Chembio
Diagnostics, Inc.
|
Nevada
|
333-85787
|
88-0425691
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
N/A
|
o
|
Inverness
will market the SURE CHECK product under Inverness brands
globally
[subject only to certain existing international agreements
Chembio and
StatSure may keep in place for up to one year].
|
o
|
Inverness
will exclusively market SURE CHECK under the agreement as
well as any new
HIV products in the “barrel field” that are developed, and may not compete
with any products in this field worldwide as defined.
|
o
|
Chembio
and StatSure have each granted Inverness exclusive rights
to their
intellectual property in the HIV barrel
field
|
o
|
Inverness
has a first right to negotiate any agreements to market and
distribute any new Chembio HIV antibody detection tests,
including
products that may incorporate Chembio’s patent-pending Dual Path Platform
(DPP(TM))
|
o
|
Inverness
will market this product in the US market only; Chembio has
a
non-exclusive license under the Inverness lateral flow patents
to continue
to market the product under Chembio’s brand in the rest of the
world
|
o
|
Inverness
may bring a competitive HIV cassette product to the US market,
but in that
event Chembio would expand its lateral flow license for this
product to
the US and have other options under the
agreement.
|
o
|
Chembio
has received a non-exclusive license under the Inverness
lateral flow
patents for its HIV 1/2 Dipstick for marketing outside the
United States
|
o
|
Chembio
has also received a worldwide non-exclusive license to manufacture
and
market a number of other Chembio-branded products including
all Chembio’s
rapid tests for human and veterinary and tuberculosis, Chagas
disease, and
tests for other defined emerging and neglected
diseases.
|
o
|
Inverness
has the right to market each of these products (except the
HIV 1/2 STAT
PAK Dipstick) under an Inverness brand pursuant to an agreed-upon
pricing
and margin sharing formula similar to the other
agreements.
|
99.1
|
Press
Release titled “Inverness Medical Innovations, Chembio Diagnostics, Inc.
and StatSure Diagnostic Systems, Inc. Announce Agreements
to Market Rapid
HIV and Other Tests” issued October 5,
2006
|
99.2
|
Press
Release titled “StatSure and Chembio Agree to End Litigation and Enter
Agreement to Commercialize HIV Barrel Technology” issued October 5,
2006
|
1.
Definitions.
|
2
|
1.1.
Certain
Definitions
|
2
|
1.2.
Additional
Definitions
|
7
|
2.
HIV
Barrel Product: Exclusive Licenses and Manufacturing and
Distribution
Arrangements.
|
8
|
2.1.
Exclusive
Right to Manufacture
|
8
|
2.2.
Exclusive
Right to Purchase and Exploit
|
8
|
2.3.
Exclusive
License to SDS Patents
|
10
|
2.4.
Exclusivity
an Essential Term
|
10
|
2.5.
Patent
Marking
|
10
|
2.6.
Treatment
of New HIV Barrel Product
|
10
|
2.7.
Inverness
Licenses
|
11
|
2.8.
Termination
of Licenses Upon Challenge of Validity
|
11
|
3.
Non-Competition;
Termination of Exclusivity.
|
11
|
4.
Limits
to Scope of Inverness Licenses
|
13
|
5.
Royalties
and Payments.
|
13
|
5.1.
Exclusive
Payment Arrangements
|
13
|
5.2.
Pricing
of HIV Products
|
13
|
5.3.
Inverness
Sale of HIV Barrel Products - Division of Net Sales
|
14
|
5.4.
Payment
of Cost of HIV
Products
|
14
|
5.5.
Payment
by Inverness for Samples
|
14
|
5.6.
Royalties
Payable by Chembio on Inverness Lateral Flow Patents
|
15
|
5.7.
Reporting
and Calculation of Payments.
|
15
|
6.
Regulatory
and License Matters.
|
17
|
6.1.
Facility
Registration/Inspections
|
17
|
6.2.
Regulatory
Filings
|
18
|
6.3.
Authorization
for Sales in European Union
|
18
|
6.4.
Bio-Rad
Laboratories, Inc
|
18
|
7.
Manufacture
and Sale.
|
19
|
7.1 Chembio
Efforts
|
19
|
7.2 Forecasts
|
19
|
7.3 Purchase
Orders
|
19
|
7.4 Shipment
Terms
|
19
|
7.5 Acceptance
|
20
|
7.6 Sales
Effort
|
20
|
7.7 Inverness
Responsibilities; Rights
|
20
|
7.8 Marketing
Plans and Budgets
|
20
|
8.
Trademarks
|
20
|
8.1.
Trademark
License
|
20
|
8.2.
Compliance
with Law; Registration
|
21
|
8.3.
Termination
|
21
|
8.4.
Labeling
|
21
|
9.
Prosecution
and Enforcement of Licensed Intellectual Property.
|
21
|
9.1.
Prosecution
|
21
|
9.2.
Enforcement
of Licensed Patents
|
21
|
10.
Confidentiality.
|
22
|
10.1.
Limited
Disclosure and Use
|
22
|
10.2.
Exceptions
|
22
|
10.3.
Use
of Name; Disclosure of Terms of the Agreement
|
22
|
10.4.
Effect
of Termination
|
23
|
10.5.
Survival
|
23
|
11.
Representations;
Warranties.
|
23
|
11.1.
Corporate
Power
|
23
|
11.2.
No
Default or Violation
|
23
|
11.3.
Licensed
Intellectual Property
|
23
|
11.4.
Regulatory
Matters
|
23
|
11.5.
Product
Quality
|
24
|
11.6.
Exclusion
of Other Representations and Warranties
|
24
|
12.
Indemnification
|
24
|
12.1.
By
Manufacturers
|
24
|
12.2.
By
Sellers
|
25
|
12.3.
Notice
of Claims
|
25
|
12.4.
Disputes
|
26
|
13.
Term
and Termination.
|
26
|
13.1.
Term
of Agreement
|
26
|
13.2.
Material
Breach.
|
26
|
13.3.
Section
365(n); Agreement to Deliver Embodiments
|
27
|
13.4.
Effect
of Termination for Breach by Inverness
|
28
|
13.5.
Effect
of Termination for Breach by Chembio
|
28
|
13.6.
Sole
Remedy
|
28
|
13.7.
Survival
|
28
|
14.
Limitation
of Liability.
|
29
|
14.1.
Exclusion
of Liability for Certain Damages
|
29
|
14.2.
Limitation
on Liability for Direct Damages
|
29
|
15.
General.
|
29
|
15.1.
Waivers
and Amendments.
|
29
|
15.2.
Entire
Agreement
|
30
|
15.3.
Severability
|
30
|
15.4.
Relationship
of the Parties
|
30
|
15.5.
No
Election of Remedies
|
30
|
15.6.
Notices
|
30
|
15.7.
Governing
Law
|
31
|
15.8.
Dispute
Resolution
|
31
|
15.9.
Waiver
of Jury Trial
|
31
|
15.10.
Counterparts
|
31
|
15.11.
Assignment
|
32
|
15.12.
Force Majeure
|
32
|
15.13.
Further Assurances
|
32
|
1.
Definitions.
|
2
|
1.1.
Certain Definitions
|
2
|
1.2.
Additional Definitions
|
7
|
2.
HIV Cassette Product: Exclusive Licenses and Manufacturing
and
Distribution Arrangements.
|
7
|
2.1.
Exclusive Right to Manufacture for United States
Sale
|
7
|
2.2.
Exclusive Right to Purchase and Exploit in the United
States
|
7
|
2.3.
Non-Exclusive License under Inverness Lateral Flow
Patents
|
8
|
2.4.
Patent Marking
|
8
|
2.5.
SDS Access
|
8
|
2.6.
Termination of Licenses Upon Challenge of Validity
|
8
|
3.
Termination of Exclusivity in event of Competition.
|
9
|
4.
Limits to Scope of Inverness Licenses 1
|
10
|
5.
Royalties and Payments.
|
10
|
5.1.
Exclusive Payment Arrangements
|
10
|
5.2.
Pricing of HIV Cassette Products
|
10
|
5.3.
Inverness Sale of HIV Cassette Products - Division
of Net
Sales
|
11
|
5.4.
Payment Mechanism for HIV Cassette Products Sold
by Inverness
|
11
|
5.5.
Royalties Payable by Chembio on Inverness Lateral
Flow Patents
|
11
|
5.6.
Payment by Inverness for Samples
|
12
|
5.7.
Reporting and Calculation of Payments.
|
12
|
6.
Regulatory and License Matters.
|
14
|
6.1.
Facility Registration/Inspections
|
14
|
6.2.
Regulatory Filings
|
14
|
6.3.
Bio-Rad Laboratories, Inc
|
15
|
7.
Manufacture and Sale.
|
15
|
7.1 Chembio
Efforts
|
15
|
7.2 Forecasts
|
15
|
7.3 Purchase
Orders
|
16
|
7.4 Shipment
Terms
|
16
|
7.5 Acceptance
|
16
|
7.6 Sales
Effort
|
16
|
7.7 Inverness
Responsibilities; Rights
|
16
|
7.8 Marketing
Plans and Budgets
|
17
|
8.
Trademarks
|
17
|
8.1.
Trademark License
|
17
|
8.2.
Compliance with Law; Registration
|
17
|
8.3.
Termination
|
17
|
8.4.
Labeling
|
17
|
9.
Prosecution and Enforcement of Licensed Intellectual
Property.
|
18
|
9.1.
Prosecution
|
18
|
9.2.
Enforcement of Licensed Patents
|
18
|
10.
Confidentiality.
|
18
|
10.1.
Limited Disclosure and Use
|
18
|
10.2.
Exceptions
|
19
|
10.3.
Use of Name; Disclosure of Terms of the Agreement
|
19
|
10.4.
Effect of Termination
|
19
|
10.5.
Survival
|
19
|
11.
Representations; Warranties.
|
20
|
11.1.
Corporate Power
|
20
|
11.2.
No Default or Violation
|
20
|
11.3.
Licensed Intellectual Property
|
20
|
11.4.
Regulatory Matters
|
20
|
11.5.
Product Quality
|
20
|
11.6.
Exclusion of Other Representations and Warranties
|
21
|
12.
Indemnification
|
21
|
12.1.
By Manufacturer
|
21
|
12.2.
By Sellers
|
22
|
12.3.
Notice of Claims
|
22
|
12.4.
Disputes
|
23
|
13.
Term and Termination
|
23
|
13.1.
Term of Agreement
|
23
|
13.2.
Material Breach
|
23
|
13.3.
Section 365(n); Agreement to Deliver Embodiments
|
24
|
13.4.
Effect of Termination for Breach by Inverness
|
24
|
13.5.
Effect of Termination for Breach by Chembio
|
25
|
13.6.
Survival
|
25
|
14.
Limitation of Liability
|
25
|
14.1.
Exclusion of Liability for Certain Damages
|
25
|
14.2.
Limitation on Liability for Direct Damages
|
26
|
15.
General.
|
26
|
15.1.
Waivers and Amendments.
|
26
|
15.2.
Entire Agreement
|
26
|
15.3.
Severability
|
26
|
15.4.
Relationship of the Parties
|
26
|
15.5.
No Election of Remedies
|
27
|
15.6.
Notices
|
27
|
15.7.
Governing Law
|
27
|
15.8.
Dispute Resolution
|
28
|
15.9.
Waiver of Jury Trial
|
28
|
15.10.
Counterparts
|
28
|
15.11.
Assignment
|
28
|
15.12.
Force Majeure
|
28
|
15.13.
Further Assurances
|
29
|
1.
Definitions
|
1
|
1.1.
Certain Definitions
|
1
|
1.2.
Additional Definitions
|
6
|
2.
License Grants.
|
6
|
2.1.
Inverness License
|
6
|
2.2.
Non-Exclusive Right to Purchase and Exploit
|
7
|
2.3.
Patent Marking
|
7
|
2.4.
SDS Access
|
8
|
2.5.
Termination of Licenses Upon Challenge of Validity
|
8
|
3.
Royalties and Payments.
|
8
|
3.1.
Exclusive Payment Arrangements
|
8
|
3.2.
Pricing of Licensed Products
|
8
|
3.3.
Inverness Sale of Licensed Products - Division of Net
Sales
|
8
|
3.4.
Minimum Price
|
8
|
3.5.
Payment Mechanism for Licensed Products Sold by Inverness
|
8
|
3.6.
Royalties Payable by Chembio on Inverness Lateral Flow
Patents
|
9
|
3.7.
Payment by Inverness for Samples
|
10
|
3.8.
Reporting and Calculation of Payments.
|
10
|
4.
Regulatory and License Matters.
|
12
|
4.1.
Facility Registration/Inspections
|
12
|
4.2.
Regulatory Filings
|
12
|
5.
Manufacture and Sale.
|
12
|
5.1.
Chembio Efforts
|
12
|
5.2.
Forecasts
|
12
|
5.3.
Purchase Orders
|
13
|
5.4.
Shipment Terms
|
13
|
5.5.
Acceptance
|
13
|
5.6.
Inverness Responsibilities; Rights
|
13
|
6.
Trademarks
|
14
|
6.1.
Trademark License
|
14
|
6.2.
Compliance with Law; Registration
|
14
|
6.3.
Termination
|
14
|
6.4.
Labeling
|
14
|
7.
Prosecution and Enforcement of Licensed Intellectual
Property
|
14
|
7.1.
Prosecution
|
14
|
7.2.
Enforcement of Licensed Patents
|
15
|
8.
Confidentiality
|
15
|
8.1.
Limited Disclosure and Use
|
15
|
8.2.
Exceptions
|
15
|
8.3.
Use of Name; Disclosure of Terms of the Agreement
|
16
|
8.4.
Effect of Termination
|
16
|
8.5.
Survival
|
16
|
9.
Representations; Warranties
|
16
|
9.1.
Corporate Power
|
16
|
9.2.
No Default or Violation
|
16
|
9.3.
Licensed Intellectual Property
|
17
|
9.4.
Regulatory Matters
|
17
|
9.5.
Product Quality
|
17
|
9.6.
Exclusion of Other Representations and Warranties
|
17
|
10.
Indemnification
|
18
|
10.1.
By Chembio as Manufacturer
|
18
|
10.2.
By Sellers
|
18
|
10.3.
Notice of Claims
|
18
|
10.4.
Disputes
|
19
|
11.
Term and Termination
|
19
|
11.1.
Term of Agreement
|
19
|
11.2.
Material Breach
|
19
|
11.3.
Section 365(n); Agreement to Deliver Embodiments
|
20
|
11.4.
Effect of Termination for Breach
|
20
|
11.5.
Survival
|
21
|
12.
Limitation of Liability
|
21
|
12.1.
Exclusion of Liability for Certain Damages
|
21
|
12.2.
Limitation on Liability for Direct Damages
|
21
|
13.
General
|
21
|
13.1.
Waivers and Amendments
|
21
|
13.2.
Entire Agreement
|
22
|
13.3.
Severability
|
22
|
13.4.
Relationship of the Parties
|
22
|
13.5.
No Election of Remedies
|
22
|
13.6.
Notices
|
22
|
13.7.
Governing Law
|
23
|
13.8.
Dispute Resolution
|
23
|
13.9.
Waiver of Jury Trial
|
23
|
13.10.
Counterparts
|
23
|
13.11.
Assignment
|
24
|
13.12.
Force Majeure
|
24
|
13.13
Further Assurances
|
24
|