Exhibit 10.14
This production contract made and entered into as of the 13th
day of February, 1995 by and between XXXXXXXXXX LABORATORIES,
INC., a Texas corporation, with offices at 2001 Walnut Hill Xxxx,
Xxxxxx. Texas, its subsidiaries and successors (hereinafter
referred to as "Purchaser") and OREGON FREEZE DRY, INC., an
Oregon corporation, with offices at 000 00xx Xxxxxx XX, Xxxxxx,
Xxxxxx, its subsidiaries and successors (hereinafter referred to
as "Seller")
WITNESSES THAT
WHEREAS, Purchaser is a producer and marketer of numerous
medical devices and other products; and
WHEREAS, Seller is a producer and marketer of numerous food,
drug, microbial, chemical, and other products prepared chiefly,
but not exclusively, through low-temperature drying processes;
and
WHEREAS, Purchaser has developed medical devices for wound
care which are freeze-dried in their final form for topical or
oral use, which are subjects of approved US FDA 510(k)
applications or a therapeutical regulatory approval (including
material for clinical trials), and for which Seller has developed
commercial drying processes and packaging, but specifically
excluding diagnostics and cosmetics; and
WHEREAS, the parties hereto now wish to enter into a
production contract subject to the provisions, terms and
conditions hereinafter stated,
NOW, THEREFORE, in consideration of the respective
representations, warranties, covenants and agreements contained
herein, Purchaser and Seller hereby agree as follows:
Article One
Definitions
For the purpose of this production contract, the following
definitions will apply:
A. "Purchaser" shall mean Xxxxxxxxxx Laboratories, Inc., a
Texas corporation, with offices at 0000 Xxxxxx Xxxx Xxxx,
Xxxxxx, Xxxxx.
B. "Seller" shall mean Oregon Freeze Dry, Inc., an Oregon
corporation, with offices at 000 00xx Xxxxxx XX, Xxxxxx,
Xxxxxx.
C. "Product" shall mean medical device(s) for wound care which
are freeze-dried in their final form for topical or oral
use, which are subjects of approved US FDA 510(k)
applications or a therapeutical regulatory approval
(including material for clinical trials), but specifically
excluding diagnostics and cosmetics, described in Exhibit A
hereto.
D. "Item" shall mean a specific medical device product of the
type defined above, identified by a unique product
specification which includes formula, process, packaging
format and materials, and performance requirements. Prior to
production of commercial Product, an Item shall be defined
within Exhibit A by such a product specification.
E. "Production Contract" shall mean the written contract for
the production and supply of Product between the parties
hereto, plus all exhibits and contract modifications, if
any, which may be agreed to by and between the parties
hereto.
F. "Commercial production" shall mean Product produced for sale
with Quality Assurance release, in accordance with Exhibit
A, as mutually agreed-upon and/or periodically amended.
G. "Minimum Total Commitment" shall mean the minimum amount of
Product Purchaser is required to purchase from Seller during
the term of this Production Contract, expressed in sales
dollars.
Article Two
Effective Date
The effective date of this contract shall be the date of
execution of this contract by both parties hereto.
Article Three
Product, Quantities, Orders, Scheduling, Raw Materials
Revisions to, Expansion of, and Deletions from, Product Line
Subsection A. Product and Quantities
Subject to the terms and conditions of this Production
Contract, Seller shall sell to Purchaser and Purchaser shall
purchase from Seller, Product produced in accordance with agreed-
upon Item specifications, up to the limits set forth in Exhibit
E, which are attached hereto and incorporated into this contract.
Exhibit A enumerates Item specifications that shall be finalized
by written mutual consent of Purchaser and Seller based on the
results of scale-up.
Subsection B. Purchase Orders Shipping Schedule, and Lead
Time.
All shipments will be initiated by a Purchase Order. Product
shipment dates will be specified in the Purchase Order. These
dates may not be scheduled prior to ninety (90) days after the
date the Purchase Order is received and acknowledged in writing
by Seller, unless by mutual consent of the parties. Purchase
Orders will be non-cancelable, and all Product included in a
Purchase Order must be shipped and invoiced within six (6) months
of the first scheduled shipping date,
Subsection C. Minimum Purchases.
From the date Commercial Production first commences,
Purchaser is obligated to accept, subject to the provisions of
Article Eleven, and Seller is required to make available, during
each calendar month of the Production Contract, aggregate
shipments of not less than $30,000.
Subsection D Late or Partial Shipments.
Late or partial shipments against a shipping date scheduled
in a Purchase Order will incur liquidated damages of 50% of the
purchase order price of the Product not shipped as scheduled, to
be credited to Purchaser's account. Seller shall have a two (2)
working day grace period (that is, two days after the scheduled
shipping date) in which to complete the actual shipment, before
said liquidated damages apply. In the context of the
aforementioned sentence, the actual shipping date shall be
defined as the date on which Product leaves Seller's dock.
Liquidated damages shall not apply to late or partial shipments
which: 1) are arranged in advance with Purchaser by written
consent, or 2) arise due to Force Majeure situations (for
example, governmental acts, acts of God, severe weather, fire,
flood, explosions, work stoppages, strikes, force majeure
situations, impacting major subcontractors and suppliers,
unavailability or scarcity of raw materials or ingredients, and
acts of the public enemy and war) production by Purchaser
pursuant to Article Eight, pursuant to Article Eleven or 4) are
rejected by purchaser pursuant to Article Eleven prior to
shipment, or 5) arise from delays in Purchaser arranged
transportation. These liquidated damages shall constitute
Purchaser's sole remedy for late or partial shipments, and Seller
shall in no way be liable for any indirect, consequential, or
special damages for such shipments, including, but not limited
to, loss of use, loss of business opportunities, loss of profits,
and other damages.
Subsection E. Raw Materials: Ingredients Packaging
Materials and Artwork.
Purchaser will provide Seller with all raw materials (that
is, packaging materials and any required artwork, and ingredients
excluding water and production supplies) necessary for the
manufacture of Product, in accordance with the agreed upon Item
specifications outlined in Exhibit A, as mutually agreed-upon
and/or periodically amended, as of the date of the transmittal and
acknowledgement in writing of a Purchase Order which requires said
raw materials for fulfillment. Purchaser will provide the
appropriate Quality Assurance release documentation for all such
raw materials it supplies, except packaging. Seller will provide
the appropriate Quality Assurance release documentation for
packaging, and will notify Purchaser promptly of any deviations
from specifications.
Package artwork shall be developed by Purchaser, and shall
be provided to Seller with proper transmittal documentation
indicating Quality Assurance release for the printing of it, Seller
will provide to Purchaser the relevant technical costs associated
with: and mechanical requirements to which Purchaser's artwork must
conform. Purchaser shall be responsible for
1, Any changes in packaging or artwork made at Purchaser's
request, or the development of any new packaging or
artwork, and/or
2. Changes made to fulfill government regulations or
requirements directly associated with Product produced
hereunder.
Subsection F. Revisions to Existing Items
Should Purchaser determine that it wishes to implement
improvements or modifications to an existing Item, these shall
become effective through mutual written agreement of Seller and
Purchaser and amendment of Exhibit A, and of Exhibits D (defined
in Article Five below) and E, if necessary, to define a revised
product specification, price, and production capacity.
Notwithstanding whether written revisions to an existing product
specification are required, no changes in process parameters,
flow or location, shall be made by Seller without prior written
authorization from Purchaser's Director of Quality Assurance.
Purchaser will communicate in writing to Seller any change in raw
material vendors.
Purchaser shall be responsible to reimburse Seller for
Seller's (i) finished product inventory of the Item prepared for
open Purchase Orders, and up to an additional five percent (5 %)
(in units) of the Purchase Order quantity, under the superseded
technical specification at prices then in effect, and (ii)
product-in-process unique to the superseded technical
specification, at Seller's cost, to fill open Purchase Orders.
Seller will destroy in a secure manner (e.g., deface, incinerate,
or similar) any obsolete labeling, and keep adequate records of
same,
Notwithstanding any provision to the contrary herein, Seller
and Purchaser may mutually agree that Seller develop, to
Purchaser's requirements, potential improvements or modifications
to existing Items with respect to ingredient(s), shape or size, or
packaging materials or format, Purchaser shall reimburse Seller's
out-of-pocket expenses for such development activities, together
with other reasonable and necessary costs for the use of
developmental facilities and personnel for testing and consumer
research, as shall be mutually agreed upon by Purchaser and
Seller, and authorized in advance by Purchaser's purchase order.
Subsection G. Expansion of Product Line.
Should Purchaser determine that it wishes to commercialize
additional products pursuant to the prior paragraph as new Items,
each Item shall become a part of contractual Product through
mutual agreement of Seller and Purchaser and amendment of Exhibits
A, D, and E, to define the new Item's specifications, price, and
production capacity, respectively.
Subsection H. Deletions from Product Line
Purchaser may delete Items from the Product line set forth in
Exhibits A and D, or any amendments thereto, provided that
Purchaser shall continue to be obligated to accept Product
prepared under open Purchase Orders, and up to an additional five
percent (5%) (in units) of the Purchase Order quantity, and to
fulfill the Minimum Total Commitment as defined in Article Seven
below. Seller will destroy in a secure manner (e.g., deface,
incinerate, or similar) any obsolete labeling, and keep adequate
records of same,
Article Four
Modifications to Seller's Facilities
Seller shall make such physical changes to its facilities, as
described in Exhibit B, as are necessary to reach and comply with
the pertinent current Good Manufacturing Practices (cGMPs), as
described in Exhibit C.
Article Five
Price
Subsection A. Prices.
As compensation for the Product required under this
Production Contract, Purchaser shall pay to Seller the prices set
forth in Exhibit D as amended, which is attached hereto and
incorporated into this contract Prices shall be fixed through the
first forty-two (42) months of the Production Contract, and
subject to a one-time price increase of up to five percent (5%),
effective after the first forty-two (42) months of the Production
Contract. The relevant price for a given shipment shall be
determined by the price in effect at the date of actual shipment,
as actual shipment is defined in Article Three, Subsection D.
Subsection B. Adjustments for Regulatory Changes.
Should government regulations cause an Increase in Seller's
manufacturing costs for the production of Product hereunder, the
parties to this Production Contract will meet and attempt to
develop viable manufacturing and business strategies to minimize
the net cost impact of said regulations on Seller. If such
strategies do not fully offset the costs of said regulation,
Seller may adjust prices to reflect the net impact of said
regulation. Seller will provide appropriate data and analysis to
support such price adjustments.
Article Six
Term and Termination
Subsection A Term,
The term of this Production Contract shall be a period
beginning the effective date of its execution by both parties
hereto and automatically ending sixty-six (66) months thereafter,
or as extended by written consent of both parties.
Subsection B. Termination.
This production contract may not he canceled or otherwise
terminated by either party except as set forth in this Article.
Subsection C. Termination For Convenience of Purchaser.
Purchaser shall have the right to unilaterally terminate
this Production Contract subject to its performance of the
provisions of this Article Six. Subsection C. In order to exercise
this right to terminate for convenience Purchaser shall give
Seller ninety (90) days written notice of termination for the
convenience of Purchaser, expressly citing this subsection of
Article Six, Subsection C. and shall within thirty (30) days of
termination, pay to Seller any amount applicable under Article
Seven.
Subsection D. Termination for Default.
In the event of a breach of contract or default of
performance by either party, the party claiming such breach or
default shall give written notice of such breach or default,
citing the grounds and providing information supporting such
grounds, to the breaching or defaulting party and the latter shall
have thirty (30) days from receipt within which to cure such
breach or default, or, if cure can not be reasonably completed
within such 30-day period, the defaulting party shall, within such
30-day period begin commercially reasonable efforts to cure such
default and shall timely continue such efforts after such 30-day
period until such default has been cured, provided however, such
period of cure may not exceed ninety (90) days after the end of
the 30-day period.
In the event that the breaching or defaulting party shall
refuse or fail to cure such claimed breach or default, within
said thirty (30) days, or such longer period if the cure can not
be reasonably completed within such 30-day period, but in no
event longer than ninety (90) days after the end of the 30-day
period, the party claiming breach or default may terminate this
Production Contract and seek its remedies at law or in equity
against the other.
Article Seven
Minimum Commitments and Take or Pay Guaranty
Subsection A. Minimum Total Commitment
As partial inducement for Seller to enter into this
Production Contract, Purchaser agrees to take delivery of and pay
for Product with a cumulative price, excluding freight-out, of
not less than Two Million Five Hundred Thousand Dollars
($2,500,000.00) during the term of this Production Contract.
Subsection B. Adjustments to Minimum Total Commitment.
In the case of significant changes in manufacturing
requirements, particularly (but not exclusively) as they relate
to Amendments to Exhibits A and E, requiring significant
increases in the rate of total deliveries and/or in the number of
Items delivered within limited time periods, to accommodate the
manufacture of new Items requiring additional equipment or
facilities modifications, or to adapt to substantive changes in
the pertinent regulatory environment, the parties to this
Production Contract may adjust the Minimum Total Commitment in
writing and by common consent of both parties, as partial
inducement for Seller to make such changes as may be required to
meet these requirements.
Subsection C. Take or Pay Guaranty: Minimum Total Commitment.
In the event Purchaser takes delivery of and pays for,
during the term of this Production Contract, less than the
Minimum Total Commitment specified in Subsection A of this
Article or as amended under the terms of Subsection B of the
Article, or in the event of early termination as provided for in
Article Six, Purchaser agrees to pay Seller for Product not taken
in accordance with the following formula: Purchaser shall be
responsible to pay to Seller within 30 days after the expiration
of the original term of this Production Contract or after the
date of early termination (whichever is earlier), an amount equal
to Sixty Percent (60%) of the Minimum Total Commitment not taken
and paid for by Purchaser, in addition to payments made for
Product previously taken under the terns of this Production
Contract.
In the event Purchaser takes delivery of alt pays for,
during the term of this Production Contract, less than the
monthly Minimum Purchase specified in Subsection C of Article
Three except arising from suspension of production by. Purchaser
pursuant to Article Eight, Purchaser agrees to pay Seller for
Product not taken in accordance with the following formula:
Purchaser shall be responsible to pay to Seller within 30 days
after the end of the calendar month, an amount equal to Sixty
Percent (60%) of the monthly Minimum Purchase not taken and paid
for by Purchaser, in addition to payments made for Product
previously taken under the terms of this Production Contract.
Subsection D. Take or Pay Guaranty: Security.
The Take or Pay Guaranty shall be secured within six weeks
of the execution of this Production Contract by a confirmed letter
of credit, satisfactory to Seller, sufficient to secure 60% of the
Minimum Total Commitment. The Purchaser may, upon its initiative
and with Seller's prior written concurrence, said concurrence not
to be unreasonably withheld, reduce the amount of said letter of
credit over time to reflect sales of Product against the Minimum
Total Commitment, on a pro rata basis versus the Minimum Total
Commitment as amended. This security shall constitute Seller's
sole remedy for failure by Purchaser to take and pay for the
Minimum Total Commitment.
Article Eight
Yield
Losses of Purchaser-supplied ingredients while on Seller's
premises will be reimbursed to Purchaser at Purchaser's direct
cost.
From the compounding step forward, the initial standard
manufacturing yield for a given Item will be set based upon the
average yield of the three lots for process validation. Initial
yields will subsequently be revised after cumulative production
reaches ten lots, becoming the average yield of these ten lots.
Seller will report to Purchaser, on a timely basis, the yields
achieved against the then-current standard. Should yields fall
below ninety percent (90%) of standard, Purchaser may, after
consultation with Seller, require that production be suspended
until an appropriate course of action is developed by Seller in
consultation with Purchaser to bring yields above ninety percent
(90%) of standard.
Article Nine
Product Exclusivity
Seller will not produce medical devices for wound care which
are freeze-dried in their final form for topical or oral use,
which are subjects of approved US FDA 5 10(k) applications or a
therapeutical regulatory approval (including material for clinical
trials), but specifically excluding diagnostics and cosmetics, for
or on behalf of any entity other than Purchaser during the initial
tern of this Production Contract, or during such shorter period if
this Production Contract is terminated prior to the expiration of
the initial term hereof.
Seller shall be the exclusive supplier of medical devices for
wound care which are freeze-dried in their final form for topical
or oral use, which are subjects of approved US FDA 510(k)
applications or a therapeutical regulatory approval (including
material for clinical trials), but specifically excluding
diagnostics and cosmetics, to Purchaser, its subsidiaries and
successors, during the initial term of this Production Contract,
subject only to Seller's production availability given ordinary
and reasonable lead times and appropriate business commitments.
These mutual obligations of exclusivity shall pertain to
product produced for sale in the US domestic market, Seller shall
have right of first offer to provide manufacturing services for
Purchaser for product produced for sale in foreign markets.
Article Ten
Quality Control
Seller will maintain methods, facilities and controls in
conformance with current Good Manufacturing Practices (cGMPs) as
set forth in 21 CFR 820 and 21 CFR 211, as applicable. Seller
shall permit Purchaser, or its designee, to inspect and photocopy
ingredient and product analyses and batch records prepared in
accordance with the technical specifications ("Technical
Specifications"), standard operating procedures ("Standard
Operating Procedures"), and other pertinent documentation in force
at the time of production, and to perform manufacturing audits of
Seller's facilities.
Article Eleven
Product Rejection and Recalls
Any given lot of Product may be rejected 1) for failure to
meet the specifications outlined in Exhibit A, or 2) by failing to
have batch or quality records complete, or 3) due to evidence of
cGMP violations which would prevent the lot from being sold in the
market, even though all specifications outlined in Exhibit A, as
mutually agreed-upon and/or periodically amended, were met, Under
these circumstances, Seller will replace the referenced lot(s) and
Purchaser will pay only for the replacement lot(s).
Purchaser shall notify Seller, in writing, of a potential lot
rejection within ten (10) days after receipt of the lot in
question, and provide a final decision within thirty (30) days,
Should Seller not agree with the results of the tests or the
criteria to reject the lot for cGMP violations, Seller at its
discretion will conduct tests at its premises or witness the
repetition of tests at Purchaser's laboratory, and in the case of
alleged cGMP violations, Seller will present to Purchaser
sufficient proof that said cGMP violations did not in fact occur.
In the event of disagreement between Purchaser and Seller
regarding rejection of a given lot, an independent laboratory
selected with consensus between Purchaser and Seller will be given
samples of the lot(s) in question, together with standard
operating procedures for testing agreed-upon by Purchaser and
Seller, and will perform testing which will then be considered the
reference to resolve the disagreement. In the event that the
disagreement arises from alleged cGMP violations, an independent
consultant, who is an expert in the pharmaceutical cGMP field will
be selected with consensus between Purchaser and Seller, and given
the relevant lot records and any other production or quality
evidence necessary for evaluation of given cGMP issue, and his/her
opinion will then be mutually accepted as the resolution of the
disagreement.
At Purchaser's option, Purchaser may implement (i) any recall
or withdrawal required by Purchaser in connection with Product,
which has been rejected by Purchaser under this Article, and (ii)
any recall ordered by federal, state, or local governmental
authorities. Such recall or withdrawal shall be at Seller's sole
cost and expense if due to an act or omission of Seller; Seller
shall assume a pro-rata portion of such cost and expense if the
recall or withdrawal is in part due to an act or omission of
Seller: Purchaser shall indemnify and hold Seller harmless from
any costs related to any withdrawal or recall that is wholly due
to an act or omission of Purchaser, Seller shall cooperate with
Purchaser in implementing any recall or withdrawal of Product.
Purchaser shall promptly notify Seller of any recall or withdrawal
of Product.
Notwithstanding anything to the contrary contained in the
preceding paragraph of this section, Seller's liability to
Purchaser hereunder for the cost and expense of (i) physically
picking up recalled and withdrawn Product and (ii) advertising
such recall or withdrawal to consumers shall not exceed
$1,000,000.00 for each recall or withdrawal. Seller shall,
however, remain responsible for all other costs and expenses of
the recall or withdrawal to the extent set forth in the preceding
paragraph of this section, including but not limited to the cost
of rejected Product and freight and disposition costs.
Article Twelve
Shipment
Seller will deliver product FOB Origin to locations designated by
Purchaser by Seller's customary surface transportation mode,
unless Purchaser specifies other transportation arrangements.
Title shall pass from Seller to Purchaser at the time of shipment.
Article Thirteen
Payment
Payment terms are net thirty (30) days from the date of
actual shipment.
Article Fourteen
Cross Non-Disclosure Agreement
During the term of this Production Contract, each party
hereto shall disclose to the other certain information, which may
be proprietary to the disclosing party. Each party hereto agrees
to keep in confidence and prevent the disclosure of such
proprietary information received hereunder to persons or
corporations outside the parties' corporations, affiliates or
subsidiaries. Each party shall protect and safeguard the
proprietary information of the other in the same manner as it
protects and safeguards its own proprietary information. These
obligations of confidentiality shall continue for five years
beyond the term of this agreement and any extensions,
Article Fifteen
Indemnification
Purchaser shall indemnify and save Seller harmless from any
expense, cost, loss, damage or liability arising from consumer
claims or administrative actions by federal, state, or local
government agencies, including but not limited to legal costs,
except to the extent Seller failed to meet the requirements of the
product specifications then in force and, in cases where such
requirements were not met, failed to receive a waiver in writing
from an authorized representative of Purchaser to ship the Product
in question to Purchaser or otherwise release it to commerce. In
any event, Seller's total liability arising from consumer claims
or manufacturing defects of any kind shall be limited to
$1,000,000.00 (each occurrence) and $3,000,000.00 (aggregate).
Purchaser shall indemnify and save Seller harmless from any
expense, cost, loss, damage or liability (including attorney's
fees) for infringement or alleged infringement of any patent(s)
with respect to Product furnished or otherwise provided by Seller
under this Production Contract.
Article Sixteen
Insurance
During the term of this agreement, Seller and Purchaser shall
maintain product liability insurance of not less than $1,
000,000.00 (each occurrence) and $3,000,000.00 (aggregate) and
shall provide certificate(s) of such insurance to the other party.
Article Seventeen
Miscellaneous Provisions
Subsection A. Entire Agreement: Modification.
This written Production Contract, which incorporates the
preamble recitals, definitions, and exhibits hereto, constitutes
and represents the entire agreement by and between the parties
hereto and supersedes all prior and contemporaneous agreements,
representations and negotiations, whether oral or written, with
respect to the subject matter of this agreement, including the
confidential disclosure agreement dated August 29, 1994 and fully
executed August 30, 1994, and the Letter of Agreement dated
December 16, 1994 and fully executed December 30, 1994, except
that confidential information previously disclosed shall remain
confidential in accordance with the terms of Article Fourteen of
this Agreement. No modification of this agreement shall be binding
unless made in writing and executed by both parties hereto, Any
and all contract modifications hereto shall be sequentially
numbered beginning with Modification Number One to the Production
Contract.
Subsection B. Non-Assignabilitv.
The rights and obligations of this contract may not be
assigned by either party without the prior written consent of the
other of them. This contract, however, shall inure to the benefit
of the parties hereto their respective permitted successors and/or
permitted assigns.
Subsection C. Governing Law: Unenforceability,
This Production Contract is subject to and shall be
construed and interpreted in accordance with, and governed by, the
law of the State of Oregon. In the event that any provision, term,
or condition of this production contract is determined to be
unenforceable, invalid or illegal as a matter of law only that
term, condition or provision shall be deemed stricken and the
balance of the terms, conditions, and provisions of this
Production Contract shall be in full force and effect
Subsection D. Force Majeure,
A delay in performance of this Production Contract by either
party shall be excused only when such delay in performance is
caused by an act beyond the reasonable control of such party, for
example, governmental acts, acts of God, severe weather, fire,
flood, explosions, work stoppages, strikes, force majeure
situations impacting major subcontractors and suppliers,
unavailability or scarcity of raw materials or ingredients, and
acts of the public enemy and war, The foregoing provision shall
not release either party from using its reasonable best efforts to
avoid or diligently remove such circumstances. If performance is
excused under this provision, the excused party shall resume
performance with utmost dispatch as soon as such circumstances are
removed, In order for such excusable delay to be recognized, the
requesting party shall promptly give written notice, thereof, to
the other party together with evidence and support of such claim
for excusable delay
Subsection E Compliance By Parties With Law
Both Parties hereto agree to comply with all applicable
federal, state and local laws.
Subsection F Order of Precedence.
In the event of an inconsistency or ambiguity in this
contract, unless otherwise provided herein, such inconsistency or
ambiguity shall be resolved by giving precedence in the following
order: the main body of the Production Contracts as modified,
Exhibits C, B, A, E, and D as amended.
IN WITNESS WHEREOF
The undersigned parties have duly executed this agreement on the
date first written above.
XXXXXXXXXX LABORATORIES, INC. OREGON FREEZE DRY, INC.
By: /S/ By: /S/
-------------------------- --------------------
Name: _______________________ Name: __________________
Title: ______________________ Title: _________________
Date: _______________________ Date: __________________