EXHIBIT 10.15
LICENSE AND DISTRIBUTION AGREEMENT
This License and Distribution Agreement (the "Agreement") is entered
into as of this 12th day of December, 2005 (the "Effective Date") between
SAMARITAN PHARMACEUTICALS EUROPE, S.A., with offices 00 Xxxxxx Xxxxxx, Xxxxxx
--- 00000 Xxxxxx, (hereinafter referred to as "SAMARITAN") and THREE RIVERS
PHARMACEUTICALS, LLC, with offices at 000 Xxxxxxxx Xxxx Xxxxx, Xxxxxxxxx
Xxxxxxxx, Xxxxxxxxxxxx, XXX 00000 (herein referred to as "3RP").
RECITALS
WHEREAS, 3RP desires SAMARITAN to arrange for, or continue in force,
the regulatory approval and distribution of the Product in the Territory; and
WHEREAS, SAMARITAN is engaged in distributing pharmaceutical products
in the Territory and possesses qualified marketing and distribution systems to
enable it to effectively promote, market and distribute the Product throughout
the Territory.
NOW, THEREFORE, in consideration of the representations, warranties,
covenants and obligations hereinafter set forth, the parties intending to be
legally bound, mutually agree as follows:
ARTICLE 1 - DEFINITIONS AND INTERPRETATION
1.1 Definitions: Whenever used in this Agreement (including the recitals),
the words and terms set forth on Schedule "A", annexed hereto, shall
have the respective meanings ascribed thereto.
1.2 Headings: The headings of all Articles and Sections hereof are inserted
for convenience of reference only, are not intended to be full or
accurate descriptions of the contents hereof and shall not be
considered part of this Agreement or affect the construction or
interpretation of this Agreement.
1.3 No Strict Construction: The language used in this Agreement shall be
deemed to be the language chosen by the parties hereto to express their
mutual intent and no rule of strict construction against any party
shall apply to any term or condition of this Agreement.
1.4 Governing Law: This Agreement and any question concerning its validity,
construction or performance, regardless of the forum wherein any such
issue may be litigated, shall be governed by the laws of the
Commonwealth of Pennsylvania and the laws of the United States
applicable therein, without reference to the Commonwealth of
Pennsylvania's conflicts of law provisions, irrespective of the place
of execution or the order in which the signatures of the parties are
affixed, or the place or places of performance.
1.5 Reference to Laws, etc.: Any references herein to any law, statute,
regulation, order, rule or guideline of any government, governmental
body or other Regulatory Authority shall be construed as a reference
thereto as amended or re-enacted from time to time.
ARTICLE 2 - EXCLUSIVE APPOINTMENT
2.1 Exclusive Distributor: Subject to the provisions of this Agreement, 3RP
hereby appoints SAMARITAN as the sole and exclusive distributor of the
Product in the Territory and SAMARITAN hereby accepts such appointment
and agrees to act as such distributor upon terms and conditions herein
provided.
2.2 Nature of Relationship: The relationship created hereby between
SAMARITAN and 3RP is solely that of buyer and seller, and licensor and
licensee, and each is an independent contractor engaged in the
operation of its own respective business. Neither party shall be
considered to be an agent of the other for any purpose whatsoever and,
except as expressly provided herein, neither party has the power or
authority to act for, represent, or bind the other in any manner. This
Agreement does not constitute or create (and the parties do not intend
to create hereby) a joint venture or partnership of any kind between
the parties, and the rights and obligations of the parties shall be
only those expressly set forth herein.
2.3 Territorial and Product Restrictions Applicable to SAMARITAN: During
the term of this Agreement SAMARITAN shall not, directly or indirectly,
sell the Product outside of the Territory. In addition, SAMARITAN shall
not, directly or indirectly, market, sell or distribute a Competing
Product in the Territory at any time during the term of this Agreement.
In any and all events, if SAMARITAN receives an order for or an inquiry
concerning the Product from any potential customer for delivery outside
of the Territory, SAMARITAN shall promptly refer such order or inquiry,
or cause such order or inquiry to be referred, to 3RP. 3RP may suspend
supply of the Product to SAMARITAN during any period of time that
SAMARITAN is in violation of the covenant made under this Section 2.3.
2.4 Territorial Restrictions Applicable to 3RP: 3RP agrees that during the
term of this Agreement it shall not, directly or indirectly, sell the
Product or a Competing Product in the Territory. If, during the term of
this Agreement 3RP receives an order for or inquiry concerning the
Product from a potential customer for delivery in the Territory, 3RP
shall promptly refer such order or inquiry to SAMARITAN.
ARTICLE 3 - LICENSE AND TRANSFER OF PRODUCT INFORMATION
3.1 License of Product Information: 3RP hereby grants to SAMARITAN, for the
term hereof and all renewals and extensions thereof, and SAMARITAN
hereby accepts, an exclusive license to use the Product Information (as
defined in Section 3.2 below) to obtain and maintain the required
Regulatory Approval in the Territory to enable SAMARITAN to market,
sell and distribute the Product in the Territory for its approved use.
SAMARITAN hereby acknowledges and agrees that the license hereby
granted is a limited license (without right to sublicense) to use such
Product Information solely for the purpose of acquiring and maintaining
such Regulatory Approval and distributing the Product in the Territory
pursuant to and in accordance with the provisions of this Agreement and
for no other purpose (it being understood and agreed that the Product
Information shall form part of the Confidential Information of 3RP and
shall be subject to the provisions of Article 13 hereof).
3.2 Product Information:
(a) For purposes of this Agreement the "Product Information" shall be
comprised of all or such portions of the Product dossier and
Product information including, without limitation, formulation,
analytical, cleaning, dissolution and manufacturing and testing
methodologies and processes, which SAMARITAN reasonably needs,
and is required by the Regulatory Authority, to obtain and
maintain the Regulatory Approval. 3RP shall, throughout the term
of this Agreement, promptly provide to SAMARITAN all relevant
information which 3RP shall from time to time have available to
it regarding any changes or additions to the Product Information
(including, without limitation, sources of raw materials,
formulae, methods of manufacture, specifications, primary
packaging components and stability) which is applicable to
obtaining or maintaining any Regulatory Approval;
(b) 3RP agrees that during the term of this Agreement it will not
directly or indirectly use (except in fulfilling its
obligations to SAMARITAN under this Agreement), or license any
other Person to use, the Product Information in the Territory
in connection with the Product or a Competing Product.
ARTICLE 4 - REGISTRATION
4.1 Product Registration and Maintenance: SAMARITAN shall at its own cost
and expense apply for, obtain, maintain and renew all necessary
registrations, permits and other approvals necessary to obtain
Regulatory Approval of the Product in the Territory. All necessary
registrations, permits or other approvals received in connection with
any Regulatory Approval shall be held under SAMARITAN'S name. SAMARITAN
acknowledges and agrees that 3RP is the beneficial of the Regulatory
Approval and upon any termination of the Agreement SAMARITAN shall
assign cause the transfer of any such registrations, permits or other
approvals to 3RP or 3RP's designee as provided under Section 11.2
hereof;
4.2 Regulatory Compliance:
(a) 3RP shall during the term of this Agreement manufacture the
Product under the requirements of the relevant Code of Good
Manufacturing Practice of the Territory as in effect at the
time of delivery of the Product. Throughout the term of this
Agreement SAMARITAN shall notify 3RP of any changes to the
Code of Good Manufacturing Practices of the Territory;
(b) Except with SAMARITAN's prior written approval, such approval
not to be unreasonably withheld, 3RP shall not make any
alteration or change to the Specifications for the Product if
such change would adversely affect Regulatory Approval in the
Territory.
4.3 Mutual Disclosure of Adverse Effects: SAMARITAN and 3RP each agrees
that it will inform the other of them of all information that comes
into its possession or control and is not otherwise public knowledge
concerning side effects, injury, toxicity or sensitivity reactions and
incidents and severity thereof associated with commercial and clinical
uses, studies, investigations or tests (animal and human) directly
relating to the Product throughout the world, whether or not determined
to be attributable to the Product.
ARTICLE 5 - MANUFACTURE AND SUPPLY OF PRODUCT
5.1 Exclusive Supplier: 3RP shall manufacture and supply to SAMARITAN, in
accordance with the terms and conditions set forth herein and in a
timely fashion, the quantities of the Product ordered by SAMARITAN from
time to time. Subject to the provisions hereof, SAMARITAN shall order
from 3RP all of its requirements of the Product for the Territory in
accordance with the terms and conditions set forth herein.
5.2 Product Warranty: 3RP warrants that all Product supplied by it to
SAMARITAN pursuant to this Agreement shall be manufactured, packaged,
tested, stored, handled and shipped in accordance with the
Specifications and applicable Regulatory Approval in the Territory. 3RP
MAKES NO OTHER WARRANTY OF ANY KIND AND EXCLUDES AND DISCLAIMS ANY AND
ALL IMPLIED WARRANTIES TO THE FULLEST EXTENT PERMITTED BY APPLICABLE
LAW, INCLUDING WITHOUT LIMITATION THOSE CONCERNING THE MERCHANTABILITY
OF ANY PRODUCT OR ITS SUITABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE
OR USE.
ARTICLE 6 - PRODUCTION FORECASTS, ORDERS AND DELIVERIES
6.1 Forecasts:
(a) Within thirty (30) days after the Effective Date, SAMARITAN shall
submit to 3RP a written non-binding estimate of its quarterly
requirements for the Product for each of the next succeeding six
(6) Quarters. The forecast shall be updated quarterly on or
before the fifth (5th) day of the beginning of each Quarter on a
rolling basis. 3RP shall respond within fifteen (15) business
days if any additional quantities are included within the
forecast for any Quarters previously forecasted. If 3RP is unable
to accept such additional quantities, such additional quantities
shall be removed form the forecast. SAMARITAN shall have five (5)
days to respond to 3RP changes. If 3RP does not receive a
response within five (5) days, it shall be assumed that such
quantities are approved and acceptable to SAMARITAN.
(b) The forecast for the most current two (2) Quarters shall be
binding on the parties regarding the amount of Product to be
supplied and purchased. The forecast for the remaining four (4)
Quarters of each rolling forecast is for planning purposes only
and shall not constitute a commitment to purchase or supply
Product. In the event that SAMARITAN does not ultimately purchase
the forecasted quantities for the binding two (2) Quarters, it
shall nevertheless be obligated to make payment to 3RP for any
deficient quantities on the basis of the Transfer Price.
6.2 Purchase Orders: All orders for Product shall be placed using
SAMARITAN's standard form of purchase order and shall be invoiced using
3RP's standard form of invoice. Purchase orders shall not contain terms
which are inconsistent with the terms and conditions of this Agreement
and shall specify, amongst other things, the desired delivery date,
which delivery date shall be not less than thirty (30) days from the
submission date of the purchase order to 3RP. 3RP shall use its best
efforts to deliver the ordered Product to SAMARITAN within seven (7)
days of the desired delivery date specified in the purchase order.
6.3 Delivery of Product: The Product will be prepared for shipment in
accordance with the reasonable directions of SAMARITAN (or failing such
reasonable directions in a commercially reasonable manner), the storage
and transportation conditions forming part of the Product's
Specifications, cGMP and applicable laws. Title and risk of loss and/or
damage shall pass to SAMARITAN upon delivery of the Product to
SAMARITAN's warehouse site in the Territory.
6.4 Documentation to Accompany Deliveries: All deliveries of Product by or
on behalf of 3RP shall be accompanied by all documentation required
under applicable law to import the Product into, and for SAMARITAN to
offer the Product for sale in, the Territory including, without
limitation, certificate of analysis and batch manufacturing records
confirming that the Product supplied hereunder has been manufactured in
conformity with applicable requirements of the Regulatory Authority.
6.5 Assistance With Export & Import Laws: SAMARITAN and 3RP shall provide to
each other such commercially reasonable assistance as the other may
request relative to the exportation or importation of Product not
expressly provided in this Agreement.
ARTICLE 7 - TRANSFER PRICE AND INSPECTION
7.1 Purchase Price:
(a) The purchase price payable by SAMARITAN for Product supplied
to it shall be as set forth on Schedule "B" annexed hereto (the
"Transfer Price").
(b) Except as hereinafter provided, any increase to the Transfer
Price shall be mutually agreed upon by the parties. If 3RP's
manufacturing, API or distribution costs for the Product
materially increase from the date the Transfer Price was last
established, and 3RP desires to increase the Transfer Price,
SAMARITAN agrees to discuss and negotiate in good faith with 3RP
an increase to the Transfer Price to cover 3RP's increased
costs... The new Transfer Price shall apply to all orders for the
Product received by 3RP after the sixty (60) day notice period.
(c) In addition to the Transfer Price, SAMARITAN shall be
responsible for all taxes (including but not limited to
value-added and withholding taxes), customs and excise duties
with respect to the importation of the Product into the
Territory, transfer of the Product within the Territory and
promotion, marketing, distribution and sale of the Product
within the Territory, whether currently in force or coming
into force after the Effective Date of this Agreement
(collectively the "Sales Taxes").
(d) 3RP shall submit an invoice to SAMARITAN with each shipment of
the Product. Payment for the Product shall be due within sixty
(60) days after delivery date of the Product to SAMARITAN. All
payments hereunder shall be made in United States Dollars and
shall be wire transferred to an account designated by 3RP,
from time to time, or paid in accordance with any method
agreed in writing by the parties. Distributor shall notify 3RP
by facsimile when any payment is made.
(e) 3RP and SAMARITAN shall meet in good faith to discuss and
negotiate the Transfer Price, should the selling price to
hospitals in Greece as published in the official Greek
government gazette not allow SAMARITAN an operational working
margin, according to the Greek Industry Standard in similar
cases.
7.2 Inspection: 3RP shall have the right, upon reasonable advance notice
and at 3RP's expense to inspect and make copies of the records of
SAMARITAN pertaining to the Product, including but not limited to,
records relating to Regulatory Approval, pharanacovigilence, product
liability and the sale and distribution of the Product in the
Territory.
ARTICLE 8 - DISTRIBUTION
8.1 SAMARITAN's Obligation re Marketing: SAMARITAN shall use reasonable
commercial efforts to develop a market for the Product in the Territory
and to actively and continuously promote the sale of the Product in the
Territory. SAMARITAN shall be solely responsible for the advertising
and promotion of the Product and shall comply with all applicable laws,
rules and regulations in that regard including, without limitation,
applicable Regulatory Authority regulations and guidelines.
8.2 Pricing: SAMARITAN shall have sole discretion in setting the price for
the sale of the Product in the Territory, subject to guidelines
established by the Regulatory Authority.
8.3 Storage and Handling by SAMARITAN: SAMARITAN shall ensure that the
Product supplied to it by 3RP pursuant to this Agreement is received,
handled, stored and delivered in accordance with the Specifications for
the Product applicable thereto and applicable cGMP and other
requirements of the Regulatory Authority so that such Product does not
become adulterated or otherwise cease to meet its Specifications as a
result of any acts or omissions of SAMARITAN, and its respective
agents, employees, transporters or those for whom SAMARITAN is
responsible.
8.4 Release of Product by SAMARITAN: SAMARITAN shall conduct or cause to be
conducted such quality control tests as it deems necessary and/or as
are required by law (including any rules, regulations and requirements
of the Regulatory Authority) prior to sale or other release of a
Product in the Territory.
ARTICLE 9 - PRODUCT REJECTIONS AND RETURNS
9.1 Product Rejection:
(a) Within sixty (60) days from the date of receipt of delivery
of Product SAMARITAN shall inspect the Product and shall advise
3RP in writing (a "Rejection Notice") if a shipment of Product is
not in conformity with 3RP's obligations hereunder or is
otherwise defective. If SAMARITAN delivers a Rejection Notice in
respect of all or any part of a shipment of Product, then 3RP and
SAMARITAN shall have thirty (30) days from the date of 3RP's
receipt of such notice to resolve any dispute regarding whether
all or any part of such shipment of Product fails to conform with
the Specifications or is otherwise defective. Disputes between
such parties as to whether all or any part of a shipment rejected
by SAMARITAN conforms with Specifications not resolved in the
thirty (30) day period shall be resolved by an independent
testing laboratory or a consultant (if not a laboratory analysis
issue) mutually acceptable to SAMARITAN and 3RP, the cost of
which shall be paid by the party least successful in such dispute
as determined by such independent testing laboratory or
consultant.
(b) In the event any Product is appropriately rejected by
SAMARITAN as aforesaid, (being Product which does not satisfy the
Product warranty contemplated in Section 5.2 or are otherwise
defective as a result of any act by or omission of 3RP or those
for whom it is responsible), 3RP shall replace such Product with
conforming goods as quickly as possible, or if requested by
SAMARITAN, provide a credit to SAMARITAN for the Transfer Price
previously paid by SAMARITAN to 3RP on account of the Product in
question. The credit shall be provided immediately following the
expiry of the period during which 3RP may dispute a Rejection
Notice as contemplated in Subsection (a) above (unless the
Rejection Notice is disputed by 3RP, in which event such credit
shall only be given upon resolution of the dispute). Replacement
Product shall be delivered to SAMARITAN at no cost to SAMARITAN
if SAMARITAN has already paid for the rejected Product and not
received a credit therefore, as aforesaid.
(c) For purposes of this Agreement once a Product is rejected by
SAMARITAN, SAMARITAN's obligation to pay for such Product
shall be suspended until such time as it is determined:
(i) by the independent testing laboratory or consultant
that the Product should not have been rejected by
SAMARITAN; or
(ii) by the parties or by an arbitration conducted
pursuant hereto or by a final order of a court of
competent jurisdiction (which is not subject to
further appeal) that no act or omission of SAMARITAN
was the cause of the problem.
9.2 Exclusive Remedy: Subject to Section 10.1 hereof and to its rights, if
any, to recover expenses associated with a Recall as herein
contemplated, SAMARITAN hereby acknowledges and agrees that the sole
remedy of SAMARITAN against 3RP for failure of Product supplied
hereunder to meet the Product warranty set forth in Section 5.2 hereof
shall be to require 3RP to replace the Product that does not meet the
Product warranty hereunder with conforming goods or to provide
SAMARITAN with a credit for the Transfer Price and that 3RP shall not
be liable to SAMARITAN for any indirect, special, consequential or
incidental damages including, without limitation, loss of profits or
prospective profits of any kind.
9.3 Return Policy: Other than Product which has been appropriately rejected
by SAMARITAN pursuant to Section 9.1 above, SAMARITAN shall not have
the right to return to 3RP any Product purchased by it without 3RP's
prior written consent.
9.4 Survival of Provisions: The provisions of this Article 9 shall
survive the termination or expiration of the Agreement.
ARTICLE 10 - DAMAGES, INDEMNIFICATION AND INSURANCE
10.1 Indemnity by 3RP: Subject to the limitations set forth in this Section
10.1 and Section 10.3 hereof, 3RP covenants and agrees to indemnify and
save harmless and compensate SAMARITAN and its directors, officers and
employees (collectively, "SAMARITAN Indemnified Parties") from and
against any and all claims, demands, actions, causes of action, suits,
proceedings, judgments, liabilities, damages, losses, costs, expenses,
fines, penalties and other similar assessments, including but not
limited to reasonable attorney's fees and expenses incurred and
documented (collectively, "Liabilities") relating to or arising out of
(i) a breach by 3RP of any of 3RP's representations, warranties,
covenants or agreements contained in this Agreement; (ii) a claim by
any Person that the Product as manufactured by 3RP infringes or
allegedly infringes any proprietary right or other intellectual or
industrial right of any Person (other than rights of any Person
relating to patents enforceable in the Territory or the use of any
name, logo, trade-xxxx (other than the Marks) or design used by
SAMARITAN in connection with the packaging and labeling of the
Product); (iii) the design or inherent safety of the Product (iv) any
negligence or willful misconduct by 3RP or any 3RP Indemnified Party
(as defined below); or (v) a regulatory enforcement action, inspection
of Product or Recall resulting from 3RP's failure to manufacture the
Product in accordance with the Specifications or resulting from any
other act or omission of 3RP or those for whom it is responsible;
provided that, except where the breach arises out of the representation
or warranty being intentionally false or inaccurate or constitutes a
willful material breach by 3RP of its duties or obligations hereunder
or an act or omission constituting gross negligence, the SAMARITAN
Indemnified Parties shall not be entitled to recover from 3RP any of
their indirect, special, consequential or punitive damages, including
loss of profits or loss or damage to goodwill or reputation. SAMARITAN
shall hold the benefit of this indemnity in trust for those SAMARITAN
Indemnified Parties who are not parties to this Agreement.
10.2 Indemnity by SAMARITAN: Subject to the limitations set forth in this
Section 10.2 and in Section 10.3 hereof, SAMARITAN covenants and agrees
to indemnify and save harmless and compensate 3RP and its respective
directors, officers and employees {collectively, "3RP Indemnified
Parties") from and against any and all Liabilities relating to or
arising out of (i) a breach by SAMARITAN of any of SAMARITAN's
representations, warranties, covenants or agreements contained in this
Agreement; (ii) the receiving, storage, handling, marketing,
distribution, sale or delivery of the Product by SAMARITAN (except to
the extent that 3RP is responsible therefor pursuant to Section 10.1
above); (iii) any claim by any Person that any trade xxxx, trade dress,
logo, name or design used by SAMARITAN in labeling or packaging of the
Product (other than the Marks) or, in the case of trade dress, the
manufacture of the Product in accordance the directions of SAMARITAN,
infringes any trade-xxxx or other intellectual property right of any
Person; (iv) any death or bodily injury to any Person or any damage to
property arising out of, or any regulatory enforcement action,
inspection of Product or Recall resulting from a breach by SAMARITAN of
its obligations hereunder; or (v) any negligence or willful misconduct
of SAMARITAN or of an SAMARITAN Indemnified Party; provided that, except
where the breach arises out of the representation or warranty being
intentionally false or inaccurate or constitutes a willful material
breach by SAMARITAN of SAMARITAN's duties or obligations hereunder or an
act or omission constituting gross negligence, the 3RP Indemnified
Parties shall not be entitled to recover from SAMARITAN any indirect,
special, consequential or punitive damages, including loss of profits or
loss or damage to goodwill or reputation. 3RP shall hold the benefit of
this indemnity in trust for those 3RP Indemnified Parties who are not
parties to this Agreement.
10.3 Indemnification Procedure for Third Party Claims: Upon the assertion by
any third party of a claim against a 3RP Indemnified Party or an
SAMARITAN Indemnified Party that may give rise to right of
indemnification under this Agreement, the party who, or whose directors,
officers or employees, is claiming a right to indemnification (the
"Indemnified Party") shall give prompt notice to the party alleged to
have the duty to indemnify (the "Indemnifying Party") of the existence
of such claim (provided that the failure to give such notice in timely
fashion shall not release the Indemnifying Party of its obligations of
indemnification hereunder except to the extent that the Indemnifying
Party has been prejudiced thereby) and shall give the Indemnifying Party
reasonable opportunity to control, defend and/or settle such claim at
its own expense and with counsel of its own selection; provided,
however, that the Indemnified Party shall, at all times, have the right
to fully participate in such defense at its own expense with separate
counsel and, provided that both parties to the extent that they are not
contractually or legally excluded therefrom, or otherwise prejudiced in
a legal position by so doing, shall cooperate with each other and with
their respective insurers in relation to the defense of such third party
claim. The Indemnifying Party shall consult with the Indemnified Party
with respect to settlement of any claim. The Indemnifying Party shall
have the right to settle any claim without the consent of the
Indemnified Party, provided that the Indemnified Party is
unconditionally released from such claim and it is not otherwise
prejudiced by the terms of settlement (including, without limitation,
that no obligations in addition to those set forth herein are imposed
upon the Indemnified Party). In the event the Indemnifying Party elects
to defend such claim, the Indemnified Party may not settle such claim
without the prior written consent of the Indemnifying Party. If the
Indemnifying Party shall, within a reasonable time after such notice has
been given, fail to defend, compromise or settle such claim, (or
thereafter fails to diligently defend such claim) then the Indemnified
Party shall have the right to defend, compromise or settle such claim
without prejudice to its rights of indemnification hereunder.
Notwithstanding the foregoing, in the event of any dispute with respect
to indemnity hereunder, each party shall be entitled to participate in
the defense of such claim and to join and implead the other in any such
action.
10.4 Insurance: During the term of this Agreement and for a period of not
less than thirty-six (36) months following the termination of this
Agreement, each of SAMARITAN, on the one hand, and 3RP, on the other
hand, shall carry or be subject to coverage under (as a named insured
under its own policy or a policy of its parent corporation), at their
own cost and expense, comprehensive general liability insurance,
including product liability and contractual liability insurance in an
amount of not less than $2 Million EURO in the aggregate and $1 Million
EURO per occurrence, which insurance will be written on a claims made
policy form with an insurance carrier reasonably acceptable to the other
party. Each of 3RP and SAMARITAN shall, at the request of the other,
provide evidence to such requesting party of compliance with its
insurance obligations under this Section and evidence of renewals of any
such policy, from time to time. Each party shall cause the other to be
named as an additional insured for death, bodily injury and property
damage caused by those acts or omissions for which such party is
responsible hereunder under the product liability insurance policy or
policies to be obtained and maintained by such party pursuant hereto.
10.5 Survival: The provisions of this Article 10 shall survive termination or
expiration of this Agreement.
ARTICLE 11 - TERM AND TERMINATION
11.1 Term: The term of this Agreement shall be for ten (10) years commencing
on the Effective Date, unless earlier terminated in accordance with the
provisions of this Agreement. Thereafter, this Agreement shall
automatically renew for successive periods of five (5) years each unless
SAMARITAN or 3RP gives written notice of termination to the other at
least twelve (12) months prior to the expiration of the any tern,
subject to earlier termination as provided in this Agreement.
11.2 Transfer of Approvals: Upon any termination or expiration of this
Agreement SAMARITAN shall immediately assign or cause to be transferred
to 3RP or its nominee all Regulatory Approvals and all licenses,
registered uses, distribution arrangements and other rights SAMARITAN
may have acquired hereunder with respect to the Product, including the
Marks, and SAMARITAN shall have no further rights thereto. To the
extent assignment or transfer of the Regulatory Approvals and all
licenses, registered uses, distribution arrangements and other rights is
not permitted under local law in the Territory, SAMARITAN shall
cooperate in the cancellation or abandonment of same, and in the
reissuance thereof to 3RP or its nominee. SAMARITAN shall not after
termination or expiration of this Agreement use in the Territory any
name or marks confusingly similar to the Marks.
11.3 Material Breach: 3RP or SAMARITAN may, by notice in writing to the
other, terminate this Agreement, if such other party shall have breached
any of its duties or obligations under this Agreement and such default
continues unremedied for a period of thirty (30) days following receipt
of written notice of such default (or, if such default is not a payment
or repayment default and is capable of being remedied, but is not
reasonably capable of being remedied within such thirty (30) day period,
such longer period of time as is reasonable in the circumstances, not
exceeding ninety (90) days in the aggregate, provided that the
defaulting party has, within such thirty (30) day period, commenced and
thereafter actively and diligently pursues the remedying of such
default). Notice of termination may only be given during the period that
the default in question continues. In the event that a party has been
given notice pursuant to this Section 11.2 and such party disputes the
alleged breach or the continuation of such breach beyond the cure
period, the dispute shall be submitted to arbitration pursuant to
Article 15 hereof, and this Agreement shall continue in full force until
such time as the arbitrator renders his decision. The arbitrator shall
determine whether or not there has been a breach and/or whether or not
the same has been remedied within the required cure period. Termination
of this Agreement pursuant hereto shall be without prejudice to any
other right or remedy the party terminating this Agreement may have
against the defaulting party arising out of the breach in question
including the right to obtain compensation for its damages (provided
that such right shall be subject to the limitations set forth in Article
10 hereof).
11.4 Bankruptcy or Insolvency: 3RP or SAMARITAN shall have the right to
terminate this Agreement upon written notice to the other in the event
that any one or more of the following events shall become applicable to
such other party (herein referred to as the "Party"):
(a) an order is made or a resolution or other action of such Party
is taken for the dissolution, liquidation, winding up or other
termination of its legal existence;
(b) the Party commits a voluntary act of bankruptcy, becomes
insolvent, makes an assignment for the benefit of its creditors
or proposes to its creditors a reorganization, arrangement,
composition or readjustment of its debts or obligations or
otherwise proposes to take advantage of or shelter under any
statute in force in the United States or in the Territory for
the protection of debtors;
(c) a proceeding is commenced to have such Party declared bankrupt
or to have a receiver appointed in respect of such Party or a
substantial portion of its property and such proceeding is not
fully stayed or dismissed within thirty (30) days after such
commencement;
(d) a receiver or a receiver and manager of any of the assets of
such Party is appointed and such receiver or receiver and
manager is not removed within thirty (30) days of such
appointment; or
(e) such Party ceases or takes steps to cease to carry on its
business.
11.5 No Regulatory Approval: Either party may terminate this Agreement if
SAMARITAN is denied, is otherwise unable to obtain or maintain, the
Regulatory Approval.
11.6 Other Contractual Terminations: 3RP and SAMARITAN may terminate this
Agreement under other Sections of this
Agreement as may be specifically provided under those Sections.
11.7 Survival: Any cause of action for breach of contract shall survive the
termination or expiration of this Agreement. The termination or
expiration of this Agreement shall not affect any right or obligation of
3RP or SAMARITAN existing prior to the effective date of termination or
expiration and which is expressly set forth hereunder as surviving
termination. Without limiting the generality of the foregoing,
termination or expiration of this Agreement shall not affect any right,
duty or obligation which is expressly stated hereunder as surviving
termination.
ARTICLE 12 - REGULATORY MATTERS AND ACCESS TO FACILITIES
12.1 Retention of Technical Records and Samples: Each of 3RP and SAMARITAN
shall keep such samples and such records (or copies thereof) in respect
of the Product being manufactured, supplied or distributed by it as are
required by the applicable Specifications and/or applicable law of the
Territory for such period of time as may be required thereunder. 3RP
shall permit SAMARITAN to have access to such samples and original
records as are required to be maintained by 3RP at all reasonable times
upon prior reasonable notice and shall, upon written request, promptly
provide SAMARITAN with a copy of all such records.
12.2 Co-operation re Product Safety: 3RP and SAMARITAN shall promptly advise
the other of any safety or toxicity problem of which such party becomes
aware regarding the Product (or any intermediates or other ingredients
or processes used in the manufacture thereof) being supplied or
distributed by it.
12.3 Regulatory Authority Correspondence: 3RP and SAMARITAN shall, subject to
Section 12.5 hereof, provide the other with a copy of any correspondence
or notices received by such party from the Regulatory Authority relating
to or referring to the Product within ten (10) days of receipt and a
copy of any response to any such correspondence or notices with ten (10)
days of making a response. 3RP shall notify SAMARITAN promptly of any
materially adverse inspections by the Regulatory Authority which pertain
to the Product or to the facility where the Product is being
manufactured and provide SAMARITAN with a copy of the report.
12.4 Notification of Adverse Events:
(a) 3RP shall notify SAMARITAN promptly of any pending or
threatened litigation or governmental investigation,
proceeding or action involving the Product or the facility
where the Product is being manufactured of which 3RP becomes
aware and of any defective, adulterated or misbranded Product
or any other information which may suggest that the Product is
or may be defective, adulterated or misbranded or fail to meet
the Specifications or to maintain the stability as indicated.
3RP shall notify SAMARITAN promptly of any material product
quality complaints which it receives from customers of
SAMARITAN or others concerning the Product.
(b) SAMARITAN shall notify 3RP:
(i) of any customer complaints or alleged adverse drug reaction
relating to a Product within the meaning of the FDA Safety
Information and Adverse Event Reporting Program (21 CFR,
Part 20) (an "ADR" which, on the Effective Date, means a
noxious and unintended response to the Product, which occurs
at dosages normally used or tested for the diagnosis,
treatment or prevention of a disease or the modification of
an organic function) promptly following their receipt by
SAMARITAN (but in any event within ten (10) days of receipt
thereof, except in the case of a Serious ADR [as defined
below] in which event SAMARITAN shall notify 3RP of same
within seventy-two (72) hours, which latter notification
shall be by telephone with a facsimile confirmation
immediately following; or
(ii) of any Regulatory Authority complaints or complaints of any
other governmental or regulatory body, agency or official in
the Territory within five (5) days, except on weekends and
holidays.
For purposes of this Agreement "Serious ADR" shall have the meaning
attributed thereto under the FDA Safety Information and Adverse Event
Reporting Program (21 CFR, Part 20), from time to time, which, on the
Effective Date means a noxious and unintended response to a drug that
occurs at any dosage and that is fatal or life-threatening, results in
persistent or significant disability/incapacity, requires or prolongs
inpatient hospitalization, necessitates medical or surgical
intervention to preclude permanent impairment of a body function or
permanent damage to a body structure, or is a congenital anomaly. 3RP
shall notify SAMARITAN in the manner and within the time periods
hereinbefore contemplated of any Regulatory Authority complaint (or of
the complaint of any other governmental body, agency or official in the
Territory) relating to the Product following their receipt by 3RP.
(c) SAMARITAN shall be responsible for filing any necessary reports
required by the Regulatory Authority in accordance with the applicable
laws of the Territory.
(d) To enable SAMARITAN to respond to any requirements of the Regulatory
Authority in connection with a complaint or ADR, 3RP agrees to
investigate any complaint or ADR forwarded to it by SAMARITAN and to
respond thereto to SAMARITAN in writing as promptly as reasonably
possible and, in no event, later than thirty (30) days after receipt of
the ADR or complaint from SAMARITAN. In addition, 3RP shall provide
SAMARITAN with a copy of any correspondence, reports, or other
documents relating to a complaint or ADR received by 3RP relating to
the Product promptly following the receipt thereof and shall also
provide to SAMARITAN 3RP's response thereto within a reasonable period
following generation of such document by 3RP. Upon the request of 3RP,
SAMARITAN shall use reasonable commercial efforts to retrieve and
deliver to 3RP such samples of the Product which are the object of a
complaint or ADR as 3RP may reasonably request to enable 3RP to conduct
such tests, studies and investigations as it determines to be necessary
to respond to such ADR or complaint or to take appropriate corrective
action.
12.5 Recalls:
(a) In the event that SAMARITAN shall be required (or shall
voluntarily decide) to initiate a recall, product withdrawal or
field correction of any Product (a "Recall"), whether or not
such Recall has been requested or ordered by the Regulatory
Authority (or any other governmental body, agency or official
having jurisdiction in the Territory) or by a court, SAMARITAN
shall notify 3RP and 3RP shall fully co-operate with SAMARITAN
in notifying their customers to return all such Product and
shall follow any other instructions provided by SAMARITAN.
(b) In the event that 3RP believes that a Recall may be necessary
and/or appropriate, prior to taking any action 3RP shall
immediately notify SAMARITAN and 3RP and SAMARITAN shall
co-operate with each other in determining the necessity and
nature of the action to be taken.
(c) With respect to any Recall, SAMARITAN shall make all contacts
with the Regulatory Authority, or other applicable party, and
shall be responsible for co-ordinating all of the necessary
activities in connection with such Recall and 3RP and SAMARITAN
shall each co-operate with the other in recalling the affected
Product.
(d) In the event that a Recall results solely from any cause or
event arising from the manufacture, testing, storage,
handling, packaging, labeling or shipping of the Product by
3RP or those for whom it is responsible or other cause or event
attributable to 3RP or those for whom it is responsible, 3RP
shall be responsible for all expenses of such Recall. In the
event that a Recall results solely from any cause or event
arising from the receiving, storage, handling, marketing or
distribution of the Product by SAMARITAN or those for
whom it is responsible or other cause or event attributable
to SAMARITAN, SAMARITAN shall be responsible for all
expenses of such Recall. In all other cases the parties shall
share the Recall Expenses equally and each party shall
reimburse the other party for 50% of the Recall Expenses
incurred by such other party.
(e) For purposes of this Agreement, Recall expenses shall include,
but not be limited to, the expenses of notification and
destruction or return of the recalled Product, as the case may
be, and SAMARITAN and 3RP's reasonable out-of-pocket costs in
connection with such Recall including but not limited to
reasonable attorney's fees and expenses and credits and recall
expenses claimed and paid to customers (the "Recall
Expenses"). Each of the parties shall use its reasonable best
efforts to minimize the Recall Expenses which it incurs and
shall provide to the other, upon request, reasonable evidence
of the out-of-pocket expenses being claimed by it.
(f) All communications relating to a Recall shall be held in
confidence and shall be subject to the terms of Article 13
hereof.
ARTICLE 13 - CONFIDENTIALITY
13.1 Confidential Nature of Agreement: Each of the parties hereto agrees
that, without the prior written consent of the other, or except as may
be required by law or court order, the terms of this Agreement shall
remain confidential and shall not be disclosed to any Person other
employees and professional advisers of such party or its Affiliates who
reasonably require knowledge of the existence or terms of this Agreement
and who are bound to such party or its Affiliates by a like obligation
of confidentiality. Such employees and advisors will be advised of the
nature and existence of the confidentiality undertakings of this
Agreement and of the applicability of such undertakings to them and will
agree to be bound hereby.
13.2 Duty of Confidentiality: Each of 3RP and SAMARITAN agrees to hold in
trust and confidence (and to cause its Affiliates to hold in trust and
confidence) for the benefit of the other party (and its Affiliates) all
Confidential Information of such other party and its Affiliates and each
further agree to safeguard, and to cause its Affiliates to safeguard,
the Confidential Information of the other (or its Affiliates) to the
same extent that it does with its own confidential information. Neither
party will, without the express written consent of the other, directly
or indirectly, use (or authorize, permit or suffer any of its Affiliates
to use) any Confidential Information of the other party or of its
Affiliates for any purpose other than to implement the provisions of
this Agreement (including, without limitation, to obtain the Regulatory
Approval for the Product) or in regulatory proceedings or in litigation.
Neither party will disclose Confidential Information to any Person,
other than (i) its employees or other representatives or those of its
Affiliates who have a need to know such information to fulfill the
provisions and intent of this Agreement (where such provisions and
intent cannot properly be fulfilled without such disclosure) and who
have been informed of the confidential nature of the information and
have agreed to be bound by the terms hereof, and (ii) a Regulatory
Authority. Each of 3RP and SAMARITAN shall use its best efforts to
prevent unauthorized use or disclosure of the Confidential Information
of the other and shall use protective measures no less stringent than
those used by it in its own business to protect its own confidential
information.
13.3 Compulsory Disclosures: In the event that either 3RP or SAMARITAN (or
its Affiliate) shall be legally compelled or required by a court of
competent jurisdiction to disclose all or any part of the Confidential
Information of the other (or its Affiliates), it shall provide notice
thereof to the other prior to such disclosure so that such other party
(or its Affiliate) may determine whether or not to seek, at its own
expense, a protective order or any other appropriate remedy. If a
protective order or other appropriate remedy is not obtained before such
disclosure is required, the party required to make disclosure will
disclose only those portions of the Confidential Information in question
which it is advised by written opinion of counsel (which opinion shall
be addressed to such party and to the other party), it is legally
required to disclose and will cooperate with the efforts of the other
party at the other party's expense, to obtain reliable assurances that
confidential treatment will be accorded such Confidential Information.
13.4 Survival: The obligations of confidentiality contained herein shall
survive the termination of this Agreement.
ARTICLE 14 - LICENSE OF MARKS
14.1 Marks: During the term of this Agreement, SAMARITAN shall have the
non-exclusive right to use the trademarks, logos and brand names
("Marks") belonging to 3RP in connection with the promotion, sale,
marketing and distribution of the Product. SAMARITAN acknowledges that
the Marks and any registrations thereof are and shall remain the
property of 3RP and SAMARITAN disclaims any rights to such Marks and
registrations other than the rights granted pursuant to this Section
14.1 and will not represent in any way that it has any right or title to
the ownership of the Marks or registrations thereof.
(a) All Product and all labeling, advertising and promotional
material in connection therewith shall feature the applicable
Marks. SAMARITAN will first obtain the written approval of 3RP
of the form and manner in which the Marks will be used upon, in
connection with, or in relation to, the Product, labels,
package inserts, containers, advertisements and other
materials.
(b) SAMARITAN shall, upon 3RP's request, assist 3RP in any action
reasonable necessary or desirable to protect the Marks.
SAMARITAN shall as soon as practicable notify 3RP of any
apparent infringement by a third party of any of the Marks.
(c) After consultation with 3RP, SAMARITAN shall immediately
discontinue the use of any of the Marks upon notice from a
third party that such use is or is alleged to be an
infringement of such third party's trademark rights and all
liability arising out of SAMARITAN's use of any such Xxxx after
such Notice shall be borne by SAMARITAN.
ARTICLE 15 - DISPUTE RESOLUTION
15.1 Dispute Resolution Committee: If any dispute or question (in this
Article called a "Dispute") shall arise between the parties during the
term of this Agreement concerning the interpretation of this Agreement
or any part hereof, the parties shall in good faith attempt to resolve
such Dispute promptly and in an amicable manner under the following
informal dispute resolution procedure. If a Dispute arises which is not
resolved by the operational personnel involved, the Chief Executive
Officer of each party or such other senior operations manager of each
party as is designated by such party from time to time to serve in such
capacity (in this Section collectively called the "Dispute Resolution
Committee") shall be notified. The Dispute Resolution Committee, made up
of equal representation, shall meet within ten (10) days of being
notified of a Dispute, or at such time as is mutually agreed by the
parties, and shall conduct negotiations in good faith in an effort to
resolve the Dispute.
15.2 Arbitration: In the event the Dispute Resolution Committee is unable to
resolve a Dispute within fifteen (15) days of the first written
notification of the Dispute, then such Dispute shall be resolved by
arbitration. Any controversy or claim arising out of or related to this
contract shall be determined by arbitration in accordance with the
International Arbitration Rules of the international Centre for Dispute
Resolution. The arbitration shall be administered by the International
Centre for Dispute Resolution (ICDR) and shall take place in New York,
New York, United States of America. The parties agree: (a) one
arbitrator shall determine the resolution of the Dispute; (b) the
arbitrator shall be chosen from a list provided by the ICDR; (c) the
arbitration itself and all documentation will be in the English
language; (d) the decision of the arbitrator shall be binding and
non-appealable; and (e) the cost of the arbitration shall be shared
equally by each party and the responsibility for each party's related
expenses, including attorneys fees, shall be absorbed by each respective
party.
15.3 Pre-Conditions: Subject only to Section 15.4, no Dispute shall be the
subject of arbitration or any other formal proceeding between the
parties before being considered by the Dispute Resolution Committee as
set forth in this Article.
15.4 Equitable Relief: Either party may seek injunctive or equitable relief
without complying with the above described procedures.
ARTICLE 16 - GENERAL CONTRACT TERMS AND CONDITIONS
16.1 Notice: Subject to the express provisions of this Agreement, any notice
required or permitted to be given under this Agreement shall be
sufficiently given if in writing and delivered by facsimile (with
confirmation of transmittal) or overnight courier (with confirmation of
delivery), as well as by prepaid registered mail (with return receipt
requested) or hand delivery to the appropriate party at the address set
forth below, or at such other address or to the attention of such other
individual as such party may from time to time specify for that purpose
in a notice similarly given at least fifteen (15) days prior to the date
such change is to become effective:
To SAMARITAN at:
00 Xxxxxx Xxxxxx Xxxxxx -
00000 Xxxxxx
Attention: Xx. Xxxxxxxx Xxxxx
Fax Number: 00 0000000000
Phone Number: 00 0000000000
To 3RP at:
000 Xxxxxxxx Xxxx Xxxxx,
Xxxxxxxxx Xxxxxxxx, Xxxxxxxxxxxx, Xxxxxx
Xxxxxx of America, 16066.
Attention: Legal Department
Fax Number: (000) 000-0000
Phone Number: (000) 000-0000
Any such notice shall be deemed delivered (i) if sent by mail, as
aforesaid, on the date upon which the return receipt is signed or
delivery is refused or the notice is designated by the postal
authorities as not deliverable, as the case may be, (ii) if sent by
facsimile, as aforesaid, when sent (with confirmation of receipt), and
(iii) if sent by courier or hand delivered, as aforesaid, when received
16.2 Force Majeure: Neither party shall be considered to be in default in
respect of any obligation hereunder if failure of performance shall be
due to Force Majeure (as hereinafter defined). If either party is
affected by a Force Majeure event such party shall, give prompt notice
to the other party stating the nature of the event, its anticipated
duration and any action being taken to avoid or minimize its effect. The
suspension of performance shall be of no greater scope and no longer
duration than is required by such Force Majeure event and the
non-performing party shall use commercially reasonable efforts to remedy
its inability to perform. The obligation to pay money in a timely manner
is absolute and shall not be subject to the Force Majeure provisions,
except to the extent payment is prohibited by governmental rule or
regulations other than rules or regulations incident to bankruptcy or
insolvency proceedings of a party. Force Majeure shall mean a cause
beyond the reasonable control and without the fault or negligence of a
party including, but not limited to, explosion, flood, war (whether
declared or otherwise), accident, labor strike or other labor
disturbance, inability to obtain materials or services, sabotage, acts
of God, newly enacted legislation, newly issued orders or decrees of any
Court and any binding act or order of any governmental agency.
Notwithstanding anything in this Section, the party to whom performance
is owed but to whom it is not rendered because of an event of Force
Majeure as contemplated in this Section shall, after the passage of one
hundred eighty (180) days and while such event continues, have the
option to immediately terminate this Agreement upon written notice to
the other party hereto.
16.3 Further Assurances: Each party agrees to execute and deliver any and all
such other and additional instruments and documents and do any and all
such other acts and things as may be necessary or expedient to
effectuate more fully this Agreement and to carry out the business
contemplated by this Agreement.
16.4 Entire Agreement: This Agreement and the Schedules attached hereto
contains the entire Agreement and understanding of the parties with
respect to its subject matter and supersedes all negotiations, prior
discussions and any agreements relating to the Product. This Agreement
may not be amended or modified except by a written instrument signed by
the parties.
16.5 Waiver: Any representation, warranty, covenant, term or condition of
this Agreement which may legally be waived, may be waived, or the time
of performance thereof extended, at any time by the party hereto
entitled to the benefit thereof, and any term, condition or covenant
(including, without limitation, the period during which any condition is
to be satisfied or any obligation performed) may be amended by the
parties hereto at any time. Any waiver, extension or amendment shall be
effective only if it is in writing and signed by the party giving it,
and only in the specific instance and for the specific purpose for which
it has been given. No failure on the part of any party to exercise, and
no delay in exercising, any right under this Agreement shall operate as
a waiver of such right. No single or partial exercise of any such right
shall preclude any other or further exercise of such right or the
exercise of any other right.
16.6 Counterparts: This Agreement may be executed in identical duplicate
copies exchanged by facsimile transmission. The parties agree to execute
two identical original copies of the Agreement after exchanging signed
facsimile or electronic versions. Each identical counterpart shall be
deemed an original, but all of which together shall constitute one and
the same instrument.
16.7 No Third Party Rights: The provisions of this Agreement are for the
exclusive benefit of the parties to this Agreement and no other Person
(including, without limitation, any creditor of any party to this
Agreement) shall have any right or claim against any party to this
Agreement by reason of those provisions or be entitled to enforce any of
those provisions against any party to this Agreement.
16.8 Severability of Provisions: If, for any reason whatsoever, any term,
covenant or provision of this Agreement or the application thereof to
any party or circumstance or in any jurisdiction is to any extent held
or rendered invalid, unenforceable or illegal, then such term, covenant
or condition (a) is deemed to be independent of the remainder of this
Agreement and to be severable and divisible therefrom and its
invalidity, unenforceability or illegality shall not affect, impair or
invalidate the remaining provisions hereof(.), and (b) continue to be
applicable and enforceable to the fullest extent permitted by law in
every other jurisdiction and against any party and circumstances other
than those as to which or in respect of which it has been held or
rendered unenforceable or illegal.
16.9 Assignment: Neither party shall assign or otherwise transfer this
Agreement without the written consent of the other party, which consent
shall not be unreasonably withheld; provided, however, that 3RP may
assign this Agreement, in whole, or in part, to an Affiliate, purchaser
or transferee of all or substantially all of 3RP's business relating to
the Product without the consent of SAMARITAN. SAMARITAN may distribute
the Product through its Affiliates within the Territory and guarantees
the performance of any such Affiliates in relation to this Agreement.
Any purported assignment in violation of the preceding sentence shall be
void. Any permitted assignee shall assume all obligations of its
assignor under this Agreement. No assignment shall relieve a party of
responsibility for the performance of any obligations that have already
accrued.
16.10 Non Contravention: Each party represents and warrants that the
execution, delivery and performance of this Agreement by it will not
contravene any other contract or agreement to which it is a party or by
which it is bound.
16.11 Remedies Cumulative: The rights and remedies provided in this Agreement
to a non-defaulting party shall be deemed cumulative, and the exercise
of one of such remedies shall not operate to bar the exercise of any
other rights and remedies reserved to a non-defaulting party under the
provisions of this Agreement or given to a non-defaulting party at law
or in equity (subject to the limitations contemplated in Article 10
hereof).
16.12 Binding Effect: This Agreement and all of the provisions hereof shall
be binding upon and inure to the benefit of the parties hereto, their
Affiliates, and each of their successors and permitted assigns.
16.13 Announcements: Neither party shall make any public announcement or
press release concerning the existence of this Agreement or the
relationship of the parties created hereby without the prior written
consent of the other party, which consent shall not be unreasonably
withheld or unduly delayed. Subject to the foregoing, any such
announcement or press release shall only be made at such time and in
such manner as the parties may agree upon.
IN WITNESS WHEREOF, each of the parties hereto has caused this Agreement to be
executed by its duly authorized officer as of the date first above written.
SAMARITAN PHARMACEUTICALS, SA
By: /s/ Xx. Xxxxxxxx Xxxxx
------------------------------------------------------------
Xx. Xxxxxxxx Xxxxx, Managing Director
THREE RIVERS PHARMACEUTICALS, LLC
By: /s/ Xxxxxxx Xxxxxxx
----------------------------------------------------------
Xxxxxxx Xxxxxxx, Xx. VP, Business Development
SCHEDULE "A"
DEFINITIONS
"Affiliate" means, in relation to SAMARITAN, 3RP or a Person, any Person which,
directly or indirectly, controls, is controlled by or is under common control
with such Person. For purposes of this definition, the term `"control" (as used
in the terms "controls", "controlled by" and "under common control") means
either (i) holding 50% or more of the voting securities of such Person or, (ii)
in the case of a Person that has no outstanding voting securities, having the
right to 50% or more of the profits of such Person or having the right in the
event of dissolution to 50% or more of the net assets of such Person or, (iii)
the power to direct or cause the direction of the management and policies of
such Person, whether pursuant to the ownership of voting securities, by contract
or otherwise;
"Business day" means a day other than a Saturday, a Sunday or a day which is a
statutory holiday in the Territory or the United States of America;
"cGMP" means the current Good Manufacturing Practices of the Territory as
applicable to the Product (as in effect from time to time);
"Competing Product" means a pharmaceutical product which is in the same dosage
form, has the same active ingredient, the same strength and is for the same
indication as the Product and which, in the case of the restrictions applicable
to SAMARITAN hereunder, is manufactured and supplied by or purchased or acquired
from any Person other than 3RP;
"Confidential Information" shall mean information disclosed to or obtained by
one party from another party (including information obtained by one party as a
result of access to the facilities of the other party) either prior to or during
the term of this Agreement which is non-public, confidential or proprietary in
nature (including, without limitation, trade secrets, financial data, product
information, manufacturing methods, market research data, marketing plans,
identity of customers, or product information [including, without limitation, in
the case of 3RP, the nature and source of raw materials, Product formulation and
methods of producing, testing and packaging the Product]) and which relates to
the disclosing party's past, present or future research, development or business
activities. Confidential Information shall not, however, include information
that a party can demonstrate by written evidence:
(i) is in the public domain (provided that information in the
public domain has not and does not come into the public domain
as a result of a breach by a party hereto of its obligations
of confidentiality contained herein;
(ii) is known by the receiving party prior to disclosure by the
other party; or
(iii) which has been developed by the receiving party independent of
any disclosure by the other party;
(iv) is subsequently, lawfully and in good faith obtained by the
receiving party on a non-confidential basis from a third party
as shown by documentation sufficient to establish the third
party as the source of the information, provided that such
third party was not under an obligation to treat such
information in a confidential manner and had a lawful right to
make such disclosure;
"FDA" means the United States Food and Drug Administration.
"Person" shall be broadly interpreted and shall include an individual,
partnership, joint venture, association, corporation, company and any other form
of business organization, government, regulatory or governmental agency,
commission, department and instrumentality;
"Product" means 3RP's proprietary AMPHOCIL(R) brand of Amphotericin B with
sodium cholesteryl sulphate as manufactured and supplied by 3RP to SAMARITAN
pursuant hereto;
"Quarter" means a complete period consisting of three months from January to
March, April to June, July to September and October to December, all inclusive.
"Regulatory Approval" means receipt of final approval from applicable regulatory
authorities which permit the importation and commercial sale of the Product in
the Territory;
"Regulatory Authority" means the applicable government ministry, department or
regulatory body responsible in the Territory for issuing Regulatory Approval or
licenses and/or for enacting, monitoring and/or enforcing the applicable laws
relating to the importation and sale of pharmaceutical products in the
Territory;
"Specifications" means the terms and conditions applicable to the Product as
contained in the application filed with the Regulatory Authority and the terms
and conditions applicable to the final approval covering such Product issued by
the Regulatory Authority, as the same may be supplemented from time to time;
"Territory" means the countries Greece and Cyprus.
