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Title: |
Exclusive License and Distribution Agreement |
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Date: |
2001 |
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Preview shows 12KB of 92KB total |
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$54 |
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ID: |
#281717 |
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EXCLUSIVE LICENSE
AND DISTRIBUTION AGREEMENT
BETWEEN
NOVAVAX, INC.
AND
KING PHARMACEUTICALS, INC.
JANUARY 8, 2001
{PAGE} 2
TABLE OF CONTENTS
1. DEFINITIONS............................................................1
2. APPOINTMENT AND GRANT OF RIGHTS........................................1
2.1 Appointment.......................................................1
2.2 Right to Promote Products.........................................2
2.3 Trademark.........................................................2
2.4 Ownership of Property Rights......................................3
3. SUPPLY OF PRODUCTS.....................................................4
3.1 Manufacture and Supply of Products................................4
3.2 Quarterly Forecasts; Purchase Orders..............................4
3.3 Delivery of Products..............................................6
3.4 Product Samples...................................................7
3.5 Labeling and Packaging Costs......................................7
4. CERTAIN REGULATORY MATTERS.............................................7
4.1 Licenses..........................................................7
4.2 Regulatory Responsibility.........................................7
4.3 Efficacy and Safety Information...................................8
4.4 Notice of Adverse Events..........................................8
4.5 Recalls; Product Technical Complaints.............................9
4.6 Notice of Government Inspections.................................10
4.7 Government Inquiries.............................................10
4.8 Medical Inquiries................................................10
5. FEES AND EXPENSES.....................................................10
5.1 Purchase Price...................................................10
5.2 Royalty Payment..................................................11
6. INSPECTION AND WARRANTY OF PRODUCTS...................................12
6.1 Inspection by KING...............................................12
6.2 Disputes over Products...........................................12
6.3 Replacement of Products that are not Acceptable Products.........12
7. TERM AND TERMINATION..................................................13
7.1 Term of Agreement................................................13
7.2 Termination by NOVAVAX...........................................13
7.3 Termination by KING..............................................14
7.4 Effects of Termination...........................................14
7.5 Actions Upon Termination.........................................15
7.6 Survival.........................................................15
7.7 Payments Upon Termination........................................15
i
{PAGE} 3
8. CONFIDENTIAL INFORMATION..............................................16
9. INDEMNIFICATION AND INSURANCE.........................................17
9.1 Indemnification by KING..........................................17
9.2 Indemnification by NOVAVAX.......................................18
9.3 Claims Procedures................................................18
9.4 Insurance........................................................19
10. REPRESENTATIONS AND WARRANTIES........................................19
10.1 By KING..........................................................19
10.2 By NOVAVAX.......................................................19
11. NOTICES...............................................................21
12. MISCELLANEOUS PROVISIONS..............................................22
12.1 Assignment; Change of Control....................................22
12.2 Governing Law....................................................23
12.3 Non-Waiver.......................................................23
12.4 Entire Agreement.................................................23
12.5 Jurisdiction; Venue..............................................23
12.6 Severability.....................................................25
12.7 Relationship of the Parties......................................25
12.8 Public Announcements.............................................25
12.9 Counterparts.....................................................25
12.10 Force Majeure....................................................26
12.11 Interpretation...................................................26
12.12 Certain Expenses and Commissions.................................26
12.13 Third Party Beneficiaries........................................26
12.14 Covenant Not to Promote Competing Product........................26
12.15 Headings.........................................................27
ii
{PAGE} 4
EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT
THIS EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT (this
"AGREEMENT") is entered into and effective as of this 8th day of January, 2001
(the "EFFECTIVE DATE"), by and between KING PHARMACEUTICALS, INC., a Tennessee
corporation ("KING"), and NOVAVAX, INC., a Delaware corporation ("NOVAVAX").
WHEREAS, KING is engaged in the business of and has expertise
in, among other things, the promotion of pharmaceutical products to physicians
and health care practitioners who specialize in the practice of obstetrics or
gynecology or who frequently prescribe hormone replacement therapy products
("OB/GYN"), and has a field representative sales force focused on the OB/GYN
community;
WHEREAS, NOVAVAX owns or will own a patent or patents related
to the Products (as well as other intellectual property rights in the Products)
and expects to file with the FDA a New Drug Application for ESTRASORB(TM);
WHEREAS, KING and NOVAVAX desire for NOVAVAX to manufacture or
have manufactured and supply KING with Products for promotion, distribution and
sale by KING in the Territory and NOVAVAX desires to manufacture or have
manufactured and supply KING with such Products on the terms and conditions set
forth herein.
NOW, THEREFORE, in consideration of the mutual covenants and
agreements set forth in this Agreement, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereto agree as follows:
1. DEFINITIONS
Capitalized terms used herein without definition shall have
the respective meanings assigned thereto in ANNEX I attached hereto and
incorporated herein for all purposes of this Agreement (such definitions to be
equally applicable to both the singular and plural forms of the terms defined).
Unless otherwise specified, all references herein to "Sections" are to Sections
of this Agreement.
2. APPOINTMENT AND GRANT OF RIGHTS
2.1 APPOINTMENT.
NOVAVAX hereby appoints KING as its exclusive distributor of
the Products within the Territory during the Term of this Agreement, upon and
{PAGE} 5
subject to the terms and conditions set forth in this Agreement. The exclusivity
set forth in this Agreement shall be subject to any limitations provided under
applicable law, regulation or governmental guideline including, without
limitation, any published directive of the European Union.
2.2 RIGHT TO PROMOTE PRODUCTS.
NOVAVAX hereby grants to KING and its Affiliates, the
exclusive right and license to promote, market, distribute and sell the Products
within the Territory during the Term of this Agreement, upon and subject to the
terms and conditions set forth in this Agreement. NOVAVAX shall not, nor shall
it permit its Affiliates, sublicensees, or any other party to, promote, market,
distribute or sell the Products within the Territory during the Term of this
Agreement. KING agrees to use Commercially Reasonable Efforts to obtain
regulatory authority to market and sell the Products within such countries in
the Territory as KING determines in its reasonable judgment is reasonable and,
after obtaining such regulatory authority, to use Commercially Reasonable
Efforts to promote, market, offer-to-sell and sell the Products in the
Territory, in such a manner as to effectuate KING's and NOVAVAX's purposes in
this Agreement.
2.3 TRADEMARK.
(a) REQUIRED USE AND COMPLIANCE. NOVAVAX hereby grants to KING
a license to use the NOVAVAX Trademarks, which are set forth in EXHIBIT 2.3(a),
for the duration of this Agreement solely for advertising, displaying,
marketing, promoting, using, offering-for-sale, selling, distributing, importing
and/or exporting the Products in accordance with this Agreement. KING shall
promote the Products only under the NOVAVAX Trademarks. KING shall not use any
trademark or servicemark other than the NOVAVAX Trademarks in promoting the
Products without the prior written approval of NOVAVAX. In connection with the
subject matter hereof, KING shall use the NOVAVAX Trademarks only in a manner
consistent with NOVAVAX's trademark usage guidelines (the "NOVAVAX GUIDELINES")
and shall not use any NOVAVAX Trademark in connection with any goods or products
other than the Products, notwithstanding that such goods or products are
dissimilar to the Products or have a different use. The parties shall develop
the NOVAVAX Guidelines as soon as practicable after the Effective Date. KING
shall use the NOVAVAX Trademarks only to the extent authorized herein. NOVAVAX
shall not use, nor permit any third party to use, the NOVAVAX Primary Brand
Trademarks or other NOVAVAX Trademarks used exclusively with respect to the
Products in the Territory during the Term of this Agreement.
(b) VALIDITY OF TRADEMARKS. KING acknowledges the validity of
NOVAVAX's right, title and interest in and to the NOVAVAX Trademarks and KING
shall not have, assert or acquire any right, title or interest in or to any of
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