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COMMERCIAL LICENSING & ROYALTY AGREEMENT

Royalty Agreement

COMMERCIAL LICENSING & ROYALTY AGREEMENT | Document Parties: MANNATECH INC | Wellness Enterprises, LLC You are currently viewing:
This Royalty Agreement involves

MANNATECH INC | Wellness Enterprises, LLC

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Title: COMMERCIAL LICENSING & ROYALTY AGREEMENT
Governing Law: Delaware     Date: 3/16/2006
Industry: Biotechnology and Drugs    

COMMERCIAL LICENSING & ROYALTY AGREEMENT, Parties: mannatech inc , wellness enterprises  llc
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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

 

 

 

 

 

 

 

 

 

 

 

 

1.

  

DEFINITIONS

  

1

2.

  

SUPPLY OF MANNATECH MATERIALS

  

4

3.

  

WATER TECHNOLOGY

  

4

 

  

3.1

  

Technology

  

4

 

  

3.2

  

Product Specifications per Country.

  

4

 

  

3.3

  

Mannatech Representative in Facility

  

4

 

  

3.4

  

Time Schedule

  

5

 

  

3.5

  

Supply of Raw Materials for Product

  

5

 

  

3.6

  

Licenses and Permits

  

5

 

  

3.7

  

Health and Safety

  

5

4.

  

TRANSPORTATION OF PRODUCT AND DEFECTS

  

6

 

  

4.1

  

Shipping Instructions

  

6

 

  

4.2

  

Risk of Loss

  

6

5.

  

QUALITY ASSURANCE AND REGULATORY

  

6

 

  

5.1

  

Specifications

  

6

 

  

5.2

  

Regulatory Responsibilities

  

6

 

  

5.3

  

Regulatory Requirements

  

6

 

  

5.4

  

Regulatory Agency Inspections and Interactions

  

6

 

  

5.5

  

Storage Requirements

  

7

 

  

5.6

  

Nonconforming Materials

  

7

 

  

5.7

  

Quality Tests and Checks

  

7

 

  

5.8

  

Production Codes and Records

  

7

 

  

5.9

  

Training

  

7

 

  

5.10

  

Inspections and Audits

  

7

 

  

5.11

  

Retention of Records and Samples

  

7

 

  

5.12

  

Government Inspections and Seizures

  

8

 

  

5.13

  

Legal/and Regulatory Filings and Requests

  

8

 

  

5.14

  

Quality Responsibilities

  

8

 

  

5.15

  

Lot Documentation

  

8

 

  

5.16

  

Lot and Batch Release

  

8

 

  

5.17

  

Laboratory Services

  

8

 

  

5.18

  

Use of Subcontractors

  

8

 

  

5.19

  

Reprocessing

  

8

 

  

5.20

  

Product Complaints, Adverse Events, and Product Recalls

  

9

6.

  

PRICE, TERMS OF PAYMENT, ROYALTIES & LICENSE

  

9

 

  

6.1

  

Payment Terms

  

9

 

  

6.2

  

Taxes

  

9

 

  

6.3

  

Invoicing of Product

  

9

 

  

6.4

  

Invoice Disputes

  

9

 

  

6.5

  

Financial Recordkeeping

  

10

 

  

6.6

  

Initial Price and Annual Price Adjustments

  

10

 

  

6.7

  

Estimates/Forecasting

  

10

 

  

6.8

  

Orders

  

10

 

  

 

  

6.8.1

  

Initial Order

  

10

 

  

 

  

6.8.2

  

Purchase Orders

  

10

 

  

6.9

  

Royalties

  

11

 

  

 

  

6.9.1

  

Payment of Royalties

  

11


 

 

 

 

 

 

 

 

 

 

 

 

  

6.10

  

License of Haru Naito’s Story

  

11

7.

  

INTELLECTUAL PROPERTY

  

11

 

  

7.1

  

Protection of Technology

  

11

 

  

7.2

  

Confidentiality

  

12

 

  

7.3

  

Rights to Mannatech Technology and Mannatech Materials

  

12

 

  

7.4

  

Title to Inventions

  

12

 

  

7.5

  

Notice of Infringement

  

12

 

  

7.6

  

Notice of Infringement by One or Both Parties

  

12

 

  

7.7

  

Wellness Intellectual Property Representations

  

13

 

  

7.8

  

Survival

  

13

 

  

7.9

  

Trademarks and Tradenames

  

13

8.

  

FORCE MAJEURE

  

14

 

  

8.1

  

Force Majeure

  

14

 

  

8.2

  

Term of Force Majeure

  

14

9.

  

REPRESENTATIONS AND WARRANTIES

  

15

 

  

9.1

  

Mannatech Representations and Warranties

  

15

 

  

9.2

  

Wellness Representations and Warranties

  

15

 

  

 

  

9.2.1

  

Production

  

15

 

  

 

  

9.2.2

  

Organization

  

15

 

  

 

  

9.2.3

  

Wellness Authorization and Agreement

  

15

 

  

 

  

9.2.4

  

No Consent

  

15

 

  

 

  

9.2.5

  

Insurance

  

15

 

  

 

  

 

  

9.2.5.1

  

Commercial General Liability

  

16

 

  

 

  

 

  

9.2.5.2

  

Auto Liability

  

16

 

  

 

  

 

  

9.2.5.3

  

Worker’s Compensation

  

16

 

  

 

  

 

  

9.2.5.4

  

Commercial Umbrella Liability

  

16

 

  

 

  

 

  

9.2.5.5

  

Insurance to Wellness

  

16

 

  

 

  

9.2.6

  

Validity and Enforceability

  

16

 

  

 

  

9.2.7

  

No Breach

  

16

 

  

 

  

9.2.8

  

Compliance with Laws

  

17

 

  

9.3

  

Notice of Material Events

  

17

 

  

9.4

  

Survival

  

17

10.

  

DISCLAIMER; LIMITATION OF LIABILITY

  

17

11.

  

INDEMNIFICATION

  

18

 

  

11.1

  

Wellness’ Indemnification of Mannatech

  

18

 

  

11.2

  

Indemnification Procedure

  

18

 

  

11.3

  

Survival

  

19

12.

  

CONFIDENTIALITY OBLIGATIONS

  

19

 

  

12.1

  

Parties Confidential Information

  

19

 

  

12.2

  

Exclusions from Confidential Information

  

19

 

  

12.3

  

Term of Confidentiality

  

20

 

  

12.4

  

Necessary Disclosures

  

20

 

  

12.5

  

Limited Disclosure

  

20

 

  

12.6

  

Press Releases

  

20

 

  

12.7

  

Remedies

  

21

13.

  

TERM AND TERMINATION

  

21

 

  

13.1

  

Term

  

21

 

  

13.2

  

Termination with Cause

  

21

 

  

 

  

13.2.1

  

Material Breach

  

21

 

ii


 

 

 

 

 

 

 

 

 

 

 

 

  

 

  

13.2.2

  

Inaccurate Warranty

  

21

 

  

 

  

13.2.3

  

Termination Upon Insolvency or Sale of the Ass

  

21

 

  

13.3

  

Termination Date

  

22

 

  

13.4

  

Termination by Mannatech

  

22

 

  

 

  

13.4.1

  

Breach

  

22

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

  

13.4.2

  

Failure to Meet Quality Control Standards

  

22

 

  

 

  

13.4.3

  

Illegality

  

22

 

  

 

  

13.4.4

  

Fair Trade Practices

  

22

 

  

 

  

13.4.5

  

Termination Due to Regulatory Requirements

  

22

 

  

 

  

13.4.6

  

Termination for Failure to Meet Mannatech’s Production Requirements

  

23

 

  

13.5

  

Obligations of Mannatech upon Termination for Withdrawal from Commercial Product Sale

  

23

 

  

13.6

  

Obligations of Wellness upon Termination for Breach

  

23

 

  

 

  

13.6.1

  

Obligations of Wellness upon Termination for Breach

  

23

 

  

13.7

  

Termination of the Agreement with or without Cause

  

23

 

  

13.8

  

Infeasibility/Replacement

  

23

 

  

13.9

  

Termination by Wellness

  

23

 

  

 

  

13.9.1

  

Breach

  

23

 

  

 

  

13.9.2

  

Fair Trade Practices

  

23

14.

  

MISCELLANEOUS

  

24

 

  

14.1

  

Assignment

  

24

 

  

14.2

  

Information Sharing

  

24

 

  

14.3

  

Information in Support of this Agreement

  

24

 

  

14.4

  

Governing Law

  

24

 

  

14.5

  

Notices

  

24

 

  

14.6

  

Waiver

  

25

 

  

14.7

  

Severability

  

25

 

  

14.8

  

No Implied Licenses

  

25

 

  

14.9

  

Independent Contractors

  

25

 

  

14.10

  

Compliance With Laws

  

25

 

  

14.11

  

Entire Agreement

  

25

 

  

14.12

  

Counterparts

  

26

 

  

14.13

  

Schedules and Attachments

  

26

 

  

14.14

  

Independent Judgment

  

26

 

  

14.15

  

Ambiguities

  

26

 

  

14.16

  

Approval

  

26

 

  

14.17

  

Condition Precedent.

  

26

 

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

“Delivery Point” means the location as designated by Mannatech in each purchase order for Water Technology.

 

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.

 

3


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

 

4


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.

 

5


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:

 

 

5.3.1

Mannatech shall be responsible for informing Wellness in writing of the precise foreign requirements that Mannatech is requesting them to observe;

 

 

5.3.2

Such foreign requirements do not conflict with any applicable laws of the United States of America or any of the States;

 

 

5.3.3

Wellness shall use reasonable commercial efforts to ensure that any written information complies with the applicable requirements of any foreign jurisdiction; and

 

 

5.3.4

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.

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.

 

 

5.10.1

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.

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


 
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