MANUFACTURING AND DISTRIBUTION AGREEMENT
CONFIDENTIAL
TREATMENT REQUESTED
This
Manufacturing and Distribution Agreement (the “Agreement”),
effective June 6, 2008 (the “Effective
Date”),
is
between TG United Pharmaceuticals, Inc., a Florida corporation with offices
at
00000 Xxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxxx 00000 (“Manufacturer”)
and
Neuro-Hitech, Inc., a Delaware corporation with offices at Xxx Xxxx Xxxxx,
Xxxxx
0000, Xxx Xxxx, XX 00000 (“Distributor”).
TG
United Labs, LLC, a Florida limited liability company, TG United, Inc., a
Florida corporation, and TG United Liquid, Inc., a Florida corporation
(collectively, the “Other
TG United Companies”)
join
in this Agreement solely for the purposes set forth in Section 19.9 of this
Agreement.
Manufacturer
and Distributor agree as follows:
1. Definitions.
“Affiliate”
of
a
party hereto shall mean any person, corporation or other entity, which controls,
is controlling or is under common control with such party.
“Batch”
means,
with respect to solid doses, 500 bottles of 100 tablets per bottle and, with
respect to liquid doses, 800 bottles of 16 ounces per bottle, in either case
with such minor deviations as may occur from time to time.
“FDA”
means
the United State Food and Drug Administration or any successor.
“NDC”
means
national drug code number.
“Products”
shall
mean the branded products set forth on Attachment
A
hereto,
all corresponding generics of the Products, and at the specific request of
Distributor, any line extension or reformulations of the Products, each of
which
shall be deemed a separate “Product” for purposes hereof.
“Territory”
shall
mean the geographical area set forth in Attachment
A-2
hereto.
“Contract
Year”
means
each of the successive 12-month periods commencing on the Effective Date and
ending on the next anniversary of the Effective Date.
2. Grant
of Distributorship.
2.1 Manufacturer’s
Exclusivity.
(a) Manufacturer
hereby grants to Distributor for the Term (as defined in Section 3.1 of this
Agreement) the exclusive right to purchase the Products from Manufacturer,
and
Distributor accepts such grant, subject to the limitations, terms and conditions
stated in this Agreement. Subject to any increases permitted hereunder, the
initial prices for the Products shall be as set forth on Attachment
A-1
hereto.
(b) Notwithstanding
the foregoing, in the event that Distributor fails to purchase in any Contract
Year at least ten (10) Batches of each Product, then Manufacturer may, at its
sole election, deliver to Distributor written notice thereof (a “Manufacturer
Non-Exclusivity Notice”)
within
60 days of the end of such Contract Year. Upon the delivery of a Manufacturer
Non-Exclusivity Notice, Distributor shall have ten (10) business days during
which to purchase such amount of such Product as to which a Manufacturer
Non-Exclusivity Notice was delivered as would have resulted in Distributor
purchasing ten (10) Batches of such Product for the Contract Year just-ended.
If
Distributor fails to make such purchase, then Manufacturer shall be permitted
thereafter to manufacture such Product for, or sell such Product to, any other
person, irrespective of whether such other person competes with Distributor.
Notwithstanding the foregoing, but without limiting Manufacturer’s rights
hereunder, it shall not be construed as a breach of this Agreement for which
damages or injunctive relief shall obtain, for Distributor to fail to purchase
at least ten (10) Batches of each Product.
(c) If
Distributor shall purchase a Product in quantities other than Batches (as
defined herein), the minimum purchase commitment set forth in Section 2.1(b)
hereof required to maintain Manufacturer’s exclusivity shall be equitably
adjusted to reflect the actual amounts purchased, it being the intent of the
parties that the economic return to Manufacturer be not less than that as would
have resulted from the purchase of such minimum quantity set forth in Section
2.1(b) hereof.
2.2 Distributor’s
Exclusivity.
Unless
Distributor gives written notice to Manufacturer not later than 60 days prior
to
Distributor’s commencement thereof (a “Distributor
Non-Exclusivity Notice”),
Distributor shall not itself manufacture or have manufactured for it, or
directly or indirectly sell, any products from third parties that are
substantially similar to the Products. Distributor shall itself purchase
products from third parties that are substantially similar to the Products
only
if Manufacturer (a) breaches its obligations to manufacture and deliver Products
to Distributor in a timely and complete manner, (b) is unable to produce
Products to required specifications or (c) is unable to produce Products at
or
below the per unit price offered by another manufacturer for the same or similar
batch size (provided, when comparing per unit prices, consideration shall be
given to any up-front, start up or development or other fees and expenses
charged by such other manufacturer, which fees and expenses shall be pro rated
among units purchased) and, in any such case, such breach or inability to
produce Products continues for a period of 60 days following written notice
thereof from Distributor. Upon delivery of a Distributor Non-Exclusivity Notice,
Manufacturer shall be permitted thereafter to manufacture Products for, or
sell
Products to, any other person, irrespective of whether such other person
competes with Distributor, and Distributor shall be permitted thereafter to
have
manufactured for it, or directly or indirectly sell, any products from third
parties that are substantially similar to the Products.
2.3 Discounts.
(a) Until
the
aggregate amount of discounts given to Distributor by Manufacturer under this
Section 2.3 equals four hundred thousand dollars ($400,000), Distributor shall
receive a discount equal to twenty-five percent (25%) of the gross amount of
each invoice delivered by Manufacturer to Distributor.
(b) Pursuant
to that certain Consulting Agreement, dated the Effective Date, Xxxxx Xxxxxxx
has agreed to use commercially reasonable efforts to propose to Distributor
a
certain number of pharmaceutical products for distribution by Distributor.
For
any such products which Distributor determines to launch and for which
Manufacturer is engaged to manufacture on behalf of Distributor, Distributor
shall receive a discount equal to ten percent (10%) of the gross amount of
each
invoice delivered by Manufacturer to Distributor with respect to such products
until the aggregate amount of discounts given to Distributor in any Contract
Year equals
one hundred thousand dollars ($100,000).
2.4 Pricing.
Distributor will have sole control over market pricing and strategy relating
to
Products purchased by Distributor. Distributor market and pricing decisions
with
respect to sales by Distributor will be independent of the price of Products
as
listed in Attachment
A-1,
which
Product prices are subject to change as set forth in Section 6.2.
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3.
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Term
and Renewal.
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3.1 Term.
This
Agreement shall remain in effect for an initial term beginning on the Effective
Date and ending on the fifth (5th)
anniversary of the Effective Date (the “Initial
Term”).
This
Agreement is subject to renewal for additional periods as set forth in Section
3.2 hereof (each a “Renewal
Term”
and
together with the Initial Term, the “Term”).
3.2 Renewal.
After
the expiration of the Initial Term, Manufacturer and Distributor may, upon
mutual written agreement, extend the term of this Agreement for additional,
successive one (1) Contract Year terms. In the event Distributor desires to
renew this Agreement, Distributor shall provide Manufacturer with written notice
(“Notice
of Renewal”)
sixty
(60) calendar days in advance of the expiration of the Initial Term or any
Renewal Term. A Notice of Renewal shall contain a proposed revision to the
minimum purchase commitment set forth in Section 2.1(b) hereof required to
maintain Manufacturer’s exclusivity. Within 15 calendar days of receipt of the
Notice of Renewal, Manufacturer and Distributor shall meet to negotiate such
minimum quantity and the amount shall be agreed to in writing. If the parties
fail to reach an agreement on such amounts by the commencement of the Renewal
Term, the amounts for the preceding quarter shall remain in place and the
parties shall seek to resolve such amounts for such Renewal Term in accordance
with Section 19.8 of this Agreement.
3.3 New
Products.
(a) In
addition to the exclusivity provisions of Section 2.1 above, during the Term
and
as long as Distributor is not in material breach of this Agreement, Manufacturer
will offer Distributor the right to become the exclusive distributor for any
new
pharmaceutical products constituting a branded product that Manufacturer has
internally developed and can legally offer (a “New
Product”).
New
Products shall be deemed to specifically exclude OTC Monograph products, ANDA’s
and other generic products. Manufacturer’s offer will be on terms and conditions
not less favorable to Distributor in any material respect than those terms
which
Manufacturer offers or is willing to offer to any other third party. Distributor
will have 60 days from the date Manufacturer provides written notice of such
New
Product and such terms and conditions to exercise such right on the terms and
conditions set forth in such notice. If Distributor acquires the exclusive
right
to distribute any such New Product, then such New Product shall be added to
Attachment
A-1
hereto
and the parties shall agree on the minimum quantity of product to be purchased
from Manufacturer during the first four full quarters of Distributor’s purchase
thereof, which shall be set forth with such New Product on Attachment
A-1.
If the
parties shall be unable to agree on such minimum quantity by the conclusion
of
such 60 day period, then Manufacturer shall be free to sell on a non-exclusive
basis unless until such time as Manufacturer and Distributor agrees to a minimum
quantity with respect to such New Product.
4. Certain
Representations and Warranties of Manufacturer and
Distributor.
Each
of
the Manufacturer and the Distributor represents and warrants to the other that,
with respect to itself:
4.1 Authorization
of Transaction.
Such
party has full and corporate power and authority to execute and deliver this
Agreement and to perform their respective obligations hereunder. This Agreement
constitutes the valid and legally binding obligation of such party, enforceable
in accordance with its terms and obligations. Such party need not give any
notice to, make any filing with, or obtain authorization, consent, or approval
of any government or governmental agency in order to consummate the transactions
contemplated by this Agreement.
4.2 Noncontravention.
The
execution and delivery of this Agreement and the consummation of the
transactions contemplated hereby, do not and will not, with or without the
giving of notice or the passage of time or both, (a) violate any constitution,
statute, regulation, rule, injunction judgment, order, decree, ruling, charge,
or other restriction of any government, governmental agency, or court to which
such party is subject or any provision of its respective charter or bylaws
or
(b) conflict with, result in a breach of, constitute a default under, result
in
the acceleration of, create in any party the right to accelerate, terminate,
modify, or cancel, or require any notice under any agreement, contract, lease,
license, instrument, or other arrangement to which such party is a party or
by
which it is bound or to which any of its assets is subject.
5. Distributor’s
Duties.
Distributor
shall:
(a) submit
its non-cancelable orders for Products by written purchase order, it being
agreed that the terms and conditions of Distributor’s standard purchase order
form shall not apply to transactions pursuant to this Agreement;
(b) pay
for
such orders within 30 days from date of invoice in U.S. dollars and payment
shall be made by wire transfer, check or letter of credit approved by
Manufacturer; all prices are quoted FOB Brooksville, Florida, USA. Past due
amounts not received within 30 days incur interest thereafter at the rate of
1.5% of the invoice amount per month;
(c) provide
to its customers instructions in the use of the Products and field service
for
such Products in accordance with Product information provided by
Manufacturer;
(d) use
its
commercially reasonable efforts to purchase the quantities of each Product
set
forth in Section 2.1;
(e) not
give
any warranties, above and beyond those in Section 10 hereto, to any end-use
customers;
(f)
provide
instruction and assistance on compliance with any regulatory and labeling
requirements of the Territory; however, Manufacturer does not hereby delegate
or
attempt to delegate any of its federal and state regulatory and labeling
obligations with respect to the Products;
(g) cooperate
to a reasonable degree with Manufacturer to obtain any regulatory approval
of
the Products as required by the Territory;
(h) register
all products with correct NDC’s and provide such information to
Manufacturer.
6. Manufacturer’s
Duties.
6.1
Manufacturer
shall:
(a)
ship
promptly Distributor’s orders for Products, FOB Brooksville, Florida, USA, at
the prices set forth on Attachment
A-1
hereto,
subject to Section 6.2 hereof;
(b) adequately
package and label Products to conform with any federal and state regulatory
and
labeling requirements of the Territory with respect to the Products;
and
(c) products
will be co-labeled with Manufacturer and Distributor information under
Distributor’s NDC’s.
6.2
Manufacturer
has the right to change the prices for Products at any time during the Term
only
to the extent of [*]; provided, however, that no such price change shall be
effective without at least sixty (60) days prior notice by Manufacturer to
Distributor and that during any calendar year, Manufacturer may not raise the
price of Products sold to Distributor by any [*] for the prior calendar year.
7. Trademarks
and Trade Names; Intellectual Property.
7.1 Any
and
all trademarks and trade names owned by Manufacturer or its Affiliates shall
remain the property of Manufacturer or its Affiliates and nothing in this
Agreement shall confer in Distributor any ownership in any trademarks or trade
names owned by Manufacturer or its Affiliates. Trademarks and trade names owned
by Manufacturer or its Affiliates in connection with the Products shall be
used
by Distributor only with reference to such Products and only in the manner
approved by the Manufacturer. Any and all goodwill associated with
Manufacturer’s trademarks and trade names used by Manufacturer or Distributor in
connection with the Products shall belong to Manufacturer.
7.2 Any
and
all trademarks and trade names owned by Distributor or its Affiliates shall
remain the property of Distributor or its Affiliates and nothing in this
Agreement shall confer in Manufacturer any ownership in any trademarks or trade
names owned by Distributor or its Affiliates. Trademarks and trade names owned
by Distributor or its Affiliates in connection with the Products shall be used
by Manufacturer only with reference to such Products and only in the manner
approved by the Distributor. Any and all goodwill associated with Distributor’s
trademarks and trade names used by Manufacturer or Distributor in connection
with the Products shall belong to Distributor.
8. Industrial
Property Rights; Confidentiality.
8.1
All
technical and commercial information, data regarding processes and know-how
furnished by Manufacturer to Distributor shall remain the property of
Manufacturer, and Distributor shall not acquire any proprietary rights or other
interests therein. Subject to the limitations listed below, all such information
which is written or is in machine-readable (computer) form and which is marked
“Confidential” or “Proprietary” shall be regarded as confidential information of
Manufacturer; and any such information disclosed orally and as to which
Manufacturer shall notify Distributor in writing that it is confidential within
30 days after disclosure to Distributor, shall also be considered confidential;
and in each case, Distributor shall not disclose such information to any third
party except to the extent such information:
(a)
is
freely
available to the public at the time it is disclosed or made available by
Manufacturer or subsequently becomes freely available to the public other than
by default of Distributor or any third party who owes an obligation of
confidence to Manufacturer; or
(b)
was
known
to Distributor prior to it being disclosed or made available by
Manufacturer;
8.2
If
during
the term of this Agreement, Distributor supplies to Manufacturer any
confidential information relating to Distributor’s business activities,
Manufacturer shall be bound by like obligations of confidence to those set
out
above in relation to that confidential information.
9. Infringement
Claims.
Manufacturer
shall defend at its own expense, any claim by way of suit or proceeding against
Distributor for the infringement of third party patents or trademarks in respect
of Products purchased from Manufacturer hereunder, and shall fully indemnify
Distributor for any damages, costs or expenses incurred by Distributor in
respect of any such claim provided that Distributor shall have given
Manufacturer prompt written notice of any such claim and furnished Manufacturer
with a copy of each communication relating thereto and give Manufacturer the
requisite authority to defend or settle such claim.
*
Confidential treatment has been requested for
certain portions of this document pursuant to an application for confidential
treatment sent to the Securities and Exchange Commission. Such portions are
omitted from this filing and filed separately with the Securities and Exchange
Commission.
10. Product
Warranties.
MANUFACTURER
WARRANTS THAT THE PRODUCTS WILL CONFORM TO MANUFACTURER’S STANDARD WARRANTY, IN
THE FORM ANNEXED HERETO AS ATTACHMENT B (“WARRANTY”).
EXCEPT
FOR MANUFACTURER’S WARRANTY, MANUFACTURER MAKES NO REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO ANY PRODUCTS, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR
PURPOSE, AND MANUFACTURER WILL NOT BE HELD TO ANY LIABILITY WITH RESPECT TO
ANY
CLAIM BY DISTRIBUTOR, ITS AFFILIATES, EMPLOYEES OR AGENTS OR ANY THIRD PARTY
ON
ACCOUNT OF OR ARISING FROM ANY OF THE PRODUCTS SOLD HEREUNDER OR THEIR USE,
INCLUDING, BUT NOT LIMITED TO, ANY LIABILITY FOR ANY INCIDENTAL OR CONSEQUENTIAL
DAMAGES, LOSS OF PROFITS OR GOODWILL. DISTRIBUTOR HEREBY ACKNOWLEDGES THAT
THE
ONLY WARRANTY APPLICABLE TO THE PRODUCTS SHALL BE MANUFACTURER’S WARRANTY.
MANUFACTURER SHALL AT ITS SOLE OPTION, ISSUE A CREDIT FOR OR REPLACE, AT NO
CHARGE TO DISTRIBUTOR, ALL PRODUCTS RETURNED BY DISTRIBUTOR OR RETURNED BY
CUSTOMERS TO DISTRIBUTOR WHICH DO NOT CONFORM TO MANUFACTURER’S WARRANTY.
11. Insurance.
Manufacturer
and Distributor shall each maintain in full force and effect for the Term of
this Agreement product liability insurance policies having substantially the
coverages provided for in Attachment C and shall, upon reasonable request,
provide each other evidence of such insurance.
12. Indemnification;
Limitation of Liability.
12.1 In
no
event shall either party be liable to the other party or any other entity for
any special, consequential, incidental, or indirect damages relating to or
resulting from such party’s failure to perform its obligations under this
Agreement, however caused, on any theory of liability, and notwithstanding
any
failure of essential purpose of any limited remedy. Notwithstanding the
limitation of liability set forth above, Distributor will not be liable for
any
fines incurred solely as a result of Manufacturer’s failure to promptly ship
Distributor’s orders for Products pursuant to Section 6.1(a) to this
Agreement.
12.2 Each
party agrees to indemnify, defend and hold the other (and its officers,
directors, shareholders, agents and employees) harmless from and against any
and
all losses, liabilities, damages, costs, fees and expenses, including reasonable
legal costs and attorneys’ fees (“Losses”)
resulting from any claim, suit or action based upon harm or damages caused
by
the negligence or willful misconduct of such indemnifying party.
13. Regulatory
Matters.
13.1
Product
Recall.
The
parties shall immediately provide to each other in writing all information
reasonably available relating to: (a) any incident relating to a Product that
is
subject to a recall, market withdrawal or correction; or (b) any Product that
may require, whether based on a manufacturing defect, tampering or otherwise,
a
recall, field alert, product withdrawal or field correction arising from any
defect. In the event Distributor or Manufacturer recalls any of the Products
distributed by Distributor because such Products are believed to violate any
provision of applicable law or were not manufactured in accordance with the
required specifications, all costs and expenses of any such recall or other
action determined to be necessary, including, without limitation, expenses
or
obligations to third parties, the cost of notifying customers and cost
associated with the shipment of recalled Product from customers to Distributor
to Manufacturer, shall be borne by the party whose negligent or defective
manufacturing, processing, testing, packing or storage necessitated such action;
provided, however, that Distributor shall not unilaterally recall any Product
supplied by Manufacturer without first obtaining the consent of Manufacturer,
which shall not be unreasonably withheld. Distributor shall maintain complete
and accurate records, for such period as may be required by applicable law,
of
all the Products sold, or otherwise distributed, by it. The parties will
cooperate fully with each other in effecting any recall of the Products,
including communications with any purchasers or users. For the avoidance of
doubt, Manufacturer shall not be liable for, or responsible for costs associated
with, any general business returns of Products, expired Products, or any action
taken by the U.S. Food & Drug Administration or any other governmental
authority unless such action arises from manufacturing defects in the
Products.
13.2
Customer
Complaint Reporting.
Distributor shall be responsible for notifying the appropriate federal, state,
and local governmental authorities (United States or any country in the
Territory, as the case may be) of any customer complaints or other occurrences
regarding the Products which are required to be so reported. Distributor shall
provide Manufacturer promptly with any information it receives regarding such
occurrences.
13.3 Inspections.
Manufacturer shall provide Distributor within 10 days information on any
regulatory inspection of the Manufacturer’s manufacturing facilities, including
providing Distributor copies of (i) any Form FDA-483 “Notice of Inspectional
Observations” delivered by an FDA investigator or any similar notice delivered
by any other regulatory authority, (ii) any response by the Manufacturer to
any
such notice, (iii) any Warning Letter or other letter delivered by the FDA
or
any other regulatory authority that affects the Products or the manufacture
of
the Products in any way, and (iv) any response to any such Warning Letter or
other letter.
14. Termination.
14.1
Either
party shall have the right to terminate this Agreement on written notice if
the
other (i) commits or suffers any act of bankruptcy or insolvency or (ii) within
ninety (90) days after written notice of a material breach of this Agreement
has
been given, either fails to cure any such material breach which is capable
of
cure within thirty (45) days or has failed to commence a cure of any such
material breach which is not capable of cure within thirty (45) days.
Notwithstanding the foregoing, Manufacturer shall have the right to terminate
this Agreement immediately if Distributor shall fail to pay any amount owed
by
Distributor to Manufacturer within 10 days after receipt of the notice of
non-payment from Manufacturer.
14.2 This
Agreement will survive a change in control of either party during the
Term.
15. Effects
of Termination.
On
the
termination of this Agreement, for whatever reason, (i) Manufacturer shall
continue to honor Distributor’s orders for Products up to the effective date of
termination, (ii) Distributor shall pay all past due invoices and shall pay
for
all undamaged, delivered Products in accordance with the terms and conditions
of
this Agreement, (iii) Distributor shall return to Manufacturer all promotional
and all confidential information or other documents relating to the Products,
(iv) Manufacturer shall return to Distributor all promotional and all
confidential information or other documents relating to the Products, (v)
Distributor shall cease to use all trademarks and trade names used by
Manufacturer in connection with the Products and (vi) Manufacturer shall cease
to use all trademarks and trade names used by Distributor in connection with
the
Products.
16. Nature
of Relationship.
Distributor
is an independent party and shall in no respect be or be deemed to be an
employee, partner or co-venturer of Manufacturer or an agent of or subject
to
the authority of Manufacturer. Except as specifically authorized in writing,
Distributor shall not be in any way authorized or empowered to bind
Manufacturer.
17. Severability.
If
any
provision of this Agreement shall be void or unenforceable by reason of any
applicable law, it shall be deleted and the remaining provisions hereof shall
continue in full force and effect and, if necessary, so amended as may be
necessary to give effect to the spirit of this Agreement so far as possible.
18. Force
Majeure.
The
obligations of each party to perform under this Agreement shall be excused
during each period of delay caused by matters such as strikes, shortages of
raw
material, government orders, acts of terror or acts of God, which are reasonably
beyond the control of the party whose obligation to perform is affected by
such
matters and such excuse from performance shall be coextensive with the cause
of
such delay.
19. Miscellaneous.
19.1
Notices.
All
notices required or permitted shall be in writing and shall be deemed given
when
received personally or by facsimile (when confirmation copy is sent by
registered airmail, postage prepaid, or by such other method, including air
courier) addressed as follows, or to such other person or address as may be
designated by notice given in accordance with this Section to the other party:
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If
to Distributor:
Xxx
Xxxx Xxxxx, Xxxxx 0000,
Xxx
Xxxx, XX 00000
Attn:
Xxxx Xxxxxxx
with
a copy to:
Arent
Fox LLP
0000
Xxxxxxxxxxx Xxx, XX
Xxxxxxxxxx,
XX 00000
Attention:
Xxxxxxx X. Xxxxxx, Esq.
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If
to Manufacturer:
TG
United Labs, LLC
00000
Xxxxxxxx Xxxx
Xxxxxxxxxxx,
Xxxxxxx 00000
Attn:
Xxxxx Xxxxxxx
with
a copy to:
Xxxxxx
Xxxxxxx Xxxxxx & Xxxxx, LLP
000
Xxxxx Xxxxxx, Xxxxx 0000
Xxxxxxxxx,
Xxxxxxxxx 00000
Attention:
Xxxxxxx X. Xxxxxxxxx, Esq.
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19.2
Entire
Agreement.
This
Agreement is the entire agreement between the parties hereto relating to this
subject matter, there being no prior written or oral promises or representations
not incorporated herein.
19.3
Applicable
Law.
This
Agreement shall be governed by and construed under the laws of the State of
New
York without regard to the principles of conflicts of law. Subject to any
statutes of repose or other statutory limitations period in effect under New
York law, any claim by Distributor against Manufacturer shall be brought within
one (1) year after Distributor first learns of such claim. Any controversy
or
claim arising in connection with this Agreement shall be finally settled in
Tampa, Florida under the Rules of the American Arbitration Association by one
or
more arbitrators appointed in accordance with the said Rules and judgment upon
the award rendered by the arbitrators may be entered in any court having
jurisdiction thereof.
19.4
Amendments.
No
amendment or modification of the terms of this Agreement shall be binding on
either party unless reduced to writing and signed by an authorized officer
of
the party to be bound.
19.5
Existing
Obligations.
Each
party represents and warrants to the other party that the terms of this
Agreement do not violate any existing obligations or contracts of such party.
Each party shall defend, indemnify and hold harmless the other party from and
against any and all claims, demands, actions or causes of action, which allege
any such violation.
19.6
Assignment.
This
Agreement shall be binding upon and inure to the benefit of the parties hereto
and their respective successors and assigns, provided, however, that neither
party shall transfer or assign its interests in this Agreement without the
prior
written consent of the other party.
19.7
Counterparts.
For
convenience of the parties hereto, this Agreement may be executed in one or
more
counterparts, each of which shall be deemed an original for all
purposes.
19.8
Disputes.
If a
dispute arises under this Agreement which cannot be resolved by the personnel
directly involved, either party may give written notice to the other designating
an executive officer with appropriate settlement authority to be its
representative in negotiations relating to the dispute. Upon receipt of this
notice, the other party shall, within five business days, designate an executive
officer with similar authority to be its representative. The designated
executive officers shall, following whatever investigation each deems
appropriate, promptly enter into discussions concerning the dispute. If the
dispute is not resolved as a result of such discussions within 30 days, such
dispute shall be referred to final and binding arbitration before three
arbitrators (one picked by each party, and those two picking the third neutral
arbitrator) in accordance with the commercial rules of the American Arbitration
Association. Unless the parties agree otherwise in writing, such arbitration
shall be held in Tampa, Florida. The expense of arbitration shall be borne
one-half (1/2) by Manufacturer and one-half (1/2) by Distributor. Each party
shall pay the fees and expenses of its own counsel. Arbitration relative to
any
unresolved dispute must be commenced within two years after the cause of action
has accrued.
19.9
Other
TG United Companies.
Manufacturer and the Other TG United Companies are, as of the date hereof,
under
common control. Each Other TG United Company acknowledges the representations,
warranties and covenants made by Manufacturer in this Agreement, and each Other
TG United Company covenants and agrees not to take any action that would make
impossible or impracticable the performance by Manufacturer of this
Agreement.
Signature
page follows
IN
WITNESS WHEREOF,
the
parties hereto have caused this Agreement to be executed by their authorized
representatives named below.
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TG
United Pharmaceuticals, Inc.
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By:
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/s/
Xxxxx Xxxxxxx
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By:
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/s/
Xxxxx Xxxxxxx
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Name:
Xxxxx Xxxxxxx
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Name:
Xxxxx Xxxxxxx
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Title:
Chief Financial Officer
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Title:
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The
following “Other TG United Companies” hereby join in this Agreement solely for
the purposes set forth in Section 19.9 of this Agreement:
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TG
United Labs, LLC
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TG
United, Inc.
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By:
|
/s/
Xxxxx Xxxxxxx
|
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By:
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/s/
Xxxxx Xxxxxxx
|
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Name:
Xxxxx Xxxxxxx
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Name:
Xxxxx Xxxxxxx
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Title:
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Title:
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TG
United Liquid, Inc.
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||
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By:
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/s/
Xxxxx Xxxxxxx
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Name:
Xxxxx Xxxxxxx
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Title:
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ATTACHMENT
A
PRODUCTS
ATTACHMENT
A-1
PRICE
OF EACH PRODUCT
*
Confidential treatment has been requested for certain portions of this document
pursuant to an application for confidential treatment sent to the Securities
and
Exchange Commission. Such portions are omitted from this filing and filed
separately with the Securities and Exchange Commission.
|
Maxifed
CDX
|
00000-0000-00
|
60mg
Pseudoephedrine HCl
400mg
Guaifenesin
20mg
Codeine Phosphate
|
[*]
|
[*]
|
||||
|
Maxifed
DM
|
00000-0000-00
|
40mg
Pseudoephedrine HCl
400mg
Guaifenesin
20mg
Dextromethorphan HBr
|
[*]
|
[*]
|
||||
|
Maxifed
DMX
|
00000-0000-00
|
60mg
Pseudoephedrine HCl
400mg
Guaifenesin
20mg
Dextromethorphan HBr
|
[*]
|
[*]
|
||||
|
Maxifed-G
|
00000-0000-00
|
40mg
Pseudoephedrine HCl
400mg
Guaifenesin
|
[*]
|
[*]
|
||||
|
Maxifed-G
CD
|
00000-0000-00
|
40mg
Pseudoephedrine HCl
400mg
Guaifenesin
10mg
Codeine Phosphate
|
[*]
|
[*]
|
||||
|
Maxifed-G
CDX
|
00000-0000-00
|
40mg
Pseudoephedrine HCl
400mg
Guaifenesin
20mg
Codeine Phosphate
|
[*]
|
[*]
|
||||
|
Maxiflu
CD
|
00000-0000-00
|
40mg
Pseudoephedrine HCl
400mg
Guaifenesin
10mg
Codeine Phosphate
500mg
Acetaminophen
|
[*]
|
[*]
|
||||
|
Maxiflu
CDX
|
00000-0000-00
|
60mg
Pseudoephedrine HCl
400mg
Guaifenesin
20mg
Codeine Phosphate
500mg
Acetaminophen
|
[*]
|
[*]
|
||||
|
Maxiflu
DM
|
00000-0000-00
|
60mg
Pseudoephedrine HCl
400mg
Guaifenesin
20mg
Dextromethorphan HBr
500mg
Acetaminophen
|
[*]
|
[*]
|
||||
|
Maxiphen
|
00000-0000-00
|
10mg
Phenylephrine HCl
400mg
Guaifenesin
|
[*]
|
[*]
|
||||
|
Maxiphen
CD
|
00000-0000-00
|
10mg
Phenylephrine HCl
400mg
Guaifenesin
10mg
Codeine Phosphate
|
[*]
|
[*]
|
||||
|
Maxiphen
CDX
|
00000-0000-00
|
10mg
Phenylephrine HCl
400mg
Guaifenesin
20mg
Codeine Phosphate
|
[*]
|
[*]
|
||||
|
Maxiphen
DM
|
00000-0000-00
|
10mg
Phenylephrine HCl
400mg
Guaifenesin
20mg
Dextromethorphan HBr
|
[*]
|
[*]
|
||||
|
Phenflu
CD
|
00000-0000-00
|
10mg
Phenylephrine HCl
400mg
Guaifenesin
10mg
Codeine Phosphate
500mg
Acetaminophen
|
[*]
|
[*]
|
||||
|
Phenflu
CDX
|
00000-0000-00
|
10mg
Phenylephrine HCl
400mg
Guaifenesin
20mg
Codeine Phosphate
500mg
Acetaminophen
|
[*]
|
[*]
|
||||
|
Phenflu
DM
|
00000-0000-00
|
10mg
Phenylephrine HCl
400mg
Guaifenesin
20mg
Dextromethorphan HBr
500mg
Acetaminophen
|
[*]
|
[*]
|
*
Confidential treatment has been requested for certain portions of this document
pursuant to an application for confidential treatment sent to the Securities
and
Exchange Commission. Such portions are omitted from this filing and filed
separately with the Securities and Exchange Commission.
ATTACHMENT
X-0
XXXXXXXXX:
|
Xxxxxx
Xxxxxx (being the contiguous 48 states, Alaska, Hawaii, the District
of
Columbia, Puerto Rico and the other territories and possessions
thereof)
|
ATTACHMENT
B
LIMITED
WARRANTY AND LIMITATION OF LIABILITY
WARRANTY
Manufacturer
warrants and guarantees that, when delivered to distributor FOB Brooksville,
Florida, the Product shall conform to Manufacturer’s registered specifications
and guidelines with respect to the Products and shall not be adulterated or
misbranded within the meaning of the Federal Food and Cosmetic and shall conform
to all applicable regulations of the FDA (the “Limited
Warranty”).
EXCEPT FOR THE LIMITED WARRANTY, MANUFACTURER MAKES NO REPRESENTATIONS OR
WARRANTIES OF ANY KIND REGARDING THE PRODUCTS, EXPRESS, IMPLIED OR OTHERWISE,
AND SPECIFICALLY DISCLAIMS: ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.
THIS
WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES (EXCEPT OF TITLE), EXPRESSED,
IMPLIED, OR STATUTORY, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS
FOR A PARTICULAR PURPOSE.
TG
UNITED
LABS, LLC AND ITS DISTRIBUTORS SHALL IN NO EVENT BE LIABLE TO THE USER, OR
TO
ANY SUCCESSOR IN INTEREST OR ANY BENEFICIARY OR ASSIGNEE THEREOF, ON ACCOUNT
OF
ANY TG UNITED LABS, LLC PRODUCT FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT,
SPECIAL OR PUNITIVE DAMAGES ARISING OUT OF THE SALE OR DELIVERY OF SUCH PRODUCT,
OR ANY DEFECTS IN, OR FAILURE OF, OR MALFUNCTION OF THE PRODUCT INCLUDING,
BUT
NOT LIMITED TO, DAMAGES BASED UPON LOSS OF USE, LOST PROFITS OR REVENUE,
INTEREST, LOST GOODWILL, INCREASED EXPENSES AND/OR CLAIMS OF CUSTOMERS OF THE
USER, WHETHER OR NOT SUCH LOSS OR DAMAGE IS BASED ON CONTRACT, WARRANTY,
NEGLIGENCE, INDEMNITY, STRICT LIABILITY OR OTHERWISE.
ATTACHMENT
C
INSURANCE
COVERAGES
