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Document Preview Development, License and Supply Agreement |
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Title: |
Development, License and Supply Agreement |
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Entities: |
Cima Labs Inc.; Schwarz Pharma, Inc.; Mayer, Brown, Rowe & Maw |
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Date: |
2000 |
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Preview shows 16KB of 114KB total |
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Price: |
$43 |
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ID: |
#296738 |
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DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
by and between
CIMA LABS INC.
and
SCHWARZ PHARMA, INC.
dated as of September 29, 2000
{PAGE} 2
Exhibit 10.26
TABLE OF CONTENTS
{TABLE}
{S} {C} {C} {C}
SECTION 1 DEFINITIONS...........................................................1
SECTION 2 GRANT OF LICENSES; LICENSE OPTION.....................................5
2.1 Grant of Licenses................................................5
2.2 Sublicenses......................................................5
2.3 Marketing, Distribution and Sale.................................5
2.4 Minimum Annual Net Sales; Amendment to June Agreement............5
SECTION 3 PRODUCT DEVELOPMENT...................................................6
3.1 Obligations of CIMA..............................................6
3.2 Obligations of Schwarz...........................................6
3.3 License of Schwarz Technology....................................6
3.4 Regulatory Matters...............................................6
SECTION 4 ROYALTY, COST OF GOODS AND MILESTONE PAYMENTS.........................7
4.1 Royalty and Milestone Payments...................................7
4.2 Records and Audit................................................7
4.3 Quarterly Reports of Royalties...................................7
SECTION 5 SUPPLY OF PRODUCT.....................................................8
5.1 Supply of Product................................................8
5.2 Identification...................................................9
5.3 Trade, Sample and Placebo Product Price..........................9
5.4 Forecasts, Delivery and Quality..................................9
5.5 Rejection and Replacement........................................9
5.6 Invoice and Payment.............................................10
5.7 Supply Disruption; Alternate Manufacturing Site.................10
5.8 CIMA's Obligation to Continue Manufacture.......................10
SECTION 6 CONDITIONS PRECEDENT TO THE CLOSING; CLOSING DATE....................11
6.1 Conditions Precedent to Schwarz's Obligations...................11
6.2 Conditions Precedent to CIMA's Obligations......................11
6.3 Closing Date....................................................12
SECTION 7 REPRESENTATIONS AND WARRANTIES OF CIMA...............................12
7.1 Organization, Power and Authority...............................12
7.2 Due Authority; No Breach........................................12
7.3 Intellectual Property...........................................13
7.4 Technology Rights...............................................13
7.5 Litigation......................................................13
7.6 Governmental Approval...........................................14
{/TABLE}
{PAGE} 3
Exhibit 10.26
{TABLE}
{S} {C} {C} {C}
7.7 Brokerage.......................................................14
SECTION 8 REPRESENTATIONS AND WARRANTIES OF SCHWARZ............................14
8.1 Organization, Power and Authority...............................14
8.2 Due Authority; No Breach........................................14
8.3 Brokerage.......................................................15
8.4 Litigation......................................................15
8.5 Governmental Approval...........................................15
SECTION 9 ADDITIONAL COVENANTS AND AGREEMENTS OF THE PARTIES...................15
9.1 Governmental Filings............................................15
9.2 Compliance with Law.............................................15
9.3 Recall..........................................................16
9.4 Confidentiality.................................................16
9.5 Expenses........................................................17
9.6 Reasonable Efforts..............................................17
9.7 Publicity.......................................................17
9.8 Cooperation.....................................................17
9.9 Competition; No Sale for Resale.................................17
9.10 Conflicting Rights..............................................18
9.11 Patent and Trademark Maintenance................................18
9.12 Infringement; Enforcement of Proprietary Rights.................19
9.13 Supply of Product...............................................20
9.14 Liability Insurance.............................................20
9.15 Referral of Orders and Inquiries................................20
9.16 Deemed Breach of Covenant.......................................20
SECTION 10 INDEMNIFICATION.....................................................20
10.1 Indemnification.................................................20
10.2 Notice and Opportunity To Defend................................21
10.3 Indemnification Payment Obligation..............................22
10.4 Indemnification Payment Adjustments.............................22
10.3 Indemnification Payment.........................................22
10.4 Survival........................................................22
SECTION 11 TERMINATION.........................................................23
11.1 Termination.....................................................23
SECTION 12 MISCELLANEOUS.......................................................24
12.1 Successors and Assigns..........................................24
12.2 Notices.........................................................24
12.3 Waiver; Remedies................................................24
{/TABLE}
ii
{PAGE} 4
Exhibit 10.26
{TABLE}
{S} {C} {C} {C}
12.4 Survival of Representations.....................................25
12.5 Independent Contractors.........................................25
12.6 Entire Agreement................................................25
12.7 Amendment.......................................................25
12.8 Counterparts....................................................25
12.9 Governing Law...................................................25
12.10 Arbitration.....................................................25
12.11 Captions........................................................26
12.12 No Third-Party Rights...........................................26
12.13 Severability....................................................26
12.14 Attachments.....................................................26
12.15 Force Majeure...................................................26
{/TABLE}
iii
{PAGE} 5
Exhibit 10.26
SCHEDULES
{TABLE}
{S} {C}
Schedule 2.4 Minimum Annual Net Sales Targets
Schedule 3.1 Development Schedule
Schedule 4.1(a) Royalty Rates
Schedule 4.1(b) Milestone Payments
Schedule 5.1(b) Schwarz Purchase Order
Schedule 5.3 Cost of Goods
Schedule 5.4(d) Quality Assurance Addendum
Schedule 9.9(a) Competitive Products
{/TABLE}
iv
{PAGE} 6
Exhibit 10.26
DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
This DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT ("this Agreement"),
dated as of September 29, 2000, is by and between CIMA LABS INC., a Delaware
corporation ("CIMA"), and SCHWARZ PHARMA, INC., a Delaware corporation
("Schwarz").
W I T N E S S E T H
- - - - - - - - - -
WHEREAS, CIMA is engaged, among other things, in the business of
research, development, manufacturing and commercialization of pharmaceutical
products through its proprietary drug delivery technologies;
WHEREAS, Schwarz is engaged, among other things, in the business of
marketing and selling of pharmaceutical products;
WHEREAS, subject to the terms and conditions set forth in this
Agreement, CIMA and Schwarz wish to collaborate in the development,
registration, marketing and sale of a certain prescription product; and
WHEREAS, subject to the terms and conditions set forth in this
Agreement, CIMA wishes to license to Schwarz and Schwarz wishes to license from
CIMA rights to CIMA's DuraSolv(TM) technology for use with such prescription
product.
NOW, THEREFORE, the parties hereto, intending to be legally bound,
hereby agree as follows:
SECTION 1
DEFINITIONS
For purposes of this Agreement, the following terms shall have the
meanings set forth below:
"Activities" shall mean the development, manufacturing, marketing,
selling and distributing of the Product in the Territory as contemplated by this
Agreement.
"Affiliates" shall mean, with respect to any Person, any Persons
directly or indirectly controlling, controlled by, or under common control with,
such other Person. For purposes hereof, the term "controlled" (including the
terms "controlled by" and "under common control with"), as used with respect to
any Person, shall mean the direct or indirect ability or power to direct or
cause the direction of management policies of such Person or otherwise direct
the affairs of such Person, whether through ownership of voting securities or
otherwise.
"Annual Net Sales" shall mean, for any Year, the Net Sales for such
Year.
"API" shall mean the active ingredient [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***].
{PAGE} 7
Exhibit 10.26
"cGMP" shall mean current Good Manufacturing Practices, as determined
by the FDA from time to time.
"CIMA" shall have the meaning given in the preamble and shall include
its Affiliates.
"CIMA Intellectual Property" shall mean, collectively, the CIMA
Patents, the CIMA Technology, the CIMA Trademarks, and the CIMA Marketing
Materials.
"CIMA Marketing and Market Research Data" shall mean, with respect to
the Product, all CIMA marketing data, studies, market research data and reports
that pertain to the Product, and any further market research data whose
disclosure to Schwarz is not prohibited by confidentiality obligations under
agreements, dated prior to the date hereof, between CIMA and Persons who are not
Affiliates of CIMA.
"CIMA Marketing Materials" shall mean all labeling, marketing and
promotional materials and inserts currently used by CIMA that are useful in
connection with the Activities.
"CIMA Patents" shall mean United States patent no. 6024981 (Rapidly
Dissolving Robust Dosage Form) and any patents and patent applications resulting
therefrom, including any extension, reissue, renewal, reexamination or
continuation-in-part of such patent or patent application.
"CIMA Technology" shall mean all of CIMA's Patents, trade secrets,
technology, know-how and all other information necessary for the manufacture of
the Product including, without limitation, that related to CIMA's DuraSolv(TM)
technology.
"CIMA Trademarks" shall mean the CIMA(TM), DuraSolv(TM) and Meltabs(TM)
trademarks.
"Closing Date" shall have the meaning given in Section 6.3 hereof.
"Damages" shall mean any and all actions, costs, losses, lost profits,
claims, liabilities, fines, penalties, demands, damages and expenses, court
costs, and reasonable fees and disbursements of counsel, consultants and expert
witnesses incurred by a party hereto (including interest which may be imposed in
connection therewith).
"Defective" shall mean, as to the Product, the failure of such to
strictly conform to the Specifications, this Agreement and all applicable law,
including, without limitation, PDMA.
"Development Schedule" shall mean the schedule of development
activities set forth on Schedule 3.1 hereto.
"FDA" shall mean the United States Food and Drug Administration.
"Force Majeure" shall mean acts of God, explosion, fire, flood,
tornadoes, thunderstorms, earthquake or tremor, war whether declared or not,
civil strife, riots, embargo, losses or shortages of power, labor stoppage,
substance shortages, damage to or loss or product in transit, currency
restrictions, or events caused by reason of laws, regulations or orders by any
government, governmental agency or instrumentality or by an other supervening or
unforeseeable circumstances reasonably beyond the control of each party.
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