Exhibit 10.19
*** Indicates omitted material
that is the subject of a confidential treatment request filed
separately with the Commission.
COMMERCIAL LICENSING &
ROYALTY AGREEMENT
by and between
Mannatech, Incorporated
(“Mannatech”), a Texas (USA) corporation
and
Wellness Enterprises, LLC
(“Wellness”), a Delaware (USA) company
TABLE OF CONTENTS
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1.
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DEFINITIONS
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1
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2.
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SUPPLY OF
MANNATECH MATERIALS
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4
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3.
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WATER
TECHNOLOGY
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4
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3.1
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Technology
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4
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3.2
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Product
Specifications per Country.
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4
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3.3
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Mannatech
Representative in Facility
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4
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3.4
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Time
Schedule
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5
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3.5
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Supply of Raw
Materials for Product
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5
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3.6
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Licenses and
Permits
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5
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3.7
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Health and
Safety
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5
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4.
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TRANSPORTATION
OF PRODUCT AND DEFECTS
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6
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4.1
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Shipping
Instructions
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6
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4.2
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Risk of
Loss
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6
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5.
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QUALITY
ASSURANCE AND REGULATORY
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6
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5.1
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Specifications
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6
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5.2
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Regulatory
Responsibilities
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6
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5.3
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Regulatory
Requirements
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6
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5.4
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Regulatory
Agency Inspections and Interactions
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6
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5.5
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Storage
Requirements
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7
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5.6
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Nonconforming
Materials
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7
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5.7
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Quality Tests
and Checks
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7
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5.8
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Production
Codes and Records
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7
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5.9
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Training
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7
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5.10
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Inspections and
Audits
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7
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5.11
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Retention of
Records and Samples
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7
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5.12
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Government
Inspections and Seizures
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8
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5.13
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Legal/and
Regulatory Filings and Requests
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8
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5.14
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Quality
Responsibilities
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8
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5.15
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Lot
Documentation
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8
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5.16
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Lot and Batch
Release
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8
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5.17
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Laboratory
Services
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8
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5.18
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Use of
Subcontractors
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8
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5.19
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Reprocessing
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8
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5.20
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Product
Complaints, Adverse Events, and Product Recalls
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9
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6.
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PRICE, TERMS OF
PAYMENT, ROYALTIES & LICENSE
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9
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6.1
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Payment
Terms
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9
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6.2
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Taxes
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9
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6.3
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Invoicing of
Product
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9
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6.4
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Invoice
Disputes
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9
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6.5
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Financial
Recordkeeping
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10
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6.6
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Initial Price
and Annual Price Adjustments
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10
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6.7
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Estimates/Forecasting
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10
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6.8
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Orders
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10
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6.8.1
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Initial
Order
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10
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6.8.2
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Purchase
Orders
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10
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6.9
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Royalties
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11
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6.9.1
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Payment of
Royalties
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11
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6.10
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License of Haru
Naito’s Story
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11
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7.
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INTELLECTUAL
PROPERTY
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11
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7.1
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Protection of
Technology
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11
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7.2
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Confidentiality
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12
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7.3
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Rights to
Mannatech Technology and Mannatech Materials
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12
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7.4
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Title to
Inventions
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12
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7.5
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Notice of
Infringement
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12
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7.6
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Notice of
Infringement by One or Both Parties
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12
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7.7
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Wellness
Intellectual Property Representations
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13
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7.8
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Survival
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13
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7.9
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Trademarks and
Tradenames
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13
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8.
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FORCE
MAJEURE
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14
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8.1
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Force
Majeure
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14
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8.2
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Term of Force
Majeure
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14
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9.
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REPRESENTATIONS
AND WARRANTIES
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15
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9.1
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Mannatech
Representations and Warranties
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15
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9.2
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Wellness
Representations and Warranties
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15
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9.2.1
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Production
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15
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9.2.2
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Organization
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15
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9.2.3
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Wellness
Authorization and Agreement
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15
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9.2.4
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No
Consent
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15
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9.2.5
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Insurance
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15
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9.2.5.1
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Commercial
General Liability
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16
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9.2.5.2
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Auto
Liability
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16
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9.2.5.3
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Worker’s
Compensation
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16
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9.2.5.4
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Commercial
Umbrella Liability
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16
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9.2.5.5
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Insurance to
Wellness
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16
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9.2.6
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Validity and
Enforceability
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16
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9.2.7
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No
Breach
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16
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9.2.8
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Compliance with
Laws
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17
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9.3
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Notice of
Material Events
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17
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9.4
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Survival
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17
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10.
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DISCLAIMER;
LIMITATION OF LIABILITY
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17
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11.
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INDEMNIFICATION
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18
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11.1
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Wellness’
Indemnification of Mannatech
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18
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11.2
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Indemnification
Procedure
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18
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11.3
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Survival
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19
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12.
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CONFIDENTIALITY
OBLIGATIONS
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19
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12.1
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Parties
Confidential Information
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19
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12.2
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Exclusions from
Confidential Information
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19
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12.3
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Term of
Confidentiality
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20
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12.4
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Necessary
Disclosures
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20
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12.5
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Limited
Disclosure
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20
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12.6
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Press
Releases
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20
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12.7
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Remedies
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21
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13.
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TERM AND
TERMINATION
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21
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13.1
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Term
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21
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13.2
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Termination
with Cause
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21
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13.2.1
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Material
Breach
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21
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ii
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13.2.2
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Inaccurate
Warranty
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21
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13.2.3
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Termination
Upon Insolvency or Sale of the Ass
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21
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13.3
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Termination
Date
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22
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13.4
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Termination by
Mannatech
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22
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13.4.1
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Breach
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22
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13.4.2
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Failure to Meet
Quality Control Standards
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22
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13.4.3
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Illegality
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22
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13.4.4
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Fair Trade
Practices
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22
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13.4.5
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Termination Due
to Regulatory Requirements
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22
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13.4.6
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Termination for
Failure to Meet Mannatech’s Production
Requirements
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23
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13.5
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Obligations of
Mannatech upon Termination for Withdrawal from Commercial Product
Sale
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23
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13.6
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Obligations of
Wellness upon Termination for Breach
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23
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13.6.1
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Obligations of
Wellness upon Termination for Breach
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23
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13.7
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Termination of
the Agreement with or without Cause
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23
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13.8
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Infeasibility/Replacement
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23
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13.9
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Termination by
Wellness
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23
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13.9.1
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Breach
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23
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13.9.2
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Fair Trade
Practices
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23
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14.
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MISCELLANEOUS
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24
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14.1
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Assignment
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24
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14.2
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Information
Sharing
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24
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14.3
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Information in
Support of this Agreement
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24
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14.4
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Governing
Law
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24
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14.5
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Notices
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24
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14.6
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Waiver
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25
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14.7
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Severability
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25
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14.8
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No Implied
Licenses
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25
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14.9
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Independent
Contractors
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25
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14.10
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Compliance With
Laws
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25
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14.11
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Entire
Agreement
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25
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14.12
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Counterparts
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26
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14.13
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Schedules and
Attachments
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26
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14.14
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Independent
Judgment
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26
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14.15
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Ambiguities
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26
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14.16
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Approval
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26
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14.17
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Condition
Precedent.
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26
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iii
COMMERCIAL LICENSING &
ROYALTY AGREEMENT
This Commercial Supply Agreement
(“Agreement”) effective as of the Effective Date
defined herein (“Effective Date”) by and between
Mannatech, Incorporated (“Mannatech”), a Texas (USA)
corporation, with its primary place of business located at 600 S.
Royal Lane, Suite 200, Coppell, Texas 75019, and Wellness
Enterprises, LLC (“Wellness”), a Delaware (USA)
company, with its primary place of business located at 418 SW 140th
Terrace, Newberry, Florida 32669, hereinafter collectively referred
to as the “Parties”.
RECITALS
WHEREAS , Mannatech develops and sells proprietary
nutritional supplements and topical products through a network
marketing system throughout the United States, Canada, Australia,
New Zealand, the United Kingdom, Denmark, S. Korea, Taiwan and
Japan by distributors referred to as Independent Associates
(“Associates”);
WHEREAS, Mannatech desires to enter into this Agreement
to obtain commercial manufacture of an exclusive line of skin care
products by which Wellness will license its proprietary Tensa Water
(the “Water Technology”) for the development of a
proprietary skin care line as set forth in Attachment 1 –
“Product” to be manufactured and supplied by Fine
Chemetics Ltd. (“FCL”) using FCL’s existing
technology and may use Mannatech’s existing glyconutrient
formulations (defined herein as “Product”) for
Mannatech;
WHEREAS , Wellness has represented that it will license
to Mannatech Haru Naito’s personal story and the story
surrounding the discovery of the Water Technology (collectively,
the “Story”) and further that Wellness possesses the
right and title to license the Story to Mannatech;
WHEREAS , Wellness has represented that its Water
Technology is specially processed and hyper -enhanced and is
proprietary in nature and that it further has all right, title and
license in such technology;.
WHEREAS, Wellness has represented that it presently has
the ability to supply the Water Technology in the quantities needed
and in accordance Mannatech’s quality control specifications;
attached hereto as Attachment “2”;
WHEREAS, Wellness has represented that it presently has
the ability to develop the Water Technology in the quantities
needed and in accordance Mannatech’s quality control
specifications; attached hereto;
NOW, THEREFORE
, in consideration of the foregoing
premises and the mutual covenants and agreements hereinafter
contained, and for good and valuable consideration the receipt and
sufficiency of which is hereby acknowledged, the Parties agree as
follows:
1. DEFINITIONS
For the purposes of the Agreement,
the following words and phrases shall be defined as
follows:
1.1
“Affiliate” means any corporation,
company, joint venture, partnership or other entity, which,
directly or indirectly, is controlled by, or is under common
control with a Party to this Agreement. “Control” means
the ownership of more than fifty percent (50%) of the issued
share capital or business assets of another entity, the power to
exercise more than fifty percent (50%) of the voting rights of
another entity, the
power to appoint more than fifty percent
(50%) of the Board of Directors of another entity, or the
right to control the affairs of another entity. Each Party
acknowledges that the direct or indirect ownership of a lesser
percentage of such shares shall not necessarily preclude the
existence of control.
1.2
“Agreement” means this Commercial License
and Royalty Agreement between Wellness and Mannatech and the
Attachments attached hereto for the commercial development,
licensing and supply of Product and its related Story.
1.3
“Batch” means a specific quantity of an
ingredient that is intended to meet specifications for identity,
purity, quality, strength, and composition and is produced during a
specified time period according to a single manufacturing record
during the same cycle of manufacture.
1.4 “Bill of
Materials ” means a list of raw materials that are
specific and identifiable for the manufacture of the
Product.
1.5 “GMP”
means all requirements imposed on a licensed manufacturer and
distributor of cosmetics in Japan under the Pharmaceutical Affairs
Law (Law No. 145 of 1960) and related regulations, including,
without limitation, (i) Article 13 of the Pharmacy, Etc.
Structure and Facilities Regulations (providing standards for the
structure and facilities of places of manufacture of ordinary
cosmetics), (ii) Chapter III of the Ministerial Ordinance
Concerning Quality Control Standards for Pharmaceuticals,
Quasi-Pharmaceuticals, Cosmetics and Medical Equipment,
(iii) Article 3 of the Ministerial Ordinance Concerning
Post-Manufacture / Sale Safety Control Standards for
Pharmaceuticals, Quasi-Pharmaceuticals, Cosmetics and Medical
Equipment, (iv) the “Negative / Positive List” of
Cosmetics Standards under Ministry of Health Labor &
Welfare Notification No. 331 of September 29, 2000, and
(v) labeling standards concerning the ingredients and shelf
life of cosmetics as contained in Ministry of Health
Labor & Welfare Notification No. 332 of
September 29, 2000 and Ministry of Health Labor &
Welfare Notification No. 66 of September 26, 1980, as the
same may be amended or re-enacted from time to time.
Wellness’ operational quality standards are defined in
internal GMP documents.
1.6 “Change
Control” means a process defined in a standard
operating procedure (“SOP”) agreed to and followed by
Wellness in accordance with Mannatech’s requirements to
identify, review, track, approve and implement changes to a
production process, raw materials, quality control, quality
assurance, documentation, equipment, responsible personnel,
packaging, specifications, software/hardware, and other systems
used in the manufacture of Product, which may be provided to
Mannatech by Wellness from time to time.
1.7 “Mannatech
Materials” means any and all materials, including the
specifications, know-how or other suggestions for improving the
processing and Product packaging and shipping in which Mannatech
provides know-how and/or has intellectual property rights,
including, but not limited to patent rights, trade secret rights
and copyrights, or which Mannatech is otherwise authorized to
use.
1.8 “Mannatech
Technology” means all technical and other information
and know-how not known to WELLNESS prior to the commencement of
this Agreement relating to Mannatech and its current and projected
operation, including without limitation those Specifications
relating to the Processes and the Product that may be supplied by
Mannatech to Wellness from time to time.
1.9 “Mannatech
Tests” means the tests to be carried out by Mannatech
or by a third party as directed by Mannatech, on the Product during
or following production of such Product.
|
1.10
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“Delivery Point”
means the location as designated by
Mannatech in each purchase order for Water Technology.
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2
1.11 “Effective Date”
means the date on which this Agreement is executed and all the
conditions precedent are met.
1.12
“Facility” means Wellness’ enhanced
water production facility located in Oneonta, NY.
1.13 “Initial
Term” means the period commencing with the Effective
Date and expiring at the end of two (2) full calendar
years.
1.14 “Lot”
or “ Lots ” means a Batch, or
specifically identified portion of a Batch, intended to have
uniform identity, purity, quality, strength and
composition.
1.15
“Manufacturer” means FCL or a third-party
firm that FCL shall contract with and oversee the manufacturing and
packaging of the final Product or any other manufacturer selected
by Mannatech in its sole discretion to manufacture and package the
Product.
1.16
“Parties” means Wellness, Mannatech and
their Affiliates and Companies.
1.17
“Price” means for any particular unit of
Water Technology, the price as set forth herein.
1.18 “
Processes” means the methods for developing the
Product, including any improvements thereto from time to time, the
details of which are contained in Wellness’ standard
operating procedures.
1.19
“Product” means any proprietary
cosmetics, body care products, skin care products, including but
not limited to cleansers, lotions and creams, evidence and
specifications, developed by Wellness using Water Technology, FCL
proprietary technology, incorporated herein as Attachment 1 and
agreed to in advance by Mannatech.
1.20
“Recall” means an instance where:
(i) a request, directive or order of any government authority
is received by Wellness or Mannatech that Product be recalled;
(ii) a court of competent jurisdiction orders such a Recall;
or (iii) Mannatech reasonably determines that Product should
be recalled due to evident facts which would otherwise lead to
actions referred to under (i) and/or (ii).
1.21
“Services” means any and all of the work
to be performed by Wellness pursuant to this Agreement.
1.22 “
Specifications” means the technical criteria in
process tests, and Product Tests and any additional or supplemental
specifications and conditions from time to time agreed in writing
between Wellness and Mannatech. All Specifications to be contained
in the Product Specification attached.
1.23
“Territory” shall mean Japan, Taiwan, S.
Korea and future markets as may be agreed to between the Parties by
separate written agreement from time-to-time. The Parties agree
that Mannatech will have right of first refusal to licensing Water
Technology for use in skin care products for the network marketing
and direct selling industry in those non-licensed countries in
which Mannatech currently sells its products.
1.24 “Testing
Laboratory” means any third party selected by
Mannatech to carry out tests that are not otherwise performed by
FCL or which are required by Mannatech.
Unless the content requires
otherwise, words and phrases as defined above shall bear the same
meaning in any other part of this Agreement. References to the
singular number include the plural and vice versa, references to
clauses are references to clauses of this Agreement.
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2. SUPPLY OF MANNATECH MATERIALS
The Parties understand and
agree that Mannatech will not supply any of its technology to
Wellness under the terms of this Agreement.
3. WATER
TECHNOLOGY
3.1 Technology .
3.1.1 Wellness represents that is
currently owns all technology and intellectual property, and pieces
of equipment dedicated to the supply of its Water Technology (for
patents, copyrights, trademarks, proprietary formulations, vats,
processing tanks, processing facilities, freezers, refrigerators,
and storage containers) that may be required to perform its
obligations under this Agreement.
3.1 2. Subject to 3.3 hereof, the
Water Technology shall be supplied and licensed by Wellness for the
exclusive use and benefit of Mannatech in the Product formulations
represented in Appendix 1. Wellness shall not make or enter into an
agreement to make these product formulations for itself or any
third party in the licensed territory throughout the term of this
Agreement or any extension thereof. Mannatech acknowledges that
Wellness is the business of producing Water Technology for skin and
body care products, which may perform similar functions to those of
the unique Product being licensed to Mannatech without being the
same formulation. Such products shall not be deemed to violate this
section 3.1.2 merely because they contain the Water Technology
unless they consist of the same formulations
3.1.3 Mannatech shall retain
exclusive rights to the Water Technology for the purposes of
production of the Product developed by Wellness throughout the
Territory provided Mannatech places a minimum order of 800 gallons
of Water Technology per month (“Minimum Order”)
beginning in April 2006 through December 2006. In January 2007, all
purchase obligations of the Water Technology will be suspended
until such time that the Parties can account for balance on hand
and project amounts (if any) required for the next year of the
Term. If, at the end of year 1, Mannatech’s inventory of the
Water Technology exceeds its projected requirements for the second
year of the Initial Term, Wellness agrees it will adjust the
Minimum Order and continue the exclusive License. The Parties agree
to cooperate fully in the event an adjustment to the Minimum Order
is requested by Mannatech. The Parties agree that so long as
Mannatech places such Minimum Order in April through December 2006,
it will retain an exclusive license to the Product throughout the
Territory.
3.2 Product Specifications per
Country . Wellness acknowledges that Mannatech is a
multi-national nutritional supplement company that must comply with
the cosmetics and skin care laws and regulations of each country
(present and future) in which it conducts business, which
regulations may change from time to time. Wellness shall comply
with the GMP (if any) with respect to Water Technology manufactured
for inclusion in the Product in the Territory and any variations to
the specifications, marking, packaging, labeling, and the like as
may be presented from time-to-time by Mannatech to meet or exceed
the applicable cosmetic and skin care laws and regulations of each
country where the Product is sold.
3.3 Mannatech Representative in
Facility . Mannatech will have the right to have a
representative in Wellness’ Facility provided that the
Mannatech representatives shall not be in attendance on a fulltime
basis. Mannatech shall have no more than one (1) person on
site at any time unless mutually agreed to by the Parties.
Mannatech shall give Wellness reasonable notice as to the
scheduling of Mannatech personnel in the Facility. Wellness retains
the right to limit access should risk be posed to existing
operations, such access not to be unreasonably denied. The Parties
shall work together to maintain confidentiality and the
confidentiality of other and to keep strictly confidential any
information received, learned or viewed while
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in the Facility or the others’ premises.
While in the Facility, Mannatech employee shall be primarily
observing and providing advice, and shall have no direct control or
decision-making authority over Wellness employees or their
activities. Mannatech agrees that Wellness may request individual
Mannatech employees to enter into confidentiality agreements
according to their own confidentiality terms and conditions,
individually and on behalf of Mannatech, subject to prior review by
Mannatech’s Legal Department. Mannatech shall be responsible
for all costs associated with this Section 3 including but not
limited to meals, transportation, accommodation and office support
services as may be incurred while Mannatech personnel are located
at the Facility .
3.4 Time Schedule . The time
schedule for delivery of Water Technology to FCL shall be included
in each purchase order from Mannatech.
3.5 Supply of Raw Materials for
Product . All cleaning equipment, processing stations, vats,
processing equipment, storage, freezers, storage facilities, docks
and the like required to manufacture, store and deliver the Water
Technology shall be under the control of Wellness or its Affiliates
in sufficient quantities or availability to fulfill its Minimum
Order obligations. Mannatech agrees to provide reasonable notice to
Wellness in the event it anticipates demand for the Water
Technology will significantly increase over the Minimum Order
obligations.
3.6 Licenses and Permits
.
3.6.1 Wellness shall be responsible
for using commercially reasonable efforts to obtain all licenses
and permits required by law in order for Wellness to meet its
obligations under this Agreement. Wellness shall supply Mannatech
with all governmental permits and licenses applications, including
but not limited to environmental permits, necessary for its
production and delivery, F.O.B. Delivery Point, of Water Technology
in accordance with this Agreement. Upon written prior approval by
Mannatech, Mannatech will reimburse Wellness for reasonable costs
for governmental permits and licenses necessary for Wellness
delivery of Water Technology in accordance with this Agreement.
Wellness agrees to provide Mannatech, via overnight delivery, with
copies of all governmental permits and licenses necessary for its
production delivery of its Water Technology in accordance with this
Agreement upon request by Mannatech.
3.6.2 The Parties agree that this
Agreement is contingent upon FCL providing Mannatech with
certification from the Japanese Ministry of Health that the
Product(s) developed, produced and manufactured for Mannatech are
preservative-free skin care products (the
“Certification”) In the event FCL fails to
produce the Certification within a reasonable amount of time after
execution hereof, such time frame at Mannatech’s sole
discretion and to Mannatech’s satisfaction, this Agreement
shall be null and void.
3.7 Health and Safety . Upon
Mannatech’s request, Wellness shall provide to Mannatech all
required Material Safety Data Sheets (MSDS) or equivalents for
Water Technology supplied to Mannatech (if applicable). The Parties
agree to coordinate with one another to develop specifications
acceptable to Mannatech’s Quality Assurance Department, the
approval of which shall not be unreasonably withheld. If required
by Japanese law or the respective laws, rules and regulations of
the Territory, Wellness will manufacture its Water Technology in
accordance with Pharmaceutical Affairs Law (Law No. 145 of
1960), the GMP, and all other health and safety laws and
regulations applicable to the Product or any material in question
having regard to the location at which it is produced or to which
is will be delivered, used or consumed.
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4. TRANSPORTATION OF PRODUCT AND
DEFECTS
4.1 Shipping Instructions .
Wellness shall arrange the transportation of Water Technology by
ocean cargo from its premises to FCL (Delivery Point) indicated in
the purchase order by Mannatech together with insurance to cover
the Water Technology in transit, at its invoiced value.
4.2 Risk of Loss . Risk in
and title to Water Technology shall pass on delivery to the
shipping agents F.O.B. Delivery Point, as set-forth in each
purchase order. All ocean freight, insurance, handling and
forwarding agent’s fees, taxes, storage and all other charges
applicable to the Water Technology, if any, shall be the
responsibility of Wellness. The foregoing notwithstanding, Wellness
warrants and represents that the Water Technology will comply with
the Specifications and will retain its preservative-free
characteristics through final delivery to FCL.
5. QUALITY ASSURANCE AND
REGULATORY
5.1 Specifications . The
Specifications may be modified or changed only by Change Control,
which modification or change shall address any related price
increases or decreases arising from such modification or change.
The Specifications contained in Attachment 2 herein represent the
current Specifications for the Product.
5.2 Regulatory
Responsibilities . A Mannatech official will be the primary
contact person for regulatory authorities, except during facility
inspections where Wellness official will be the primary
contact.
5.3 Regulatory Requirements .
Wellness shall comply with the regulatory requirements applicable
to the manufacture of its Water Technology. If Mannatech requests
Wellness to comply with any other regulatory or statutory
requirements of any foreign government body, Wellness shall use all
reasonable commercial endeavors to do so, provided that:
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5.3.1
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Mannatech shall
be responsible for informing Wellness in writing of the precise
foreign requirements that Mannatech is requesting them to
observe;
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5.3.2
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Such foreign
requirements do not conflict with any applicable laws of the United
States of America or any of the States;
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5.3.3
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Wellness shall
use reasonable commercial efforts to ensure that any written
information complies with the applicable requirements of any
foreign jurisdiction; and
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5.3.4
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All reasonable
costs and expenses incurred by Wellness in complying with such
foreign requirement shall be negotiated between the Parties.
Mannatech shall provide prior written consent of the expenditures
prior to Wellness executing Mannatech’s request.
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5.4 Regulatory Agency Inspections
and Interactions . Wellness agrees to inform Mannatech of any
regulatory inspection and/or communications that might, in its best
judgment, affect the manufacture of the Water Technology. In the
event of an inspection by any government agency that affects the
Water Technology, Mannatech shall be immediately informed of the
issuance of the notice inspection or the presence of an inspector.
Mannatech shall have the right to attend the inspection at the
Facility. In the event there are written observations by any agency
that involve any of the Product Substances or the Product,
Mannatech shall have the opportunity to review and have input to
the response. Wellness shall be responsible for responding to any
notices of deficiencies and observations. If Mannatech elects to
provide input to the response, that input shall be provided by
Mannatech to Wellness as promptly as practicable.
6
5.5 Storage Requirements . Wellness shall
cause all Mannatech Materials and its Water Technology to be stored
in accordance with the Specifications, rules, laws and regulations,
where they apply.
5.6 Nonconforming Materials .
Wellness shall not knowingly use any materials that do not comply
with the Specifications. Wellness shall promptly contact Mannatech
in the event that Wellness anticipates making changes to the Water
Technology or in the event they consider any such material to be
nonconforming or unacceptable. If Wellness uses any nonconforming
material without prior written approval by Mannatech, Wellness
shall be responsible for all losses, costs and expenses suffered or
incurred by Mannatech as a result of such use and any expenses
incurred by Wellness in the correction thereof, provided that such
nonconformance did not arise due to the scheduling of planned
manufacturing that was postponed or cancelled by
Mannatech.
5.7 Quality Tests and Checks
. In accordance with paragraph 3.7 hereof, Wellness shall perform
all in-process and tests required of its Water Technology or checks
required by the Specifications, if applicable. For purposes of this
Agreement, such tests shall be considered routine and shall, where
internal testing is required, be performed by FCL at its
facilities. All tests and test results shall be performed,
documented and summarized by Wellness in accordance with the
Specifications. Test results shall be reviewed by Wellness prior to
release of test results to Mannatech.
5.8 Production Codes and
Records . Wellness shall maintain detailed records on the Water
Technology material usage, including, but not limited to, Raw
Materials, batch records, quality control reports, test data,
including technical, analytical, quantitative, and qualitative test
results in connection with the supply of the Water Technology.
Records shall be maintained according to requirements such that
Wellness shall be capable of responding to inquiries by Mannatech
within twenty-four (24) hours of notification.
5.9 Training . Where
necessary, Wellness shall educate and train those employees and
subcontractors of applicable requirements responsible for
performing the Services provided under this Agreement.
5.10 Inspections and Audits .
Subject to 3.3 hereof, Mannatech, or a designated representative
shall have access to the Facility, for the purpose of conducting
inspections, performing quality control audits or witnessing the
storage or transportation of the Water Technology or materials
related to or used in the qualification and development of
Products. Mannatech shall have access to the results of any tests
performed by Wellness or at its direction. Wellness shall use
commercially reasonable efforts to ensure that Mannatech has
similar access to the facilities, data and records of its suppliers
or manufacturers. Such inspections do not relieve Wellness of any
of its obligations under this Agreement or create new obligations
on the part of Mannatech. Inspections and audits by Mannatech
personnel hereunder shall be conducted upon reasonable notice,
during normal business hours and in compliance with the
confidentiality provisions set out in Section 12 hereof and
Wellness’ rules and regulations relating to facility
security, health and safety and confidentiality. Mannatech shall be
entitled to one (1) audit per year at no charge to
Mannatech.
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5.10.1
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Additional
audits shall be performed at Wellness’ expense in the event
of (a) recurring Water Technology failure,
(b) notification of non-compliance by regulatory authorities,
(c) review of any significant items identified in an annual
audit for which confirmation of conformance is required.
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5.11 Retention of Records and
Samples . Wellness shall for the duration required by any
governing regulatory agency, or as specified otherwise by Mannatech
in writing, whichever is longer, retain, and upon request by
Mannatech make available to Mannatech, (a) copies of the Batch
Records, quality control records maintained in accordance with
Section 5.13 and otherwise in relation to the Water Technology
(b) copies of testing results of all the tests performed in
relation to the Services or the Water Technology.
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At the termination of this Agreement, Mannatech
shall, upon the written request of Wellness, return all copies of
all documents, writings, invoices, test reports, and other memos
which are the property of Wellness and which have been shared with
Mannatech. The foregoing notwithstanding, Mannatech will be
permitted to retain batch records for a period of time in
accordance with its own policies and procedures and upon expiration
of such time period shall return the records to
Wellness.
5.12 Government Inspections and
Seizures . If the any federal, state or local governmental
authority makes an inspection of that portion of Wellness’
premises used to manufacture the Water Technology or Water
Technology, Wellness shall immediately notify Mannatech thereof.
The seized party shall promptly send retained samples of the seized
Water Technology by such authority and duplicate reports relating
to such inspections to Mannatech, provided such action does not
violate any applicable federal, state or local governmental
authority.
5.13 Legal/and Regulatory Filings
and Requests . Wellness and Mannatech shall cooperate and be
diligent in responding to all requests for information from, and on
making all required filings with, regulatory authorities having
jurisdiction to make such requests or require such filings.
Wellness shall obtain and comply with all licenses, consents,
permits and regulations which may from time to time be required by
appropriate legal and regulatory authorities with respect to the
performance of its obligations hereunder.
5.14 Quality Responsibilities
. Wellness will ensure that the manufacture of its Water Technology
is performed in accordance with all applicable requirements and
internal Wellness procedures and practices. Wellness shall ensure
that it maintains its facilities to comply with all laws, rules and
regulations. Mannatech and Wellness will each designate contact
persons relating to manufacture and quality control of the Water
Technology.
5.15 Lot Documentation .
Wellness shall keep such documentation as described in their
internal procedures to adequately conform to applicable
requirements. Each shipment of Water Technology as designated by
Wellness to FCL or to the destination as instructed by FCL shall be
accompanied by documentation (Certificate of Analysis). Wellness
will designate internally its own Lot numbers for the Water
Technology produced pursuant to the Agreement.
5.16 Lot and Batch Release .
Wellness shall test the Water Technology against the Specifications
described in the product specification. Wellness Quality Assurance
shall be responsible for review of the Water Technology batch
record and approval and release of the Water Technology. Upon Lot
approval by Wellness, a Certificate of Analysis for each Lot shall
be sent by Wellness to Mannatech.
5.17 Laboratory Services .
Wellness shall test the Water Technology against the pre-determined
release Specification. Wellness Quality Assurance shall be
responsible for review of the batch record and approval and release
of the Water Technology. Upon Lot approval by Wellness, a
Certificate of Analysis for each Lot shall be sent by Wellness to
Mannatech.
5.18 Use of Subcontractors .
In the event that Wellness proposes use of subcontractors for
particular laboratory services, Mannatech may require access to
these subcontractors for audit purposes. A Wellness representative
may accompany Mannatech on such audits. Any subcontractors shall be
subject to the confidentiality and other provisions set forth
herein.
5.19 Reprocessing . Reworking
or reprocessing of Batches or Lots will only be acceptable only if
approved by Mannatech QA.
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5.20 Product Complaints, Adverse Events, and
Product Recalls . Wellness shall have responsibility for
handling of complaints and adverse events related to its Water
Technology. Wellness shall provide technical support as needed in
the investigation of these events inasmuch as they relate to the
Water Technology manufactured at Wellness’ sole expense. In
the event of a Recall of Product, Mannatech shall be responsible
for the coordination of all Recall activities and have sole
decision regarding Recall of Product. For each Recall event, and
where the Recall is caused by Wellness’ gross negligence or
willful misconduct or its material breach of this Agreement, prior
to any reimbursement, Mannatech shall provide Wellness with
supporting documentation of all reimbursable costs and expenses,
respectively. Wellness’ sole responsibility, as it relates to
the costs of such Recall, shall be fully reimbursement to Mannatech
for all costs incurred for each Recall event.
5.20.1 If the Recall is not caused
by Wellness’ gross negligence, willful misconduct or material
breach under this Agreement, Mannatech shall pay all of the costs
and expenses of whatever nature for such Recall, and Wellness shall
have no responsibility to replace any of the recalled Product Lots
at its own expense.
5.20.2 Mannatech shall provide
Wellness with notice describing in reasonable detail any Recall. If
Wellness does not believe its actions or inactions caused the
Recall, then the Parties shall meet to determine in good faith
which Party should be liable for the Recall. Any situation
un-resolvable within thirty (30) days of the date of Recall
will then be forwarded to senior management sponsors of each Party
for resolution. If resolution is not resolvable within thirty
(30) days of such date, then each Party agrees to the
following: (a) each Party shall select an independent
consultant or laboratory; (b) the consultant or laboratory
selected by each Party shall mutually select a third independent
consultant or laboratory (the “Deciding Laboratory”)
and (c) the Deciding Laboratory shall review all relevant data
and determine which Party’s action or inaction resulted in
the need for a Recall. Mannatech shall provide Wellness with the
right to audit documents relating to direct costs incurred in
connection with a Recall subject to audit provisions in
Section 5 of this Agreement.
6. PRICE, TERMS OF PAYMENT,
ROYALTIES & LICENSE
6.1 Payment Terms . Mannatech
will purchase from Wellness its Water Technology at $.0161per ml.
Pricing shall include the cost of transportation via sea cargo ship
from Wellness’ production operation to the Manufacturer.
Payment terms are 50% down payment at the time of issuance of the
P.O. and the balance of 50% net 30 days delivery to Manufacturer.
Invoicing and payment shall be made in U.S. Dollars
(USD).
6.2 Taxes . The price set
forth in Section 6.1 is exclusive of sales taxes or any other
applicable taxes, levies, duties and fees imposed by or under the
authority of any government or public authority, which shall be
paid by Mannatech, either directly or as invoiced by Wellness.
Mannatech, however, is not responsible for taxes based on the
income of Wellness.
6.3 Invoicing of Product .
The Water Technology shall be invoiced per purchase
order.
6.4 Invoice Disputes . In the
event that Mannatech in good faith believes there is a dispute
concerning the applicability or accuracy of any invoice amount,
Mannatech will notify Wellness immediately in writing of the nature
of such dispute, and will provide detailed written support for such
disputed invoice amount, within ten (10) business days from
the receipt of the invoice. In such an event, the Parties shall
resolve such disputed amounts within thirty (30) days from the
receipt by Wellness of Mannatech’s written notice of the
disputed amount and Mannatech may withhold fifty percent
(50%) of the payment of such disputed amount for such thirty
(30) day period which withholding shall not be considered as a
breach, or default or as grounds for termination under this
Agreement.
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6.5 Financial Recordkeeping . Wellness
shall maintain financial records relating to the terms of this
Agreement and agrees that such records may be audited by an
independent public accountant selected by Mannatech and at
Mannatech’s expense, during normal business hours within a
three-month period following the initial Price calculation and
subsequent price adjustments. In addition, within the term of this
Agreement, Mannatech’s independent public accountant may
inspect Wellness’ time sheet records for the preceding year
for the purpose of determining costs paid in addition to the price
to Wellness by Mannatech. The independent public accountant shall
keep confidential any information obtained during such inspection
and shall report to Mannatech only the correctness of the
information given by Wellness.
6.6 Initial Price and Annual
Price Adjustments . The Initial Price for the first-year of
Water Technology is $.0161 per ml. Every year thereafter, the Price
shall be negotiated between the Parties, but in no event shall the
price increase more that five percent (5%) per annum unless
Wellness can demonstrate that real costs have increased beyond the
five percent (5%) per annum level. The Initial Price shall
remain valid for one year from the Effective Date. Two
(2) months prior to the anniversary date of the Effective Date
and every twelve (12) month period thereafter, the Price shall
be negotiated. Annual price adjustments shall be effective on the
anniversary date of the Effective Date. Wellness shall maintain
financial records relating to any increases in the cost to
manufacture Water Technology and agrees that such records may be
audited by an independent public accountant selected by Mannatech
during normal business hours within a three (3) month period
following the initial Price calculation and subsequent Price
adjustments.
6.7 Estimates/Forecasting .
On an annual basis, Mannatech and Wellness shall meet and discuss
Mannatech’s forecasted contract requirements for the Water
Technology. Mannatech shall provide Wellness with an estimate of
the quantity of the Water Technology that Mannatech anticipates may
be required from Wellness during the following year of the Term.
The Parties acknowledge that this estimate is for planning purposes
only and does not constitute a commitment to manuf