MANUFACTURING AND PACKAGING AGREEMENT
Between
AQUA THIRST, INC.
And
PROTON LABORATORIES, INC.
Page 1 of 29
CONTENTS PAGE
ARTICLE 1 Definitions 3
ARTICLE 2 Validation, Manufacture, Packaging & Related Services 6
ARTICLE 3 Materials 7
ARTICLE 4 Minimum Commitment, Purchase Orders & Forecasts 8
ARTICLE 5 Testing; Samples; Release 10
ARTICLE 6 Delivery 11
ARTICLE 7 Pricing And Payment 11
ARTICLE 8 Changes To Specifications 13
ARTICLE 9 Records; Regulatory Matters 13
ARTICLE 10 Representations And Warranties 15
ARTICLE 11 Confidential Information 17
ARTICLE 12 Intellectual Property 17
ARTICLE 13 Indemnification 17
ARTICLE 14 Insurance 18
ARTICLE 15 Term And Termination 20
ARTICLE 16 Limitations Of Liability 21
ARTICLE 17 Notice 21
ARTICLE 18 Miscellaneous 22
EXHIBIT A: Per Product Manufacturing Specifications 24
EXHIBIT B: Per Product Packaging Specifications 25
EXHIBIT C: Per Product Additional Services/ Validation Services 26
EXHIBIT D: Per Product Unit Pricing, Fees And Minimum Requirement 27
EXHIBIT E: Per Product Form Of Quality Agreement 28
Page 2 of 29
MANUFACTURING AND PACKAGING AGREEMENT
This MANUFACTURING AND PACKAGING AGREEMENT ("Agreement") is made this 12th
day of February, 2007, by and between AQUA THIRST Inc. a Delaware Corporation
having its principal place of business at 0000 Xx. Xxxxxxxxx Xxxx, Xxxxx X-000
Xxx Xxxxxxx, Xxxxxxxxxx 00000 ("AQUA THIRST") and PROTON Laboratories, Inc., A
Washington Corporation having its principal place of business at 0000 Xxxxxxxx
Xxx. Xxx. 000 Xxxxxxx, Xxxxxxxxxx 00000 ("PROTON").
RECITALS:
A. AQUA THIRST is engaged in the business of manufacturing and packaging
new and existing products for the retail consumer and the commercial and
industrial industries, including analytical and sales and marketing services.
B. PROTON has certain patent rights technology and know-how relating to a
series of products either crated by PROTON or licensed to PROTON and or too be
developed by PROTON.
C. PROTON desires to contract with a business capable of formulating,
filling, manufacturing, packaging and testing products, In order to bring its
product line to the marketplace.
D. PROTON desires to engage AQUA THIRST to provide certain services to
PROTON in connection with the manufacture and packaging the Product(s)
(Identified and defined below); and AQUA THIRST desires to provide such services
pursuant to the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms and
conditions set forth below, the parties agree as follows:
ARTICLE 1
DEFINITIONS
The following terms have the following meanings in this Agreement:
1.1 "Administrative Costs" means all costs related to conducting a recall in
accordance with Applicable Laws.
1.2 "Affiliate(s)" means any corporation, firm, partnership or other entity
which controls, is controlled by or is under common control with a party.
For purposes of this definition, "control" shall mean the ownership of at
least fifty percent (50%) of the voting share capital of such entity or any
other comparable equity or ownership interest.
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1.3 "Applicable Laws" means all laws, ordinances, rules and regulations within
the Territory applicable to the Manufacturing and Packaging of the Product
or any aspect thereof and the obligations of AQUA THIRST or PROTON, as the
context requires under this Agreement, including, without limitation, (i)
all applicable federal, state and local laws and regulations of each
Territory; (ii) the U.S. Federal Food, Drug and Cosmetic Act, and (iii) the
current Good Manufacturing Practices promulgated by the Regulatory
Authorities, as amended from time to time ("GMPs").
1.4 "Calendar Quarter" means a period of three (3) consecutive months
commencing on January 1, April 1, July 1 or October 1 of any calendar year.
1.5 "AQUA THIRST Information" shall have the meaning set forth in Article 12.
1.6 "Change Order" shall have the meaning set forth in Section 4.5(a).
1.7 "Commencement Date" means the first date upon which AQUA THIRST
manufactures the Product.
1.8 "Confidential Information" is as defined in Section 11.2.
1.9 "Contract Year" means each consecutive twelve (12) month period beginning
on the Commencement Date.
1.10 "PROTON Information" shall have the meaning set forth in Article 12.
1.11 "Defective Product" shall have the meaning set forth in Section 5.3.
1.12 "Delivery Date" shall mean the date on which AQUA THIRST shall tender the
relevant completed product to PROTON. Each Delivery Date shall be specified
by PROTON on the relevant Purchase Order and confirmed by AQUA THIRST as
set forth in paragraph 4.3.
1.13 "Dispute" shall have the meaning set forth in Section 18.9.
1.14 "Effective Date" means the date first written above.
1.15 "FDA" means the United States Food and Drug Administration.
1.16 "Firm Commitment" shall have the meaning set forth in Section 4.2.
1.17 "Manufacture" or "Manufacturing" means the compounding, encapsulation and
inspection of the Product in the primary packaging in accordance with the
Specifications and the terms and conditions set forth in this Agreement.
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1.18 "Manufacture Date" means the day on which the Product is to be compounded
by AQUA THIRST at the Manufacturing Facilities, which shall not be more
than 75 days prior to the relevant Delivery Date.
1.19 "Manufacturing Facilities" means AQUA THIRST'S facilities or third party
facilities employed or contracted by AQUA THIRST
1.20 "Manufacturing Specifications" means the Manufacturing specifications set
forth in Exhibit A.
1.21 "Minimum Requirement" shall have the meaning set forth in Section 4.1.
1.22 "Package" or "Packaging" means the labeling and the packaging of the
Product into the secondary packaging in accordance with the Packaging
Specifications and the terms and conditions of this Agreement.
1.23 "Packaging Facilities" means AQUA THIRST'S facilities, or third party
facilities employed or contracted by AQUA THIRST
1.24 "Packaging Specifications" means the Packaging specifications set forth in
Exhibit B.
1.25 "Product" means any and all products to which PROTON has patents, patent
rights, Licenses, or which are or will be developed by PROTON or by or
through PROTON'S contractors, as fully compounded finished product which
has been Manufactured and Packaged in accordance with the Specifications.
1.26 "Purchase Order" shall have the meaning set forth in Section 4.3.
1.27 "Raw Materials" means all raw materials, supplies, components and packaging
necessary to manufacture, package and ship the Product in accordance with
the Specifications.
1.28 "Regulatory Approval" shall have the meaning set forth in Section 7.4.
1.29 "Regulatory Authority" means any governmental regulatory authority within a
Territory involved in regulating any aspect of the development,
manufacture, market approval, sale, distribution, packaging or use of the
Product.
1.30 "Review Period" shall have the meaning set forth in Section 5.1.
1.31 "Rolling Forecast" shall have the meaning set forth in Section 4.2.
1.32 "Sample" shall have the meaning set forth in Section 5.1.
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1.33 "Specifications" means, collectively, the Manufacturing Specifications and
the Packaging Specifications.
1.34 "Term" shall have the meaning set forth in Section 15.1.
1.35 "Territory" means the United States of America, Canada and any other
country which the parties agree in writing to add to this definition of
Territory in an amendment to this Agreement.
1.36 "Unit" means each individually Packaged unit of Product, as described more
fully in the Specifications.
1.37 "Unit Pricing" shall have the meaning set forth in Section 7.1.
ARTICLE 2
VALIDATION, MANUFACTURE, PACKAGING & RELATED SERVICES
2.1 VALIDATION SERVICES. AQUA THIRST shall perform the qualification,
validation and stability services described in EXHIBIT C of this Agreement
for the prices specified therein, in addition AQUA THIRST will be
responsible for and secure for PROTON all or any appropriate regulatory
certifications, approvals, or permits i.e. NSF, EPA, FDA, etc. all costs
and expenses associated therewith shall be immediately reimbursed by PROTON
upon invoice therefore.
2.2 DELIVERY AND ACCEPTANCE. The parties shall develop a work plan for each
product to be manufactured by AQUA THIRST for PROTON which shall include
the procedures for final testing of each Product developed to determine
whether the Product materially conforms to the applicable Specifications in
the Work Plan. As set forth in further detail in the Work Plan, PROTON will
provide AQUA THIRST with a written acceptance of the Product or one or more
written statements of errors to be corrected (a "STATEMENT OF ERRORS"). If
PROTON fails to provide AQUA THIRST with written acceptance or Statement of
Errors within the period of time set forth in the Work Plan, then the
Product will be deemed accepted. If PROTON provides AQUA THIRST with a
Statement of Errors, then AQUA THIRST shall promptly correct such errors
and thereafter make the Product available for re-testing. The foregoing
procedure will be repeated until PROTON accepts or finally rejects each
Product. Upon acceptance of the Product, AQUA THIRST will make the Product
available for use to the commercial market and to end users, or conduct
such other activities to make the Product available as described in the
Work Plan.
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2.3 SUPPLY AND PURCHASE OF PRODUCT. During the Term, AQUA THIRST shall
Manufacture and Package the Products in accordance with the Specifications,
the Applicable Laws, the work plan and the terms and conditions of this
Agreement. PROTON'S purchases of the Product from AQUA THIRST shall be in
accordance with the terms and conditions of this Agreement.
2.4 AQUA THIRST will manufacture all of PROTON'S products either directly or
through sub-contractors and agrees that no product containing proprietary
information will be manufactured off shore. All products shall be
manufactured by AQUA THIRST on an exclusive basis under the following
conditions:
a. There is an exclusive agreement between PROTON and a company called
E Water of Life regarding a veterinary product called Xx. Xxxxx'x Formula,
AQUA THIRST shall have no involvement with this excluded product, which
must be sold only for the Veterinary market.
b. Any product that AQUA THIRST in not capable of manufacturing or
having manufactured by its sub-contractors within 160 days of PROTON
submitting that product and specifications to AQUA THIRST, will be excluded
from this Exclusive agreement.
2.5 OTHER RELATED SERVICES. AQUA THIRST may provide other services upon terms
and conditions agreed to from time to time by the parties in writing.
ARTICLE 3
MATERIALS
3.1 ARTWORK AND PACKAGING. PROTON shall provide or approve, prior to the
procurement of applicable components, all artwork, advertising and packaging
information necessary to Manufacture or Package the Product. Such artwork,
advertising and packaging information is and shall remain the exclusive property
of PROTON, and PROTON shall be solely responsible for the content thereof. Such
artwork, advertising and packaging information or any reproduction thereof may
not be used by AQUA THIRST following the termination of this Agreement, or
during the Term of this Agreement in any manner other than solely for the
purpose of performing its obligations hereunder.
3.2 TECHNICAL DATA SHEETS, INSTRUCTION MANUALS. PROTON shall provide or approve
the use of information which may be included with any product which shall be
manufactured and packaged in accordance with the terms of this agreement.
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3.3 REIMBURSEMENT FOR MATERIALS. In the event of (i) a Specification change
requested by PROTON or AQUA THIRST for PROTON'S benefit and agreed to by the
parties or to comply with any new requirement of a Regulatory Authority, (ii)
termination by PROTON without cause or expiration of this Agreement; or (iii)
unforeseeable obsolescence of any Raw Material, PROTON shall bear the cost of
any unused Raw Materials which cannot be otherwise used by AQUA THIRST nor
returned for credit, provided that AQUA THIRST purchased such Raw Materials in
quantities consistent with PROTON'S most recent Firm Commitment and the
supplier's minimum purchase obligations.
ARTICLE 4
MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS
4.1 MINIMUM ORDERS. During each Contract Year, PROTON shall order the minimum
number of units of Product ("Minimum Orders") set forth on EXHIBIT D. If PROTON
does not purchase such Minimum Orders during any Contract Year, within thirty
(30) days after the end of such Contract Year, PROTON shall pay AQUA THIRST the
difference between (i) the total amount PROTON would have paid to any supplier
or sub-contractor. if the Minimum Orders had been fulfilled for the Product
(calculated using an average product price as shown in EXHIBIT D) and (ii) the
sum of (a) all purchases from AQUA THIRST for the Product during the
just-concluded Contract Year plus (b) AQUA THIRST'S cost of all Raw Materials
for that portion of the Minimum Orders not placed. For clarity, PROTON shall not
be obligated to pay for any Product ordered but not delivered by AQUA THIRST in
accordance with this Agreement.
4.2 FORECAST. On or before the first (1st) day of each calendar month following
the Commencement Date and at least four months prior to the first Delivery Date,
PROTON shall furnish to AQUA THIRST a written twelve (12) month rolling forecast
of the quantities of Product that PROTON intends to order from AQUA THIRST
during such period ("Rolling Forecast"). The first 3 months of such Rolling
Forecast shall constitute a binding commitment for the quantities of Product
specified therein ("Firm Commitment") and the following 9 months of the Rolling
Forecast shall be non-binding, good faith estimates.
4.3 PURCHASE ORDERS. At least quarterly, PROTON shall submit purchase orders for
the Firm Commitment portion of the Rolling Forecast, which specify the actual
number of units to be Manufactured and Packaged, the approximate number of Units
in each order, and the requested Delivery Dates therefore ("Purchase Order").
PROTON shall submit each Purchase Order to AQUA THIRST at least one hundred and
twenty (120) days in advance of the earliest Delivery Date requested in the
Purchase Order. AQUA THIRST will confirm such Delivery Dates within fifteen (15)
business days of receipt of the Purchase Order. If AQUA THIRST indicates within
such 15-day period that it is unable to meet any such delivery date, the parties
will work together in good faith to set an amended delivery date or dates. In
the absence of such indication, the Delivery Date(s)
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shall be deemed accepted. In the event of a conflict between the terms of any
Purchase Order and this Agreement, this Agreement shall control. Notwithstanding
the foregoing, AQUA THIRST shall supply PROTON with quantities of Product which
exceed by not more than 25% the quantities specified in the Firm Commitment, and
shall use commercially reasonable efforts to supply additional excess quantities
requested by PROTON.
4.5 CUSTOMER'S MODIFICATION OR CANCELLATION.
(a) At any time up to 90 days prior to any relevant Delivery Date, PROTON
may cancel a Purchase Order or request a modification of the confirmed Delivery
Date Specifications or quantity of Product in such Purchase Order by submitting
a written change order ("Change Order") to AQUA THIRST. If a Change Order is
submitted less than 90 days prior to the relevant Delivery Date, such Change
Order shall be effective and binding against AQUA THIRST only upon the written
approval of AQUA THIRST, which approval shall not be unreasonably withheld.
Notwithstanding the foregoing, PROTON shall remain responsible for the Firm
Commitment portion of the Rolling Forecast.
(b) Notwithstanding any amounts due to AQUA THIRST under Section 4.1, if
PROTON fails to place Purchase Orders sufficient to satisfy the Firm Commitment,
PROTON shall, within thirty (30) days of receipt of invoice, pay to AQUA THIRST
the difference between (i) the Unit Price for all Units that would have been
Manufactured and Packaged if PROTON had placed Purchase Orders sufficient to
satisfy the Firm Commitment and (ii) AQUA THIRST'S cost of any Raw Materials
that would have been used in such Units. Any amounts paid under this paragraph
shall be credited against any amounts subsequently due for failure to meet
Minimum Orders under paragraph 4.1.
4.6 UNPLANNED DELAY OR ELIMINATION OF MANUFACTURE OR PACKAGING. AQUA THIRST
shall timely fill each Purchase Order, subject to the terms and conditions of
this Agreement. AQUA THIRST shall notify PROTON within fifteen (15) days of
receipt of any Firm Commitment or Purchase Order if AQUA THIRST determines that
any Manufacturing or Packaging will be delayed or eliminated for any reason,
provided however that such notice shall not relieve AQUA THIRST of any of its
obligations, absent written consent of PROTON.
4.7 CUSTOMER INSPECTION. PROTON may base up to two (2) representatives at the
Facilities to observe, subject to AQUA THIRST'S reasonable measures in
furtherance of its obligations to protect the confidential information of third
parties, the Manufacturing and Packaging provided that PROTON provide AQUA
THIRST at least ten (10) days advance written notice of the attendance of such
PROTON representatives. PROTON will specify whether PROTON will observe the
Manufacturing, Packaging, or both. Such inspection may include inspection for
proper use and confidentiality of PROTON intellectual property. Any information
received or observed by PROTON representatives
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shall be treated in accordance with the terms of the Confidentiality Agreement
between the parties. PROTON shall indemnify and hold harmless AQUA THIRST for
any action or activity of such representatives while on AQUA THIRST'S premises.
ARTICLE 5
TESTING; SAMPLES; RELEASE
5.1 TESTING; ACCEPTANCE. Within twelve (12) business days after AQUA THIRST
completion of compounding, filling, and or manufacturing and packaging of each
order and not later than 12 business days prior to the relevant Delivery Date,
AQUA THIRST shall deliver to PROTON any product samples that may be required
under the term and guidelines of this agreement.
5.2 DISAGREEMENTS REGARDING PRODUCT CONFORMITY. In the event of a disagreement
between the parties as to whether the Product meets the Specifications, the
parties shall cause a mutually acceptable independent laboratory to review
records, test data and to perform the tests and/or analyses set forth in the
Specifications on samples of the alleged Defective Product. The independent
laboratory's results shall be final and binding. Unless otherwise agreed to by
the parties in writing, the costs associated with such testing and review shall
be borne by the party which was incorrect about whether the Product meets the
Specifications.
5.3 REPLACEMENT OF DEFECTIVE PRODUCT. In accordance with the terms set forth in
this Agreement, AQUA THIRST shall replace, at its sole expense, all Product that
does not comply with the warranty in Section 10.1 ("Defective Product"). THE
OBLIGATION OF AQUA THIRST TO REPLACE DEFECTIVE PRODUCT OR CREDIT PROTON IN
ACCORDANCE WITH SECTION 5.1 SHALL BE SUBJECT TO SECTION 16.1 AND SHALL BE
PROTON'S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY INDEMNIFICATION
OBLIGATIONS UNDER SECTION 13.1 OR THE OBLIGATIONS OF SECTION 9.5 (RECALL)) UNDER
THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY,
EXPRESS OR IMPLIED.
5.4 SUPPLY OF MATERIAL FOR DEFECTIVE PRODUCT. In the event AQUA THIRST is
required to replace Product pursuant to Section 5.3, above, in no instance shall
AQUA THIRST be liable for damages in excess of fees paid for the Defective
Product, subject to the limitation of liability in Section 16.1 (without
prejudice to any indemnification obligations under section 13.1 or the
obligations of section 9.5 (Recall)).
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ARTICLE 6
DELIVERY
6.1 DELIVERY. AQUA THIRST shall segregate and store all PROTON products until
acceptance as set forth in Section 5.1 above. Upon such acceptance, AQUA THIRST
shall tender the Product for delivery and subsequent shipment, F.O.B. the PROTON
Facility. PROTON shall be responsible for all costs and risk of loss associated
with shipment of the Product. PROTON shall qualify at least one (1) carrier to
ship the Product from AQUA THIRST or its sub-contractor to PROTON.
6.2 FAILURE TO TAKE DELIVERY. If PROTON fails to provide for shipment of Product
within seven (7) business days after acceptance, PROTON shall be invoiced on the
first day of each month thereafter for reasonable administration and storage
costs. For each such Unit of accepted but unshipped Product, PROTON agrees that:
(i) PROTON has made a fixed commitment to purchase such Product, (ii) title to
such Product passes to PROTON, (iii) such Product shall be on a xxxx and hold
basis for legitimate business purposes, (iv) if no shipment date is determined
at the time of billing, AQUA THIRST shall have the right to ship the Product to
PROTON or PROTON'S designee within four months after billing, and (v) PROTON
will be responsible for any decrease in market value of such Product that
relates to factors and circumstances outside of AQUA THIRST'S control. Within
five (5) days following a notice of request from AQUA THIRST, PROTON shall
provide AQUA THIRST with a letter confirming items (i) through (v) of this
Section for each Unit of undelivered Product.
ARTICLE 7
PRICING AND PAYMENT
7.1 AQUA THIRST will manufacture or arrange for the manufacture of all PROTON
products, whether now existing or to be developed in the future, such
arrangement shall be on an exclusive basis except as defined and set forth in
paragraph 2.4.
7.2 COMPENSATION. AQUA THIRST will charge PROTON a commission/override of thirty
percent (30%) on the actual cost of the manufacturing and packaging for each
product. This commission/override may at the sole discretion of AQUA THIRST be
taken either in the form of cash, or PROTON stock, provided however, that AQUA
THIRST may not accept stock in lieu of cash payment at any time that acceptance
of such stock would make AQUATHIRST or its officers, directors or control
persons a 10% or greater stockholder in PROTON, If AQUA THIRST elects to be paid
in PROTON stock, AQUA THIRST shall be paid with stock based on a twenty-five
percent (25%) reduction from the trading price for such stock, this price
reduction shall be
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determined by averaging the previous 30 day trading value for the said shares,
and such shares shall have piggy-back registration rights.
7.3 ALL OUT OF POCKET COSTS OF AQUA THIRST TO BE PAID BY PROTON. UNIT PRICING
PROTON shall pay to AQUA THIRST the unit pricing set forth on EXHIBIT D ("Unit
Pricing") for all Product In the event PROTON requests services other than
Manufacturing or Packaging of Product, AQUA THIRST shall provide a written quote
of the fee for such additional services and PROTON shall advise AQUA THIRST
whether it wishes to have such additional services performed by AQUA THIRST.
7.4 PRICE ADJUSTMENT. The Unit Pricing may be adjusted on an annual basis,
effective on each anniversary date of this Agreement, upon sixty (60) days prior
written notice from AQUA THIRST to PROTON. Such adjustment shall be based on
actual increases or decreases in relevant labor and/or materials costs, subject
to the following limitations:
a. The Unit Pricing for Product shall include but not be limited to:
(i) the cost of Raw and packaging materials and (ii) processing, i.e.
manufacturing, compounding, filling, testing (including any clinical
testing) regulatory certification activity, general business expenses
and packaging. Any price adjustment shall limit the increase in
component (ii) to not more than the increase in the most recent
calendar year Producer Price Index, by appropriate Industry: as
published by the U.S. Department of Labor, Bureau of Labor Statistics.
AQUA THIRST agrees to provide back-up documentation of labor and/or
materials costs for all annual increases and such costs and related
documentation shall be auditable upon reasonable notice, by an
independent third party reasonably acceptable to PROTON and AQUA
THIRST.
7.5 TAXES; DUTY. All taxes, duties and other amounts assessed by government
authorities on the Product upon or after sale to PROTON are the responsibility
of PROTON, and PROTON shall reimburse AQUA THIRST for any such taxes, duties or
other amounts paid by AQUA THIRST.
7.6 PRODUCT APPROVAL. Notwithstanding the terms set forth above, PROTON and AQUA
THIRST shall use their commercially reasonable efforts to expedite and obtain
all regulatory approvals as may be necessary for AQUA THIRST to commence
production at the Manufacturing Facility and the Packaging Facility ("Regulatory
Approvals"), and in the event such Regulatory Approvals have not been obtained
by AQUA THIRST, through no fault of AQUA THIRST, within thirty (30) months
following the Effective Date, provided that AQUA THIRST installs and qualifies
the equipment required by PROTON within ninety (90) days following the Effective
Date, then PROTON shall pay to AQUA THIRST a monthly fee as provided in EXHIBIT
D ("Delayed Approval Fee") until
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such Regulatory Approvals have been obtained and AQUA THIRST is able to commence
production.
7.7 PAYMENT TERMS. AQUA THIRST shall invoice PROTON for all product as provided
in Section 5.1, and payment for the undisputed portions of such invoices shall
be due within forty-five (45) days after the date of such invoice. In the event
payment is not received by AQUA THIRST on or before the forty-fifth (45th) day
after the date of the invoice, then such unpaid amount shall accrue interest
each month at the rate of one percent (1%) per month until paid in full.
ARTICLE 8
CHANGES TO SPECIFICATIONS
All Specifications and any changes thereto agreed to by the parties from
time to time shall be in writing, dated and signed by the parties. No change in
the Specifications shall be implemented by AQUA THIRST, whether requested by
PROTON or requested or required by any Regulatory Authority, until the parties
have agreed in writing to such change, the implementation date of such change,
and any increase or decrease in costs, expenses or fees associated with such
change. AQUA THIRST shall respond promptly to any request made by PROTON for a
change in the Specifications, and both parties shall use commercially
reasonable, good faith efforts to agree to the terms of such change in a timely
manner. If after initial Product qualification PROTON requires a change in the
Specifications for its own benefit or to comply with the requirements of any
Regulatory Authority, the Specifications shall be amended and as soon as
possible after a request is made for any change in Specifications, AQUA THIRST
shall notify PROTON of the costs associated with such change and shall provide
such supporting documentation as PROTON may reasonably require. PROTON shall pay
all costs associated with such PROTON-requested or regulatory required changes.
Agreed changes to the Specifications for the benefit of PROTON shall be at the
expense of PROTON. If there is a conflict between the terms of this Agreement
and the terms of the Specifications, this Agreement shall control.
ARTICLE 9
RECORDS; REGULATORY MATTERS
9.1 RECORDKEEPING. AQUA THIRST shall maintain true and accurate books,
records, test and laboratory data, reports and all other information relating to
Manufacturing and Packaging under this Agreement, including all information
required to be maintained by the Specifications and all Applicable Laws. Such
information shall be maintained in forms, notebooks and records for a period of
at least two (2) years from the relevant finished Product expiration date or
longer if required under Applicable Laws.
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9.2 REGULATORY COMPLIANCE. Except as provided in the next sentence, PROTON shall
be solely responsible for all permits and licenses required by any regulatory
agency with respect to the Product and the Manufacturing and Packaging under
this Agreement, including any product licenses, applications and amendments in
connection therewith. AQUA THIRST will be responsible to maintain all permits
and licenses required by any Regulatory Authority with respect to the
Manufacturing Facility, Packaging Facility and the equipment in such facilities.
During the Term, AQUA THIRST will assist PROTON in its regulatory matters
relating to the Manufacturing and Packaging as described above, at PROTON'S
request and at PROTON'S expense. Each party intends and commits to cooperate to
satisfy all Applicable Laws with respect to Manufacturing and Packaging under
this Agreement.
9.4 GOVERNMENTAL INSPECTIONS AND REQUESTS. AQUA THIRST shall immediately advise
PROTON if an authorized agent of any Regulatory Authority visits either the
Manufacturing Facility or the Packaging Facility if related to the Manufacturing
or Packaging of the Product. AQUA THIRST shall furnish to PROTON a copy of the
report by such Regulatory Authority, if any, within ten (10) days of AQUA
THIRST'S receipt of such report. Further, upon receipt of a Regulatory Authority
request to inspect the Facilities or audit AQUA THIRST books and records with
respect to Manufacturing or Packaging under this Agreement, AQUA THIRST shall
immediately notify PROTON, and shall provide PROTON with a copy of any written
document received from such Regulatory Authority and AQUA THIRST shall permit
PROTON to have a representative present for any such Facility inspection unless
such presence would be unreasonable under the circumstances. Absence of a PROTON
representative shall not impede any such inspection, provided AQUA THIRST has
complied with the foregoing. To the extent related to Manufacturing or Packaging
hereunder, AQUA THIRST shall provide to PROTON a copy of any proposed written
response to any such inspection prior to its submission and a reasonable
opportunity for PROTON to review and approve such response, provided that such
approval shall not be unreasonably withheld.
9.5 RECALL. In the event AQUA THIRST believes a recall, field alert, Product
withdrawal or field correction may be necessary with respect to any Product
provided under this Agreement, AQUA THIRST shall immediately notify PROTON in
writing. AQUA THIRST will not act to initiate a recall, field alert, Product
withdrawal or field correction without the express prior written approval of
PROTON, unless otherwise required by Applicable Laws. In the event PROTON
believes a recall, field alert, Product withdrawal or field correction may be
necessary with respect to any Product provided under this Agreement, PROTON
shall immediately notify AQUA THIRST in writing and AQUA THIRST shall provide
all necessary cooperation and assistance to PROTON. The cost of any recall,
field alert, Product withdrawal or field correction shall be borne by PROTON
except to the extent such recall, field alert, Product withdrawal or field
correction is caused by AQUA THIRST'S breach of its warranties,
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representations or obligations under this Agreement or Applicable Laws or its
negligence or willful misconduct, then such cost shall be borne by AQUA THIRST.
For purposes hereof, such cost shall be limited to reasonable, actual and
documented Administrative Costs incurred by PROTON for such recall, withdrawal
or correction, and replacement of the Defective Product to be recalled, in
accordance with Article 5. PROTON shall solely control the implementation of any
such recall, field alert, withdrawal or field correction.
9.6 QUALITY AGREEMENTS. Within six (6) months following the execution of this
Agreement, the parties shall execute a Quality Agreement in substantially the
form attached to this Agreement as EXHIBIT E. The Quality Agreement shall in no
way determine liability or financial responsibility of the parties for the
responsibilities set forth therein. In the event of a conflict between the terms
of this Agreement and the Quality Agreement, this Agreement shall control.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
10.1 LIMITED WARRANTY. AQUA THIRST represents and warrants to PROTON that at the
time of delivery of the Product as provided in Section 6.1, such Product will
conform to and will have been Manufactured and Packaged in conformance with the
Product Specifications and Applicable Laws. THE LIMITED WARRANTY SET FORTH IN
THIS SECTION 10.1 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY, WARRANTY OF NON-INFRINGEMENT AND ANY
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSED
IN THIS ARTICLE 10, AQUA THIRST MAKES NO OTHER WARRANTY, AND DISCLAIMS ALL
WARRANTIES EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE MANUFACTURING,
PACKAGING OR THE PRODUCT.
10.2 RELEASE RESPONSIBILITY. The party responsible for release of the finished
Product warrants that it will not release any UNIT of Product if the required
Certificates of Analysis indicate that the Product does not comply with the
Specifications.
10.3 ARTWORK. PROTON shall indemnify and hold harmless AQUA THIRST from any
damages or costs caused by infringement of the artwork provided by PROTON to
AQUA THIRST on any third party's intellectual property rights, including, but
not limited to, copyright, trademark or trade name or by failure of such artwork
to comply with all Applicable Laws, except to the extent that any of the
foregoing arises out of or results from the breach by AQUA THIRST of its
representations, warranties or obligations under this Agreement, or the
negligence or willful misconduct of AQUA THIRST.
Page 15 of 29
10.4 INTELLECTUAL PROPERTY. PROTON represents and warrants to AQUA THIRST that
PROTON has all necessary authority and right title or interest in and to any
copyrights, trademarks, trade secrets, patents, inventions, know-how and
developments related to the Product ("Intellectual Property") which right, title
or interest is necessary to the manufacture thereof, and PROTON hereby grants to
AQUA THIRST a non-exclusive, royalty-free license to use any and all of such
right title and interest to the extent necessary for AQUA THIRST to perform its
obligations under this Agreement. AQUA THIRST shall use such Intellectual
Property, whether supplied by PROTON or a third party, solely for the purpose of
performing such obligations. In addition, PROTON shall indemnify and hold
harmless AQUA THIRST against any damages or costs arising from the violation or
infringement upon any trademark, trade name, copyright, patent or other rights
held by any person or entity in the making of Product in accordance with the
Specifications, except to the extent that any of the foregoing arises out of or
results from the breach by AQUA THIRST of its representations, warranties or
obligations under this Agreement, or the negligence or willful misconduct of
AQUA THIRST. AQUA THIRST shall not use any disclosure hereunder of such
Intellectual Property nor any confidential information of PROTON to challenge
the validity or enforceability of such Intellectual Property.
10.5 EXISTENCE AND POWER. Each party hereby represents and warrants to the other
party that such party (i) is duly organized, validly existing and in good
standing under the laws of the state in which it is organized, (ii) has the
power and authority and the legal right to own and operate its property and
assets, and to carry on its business as it is now being conducted, and (iii) is
in compliance with all requirements of applicable law, except to the extent that
any noncompliance would not materially adversely affect such party's ability to
perform its obligations under the Agreement.
10.6 AUTHORIZATION AND ENFORCEMENT OF OBLIGATIONS. Each party hereby represents
and warrants to the other party that such party (i) has the power and authority
and the legal right to enter into this Agreement and to perform its obligations
hereunder and thereunder and (ii) has taken all necessary action on its part to
authorize the execution and delivery of the Agreement and the performance of its
obligations hereunder. The Agreement has been duly executed and delivered on
behalf of such party, and constitutes a legal, valid, binding obligation,
enforceable against such party in accordance with its terms.
10.7 NO CONSENTS. Each party hereby represents and warrants to the other party
that all necessary consents, approvals and authorizations of all agencies and
other persons required to be obtained by such party in connection with the
Agreement have been obtained.
10.8 NO CONFLICT. Each party hereby represents and warrants to the other party
that the execution and delivery of this Agreement and the performance of such
party's obligations hereunder (i) do not conflict with or violate any
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requirement of applicable laws or regulations or any material contractual
obligation of such party and (ii) do not materially conflict with, or constitute
a material default or require any consent under, any material contractual
obligation of such party.
ARTICLE 11
CONFIDENTIAL INFORMATION
11.1 The use and disclosure of confidential information exchanged between the
parties shall be governed by the Confidentiality Agreement by and among PROTON,
and AQUA THIRST
ARTICLE 12
INTELLECTUAL PROPERTY
Subject to the foregoing Confidentiality Agreement, all AQUA THIRST
Information, including without limitation, all improvements, developments,
derivatives or modifications to the AQUA THIRST Information, shall be owned
exclusively by AQUA THIRST. All PROTON Information, including, without
limitation, all improvements, developments, derivatives or modifications to the
PROTON Information shall be owned exclusively by PROTON. PROTON grants AQUA
THIRST a non-exclusive, royalty-free license for the term of this Agreement to
use PROTON Information, but solely for the purpose of carrying out AQUA THIRST'S
obligations hereunder. For purposes hereof, "AQUA THIRST Information" means all
AQUA THIRST proprietary information, intellectual property, and developments
(including, all patents, patent applications, know-how, inventions, designs,
concepts, improvements, technical information, manuals, instructions or
specifications), owned, licensed or used by AQUA THIRST in developing,
formulating, manufacturing, filling, processing or packaging products and the
packaging equipment, processes or methods of packaging, or any improvements to
any of the foregoing, including any container, pouch, vial, ampoule or other
form of container developed by AQUA THIRST in each case prior to the date of
this Agreement. For purposes hereof, "PROTON Information" means all proprietary
information, intellectual property and developments owned, developed, licensed
or used by PROTON relating to its products, including, without limitation,
patents, patent applications, know-how, inventions, designs, concepts,
improvements, technical information, trademarks or trade names, developed by
PROTON in each case prior to the date of this Agreement. Ownership of
intellectual property and improvements related to the Product shall be governed
exclusively by the Confidentiality Agreement.
ARTICLE 13
INDEMNIFICATION
13.1 INDEMNIFICATION BY AQUA THIRST. AQUA THIRST shall indemnify and
hold harmless PROTON, its Affiliates, directors, officers, employees and agents
Page 17 of 29
from and against any suits, claims, losses, demands, liabilities, damages, costs
and expenses (including costs, reasonable attorney's fees and reasonable
investigative costs) in connection with any suit, demand or action by any third
party arising out of or resulting from any negligence, willful misconduct or
breach of this Agreement by AQUA THIRST, except to the extent that such breach,
negligence or willful misconduct arises out of or results from the breach of its
representations, warranties or obligations under this Agreement by PROTON or the
negligence or willful misconduct of PROTON.
13.2 INDEMNIFICATION BY PROTON. PROTON shall indemnify and hold harmless AQUA
THIRST, its Affiliates, directors, officers employees and agents from and
against all suits, claims, losses, demands, liabilities, damages, costs and
expenses (including costs, reasonable attorney's fees and reasonable
investigative costs) in connection with any suit, demand or action by any third
party arising out of or resulting from (a) any breach of its representations,
warranties or obligations set forth in this Agreement; (b) any manufacture by
PROTON, sale, promotion, distribution or use (other than by AQUA THIRST) of the
Product, including, without limitation, product liability or strict liability;
(c) PROTON'S exercise of any control over the Manufacturing or Packaging under
this Agreement, to the extent that PROTON'S instructions or directions violate
applicable law or regulation; (d) any actual or alleged infringement or
violation of any patent, trade secret, copyright, trademark or other proprietary
rights used by AQUA THIRST in manufacturing Product; or (e) any negligence or
willful misconduct by PROTON, except to the extent that any of the foregoing
arises out of or results from the breach by AQUA THIRST of its representations,
warranties or obligations under this Agreement, or the negligence or willful
misconduct of AQUA THIRST.
13.3 INDEMNIFICATION PROCEDURES. All indemnification obligations in this
Agreement are conditioned upon the party seeking indemnification promptly
notifying the indemnifying party of any claim or liability of which the party
seeking indemnification becomes aware (including a copy of any related
complaint, summons, notice or other instrument), cooperating with the
indemnifying party in the defense of any such claim or liability (at the
indemnifying party's expense), and not compromising or settling any claim or
liability without prior written consent of the indemnifying party.
ARTICLE 14
INSURANCE
14.1 AQUA THIRST. AQUA THIRST shall, at its own cost and expense, obtain and
maintain in full force and effect the following insurance during the term of
this Agreement: (i) Umbrella/Commercial General Liability insurance with
per-occurrence and general aggregate limits of not less than $1,000,000; (ii)
Products and Completed Operations Liability Insurance with per-occurrence and
general aggregate limits of not less than $1,000,000; (iii) Workers'
Compensation
Page 18 of 29
and Employer's Liability Insurance with statutory limits for Workers'
Compensation and Employer's Liability insurance limits of not less than
$1,000,000; (iv) Professional Services Errors & Omissions Liability Insurance
with per claim and aggregate limits of not less than $500,000 covering sums that
AQUA THIRST becomes legally obligated to pay as damages resulting from claims
made by PROTON for errors or omissions committed in the conduct of the services
outlined in the Agreements. In lieu of insurance, AQUA THIRST may self-insure
any or a portion of the above required insurance. In the event that any of the
required policies of insurance are written on a claims made basis, then such
policies shall be maintained during the entire term of this Agreement and for a
period of not less than three (3) years following the termination or expiration
of this Agreement. AQUA THIRST shall obtain a waiver from any insurance carrier
with whom AQUA THIRST carries Workers' Compensation insurance releasing its
subrogation rights against PROTON. PROTON shall be named as an additional
insured under the Commercial General Liability and Products and Completed
Operations Liability insurance policies as respects the manufacturing services
outlined in this Agreement. AQUA THIRST shall furnish certificates of insurance
for all of the above noted policies and required additional insured status to
PROTON as soon as practicable after the Effective Date of the Agreement and upon
renewal of any such policies. Each insurance policy that is required under this
Section shall be obtained from an insurance carrier with an A.M. Best rating of
at least A- VII.
14.2 PROTON INSURANCE. PROTON shall, at its own cost and expense, obtain and
maintain in full force and effect the following insurance or program of self
insurance (provided PROTON maintains a financial condition reasonably sufficient
to cover such commitments) during the term of this Agreement: (i) Products and
Completed Operations Liability Insurance with per-occurrence and general
aggregate limits of not less than $1,000,000; (ii) Workers' Compensation and
Employer's Liability Insurance with statutory limits for Workers' Compensation
and Employer's Liability insurance limits of not less than $1,000,000; (iii) All
Risk Property Insurance, including transit coverage, in an amount equal to full
replacement value covering PROTON'S property while it is at AQUA THIRST'S
facility or in transit to or from AQUA THIRST'S facility. In the event that any
of the required policies of insurance are written on a claims made basis, then
such policies shall be maintained during the entire term of this Agreement and
for a period of not less than three (3) years following the termination or
expiration of this Agreement. PROTON shall obtain a waiver from any insurance
carrier with whom PROTON carries Workers' Compensation insurance releasing its
subrogation rights against AQUA THIRST. PROTON shall obtain a waiver from any
insurance carrier with whom PROTON carries Property Insurance releasing its
subrogation rights against AQUA THIRST. PROTON shall not seek reimbursement for
any property claim, or portion thereof that is not fully recovered from PROTON'S
Property Insurance policy. AQUA THIRST and its Subsidiaries and Parent
Corporation shall be named as additional insureds under the Products and
Completed Operations Liability insurance policies as respects
Page 19 of 29
the products and completed operations outlined in this Agreement. PROTON shall
furnish certificates of insurance for any policies obtained hereunder and
required additional insured status to AQUA THIRST as soon as practicable after
the Effective Date of the Agreement and upon renewal of any such policies. Any
insurance policy that is that is obtained in satisfaction of this Section shall
be obtained from an insurance carrier with an A.M. Best rating of at least
A-VII.
ARTICLE 15
TERM AND TERMINATION
15.1 TERM. This Agreement shall commence on the Effective Date and shall
continue for a period of ten (10) Contract Years thereafter, unless earlier
terminated under Section 15.2 below (the "Term"). This Agreement will
automatically thereafter roll over for additional two (2) year terms, unless and
until either PROTON'S or AQUA THIRST provide to the other a written notice of
cancellation which MUST be provided not later than 180 days prior to the end of
the then current contract Term.
15.2 TERMINATION BY EITHER PARTY.
(a) MATERIAL BREACH. Either party may terminate this Agreement effective
upon sixty (60) days prior written notice to the other party, if the other party
commits a material breach of this Agreement and fails to cure such breach by the
end of such sixty (60) day period.
(b) BANKRUPTCY. Either party may terminate this Agreement effective upon
written notice to the other party, if the other party becomes insolvent or is
unable to pay its debts as they become due, files a petition for bankruptcy,
makes an assignment for the benefit of its creditors or has a receiver, trustee
or other court officer appointed for its properties or assets.
(c) NO APPROVAL. PROTON shall have the option of terminating this Agreement
effective upon written notice to AQUA THIRST if for any reason the Manufacturing
Facility does not receive if necessary any Regulatory Approvals within 30 months
after the Effective Date.
15.3 FORCE MAJEURE. Except as to payments required under this Agreement, if any
default or delay occurs which prevents or materially impairs a party's
performance and is due to a cause beyond the party's reasonable control, and
provided that the default or delay is not caused by or the fault of such party,
including but not limited to an act of God, flood, fire, explosion, earthquake,
casualty, accident, war, revolution, civil commotion, blockade or embargo,
injunction, law, proclamation, order, regulation or governmental demand, the
affected party shall promptly notify the party in writing of such cause and
shall exercise diligent efforts to resume performance under this Agreement as
soon as possible. Neither party will be liable to the other party for any loss
or damage due
Page 20 of 29
to such cause, and the Term will not be extended thereby. Neither party may
terminate this Agreement because of such default or delay except upon thirty
(30) days prior written notice to the other party if the default or delay has
existed for five (5) months and is continuing at the end of the thirty (30) day
notice period.
15.4 EFFECT OF TERMINATION. Expiration or termination of this Agreement shall be
without prejudice to any rights or obligations that accrued to the benefit of
either party prior to such expiration or termination. The rights and obligations
of the parties shall continue under Articles 5, 7, 9, 10, 11, 12, 13, 16, 17 and
18, and Sections 3.5, 6.2, 15.4, notwithstanding expiration or termination of
this Agreement.
ARTICLE 16
LIMITATIONS OF LIABILITY
16.1 AQUA THIRST'S TOTAL LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED
THE LESSER OF (A) TOTAL FEES PAID BY PROTON TO AQUA THIRST HEREUNDER DURING THE
SIX MONTHS PRIOR TO THE EVENT(S) GIVING RISE TO THE LIABILITY OR (B) $100,000.
16.2 EXCEPT AS PROVIDED IN ARTICLES 5, 9 AND 13, NEITHER PARTY SHALL BE LIABLE
TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT
OF PERFORMANCE UNDER THIS AGREEMENT.
ARTICLE 17
NOTICE
Any notice from either party to the other party will be effective upon
receipt and must be personally delivered to such party or sent to such party by
deposit in the United States mail, first class, postage prepaid, overnight
courier or telecopy transmission (with written confirmation copy to follow via
United States mail), to the address for such party below or such other address
as a party may designate from time to time in accordance with this Section:
To PROTON:
Xx Xxxxxxxxx
0000 Xxxxxxxx Xxx. Xxx. 000
Xxxxxxx, Xxxxxxxxxx 00000
To AQUA THIRST:
Xx Xxxxxxx Xxxxxx
0000 Xx. Xxxxxxxxx Xxxx. Xxxxx X-000
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Page 21 of 29
ARTICLE 18
MISCELLANEOUS
18.1 ENTIRE AGREEMENT; AMENDMENTS. This Agreement is the entire understanding
between the parties and supersedes any contracts, agreements or understanding
(oral or written) of the parties with respect to the subject matter hereof. No
term of this Agreement may be amended except upon written agreement of both
parties, unless otherwise provided in this Agreement.
18.2 CAPTIONS. The captions in this Agreement are for convenience only and are
not to be interpreted or construed as a substantive part of this Agreement
18.3 FURTHER ASSURANCES. The parties agree to execute, acknowledge and deliver
such further instruments and of all such other incidental acts as may be
reasonably necessary or appropriate to carry out the purpose and intent of this
Agreement.
18.4 NO WAIVER. Failure by either party to insist upon strict compliance with
any term of this Agreement in one (1) or more instances will not be deemed to be
a waiver of its rights to insist upon such strict compliance with respect to any
subsequent failure. There shall be NO implied waivers.
18.5 SEVERABILITY. If a court or other body of competent jurisdiction declares
any term of this Agreement invalid or unenforceable, the remaining terms of this
Agreement will continue in full force and effect. The offending provision
thereafter shall be automatically modified so a to be enforced to the maximum
extent possible.
18.6 INDEPENDENT CONTRACTORS. The relationship of the parties is that of
independent contractors, and neither party will incur any debts or make any
commitments for the other party except to the extent expressly provided in this
Agreement. Nothing in this Agreement is intended to create or will be construed
as creating between the parties the relationship of joint ventures, co-partners,
employer/employee or principal and agent.
18.7 SUCCESSORS AND ASSIGNS. This Agreement will be binding upon and inure to
the benefit of the parties, their successors and permitted assigns. Neither
party may assign this Agreement, in whole or in part, without the prior written
consent of the other party, except that either party may without the other
party's consent assign this Agreement to an Affiliate or to a successor to
substantially all of the business or assets of the assigning company.
18.8 GOVERNING LAW. This Agreement shall be governed by and construed under the
laws of the State of California, excluding its conflicts of law provisions.
Page 22 of 29
18.9 ALTERNATIVE DISPUTE RESOLUTION. If a dispute, controversy or disagreement
("Dispute") arises between the parties in connection with this Agreement, then
the Dispute shall be presented to the respective presidents or Senior Executives
of AQUA THIRST and PROTON for their consideration and resolution. If such
parties cannot reach a resolution of the Dispute, then such Dispute shall be
resolved by binding Alternative Arbitration Dispute Resolution in accordance
with the then existing commercial arbitration rules of The State of California ,
Arbitration shall be conducted in California.
18.10 PREVAILING PARTY. In any dispute resolution proceeding between the parties
in connection with this Agreement, the prevailing party will be entitled to its
reasonable attorney's fees and costs in such proceeding.
18.11 COUNTERPARTS. This Agreement may be executed in one (1) or more
counterparts, each of which will be deemed an original but all of which together
will constitute one (1) and the same instrument.
18.12 PUBLIC ANNOUNCEMENTS. Neither party will make any press release or other
public disclosure regarding this Agreement or the transactions contemplated
hereby without the other party's express prior written consent, except as
required under applicable law or regulation, including SEC regulation, or by any
governmental agency, in which case the party required to make the press release
or public disclosure shall use commercially reasonable efforts to obtain the
approval of the other party as to the form, nature and extent of the press
release or public disclosure prior to issuing the press release or making the
public disclosure.
IN WITNESS WHEREOF, the parties have caused their duly authorized
representative to execute this Agreement effective as of the date first written
above.
AQUA THIRST, INC. PROTON LABORATORIES, INC.
----------------------- ---------------------------
By Xx Xxxxxxx Xxxxx CEO By Xx Xxxxxxxxx CEO
Page 23 of 29
EXHIBIT A
Per Product
MANUFACTURING SPECIFICATIONS
***
Page 24 of 29
EXHIBIT B
Per Product
PACKAGING SPECIFICATIONS
***
Page 25 of 29
EXHIBIT C
Per Product
ADDITIONAL SERVICES/ VALIDATION SERVICES
***
Page 26 of 29
EXHIBIT D
Per Product
UNIT PRICING, FEES AND MINIMUM REQUIREMENT
***
Page 27 of 29
EXHIBIT E
Per Product
FORM OF QUALITY AGREEMENT
Appendix E
SPECIFICATIONS
1. Active Ingredients
2. RAW MATERIALS (CONTRACTOR SUPPLIED)
a. Ingredient A
b. Ingredient B
c. Ingredient C
d. Ingredient D
e. Ingredient E
3. Inprocess and bulk products
4. Finished Product
5. PACKAGING COMPONENTS
a. Bottle
b. Cap
c. Insert
d. Label
e. Shipper
Appendix F
APPROVED VENDOR LIST
Appendix G
METHODS
1. GENERAL METHODS (GM)
Page 28 of 29
2. SPECIFIC METHODS (SM) AND CORRESPONDING VALIDATION REPORT
3. MICROBIOLOGICAL TEST (USP) (CONTRACTOR SUPPLIED) If required
Appendix H
MATERIAL SAFETY DATA SHEETS (MSDS)
1. Active Ingredient
2. Drug Product
Appendix I
Page 29 of 29
