EXCLUSIVE MANUFACTURING AND DISTRIBUTION AGREEMENT
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THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT, WHICH
HAVE BEEN REMOVED AND REPLACED WITH AN
ASTERISK, HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT UNDER RULE 406 PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
EXCLUSIVE
MANUFACTURING AND DISTRIBUTION AGREEMENT
This
Exclusive Distribution Agreement (the "Agreement"), effective June 9, 2004
(the
"Effective Date"), is between MINRAD, INC., a Delaware corporation with offices
at 000 Xxxx Xxxxxx, Xxxxxxx, Xxx Xxxx 00000, XXX ("Manufacturer") and RxElite
Holdings Inc., a Delaware corporation with offices at 0000 X. Xxxx, Xxxxx 000,
Xxxxxxxx, Xxxxx 00000 ("Distributor").
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.
"ANDA"
shall
mean abbreviated new drug application.
"Hospital
Market"
shall
mean those accounts that purchase anesthetic agents for human use.
"Manufacturer's
Representative"
shall
mean MINRAD Inc., which is a manufacturer's representative of Manufacturer
with
respect to the Products.
"NDC"
means
national drug code number.
"Products"
shall
mean the MlNRAD branded products set forth on Attachment
A
hereto.
"Purchase
Commitments"
shall
mean those outlined in Attachment
A-1
hereto.
"Territory"
shall
mean the geographical area set forth in Attachment
A-2
hereto.
2.
Grant
Exclusive Distributorship
2.1
Appointment.
Subject
to Distributor's compliance with Section 2.2 hereof, Manufacturer hereby grants
to Distributor for the Term the exclusive right to purchase the Products from
Manufacturer for the sole purpose of selling the Products to end-use customers
in the human market in the Territory, 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.
Distributor shall not itself manufacture or have manufactured for it or directly
or indirectly sell, any products from third parties that are similar to the
Products. Notwithstanding anything herein to the contrary, Manufacturer and
Distributor acknowledge Manufacturer's right to sell, from time to time,
Enflurane to Xxxxxx, who bottles and markets the Products under its own name
for
the purpose of selling the Products to end-use customers in the human market
in
the Territory (the "Private Label Distributor").
2.2
Initial
Order.
Distributor agrees to place an initial non-cancelable stocking order for
Products as set forth on Attachment
A-1
hereto
at the time of signing (the "Initial Order"). The Sevoflurane component of
the
Initial Order is subject to and will be shipped after FDA approval has been
received and any existing exclusivity granted by the FDA has expired.
2.3
Purchase
Commitment.
Distributor agrees to purchase Products from Manufacturer as set forth in
Attachment
A-1
hereto
during the Term. The purchase commitment for Sevoflurane will commence when
FDA
approval to sell Sevoflurane in the Market has been received and any existing
exclusivity granted by the FDA has expired. The Initial Order will be shipped
by
Manufacturer no later than October 2004 and will be considered as part of the
Distributor's annual commitment for 2005. The terms of this Initial Order only
will be net *. All subsequent orders will have terms as set forth in section
4(b) of this Agreement.
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 each Product
as listed in Attachment
A-1
which
Product prices are subject to change as set forth in Section 5.2.
2.5
Other
Accounts.
Manufacturer has established various accounts for the Products in the Territory
prior to the implementation of this agreement. Upon signature of this agreement,
Manufacturer will effectively assign over to the Distributor all accounts and
any purchases of product in the Territory from the signature date forward at
the
terms stipulated in this agreement and will decrement the annual purchase
commitments outlined in Attachment
A-1
regardless if the product is Manufacturer labeled or co-labeled and regardless
of the NDC number on the product. Effective assignment shall mean any means
necessary for the contract to be fulfilled by Distributor through whatever
means
necessary to maintain a legal contract with customer.
3.
Term
and Renewal
-2-
3.1
Term.
This
Agreement shall remain in effect for an initial term beginning on the Effective
Date and ending on December 31, 2007 (the "Initial Term"). After the Initial
Order, Distributor must purchase a minimum of * of the annual commitment during
the first month of each calendar quarter beginning January 1, 2005 as specified
in Attachment
A-1.
At the
end of each calendar year during the Initial Term, Distributor must order
Product to fulfill each year's annual commitment. Manufacturer will have 60
days
to deliver this order. 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 and each Renewal Term, if any, this Agreement
may be extended or renewed for successive one (1) year extension periods for
so
long as, and provided that, Distributor issues to Manufacturer a non-cancelable
purchase order for an amount equal to the (highest annual commitment) of the
Products as set forth on Attachment
A-1
hereto.
Manufacturer
must receive such purchase order from Distributor at least 60 days prior to
the
end of the previous term. Other than the initial order, the renewal terms will
be consistent with section 3.1 and the other parts of this agreement.
3.3
New
Products.
During
the Term and as long as the Distributor is not in breach of any part of this
Agreement, Manufacturer will offer Distributor the right of first refusal to
become its exclusive distributor in the Territory of any human generic
pharmaceutical products (Manufacturer ANDA) that is a new Product and that
the
Manufacturer can legally offer. The offer will be on similar or better terms
than ones the Manufacturer will offer or is willing to offer to any other third
party in the human market. Distributor will have 30 days from the date
Manufacturer provides written notice to exercise such right on the terms and
conditions set forth in such notice. For the purpose of clarity, and not by
way
of limitation, Manufacturer's conscious sedation product is acknowledged by
the
parties to be a proprietary product and is specifically excluded from this
Agreement.
4.
Distributor's
Duties
Distributor
shall:
(a)
submit its non-cancelable orders for the 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 * net * from date of invoice (excluding only the Initial Order)
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 Bethlehem,
Pennsylvania, USA. Past due amounts incur interest at the rate of * of the
invoice amount per month or the highest rate allowable by law, whichever is
less;
(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;
-3-
(d)
purchase the minimum commitment as per Attachment
A-1.
and use
its best efforts to exceed these minimum commitments;
(e)
refrain, outside the Territory and in relation to the Products, from seeking
customers, from establishing any branch and from maintaining any distribution
depot;
(g)
not
give any warranties, above and beyond those in Article 9 hereto, to any end-use
customers;
(h)
provide instruction and assistance on compliance with any regulatory and
labeling requirements of the Territory; However, Manufacturer remains solely
responsible for compliance with all regulatory and labeling requirements of
the
Territory - in its role as holder of the ANDA.
(i)
cooperate to a reasonable degree with Manufacturer to obtain any regulatory
approval of the Products as required by the Territory;
(j)
not
use sub-distributors or any other agent, other than itself, without the prior
written consent of the Manufacturer;
(k)
have
a Dedicated Head of Sales for the Hospital Market in place upon signing this
Agreement;
(l)
have
a minimum of five (5) Hospital Market Field Sales Representatives in place
within 3 months of signing this Agreement (one in each of the Manufacturer
defined US Regions). A reasonable number will be added upon the launch of
Sevoflurane as per mutual agreement between Manufacturer and Distributor;
(m)
provide monthly unit sales broken down by product, size and by hospital specific
DEA code to Manufacturer within thirty (30) days of the end of the preceding
month;
(n)
register all products with correct NDC's and provide this information to the
Manufacturer.
5.
Manufacturer's
Duties
5.1
Manufacturer shall:
(a)
ship
promptly Distributor's orders for Products, FOB Bethlehem, Pennsylvania, USA,
at
the prices set forth on Attachment
A-1
hereto,
subject to Section 5.2 hereof;
(b)
adequately package and label the Products to conform with any regulatory and
labeling requirements of the Territory. Product will be co-labeled with
Manufacturer and Distributor information under Distributor's NDC's;
(c)
have
5 US regional sales managers in place upon signing this Agreement;
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(d)
have
a minimum of five (5) Hospital Market Field Sales Representatives in place
within 3 months of signing this Agreement (one in each of the MINRAD defined
US
Regions);
(e)
add
three (3) additional professional people to help expand the product line within
six (6) months of signing this Agreement.
5.2
Manufacturer has the right to change the prices for the Products at any time
during the Term only to the extent of demonstrated increases in its direct
costs
of manufacturing the Products; provided, however, that no such price change
shall be effective without at least sixty (60) days prior notice by Manufacturer
to Distributor. The price that Distributor pays Manufacturer for the Products
shall be its lowest price in the Territory for the Human Market with the
exclusion of those existing accounts referenced in Section 2.5.
6.
Trademarks
and Trade Names
6.1
Trademarks and trade names used by Manufacturer and Manufacturer's
Representative in connection with the Products shall be used by Distributor
only
with reference to such Products and only in the manner approved by Manufacturer.
Distributor acknowledges that it has and will obtain no proprietary interest
in
such trademarks and trade names and agrees not to use the same as part of its
corporate or business name and to discontinue all use thereof immediately upon
termination of this Agreement.
6.2
All
and any goodwill associated with the trademarks and trade names used by
Manufacturer and Manufacturer's Representative in connection with the Products
shall belong to Manufacturer. Distributor shall not do or omit to do any act
or
thing likely to affect adversely the goodwill and reputation associated with
the
Products and the said trademarks and trade names.
7.
Industrial
Property Rights; Confidentiality
7.1
All
technical and commercial information, data regarding processes and know-how
furnished by Manufacturer and/or Manufacturer's Representative to Distributor
shall remain the property of Manufacturer and/or Manufacturer's Representative,
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/or Manufacturer's Representative; and any such information
disclosed orally and as to which Manufacturer and/or Manufacturer's
Representative shall notify Distributor in writing that it is confidential
within thirty (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 and/or Manufacturer's Representative or subsequently becomes freely
available to the public otherwise than by default of Distributor or any third
party who owes an obligation of confidence to Manufacturer and/or Manufacturer's
Representative or any company within Manufacturer's and/or Manufacturer's
Representative's group; or
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(b)
was
known to Distributor prior to it being disclosed or made available by
Manufacturer and/or Manufacturer's Representative.
(c)
Both
parties will be bound by the terms of the separate mutually confidential
agreement signed on May 19, 2004.
7.2
If
during the term of this Agreement, Distributor supplies to Manufacturer and/or
Manufacturer's Representative any confidential information relating to
Distributor's business activities, Manufacturer and/or Manufacturer's
Representative shall be bound by like obligations of confidence to those set
out
above in relation to that confidential information.
8.
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 direct 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.
9.
Product
Warranties
MANUFACTURER
WARRANTS THAT THE PRODUCTS WILL CONFORM TO THE MANUFACTURER'S STANDARD WARRANTY,
IN THE FORM ANNEXED HERETO AS ATTACHMENT B ("WARRANTY").
EXCEPT
FOR THE MANUFACTURER'S WARRANTY, MANUFACTURER MAKES NO REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT OR 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 THE 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 THE MANUFACTURER'S WARRANTY.
10.
Insurance
Manufacturer
warrants the product liability insurance for the Products being sold under
this
Agreement.
-6-
11.
Limitation
of Liability
In
no
event, except as set forth below, shall Manufacturer be liable to Distributor
or
any other entity for any special, consequential, incidental, or indirect damages
relating to or resulting from manufacturer'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, the 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
5.1(a) to this Agreement.
12.
Regulatory
Matters
12.1
Product
Recall.
In the
event Distributor or Manufacturer recalls any of the Products rented or
distributed by Distributor because such Products are believed to violate any
provision of applicable law, Manufacturer shall bear all reasonable costs and
expenses of such recall, 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;
provided, however, that Distributor shall not unilaterally recall any Product
supplied by Manufacturer without first obtaining the consent of the
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.
12.2
Customer
Complaint Reporting.
Manufacturer 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.
Termination
13.1
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 (30) days or has failed to commence a cure of
any
such material breach which is not capable of cure within thirty (30) days.
13.2
Manufacturer shall have the right to terminate this Agreement immediately if
Distributor shall fail to pay any amount owed by Distributor to Manufacturer
within ten (10) days after receipt of the notice of non-payment from
Manufacturer.
13.3
This
Agreement will survive a change in control of either party during the Term.
14.
Effects
of Termination
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14.1
Procedures.
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
and
(iv) Distributor shall cease to use all trademarks and trade names used by
Manufacturer and Manufacturer's Representative in connection with the Products.
14.2
No
Compensation.
Upon
termination or expiration without renewal of this Agreement, except tender
offer, Manufacturer shall not be obligated to pay to Distributor any
compensation, damages or other amount on account thereof, and Distributor freely
and fully waives any claim it may have to payment of any such amount whether
under contract, statute or national policy, including Manufacturer's
indemnification of Distributor.
15.
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.
16.
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.
17.
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 effected by
such
matters and such excuse from performance shall be coextensive with the cause
of
such delay.
18.
Miscellaneous
18.1
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:
-8-
If
to Distributor:
RxElite
Holdings Inc.
0000
X. Xxxx, Xxxxx 000 Xxxxxxxx, Xxxxx 00000
Attn:
Xxxx X. Xxxxxxxx
Fax
No.: 000-000-0000
with
a copy to:
Oles,
Morrison, Xxxxxx & Xxxxx LLP
000
Xxxx Xx., Xxxxx 0000
Xxxxxxx,
Xxxxxxxxxx 00000-0000
Attn:
Xxxxxxx X. Xxxx
Fax
No.: 000-000-0000
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If
to Manufacturer:
Minrad
Inc.
000
Xxxx Xxxxxx
Xxxxxxx,
Xxx Xxxx 00000
Attn:
Xxxxxxx X. Xxxxx, Xx.
Fax
No.: 000-000-0000
with
a copy to:
Xxxxxxx
Xxxx LLP
Xxx
X&X Xxxxx, Xxxxx 0000
Xxxxxxx,
Xxx Xxxx 00000
Attention:
Xxxxxx X. Xxxxxxx, Xx.
Fax
No.: 000-000-0000
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18.2
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.
18.3
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. 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 New York, New York
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.
18.4
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.
18.5
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.
18.6
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.
-9-
18.7
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.
18.8
Board
Approval-Manufacturer.
As the
undersigned President and CEO of Manufacturer requires both the approval and/or
ratification of this Agreement and the authorization to execute and deliver
this
Agreement from Manufacturer's Board of Directors, this Agreement is contingent
upon and subject to such approval and/or ratification by Manufacturer's Board
of
Directors, in its sole discretion, at its next meeting of the Board of
Directors, which meeting is expected to occur on or about June 9, 2004 and
which
approval and/or ratification shall be deemed received unless Manufacturer
notifies Distributor to the contrary no later than June 16, 2004.
18.9
Board
Approval-Distributor.
As the
undersigned President and CEO of Distributor requires both the approval and/or
ratification of this Agreement and the authorization to execute and deliver
this
Agreement from Distributor's Board of Directors, this Agreement is contingent
upon and subject to such approval and/or ratification by Distributor's Board
of
Directors, in its sole discretion, at its next meeting of the Board of Directors
and which approval and/or ratification shall be deemed received unless
Distributor notifies Manufacturer to the contrary no later than June 16, 2004.
IN
WITNESS WHEREOF,
the parties hereto have caused this Agreement to be executed by their authorized
representatives named below.
MINRAD
INC.
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RXELITE
HOLDINGS INC.
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|||
By:
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/s/
Xxxxxxx X. Xxxxx, Xx.
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By:
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/s/
Xxxxxx Xxxx
|
|
Name:
Xxxxxxx X. Xxxxx, Xx.
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Name:
Xxxxxx Xxxx
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|||
Title:
President & CEO
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Title:
CEO
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ATTACHMENT
A
PRODUCTS
1.
|
Human
Inhalation Anesthetic agents Xxxxxxx Isoflurane USP, Compound 347
Enflurane USP (Non-Private Label Distributor) and Sevoflurane (when
and if
available)
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ATTACHMENT
A-1
Annual
Purchase Commitments
Territory:
United States Human Market
|
|
Initial
|
|
Annual
|
|
|||||
Product
|
|
Price
Per Bottle
|
|
Stocking
Order
|
|
Commitment*
|
||||
|
|
|
|
|||||||
Compound
347™ Enflurane USP 250
ml bottle
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$
|
*
|
*
|
*
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||||||
Xxxxxxx™
lsoflurane USP 100
ml bottle
|
$
|
*
|
*
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[Initial
Stock Order Only
|
]
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|||||
Xxxxxxx™
Isoflurane USP 250
ml bottle
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$
|
*
|
*
|
*
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||||||
Sevoflurane
250 ml bottle
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$
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*
|
*
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*
**
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Prices
are FOB Bethlehem, Pennsylvania, USA.
Terms:
*
net *
*
Shipments will be made monthly in lot-size multiples. Purchases will be measured
in 250ml equivalents but will not be limited to the percentage allocations
listed above. For example: Distributor purchases 5 -100mL units will equal
2 -
250mL unit equivalents and decrement from the total commitment of ml to be
purchased as outlined in Attachment A-1
**
When
and if available and increasing to * bottles and * bottles in the second and
third years, respectively, during the Initial Term and * during each Renewal
Term.
ATTACHMENT
X-0
XXXXXXXXX:
Xxxxxx
Xxxxxx (being the contiguous 48 states, Alaska and Hawaii)
Human
Market
(Non-OEM)
ATTACHMENT
B
LIMITED
WARRANTY AND LIMITATION OF LIABILITY
WARRANTY
Manufacturer
warrants and guarantees that, when delivered to distributor FOB Bethlehem,
Pennsylvania, the Product shall conform to the Registered Specifications, shall
not be adulterated or misbranded within the meaning of the Act 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.
THE
REMEDIES OF THE USER IN THE WARRANTY SET FORTH ABOVE ARE EXCLUSIVE, AND THE
TOTAL LIABILITY OF MINRAD AND/OR ANY MINRAD DISTRIBUTOR WITH RESPECT TO PRODUCT
SOLD TO THE USER, IN CONNECTION WITH THE PERFORMANCE THEREOF, OR ARISING OUT
OF
THE SALE, DELIVERY, INSTALLATION OR REPAIR OF ANY MINRAD PRODUCT WHETHER BASED
ON CONTRACT, WARRANTY, NEGLIGENCE, INDEMNITY, STRICT LIABILITY, OR OTHERWISE,
SHALL NOT EXCEED THE PURCHASE PRICE OF THE DRTSÔ PLATFORM UPON WHICH SUCH
LIABILITY IS PLACED.
MINRAD
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
MINRAD PRODUCT FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL OR PUNITIVE
DAMAGES ARISING OUT OF THE SALE, DELIVERY, INSTALLATION OR REPAIR 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.
ADDENDUM
TO DISTRIBUTION AGREEMENT
THIS
ADDENDUM TO DISTRIBUTION AGREEMENT (this "Addendum") is made as of March 28,2005
(the "Addendum Effective Date"), by and between MINRAD INC., with offices at
000
Xxxx Xxxxxx, Xxxxxxx, Xxx Xxxx 00000 ("Manufacturer") and RxElite
Holdings Inc.,
a
Delaware corporation with offices at 0000 X. Xxxx, Xxxxx 000, Xxxxxxxx, Xxxxx
00000 ("Distributor").
WHEREAS,
Manufacturer and Distributor entered into a Distribution Agreement, effective
June 9, 2004 (the "Agreement"), regarding the distribution by Distributor of
certain of Manufacturer's products and related accessories; and
WHEREAS,
Manufacturer and Distributor desire to amend the Agreement to include certain
other products and related accessories in addition to those originally covered
within the scope of the Agreement.
NOW,
THEREFORE, Manufacturer and Distributor agree as follows:
1.
Section 2.1 is amended by adding the follow sentence:
Notwithstanding
anything herein to the contrary, Manufacturer and Distributor also acknowledge
Manufacturer's right to sell, from time to time, Enflurane to Xxxxxx, who
bottles and markets the Products under its own name for the purpose of selling
the Products to end-use customers in the human market in the Territory (the
"Private Label Distributor").
2.
Section 5.1 (c) is replaced with:
(c)
have
5 US regional sales managers in place by June 30, 2005;
3.
Section 5.1 (d) is replaced with:
(d)
have
a minimum of five (5) Hospital Market Field Sales Representatives in place
by
June 30, 2005 (one in each of the MINRAD defined US Regions);
4.
Attachment A of the Agreement is amended by adding the following products and
market:
a.
Manufacturer hereby grants to Distributor for the Term the non-exclusive right
to purchase MINRAD Attane™
branded
product from Manufacturer for the sole purpose of selling the Products to
end-use customers in the veterinary market in the Territory, and Distributor
accepts such grant, subject to the limitations, terms and conditions stated
in
this Agreement. The Distributor will not sell MINRAD Attane ™
branded
product to veterinary distributors. Manufacturer will turn over its existing
end-user veterinary customers to the Distributor.
b.
Manufacturer hereby grants to Distributor for the Term the exclusive right
to
purchase Desflurane from Manufacturer for the sole purpose of selling the
Products to end-use customers in the human market in the Territory, and
Distributor accepts such grant, subject to the limitations, terms and conditions
stated in this Agreement.
2.
Attachment A-1 of the Agreement is amended by adding the following initial
order, minimum order, pricing and annual order requirements:
a.
Veterinary Products
Product
|
Price
per bottle
|
|
Initial
Stocking Order
|
|
Minimum
Order
|
|||||
Attane™
Isoflurane USP 100
ml bottle
|
$
|
*
|
*
|
*
|
||||||
Attane™
Isoflurane USP 250
ml bottle
|
$
|
*
|
*
|
*
|
||||||
Sustane™
Sevoflurane 250 ml bottle
|
$
|
*
|
*
|
*
*
|
b.
Desflurane (when available)
Product
|
Price
per bottle
|
|
Initial
Stocking Order
|
|
Annual
Commitment
|
|||||
Desflurane
USP 250 ml bottle
|
$
|
*
|
*
|
*
*
|
*
When
available - pricing and annual commitments to be re-evaluated when product
is
nearing availability.
4.
Manufacturer will provide Distributor at no charge "Free Goods", *
Xxxxxxx™
100 ml
bottles and * Compound 347™
250 ml
bottles for sale or distribution in the Territory. These Free Goods are to
compensate Distributor for any pricing issues in the Territory through the
life
of the agreement.
5.
Except
as modified by this Addendum, the Agreement is hereby ratified and will remain
in full force and effect in accordance with its terms.
-2-
IN
WITNESS WHEREOF, the parties have executed this Addendum as of the date first
above written.
MINRAD
INC.
|
RXELITE
HOLDINGS INC.
|
|||
By:
|
/s/ Xxxxxxx X. Xxxxx, Xx. |
By:
|
/s/ Xxxxxx Xxxx | |
Name:
Xxxxxxx X. Xxxxx, Xx.
|
Name:
Xxxxxx Xxxx
|
|||
Title:
President & CEO
|
Title:
CEO
|
-3-
THE
CONFIDENTIAL PORTIONS OF THIS EXHIBIT, WHICH
HAVE BEEN REMOVED AND REPLACED WITH AN
“XX”,
HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT UNDER RULE 406 PROMULGATED
UNDER THE SECURITIES ACT OF 1933 AND RULE
24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934.
AMENDMENT
NO. 2 TO
EXCLUSIVE
MANUFACTURING AND DISTRIBUTION AGREEMENT
RxElite
Holdings Inc.("Distributor")
and MINRAD,
INC.("Manufacturer")
hereby agree as follows:
1.
Reference is made to a certain Exclusive Manufacturing and Distribution
Agreement, between Distributor and Manufacturer dated on or about June 9, 2004,
as amended by an Addendum to Distribution Agreement dated on or about March
28,
2005 (as amended, the "Distribution
Agreement").
Any
specially capitalized terms used in this Amendment No. 2 shall have the same
defined meanings as provided for in the Distribution Agreement.
2.
Reference is made to two purchase orders by Distributor to purchase Sevoflurane
in bulk drums, the first of which shall be referred to herein as the
"Initial
Sevo Order",
and
the second of which as the "Second
Sevo Order"
(and
collectively as the "Orders").
The
Orders shall be subject to the Distribution Agreement as hereby further amended.
The Initial Sevo Order will be delivered in 2 (two) parts; the first part being
delivered in June 2006 and consisting of the equivalent of XX250ml
bottles of Sevoflurane and the second part being delivered in September 2006
and
consisting of the equivalent of XX250ml
bottles of Sevoflurane. The Second Sevo Order will be delivered in
November/December 2006 and will consist of the equivalent of XX
250ml
bottles of Sevoflurane. The bottles shall have an expiration dating of 2 (two)
years when bottled.
3.
The
Distribution Agreement is hereby further amended as follows:
A.
Section 2.3 and Section 4(b) of the Distribution Agreement are hereby amended
to
provide that (i) for the Initial Sevo Order, the terms of payment are
XX%
XX
days,
net XX
days;
and (ii) for the Second Sevo Order and for all product orders under the
Distribution Agreement after the date hereof, the terms of payment will be
XX%
XX
days,
net XX
days.
B.
For
clarification, in addition to the RxElite trademark, Distributor will use
Manufacturer's MINRAD® and Sojourn™ trademarks in connection with the resale of
Sevoflurane to the market. This shall be done in a similar manner to the
Distributor's Isoflurane and Enflurane labels.
C.
Section 3.1 of the Distribution Agreement is hereby amended to provide that
the
Distributor must purchase a minimum XX%
of the
annual minimum commitment.
D.
Section 4(1) of the Distribution Agreement is hereby amended to read in its
entirety as follows:
"(l)
Distributor shall have hired a minimum of four (4) Regional sales managers
within thirty (30) days of signing this agreement. Distributor shall have hired
a minimum of twenty-four (24) hospital market sales representatives within
eighty (180) days after US FDA Sevoflurane approval and will use its reasonable
commercial efforts to do so within 90 days after such approval;"
E.
The
price
for Sevoflurane provided for in Attachment
A-I to
the
Agreement is changed from $XX
per
bottle to $XX
per
bottle (the "Base Price") for all orders after and excluding the Initial Sevo
Order (60,000 bottles), which Base Price shall remain in effect until June
30,
2007 (regardless of when the FDA approval for Sevoflurane is received by
Manufacturer).
F.
Section
5.2 of the Distribution Agreement is amended to provide that for sales of
Sevoflurane after June 30, 2007, the Base Price will be adjusted, up or down,
on
an annual basis (with the contract year, for this purpose running from July
1 to
June
30) to reflect changes in Manufacturer's total costs of producing Sevoflurane
(using May 31, 2006 as the baseline date for comparing Manufacturer's costs)
including but not limited to (a) raw materials and other product components
and
(b) Manufacturer's standard production costs as already used internally by
Minrad management; provided, however, that no reduction of the Base Price shall
be effective until Manufacturer has received the economic benefit from cost
reductions of $XX
in total
costs of producing Sevoflurane (to cover certain cost increases absorbed by
Manufacturer for Sevoflurane). The Manufacturer shall provide Distributor with
such information and documentation as it may reasonably request to evidence
and
support any changes to the Base Price provided for hereunder including sharing
the Manufacturer's internal standard production costs used in calculating
management compensation at the Manufacturer. The parties shall meet (in person
or by conference call) prior to the beginning of each contract year (starting
immediately prior to July 1, 2007) to review any changes in costs that may
trigger a price change contemplated hereunder.
G.
The
parties agree that the Distributor's Annual Commitments to purchase Isoflurane
and Enflurane for years 2006 and 2007 only that are set forth in Attachment
A-I to
the
Distribution Agreement, are reduced to XX.
H.
Section
18.6 of the Distribution Agreement is hereby amended to read in its entirety
as
follows:
"18.6
Assignment;
Change of Control.
Neither
this Agreement, nor any interest therein, nor any of the rights and obligations
of either party hereunder, may be directly or indirectly assigned, sold,
delegated, or otherwise disposed of by either party, in whole or in part,
without the prior written consent of the other party, which will not be
unreasonably withheld. For the purposes of this Section, in the ease of the
Distributor, an
"assignment" shall be deemed to have occurred upon (a) a change of control
resulting from a single transaction or series of related transactions, or (b)
a
restructuring of the Distributor, or transfer or removal of a material amount
of
assets from the Distributor, or assumption of debt by the Distributor such
that
as a result of such restructuring, transfer, removal or assumption, the
Distributor possesses a net worth materially less than that of the Distributor
on the effective date of this Agreement. In addition, for clarification, (a)
a
"change of control" will occur if any person, company, or other entity acquire
beneficial ownership of 80% or more of Distributor's capital stock or the
executive management of Distributor is materially changed in connection with
any
ownership change affecting Distributor; and (b) if a change in control occurs
in
which a competitor of Manufacturer (wherever located) acquires an ownership
or
management position in Distribution, Manufacturer can withhold its consent
and
terminate the New Agreement." A competitor shall be defined as a manufacturer
or
distributor of anesthetic products or products that compete with other products
produced by Manufacturer.
4.
Except
as
provided for in this Amendment No. 2, the Distribution Agreement shall remain
in
full force and effect.
This
Amendment No. 2 has been executed below by the duly authorized representatives
of the Distributor and the Manufacturer.
RxELITE
HOLDINGS INC.
|
MINRAD, INC. | |||
By: | /s/ Xxxxxxxx Xxxxxxxx | /s/ Xxxxxxx X. Xxxxx, Xx., CEO | ||
Title: President |
Xxxxxxx X. Xxxxx, Xx., CEO |
|||
Date: June 14, 2006 | Date: June 14, 2006 |