or
patent which constitutes an extension, registration, confirmation, reissue,
renewal, reexamination or continuation-in-part of such patent application or
patent. Notwithstanding anything herein to the contrary, "Product Patents"
shall not include any Bulk Patents whatsoever.
"PRODUCT TECHNOLOGY" shall mean all of Lilly's Product Patents,
technology, know-how and all other information necessary to the manufacture
of the
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Products. Notwithstanding anything herein to the contrary, "Product
Technology" shall not include any Bulk Technology whatsoever.
"PRODUCTS" shall mean Ceclor CD and Keftab.
"PROMOTIONAL MATERIALS" shall mean any tangible advertising and
promotional labeling bearing a Product name (trade name or generic name) used
in the promotion of the Product including promotional materials produced by
Dura (examples include, but are not limited to, journal ads, brochures,
service items, managed care pull through sheets, formulary presentations,
price lists, monographs, Internet pages and telephone or television
advertisements) and materials produced by outside sources (examples include,
but are not limited to, medical reprints, textbooks and CME materials) to the
extent funded by, created in cooperation with, reviewed, or distributed by
Dura. The definition of Promotional Materials shall also include press
releases and other releases of information to the media regarding any Product.
"TRADEMARKS" shall mean all of Lilly's right, title and interest in and
to:
(a) the United States trademark CECLOR-Registered Trademark- CD;
(b) the United States registered trademark KEFTAB-Registered
Trademark-, U. S. Trademark registration number 1,473,842,
registration date January 26, 1988; and
(c) all registrations thereof, all variations thereof and logos used
in connection therewith, and all goodwill associated therewith.
With respect to Ceclor CD, "Trademarks" shall include the non-exclusive
license from Lilly to use the U. S. Registered Trademark CECLOR-Registered
Trademark-, registration number 1,101,155, registration date September 5,
1978, solely in connection with the trademark CECLOR-Registered Trademark- CD.
"UNITED STATES" shall mean the fifty (50) states and the District of
Columbia comprising the United States of America.
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SECTION 2
GRANT OF LICENSES, OPTION TO TRANSFER ASSETS, AND ASSUMPTION OF LIABILITIES
2.1 GRANT OF MARKETING AND SALES LICENSES. Upon the terms and subject to
the conditions of this Agreement, Lilly hereby grants to Dura:
(a) an exclusive, even as to Lilly (except as set forth in Section
2.8 of this Agreement), license under the following assets solely
for the purpose of marketing and selling the Products in the
United States (such assets are referred to herein collectively as
the "LICENSED ASSETS"):
(i) all of Lilly's rights under the approved New Drug
Applications filed by Lilly with the FDA for each Product,
and all subsequent submissions thereto (collectively, the
"NDAs"), which NDAs are described in SCHEDULE 2.1(A);
(ii) the Intellectual Property;
(iii) the Marketing and Pricing Data; and
(b) a non-exclusive, limited license to use the registered trademark
CECLOR-Registered Trademark-, registration number 1,101,155,
registration date September 5, 1978, solely in connection with
the trademark CECLOR-Registered Trademark- CD. With respect to
such license, Dura shall ensure that any use of CECLOR-Registered
Trademark- on or in Promotional Materials (i) shall not cause
confusion as to source of origin or adversely affect the goodwill
of Lilly in CECLOR-Registered Trademark-, (ii) shall not be false
or misleading with regard to Ceclor-Registered Trademark- or
violate in any other manner Dura's obligations under Section 7.3,
and (iii) shall be consistent in manner and style with the
Promotional Materials reviewed by Lilly
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and pre-cleared by the FDA for use in the launch by Dura of
CECLOR-Registered Trademark-CD.
2.2 GRANT OF TECHNOLOGY LICENSES. Subject to the terms of this Agreement
and the Manufacturing Agreement, Lilly hereby grants to Dura:
(a) an exclusive, even as to Lilly (except as set forth in Section
2.8 of this Agreement), license to the Product Patents and
Product Technology solely for the purposes of manufacturing, or
having manufactured, marketing and selling the Products for sale
within the United States, solely to the extent such action is
authorized by, and in accordance with, the provisions of this
Agreement and the Manufacturing Agreement, and
(b) a non-exclusive, limited license to the Bulk Patents and Bulk
Technology solely for the purpose of manufacturing, or having
manufactured, the Products for sale within the United States and
solely to the extent such manufacturing is authorized by, and in
accordance with, the provisions of this Agreement and the
Manufacturing Agreement.
2.3 EXCLUDED ASSETS. Anything herein to the contrary notwithstanding,
the Licensed Assets exclude the trademarks "ELI LILLY AND COMPANY" and
"LILLY" and any variation thereof and any other rights in or to such names.
2.4 LILLY'S OPTION TO TRANSFER LICENSED ASSETS. At any time after Lilly
has ceased to provide Dura with bulk cefaclor and/or bulk cephalexin pursuant
to and in accordance with the terms of the Manufacturing Agreement, Lilly
shall have the right and option, upon twelve (12) months prior written notice
to Dura, to assign, transfer and convey to Dura all of Lilly's right, title
and interest in and to the Licensed Assets (including the underlying NDA(s))
and Dura hereby agrees to accept such assignment, transfer and conveyance.
To effectuate the assignment, transfer and conveyance of the Licensed Assets,
Lilly shall execute and deliver to Dura at the end of the twelve (12) month
notice period: (i) a Bill of Sale (substantially in the form of EXHIBIT A),
(ii) a Trademark Assignment
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(substantially in the form of EXHIBIT B), (iii) a Copyright Assignment
(substantially in the form of EXHIBIT C), and (iv) a certificate, dated as of
the date of the transfer of the Licensed Assets and executed by an officer of
Lilly, certifying that the representations and warranties set forth in
Sections 5.3, 5.4, 5.5, 5.6, and 5.7 of this Agreement are true and correct
as of such date. The licenses granted to Dura pursuant to Section 2.2 hereof
shall remain in effect in accordance with the provisions of this Agreement
and the Manufacturing Agreement.
2.5 LIABILITIES ASSUMED BY DURA. Except as otherwise provided in this
Agreement, Dura 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 Dura's licensing, operation and/or use of the Licensed Assets
(and ownership of the Licensed Assets in the event of transfer of the
Licensed Assets by Lilly to Dura pursuant to Section 2.4), as well as those
associated directly or indirectly with the manufacture (but only after the
manufacturing has been transferred to Dura pursuant to the provisions of the
Manufacturing Agreement), marketing and sale of the Products from and after
the Closing Date, including, without limitation, all recalls, 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 Products sold on or after the Closing Date, except for (i)
those Obligations with respect to which Lilly is providing indemnification
pursuant to the provisions of Section 8.1 of this Agreement, and (ii) the
hereinafter defined Excluded Liabilities, which items shall remain the
responsibility of Lilly as set forth herein. All of the foregoing are
hereinafter collectively referred to as the "ASSUMED LIABILITIES."
2.6 LIABILITIES NOT ASSUMED BY DURA. Anything herein to the contrary
notwithstanding, Dura shall not be deemed to assume any of the following
(collectively, the "Excluded Liabilities"):
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(a) Any Damages arising out of a claim of any third party with
respect to Lilly's activities relating to the Products prior to
the Closing Date.
(b) Any Damages arising out of any claim of any third party in
connection with Lilly's activities in manufacturing the Products
for Dura under the Manufacturing Agreement;
(c) Any Damages arising out of any claim by the FDA that Lilly has
failed to fulfill Lilly's regulatory obligations in connection
with the NDAs (unless such Damages arise as a result of any
action or inaction on the part of Dura);
(d) Any Damages arising with respect to the manufacture, marketing or
sale of the Products prior to the Closing Date; and
(e) Any Damages arising out of any claim of any third party relating
to the Product Patents, the Product Technology, the Bulk Patents
or the Bulk Technology (unless such Damages arise as a result of
any action or inaction on the part of Dura).
2.7 SUBLICENSES. This Agreement and the licenses granted herein shall
not, except as expressly provided herein, be sublicensed by Dura without the
prior written consent of Lilly, which consent shall not be unreasonably
withheld; provided, however, that such consent shall be conditioned upon the
following:
(a) Dura shall inform Lilly in advance of the identity of the
potential sublicensee and the scope of work it will be engaged to
perform;
(b) Lilly shall have the opportunity to prohibit such sublicense for
good cause shown;
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(c) the potential sublicensee to which Lilly consents shall enter
into an agreement of confidentiality and non-use substantially
similar to that set forth in Section 7.5 of this Agreement; and
(d) Dura shall guarantee the performance of such sublicensee in a
form reasonably acceptable to Lilly.
2.8 LILLY RETAINED RIGHTS. Anything herein contained to the contrary
notwithstanding, Lilly shall retain at all times during the term of this
Agreement, and shall bear all costs associated with, all rights necessary:
(a) to manufacture, or to have manufactured, the Products for Dura under the
Manufacturing Agreement and otherwise fulfill its obligations under this
Agreement, (b) to make or have the Products made in the United States to use
or sell the Products outside of the United States, (c) to make such changes
as Lilly may deem reasonably appropriate in connection with any differing
approach to manufacturing it may adopt in a facility(ies) in which any of the
Products are produced, and (d) to make or have made in the United States to
use or sell in or outside of the United States bulk cefaclor and bulk
cephalexin subject to the licenses granted to Dura under Section 2.2 of this
Agreement; provided, however, that the rights retained by Lilly in subsection
(a), above, shall terminate effective upon the termination of the
Manufacturing Agreement and Dura's rights under Section 2.2 shall thereafter
be effective in accordance with the terms of this Agreement.
2.9 NO INUREMENT. Lilly retains ownership of all right, title, and
interest in and to the registered trademark CECLOR-Registered Trademark-,
registration number 1,101,155, registration date September 5, 1978, except
those rights specifically granted to Dura in Section 2.1(b), above. Without
limiting the foregoing, all use by Dura of the registered trademark
CECLOR-Registered Trademark- shall inure solely to the benefit of Lilly.
SECTION 3
PAYMENTS
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In consideration of Lilly granting to Dura the licenses and other rights
herein contained, Dura shall pay the following amounts to Lilly:
3.1 PAYMENT UPON SIGNING. On the Closing Date, Dura shall pay to Lilly
the sum of One Hundred Million Dollars ($100,000,000) by Federal Reserve
electronic wire transfer in immediately available funds to an account designated
by Lilly.
3.2 ANNUAL PAYMENTS. Subject to the provisions set forth in Section 3.3,
Dura shall pay the following amounts to Lilly, on the scheduled due dates, by
Federal Reserve electronic wire transfer in immediately available funds to an
account designated by Lilly:
AMOUNT DUE DATE
Fifteen Million Dollars ($15,000,000) June 30, 1999
Fifteen Million Dollars ($15,000,000) June 30, 2000
Fifteen Million Dollars ($15,000,000) June 29, 2001
Fifteen Million Dollars ($15,000,000) June 28, 2002
Fifteen Million Dollars ($15,000,000) June 30, 2003
3.3 AVAILABILITY OF COMPETITIVE PRODUCT. Dura shall not be required to
make any of the scheduled payments to Lilly as set forth in Section 3.2,
above, if, at any time in the twelve (12) month period preceding the date on
which a particular payment becomes due and payable, a third party has made
available for sale on a national basis through normal retail channels a
therapeutically equivalent compound with cefaclor in an extended release
formulation (a "Competitive Product"). If the Competitive Product is no
longer available for sale on a national basis through normal retail channels
for the twelve (12)-month period immediately preceding a scheduled payment
date, then any remaining scheduled payments shall become due and payable in
accordance with the terms of Section 3.2. Dura agrees that neither it nor
any of its Affiliates shall, directly
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or indirectly, assist any third party in making a competitive Product
available for purchase in accordance with the terms of this Section 3.3 until
on or after July 1, 2003.
3.4 AUDITS. Lilly and Dura shall each keep full and accurate books and
records relating to the performance required of it under this Agreement.
Each party shall have the right, during regular business hours and upon
reasonable advance notice, to have such books and records of the other party
audited so as to verify the accuracy of the information previously reported
to the requesting party. The party requesting the audit shall, for purposes
of such audit, utilize only the services of the other party's regular outside
certified public accounting firm. As of the date of this Agreement, Lilly's
regular outside certified public accounting firm is Ernst & Young and Dura's
is Deloitte & Touche, LLP. Such audit may cover the two (2) calendar years
preceding the date of the request for such audit, and shall occur no more
frequently than one (1) time per calendar year. Such accountants shall keep
confidential any information obtained during such audit and shall report to
the requesting party and the other party only their conclusions. The cost of
such audit shall be borne by the party requesting the audit; however, in the
event such audit reveals that the information previously reported to the
requesting party deviates by five percent (5%) or more from that revealed by
the audit, the cost of the audit shall be borne by the other party. Dura
shall include in all sublicenses an audit provision substantially similar to
the foregoing requiring the sublicensee to keep full and accurate books and
records relating to the Products and granting Lilly the right to have an
independent public accounting firm audit the accuracy of the information
reported by the sublicensee in connection therewith.
3.5 REFUND. Except as set forth below in this Section 3.5, Dura shall pay
to Lilly the amounts described in Sections 3.1 and 3.2 without offset, refund or
other relief:
(a) In the event that (i) Lilly breaches any of its representations,
warranties or covenants contained in this Agreement or the
Manufacturing Agreement (collectively, a "Termination Event")
(other than a Termination Event directly or indirectly caused by
the action or inaction of
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Dura) and such breach results in Dura's being able to
terminate this Agreement with respect to one or both Products
pursuant to the provisions of Section 9 hereof or the
Manufacturing Agreement pursuant to the provisions of Section 6
thereof, or (ii) a force majeure event occurs to Lilly that
would permit Dura to terminate the Manufacturing Agreement
with respect to one or both Products pursuant to Section 8.14
thereunder ("Force Majeure Event" and collectively with a
Termination Event, the "Refund Event"), Lilly shall refund
(or, if not yet paid by Dura, Dura shall not be obligated to
pay) a portion of the amounts otherwise paid or due pursuant
to such sections according to the following schedule:
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LILLY SHALL REFUND
IF THE REFUND EVENT OCCURS: (OR DURA MAY WITHHOLD):
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FOR A CECLOR CD FOR A KEFTAB
REFUND EVENT REFUND EVENT
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On or before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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After * and on or
before * * *
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Thereafter -0- -0-
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(b) In addition to the right to refund set forth in subparagraph (a),
above, Dura shall have a fully paid-up exclusive license as set
forth in Section 2.1; provided, however, that Dura shall
* as
appropriate, beginning with Net Sales of the appropriate
Product(s) occurring after the date of termination of this
Agreement. The * if the Refund
Event resulted from a Force Majeure Event and * if
the Refund Event resulted from a Termination Event.
3.6 LATE PAYMENTS. Any amounts not paid by Dura when due under this
Agreement or the Manufacturing Agreement shall be subject to interest from and
including the date payment is due through and including the date upon
*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.
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which Lilly has collected immediately available funds in an account
designated by Lilly at a rate equal to the sum of two percent (2%) plus the
prime rate of interest quoted in the Money Rates section of THE WALL STREET
JOURNAL, calculated daily on the basis of a 360-day year, or similar
reputable data source.
3.7 NO EXCUSE. Dura shall not be excused from or relieved of its
obligations to pay the amounts described in this Section 3 by any claimed or
actual event of force majeure, commercial or other impracticability or
impossibility, or frustration of essential purpose, except to the extent
otherwise provided in this Agreement or Manufacturing Agreement.
SECTION 4
CONDITIONS PRECEDENT TO THE CLOSING; CLOSING DATE;
TERM OF AGREEMENT
4.1 CONDITIONS PRECEDENT TO DURA'S OBLIGATIONS. Subject to waiver as set
forth in Section 10.3, all obligations of Dura to close the transactions
contemplated under this Agreement are subject to the fulfillment or satisfaction
of each of the following conditions precedent:
(a) REPRESENTATIONS AND WARRANTIES TRUE AS OF THE CLOSING DATE. The
representations and warranties of Lilly contained in this
Agreement or in any schedule, certificate or document delivered
by Lilly to Dura pursuant to the provisions hereof shall have
been true on the date hereof and shall be true on the Closing
Date with the same effect as though such representations and
warranties were made as of such date.
(b) COMPLIANCE WITH THIS AGREEMENT. Lilly shall have performed and
complied with all agreements and conditions required by this
Agreement to be performed or complied with by it prior to or by
the Closing Date.
(c) CLOSING CERTIFICATE. Dura shall have received a certificate from
Lilly, executed by an officer of Lilly, certifying in such detail
as Dura may reasonably request that the conditions
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specified in Sections 4.1(a) and 4.1(b), above, have been
fulfilled and certifying that Lilly has obtained all consents
and approvals required by Section 4.1(e), below.
(d) NO THREATENED OR PENDING LITIGATION. On the Closing Date, no
suit, action or other proceeding, or injunction or final judgment
relating thereto, shall, to the best of Lilly's knowledge, be
threatened or be pending before any court or governmental or
regulatory official, body or authority in which it is sought to
restrain or prohibit or to obtain damages or other relief in
connection with this Agreement or the consummation of the
transactions contemplated hereby, and no investigation that might
result in any such suit, action or proceeding shall be pending
or, to the best of Lilly's knowledge, threatened.
(e) CONSENTS AND APPROVALS. Lilly shall have either received notice
from the Federal Trade Commission (the "FTC") of early
termination of the waiting period provided by Section 7A(b)(1) of
the Clayton Act and Section 803.10(b) of the premerger
notification rules or such waiting period shall have expired with
no further action required by the FTC on the part of Lilly.
4.2 CONDITIONS PRECEDENT TO LILLY'S OBLIGATIONS. Subject to waiver as set
forth in Section 10.3, all obligations of Lilly to close the transactions
contemplated under this Agreement are subject to the fulfillment or satisfaction
of each of the following conditions precedent:
(a) REPRESENTATIONS AND WARRANTIES TRUE AS OF THE CLOSING DATE. The
representations and warranties of Dura contained in this
Agreement or in any schedule, certificate or document delivered
by Dura to Lilly pursuant to the provisions hereof shall have
been true on the date hereof and shall be true on the Closing
Date with the same effect as though such representations and
warranties were made as of such date.
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(b) COMPLIANCE WITH THIS AGREEMENT. Dura shall have performed and
complied with all agreements and conditions required by this
Agreement to be performed or complied with by it prior to or by
the Closing Date.
(c) CLOSING CERTIFICATE. Lilly shall have received a certificate
from Dura, executed by an officer of Dura, certifying in such
detail as Lilly may reasonably request that the conditions
specified in Sections 4.2(a) and 4.2(b), above, have been
fulfilled and certifying that Dura has obtained all consents and
approvals required by Section 4.2(e), below.
(d) NO THREATENED OR PENDING LITIGATION. On the Closing Date, no
suit, action or other proceeding, or injunction or final judgment
relating thereto, shall, to the best of Dura's knowledge, be
threatened or be pending before any court or governmental or
regulatory official, body or authority in which it is sought to
restrain or prohibit or to obtain damages or other relief in
connection with this Agreement or the consummation of the
transactions contemplated hereby, and no investigation that might
result in any such suit, action or proceeding shall be pending
or, to the best of Dura's knowledge, threatened.
(e) CONSENTS AND APPROVALS. Dura shall have either received notice
from the FTC of early termination of the waiting period provided
by Section 7A(b)(1) of the Clayton Act and Section 803.10(b) of
the premerger notification rules or such waiting period shall
have expired with no further action required by the FTC on the
part of Dura.
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4.3 CLOSING DATE.
(a) Subject to Section 4.3(b), below, the closing of the transactions
contemplated by this Agreement shall take place at 10:00 a.m.,
local time, on the business day following the day on which the
last of the certificates required by Sections 4.1(c) and 4.2(c)
has been delivered by one party to the other or on such other
date as may be mutually agreed upon in writing by the parties
(the "Closing Date") at the offices of Eli Lilly and Company,
Lilly Corporate Center, Indianapolis, Indiana. Each party hereby
agrees to use its best efforts to deliver the certificate
described herein to the other in a timely manner.
(b) If the closing of the transactions contemplated hereby shall not
have taken place on or before November 1, 1996, or such later
date as shall be mutually agreed to in writing by Lilly and Dura,
because the conditions described in Sections 4.1(e) and 4.2(e),
above, have not been satisfied, then Lilly and Dura agree to
discuss in good faith which substantive terms set forth in this
Agreement, the Manufacturing Agreement, or any document attached
thereto need to be modified as a result of the delay in such
closing. Each party hereby agrees to use its best efforts to
consummate the transactions contemplated herein, as modified, on
or before such November 1 date; provided, however, that if the
parties are unable to close the transactions contemplated hereby
by December 20, 1996, or such later date as shall be mutually
agreed to in writing by Lilly and Dura, then all of the rights
and obligations of the parties under this Agreement shall
terminate without liability.
4.4 TERM. The term of this Agreement shall begin upon the Closing Date
and, unless sooner terminated as hereinafter provided, shall end upon the
fortieth (40th) annual anniversary thereof.
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SECTION 5
REPRESENTATIONS AND WARRANTIES OF LILLY
Lilly hereby represents and warrants to Dura that, as of the date hereof:
5.1 ORGANIZATION, POWER AND AUTHORITY. Lilly is a corporation duly
organized and validly existing under the laws of the State of Indiana. Lilly
has all necessary corporate power and authority to enter into, and be bound by
the terms and conditions of, this Agreement, the Manufacturing Agreement, and to
license the Licensed Assets, Product Technology, and Bulk Technology to Dura
pursuant hereto.
5.2 DUE AUTHORITY; NO BREACH. The execution, delivery and performance by
Lilly of this Agreement, the Manufacturing Agreement, and each agreement or
instrument contemplated by this Agreement, and the performance of the
transactions contemplated hereby and thereby, have been duly authorized by all
necessary corporate action by Lilly. This Agreement and the Manufacturing
Agreement are, and each agreement or instrument contemplated by this Agreement,
when executed and delivered by Lilly in accordance with the provisions hereof,
will be (assuming the due execution and delivery hereof and thereof by Dura) the
legal, valid and binding obligation of Lilly, in each case enforceable against
Lilly in accordance with its terms, except as such enforceability may be limited
by applicable bankruptcy, insolvency, moratorium, reorganization, or similar
laws from time to time in effect which affect the enforcement of creditors'
rights generally and by legal and equitable limitations on the availability of
specific performance and other equitable remedies against Lilly. All persons
who have executed this Agreement or the Manufacturing Agreement on behalf of
Lilly, or who will execute on behalf of Lilly any agreement or instrument
contemplated by this Agreement or the Manufacturing Agreement, have been duly
authorized to do so by all necessary corporate action. Neither the execution
and delivery of this Agreement or the Manufacturing Agreement by Lilly, or any
such other agreement or instrument by Lilly, nor the performance of the
obligations contemplated hereby and thereby, will (i) conflict with or result in
any violation of or constitute a breach of any of the terms or provisions of, or
result in the acceleration of any obligation under, or constitute a default
under any provision of the Articles of Incorporation or By-laws of Lilly or
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any material contract or any other material obligation to which Lilly is a
party or to which it is subject or bound, or (ii) violate any judgment,
order, injunction, decree or award of any court, administrative agency,
arbitrator or governmental body against, or affecting or binding upon, Lilly
or upon the securities, property or business of Lilly, or (iii) constitute a
violation by Lilly of any applicable law or regulation of any jurisdiction as
such law or regulation relates to Lilly, or to the property or business of
Lilly except for such conflict, acceleration, default, breach or violation
that is not reasonably likely to have a material adverse effect on Lilly's
ability to perform its obligations under this Agreement or under any
agreement or instrument contemplated hereby.
5.3 NDAS. Lilly has furnished Dura with access to a complete copy of each
of the NDAs, including all material amendments and supplements thereto. Lilly
is the lawful holder of all rights under each of the NDAs. Although the Keftab
NDA is not "state-of-the-art", to the best of Lilly's knowledge, Lilly has
complied in all material respects with all applicable laws and regulations in
connection with the preparation and submission to the FDA of each of the NDAs,
and each of the NDAs has been approved by, and nothing has come to the attention
of Lilly which has, or reasonably should have, led Lilly to believe that any of
the NDAs are not in good standing with, the FDA. Lilly has filed with the FDA
all required notices, supplemental applications and annual or other reports,
including adverse experience reports, with respect to each NDA (to the extent
applicable with respect to the Ceclor CD NDA) which are material to the ability
of Lilly to conduct the Activities. There is no pending or overtly threatened
action by the FDA which will have a material adverse effect on the Activities
and, to the best of Lilly's knowledge, no future action by the FDA is required
to lawfully market the Products. Except for the representations contained in
this Section 5.3, upon which Dura is relying (which Lilly hereby acknowledges),
Dura has had full and adequate opportunity to review and evaluate the NDAs and
Dura is relying solely upon its own judgment and experience in connection
therewith.
5.4 INTELLECTUAL PROPERTY. Set forth on SCHEDULE 5.4 hereto is a list of
all Intellectual Property, Product Patents, and Bulk Patents. Except as set
forth on SCHEDULE 5.4 hereto, (i) Lilly is the lawful owner of the Intellectual
Property, Product Technology, and Bulk Technology, (ii) Lilly can license the
Intellectual
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Property, Product Technology, and Bulk Technology without the
consent of any third party, (iii) there is no pending or overtly threatened
claim against Lilly asserting that any of the Intellectual Property, Product
Technology, or Bulk Technology infringes or violates the rights of third parties
or that Dura, by practicing under the Licensed Assets in running the Activities,
would violate any of the intellectual property rights of any third party, and
(iv) nothing has come to the attention of Lilly which has, or reasonably should
have, led Lilly to believe that the Intellectual Property, Product Technology,
and Bulk Technology infringe or violate the right of third parties. Except as
set forth on SCHEDULE 5.4 hereto, Lilly has not given any notice to any third
parties asserting infringement by such third parties upon any of the
Intellectual Property, Product Technology, or Bulk Technology. Lilly is not
aware of and has not received any communications challenging the ownership,
validity or effectiveness of the Intellectual Property, the Product Technology,
the Bulk Technology, or any other intellectual property rights relating to the
Activities. Lilly has not granted any right to any third party relating to the
Activities which would violate the terms of or conflict with the rights granted
to Dura pursuant to this Agreement or the Manufacturing Agreement.
5.5 TECHNOLOGY RIGHTS. The Product Patents and the Product Technology
contain all the technology, patents, know-how, trade secrets and other
intellectual property necessary to manufacture the Products. The Bulk Patents
and the Bulk Technology contain all the technology, patents, know-how, trade
secrets and other intellectual property necessary to manufacture bulk cefaclor
and bulk cephalexin.
5.6 LITIGATION. There are no pending or, to the best of Lilly's
knowledge, threatened judicial, administrative or arbitral actions, claims,
suits or proceedings pending as of the date hereof against Lilly relating to the
Activities, the Licensed Assets, the Product Patents or the Bulk Patents which,
either individually or together with any other, would have a material adverse
effect on the Activities, the Licensed Assets, the Product Patents or the Bulk
Patents or the ability of Lilly to perform its obligations under this Agreement
or any agreement or instrument contemplated hereby. Except as set forth on
SCHEDULE 5.4 hereto, there are no pending actions or suits relating to the
Activities, the
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Licensed Assets, the Product Patents or the Bulk Patents brought by Lilly
against others.
5.7 GOVERNMENTAL APPROVAL. No consent, approval, waiver, order or
authorization of, or registration, declaration or filing with, any
governmental authority is required in connection with the execution, delivery
and performance of this Agreement, or any agreement or instrument
contemplated by this Agreement, by Lilly or the performance by Lilly of its
obligations contemplated hereby and thereby other than (a) the filings
required of both parties pursuant to the Hart-Scott-Rodino Antitrust
Improvements Act (the "H-S-R Act"), and (b) in the case of Lilly exercising
its right to assign, transfer and convey the Licensed Assets to Dura pursuant
to Section 2.4, the information submissions to the FDA provided for in
Section 7.1 and compliance with FDA requirements, if any, in connection
therewith.
5.8 BROKERAGE. No broker, finder or similar agent has been employed by
or on behalf of Lilly, and no Person with which Lilly has had any dealings or
communications of any kind is entitled to any brokerage commission, finder's
fee or any similar compensation, in connection with this Agreement or the
transactions contemplated hereby.
5.9 IMPLIED WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION
5, LILLY MAKES NO REPRESENTATION OR WARRANTY AS TO THE LICENSED ASSETS, THE
PRODUCT PATENTS, THE BULK PATENTS, THE PRODUCT TECHNOLOGY, THE BULK
TECHNOLOGY OR THE ACTIVITIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY
OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND LILLY SPECIFICALLY DISCLAIMS
ANY AND ALL IMPLIED OR STATUTORY WARRANTIES. Without limiting the foregoing,
Dura acknowledges that it has not and is not relying upon any 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 date of this Agreement.
SECTION 6
REPRESENTATIONS AND WARRANTIES OF DURA
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Dura represents and warrants to Lilly that, as of the date hereof:
6.1 ORGANIZATION, POWER AND AUTHORITY. Dura is a corporation duly
organized, validly existing and in good standing under the laws of the State
of California. Dura has all necessary corporate power and authority to enter
into, and be bound by the terms and conditions of, this Agreement, the
Manufacturing Agreement, and to license the Licensed Assets, the Product
Technology, and the Bulk Technology from Lilly pursuant hereto.
6.2 DUE AUTHORITY; NO BREACH. The execution, delivery and performance
by Dura of this Agreement, the Manufacturing Agreement, and each agreement or
instrument contemplated by this Agreement, and the performance of the
transactions contemplated hereby and thereby, have been duly authorized by
all necessary corporate action by Dura. This Agreement and the Manufacturing
Agreement are, and each agreement or instrument contemplated by this
Agreement, when executed and delivered by Dura in accordance with the
provisions hereof, will be (assuming due execution and delivery hereof and
thereof by Lilly) the legal, valid and binding obligation of Dura, in each
case enforceable against Dura in accordance with its terms, except as such
enforceability may be limited by applicable bankruptcy, insolvency,
moratorium, reorganization, or similar laws from time to time in effect which
affect the enforcement of creditors' rights generally and by legal and
equitable limitations on the availability of specific performance and other
equitable remedies against Dura. All persons who have executed this
Agreement or the Manufacturing Agreement on behalf of Dura, or who will
execute on behalf of Dura any agreement or instrument contemplated by this
Agreement or the Manufacturing Agreement, have been duly authorized to do so
by all necessary corporate action. Neither the execution and delivery of
this Agreement or the Manufacturing Agreement by Dura, or any such other
agreement or instrument by Dura, nor the performance of the obligations
contemplated hereby and thereby, will (i) conflict with or result in any
violation of or constitute a breach of any of the terms or provisions of, or
result in the acceleration of any obligation under, or constitute a default
under any provision of the Articles of Incorporation or By-laws of Dura or
any material contract or any other material obligation to which Dura is a
party or to which it is subject or bound, or (ii) violate any judgment,
order, injunction,
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decree or award of any court, administrative agency, arbitrator or government
body against, or affecting or binding upon, Dura or upon the securities,
property or business of Dura, or (iii) constitute a violation by Dura of any
applicable law or regulation of any jurisdiction as such law or regulation
relates to Dura or to the property or business of Dura, except for such
conflict, acceleration, default, breach or violation that is not reasonably
likely to have a material adverse effect on Dura's ability to perform its
obligations under this Agreement or any agreement or instrument contemplated
hereby.
6.3 BROKERAGE. No broker, finder or similar agent has been employed by
or on behalf of Dura and no Person with which Dura has had any dealings or
communications of any kind is entitled to any brokerage commission, finder's
fee or any similar compensation, in connection with this Agreement or the
transactions contemplated hereby.
6.4 LITIGATION. There are no pending or, to the best of Dura's
knowledge, threatened judicial, administrative or arbitral actions, claims,
suits or proceedings pending as of the date hereof against Dura which, either
individually or together with any other, will have a material adverse effect
on the ability of Dura to perform its obligations under this Agreement or any
agreement or instrument contemplated hereby.
6.5 GOVERNMENTAL APPROVAL. No consent, approval, waiver, order or
authorization of, or registration, declaration or filing with, any
governmental authority is required in connection with the execution, delivery
and performance of this Agreement, or any agreement or instrument
contemplated by this Agreement, by Dura or the performance by Dura of its
obligations contemplated hereby and thereby other than (a) the filings
required of both parties pursuant to the H-S-R Act, and (b) in the case of
Lilly exercising its right to assign, transfer and convey the Licensed Assets
to Dura pursuant to Section 2.4, the information submissions to the FDA
provided for in Section 7.1 and compliance with FDA requirements, if any, in
connection therewith.
SECTION 7
ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES
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7.1 GOVERNMENTAL FILINGS. Lilly and Dura each agree to prepare and file
whatever filings, requests or applications are required to be filed with any
governmental authority in connection with this Agreement and to cooperate
with one another as reasonably necessary to accomplish the foregoing
including, without limitation, the filing required by the parties under the
H-S-R Act, which the parties agree shall be filed as promptly as possible
following the execution of this Agreement but in no event later than ten (10)
business days following such execution. Without limiting the generality of
the foregoing, prior to the assignment, transfer and conveyance by Lilly to
Dura of the Licensed Assets pursuant to Section 2.4, Lilly shall submit to
the FDA the information required of a former owner pursuant to 21 C.F.R.
Section 314.72 with respect to each NDA, and Dura shall submit to the FDA the
information required of a new owner pursuant to 21 C.F.R. Section 314.72 with
respect to each NDA.
7.2 RESPONSIBILITY FOR NDAS.
(a) Lilly shall remain responsible (until transfer of the NDAs by
Lilly to Dura pursuant to Section 2.4, at which time Dura
shall become and remain responsible) for fulfilling all
regulatory requirements with respect to the Products that are
imposed upon Lilly as the owner of the NDAs; PROVIDED,
HOWEVER, that Dura * days of written request by Lilly
therefor, for the amount of any and all * in connection with *
and * in connection with the NDAs or sale of the Products from
and after the date of this Agreement (except * other than
those mentioned in this sentence, all of which shall *).
Lilly shall provide Dura, upon request after reasonable notice
from Dura, with access to copies of all filings submitted by
Lilly to the NDAs and, with respect to Ceclor CD, copies of
the Application Summary, which provides a comprehensive
summary of all clinical trials conducted under the Ceclor CD
NDAs. Nothing set forth
*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.
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herein shall permit Dura to photocopy or otherwise make a
reproduction of the NDAs without the consent of Lilly. Dura
shall, on a timely basis, provide to Lilly all information
that Dura has that Lilly does not have that is reasonably
necessary and relevant to Lilly's obligations hereunder to
fulfill such requirements including, but not limited to, sales
distribution information concerning the Products, and shall
otherwise cooperate with Lilly as reasonably necessary in
connection therewith. Without limiting the generality of the
foregoing sentence, in the event that any supplements to the
NDAs or any other regulatory requirements are necessitated as
a result of transferring manufacturing of the Products from
Lilly to any other manufacturer or as a result of any action
by Dura (including, but not limited to, acquisition by a third
party of substantially all of the assets or outstanding shares
of Dura, or merger with Dura) or such other manufacturer, Dura
shall, on a timely basis and at Dura's expense, develop and
provide to Lilly all information that is reasonably necessary
and relevant to Lilly's obligation hereunder to file such
supplements or to fulfill such requirements and shall
otherwise cooperate with Lilly as reasonably necessary in
connection therewith. Lilly shall have the final
decision-making authority (until transfer of the NDAs by Lilly
to Dura pursuant to Section 2.4, at which time Dura shall have
the final decision-making authority) in every case on whether
and how to supplement, amend or otherwise alter the NDAs and
any other issues in connection with the NDAs (including, but
not limited to, decisions to recall the Products) and on
whether and how to communicate with the FDA in connection
therewith. Dura shall submit to Lilly for Lilly's prior
review and approval any request by Dura to pursue approval of
any new indication for any Product, to conduct any studies
with respect to any Product, and to make any submissions to
the FDA with respect to any Product; provided, however, that
Lilly shall have the right, in its reasonable judgment and
based solely on the scientific
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merit of the request, to refuse any such request. If Lilly
elects to undertake such an obligation, such election shall be
subject to Lilly and Dura mutually agreeing upon the terms and
conditions (including, but not limited to, compensation to
Lilly) of any such obligation.
(b) Dura and Lilly have jointly developed written procedures for
(i) the reporting of adverse drug experiences, as set forth on
EXHIBIT D, (ii) the submission by Dura to Lilly and by Lilly
to FDA of labeling and promotional materials related to the
Products as set forth in EXHIBIT E, (iii) the administration
of and response to medical inquiries concerning the Products
by consumers, physicians, pharmacists and other health care
professionals as set forth in EXHIBIT F, and (iv) the
administration and analysis of and response to complaints
concerning the Products as set forth in EXHIBIT G. Dura and
Lilly shall each comply with the provisions thereof.
7.3 COMPLIANCE WITH LAW. Dura and Lilly shall each comply with all
federal, state and local laws and regulations applicable to manufacturing,
marketing and selling the Products in the United States, the Licensed Assets,
the Product Patents, the Product Technology, the Bulk Patents, the Bulk
Technology or the performance of their respective obligations hereunder and
under the Manufacturing Agreement Without limiting the generality of the
foregoing sentence, Dura shall not promote the Products for any indications not
contained in the approved NDAs or in any manner in conflict with (i) the
approved labeling, (ii) with respect to Ceclor CD, the FDA approval letter dated
June 25, 1996, and (iii) all other applicable laws or regulations. Dura shall
store and distribute samples of the Products in compliance with all applicable
laws, including, without limitation, the PDMA. Lilly and Dura each shall keep
all records and reports required to be kept by applicable laws and regulations,
and each shall make its facilities available at reasonable times during business
hours for inspection by representatives of governmental agencies. Lilly and
Dura each shall notify the other within twenty-four (24) hours of receipt of any
notice or any other indication whatsoever of any FDA or other governmental
agency inspection, investigation or other inquiry, or other material notice or
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communication of any type, involving the Products. Dura and Lilly shall
cooperate with each other during any such inspection, investigation or other
inquiry including, but not limited to, allowing upon request a representative of
the other to be present during the applicable portions of any such inspection,
investigation or other inquiry and providing copies of all relevant documents.
Dura and Lilly shall discuss any response to observations or notifications
received in connection with any such inspection, investigation or other inquiry
and each shall give the other an opportunity to comment upon any proposed
response before it is made. In the event of disagreement concerning the form or
content of such response, however, Lilly shall be responsible for deciding the
appropriate form and content of any response with respect to any of its cited
activities and Dura shall be responsible for deciding the appropriate form and
content of any response with respect to any of its cited activities.
7.4 RECALL. Lilly and Dura shall each maintain such traceability records
as may be necessary to permit a recall or field correction of any Products.
Each party shall give telephonic notice (to be confirmed in writing) to the
other within twenty-four (24) hours of the receipt of any information which
indicates a recall may be necessary. The decision to conduct and the right to
control a recall shall be solely that of the NDA holder after appropriate
consultation with the other party. Each party will cooperate fully with the
other in connection with any recall efforts.
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7.5 CONFIDENTIALITY. Dura shall treat as confidential the Licensed
Assets, the Bulk Patents, the Bulk Technology, the Product Patents, the Product
Technology, and all other information of Lilly of which Dura becomes aware
(whether in writing or orally or by sensory detection) in connection with this
Agreement or the Manufacturing Agreement (collectively, "Lilly Proprietary
Information"). Dura shall neither disclose Lilly Proprietary Information to any
third party nor use Lilly Proprietary Information for any purpose other than as
set forth in this Agreement. Lilly shall treat as confidential all information
of Dura of which Lilly becomes aware (whether in writing or orally or by sensory
detection) in connection with this Agreement or the Manufacturing Agreement
(collectively, "Dura Proprietary Information"). Lilly shall neither disclose
Dura Proprietary Information to any third party nor use Dura Proprietary
Information for any purpose other than as set forth in this Agreement.
Nothing contained herein will in any way restrict or impair either party's
(the "Using Party's") right to use, disclose or otherwise deal with any
Proprietary Information of the other party which:
(a) at the time of disclosure is known to the public or thereafter
becomes known to the public by publication or otherwise through
no fault of the Using Party;
(b) the Using Party can establish was in its possession prior to the
time of the disclosure and was not obtained directly or
indirectly from the other party;
(c) is independently made available as a matter of right to the Using
Party by a third party who is not thereby in violation of a
confidential relationship with the other party;
(d) is developed by the Using Party independently of the Proprietary
Information received from the other party and the Using Party can
establish such development; or
(e) is information required to be disclosed by legal or regulatory
process; provided, in each case the Using Party timely
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informs the other party and uses reasonable efforts to limit
the disclosure and maintain confidentiality to the extent
possible and permits the other party to intervene and contest
or attempt to limit the disclosure.
Dura shall obtain no right or license of any kind under the Lilly
Proprietary Information except as set forth in this Agreement. Lilly shall
obtain no right or license of any kind under the Dura Proprietary Information
except as set forth in this Agreement.
7.6 EXPENSES. Lilly and Dura shall each bear their own direct and
indirect expenses incurred in connection with the negotiation and preparation of
this Agreement and, except as set forth in this Agreement, the performance of
the obligations contemplated hereby.
7.7 CUSTOMERS. Lilly and Dura shall cooperate with each other in
notifying all customers relating to the Activities and other interested parties
of the consummation of the transactions contemplated hereby as set forth in
APPENDIX B to the Manufacturing Agreement.
7.8 REASONABLE EFFORTS. Lilly and Dura each hereby agrees to use all
reasonable efforts to take, or cause to be taken, all actions and to do, or
cause to be done, all things necessary or proper to make effective the
transactions contemplated by this Agreement, including such actions as may be
reasonably necessary to obtain approvals and consents of governmental Persons
and other Persons (including, without limitation, all applicable drug listing
and NDA notifications to the FDA identifying Dura as a distributor of the
Products); PROVIDED that no party shall be required to (i) pay money (other than
as expressly required pursuant to this Agreement), or (ii) assume any other
material obligation not otherwise required to be assumed by this Agreement.
7.9 PUBLICITY. The parties agree that no publicity release or
announcement concerning the transactions contemplated hereby or in the
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Manufacturing Agreement shall be issued without the advance written consent of
the other, except as such release or announcement may be required by law, in
which case the party making the release or announcement shall, before making any
such release or announcement, afford the other party a reasonable opportunity to
review and comment upon such release or announcement. Dura and Lilly recognize
that disclosure of this Agreement and the Manufacturing Agreement (including
copies of each) to the IRS and other tax authorities is likely to be required,
and each waives the requirements of this subsection with respect to disclosure
(and copies) to such entities.
7.10 COOPERATION. If either party shall become engaged in or
participate in any investigation, claim, litigation or other proceeding with
any third party, including the FDA, relating in any way to the Products or
any of the Licensed Assets, the Product Patents, the Product Technology, the
Bulk Patents, or the Bulk Technology, the other party shall cooperate in all
reasonable respects with such party in connection therewith, including,
without limitation, using its reasonable efforts to make available to the
other such employees who may be helpful with respect to such investigation,
claim, litigation or other proceeding, provided that, for purposes of this
provision, reasonable efforts to make available any employee shall be deemed
to mean providing a party with reasonable access to any such employee at no
cost for a period of time not to exceed 24 hours (e.g., three 8-hour business
days). Thereafter, any such employee shall be made available for such time
and upon such terms and conditions (including, but not limited to,
compensation) as the parties may mutually agree.
7.11 NO SALE FOR RESALE. Neither Dura nor any sublicensee of Dura shall
knowingly sell any Products to anyone in the United States for subsequent
distribution or resale outside the United States and each shall take all
reasonable precautions to prevent such distribution or resale outside the
United States. Lilly shall not knowingly sell any Products to anyone in the
United States or outside the United States for subsequent distribution or
resale in the United States and Lilly shall take all reasonable precautions
to prevent such distribution or resale in the United States.
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7.12 PRODUCT RETURNS. Dura shall be responsible for all rebates,
chargebacks and returns of Products sold on or after the date of this
Agreement and Lilly shall be responsible for all rebates, chargebacks and
returns of Products sold prior to the date of this Agreement; provided,
however, that if the parties are unable to determine whether a particular
Product was sold before or after the date of this Agreement, then with
respect to any such Product, Dura shall be responsible for all rebates,
chargebacks and returns of Products returned more than sixty (60) days after
the date of this Agreement, and Lilly shall be responsible for all rebates,
chargebacks and return of Products returned within sixty (60) days after the
date of this Agreement. Notwithstanding the above, Lilly shall (a) replace
any Keftab trade bottles bearing lot numbers OAC 84A, OAD 64A, OAE 57A, OAE
58A, OAE 59B, OAE 60B, 9AS 53C, OAC 83A, OAF 23M, OAF 25M, and OAF 27M with
new Keftab trade bottles and shall use its best reasonable efforts to deliver
such replacement bottles, at its sole cost and expense (excluding freight),
to Dura with the next order of Keftab trade bottles to be shipped by Lilly to
Dura under the Manufacturing Agreement, and (b) replace up to 175,000 Ceclor
CD sample units bearing lot numbers 8AK 39N, 8AK 40P, 8AK 41N, 8AK 42N, 8AK
48, and 8AK 49 with new Ceclor CD samples and shall use its best reasonable
efforts to deliver such replacement samples, at its sole cost and expense
(excluding freight), to Dura with the next order of Ceclor CD samples to be
shipped by Lilly to Dura under the Manufacturing Agreement.
7.13 CONFLICTING RIGHTS. Lilly shall not grant any right to any third
party relating to the Activities which would violate the terms of or conflict
with the rights granted to Dura pursuant to this Agreement or the Manufacturing
Agreement.
7.14 PATENT MAINTENANCE. Lilly shall be solely responsible for filing,
prosecuting, and maintaining all of the Product Patents and Bulk Patents, and
Lilly shall pay the costs associated therewith. Lilly shall file, prosecute,
and maintain all Product Patents and Bulk Patents so as to fully continue the
benefits under the licenses granted to Dura hereunder. In the event that any
extension, registration, confirmation, reissue, renewal, reexamination or
continuation-in-part is to be filed with respect to a Product Patent, Lilly
shall provide Dura with the opportunity to review such extension, registration,
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confirmation, reissue, renewal, reexamination or continuation-in-part and
provide input thereto.
7.15 INFRINGEMENT; ENFORCEMENT OF PROPRIETARY RIGHTS.
(a) INFRINGEMENT OF PATENT RIGHTS. Each party shall promptly notify
the other of any alleged infringement by third parties of any
Product Patent or Bulk Patent and provide any information
available to that party relating to such alleged infringement.
Lilly shall have the responsibility to investigate such alleged
infringement and act diligently to end any infringement of such
rights, including, but not limited to, bringing suit against such
third party infringer.
(b) PROCEDURES. No settlement, consent judgment or other voluntary
final disposition of the suit may be entered into without the
consent of each party, which consent shall not be unreasonably
withheld or delayed. Any recovery of damages in any such suit
shall be retained by the party bearing the costs of such suit.
In the event of any infringement suit against a third party
brought by either party pursuant to this Section 7.15, the party
not bringing such suit shall cooperate in all respects, execute
any documents reasonably necessary to permit the other party to
prosecute such suit, and to the extent reasonable shall make
available its employees and relevant records to provide evidence
for such suit.
(c) INFRINGEMENT OF THIRD PARTY RIGHTS. If, during the term of this
Agreement, any third party (other than an Affiliate of Dura)
claims that Dura's marketing or selling of Products hereunder
infringes on a third party patent based upon claims that dominate
claims in the Product Patents, within 120 days after notice by
Dura, Lilly shall (i) initiate an action for a declaratory
judgment of invalidity and/or non-infringement of any such
patents, or (ii) procure for Dura the
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right to exercise all rights licensed under this Agreement
without any additional payment therefor by Dura.
7.16 SUPPLY OF PRODUCT. Subject to the terms and conditions set forth in
the Manufacturing Agreement, Lilly shall maintain the capacity throughout the
term of the Manufacturing Agreement to meet the requirements of Dura thereunder.
7.17 TECHNOLOGY. Lilly shall be solely responsible for maintaining the
Product Technology and the Bulk Technology in accordance with the terms set
forth herein and in the Manufacturing Agreement.
7.18 DEEMED BREACH OF COVENANT. Neither Lilly nor Dura shall be deemed to
be in breach of any covenant contained in this Section 7 if such party's deemed
breach is the result of any action or inaction on the part of the other party.
SECTION 8
INDEMNIFICATION
8.1 INDEMNIFICATION. (a) Lilly shall indemnify, defend and hold Dura (and
its directors, officers, employees, and Affiliates) harmless from and against
any and all Damages incurred or suffered by Dura (and its directors, officers,
employees, and Affiliates) (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 Lilly
in this Agreement, or in the Manufacturing Agreement,
provided that, in the case of a breach of any representation
or warranty made by Lilly in this Agreement, notice of a
claim based upon any such breach is received by Lilly prior
to the expiration of
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such representation and warranty pursuant to Section 10.4;
(ii) any failure to perform duly and punctually any covenant,
agreement or undertaking on the part of Lilly contained in
this Agreement or in the Manufacturing Agreement;
(iii) any material misrepresentation in or material omission from
any agreement, instrument or document delivered by Lilly
pursuant to the terms of this Agreement, or the
Manufacturing Agreement; or
(iv) any Excluded Liabilities.
(b) Dura shall indemnify, defend and hold Lilly (and its directors,
officers, employees, and Affiliates) harmless from and against
any and all Damages incurred or suffered by Lilly (and its
directors, officers, employees, and Affiliates) (excluding
incidental or consequential Damages suffered or incurred by Lilly
directly (as opposed to incidental or consequential Damages
suffered or incurred by third parties who are, in turn, seeking
the same from Lilly, which shall be covered the indemnity set
forth herein)) as a consequence of:
(i) any breach of any representation or warranty made by Dura in
this Agreement, or in the Manufacturing Agreement, provided
that, in the case of a breach of any representation or
warranty made by Dura in this Agreement, notice of a claim
based upon any such breach is received by Dura prior to the
expiration of such representation and warranty pursuant to
Section 10.4;
(ii) any failure to perform duly and punctually any covenant,
agreement or undertaking on the part of
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Dura contained in this Agreement or in the Manufacturing
Agreement;
(iii) any material misrepresentation in or material omission
from any agreement, instrument or document delivered by Dura
pursuant to the terms of this Agreement or the Manufacturing
Agreement; or
(iv) any Assumed Liabilities.
8.2 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 8.1, 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
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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 8.2, (i) 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 (ii) 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).
8.3 INDEMNIFICATION PAYMENT OBLIGATION. No Indemnifying Party will have
any obligations under Sections 8.l(a) or 8.1(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 8.3 shall not limit or
otherwise affect the obligations of any Indemnifying Party under any other
Section of this Agreement.
8.4 INDEMNIFICATION PAYMENT ADJUSTMENTS. The amount of any Damages for
which indemnification is provided under this Section 8 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,
* 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.
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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 any Indemnified Party shall have received any payment pursuant
to this Section 8 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 8 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 8
with respect to such Damages.
8.5 INDEMNIFICATION PAYMENT. Upon the final determination of liability
and the amount of the indemnification payment under this Section 8, 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.
8.6 SURVIVAL. The provisions of Section 8 shall survive any termination
of this Agreement and any termination of the Manufacturing Agreement. Each
Indemnified Party's rights under Section 8 shall not be deemed to have been
waived or otherwise affected by such Indemnified Party's waiver of the breach of
any representation, warranty, agreement or covenant contained in or made
pursuant this Agreement or the Manufacturing Agreement, unless such waiver
expressly and in writing also waives any or all of the Indemnified Party's right
under Section 8.
SECTION 9
TERMINATION
9.1 TERMINATION. Anything herein to the contrary notwithstanding, this
Agreement may be terminated as follows:
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(a) TERMINATION FOR INSOLVENCY. If either Dura or Lilly (i) makes a
general assignment for the benefit of creditors or becomes
insolvent; (ii) files an insolvency petition in bankruptcy;
(iii) petitions for or acquiesces in the appointment of any
receiver, trustee or similar officer to liquidate or conserve its
business or any substantial part of its assets; (iv) commences
under the laws of any jurisdiction any proceeding involving its
insolvency, bankruptcy, reorganization, adjustment of debt,
dissolution, liquidation or any other similar proceeding for the
release of financially distressed debtors; or (v) becomes a party
to any proceeding or action of the type described above in (iii)
or (iv) and such proceeding or action remains undismissed or
unstayed for a period of more than sixty (60) days, then the
other party may by written notice terminate this Agreement in its
entirety with immediate effect.
(b) TERMINATION FOR DEFAULT.
(i) Dura and Lilly each shall have the right to terminate this
Agreement with respect to a specific Product for default
upon the other's failure to comply in any material respect
with the terms and conditions of this Agreement or the
Manufacturing Agreement that relate to such specific
Product. At least ninety (90) days prior to any such
termination for default, the party seeking to so terminate
shall give the other written notice of its intention to
terminate this Agreement in accordance with the provisions
of this Section 9.1(b), which notice shall set forth the
default(s) which form the basis for such termination. If
the defaulting party fails to correct such default(s) within
ninety (90) days after receipt of notification, or if the
same cannot reasonably be corrected or remedied within
ninety (90) days, then if the
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defaulting party has not commenced curing said default(s)
within said ninety (90) days and be diligently pursuing
completion of same, then such party immediately may
terminate this Agreement with respect to such Product.
(ii) This Section 9.1(b) shall not be exclusive and shall not be
in lieu of any other remedies available to a party hereto
for any default hereunder on the part of the other party,
including without limitation, Dura's rights with respect to
a Refund Event.
(c) TERMINATION UPON TRANSFER. If Lilly elects to transfer the
Licensed Assets relating to both Products to Dura pursuant to
Section 2.4, this Agreement shall, subject to the provision of
subparagraph (e) of this Section 9, terminate automatically, and
without the need for notice, simultaneously with the execution
and delivery by Lilly to Dura of the Bill of Sale, Trademark
Assignment and Copyright Assignment described in Section 2.4. If
Lilly elects to transfer the Licensed Assets relating solely to
one Product, this Agreement shall remain in full force and effect
with respect to the remaining Product. All of the rights under
the licenses granted by Lilly to Dura pursuant to Sections 2.1
and 2.2 hereof shall remain in full force and effect.
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(d) RIGHTS UPON TERMINATION.
(i) LILLY RIGHTS UPON TERMINATION UPON DEFAULT BY DURA. In
the event of termination of this Agreement by Lilly under
Section 9.1(b), payment by Dura to Lilly of * shall be
* and all such amounts shall be * on the date of
termination. If, on the date of termination, * then all
of the * with no further notice required on Lilly's
behalf and, notwithstanding anything else contained in
this Agreement or the Manufacturing Agreement to the
contrary, (A) * and (B) * If, on the date of
termination, * then all of *
(ii) DURA RIGHTS UPON TERMINATION UPON DEFAULT BY LILLY. In
the event of termination of this Agreement by Dura under
Section 9.1(b), Dura shall (A) have no further obligation
* if the Agreement was terminated with respect to *
(B) in the event of a Refund Event which triggers such
termination, have those rights set forth in * this
Agreement with respect to the terminated Product, and (C)
retain all
* 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.
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of the * and pursuant to the Manufacturing Agreement with
respect to the terminated Product.
(e) CONTINUING OBLIGATIONS. Termination of this Agreement for any
reason shall not relieve the parties of any obligation accruing
prior thereto with respect to the terminated Product and any
ongoing obligations hereunder with respect to the remaining
Product and shall be without prejudice to the rights and remedies
of either party with respect to any antecedent breach of the
provisions of this Agreement. Without limiting the generality of
the foregoing, no termination of this Agreement, whether by lapse
of time or otherwise, shall serve to terminate the obligations of
the parties hereto under subsections 2.2 (but only to the extent
Dura has rights to such licenses upon termination as provided for
in the provisions contained herein and in the Manufacturing
Agreement), 2.3, 3.2, 3.4, 3.6, 7.2, 7.3, 7.4, 7.5, 7.10, 7.12,
7.13, 7.14, 7.15, section 8, subsections 9.1(e), 9.1(f) and
section 10 (except for subsection 10.4, which shall expire in
accordance with the term contained therein) hereof, and such
obligations shall survive any such termination.
(f) RETURNED MATERIALS. On the termination of this Agreement (other
than pursuant to Section 9.1(c)), Lilly and Dura each shall
return to the other all information which it possesses or
controls that belongs to the other, except that each may retain a
copy for recordkeeping purposes.
* 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.
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SECTION 10
MISCELLANEOUS
10.1 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 neither Lilly nor Dura may assign any of
its rights, duties or obligations hereunder without the prior written consent of
the other, which consent may be withheld in the other's sole discretion, except
that no prior written consent shall be required in the event that a third party
acquires substantially all of the assets or outstanding shares of, or merges
with, Dura or Lilly, as the case may be. No assignment of this Agreement or of
any rights hereunder shall relieve the assigning party of any of its obligations
or liability hereunder.
10.2 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 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 Lilly, as follows:
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
Facsimile: (317) 277-3354
Attn: President, North American Pharmaceutical Operations
With a copy to:
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
Facsimile: (317) 276-6221
Attn: General Counsel
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If to Dura, as follows:
Dura Pharmaceuticals, Inc.
5880 Pacific Center Boulevard
San Diego, California 92121-4204
Attn: Office of the General Counsel
or in any case to such other address or addresses as hereafter shall be
furnished as provided in this Section 10.2 by any party hereto to the other
party.
10.3 WAIVER; REMEDIES. Any term or provision of this Agreement may be
waived at any time by the party entitled to the benefit thereof by a written
instrument executed by such party. No delay on the part of Lilly or Dura in
exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of either Lilly or Dura of any right,
power or privilege hereunder operate as a waiver of any other right, power or
privilege hereunder nor shall any single or partial exercise of any right, power
or privilege hereunder preclude any other or further exercise thereof or the
exercise of any other right, power or privilege hereunder. The indemnification
provided in Section 8 shall be the sole remedy available for any Damages arising
out of or in connection with this Agreement except for any rights or remedies
which the parties hereto may otherwise have in equity.
10.4 SURVIVAL OF REPRESENTATIONS. Each of the representations and
warranties made in this Agreement (but not including the Manufacturing
Agreement, which shall be governed by the terms and conditions contained
therein) shall survive only for a period of two (2) years after the Closing Date
and shall thereafter be extinguished.
10.5 ENTIRE AGREEMENT. This Agreement, together with the Manufacturing
Agreement, constitutes the entire agreement between the parties with respect to
the subject matter hereof and supersedes all prior agreements or understandings
of the parties relating thereto.
10.6 AMENDMENT. This Agreement may be modified or amended only by written
agreement of the parties hereto.
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10.7 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute a single instrument.
10.8 GOVERNING LAW. This Agreement shall be governed and construed in
accordance with the laws of the State of Indiana excluding any choice of law
rules which may direct the application of the law of another state.
10.9 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.
10.10 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 Person not a party to this Agreement.
10.11 SEVERABILITY. If any provision of this Agreement is found or
declared to be invalid or unenforceable by any court or other competent
authority having jurisdiction, such finding or declaration shall not invalidate
any other provision hereof, and this Agreement shall thereafter continue in full
force and effect.
10.12 ATTACHMENTS. All Schedules, Exhibits and other attachments to
this Agreement are by this reference incorporated herein and made a part of this
Agreement.
10.13 USE OF THE WORD "PRODUCTS". Unless the context indicates
otherwise, the use of the word "Products" shall be construed to mean the
individual products Ceclor CD and/or Keftab, as appropriate.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed and delivered on the day and year first above written.
ELI LILLY AND COMPANY DURA PHARMACEUTICALS, INC.
By: /s/ Sidney Taurel By: /s/ Cam L. Garner
----------------- -----------------
Title: President and Chief Title: Chairman, President and
Operating Officer Chief Executive Officer
Dura/License Agreement - 8/20/96
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