<PAGE> 1
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 18, 1997
REGISTRATION NO. 333-38389
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
------------------------
AMENDMENT NO. 4
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
------------------------
PENWEST PHARMACEUTICALS CO.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
<TABLE>
<S> <C> <C>
WASHINGTON 2834 91-1513032
(STATE OR OTHER JURISDICTION OF (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) CLASSIFICATION CODE NUMBER) IDENTIFICATION NUMBER)
</TABLE>
2981 ROUTE 22
PATTERSON, NY 12563-9970
(914) 878-3414
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER,
INCLUDING AREA CODE, OF REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
------------------------
TOD R. HAMACHEK
CHAIRMAN AND CHIEF EXECUTIVE OFFICER
PENWEST PHARMACEUTICALS CO.
2981 ROUTE 22
PATTERSON, NY 12563-9970
(914) 878-3414
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER,
INCLUDING AREA CODE, OF AGENT FOR SERVICE)
COPIES TO:
<TABLE>
<S> <C> <C>
STEVEN D. SINGER, ESQ. EDMUND O. BELSHEIM, JR., ESQ. LESLIE E. DAVIS, ESQ.
HALE AND DORR LLP PENWEST PHARMACEUTICALS CO. TESTA, HURWITZ & THIBEAULT, LLP
60 STATE STREET 2981 ROUTE 22 HIGH STREET TOWER
BOSTON, MA 02109 PATTERSON, NY 12563-9970 125 HIGH STREET
(617) 526-6000 (914) 878-3414 BOSTON, MA 02110
(617) 248-7000
</TABLE>
------------------------
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as
practicable after this registration statement becomes effective.
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. [ ]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act of 1933, please check the
following box and list the Securities Act registration number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act of 1933, check the following box and list the
Securities Act registration number of the earlier effective registration
statement for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434
under the Securities Act of 1933, check the following box. [ ]
------------------------
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
================================================================================
<PAGE> 2
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(A) Exhibits:
<TABLE>
<CAPTION>
EXHIBIT
NO. DESCRIPTION
- ------- --------------------------------------------------------------------------------
<S> <C> <C>
1.1* -- Form of Underwriting Agreement.
3.1* -- Amended and Restated Articles of Incorporation.
3.2* -- Amended and Restated Bylaws of the Company.
4.1* -- Specimen certificate representing the Common Stock.
5.1* -- Opinion of Edmund O. Belsheim, Jr.
+10.1* -- Product Development and Supply Agreement dated August 17, 1994 by and between
the Registrant and Mylan Pharmaceuticals Inc. ("Mylan").
+10.2* -- Product Development and Supply Agreement dated August 3, 1995 by and between the
Registrant and Mylan.
+10.3* -- Product Development and Supply Agreement dated March 22, 1996 by and between the
Registrant and Mylan.
+10.4* -- Sales and Distribution Agreement dated January 3, 1997 by and between the
Registrant and Mylan.
+10.5* -- Product Development and Supply Agreement dated May 31, 1996 by and between the
Registrant and Kremers Urban Development Company.
+10.6 -- Product Development and Supply Agreement dated August 30, 1996 by and between
the Registrant and Kremers Urban Development Company.
+10.7* -- Product Development, License and Supply Agreement dated February 28, 1997 by and
between the Registrant and Sanofi Winthrop International S.A., as amended.
+10.8* -- Agreement dated May 26, 1995 by and between the Registrant and Leiras OY.
+10.9* -- Agreement dated July 27, 1992 by and between the Registrant and Leiras OY.
+10.10* -- Strategic Alliance Agreement dated as of September 17, 1997 by and between the
Registrant and Endo Pharmaceuticals Inc.
10.11* -- 1997 Equity Incentive Plan.
10.12* -- 1997 Employee Stock Purchase Plan.
10.13* -- Form of Separation Agreement to be entered into between the Registrant and
Penford Corporation ("Penford").
10.14* -- Form of Excipient Supply Agreement to be entered into between the Registrant and
Penford.
10.15* -- Form of Services Agreement to be entered into between the Registrant and
Penford.
10.16* -- Form of Tax Allocation Agreement to be entered into between the Registrant and
Penford.
10.17* -- Form of Employee Benefits Agreement to be entered into between the Registrant
and Penford.
10.18* -- Recognition and Incentive Agreement dated as of May 14, 1990 between the
Registrant and Anand Baichwal, as amended.
21.1* -- Subsidiaries.
23.1* -- Consent of Ernst & Young LLP.
23.2* -- Consent of Edmund O. Belsheim, Jr. (included in Exhibit 5.1).
24.1* -- Power of Attorney.
27.1* -- Financial Data Schedule.
</TABLE>
- ---------------
* Previously filed.
+ Confidential treatment requested as to certain portions, which portions are
omitted and filed separately with the Commissioner.
II-1
<PAGE> 3
(B) Financial Statements Schedules:
Schedule II -- Valuation and Qualifying Accounts
All other schedules for which provision is made in the applicable
accounting regulations of the Securities and Exchange Commission are not
required under the related instructions or are inapplicable, and therefore have
been omitted.
II-2
<PAGE> 4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
has duly caused this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in Patterson, New York, on December 17,
1997.
PENWEST PHARMACEUTICALS CO.
By: /s/ JOHN V. TALLEY, JR.
------------------------------------
John V. Talley, Jr.
President and Chief Operating
Officer
POWER OF ATTORNEY AND SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
SIGNATURE TITLE(S) DATE
- ------------------------------------------ ------------------------------ -----------------
<C> <S> <C>
* Chairman, Chief Executive December 17, 1997
- ------------------------------------------ Officer and Director
Tod R. Hamachek (Principal Executive
Officer)
* Vice President, Finance and December 17, 1997
- ------------------------------------------ Chief Financial Officer
Jennifer L. Good (Principal Financial and
Accounting Officer)
* Director December 17, 1997
- ------------------------------------------
Paul E. Freiman
* Director December 17, 1997
- ------------------------------------------
Jere E. Goyan, Ph.D.
* Director December 17, 1997
- ------------------------------------------
Rolf H. Henel
* Director December 17, 1997
- ------------------------------------------
Robert J. Hennessey
* Director December 17, 1997
- ------------------------------------------
N. Stewart Rogers
/s/ JOHN V. TALLEY, JR. Director December 17, 1997
- ------------------------------------------
John V. Talley, Jr.
* Director December 17, 1997
- ------------------------------------------
W. Leigh Thompson, Ph.D., M.D.
</TABLE>
*By: /s/ JOHN V. TALLEY, JR.
---------------------------------
John V. Talley, Jr.
Attorney-in-fact
II-3
<PAGE> 5
EXHIBITS
<TABLE>
<CAPTION>
SEQUENTIALLY
EXHIBIT NUMBERED
NO. DESCRIPTION PAGE
- ------- --------------------------------------------------------------------- ------------
<S> <C> <C> <C>
1.1* -- Form of Underwriting Agreement.
3.1* -- Amended and Restated Articles of Incorporation.
3.2* -- Amended and Restated Bylaws of the Company.
4.1* -- Specimen certificate representing the Common Stock.
5.1* -- Opinion of Edmund O. Belsheim, Jr.
+10.1* -- Product Development and Supply Agreement dated August 17, 1994 by and
between the Registrant and Mylan Pharmaceuticals Inc. ("Mylan").
+10.2* -- Product Development and Supply Agreement dated August 3, 1995 by and
between the Registrant and Mylan.
+10.3* -- Product Development and Supply Agreement dated March 22, 1996 by and
between the Registrant and Mylan.
+10.4* -- Sales and Distribution Agreement dated January 3, 1997 by and between
the Registrant and Mylan.
+10.5* -- Product Development and Supply Agreement dated May 31, 1996 by and
between the Registrant and Kremers Urban Development Company.
+10.6 -- Product Development and Supply Agreement dated August 30, 1996 by and
between the Registrant and Kremers Urban Development Company.
+10.7* -- Product Development, License and Supply Agreement dated February 28,
1997 by and between the Registrant and Sanofi Winthrop International
S.A., as amended.
+10.8* -- Agreement dated May 26, 1995 by and between the Registrant and Leiras
OY.
+10.9* -- Agreement dated July 27, 1992 by and between the Registrant and
Leiras OY.
+10.10* -- Strategic Alliance Agreement dated as of September 17, 1997 by and
between the Registrant and Endo Pharmaceuticals Inc.
10.11* -- 1997 Equity Incentive Plan.
10.12* -- 1997 Employee Stock Purchase Plan.
10.13* -- Form of Separation Agreement to be entered into between the
Registrant and Penford Corporation ("Penford").
10.14* -- Form of Excipient Supply Agreement to be entered into between the
Registrant and Penford.
10.15* -- Form of Services Agreement to be entered into between the Registrant
and Penford.
10.16* -- Form of Tax Allocation Agreement to be entered into between the
Registrant and Penford.
10.17* -- Form of Employee Benefits Agreement to be entered into between the
Registrant and Penford.
10.18* -- Recognition and Incentive Agreement dated as of May 14, 1990 between
the Registrant and Anand Baichwal, as amended.
</TABLE>
<PAGE> 6
<TABLE>
<CAPTION>
SEQUENTIALLY
EXHIBIT NUMBERED
NO. DESCRIPTION PAGE
- ------- --------------------------------------------------------------------- ------------
<S> <C> <C> <C>
21.1* -- Subsidiaries.
23.1* -- Consent of Ernst & Young LLP.
23.2* -- Consent of Edmund O. Belsheim, Jr. (included in Exhibit 5.1).
24.1* -- Power of Attorney.
27.1* -- Financial Data Schedule.
</TABLE>
- ---------------
* Previously filed.
+ Confidential treatment requested as to certain portions, which portions are
omitted and filed separately with the Commissioner.
<PAGE> 1
Exhibit 10.6
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
PRODUCT DEVELOPMENT AND SUPPLY AGREEMENT
THIS AGREEMENT is entered into as of the 30th day of August, 1996 (the
"Effective Date"), by and between TIMERx Technologies, a division of Penwest,
Ltd., a Washington corporation, with principal place of business at 2981 Route
22, Patterson, New York 12563 ("TIMERx Technologies"), and SCHWARZ PHARMA INC.,
a Delaware corporation, with principal place of business at 5600 County Line
Road, Mequon, Wisconsin 53092 ("Schwarz Pharma").
A. TIMERx Technologies has developed a controlled-release agent
covered by one or more patents, patent applications, know-how and other
proprietary technology, which agent TIMERx Technologies markets under the name
and mark "TIMERx(R)" ("TIMERx").
B. Schwarz Pharma is interested in developing for manufacture the
active pharmaceutical ingredient verapamil ("Verapamil") and desires to
formulate Verapamil into a solid-dosage controlled-release delivery system for
oral administration in humans in two dosage strengths to be therapeutically
equivalent AB rated to the drug currently sold under the brand name "Covera-HS."
C. The parties, under a separate agreement (the "Diltiazem
Agreement"), are engaging in certain activities relating to the development and
testing of a product incorporating diltiazem and TIMERx, and designed to be
bioequivalent to the product currently being marketed in the United States under
the name "Cardizem CD." The parties now desire to engage in a separate program
of research, development, and testing activities designed to determine if a drug
that is bioequivalent to Covera-HS can be developed using TIMERx. If such
activities under this separate program are successful, Schwarz Pharma desires to
contract for a supply of TIMERx for use in the manufacture of such a
controlled-release form of Verapamil, and TIMERx Technologies is willing to
supply the same provided that Schwarz Pharma agrees to obtain all of its
requirements of TIMERx from TIMERx Technologies as provided herein.
NOW, THEREFORE, the parties hereby agree as follows:
1
<PAGE> 2
1. DEFINITIONS.
1.1 "AFFILIATE" of TIMERx Technologies or of Schwarz Pharma shall
mean entities that, directly or indirectly, own and control the voting of more
than 50% of the voting capital shares of such party ("Parent"), or more than 50%
of the voting capital shares (or equivalent control) of which is, directly or
indirectly, owned, and the voting of which is controlled, by such party or its
Parent, as of the Effective Date. For purposes of this definition and this
Agreement no Affiliate shall remain such unless it continues to meet the
foregoing criteria. Current Affiliates of TIMERx Technologies and Schwarz Pharma
are listed as such in Exhibit .
1.2 "APPROVAL DATE" shall mean the date on which a Designated
Product in either dosage strength is first approved by the U.S. Food and Drug
Administration (herein "FDA") (the "U.S. Approval Date") or other equivalent
regulatory authority in the Territory for commercial sale in oral solid-dosage
form for administration in humans, pursuant to an Abbreviated New Drug
Application (or the equivalent in such other regulatory authority) ("ANDA").
1.3 "CERTIFICATION PERIOD" with respect to the United States shall
mean the period beginning at the end of the Development Period and ending on the
earlier of:
1.3.1 the U.S. Approval Date;
1.3.2 the termination of this Agreement as provided herein. With
respect to Canada and/or Mexico, the Certification Period, if any, will mean the
period described as such for that nation in Section 3.3.
1.4 "COMPETING GENERIC VERSION" shall mean a drug that meets all of
the following criteria:
1.4.1 it is Therapeutically Equivalent to the applicable Designated
Product being studied, manufactured, or marketed, as the case may be;
1.4.2 it has been fully approved for commercial sale in oral
solid-dosage form for administration in humans by the FDA (for all purposes of
this Agreement, "solid- dosage form" shall include tablets, capsules, hydrogels,
or any combination thereof);
1.4.3 it is actively on the market and immediately available for
retail sale throughout the United States other than under the brand "Covera" or
"Covera-HS"; and
2
<PAGE> 3
1.4.4 it is not marketed by Schwarz Pharma, any of its Affiliates, or
under a license or sublicense from Schwarz Pharma or its Affiliates or
sublicensees in any tier.
1.5 "CONFIDENTIAL TECHNOLOGY" shall mean all technology that is, at
the relevant time hereunder, protected or required to be protected by both
parties hereto as confidential information pursuant to Section 7 hereof.
1.6 "DESIGNATED PRODUCT" shall mean a Therapeutically Equivalent
solid- dosage form of a controlled-release pharmaceutical for oral
administration in humans that combines Verapamil with TIMERx and other
excipients. The parties contemplate that the Designated Product will be
developed and marketed in the following dosage strengths: 180mg and 240mg.
1.7 "DEVELOPMENT PERIOD" shall mean the period from the Effective
Date through the earlier of the termination of this Agreement as provided herein
or the successful completion, through demonstration of bioequivalence to FDA
standards, of the Pivotal Biostudies.
1.8 "DISSOLUTION PROFILE STUDIES" shall mean the studies
contemplated in Section 2.2.
1.9 "FORMULATED TIMERx" shall mean TIMERx and certain additives in a
formulation to be developed hereunder specifically for use in the Designated
Product.
1.10 "LICENSE TERM" shall mean the cumulative period covered by the
Development Period, the Certification Period, and the Marketing Period.
l.11 "MARKETING PERIOD" with respect to a nation shall mean the
period beginning on the Approval Date for such nation and ending on the earlier
of:
1.11.1 the twentieth anniversary of the Effective Date; or
1.11.2 the termination of the License Term and/or this Agreement as
provided herein.
1.12 "MILESTONE FEE SCHEDULE" shall mean the schedule set forth in
Exhibit .
1.13 "NET SALES" shall mean that portion of the net sales (or
equivalent current value, where Designated Product is used without being sold,
other than as to reasonable quantities of samples of Designated Products
marketed as branded drugs, if any) recognized by Schwarz Pharma or its
Affiliate, or a sublicensee of either (excluding sales by Schwarz Pharma to its
Affiliate or sublicensee, or by Schwarz Pharma's Affiliate to Schwarz Pharma or
its sublicensee, for resale to a third party), calculated in accordance with
United States Generally Accepted Accounting Principles
3
<PAGE> 4
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
("GAAP") consistently applied, which pertains to the Designated Product. The
calculation of Net Sales shall include amounts specifically identifiable to the
Designated Product and amounts allocated to the Designated Product in accordance
with GAAP, it being understood that amounts which are not specifically
identifiable to the Designated Product by virtue of their being identifiable to
a group of products or services that includes the Designated Product shall be
allocated to the Designated Product in a consistent and equitable manner which
will not unduly or disproportionately reduce Net Sales of the Designated
Product. Net Sales shall be considered "made" as of the date of the applicable
invoice. Amounts to be included in the calculation of Net Sales shall be those
representing:
************
************************************************************
*********
************************************************************
************************************************************
************************************************************
************************************************************
************************************************************
************************************************************
**************
************************************************************
************************************************************
************************************************************
************************************************************
************************************************************
**************
************************************************************
************************************************************
******************************************
1.14 "PILOT BIOSTUDIES" shall mean the biostudies to be conducted by
Schwarz Pharma as more fully described in Section 2.3 and Exhibit 1.14.
1.15 "PIVOTAL BIOSTUDIES" shall mean the biostudies contemplated in
Section 2.4, it being understood that such Pivotal Biostudies are those that
will be designed and conducted in a manner to support the submission to the FDA
of an ANDA for the Designated Products (whether or not such ANDA is ultimately
approved).
4
<PAGE> 5
1.16 "PROJECT CONTACT(S)" shall mean the persons appointed by each
party to serve as contact persons between the parties during the Development
Period and the Certification Period. The initial Project Contact for TIMERx
Technologies for business matters is Dr. Paul K. Wotton, and the initial Project
Contact for TIMERx Technologies for technical and scientific matters is Dr.
Anand Baichwal. The initial Project Contact for Schwarz Pharma for business
matters is Dr. Klaus Veitinger, and the initial Project Contact for Schwarz
Pharma for technical and scientific matters is Dr. Tammy Antonucci. Each party
shall promptly notify the other party of any substitution of other personnel as
its Project Contact(s). Each party may select and supervise its other project
staff as needed.
1.17 "ROYALTIES" shall mean the royalties payable to TIMERx
Technologies pursuant to Section 4.3 hereof.
1.18 "SCHWARZ PHARMA IMPROVEMENTS" shall mean any and all
improvements, modifications, alterations, or enhancements to any of the
inventions covered by the TIMERx Technologies Patents, TIMERx Technologies'
Confidential Technology, or the TIMERx Production Technology, that are developed
for or are otherwise related to or useful with the Designated Product and that
are developed, owned, or controlled by Schwarz Pharma or any of its Affiliates
or sublicensees, or in which Schwarz Pharma or any of its Affiliates or
sublicensees otherwise has any rights or interests during the term of this
Agreement; together with all United States and foreign intellectual property and
other rights and interests of Schwarz Pharma and its Affiliates and sublicensees
thereto and therein, including without limitation patents, trade secrets,
copyright, periods of market exclusivity, and other related rights or interests.
1.19 "SCHWARZ PHARMA TEST AND REGULATORY DATA" shall mean any and all
test data, test designs and protocols, clinical studies and results thereof,
government licenses and applications therefor, government certifications and
findings, and related materials, information and rights (including without
limitation information regarding bioavailability and bioequivalence, and any
adverse drug reactions), developed, commissioned or otherwise obtained by
Schwarz Pharma or any of its Affiliates or sublicensees during the term of this
Agreement for the uses intended by this Agreement relating to TIMERx, Schwarz
Pharma Improvements, the Designated Product, TIMERx Technologies Patents, TIMERx
Production Technology and/or TIMERx Technologies' Confidential Technology;
together with all intellectual property and other rights and interests of
Schwarz Pharma and its Affiliates and sublicensees thereto and therein,
worldwide.
1.20 "SOLID-DOSAGE UNIT" shall mean any individual tablet, capsule,
hydrogel, or any combination thereof, manufactured to be a solid-dosage form of
the Designated Product in the following dosage strengths: 180mg and 240mg.
5
<PAGE> 6
1.21 "SPECIFICATIONS" shall mean such standards and analytical
methods established by TIMERx Technologies and Schwarz Pharma by agreement
during the Development Period; provided, however, that once such specifications
are established in an application for regulatory approval, such specifications
shall become the Specifications referred to herein, and shall remain unchanged,
unless either changes are required by the regulatory authorities or are mutually
agreed to by the parties. It is understood and agreed that the Specifications
for Formulated TIMERx for use in Designated Product to be sold outside the
United States shall be the same as those for Formulated TIMERx for use in
Designated Product to be sold in the United States, because this will be
required for the technically satisfactory production, regulatory approval, and
exploitation of the Designated Product. Accordingly, in no event will Schwarz
Pharma permit the Designated Product to be certified for sale outside the United
States on any other basis, unless TIMERx Technologies has consented thereto in
writing after detailed consultation with Schwarz Pharma.
1.22 "TERRITORY" shall, subject to Section 3.3, mean Canada, Mexico,
the United States, and the territories and possessions thereof.
1.23 "THERAPEUTICALLY EQUIVALENT" shall mean that a drug of a given
dosage strength is rated AB bioequivalent to the drug, in the same dosage
strength, currently sold in the United States under the brand name "Covera-HS".
1.24 "TIMERx TECHNOLOGIES PATENTS" shall mean:
1.24.1 those United States patents and foreign equivalents in the
Territory and United States and foreign patent applications in the Territory
listed in Exhibit and all divisions, continuations, reissues, or extensions
thereof, any periods of marketing exclusivity relating thereto, and any letters
patent that issue thereon; and
1.24.2 TIMERx Technologies' rights under United States and foreign
patents in the Territory, if any, obtained and in force during the License Term
covering any of TIMERx Technologies' improvements, modifications, alterations,
or enhancements to any of the inventions covered by the TIMERx Technologies
Patents that are developed for or are otherwise related to or useful with the
Designated Product.
1.25 "TIMERx PRODUCTION TECHNOLOGY" shall mean TIMERx Technologies'
rights under the TIMERx Technologies Patents and any and all other patents,
patent applications, and other technology belonging to TIMERx Technologies or
which TIMERx Technologies has the right to practice and to sublicense from time
to time during the term of this Agreement that directly relate to, are desirable
for, or are necessary for the production of, Formulated TIMERx for use in the
Designated Product.
6
<PAGE> 7
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
1.26 "TIMERX TECHNOLOGIES TEST AND REGULATORY DATA" shall mean any
and all test data, test designs and protocols, clinical studies and results
thereof, government licenses and applications therefor, government
certifications and findings, and related materials, information and rights
(including without limitation information regarding bioavailability and
bioequivalence, and any adverse drug reactions), developed, commissioned or
otherwise obtained by TIMERx Technologies or any of its Affiliates during the
term of this Agreement relating to TIMERx, TIMERx Technologies Patents, and/or
TIMERx Production Technology and that are developed for or are otherwise related
to or useful with the Designated Product; together with all intellectual
property and other rights and interests of TIMERx Technologies and its
Affiliates thereto and therein in the Territory.
1.27 "UNIT PRICE" shall mean the price for Formulated TIMERx as
stated in Exhibit hereto, ************************* by TIMERx Technologies to
reflect changes in the ********************************************************
*************************.
7
<PAGE> 8
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
2. DEVELOPMENT PERIOD.
2.1 In consideration of TIMERx Technologies' entering into this
Agreement, Schwarz Pharma shall pay TIMERx Technologies upon the Effective Date
a nonrefundable initial fee of ***********.
2.2 During the Development Period, TIMERx Technologies will exert
its continuing best efforts to conduct in vitro Dissolution Profile Studies in
accordance with its normal practices of a TIMERx formulation designed to be
Therapeutically Equivalent to Covera-HS in each of the dosage strengths. TIMERx
Technologies will *************************************************************
************************. Regardless of the outcome or results of such study,
Schwarz Pharma agrees to pay TIMERx Technologies a fee therefor equal to
*******, payable in four equal monthly installments of ******* each, the first
such installment to be due and payable thirty days after the Effective Date.
2.3 Following successful completion of the Dissolution Profiles
Studies, Schwarz Pharma will exert its continuing best efforts to perform the
Pilot Biostudies by engaging the laboratory stated in Exhibit to conduct the
same in accordance with that Exhibit and with a study design and budget mutually
agreed by Schwarz Pharma and TIMERx Technologies. Schwarz Pharma will pay all
costs of the initial Pilot Biostudy with respect to one or both dosage
strengths, as needed, **********************************************************
********************************************************************************
************************. The initial Pilot Biostudy will be completed within
four months of such agreement to proceed. If the initial Pilot Biostudy requires
further optimization of the TIMERx formulation, Schwarz Pharma agrees to pay
similarly all the costs for an additional biostudy to develop a formulation of
TIMERx Therapeutically Equivalent to each desired dosage strength of Covera-HS.
********************************************************************************
********************************************************************************
********************************************************************************
************************.
2.4 Within thirty days following the completion of a successful
Pilot Biostudy (i.e., a formulation of TIMERx is indicated within the limits of
such study to be Therapeutically Equivalent to either of the desired dosage
strengths of Covera- HS), Schwarz Pharma shall pay TIMERx Technologies a fee
determined as set forth in the Milestone Fee Schedule, ************************
*******************************************************************************
************************ ********. Within twelve months of successful completion
of such Pilot Biostudies, Schwarz Pharma exert its continuing best effort to
perform and complete at its expense *********************************** . TIMERx
Technologies will cooperate in such
8
<PAGE> 9
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
effort. Upon successful completion of a Pivotal Biostudy through demonstration
of AB rated bioequivalence to FDA standards, Schwarz Pharma will pay TIMERx
Technologies a fee determined as set forth in the Milestone Fee Schedule,
*******************************************************************************
************************************************************.
2.5 Each party's Project Contact(s) will provide written reports to
the other party's Project Contact(s) at least quarterly (and more often upon
reasonable request of the other party) throughout the Development Period,
stating in detail all efforts made and in process, and all significant progress
achieved and difficulties encountered in the reporting party's portion of the
development effort since the last such report. Each of the Project Contacts will
also be available throughout the Development Period to answer any reasonable
questions from the other party's Project Contacts, as appropriate.
2.6 Each party will, promptly and throughout the Development Period,
provide to the other all necessary information in or coming into its possession
or reasonably available to it to support the goals of the Development Period.
Notwithstanding anything else to the contrary contained herein, nothing shall
require either party to disclose confidential information for which such party
has an obligation of confidentiality to a third party. Each party understands
and agrees that the other does not warrant or commit that the Designated Product
will be successfully developed, and neither party shall have any liability or
responsibility to the other or to third parties for any such failure of the
development process hereunder, except wherein such failure occurs as a result of
a party's intentional misconduct, negligence, or breach of its duties or
obligations under this Agreement.
2.7 Except as provided otherwise in the cost reimbursement
provisions of Section 2.3, Schwarz Pharma will supply to TIMERx Technologies,
without charge, all Verapamil and Covera-HS (in both dosage strengths)
reasonably required to support the ********************************************
***************** for such effort, and each party shall otherwise bear its own
expenses for all activities during the Development Period.
2.8 As the term is used in this Section 2 and in Section3 , the
exertion of a party's best efforts will mean that (i) such party will exert on a
continuing basis such reasonable efforts as would be normal for sponsors or
applicants for regulatory approval of drugs under ANDAs generally, and (ii) this
project will receive a priority at least as high as any of such party's other
generic drug development efforts (if such a priority would lead to the exertion
of greater efforts than those described in clause (i).
2.9 Either party may terminate this Agreement before completion of
the Development Period by delivery of 30 days' written notice to the other, if,
due to
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
unfavorable or inconclusive results to that time, no further development efforts
are likely to lead to the successful development of the Designated Product. In
addition, Schwarz Pharma may terminate this Agreement prior to the completion of
the Development Period by delivery of 30 days' written notice to TIMERx
Technologies if at any time it determines (and reasonably demonstrates to TIMERx
Technologies) that, due to changed circumstances following the date this
Agreement is signed, the potential commercial viability of the Designated
Product will not justify the devotion of the best efforts of Schwarz Pharma
called for during the remainder of the Development Period or during the
Certification Period. No such termination under this section will lessen any
duty of Schwarz Pharma to make any of the payments called for hereunder, which
have accrued prior to the effective date of such termination.
3. CERTIFICATION PERIOD.
3.1 During the Certification Period with respect to the United
States, Schwarz Pharma will exert its continuing best efforts, at its expense,
to prepare and file an ANDA or ANDAs for the Designated Products with the FDA
and to prosecute the same successfully to the granting of an FDA license to
market the Designated Product in both of the dosage strengths. TIMERx
Technologies will, promptly and throughout the Certification Period, provide to
Schwarz Pharma all necessary information in or coming into TIMERx Technologies'
possession or reasonably available to it for such purpose. Also, during the
Certification Period, *********************************************************
************************.
3.2 Schwarz Pharma shall exert its continuing best efforts to
conduct or arrange for, at Schwarz Pharma's expense, all further testing and
studies during the Certification Period, including as to efficacy,
bioavailability, bioequivalence, and safety and toxicology, in connection with
the development, licensing, manufacture and marketing of the Designated Product,
and for compliance with all requirements imposed by the government of the United
States with respect to the Designated Products, and, if there is a Certification
Period for Canada and/or Mexico pursuant to Section 3.3, also as imposed by the
government of such nation(s). TIMERx Technologies will, promptly and throughout
the Certification Period, provide to Schwarz Pharma all necessary information in
or coming into TIMERx Technologies' possession or reasonably available to it for
such purpose.
3.3 If, at any time or times during the License Period, TIMERx
Technologies reasonably demonstrates to Schwarz Pharma that
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ASTERISKS DENOTE SUCH OMISSIONS.
(i) Covera-HS or an AB bioequivalent to it has been approved for
marketing in Canada or Mexico, or such approval has been applied for and is
reasonably likely to be granted; and
(ii) TIMERx Technologies or a third party is interested in good faith
in undertaking to market the Designated Product in such nation pursuant to the
equivalent of an ANDA in such nation,
then TIMERx Technologies shall afford Schwarz Pharma a period of 60 days in
which to agree that a Certification Period with respect to such nation, and
governed by this Section 3, shall commence hereunder, during which Schwarz
Pharma will exert its continuing best efforts, at its expense, to prepare and
file such ANDA-equivalent applications for the Designated Products with the
regulatory authorities in such nation, and to prosecute the same successfully to
the granting of marketing approvals from such authorities for the Designated
Product in both of the dosage strengths. It is understood that Schwarz Pharma
may meet such obligations with respect to such nation through the efforts of its
sublicensee, which may be TIMERx or the third party (if any) identified by
TIMERx Technologies and referenced in clause (ii) above, to whom Schwarz Pharma
may sublicense its rights as set forth in this Agreement. (If TIMERx
Technologies is the sublicensee, the same terms and conditions of this Agreement
shall apply to the sublicense.) If Schwarz Pharma fails to agree in writing
within such period to prepare, file and prosecute an ANDA equivalent, either
directly or through sublicensing as described herein, such nation and its
territories and possessions shall thereupon be removed from the Territory.
3.4 Schwarz Pharma's Project Contacts will provide written reports
to TIMERx Technologies' Project Contacts, as appropriate, at least quarterly
(and more often upon reasonable request of the other party) throughout the
Certification Period, stating in detail all efforts made and in process, and all
significant progress achieved and difficulties encountered in the certification
effort since the last such report. Schwarz Pharma's Project Contacts will also
be available throughout the Certification Period to answer any reasonable
questions from TIMERx Technologies' Project Contacts, as appropriate.
3.5 During the Certification Period, Schwarz Pharma shall provide at
its ****************************************************************************
*********** reasonably required to support the testing and certification effort,
and ***************************************************************************
************************.
3.6 If TIMERx Technologies personnel travel outside the Patterson,
New York area during the Certification Period at the request of Schwarz Pharma,
Schwarz Pharma shall bear all of the reasonable travel, lodging and meal
expenses for such
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ASTERISKS DENOTE SUCH OMISSIONS.
personnel. Otherwise, each party shall bear its own expenses for all activities
during the Certification Period.
3.7 In consideration of TIMERx Technologies' entering into this
Agreement, Schwarz Pharma agrees to pay TIMERx Technologies the following
non-refundable fees:
3.7.1 a milestone fee payable within ********************************
*******************************************************************************
************************; and
3.7.2 a milestone fee payable within
*******************************************************************************
************************.
3.8 Either party may terminate this Agreement before completion of
the Certification Period by delivery of 30 days' written notice to the other if,
due to unfavorable action by the FDA, the ANDA is not likely (regardless of any
further steps or submissions that could be made) to be approved by the FDA. In
addition, Schwarz Pharma may terminate this Agreement prior to the completion of
the Certification Period by delivery of 30 days' written notice to TIMERx
Technologies if at any time it determines (and reasonably demonstrates to TIMERx
Technologies) that, due to changed circumstances following the date this
Agreement is signed, the potential commercial viability of the Designated
Product will not justify the devotion of the best efforts of Schwarz Pharma
called for during the remainder of the Certification Period or during the
Marketing Period. No such termination under this section will lessen any duty of
Schwarz Pharma to make any of the payments called for hereunder, which have
accrued prior to the effective date of such termination.
4. MARKETING PERIOD.
4.1 Subject to the granting of all necessary governmental approvals
or concurrences to sell the Designated Products, Schwarz Pharma hereby agrees,
during the Marketing Period, to use its continuing best efforts to market,
promote and sell the Designated Products throughout the United States following
the U.S. Approval Date, and in Canada and/or Mexico, following the Approval
Date, if any, for that nation(s). As the term is used in this Section 4, the
exertion of Schwarz Pharma's best efforts will mean that Schwarz Pharma will
devote to such marketing, promotion and sales of the Designated Products
resources and priorities at least as substantial and high as any like-kind
resources and priorities devoted by Schwarz Pharma or any of its Affiliates to
the marketing, promotion or sale of any other generic drug of substantially the
same potential in the same nation of the Territory, measured in terms of sales
and profitability potentials.
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
4.2 In consideration of TIMERx Technologies' entering into this
Agreement, Schwarz Pharma agrees to pay TIMERx Technologies a non-refundable
milestone fee payable *********************************************************
******************************************************in the amount determined
as set forth in the Milestone Fee Schedule.
4.3 Schwarz Pharma hereby agrees to pay to TIMERx Technologies
Royalties equal to the percentages of all Net Sales during the License Term, as
determined under Exhibit ; provided,*******************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
************************.
4.4 All Royalties and other amounts payable pursuant to this
Agreement shall be due quarterly *************************** of each calendar
quarter for Net Sales in such calendar quarter. Each such payment shall be
accompanied by a statement of Net Sales for the quarter and the calculation of
Royalties payable hereunder. All Royalties and all other amounts payable under
this Agreement will bear interest at the rate of 1 1/2% per month or the maximum
legal rate, whichever is less, from the date due through the date of payment.
Schwarz Pharma shall keep and shall cause its Affiliates and its and their
sublicensees to keep complete, true and accurate records for the purpose of
showing the derivation of all Royalties payable to TIMERx Technologies under
this Agreement. TIMERx Technologies or its representatives shall have the right
to inspect, copy, and audit such records at any time during reasonable business
hours upon notice to Schwarz Pharma or any of its Affiliates or sublicensees,
respectively. Information gathered during such an audit shall be held in
confidence by TIMERx Technologies and its Affiliates, except to the extent any
of the exceptions stated in Sections through apply thereto. Any such audit shall
be at the expense of TIMERx Technologies, unless the audit reveals that, with
respect to the period under audit, less than 95% of the Royalties due to TIMERx
Technologies hereunder have been paid, in which event Schwarz Pharma shall pay
or reimburse TIMERx Technologies for the reasonable expenses of such audit, in
addition to TIMERx Technologies' other remedies for such underpayment.
4.5 All monies due hereunder shall be paid in United States Dollars
to TIMERx Technologies in Patterson, New York, USA. The rate of exchange to be
used shall be the average commercial rate of exchange for the 30 days preceding
the date of payment for the conversion of local currency to United States
Dollars as published by The Wall Street Journal (or if it ceases to be
published, a comparable publication to be agreed upon by the parties) or, for
those countries for which such average exchange rate is not published by The
Wall Street Journal, the exchange rate fixed on the fifth day prior to the date
of payment as promulgated by the appropriate United States governmental agency
as mutually agreed upon by the parties.
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
5. SUPPLY OF FORMULATED TIMERx.
5.1 It is understood and agreed that supply of Formulated TIMERx by
TIMERx Technologies (or otherwise as provided in Section 5.13) in accordance
with the Specifications is desired by both parties for the technically
satisfactory production, regulatory approval, and exploitation of the Designated
Product. Accordingly, except as provided in Section 5.13, and subject to the
other provisions hereof, TIMERx Technologies will supply Schwarz Pharma and its
Affiliates and sublicensees with sufficient quantities of Formulated TIMERx
produced in accordance with the Specifications in compliance with GMP and all
applicable laws and regulations, to meet their reasonable requirements for
development, testing and manufacturing of the Designated Product during the
Certification Period and the Marketing Period, and Schwarz Pharma shall purchase
all of its and its Affiliates' and sublicensees' requirements for TIMERx from
TIMERx Technologies during such period.
5.2 The price for all Formulated TIMERx sold hereunder shall equal
********************************************************************************
********************************************************************************
********************************************************************************
************************ (subject to ****** adjustment by TIMERx Technologies to
reflect changes in the Pharmaceutical Producers' Index, or an equivalent index,
********************************************************************************
********************************************************************************
its Affiliates and its and their sublicensees. Schwarz Pharma shall keep and
shall cause its Affiliates and its and their sublicensees to keep complete, true
and accurate records of the number of such Solid-Dosage Units produced. TIMERx
Technologies or its representatives shall have the right to inspect, copy, and
audit such records, and otherwise to enter upon the premises of Schwarz Pharma
or its Affiliates or such sublicensees, at any time during reasonable business
hours upon notice, for purposes of verifying the number of Solid-Dosage Units
produced. Information gathered during such an audit shall be held in confidence
by TIMERx Technologies and its Affiliates, except to the extent any of the
exceptions stated in Sections through apply thereto. Any such audit shall be at
the expense of TIMERx Technologies, unless the audit reveals that, with respect
to the period under audit, less than 95% of the aggregate price due to TIMERx
Technologies hereunder was paid, in which event Schwarz Pharma shall pay or
reimburse TIMERx Technologies for the reasonable expenses of such audit, in
addition to TIMERx Technologies' other remedies for such underpayment.
5.3 All sales of Formulated TIMERx shall be **********************
and Schwarz Pharma shall bear all transportation, insurance, taxes, duties, and
other costs and risks of loss, spoilage and damage associated with the shipping
and delivery of Formulated TIMERx to Schwarz Pharma or its Affiliates or
sublicensees.
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5.4 TIMERx Technologies shall perform routine quality control tests
with respect to all Formulated TIMERx as required by the FDA, or otherwise as
TIMERx Technologies deems necessary in accordance with its applicable policies.
TIMERx Technologies will also bear the expenses and fees for filing the Drug
Master File for TIMERx with the FDA. No other or special tests by TIMERx
Technologies with respect to the raw materials or Formulated TIMERx will be
required, unless and to the extent that Schwarz Pharma establishes that the same
are required in order to obtain or maintain a governmental license to market the
Designated Product in the Territory. In any event, the cost of providing any
such other or special tests shall be separately reimbursed to TIMERx
Technologies by Schwarz Pharma. TIMERx Technologies shall promptly, upon
completion of each lot or batch of Formulated TIMERx, deliver a copy of the
record of such test performed on said lot or batch. Schwarz Pharma will perform
quality control tests on Formulated TIMERx immediately on receipt at its plant
and advise TIMERx Technologies within thirty (30) days of any deviations from
Specifications.
5.5 If Schwarz Pharma considers any such shipment not to conform to
the applicable Specifications, Schwarz Pharma shall notify TIMERx Technologies
immediately and provide TIMERx Technologies with the relevant analysis. TIMERx
TECHNOLOGIES' SOLE OBLIGATION AND SCHWARZ PHARMA'S EXCLUSIVE REMEDY FOR ANY SUCH
NONCONFORMITY SHALL BE AS FOLLOWS:
i) TIMERx Technologies shall at its own expense accept return of
any shipment not accepted, or else reimburse Schwarz Pharma for the cost of
disposal or destruction; and
iii) TIMERx Technologies shall use its best efforts to replace the
non-conforming shipment with conforming Formulated TIMERx.
5.6 While TIMERx Technologies is supplying Formulated TIMERx
hereunder to Schwarz Pharma, TIMERx Technologies shall, after receipt of
reasonable prior notice, give duly accredited representatives of Schwarz Pharma
access at all reasonable times during regular business hours to TIMERx
Technologies' or its Affiliate's plant in which the Formulated TIMERx is being
produced, to ensure production practices created Formulated TIMERx conforming to
Specifications.
5.7 TIMERx Technologies will exert its best efforts to supply test
quantities of Formulated TIMERx during the Certification Period within 90 days
following receipt of Schwarz Pharma's firm written order therefor.
5.8 As the term is used in this Section 5, the exertion of TIMERx
Technologies' best efforts will mean that it will devote to the production and
supply of Formulated TIMERx called for hereunder efforts that would be
reasonable and
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
normal for such supply arrangements, and if, greater, that it will devote
thereto resources and priorities at least as substantial and high as any
like-kind resources and priorities devoted by TIMERx Technologies to the
production or supply of TIMERx for any other drug or project, and also (if
additional) that TIMERx Technologies will attempt at all times to maintain an
inventory of approximately six months' production of Formulated TIMERx for
Schwarz Pharma and its Affiliates and sublicensees, in light of their recent
ordering history and reasonable projections.
5.9 Schwarz Pharma shall deliver to TIMERx Technologies a firm
written order stating its (and/or its Affiliates' and sublicensees')
requirements for Formulated TIMERx to be used for production of the Designated
Product for commercial use or sale no less than ******************************
******************************.
5.10 At least ****** before Schwarz Pharma and/or its Affiliates or
sublicensees begin production of the Designated Product for commercial use or
sale (and in any event not later than concurrently with the submission of the
first order for use in the production of Designated Product intended for
commercial sale -- herein called the "Initial Order"), Schwarz Pharma shall
deliver to TIMERx Technologies a written, non-binding estimate of all
requirements of Formulated TIMERx therefor during the following ***********.
Schwarz Pharma will deliver to TIMERx Technologies updates to such estimates on
or before the first day of each January, April, July and October thereafter,
which updates may revise estimates previously submitted, and will add estimates
for additional months so that each such estimate covers the ********** period
following the end of the firm-order period (that is, the **************** after
the month in which such estimates are made).
5.11 The Initial Order will be firm and will not be cancelled or
deferred by Schwarz Pharma. No other order for Formulated TIMERx hereunder may
be cancelled or deferred by Schwarz Pharma except by written notice delivered to
TIMERx Technologies at least 90 days prior to the scheduled delivery date. No
orders may be cancelled or deferred (even with such 90-day notice) without
TIMERx Technologies' approval if such cancellation or deferral would reduce
Schwarz Pharma's purchases for the applicable ****** to less than
********************* of the quantities ordered under Section 5.9 for that
******* . TIMERx Technologies will exert its best efforts to supply Schwarz
Pharma with all amounts of Formulated TIMERx requested by Schwarz Pharma, but
TIMERx Technologies shall have no obligation to supply Schwarz Pharma with
quantities of Formulated TIMERx during any ****** in excess of ******* of the
quantity estimated in Schwarz Pharma's estimate for that ****** which estimate
was given to TIMERx Technologies ******* prior to the end of such ******
pursuant to Section .
5.12 In case TIMERx Technologies cannot supply Schwarz Pharma the
requested quantities of the Formulated TIMERx, the shipments may be made by an
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
alternate supplier designated by TIMERx Technologies with Schwarz Pharma's
consent, which consent shall not be unreasonably withheld. ********************
*******************************************************************************
******************************************* and notify Schwarz Pharma thereof
within 90 days from the filing of the first ANDA. If Schwarz Pharma has any
objections to such alternate supplier(s), it shall so notify TIMERx Technologies
within fifteen days following TIMERx Technologies' notice of such qualification,
or else Schwarz Pharma will be deemed to have consented to such qualification
and the designation of such supplier(s). Such shipment by the alternate supplier
shall be made under the same agreed terms and conditions as those set forth
herein, except that an additional 90 days shall be added to the order lead time
stated in any then-outstanding order for Formulated TIMERx hereunder to reflect
the transition time required to shift to such alternate supplier.
Notwithstanding anything to the contrary set forth herein, TIMERx Technologies
will be responsible for enforcing all relevant terms and conditions set forth
herein against such alternate supplier and remain liable to Schwarz Pharma for
any breach of such terms and conditions by such supplier.
5.13 If for any reason TIMERx Technologies or an alternate supplier,
as described in Section , fails to supply Schwarz Pharma with its and its
Affiliates' and sublicensees' requirements of Formulated TIMERx during the
Certification Period or the Marketing Period, TIMERx Technologies shall, AS
SCHWARZ PHARMA'S SOLE AND EXCLUSIVE REMEDY FOR ANY FAILURE TO SUPPLY FORMULATED
TIMERx, grant Schwarz Pharma a nonexclusive license to manufacture Formulated
TIMERx under the TIMERx Production Technology and make knowledgeable personnel
reasonably available, at TIMERx Technologies' expense, to consult with Schwarz
Pharma, all to the extent necessary to enable Schwarz Pharma to produce
Formulated TIMERx that would otherwise have been supplied by TIMERx Technologies
hereunder for Schwarz Pharma and its Affiliates and sublicensees in connection
with the production of the Designated Product pursuant to this Agreement.
5.13.1 **********************
5.13.2 Schwarz Pharma shall maintain TIMERx Production Technology
delivered to Schwarz Pharma pursuant to this Section, whether orally or in
writing, in strictest confidence and shall use such information and technology
only for the purpose of producing Formulated TIMERx for its own use and the use
of its Affiliates and sublicensees in connection with this Agreement.
5.13.3 Schwarz Pharma acknowledges that, in doing the foregoing, TIMERx
Technologies will not be providing a "turnkey" operation. Rather, TIMERx
Technologies will only be required to make reasonably available to Schwarz
Pharma the best standard of knowledge and information then available to TIMERx
Technologies and directly used in its or its Affiliate's manufacture of
Formulated
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<PAGE> 18
TIMERx. TIMERx Technologies will not be required to prepare, provide or obtain
any information not then in its possession, nor to adapt any of the knowledge or
information provided to the particular plant or manufacturing location of
Schwarz Pharma, including without limitation any local legal, licensing, or
environmental considerations.
5.13..4 Neither TIMERx Technologies nor its Affiliates or licensees will
be responsible for any failure of Schwarz Pharma or its personnel to understand
or properly to implement such knowledge and information or for any materials
made by any party other than TIMERx Technologies or such respective Affiliate or
licensee using such knowledge and information.
5.13.5 If TIMERx Technologies' non-delivery of Formulated TIMERx
resulted in whole or in part from a temporary inability to produce and deliver
the same, TIMERx Technologies may, at its option and on at least 90 days' prior
written notice to Schwarz Pharma, terminate the license to produce Formulated
TIMERx hereunder once TIMERx Technologies has demonstrated to the reasonable
satisfaction of Schwarz Pharma that it is again able and willing to reliably
supply Formulated TIMERx hereunder. If and to the extent that Schwarz Pharma
has, prior to the receipt of such notice from TIMERx Technologies, committed
itself to produce, or to purchase from a permitted sublicensee, any Formulated
TIMERx deliverable during the nine months following such notice from TIMERx
Technologies, Schwarz Pharma may continue to produce or to purchase from such
sublicensee such Formulated TIMERx during such period, but not thereafter.
5.14 Each party shall promptly notify the other of any fact,
circumstance, condition or knowledge dealing with TIMERx, Formulated TIMERx, or
the Designated Product of which the Party becomes aware that bears upon the
safety or efficacy of TIMERx, Formulated TIMERx, or the Designated Product. Each
party shall immediately notify the other of any inspection or audit relating to
TIMERx, Formulated TIMERx, or the Designated Product by any governmental
regulatory authority in the Territory. If a representative of the governmental
authority takes samples in connection with such audit or inspection, the parties
shall immediately provide each other, as appropriate, samples from the same
batch. The party in receipt of such notice will provide the other party within
72 hours, with copies of all relevant documents, including FDA Forms 482 and 483
(as applicable), warning letters and other correspondence and notifications as
such other party may reasonably request. TIMERx Technologies and Schwarz Pharma
agree to cooperate with each other during any inspection, investigation or other
inquiry by the FDA or other governmental entity, including providing information
and/or documentation, as requested by the FDA, or other governmental entity. To
the extent permissible, TIMERx Technologies and Schwarz Pharma also agree to
discuss any responses to observations or notifications received and to give the
other party an opportunity to comment on any proposed response before it is
made. In the event of disagreement
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concerning the content or form of such response, Schwarz Pharma shall be
responsible for deciding the appropriate form and content of any response with
respect to any of its cited activities and TIMERx Technologies shall be
responsible for deciding the appropriate form and content of any response with
respect to any of its cited activities. Each party shall inform the other of all
comments and conclusions received from the governmental authority.
6. OWNERSHIP AND LICENSES.
6.1 Except as otherwise explicitly licensed or transferred as
provided herein, each party will, as between it and the other party hereto,
retain ownership of any and all inventions, copyrights, trade secrets, patent
rights and other technology and rights to the extent conceived or developed by
its personnel or contractors (other than the other party hereto). Neither party
makes any grant of rights by implication. TIMERx Technologies will retain
ownership in (but Schwarz Pharma shall have the right to use within the scope of
its licenses) all Dissolution Profile Studies and Pilot Biostudies and Schwarz
Pharma will retain ownership of its Pivotal Biostudies and its ANDA. Except as
otherwise provided herein, each party shall be responsible, as it shall
determine, for the filing and prosecution of any and all patent applications
with respect, in whole or in part, to its own intellectual property and for the
maintenance of any available patent protection with respect thereto; provided
however, that neither party commits that any such patent protection will be
available or continuous hereunder.
6.2 TIMERx Technologies hereby grants to Schwarz Pharma an exclusive
license under the TIMERx Technologies Patents and TIMERx Technologies'
Confidential Technology disclosed to Schwarz Pharma hereunder to make, have
made, use and sell the Designated Product in the Territory during the License
Term. Such license does not extend to the making of TIMERx or Formulated TIMERx,
but does cover the incorporation of the same into the Designated Product.
Schwarz Pharma shall have the right to grant sublicenses of its rights hereunder
to any Affiliate(s) of Schwarz Pharma, but shall otherwise have no right to
grant sublicenses hereunder without the prior written consent of TIMERx
Technologies, which consent shall not be unreasonably withheld. TIMERx
Technologies will, throughout the License Term, promptly notify Schwarz Pharma
of all TIMERx Technologies Patents referred to in Subsection and provide Schwarz
Pharma with access to all of the same, solely for use within the scope of the
license stated in this section.
6.3 Schwarz Pharma acknowledges that TIMERx Technologies, for itself
and for others, applies, and will seek to apply, TIMERx to products (which may
include, without limitation, the Designated Product and other controlled-release
products containing Verapamil) for manufacture and sale outside the Territory,
or to products within the Territory (but in that case, during the License Term,
only for products
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
other than the Designated Product or another controlled-release product
containing Verapamil). No provision hereof, and no exclusivity hereunder, shall
prevent TIMERx Technologies from so applying TIMERx or Formulated TIMERx, so
long as the end product is not the Designated Product (or another
controlled-release product containing Verapamil) for manufacture or sale in the
Territory, it being understood that the Diltiazem Agreement will continue to
govern on this point as to the products covered by it.
6.4 Schwarz Pharma hereby grants to TIMERx Technologies a
nonexclusive, paid-up, worldwide license, with right to sublicense, under any
and all patents, patent applications, trade secrets, copyrights, and other
intellectual property rights of any sort owned or controlled by Schwarz Pharma
or its Affiliates, to make, have made, use and sell Formulated TIMERx during the
License Term for supply to Schwarz Pharma or its Affiliates or sublicensees, if
and to the extent such license is necessary for TIMERx Technologies to do so as
agreed hereunder.
6.5 Subject to and conditional upon the failure or continuing
unwillingness of TIMERx Technologies to meet Schwarz Pharma's and its
Affiliates' and sublicensees' requirements as provided in Section , TIMERx
Technologies grants to Schwarz Pharma a nonexclusive license under the TIMERx
Production Technology to make and have made Formulated TIMERx in the Territory
solely for use in the Designated Product for sale in the Territory during the
License Term, subject to Section . Schwarz Pharma shall have no right to grant
sublicenses of its rights hereunder (whether to Affiliate(s) or otherwise)
without the prior written consent of TIMERx Technologies, which consent shall
not be unreasonably withheld.
6.6 Schwarz Pharma hereby grants to TIMERx Technologies a
nonexclusive, paid-up, worldwide license, with right to sublicense, under any
and all Schwarz Pharma Improvements to make, have made, use and sell any
products or services using or based upon TIMERx or related technology. ******
********************************************************************************
******* Agreement pursuant to Section 2.9, 3.8 , or 10.2, this license to TIMERx
Technologies ******************************************************************
************************************************************** of the Designated
Product or any services involving the Designated Product. Schwarz Pharma will,
throughout the License Term, promptly notify TIMERx Technologies of all Schwarz
Pharma Improvements and provide TIMERx Technologies with access to all of the
same, solely for use within the scope of the license stated in this section.
6.7 Schwarz Pharma hereby grants TIMERx Technologies a nonexclusive
license, with right to sublicense, under all rights of Schwarz Pharma and its
Affiliates and sublicensees in and to the Schwarz Pharma Test and Regulatory
Data to use the same for purposes of complying with governmental requirements of
any country, other than with respect to the Designated Product or another
controlled-release
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
product containing Verapamil for manufacturing, marketing or use in the
Territory, it being understood that the Diltiazem Agreement will continue to
govern on this point as to the products covered by it. Schwarz Pharma hereby
consents to TIMERx Technologies' and its sublicensees' cross-referencing, in any
ANDA or NDA filings made by them within the scope of such license, any ANDA or
NDA filing made or FDA master file created by Schwarz Pharma or its Affiliates
relating to or containing any of the Schwarz Pharma Test and Regulatory Data.
Except as provided in Section 10.6, the license under this Section ************
*******************************************************************************
***** under such license,************************************************** the
only portions of the Schwarz Pharma Test and Regulatory Data so used or
referenced could have been properly accessed and used by third parties not
operating under such a license. It is also understood that ********************
**************************************** will not prevent the use of the Schwarz
Pharma Test and Regulatory Data as licensed hereunder, as such consideration may
be later determined either by agreement of the parties or pursuant to Section .
The license under this section shall survive any termination or expiration of
the term of this Agreement, except a termination under Section due to an uncured
breach by TIMERx Technologies. Schwarz Pharma will, throughout the License Term
and solely for use within the scope of the license stated in this section,
provide to TIMERx Technologies on request access to all of the Schwarz Pharma
Test and Regulatory Data in or coming into Schwarz Pharma's possession or
otherwise reasonably available to it.
6.8 TIMERx Technologies hereby grants Schwarz Pharma a nonexclusive,
paid-up license, with right to sublicense, under all rights of TIMERx
Technologies and its Affiliates in and to the TIMERx Technologies Test and
Regulatory Data to use the same for purposes of complying with governmental
requirements, but solely with respect to the Designated Product for marketing or
use in the Territory. TIMERx Technologies hereby consents to Schwarz Pharma's
and its sublicensees' cross- referencing, in any ANDA filings made by them
within the scope of such license, any NDA filing made or FDA master file created
by TIMERx Technologies or its Affiliates relating to or containing any of the
TIMERx Technologies Test and Regulatory Data. The license and rights under this
section shall survive any termination or expiration of the term of this
Agreement, except a termination under Section due to an uncured breach by
Schwarz Pharma. TIMERx Technologies will, throughout the License Term and solely
for use within the scope of the license stated in this section, provide to
Schwarz Pharma on request access to all of the TIMERx Technologies Test and
Regulatory Data in or coming into TIMERx Technologies' possession or otherwise
reasonably available to it.
6.9 Each party agrees to mark and to have marked by its sublicensees
every product manufactured, used or sold by it or its sublicensees in accordance
with the
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<PAGE> 22
laws of the United States or other applicable nation relating to the marking of
patented articles with notices of patent.
7. CONFIDENTIALITY AND NON-SOLICITATION.
7.1 In the course of performance under this Agreement, or during the
discussions leading thereto, a party may disclose, or may have disclosed, to the
other confidential information belonging to such party in writing, orally or by
demonstration or sample, which information is marked or stated in writing at or
within 30 days after its disclosure to be "confidential" or "trade secret"
information. All such confidential information of a party shall be maintained in
confidence by the other and will not be used by the other party for any purpose
except as authorized hereunder. Each party shall exercise, and shall cause its
Affiliates, sublicensees, and consultants to exercise, a reasonable degree of
care and at least the same degree of care as it uses to protect its own
confidential information of similar nature to preserve the confidentiality of
such information of the other party. Each party shall safeguard such information
against disclosure to third parties, including without limitation employees and
persons working or consulting for such party that do not have an established,
current need to know such information for purposes authorized under this
Agreement. This obligation of confidentiality does not apply to information and
material that:
7.7.1 were properly in the possession of the receiving party, without
any restriction on use or disclosure, prior to receipt from the other party;
7.1.2 are at the time of disclosure hereunder in the public domain by
public use, publication, or general knowledge;
7.1.3 become general or public knowledge through no fault of the
receiving party or its Affiliates following disclosure hereunder;
7.1.4 are properly obtained by the receiving party from a third party
not under a confidentiality obligation to the disclosing party hereto;
7.1.5 are independently developed by or on behalf of the receiving
party without the assistance of the confidential information of the other party;
7.1.6 consist merely of an idea or conception for the combination of
one or more active drug ingredients with a controlled-release agent such as
TIMERx; or
7.1.7 are required to be disclosed by order of any court or
governmental authority.
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<PAGE> 23
7.2 Neither party shall make any public announcement or other
publication regarding this Agreement (whether as to the existence or terms
hereof) or the development work or project hereunder or the results thereof
without the prior, written consent of the other party, which consent shall not
be unreasonably withheld; provided that the foregoing shall not prohibit any
disclosure which, in the opinion of counsel to the disclosing party, is required
by any applicable law or by any competent governmental authority. In no event
shall either party make any disclosure of any such results before a patent
application has been filed with respect thereto, except upon the prior written
approval of the other party.
7.3 Each of TIMERx Technologies and Schwarz Pharma agrees that
during the License Period, neither of them will directly or indirectly solicit
or encourage any employee or consultant of the other to leave or terminate such
employment or consultancy for any reason, including without limitation, becoming
employed or otherwise engaged in any capacity by such party (or any person or
entity associated with such party, whether or not an Affiliate), nor will it
assist others in doing so.
8. INFRINGEMENT.
8.1 TIMERx Technologies shall promptly inform Schwarz Pharma of any
suspected infringement of any of the TIMERx Technologies Patents or the
infringement or misappropriation of the TIMERx Production Technology by a third
party, to the extent such infringement involves the manufacture, use or sale of
the Designated Product in the Territory ("Covered Infringement"). Schwarz Pharma
shall promptly inform TIMERx Technologies of any suspected infringement of any
of the TIMERx Technologies Patents or infringement or misappropriation of the
TIMERx Production Technology of which Schwarz Pharma is aware, whether or not
the same involves a Covered Infringement.
8.2 If the suspected infringement or misappropriation does not
involve a Covered Infringement, TIMERx Technologies may take, or refrain from
taking, any action it chooses, with or without notice to Schwarz Pharma, and
Schwarz Pharma shall have no right to take any action with respect to such
suspected infringement or misappropriation, nor to any recoveries with respect
thereto. TIMERx Technologies will exert reasonable efforts to keep Schwarz
Pharma informed of actions TIMERx Technologies may take as described in the
preceding sentence to the extent the same bear on rights protected within the
Territory. If the suspected infringement or misappropriation involves a Covered
Infringement, TIMERx Technologies shall, within 120 days of the first notice
referred to in Section , inform Schwarz Pharma whether or not TIMERx
Technologies intends to institute suit against such third party with respect to
a Covered Infringement. Schwarz Pharma will not take any steps toward
instituting suit against any third party involving a Covered Infringement until
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<PAGE> 24
TIMERx Technologies has informed Schwarz Pharma of its intention pursuant to the
previous sentence.
8.3 If TIMERx Technologies notifies Schwarz Pharma that it intends
to institute suit against a third party with respect to a Covered Infringement,
and Schwarz Pharma does not agree to join in such suit as provided in Section ,
TIMERx Technologies may bring such suit on its own and shall in such event bear
all costs of, and shall exercise all control over, such suit. TIMERx
Technologies may, at its expense, bring such action in the name of Schwarz
Pharma and/or cause Schwarz Pharma to be joined in the suit as a plaintiff.
Recoveries, if any, whether by judgment, award, decree or settlement, shall
belong solely to TIMERx Technologies.
8.4 If TIMERx Technologies notifies Schwarz Pharma that it desires
to institute suit against such third party with respect to a Covered
Infringement, and Schwarz Pharma notifies TIMERx Technologies within 30 days
after receipt of such notice that Schwarz Pharma desires to institute suit
jointly, the suit shall be brought jointly in the names of both parties and all
costs thereof shall be borne equally. Recoveries, if any, whether by judgment,
award, decree or settlement, shall, after the reimbursement of each of TIMERx
Technologies and Schwarz Pharma for its share of the joint costs in such action,
be shared between TIMERx Technologies and Schwarz Pharma as the interests of the
parties were affected by the infringement.
8.5 If TIMERx Technologies notifies Schwarz Pharma that it does not
intend to institute suit against such third party with respect to a Covered
Infringement, Schwarz Pharma may institute suit on its own. Schwarz Pharma shall
bear all costs of, and shall exercise all control over, such suit. Recoveries,
if any, whether by judgment, award, decree or settlement, shall belong solely to
Schwarz Pharma; provided however that, after reimbursement of Schwarz Pharma for
its costs in such action, any portion of such net recoveries which constitutes
the equivalent of, or damages or payments in lieu of, a royalty measured by the
defendant's Net Sales, shall be shared between TIMERx Technologies and Schwarz
Pharma in accordance with Section as if they were Schwarz Pharma's Net Sales
(counting the infringing party's product as a Competing Generic Version).
8.6 Should either TIMERx Technologies or Schwarz Pharma commence a
suit under the provisions of this Section and thereafter elect to abandon the
same, it shall give timely notice to the other party, who may, if it so desires,
be joined as a plaintiff in the suit (or continue as such if it is already one)
and continue prosecution of such suit, provided, however, that the sharing of
expenses and any recovery of such suit shall be as agreed upon between TIMERx
Technologies and Schwarz Pharma.
9. REPRESENTATIONS, WARRANTIES AND INDEMNITIES.
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<PAGE> 25
9.1 Each party represents and warrants to the other that, to its
current knowledge, without undertaking any special investigation, it has the
full right and authority to enter into this Agreement and to grant the licenses
granted herein.
9.2 TIMERx Technologies represents and warrants that any Formulated
TIMERx supplied by it to Schwarz Pharma hereunder for use in the Designated
Product, at the point of delivery:
9.2.1 will conform to the Specifications in effect as of the order
date therefor; and
9.2.2 to TIMERx Technologies' current knowledge, without undertaking
any special investigation, will not infringe upon an article patent of any third
party. Without limiting the generality of this clause, TIMERx specifically
warrants that it will be able to formulate the Designated Product such that it
will not be infringing of that certain United States Patent No. 5,419,917,
issued May 30, 1995 and assigned to Andrx Pharmaceuticals, Inc. (the "Andrx
Patent").
OTHERWISE, TIMERx TECHNOLOGIES PROVIDES "AS-IS," AND MAKES NO REPRESENTATIONS OR
WARRANTIES AS TO, ANY TIMERx OR FORMULATED TIMERx SUPPLIED BY IT TO SCHWARZ
PHARMA FOR TESTING, DEVELOPMENT, OR ANY OTHER PURPOSES EXCEPT EXPLICITLY FOR USE
IN THE DESIGNATED PRODUCT FOR COMMERCIAL USE OR SALE.
9.3 Each party represents and warrants to the other that it has
obtained, and will at all times during the term of this Agreement hold and
comply with, all licenses, permits and authorizations necessary to perform this
Agreement and to test, manufacture, market, export, and import the Designated
Product or Formulated TIMERx, as now or hereafter required under any applicable
statutes, laws, ordinances, rules and regulations of the United States and any
applicable foreign, state, and local governments and governmental entities.
9.4 THE FOREGOING WARRANTIES ARE IN LIEU OF, AND THE PARTIES EACH
DISCLAIM, ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR ARISING BY LAW, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, AND NON-INFRINGEMENT. NOTHING IN THIS AGREEMENT SHALL BE
CONSTRUED AS A REPRESENTATION OR WARRANTY (i) BY TIMERx TECHNOLOGIES AS TO THE
PATENTABILITY, VALIDITY, OR SCOPE OF ANY TIMERX TECHNOLOGIES PATENTS, TIMERx
TECHNOLOGIES' CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, OR TIMERx
TECHNOLOGIES TEST AND REGULATORY DATA, NOR AS TO THE UTILITY, EFFICACY,
NONTOXICITY, SAFETY OR APPROPRIATENESS OF TIMERx OR THE DESIGNATED PRODUCT; OR
(ii) BY SCHWARZ PHARMA AS
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<PAGE> 26
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
TO THE PATENTABILITY, VALIDITY, OR SCOPE OF ANY SCHWARZ PHARMA IMPROVEMENTS OR
SCHWARZ PHARMA TEST AND REGULATORY DATA, NOR AS TO THE UTILITY, EFFICACY,
NONTOXICITY, SAFETY OR APPROPRIATENESS OF ANY PRODUCTS MADE THEREFROM.
9.5 TIMERx Technologies shall indemnify, defend and hold harmless
Schwarz Pharma and its Affiliates and sublicensees from any claim, action or
damages arising out of any alleged infringement by reason of the manufacture,
use or sale by Schwarz Pharma of the Designated Product to the extent such
infringement would apply as well to the manufacture, sale or distribution of
TIMERx alone or otherwise to the extent the same is covered by Section . If
Schwarz Pharma or its Affiliate or sublicensee, by reason of its manufacture,
sale or distribution of Designated Product, is accused of infringing the patent
of a third party, and such claim of infringement, as framed by the claimant,
would apply as well to the manufacture, sale or distribution of TIMERx alone or
otherwise to the extent the same is covered by Section , Schwarz Pharma shall
immediately so notify TIMERx Technologies and provide TIMERx Technologies all
available information, and the parties shall consult reasonably as to the proper
course of action. If TIMERx Technologies and Schwarz Pharma jointly determine
that such claim is likely to prevail, or if an arbitrator hereunder or a court
of competent jurisdiction so determines, Schwarz Pharma shall be entitled to
offset against any Royalties payable to TIMERx Technologies hereunder any third
party royalties for which Schwarz Pharma or its Affiliate or sublicensee becomes
liable.
9.6 TIMERx Technologies shall indemnify, defend and hold Schwarz
Pharma and its Affiliates and sublicensees harmless from any and all third-party
claims to the extent arising from, in connection with, based upon, by reason of,
or relating in any way to:
9.6.1 the formulation, development, supply, production, manufacture,
sale, delivery, distribution or use of TIMERx in the Designated Product;
9.6.2 TIMERx Technologies' *****************************************
************************ and the Specifications therefor hereunder, including
without limitation any infringement claims based on the Andrx Patent;
9.6.3 any failure of the Formulated TIMERx manufactured by TIMERx
Technologies or its alternate supplier (but not by Schwarz Pharma under Section
), as delivered to Schwarz Pharma hereunder for use in the Designated Product,
to conform to the Specifications; or
9.6.4 any failure of TIMERx Technologies to comply with its obligation
under Section to notify Schwarz Pharma of any information coming into TIMERx
Technologies' possession and *********************************************.
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<PAGE> 27
and not arising from any other aspect of the Designated Product or its
formulation, development, supply, production, manufacture, sale, delivery,
distribution or use, nor from any act or omission of Schwarz Pharma with respect
to the Formulated TIMERx following its delivery to Schwarz Pharma hereunder.
9.7 Schwarz Pharma shall indemnify, defend and hold TIMERx
Technologies harmless from any and all third-party claims to the extent arising
from, in connection with, based upon, by reason of, or relating in any way to,
the formulation, development, supply, production, manufacture, sale, delivery,
distribution or use of the Designated Product by Schwarz Pharma, its Affiliates
or sublicensees, except for any matters which are covered by TIMERx
Technologies' indemnities under Sections and .
9.8 Notwithstanding anything to the contrary set forth elsewhere
herein, neither Schwarz Pharma nor TIMERx Technologies shall be obligated to
indemnify the other party for claims or liabilities to the extent arising from
such other party's, or its Affiliates', sublicensees' or assigns', negligence,
intentional misconduct, or breach of its duties, obligations, warranties or
representations set forth herein.
9.9 Whenever indemnification is provided for a party under this
Agreement, such right of indemnification shall extend also to the indemnified
party's Affiliates, officers, directors, shareholders, successors, assigns,
agents, employees, and insurers to the extent the same become subject to such
claim in such capacity. The party seeking indemnification shall provide the
indemnifying party with written notice of any claim or action within ten (10)
days of its receipt thereof, and shall afford the indemnifying party the right
to control the defense and settlement of such claim or action. The party seeking
indemnification shall provide reasonable assistance to the indemnifying party in
the defense of such claim or action. If the defendants in any such action
include both Schwarz Pharma and TIMERx Technologies and either party concludes
that there may be legal defenses available to it which are different from,
additional to, or inconsistent with, those available to the other, that party
shall have the right to select separate counsel to participate in the defense of
such action on its behalf, and such party shall thereafter bear the cost and
expense of such separate defense. Should the indemnifying party determine not to
defend such claim or action, the other party shall have the right to maintain
the defense of such claim or action and the indemnifying party agrees to provide
reasonable assistance to it in the defense of such claim or action. Neither
party shall settle any such claim or action in a way that prejudices or
adversely impacts the other party to this Agreement without the prior approval
of such other party (which approval shall not be unreasonably withheld).
9.10 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS
AGREEMENT (OTHER THAN SECTION WITH RESPECT TO BREACHES OF CONFIDENTIALITY AND
NONSOLICITATION
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<PAGE> 28
AND SECTION WITH RESPECT TO INDEMNITIES FOR PATENT INFRINGEMENT AND SECTIONS AND
WITH RESPECT TO INDEMNITIES FOR HARM TO PERSONS OR TANGIBLE PROPERTY), NEITHER
PARTY SHALL UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY THIRD PARTY CLAIMS OR FOR
ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST
PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE PERFORMANCE OR
BREACH OF ANY OTHER PROVISION OF THIS AGREEMENT OR THE USE OR INABILITY TO USE
TIMERx, THE DESIGNATED PRODUCT, TIMERx TECHNOLOGIES PATENTS, TIMERx
TECHNOLOGIES' CONFIDENTIAL TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, TIMERx
TECHNOLOGIES TEST AND REGULATORY DATA, SCHWARZ PHARMA IMPROVEMENTS, OR SCHWARZ
PHARMA TEST AND REGULATORY DATA, OR ANY CLAIMS ARISING IN TORT, PERSONAL INJURY,
OR PRODUCT LIABILITY, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH DAMAGES.
10. TERM AND TERMINATION.
10.1 The term of this Agreement shall begin on the date set forth
above and shall, unless earlier terminated as provided herein, continue until
the end of the License Term.
10.2 Schwarz Pharma may at its option terminate this Agreement
following the U.S. Approval Date, upon at least 120 days' written notice to
TIMERx Technologies.
10.3 In the event that either party materially breaches any of the
terms, conditions or agreements contained in this Agreement to be kept, observed
or performed by it, then the other party may terminate this Agreement, at its
option and without prejudice to any of its other legal or equitable rights or
remedies, by giving the party who committed the breach (i) in the case of breach
of obligations other than the payment of money, 60 days' notice in writing,
unless the notified party within such 60-day period shall have cured the breach,
and (ii) in the case of breach of an obligation for the payment of money, 20
days' notice in writing, unless the notified party within such 20-day period
shall have cured the breach, including any required payment of interest on
previously unpaid amounts as set forth herein.
10.4 This Agreement will automatically terminate if Schwarz Pharma
files for protection under federal or state bankruptcy laws, becomes insolvent,
makes an assignment for the benefit of creditors, appoints or suffers
appointment of a receiver
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<PAGE> 29
or trustee over its property, files a petition under any bankruptcy or
insolvency act or has such petition filed against it.
10.5 Any sublicenses granted by Schwarz Pharma under this Agreement
shall provide for assignment to TIMERx Technologies of Schwarz Pharma's interest
therein upon termination of this Agreement, subject to TIMERx Technologies'
approval, which shall not be unreasonably withheld, but which, if properly
withheld, shall result in the termination of such sublicense.
10.6 Following any expiration or termination of the License Term, the
license to TIMERx Technologies under Section shall be thereafter extended to
include (in addition to its coverage as stated in such section) the use of
Schwarz Pharma Test and Regulatory Data for purposes of complying with
governmental requirements with respect to the Designated Product for
manufacturing, marketing or use in the Territory. While exercises of the rights
licensed under Section prior to the extension under this Section will continue
to bear a reasonable consideration as provided in Section , exercises of such
rights as so extended under this Section for purposes of complying with
governmental requirements with respect to the Designated Product or another
controlled-release product containing Verapamil for manufacturing, marketing or
use in the Territory will be fully paid-up and royalty free.
10.7 Schwarz Pharma's obligations regarding payment of Royalties
accrued as of the date of termination, TIMERx Technologies' rights under
Sections and (except if this Agreement is terminated due to an uncured breach on
the part of TIMERx Technologies), and Schwarz Pharma's rights under Section
(except if this Agreement is terminated due to an uncured breach on the part of
Schwarz Pharma), and the provisions of Sections , , and , hereof shall survive
any expiration or termination of this Agreement.
10.8 All rights and licenses granted under or pursuant to this
Agreement by TIMERx Technologies (as the "licensor") to Schwarz Pharma (as the
"licensee") or by Schwarz Pharma (as the "licensor") to TIMERx Technologies (as
the "licensee") are and shall otherwise be deemed to be, for purposes of Section
365(n) of the Bankruptcy Code, licenses of rights to "intellectual property" as
defined under Section 101(52) of the Bankruptcy Code. The parties agree that the
licensee of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code. The parties
further agree that, in the event of the commencement of a bankruptcy proceeding
by or against the licensor under the Bankruptcy Code, the licensee shall be
entitled to a complete duplicate of (or complete access to, as appropriate) any
such intellectual property and all embodiments of such intellectual property,
and the same, if not already in its possession, shall to the extent required for
the exercise of the licenses granted hereunder, be promptly delivered to the
licensee (i) upon any such commencement of a bankruptcy proceeding upon written
request therefor by the licensee, unless the
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<PAGE> 30
licensor elects to continue to perform all of its obligations under this
Agreement, or (ii) if not delivered under (i) above, upon the rejection of this
Agreement by or on behalf of the licensee upon written request therefor by the
licensee.
11. MISCELLANEOUS.
11.1 This Agreement incorporates the numbered Exhibits referenced
herein. This Agreement constitutes the entire agreement and supersedes all prior
agreements and understandings, both written and oral, between the parties hereto
with respect to the subject matter hereof, it being understood that the
Diltiazem Agreement is not superseded by or merged into this Agreement, but,
rather, shall continue in effect as to its subject matter and in accordance with
its terms.
11.2 This Agreement shall be binding upon and inure to the benefit of
the parties hereto and their successors and permitted assigns; provided,
however, that except as part of the transfer of all or substantially all assets
to a single buyer or pursuant to a merger or other corporate reorganization:
11.2.1 TIMERx Technologies shall not delegate or subcontract any of its
obligations during the Development Period, and
11.2.2 Schwarz Pharma shall not assign or delegate its rights or
obligations hereunder at any time, without the prior written consent of the
other party hereto.
11.3 All notices, requests or other communication provided for or
permitted hereunder shall be given in writing and shall be hand delivered or
sent by facsimile, reputable courier or by registered or certified mail, postage
prepaid, return receipt requested, to the address set forth on the signature
page of this Agreement, or to such other address as either party may inform the
other of in writing. Notices will be deemed delivered on the earliest of
transmission by facsimile, actual receipt or three days after mailing as set
forth herein.
11.4 Any terms of this Agreement may be amended, modified or waived
only in a writing signed by both parties.
11.5 If any provision of this Agreement shall be held invalid,
illegal or unenforceable, such provision shall be enforced to the maximum extent
permitted by law and the parties' fundamental intentions hereunder, and the
remaining provisions shall not be affected or impaired.
11.6 Nothing herein contained shall constitute this a joint venture
agreement or constitute either party as the partner, principal or agent of the
other, this being an
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<PAGE> 31
Agreement between independent contracting entities. Neither party shall have the
authority to bind the other in any respect whatsoever. Except as provided
herein, nothing contained in this Agreement shall be construed as conferring any
right on either party to use any name, trade name, trademark or other
designation of the other party hereto, unless the express, written permission of
such other party has been obtained.
11.7 In the event that either party hereto is prevented from carrying
out its obligations under this Agreement by events beyond its reasonable
control, including without limitation acts or omissions of the other party, acts
of God or government, natural disasters or storms, fire, political strife, labor
disputes, failure or delay of transportation, default by suppliers or
unavailability of parts, then such party's performance of its obligations
hereunder shall be excused during the period of such event and for a reasonable
period of recovery thereafter, and the time for performance of such obligations
shall be automatically extended for a period of time equal to the duration of
such event or events; provided, however, that the other party may, at its
election, terminate this Agreement upon 120 days' prior notice to the party
affected by such events, unless such events cease to prevent such affected
party's performance hereunder during such 120-day period.
11.8 This Agreement shall be governed by, and construed and enforced
in accordance with, the laws of the State of New York without regard to its
conflict of laws rules.
11.9 Any dispute, other than a question relating to patent validity,
between the parties which arises under this Agreement or is otherwise related to
this Agreement and which cannot be resolved by good faith negotiation between
the parties over a period of at least ninety (90) days shall be resolved by
arbitration conducted in the English language in Seattle, Washington, before a
panel of three arbitrators under the then current rules and procedures of the
American Arbitration Association (the "AAA"), or other rules and procedures as
the parties may agree. The prevailing party in any such proceeding shall be
entitled to an award of its reasonable attorneys' fees and other costs,
including the fees and expenses of the arbitrators and the AAA, provided that
the same may be apportioned between the parties by the arbitrators if they
determine that each party has prevailed in part. The arbitral award shall be
binding and conclusive on both parties and may be enforced in any court of
competent jurisdiction. Notwithstanding the foregoing, either party may, on good
cause shown, seek a temporary restraining order and/or a preliminary injunction
from a court of competent jurisdiction, to be effective pending the institution
of the arbitration process and the deliberation and award of the arbitration
panel.
IN WITNESS WHEREOF, the parties hereto have caused their duly authorized
officers to execute and acknowledge this Agreement as of the date first written
above.
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<PAGE> 32
SCHWARZ PHARMA INC. TIMERx TECHNOLOGIES
By [ILLEGIBLE] By [ILLEGIBLE]
----------------------- --------------------------
Its PRESIDENT Its PRESIDENT
Address: Address:
5600 County Line Road 2981 Route 22
Mequon, Wisconsin 53092 Patterson, N.Y. 12563
FAX: (414) 242-1641 FAX: (914) 878-3420
Attn:________________ Attn:________________
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<PAGE> 33
EXHIBIT 1.1
TIMERx Technologies Affiliates
Schwarz Pharma Affiliates
TIMERx Technologies Affiliates
PENWEST, LTD.
Edward Mendell Co., Inc.
Penford Products Co.
Edward Mendell GmBH
Edward Mendell Finland OY
PENWEST Foreign Sales Corporation
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<PAGE> 34
EXHIBIT 1.1, CONTINUED
TIMERx Technologies Affiliates
Schwarz Pharma Affiliates
Schwarz Pharma Affiliates:
Central Pharmaceuticals, Inc.
Schwarz Pharma AG
Schwarz Pharma Deutschland GmbH
Sanol GmbH
ISIS Pharma GmbH
Schwarz Pharma Ltd.
Schwarz Pharma S.p.A.
Laboratories Schwarz Pharma S.A.
Schwarz Pharma Poland Sp.zo.o.
Seloc AG
SIFA Ltd.
SICOR S.A.
HOYER GmBH & Co.
Schwarz/[illegible]
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
EXHIBIT 1.12
MILESTONE FEE SCHEDULE
The milestone payments will vary *****************************************
******************************************** for each such milestone. The
Trigger Date for a milestone is the date that the conditions to such milestone
have been satisfied, as stated in this Agreement; e.g., the Trigger Date for
each of the biostudies is the completion of the respective study, the Trigger
Date for the Filing is the date of such Filing, the Trigger Date for the
Approval is the date of the Approval, and the Trigger Date for the Launch is the
date of the Launch. The following table sets forth the applicable milestone
payments, in U.S. Dollars:
**********************************************
MILESTONE ***************************
- --------- ---------------------------------------------------------
*** *** *** ***
--- --- --- ---
*************
********** ****** ****** ****** ******
********** ****** ****** ****** ******
********** ****** ****** ****** ******
********** ****** ****** ****** ******
********** ****** ****** ****** ******
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<PAGE> 36
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
EXHIBIT 1.14
Pilot Biostudies
1. The Clinical Research Organization that we will work with for the Pilot
Biostudies ***************************.
2. The Pilot Biostudies will be based on two studies wherein the first
study is a ********************************************************************
***********. The second study is a ********************************************
*******************************************************************************
*******. These two studies can be done simultaneously and will be done only on
the ***************************************************************************
****************************************************************** described
above.
3. We will evaluate the PK data (see #2 above) prior to starting
formulation work at Central.
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EXHIBIT 1.24
TIMERx Technologies Patents
UNITED STATES:
1) U.S. Patent No. 4,994,276, entitled "Directly Compressible Slow Release
Granulation," issued February 19, 1991.
2) U.S. Patent No. 5,128,143, entitled "Sustained Release Excipient and
Tablet Formulation," issued July 7, 1992.
3) U.S. Patent No. 5,135,757, entitled "Compressible Sustained Release
Dosage Forms," issued August 4, 1992.
4) U.S. Patent No. 5,455,046, entitled "Sustained Release Hetero-Disperse
Hydrogel Systems for Insoluble Drugs," issued October 3, 1995.
CANADA:
5) Canadian Patent Application No. 611,700, filed September 18, 1989
(corresponding to items 1), 2) and 3) above).
6) Canadian Patent Application Number 2131647, filed September 8, 1994,
corresponding to item 4) above.
MEXICO:
7) Mexican Patent Application Number 94-6885, filed September 8, 1994,
corresponding to item 4) above.
37
<PAGE> 38
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
EXHIBIT 1.27
UNIT PRICES
The price for the Formulated TIMERx product to be supplied by TIMERx
Technologies to Schwarz Pharma will vary **************************************
***************************************** when the product units are ordered.
The following table sets forth the applicable prices, per kilogram, in U.S.
Dollars, subject to adjustment as stated in the Agreement:
*********************************************
**********************
---------------------------------------------------------
**** **** **** ****
---- ---- ---- ----
Price* **** **** **** ****
* In all cases, Price shall be subject to an overall cap (to be determined
annually) of ***** per tablet (subject to annual adjustment by TIMERx
Technologies to reflect changes in the Pharmaceutical Producers' Index, or an
equivalent index) calculated on a unit weighted average of both dosage
strengths.
38
<PAGE> 39
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
EXHIBIT 4.3
ROYALTY RATES
The royalty rates *************************************************************
**************************************** during the calendar quarter in which
the royalties accrue, and the Net Sales then reached for that year. ***********
**********************************************************************
**********************************************************************
**********************************************************************
**********************************************************************
***********************, in percentages of Net Sales:
Portion of Net Sales ***********************************************
during Each Year the Applicable Quarter
-----------------------------------------------
**** **** **** ****
---- ---- ---- ----
First
******** **** **** **** ****
********
******** **** **** **** ****
********
******** **** **** **** ****
******** **** **** **** ****
****
39
