Service Agreement
This
Service “Agreement”,
effective as of March 1, 2006, by and between IsoRay, Inc. (“Manufacturer”),
a
Minnesota corporation having offices at 000 Xxxx Xxxxxx, Xxxxx 000, Xxxxxxxx,
XX
00000 and Advanced Care Medical, Inc. (“ACM”,
a
Connecticut corporation having a principal business office at 000 Xxxxxx
Xxxx,
Xxxxxxxx 0X, Xxxxxx XX 00000.
Recitals
Whereas,
Manufacturer sells to the medical community devices known as “Brachytherapy
Seeds”
(specifically Cesium- 131 seeds) (the “Product”);
Whereas,
Manufacturer wants to contract with ACM to provide:
1)
services to Manufacturer pursuant to a specified patient treatment plan or
written Physician’s
Order
specified by Manufacturer’s
customers and in compliance with a specified patient treatment plan or written
Physician’s
Order.
These service specifications are included in Exhibit A (the “Directions”),
and
2)
other
Brachytherapy Seeds services to Manufacturer included in Exhibit A as specified
by Manufacturer’s
customers (together, with the Directions, the “Services”);
and
Whereas,
ACM desires to provide these Services for Manufacturer, in accordance with
the
terms and conditions of this Agreement; and
Whereas,
in connection with providing the Services, and included in the cost thereof,
ACM
will provide all products and supplies necessary to the performance of the
Services other than the Product, such as, where applicable, ACM’s
strands
for seed insertion, ACM’s
Seed-Lock pre-plugged needle assemblies, spacers, and other supplies used
or
consumed in performing the Services (the “ACM
Products”;
except
when otherwise specified below, all references in this Agreement to the Services
shall include the relevant ACM Products);
Now,
therefore, for good and valuable consideration, the receipt and sufficiency
of
which is hereby acknowledged, the parties agree as follows:
| 1. |
Terms
and Conditions of the Sale
|
| 1.1 |
On
the terms and subject to the conditions set forth in this Agreement,
ACM
shall provide to Manufacturer (as it shall relate to
Manufacturer’s
Product list), when and as requested by the Manufacturer, the Services
set
forth in Exhibit A hereto and made a part hereof, including the relevant
ACM Products. The term of this Agreement shall commence on March
1, 2006
(the “Commencement
Date”),
and shall continue thereafter for a period of one year (the “Initial
Term”).
At the end of the Initial Term, this Agreement will automatically
extend
for additional (1) year unless otherwise terminated by written notice
from
one party no less than 60 days prior to the expiration of the Initial
Term. For purposes of this Agreement, the Initial Term, and any extension
thereof, shall be referred to as the “Term”.
|
| 1.2 |
The
purchase prices to be paid for the Services provided by ACM and accepted
by Manufacturer, in accordance with the provisions of this Agreement,
are
set forth in Exhibit B attached hereto.
|
Services
will be invoiced to Manufacturer when performed and are due and payable within
30 days thereof to ACM. The unpaid balance of all payments received after
the
due date shall incur a carrying charge of 1.5% per month. In the event there
is
a dispute over an amount due, the prevailing party is entitled to recover
their
reasonable attorney fees, court costs and other costs associated with the
dispute.
The
parties acknowledge that there may be occasional cancellations by customers
after the Products have arrived at ACM. Manufacturer agrees that ACM shall
be
entitled to payment for services actually performed by ACM, if the customer
cancels an order for reasons other than ACM’s
failure
to perform in accordance with its obligations under this Agreement. Manufacturer
will inform ACM as soon as practicable after learning of cancellation of
an
order for which the Products have been shipped to ACM by Manufacturer hereunder.
If at the time ACM is notified of cancellation, ACM has loaded the Products
into
ACM’s
pre-loaded and/or stranded products, ACM shall be entitled to full payment
for
that order. If the Products have not been loaded, ACM will not perform or
be
paid for the Services on those Products. In either case, ACM will hold the
Products for disposition or shipment according to Manufacturer’s
instructions. Shipping requested by Manufacturer will be at ACM’s
cost if
ACM is to be paid for the order, and at Manufacturer’s
cost
otherwise.
| 2. |
Compliance
with all Applicable Laws
|
| 2.1 |
During
the Term, ACM shall comply, in all material respects, with all applicable
laws, ordinances, rules, regulations, orders, licenses, permits and
other
requirements, now or hereafter in effect, of any applicable governmental
authority with respect to the delivery of the Services, including
without
limitation all requirements regarding labeling and traceability of
the
Products as processed by ACM, as such requirements arise out of or
in
connection with the performance of the Services. ACM shall provide
all
reasonable cooperation to Manufacturer in connection with
Manufacturer’s
compliance with any law, ordinance, rule, regulation, order, license,
permit or other requirement regarding the provision of the Services
and
the Products.
|
| 2.2 |
During
the Term, Manufacturer shall comply, in all material respects, with
all
applicable laws, ordinances, rules, regulations, orders, licenses,
permits
and other requirements, now or hereafter in effect, of any applicable
governmental authority with respect to the delivery of the Products
as
manufactured by the Manufacturer. Manufacturer shall provide all
reasonable cooperation to ACM in connection with ACM’s
compliance with any law, ordinance, rule, regulation, order, license,
permit or other requirement regarding the provision of the Services
and
the Products.
|
| 3. |
Representations
and Warranties
|
| 3.1 |
ACM
Representations, Warranties and
Covenants.
|
ACM
hereby represents, warrants and covenants to Manufacturer as
follows:
| a. |
It
is a corporation duly organized and validly existing under the laws
of the
state of Connecticut. ACM has full corporate power to conduct its
affairs
as currently conducted and contemplated hereunder. All necessary
corporate
action has been taken to enable it to execute and deliver this Agreement
and perform its obligations hereunder.
|
| b. |
That
the services provided will be of a professional quality, conforming,
in
all material respects, to generally accepted industry standards and
practices for similar services, and, in the case of the ACM Products,
to
ACM’s
specifications thereof and to any applicable regulatory requirements
(e.g.
compliance with 510(k) requirements). ACM, without any expense to
Manufacturer, shall obtain all required licenses and permits, and
shall
obey and abide by all known laws, regulations, ordinances and other
rules
of the United States or the state in which the Products are being
provided, or any other duly constituted public authority as applicable
to
this Agreement, applicable to the performance of the Services or
to the
use or sale of the ACM Products. If ACM fails to perform such Services
as
warranted hereunder and ACM receives written notice specifying in
detail
the nature of the default during the thirty (30) day period after
the
completion of such Services, ACM will, at Manufacturer’s
option, either re-perform the Services at ACM’s
expense or credit the price of the affected Services. Except for
ACM’s
indemnity obligations hereinafter set forth, and Manufacturer’s
termination rights, the foregoing are Manufacturer’s
sole and exclusive remedies for breach of this warranty by
ACM.
|
| 3.2 |
Manufacturer
Representations, Warranties and
Covenants.
|
Manufacturer
hereby represents, warrants and covenants to ACM as follows:
| a. |
It
is a corporation duly organized and validly existing under the laws
of the
State of its incorporation, will full power to conduct its affairs
as
currently conducted and contemplated hereunder. All necessary corporate
action has been taken to enable it to execute and deliver this Agreement
and perform its obligations hereunder.
|
| b. |
That
the Products provided will be of a professional quality, conforming,
in
all material respects, to generally accepted industry standards and
practices for similar products, and shall comply with
Manufacturer’s
published specifications and ISO 2919-199E, Classification C53X42.
The
Manufacturer, without any expense to ACM, shall obtain all required
licenses and permits, and shall obey and abide by all applicable
laws,
regulations (e.g. compliance with 510(k) requirements), ordinances
and
other rules of the United States or the state in which the Products
are
being provided, or any other duly constituted public authority as
applicable to this Agreement, other than laws, regulations, etc.
which are
applicable by reason of ACM’s
performance of the Services.
|
| 4. |
Indemnification
|
| 4.1 |
By
Manufacturer: Manufacturer shall indemnify, defend and hold harmless
ACM,
and its affiliates, parent, subsidiaries, officers, directors,
shareholders, employees and agents, from and against any and all
claims,
actions, or demands (including without limitation reasonable fees
and
expenses of legal counsel incurred in settling or defending any such
claim, action or demand) arising out of or resulting, in whole or
in part
from Manufacturer’s
(i) breach of any representation, warranty, obligation or covenant
of
Manufacturer set forth in this Agreement, or (ii) gross negligence
with
respect to its provision of the Products or willful misconduct of
Manufacturer or Manufacturer’s
employees, agents and contractors, or (iii) any product liability
claims
(whether sounding negligence, strict liability or otherwise) relating
to
personal injury or death allegedly arising out of the use of the
Products,
except product liability claims arising out of or based on the Services
or
the ACM Products provided in connection therewith.
|
| 4.2 |
By
ACM: ACM shall indemnify, defend and hold harmless Manufacturer,
and its
officers, directors, shareholders, employees and agents from and
against
any and all claims, actions, or demands (including without limitation
reasonable fees and expenses of legal counsel incurred in settling
or
defending any such claim, action or demand) arising out of or resulting
from ACM’s
(i) breach of any representation, warranty, obligation or covenant
of ACM
set forth in this Agreement, or (ii) willful misconduct or gross
negligence with respect to the Services; or (iii) any product liability
claims (whether sounding in negligence, strict liability or otherwise)
relating to personal injury or death allegedly arising out of the
use of
the Products, to the extent such liability claims arise out of or
are
based on the Services or the ACM Products provided in connection
therewith.
|
| 4.3 |
The
foregoing indemnities are conditioned on prompt written notice of
any
claim, action, or demand for which indemnity is claimed; complete
control
of the defense (and, if applicable, settlement) thereof by the
indemnifying party (provided, that any such settlement shall leave
the
indemnified party with no liability whatsoever and shall not admit
to any
wrongdoing on the part of the indemnified party); and cooperation
of the
other party in such defense.
|
| 4.4 |
All
indemnity obligations under this Agreement (i) shall apply to claims
arising as a result of this agreement, whether such claims arise
before or
after the termination of this Agreement, and (ii) shall survive the
termination or expiration of this
Agreement.
|
| 4.5 |
During
the term of this Agreement, Manufacturer shall carry and maintain
in full
force and effect, at Manufacturer’s
own expense, appropriate comprehensive general and product liability
insurance coverage, in the amount of $1 million per occurrence, $2
million
aggregate, and shall take all necessary action to name ACM as an
additional insured with respect to such policies. Manufacturer agrees,
to
deliver certificates of such insurance to ACM, at ACM’s
written request and, in any event, not less than ten (10) days prior
to
the expiration of any such policy. Such insurance shall not be cancelable
except upon ten (10) days written notice to
ACM.
|
| 4.6 |
During
the term of this Agreement, ACM shall carry and maintain in full
force and
effect, at ACM’s
own expense, appropriate comprehensive general and product liability
insurance coverage, in the amount of $1 million per occurrence, $2
million
aggregate, and shall take all necessary action to name Manufacturer
as an
additional insured with respect to such policies. ACM agrees, to
deliver
certificates of such insurance to ACM at Manufacturer’s
written request, and in any event not less than ten (10) days prior
to the
expiration of any such policy. Such insurance shall not be cancelable
except upon ten (10) days written notice to Manufacturer. Such coverage
shall cover all claims arising out of Services or ACM Products provided
under this Agreement, whether such claims arise during or after the
Term
hereof.
|
| 5. |
Limitation
of Liability
|
Other
than the indemnity provisions above and the warranty and other remedies
expressly specified herein, ACM’s
and its
affiliates’
and
parent’s
entire
and collective liability arising out of or relating to this Agreement, including
without limitation on account of performance or nonperformance of obligations
hereunder, regardless of the form of the cause of action, whether in contract,
tort (including without limitation gross negligence but not including
intentional torts, fraud, or bad faith), statute or otherwise, shall in no
event
exceed the amounts paid to ACM under this Agreement for the Services. EXCEPT
AS
SPECIFIED IN THIS AGREEMENT, NEITHER PARTY NOR ITS AFFILIATES OR PARENTS
SHALL,
UNDER ANY CIRCUMSTANCES, BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES OR
PARENTS FOR ANY CONSEQUENTIAL, INCIDENTIAL, INDIRECT, PUNITIVE, EXEMPLARY
OR
SPECIAL DAMAGES OF ANY NATURE WHATSOEVER, OR FOR ANY DAMAGES ARISING OUT
OF OR
IN CONNECTION WITH ANY DELAYS, LOSS OF PROFIT, INTERRUPTION OF SERVICE OR
LOSS
OF BUSINESS OR ANTICIPATORY PROFITS, EVEN IF A PARTY OR ITS AFFILIATES HAVE
BEEN
APPRISED OF THE LIKELIHOOD OF SUCH DAMAGES OCCURRING. No action, regardless
of
form, arising out of this Agreement may be brought by either party more than
two
(2) years after the cause of action has accrued.
| 6. |
Confidential
Information
|
| 6.1 |
Each
of the parties hereto acknowledges that, from time to time during
the
Term, the parties hereto may come into the possession of confidential
information of the other party relating to such party’s,
operations, activities, intellectual property (including, without
limitation, trade secrets and know-how), products and/or services,
(collectively, the “Confidential
Information”),
and that such information is property valuable to the party that
has
developed it, and that the party that has developed it desires to
retain
it in confidence and withhold it from publication to others, and
that such
party has a legitimate business interest in such intent. Accordingly,
each
party hereby agrees that during the Term and thereafter, (a) it will
not
copy, communicate or disclose, in any manner, any of the Confidential
Information of the other party, except internally or as otherwise
provided
herein, (b) it will use Confidential Information belonging to the
other
solely for the purpose(s) for which it was disclosed hereunder or
otherwise as contemplated hereby, and (c) it will not disclose
Confidential Information (including without limitation the terms
and
conditions of the Agreement) belonging to the other party, other
than to
its employees, consultants and/or other third parties reasonably
requiring
such Confidential Information who are bound by written obligations
of
nondisclosure and non-use; provided that the foregoing shall not
restrict
any disclosure by either party required by applicable law provided
that
the other party is given prompt written notice thereof and a reasonable
opportunity to review such disclosure and, if applicable, seek a
protective order or other method of limiting the scope of such disclosure.
This provision will survive for a period of five (5) years after
the date
this Agreement is terminated, provided that the recipient’s
obligations with respect to any particular Confidential Information
will
terminate at such earlier time as any of the exceptions set forth
below in
this Section 6.1 first apply. The term “Confidential
Information”
shall also include all information of each party’s
affiliates, parents and subsidiaries which would qualify as Confidential
Information if it belonged to such party.
|
| Notwithstanding the foregoing, Confidential Information shall not include any information disclosed hereunder that, at the relevant time: (a) is or becomes available to the public without breach of this Agreement; (b) was previously known by the recipient without obligation of confidentiality; (c) is received from a third party without breach of any obligation of confidentiality; (d) is independently developed by recipient without reliance on information disclosed hereunder; (e) is approved for release by written authorization of the disclosing party (but only to the extent of such authorization); (f) can be readily determined by an examination of publicly-available products. Further, information relating to “Customers” of Brachytherapy Services is well known in the industry and does not constitute Confidential Information. ACM acknowledges that Manufacturer does not wish to be exposed to any Confidential Information relating to the design or manufacture of the ACM Products or to any confidential methods of providing the Services, unless absolutely necessary. Likewise, Manufacturer acknowledges that ACM does not wish to be exposed to any Confidential Information relating to the design or manufacture of Manufacturer’s products unless absolutely necessary. Accordingly, each party agrees not to disclose any such information to the other without the prior written consent of the recipient, after the recipient has received a written summary of the nature of the information which the other party proposes to disclose and of the reason disclosure is considered necessary. |
| 6.2 |
Each
party hereto acknowledges that its unlawful disclosure of any Confidential
Information of the other may give rise to irreparable injury to the
other,
or the owner of such information, inadequately compensable to damages.
Accordingly, each party may seek and obtain injunctive relief against
the
breach or threatened breach of the foregoing undertakings, in addition
to
any other legal remedies which may be available without requirement
of
posting bond or other security.
|
| 6.3 |
In
no event shall a party be entitled to use any of the other’s
Confidential Information, or any derivatives thereof, in connection
with
the sale or production of any products or services that are competitive
with (direct or indirect) or similar to those products and services
sold,
produced, manufactured, offered for sale, designed or developed by
the
disclosing party or any of its affiliates or parent. Each party agrees
to
refrain from knowingly infringing, in any manner, directly or indirectly,
on any Confidential Information of the other party (or any of its
affiliates or parent), regardless of whether such Confidential Information
has been registered, filed or recorded with the United States Patent
and
Trademark Office, or any similar federal, state or international
agency or
regulatory body. Each party further agrees that it shall comply with
all
obligations imposed on it by the United States Patent and Trademark
Office
or any similar federal, state or international agency or regulatory
body
with respect to the other party’s
intellectual property rights. The obligations of this provision shall
survive the termination of this Agreement (a) for the life of the
relevant
intellectual property rights, in the case of patents and trademarks,
and
(b) for the applicable period described in Section 6.1, in the case
of
Confidential Information. The foregoing restrictions shall not apply
to
the provision by Manufacturer of any of the Services pursuant to
a
subsequent agreement with ACM that permits Manufacturer to perform
them.
|
| 6.4 |
The
obligations of each party set forth in this Section 6 shall be applicable
to all of such party’s
affiliates, subsidiaries, parent(s) and related entities, such that
those
parties shall be bound by the terms and conditions of this Section
6 as if
each was an original signatory to this Agreement.
|
| 6.5 |
Protected
Health Information. ACM acknowledges that individually-identifiable
information concerning the patients scheduled to receive implants
of the
Products is “Protected
Health Information”
under 42 U.S.C. § 1320d, enacted by the Health Insurance Portability and
Accountability Act of 1996 (“HIPAA”),
and regulations promulgated thereunder, which Manufacturer and ACM
are
obligated to treat as confidential under such law and regulations,
and
which may also be covered by other confidentiality laws, rule, and
regulations. ACM agrees as follows: (a) to maintain the confidentiality
of
all such patient information in compliance with HIPAA and applicable
regulations thereunder, as the forgoing may now exist or hereafter
be
amended, and other applicable confidentiality laws, rules and regulations,
for so long as such obligations apply; (b) comply with such reasonable
or
customary obligations with respect to such patient information, as
may now
or hereafter be imposed on Manufacturer by contract with its customers
pursuant to HIPAA (e.g. under so-called Business Associate Agreements),
provided that Manufacturer shall disclose to ACM in writing the nature
of
the obligations under each such agreement; and (c) require any of
its
agents or subcontractors who may become privy to such patient information
hereunder to comply with the foregoing to the same extent ACM is
obligated
to do so, and include in its contracts with any such parties a clause
comparable to this clause.
|
| 6.6 |
Manufacturer
acknowledges that an affiliate of ACM is currently engaged in the
business
of selling a product similar in nature, form and substance to the
Product
(“BrachySciences
Business”).
Manufacturer agrees that performance of the BrachySciences Business
as it
is conducted on the Commencement Date, and as may hereinafter be
conducted, subject to this provision, shall not be limited or restricted
by any of the provisions of this Agreement, however, notwithstanding
the
previous clause, ACM acknowledges and agrees that it is responsible
for
ensuring that all Confidential Information of Manufacturer is safeguarded
in accordance with this Section 6, and that neither ACM nor any of
its
affiliates, including but not limited to the affiliate engaged in
the
BrachySciences Business, may use any Confidential Information of
Manufacturer for any use whatsoever other than as required or expressly
authorized by this Agreement.
|
| 7. |
Termination
|
| 7.1 |
Unless
extended pursuant to Section 1.1 above, this Agreement shall terminate
at
the expiration of the Initial Term, subject to the provisions of
Section
7.4 below.
|
| 7.2 |
Should
either party commit a material breach of its obligations hereunder
(except
with respect to the failure of a party to promptly pay amounts due
the
other hereunder, in which instance, the party entitled to payment
shall be
entitled to terminate this Agreement upon 10 business days written
notice
to the other party unless the payment is made within that time),
or should
any of the representations or warranties of either party in this
Agreement
prove to be untrue in any material respect, the other party may,
at its
option, terminate this Agreement by providing thirty (30) days’
prior written notice of termination, which notice shall identify
and
describe, in detail, the basis for such termination, which notice
shall
identify and describe, in detail, the basis for such termination.
If,
prior to expiration of such notice period the defaulting party cures
such
default, termination shall not take place. Notwithstanding, the foregoing,
Manufacturer may terminate this Agreement on thirty days’
notice if, at any time, ACM has availed itself of the right to cure
breaches of this Agreement three or more times in any three-month
period.
|
| 7.3 |
Should
either party admit in writing its inability to pay its debts generally
as
they become due, or make a general assignment for the benefit of
creditors, or institute proceedings to be adjudicated a voluntary
bankrupt, or consent to the filing of a petition of bankruptcy against
it,
or be adjudicated by a court of competent jurisdiction as bankrupt;
or
should either party seek reorganization under any bankruptcy act,
or
consent to the filing of a petition seeking such reorganization,
or should
either party have a decree entered against it by a court of competent
jurisdiction appointing a receiver, liquidator, trustee, or assignee
in a
bankruptcy or insolvency covering all or substantially all of such
party’s
property or providing for the liquidation of such party’s
property or business affairs; then the other party may, as its option
and
without notice, terminate this Agreement, effective
immediately.
|
| 7.4 |
Termination
of this Agreement shall not relieve either party of their obligations
(i)
with respect to those provisions of this Agreement which by their
express
terms survive termination of this Agreement, or (ii) arising prior
to the
termination or expiration of this agreement, including, without
limitation, the obligation of either party to satisfy any outstanding
payment obligations due and payable to the
other.
|
| 7.5 |
Upon
the termination of this Agreement, for any reason whatsoever, or
as
otherwise requested by either party, (i) ACM shall, within thirty
(30)
days thereof, return to Manufacturer all of Manufacturer’s
written materials, specifications and the like relating to the Product,
regardless of whether such material contains any Confidential Information,
and (ii) Manufacturer shall, within thirty (30) days thereof, return
to
ACM all of ACM’s
written materials, specifications and the like (including, without
limitation, all extracts, notes, synopses, and copies thereof) in
Manufacturer’s
control, custody or possession regardless of whether such material
contains any Confidential Information, except, in each case, one
(1)
archival copy which, if retained, shall be maintained in secure storage
and shall be used solely for purposes of evidencing what materials
of each
party the other party possessed, and for prosecuting or defending
actions
related to this Agreement. Upon the request of the disclosing party,
the
receiving party shall provide written certification, executed by
an
authorized officer of such party, that all documents and materials
relating the disclosing party’s
Confidential Information in such party’s
control or possession have either been returned to the disclosing
party,
or have been destroyed, except as provided above, and the receiving
party
is not in possession or control of any copies or other materials
relating
to the disclosing party’s
Confidential Information except as provided
above.
|
| 8. |
Independent
Contractor Status
|
| 8.1 |
Nothing
herein shall be construed to create a partnership, joint venture,
or
agency relationship between the parties hereto. Neither party shall
have
the authority to bind the other party by any act, omission,
representation, agreement or otherwise. Any employees, servants,
agents,
representatives or contractors of the parties shall be under the
exclusive
direction and control of each respective
party.
|
| 9. |
Governing
Law
|
| 9.1 |
This
Agreement shall be governed by, and construed and enforced in accordance
with the laws of the State of
Connecticut.
|
| 10. |
Dispute
Resolution
|
| 10.1 | The parties shall follow these dispute resolution processes in connection with all disputes, controversies or claims, whether based on contract, tort, statute, fraud, misrepresentation or any other legal theory (hereinafter collectively “Disputes”), except as otherwise noted, arising out of or relating to this Agreement or the breach or alleged breach hereof. The parties will attempt to settle all Disputes through good faith negotiations. If those attempts fail to resolve the Dispute within forty-five (45) days of the date of initial demand for negotiation, the Dispute shall be settled by binding arbitration conducted in Connecticut in accordance with the then current Commercial Arbitration Rules of the American Arbitration Association (“AAA”). Selection of one neutral arbitrator by the parties shall be from the AAA Panel list in accordance with the appointment Rules of the AAA. Each party shall bear its own expenses, and the parties shall equally share the filing and other administrative fees of the AAA and the expenses of the arbitrator. Any award of the arbitrator shall be in writing, shall state the reasons for the award (including any findings of fact and conclusions of law) and shall explain the breakout of any damages awarded. Judgment upon an award may be entered in any Court having competent jurisdiction. The arbitrator shall not have the power to award damages in excess of actual damages, such as punitive damages and damages excluded under the LIMITATION OF LIABILITY Section of this Agreement. The Federal Arbitration Act, 9 U.S.C. Section 1 to 14, shall govern the interpretation and enforcement of this Section governing dispute resolution. The provisions of this Section 10 shall survive any termination of this Agreement. |
| 10.2 | Notwithstanding the provisions of Section 10.1, neither a request or demand for arbitration, nor pendency of any such proceedings, shall forestall any pending notice of termination or toll any period for cure of a breach, nor shall the same preclude a party from terminating this contract pursuant to its terms. Arbitration may not be invoked, and no arbitrator may consider, any dispute as to terms of any extension, renewal or replacement of this Agreement or any decision by a party to withhold its consent or approval as to any matters as to which a specific provision of this Agreement requires such consent or approval, except as to matters where by the express terms hereof consent may not be unreasonably withheld. Nor must a party pursue arbitration in the event of a breach of its proprietary or intellectual property rights under law; in such case the aggrieved party may seek injunctive or other relief in any court of competent jurisdiction without recourse to the above procedure. In connection with a third-party claim, it may be that indemnification or other recourse can be claimed under this Agreement, or that the other party to this Agreement must or may be made a party to the third-party claim, or that other similar action is procedurally necessary or appropriate. In such case the indemnification, other recourse, or other action may be pursued in connection with the proceeding in which the third-party claim is pending without need for nay of the procedures contemplated by this Section 10. |
11.
Notices
| 11.1 | All notices and other communications required or permitted to be given under this Agreement shall be in writing and shall be considered effective when deposited in the U.S. mail as registered mail, return receipt requested, postage prepaid, and addressed to the party at the address noted above, unless by such notice a different address shall have been designated in writing. Notice should be sent to the intended recipient as follows: |
If
to
Manufacturer:
Xxxxxx
Xxxxxxxx P.L.C.
Suite
900
National
Bank Plaza
0000
X.
Xxxxxxx Xxxxxx
Xxxxxxx,
XX 00000-0000
Attention:
Xxxxxxx Xxxxxxxxxx
If
to
ACM:
Advanced
Care Medical, Inc.
000
Xxxxxx Xxxx
Xxxxxxxx
0X
Xxxxxx,
XX 00000
Attn:
Xxxx Xxxxxxxxx, President/CEO
| 12. |
Force
Majeure
|
| 12.1 | Neither party shall be in default if failure to perform any obligation hereunder is caused solely by supervening conditions beyond the party’s control, including acts of God, civil commotion, strikes, labor disputes, and governmental demands or requirements, provided, however, any delay in performance exceeding 120 days shall be grounds for terminating this Agreement by the non-defaulting party. |
| 13. |
Severability
|
| 13.1 | If any provision of this Agreement shall be held illegal, unenforceable, or in conflict with any law of a federal, state, or local government having jurisdiction over this Agreement, the validity of the remaining portions or provisions hereof shall not be affected thereby. |
| 14. |
Headings
|
| 14.1 | The headings of the sections of this Agreement have been inserted for convenience of references only. |
| 15. |
Entire
Agreement; Construction
|
| 15.1 | This Agreement supersedes all prior Service Agreement(s) between the parties (and their affiliates) only to the extent specifically expressed in this document. Unless otherwise specifically stated herein, the terms, conditions, obligations and rights set forth in the prior Service Agreement(s) between the parties (and their affiliates) shall survive in full force and effect. Except as expressly provided herein, this Agreement shall not be amended except by written agreement signed by both parties. |
| 15.2 | The language used in this Agreement will be deemed to be the language chosen by the parties to express their mutual intent, and no rule of strict construction will be applied against any party. |
| 16. |
Miscellaneous
|
| 16.1 | This Agreement shall be binding upon and inure to the benefit of the respective parties hereto and their successors and permitted assigns. |
| 16.2 | The failure of either party to insist upon strict adherence to any term of this Agreement on any occasion shall not be construed as a waiver of or deprive either party of the right thereafter to insist upon strict adherence to that term or any other term of this Agreement. Any waiver signed by either party must be in writing and signed by a duly authorized representative of such party. |
| 16.3 | The rights of the parties under and pursuant to this Agreement are personal to them, and the parties shall not assign or transfer this Agreement nor subcontract any portion of the services to be performed by them to any other person, firm, or corporation without the prior express written consent of the other party. Such consent shall be at the sole discretion of the other party and may be withheld for any reason. Any assignment of this Agreement without the other party’s prior written consent shall be void and of no effect |
IN
WITNESS WHEREOF, the parties have caused the Agreement to be duly executed
by
their authorized representatives as set forth below:
|
Advanced Care Medical, Inc.
By: /s/ Xxxx Xxxxxxxxx
Name: Xxxx Xxxxxxxxx
Title: President/CEO
Date: 2/14/06
|
By: /s/ Xxxxx X. Xxxxxx
Name: Xxxxx X. Xxxxxx
Title: CEO/Chairman
Date:
2/28/06
|
Exhibit
A -
The Directions
Manufacturer
will provide ACM a purchase order for each customer order.
The
customer patient treatment plan directions will be provided to ACM for
pre-loaded needles.
This
information will list the patient’s
name or
patient ID, radiation oncologist, calibration date of the seeds, lot number
of
the seeds, quantity of seeds, implant date of the seeds, hospital or clinic,
and
department of the hospital.
ACM
will
receive the seeds from Manufacturer and perform a 10% assay. The ACM 10%
assay
results shall not be greater than 5% different from the Manufacturer assay
Certification; if this limit exceeded, ACM will call Manufacturer for
instructions (e.g., to return the seeds, to await a modified order, to use
the
seeds to fill another order for which they are suited, etc.).
ACM
will
provide an assay certificate with each order in addition to including the
Manufacturer’s
assay
certificate.
ACM
will
prepare the Vari-Strand™, RTS™, Vari-Load™ or Readi-Load™ product per customer
patient treatment plan directions. ACM will verify the seeds in the needles
using radiographic or other techniques according to industry standard
procedures. ACM will sterilize the loaded products in accordance with the
applicable portions of ISO 11135 (sterilization standards).
ACM
shall
comply with all regulations for the safe packaging and transport of radioactive
materials in shipments to customers and other destinations including transfer
for sterilization. In the event ACM uses sub-contract for transportation,
ACM
will require that the sub-contract comply with this provision.
ACM
shall
not subject seeds provided by Manufacturer to any conditions that exceed
the
specifications of ANSI-HPS 43.6-1997 and ISO 2919-1999E classification
C53X42.
ACM
shall
abide with the conditions in its radioactive materials licenses and the
applicable radiation protection regulations for the transfer of radioactive
materials, including the requirement that recipients are appropriately licensed
for receipt of these materials.
ACM
will
ship the completed order to the end user based on the ship-to instructions
provided.
In
order
to guarantee on-time delivery to the customer, Manufacturer must have the
Products delivered to ACM no less than six (6) business days before the
scheduled implant date. ACM will use its best efforts in particular cases
to
meet a tighter schedule upon request, if necessary to meet a customer’s
requirements, but any such cases must be approved by ACM individually in
advance.
