Exhibit 10(rr)
ALLIANCE MANUFACTURING AND SUPPLIER AGREEMENT
This Manufacturing and Supplier Agreement (this "Agreement") is made and
entered into as of May 19, 2000 (the "Effective Date") by and between Alliance
Pharmaceutical Corp., a New York corporation ("Alliance") and PFC Therapeutics,
LLC, a Delaware limited liability company ("PFC").
RECITALS
WHEREAS, Xxxxxx Healthcare Corporation ("Xxxxxx") and PFC are entering
into a Marketing and Distribution Agreement, dated as of May 19, 2000 (the
"Marketing Agreement"), whereby an Affiliate of Baxter will engage in the
distribution and commercialization of products capable of transporting oxygen in
therapeutic effective amounts in the bloodstream for all medical uses, including
perflubron-based emulsion (the "Product");
WHEREAS, in conjunction with the Marketing Agreement, Alliance intends to
manufacture the Product;
WHEREAS, PFC desires to purchase on a continuing basis, and Alliance
desires to manufacture and sell on a continuing basis, the Product; and
WHEREAS, to avoid repetitive negotiations, PFC and Alliance desire to
enter into this Agreement establishing the terms and conditions which will be
applicable to each and every purchase and sale of the Product.
ARTICLE I
DEFINITIONS
Affiliate shall mean any entity controlling, controlled by, or under
common control with a person or other entity. For purposes of this definition,
the terms "controlling," "controlled by" or "under common control with" shall
mean the possession, direct or indirect, of the power to direct or cause the
direction of the management and policies of a person or entity or through the
ownership of at least 40% of the voting securities of a person or entity.
Baxter means Xxxxxx Healthcare Corporation and its Affiliates.
Baxter Manufacturing Agreement shall mean the Baxter Manufacturing and
Supplier Agreement dated as of May 19, 2000, between PFC and Baxter, whereby
Baxter will manufacture and supply the Product for distribution within the
Territory.
Components shall mean all containers and closures as well as all packaging
Components, labels and labeling necessary for the manufacture of the Product as
finished goods, as agreed upon by the parties.
FDA means the United States Food & Drug Administration and, when
appropriate herein, shall also mean any corresponding regulatory agency in any
country.
* Indicates confidential information which has been omitted and filed separately
with The Securities and Exchange Commission.
First Commercial Sale shall mean the first sale to a third party of the
Product anywhere in the world under the approval of appropriate governmental
agencies (if any) for distribution and sale of such Product.
Materials shall mean all raw materials used in the formulation of the
Product necessary for the manufacture of the Product as finished goods.
NDA shall mean a New Drug Application and all supplements submitted to the
FDA by Alliance, including all documents, data and other information concerning
the Product which are necessary for or included in FDA approval to market the
Product as more fully defined in 21 C.F.R. ss.ss.314.5 et seq., as well as
equivalent submissions to the appropriate health authorities in other countries,
provided further that with respect to the European Union, such application is to
be under the E. U. Centralized Procedure.
Operating Agreement shall mean the Limited Liability Operating Agreement
of PFC Therapeutics, LLC dated May 17, 2000, between Alliance and Baxter.
Product shall mean all injectable perfluorochemical based emulsions
capable of transporting oxygen in therapeutic effective amounts in the
bloodstream for all medical uses, including therapeutic and diagnostic, which
have been evaluated, developed and/or acquired prior to this Agreement or will
be evaluated, developed and/or acquired during this Agreement, and all Product
Know-How, Product Inventions, Product Patents and Product trademarks related
thereto, together with all enhancements, modifications, revisions, developments,
improvements and Subsequent Applications thereto, to the extent owned by,
licensed to or controlled by PFC.
Product Invention shall mean a patentable invention or discovery related
to the Product that is solely owned by PFC, or which PFC has the right to
control the use of through a license or otherwise.
Product Know-How shall mean designs, plans, specifications, methods,
systems, clinical data, processes, compositions, techniques and other technical
information or documentation, whether patentable or not, that is solely owned by
PFC, or which PFC has the right to control the use of through a license or
otherwise, relating to the Product.
Product Patent(s) shall mean all United States and foreign patent
applications and patents that relate to the Product, owned by PFC or licensed to
PFC, including any continuations, divisions, reissues, re-examinations and all
foreign counterparts thereof.
Specifications shall mean each of the specifications for each of the
Products as agreed to in writing by the parties.
Subsequent Applications has the definition given to it in the Operating
Agreement.
Territory shall have the meaning ascribed to it in Section 1.18 of the
License Agreement dated May 19, 2000 between Alliance and PFC.
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ARTICLE II
MANUFACTURING RIGHT
2.1 Right to Manufacture. Subject to Section 6.2(a) below, PFC hereby
grants to Alliance a co-exclusive license (co-exclusive with the license granted
to Baxter under the Baxter Manufacturing Agreement) to manufacture the Product
for distribution within the Territory. No rights or licenses with respect to the
Product, Product Patents, Product Know-How or Product Inventions are granted or
deemed granted hereunder or in connection herewith, other than those rights or
licenses expressly granted in this Agreement. Should Baxter exercise its right
to manufacture the Product for distribution within the Territory pursuant to
Section 2.2 of the Baxter Manufacturing Agreement, this Agreement will terminate
in accordance with Article 6, and Baxter will hold the exclusive license to
manufacture the Product for distribution within the Territory.
2.2 Right to Sublicense. Alliance has the right to grant sublicenses under
this Agreement to a third party to manufacture the Product for distribution
within the Territory; provided, however, that Alliance must obtain the written
consent of Baxter, which consent will not be unreasonably withheld, prior to
granting such sublicense to a third party. Any sublicenses granted hereunder
shall terminate in the event this Agreement is terminated.
ARTICLE III
SUPPLY SERVICES
3.1 Supply of Product. Alliance shall use commercially reasonable efforts
to supply and sell to PFC the Product under the Baxter label, subject to the
reasonable capacity of Alliance's existing facility located at 0000 Xxxxxxx Xxxx
Xxxx, Xxx Xxxxx, Xxxxxxxxxx. PFC shall provide Alliance with approved label copy
and packaging (collectively "Packaging and Labeling") for the Product, including
any amendments thereto. PFC shall retain title and ownership of all labels and
labeling supplied by PFC. Alliance, at its own expense, shall be responsible for
reproducing the Packaging and Labeling, either directly or through a
subcontractor, in accordance with the PFC approved Packaging and Labeling.
Alliance shall, at its own expense, be responsible for packaging and labeling
the Product.
3.2 Forecasts and Orders. PFC, either directly or through its designee,
agrees to forecast demand and issue purchase orders for Product in accordance
with the procedures set forth under Section 3.3. Alliance shall deliver the
Product ordered for the first two (2) months of this Agreement on the delivery
date requested by PFC. Thereafter, Alliance shall deliver the Product in
accordance with the demand schedule submitted by PFC as set forth in Section
3.3.
3.3 Demand Schedule. Commencing on a date to be agreed by the parties, PFC
or its designee shall provide Alliance monthly with a twelve (12) month rolling
forecast ("Demand Schedule") for each presentation of the Product. The first
three (3) months of the first two Demand Schedules shall constitute firm PFC
purchase orders. Commencing with the third Demand Schedule, the first two (2)
months of the Demand Schedule shall reflect PFC's firm purchase orders
communicated by previous Demand Schedules and a firm PFC purchase order for the
next succeeding (third) month. PFC shall be obligated to purchase 100% of each
issued purchase order. The remainder of the Demand Schedule shall be for
planning purposes only.
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Except for orders appearing in month one (1) of a Demand Schedule, Alliance will
make reasonable efforts to reschedule firm orders to accommodate changing demand
patterns within the market place.
3.4 Orders in Excess of Forecast. Alliance shall make commercially
reasonable efforts to deliver quantities of the Product that are ordered by PFC
and that are in excess of PFC's firm orders made pursuant to Section 3.3.
3.5 Delivery Terms. Alliance agrees to deliver the Product to PFC F.O.B.
destination as designated by PFC. Alliance and PFC will cooperate in selecting
appropriate carriers. The Product shall be stored and shipped in accordance with
label and FDA approved storage conditions.
ARTICLE IV
WARRANTY, MANUFACTURING STANDARDS
AND QUALITY ASSISTANCE
4.1 Product Warranty. Alliance warrants that the Product delivered to PFC
under this Agreement shall, at the time of delivery, (i) conform to the
Specifications, (ii) conform to all additional product specifications mutually
agreed upon for product attributes and possible cross contaminants resultant
from common equipment and facilities utilized in the manufacturing of the
Product and other products manufactured by Alliance, and (iii) Alliance's
production of the Product shall be conducted in accordance with current U.S.
Good Manufacturing Practices as listed in 21 CFR 211. Alliance further warrants
and guarantees that, as of the date of each delivery hereunder to PFC, and until
its date of expiration, the Product, whether for intended sale in the United
States or elsewhere, shall comply with the provisions of the United States Food,
Drug and Cosmetic Act, and such Product shall not, when delivered, be
adulterated or misbranded within the meaning of the United States Food, Drug and
Cosmetic Act. To the extent that the regulatory provisions of a country in the
Territory are different from those of the United States, PFC shall be
responsible for identifying those differences and the parties shall discuss an
equitable modification to the foregoing warranties with respect to the Product
to be sold in any such country. PFC shall promptly amend the Specifications
necessary to comply with the regulatory provisions in such country. Alliance
agrees that no more than three (3) months of the total approved shelf life for
each dosage form of the Product shall have expired upon delivery of such Product
to PFC, except with respect to batches of Product as to which investigative
testing or re-testing is required in accordance with Section 4.3 below. Products
shall not be misbranded provided they are labeled in accordance with PFC's
instructions. Alliance does not warrant any Product not stored or shipped by PFC
in accordance with the Specifications.
4.2 Product Inspection. Alliance will test and inspect each lot of Product
for compliance with Specifications prior to release and shipment to PFC or its
designee. After receipt, PFC or its designee shall test and inspect each lot, as
PFC or its designee deems appropriate, of Product for compliance to
Specifications. If within forty-five (45) days after receipt of a lot of Product
by PFC or its designee PFC or its designee notifies Alliance in writing that
such lot does not meet the Specifications as determined by PFC's or its
designee's testing and
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inspection of the Product, Alliance shall replace the Product (subject to
Section 4.3 below) at Alliance's expense (such expense to include the cost of
Components and Materials) within forty-five (45) days of such notice. Alliance
shall pay for shipping charges to deliver such replacement Product to PFC or its
designee. A non-conforming Product shall, upon mutual agreement by Alliance and
PFC, either (1) be returned to Alliance within a reasonable period of time or
(2) be destroyed by PFC at Alliance's expense.
4.3 Disputes with Respect to Rejection. If Alliance disputes PFC's right
to reject all or part of any shipment of the Product as set forth in Section 4.2
hereof, and such dispute is not resolved by mutual agreement between the parties
within sixty (60) days of PFC's notice of rejection, such dispute shall be
resolved by an independent FDA approved testing organization or consultant of
recognized repute within the U.S. pharmaceutical industry mutually agreed upon
by the parties, the appointment of which shall not be unreasonably withheld or
delayed by either party. The determination of such testing entity with respect
to PFC's rejection of the shipment or portion thereof shall be final and binding
upon the parties, but only as to the reasons given by PFC in rejecting the
shipment or portion thereof and shall have no effect on any matter for which
said entity did not render a determination. The fees and expenses of the third
party making the determination shall be paid by the party against which the
determination is made.
4.4 Master Formula. The composition of the Product will be as stated in
the applicable approved Product NDA or the applicable regulatory approval for
such Product.
4.5 Manufacturing and Packaging Instruction and Procedures. The Product
will be manufactured and packaged as stated in the applicable approved Product
NDA or the applicable regulatory approval for Product. Original Product master
manufacturing and packaging procedures to be set forth in the Product master
batch records shall be mutually approved by the parties.
4.6 Change Control. Alliance will notify PFC or its designee in writing of
any proposed change to Materials or Components of the Product, process
specifications and/or controls, as well as third party contractors, equipment or
facilities or analytical methodology utilized for the manufacturing, packaging
and/or analytical evaluation of the Product. Any such change must be agreed upon
and approved in writing by PFC prior to implementation or submission to
regulatory authorities for approval. Changes in the prescribing information
(package insert) and labeling shall be the responsibility of PFC or its
designee.
4.7 Batch Records. Records which include the information relating to the
manufacturing, packaging and quality operation for each lot of the Product shall
be prepared by Alliance at the time at which such operations occur. The records
shall include, but are not limited to, the following documentation:
manufacturing, Materials and Components charge-in records; mixing and fillings
records; packaging component charge-in records; packaging records; container and
component traceability records; equipment usage records; in-process and final
laboratory testing results; in-process and final product physical inspection
results; yield reconciliation for bulk and finished product; label samples;
labeling control records; as well as documentation listing any deviations and/or
excursions from approved procedure (as well as the Alliance investigation and
corrective actions) incurred during the processing and packaging of
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the lot. The original documents for each lot may be reviewed by PFC at its
request when auditing the Alliance site of manufacture of the Product.
4.8 Batch Document to be Included With Each Shipment of Product to PFC.
The minimum batch documentation required to be included with each lot of Product
shipped to PFC or its designee is a packaging xxxx of material and copies of
certificate of analysis for each lot. The certificate of analysis, signed by the
responsible quality official, must include the numerical results, if applicable,
for each test (chemical, microbiological and bacteriological) performed to
assure results are in compliance with Product Specifications, as well as a
statement that subject lot was produced in accordance to the applicable NDA and
in compliance with all applicable Good Manufacturing Practice requirements.
4.9 Chemical and Packaging Component Inspection and Release. Alliance
shall test, inspect and release Materials and Components used in the manufacture
of the Product. PFC shall supply approved masters for labels, package inserts
and labeling to Alliance to be utilized for the Product supplied hereunder.
Alliance shall inspect and release all labels, package inserts, and labeling
utilized for the Product for conformance with such approved masters. Alliance
shall test, inspect and release all other packaging Components for compliance
with Specifications.
4.10 Retention Sample. Alliance is responsible for storing and maintaining
retention samples of finished Product from each lot to meet regulatory
requirements. Alliance is responsible for storing and maintaining retention
samples of each lot of Material utilized in the manufacture of the Product in
accordance with all regulatory and FDA Good Manufacturing Practices ("GMP").
4.11 Product Complaints. If Alliance holds the NDA, Alliance or its
designated distributors shall correspond with complainants on all product
complaints associated with the Product and shall file any Drug Adverse Reaction
Experience Reports associated with the Product as required under 21 CFR 314.80
or by equivalent foreign regulations in countries outside the United States. If
Alliance holds the NDA, complaints received associated with the Product which
may require an NDA Field Alert Report as specified under 21 CFR 214.81 shall be
handled by Alliance or its designated distributors. Copies of any Drug Adverse
Reaction Experience Reports and NDA Field Alert Reports or foreign equivalents
shall be promptly forwarded to PFC by Alliance, except that when PFC in its
capacity as a licensor of the Product under this arrangement with Alliance
receives such reports in the first instance, it shall forward the same promptly
to Alliance. If Alliance holds the NDA, PFC or its designee shall assist
Alliance in investigating Product complaints by analyzing Product and Components
to determine the cause, if any, of an alleged Product manufacturing defect or
failure. PFC or its designee shall also assist Alliance in the investigation of
any adverse drug events when such adverse events are believed to be attributable
to the Product. If Alliance does not hold the NDA, Alliance or its designee
shall assist the holder of the NDA in investigating Product complaints by
analyzing Product and Components to determine the cause, if any, of an alleged
Product manufacturing defect or failure. Alliance or its designee shall also
assist the holder of the NDA in the investigation of any adverse drug events
when such adverse events are believed to be attributable to the Product. If
Alliance holds the NDA, Alliance shall diligently work to provide a written
report of its determination within thirty (30) days from receipt of a written
request and samples of the involved Product. If Alliance does not hold the NDA,
Alliance shall be responsible to
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ensure that PFC receives samples of the Product to be investigated. In the event
that Alliance determines that any reasonable additional physical, chemical,
biological, or other evaluation should be conducted in relation to an adverse
drug event or Product complaint, Alliance shall so advise PFC. If Alliance holds
the NDA, Alliance shall conduct the necessary evaluations and advise PFC of the
results. Additional evaluations requested by PFC or its designee and not
otherwise required by regulation or not otherwise carried out by Alliance in the
usual course of its investigation under its applicable standard operating
procedures (SOPs) for complaints will be at the expense of PFC.
4.12 Process Validation. Alliance shall validate all processes, equipment,
utilities facilities and computers utilized in the manufacture packaging,
storage, testing and release of the Product for regulatory submissions and
commercial sale in conformance with all current FDA and other applicable
regulatory authority guidelines and regulations. Alliance shall be responsible
for and shall ensure that all validated systems are maintained according to FDA
guidelines and that all required periodic revalidation's are performed according
to FDA guidelines. PFC shall reserve the right to review and approve all
process, utility, equipment and computer validation master validation plans
and/or the corresponding protocols prior to execution of such validation. PFC
reserves the right to review the results of all related validation studies.
4.13 Regulatory Visits.
(a) Alliance shall notify PFC within 24 hours in the event of any
FDA or other regulatory authority inspection or query regarding the Product. In
the event of an inspection by the FDA or any applicable regulatory authority
which results in a concern by the FDA or applicable regulatory authority
specifically related to the Product, then PFC through its designee will be
notified immediately of such concern. Alliance and PFC shall cooperate in
resolving the matter with the FDA or the applicable regulatory authority.
(b) PFC shall notify Alliance within 24 hours in the event of any
FDA or other regulatory authority inspection or query regarding the Product. In
the event of an inspection by the FDA or any applicable regulatory authority
which results in a concern by the FDA or applicable regulatory authority
specifically related to the Product, then Alliance through its designee will be
notified immediately of such concern. PFC and Alliance shall cooperate in
resolving the matter with the FDA or the applicable regulatory authority.
4.14 Compilation and Maintenance of Books and Records. Alliance shall make
available to PFC all reasonably requested records and information compiled or
generated in connection with Alliance's manufacturing of the Product under this
Agreement, including, but not limited to, batch records prepared under Section
4.7, Component inspections performed under Section 4.9, retention samples kept
under Section 4.10, process validation reports prepared under Section 4.12,
inventory and production reports indicating quantities of the Materials, work in
process and finished goods of the Product on hand at the beginning of each PFC
accounting period, quantities of finished goods of Product produced during such
PFC accounting period, and quantities of Materials, work in process, and
finished goods of Product on hand at the end of such accounting period.
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4.15 Audits. PFC has the right to inspect the facilities of Alliance and
to audit the books and records pertaining to the manufacture and supply of the
Product under this Agreement.
4.16 Regulatory Submissions and Approval; Product Recall. The respective
responsibilities of the parties concerning the submission of the Product to
appropriate regulatory authorities and product recall are set forth in the
Operating Agreement.
4.17 Third-Party Manufacturers. To the extent that Alliance uses a third
party manufacturer for the Product, then Alliance shall monitor such third party
manufacturer and use reasonable efforts to ensure that it is in compliance with
the manufacturing standards set forth in this Agreement. Subsequent to the
execution of this Agreement, Alliance shall comply with the provisions of
Section 4.6 prior to any additional use of a third party manufacturer for the
Product. Alliance shall use reasonable efforts to ensure that any third party
manufacturer complies with the inspection, monitoring and audit rights with
respect to such third party's manufacturing facilities and provides to PFC all
records that relate to the Product.
ARTICLE V
PRICE AND PAYMENT
5.1 Price. All purchases by PFC of the Product under this Agreement shall
be at the prices determined pursuant to Exhibit AA to this Agreement.
5.2 Payment. Except to the extent otherwise agreed to by the parties,
payment of invoiced amounts shall be due within thirty (30) days of the date
Alliance's invoice is received by PFC. Payment shall be made by check or wire
transfer to an account designated by Alliance. All payments due under this
Article 5 but not paid by PFC on the due date thereof shall bear interest at the
monthly rate which is the lesser of: (i) one and one half percent (1-1/2%) of
the amount due; and (ii) the maximum lawful interest rate permitted under
applicable law. Such interest shall accrue at such rate on a monthly basis on
the balance of unpaid amounts outstanding from the date on which portions of
such amounts become due and owing until payment thereof in full.
ARTICLE VI
TERM AND TERMINATION
6.1 Term. This Agreement shall take effect as of the date first written
above and shall continue in force until termination of the Operating Agreement.
6.2 Termination Upon Baxter Election. Notwithstanding the provisions of
Section 6.1 above, the co-exclusive license to manufacture the Product granted
to Alliance hereunder shall terminate in the event that Baxter exercises its
option to manufacture the Product for distribution in the Territory in
accordance with Section 2.2 of the Baxter Manufacturing Agreement. If Baxter so
exercises its option, Alliance's co-exclusive manufacturing rights with Baxter
shall continue for a period of time as determined by PFC in order to permit
Baxter to "ramp up" production of the Product. After such time, Alliance will
have no rights, and may not grant rights to a third party, to manufacture or
supply the Product for distribution in the Territory.
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ARTICLE VII
INDEMNIFICATION
7.1 Indemnification by Alliance. Alliance agrees to indemnify, defend and
hold harmless PFC, its affiliates and their respective employees against any and
all third party claims, including claims made against PFC by any of its
distributors, losses, damages and liabilities, including reasonable attorney's
fees, incurred by any of them arising out of any breach of any obligation by
Alliance hereunder or any misrepresentation by Alliance hereunder or any
negligent or intentionally wrongful act or omission by Alliance in connection
with its manufacturing and supply services hereunder. Alliance shall not be
responsible for indemnifying PFC against claims for lost profits, consequential
or indirect damages with respect to the Product.
7.2 Indemnification by PFC. PFC agrees to indemnify, defend and hold
harmless Alliance, its affiliates and their employees against any and all
third-party claims, losses, damages and liabilities, including reasonable
attorney's fees, incurred by any of them arising out of any breach of any
obligation by PFC hereunder or any misrepresentation by PFC hereunder or any
negligent or intentionally wrongful act or omission of PFC in connection with
the Product.
7.3 Procedure. If PFC, its affiliates or their respective employees, or
Alliance, its affiliates or their respective employees (in each case an
Indemnified Party) receive any written claim which such Indemnified Party
believes is the subject of indemnity hereunder by Alliance or PFC as the case
may be (in each case an "Indemnifying Party"), the Indemnified Party shall, as
soon as reasonably practicable after forming such belief, give notice thereof to
the Indemnifying Party; provided, that the failure to give timely notice to the
Indemnifying Party as contemplated hereby shall not release the Indemnifying
Party from any liability to the Indemnified Party unless the Indemnifying party
demonstrates that the defense of such claim is prejudiced by such failure. The
Indemnifying Party shall have the right, by prompt notice to the Indemnified
Party, to assume the defense of such claim, at its cost, with counsel reasonably
satisfactory to the Indemnified Party. If the Indemnifying Party does not so
assume the defense of such claim or, having done so, does not diligently pursue
such defense, the Indemnified Party may assume such defense, with counsel of its
choice, but at the cost of the Indemnifying Party. If the Indemnifying Party so
assumes such defense, it shall have absolute control of the conduct of the
litigation; the Indemnified Party may, nevertheless, participate therein through
counsel of its choice and at its cost. The party not assuming the defense of any
such claim shall render all reasonable assistance to the party assuming such
defense, and all out-of-pocket costs of such assistance shall be for the account
of the Indemnifying Party. No such claim shall be settled other than by the
party defending the same, and then only with the consent of the other party,
which shall not be unreasonably withheld; provided, that the Indemnified Party
shall have no obligation to consent to any settlement of any such claim which
imposes on the Indemnified Party any liability or obligation which cannot be
assumed and performed in full by the Indemnifying Party.
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ARTICLE VIII
INSURANCE
8.1 Insurance. Alliance shall carry comprehensive general liability
insurance, including product liability insurance against claims for bodily
injury or property damage in an amount of not less than $1,000,000 per
occurrence and $2,000,000 in the aggregate. Such policy shall be endorsed to
include the following: (a) the policies shall provide for thirty (30) days
notice to the other party of cancellation before such cancellation takes effect;
and (b) contractual liability including liability arising from this Agreement.
Alliance shall carry the insurance coverage set forth herein during the term of
this Agreement and for five (5) years following termination of this Agreement.
Such insurance shall be with insurance companies licensed to do business in
California and the insurers shall have a Best's Insurance rating of A-:VIII or
better.
ARTICLE IX
TRADENAMES AND TRADEMARKS
9.1 Rights Regarding Product Trademarks. The name and xxxx (or successor
name and xxxx) with respect to the Product for distribution within the Territory
shall be selected and owned exclusively by Xxxxxx. Alliance and its Affiliates
have no right to use any of such names and marks on the Product unless
explicitly granted such right by PFC.
9.2 Xxxxxx'x Rights. Alliance hereby acknowledges that it does not have,
and shall not acquire by virtue of this Agreement, any rights to or under any
goodwill, trademark, tradename, copyright, patent or other intellectual property
of Baxter, nor in any of Baxter' s trademarks or tradenames appearing on the
label or packaging materials of the Product, unless such rights are explicitly
granted to Alliance by Xxxxxx. Alliance agrees to do nothing by act or omission
which would impair Xxxxxx'x or its Affiliates' rights, ownership and title in
the aforementioned.
9.3 Infringement. Each party shall immediately report in writing to the
other party upon being acquainted through any source whatsoever of any and all
infringements or threatened infringements of the tradenames or trademarks owned
by such other party appearing on the labels and packaging materials of the
Product, and any attempt on the part of anyone to register, copy, infringe upon
or imitate such trademarks or tradenames, and if required by such party, the
notifying party will, at the other party's sole expense, take such steps as the
other party may deem advisable against the infringement or otherwise for the
protection of the other party's rights.
ARTICLE X
CONFIDENTIALITY
10.1 Nondisclosure. Alliance and PFC realize that some information
received by one party from the other pursuant to this Agreement will be
confidential. It is therefore agreed that any information received by one party
from the other which is in writing, or reduced to writing within thirty (30)
days of the date of disclosure, and designated as "Confidential," shall not
during or for a period of five (5) years after the term of this Agreement be (i)
disclosed by the receiving party to any third party, except to the extent that
(A) such third party is an employee, agent, representative, consultant of or to
Xxxxxx, Alliance, PFC or their Affiliates or is
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contemplating investing in PFC or Alliance, (B) such third party has agreed in
writing to abide to these confidentiality obligations and (C) such third party
has a need to know such information in order for the parties to perform their
obligations under this Agreement, or (ii) used by the receiving party for
purposes other than those contemplated by this Agreement.
10.2 Permitted Disclosure. Nothing in this Agreement shall prevent the
receiving party from disclosing any such information: (i) which is or becomes
publicly known through no fault of the receiving party; (ii) which the receiving
party rightfully had in its possession prior to the disclosure to the receiving
party or is independently developed by the receiving party, in either case, as
evidenced by written documentation; (iii) which the receiving party lawfully
obtained without restriction from a third party with no secrecy or
confidentiality obligation to the disclosing party; (iv) which is approved in
writing by the disclosing party for disclosure by the receiving party; or (v)
which is disclosed pursuant to court order or as otherwise compelled by law.
ARTICLE XI
MISCELLANEOUS TERMS
11.1 Compliance With Laws. Each party shall comply in all material
respects with, and shall not be in material violation of, any valid, applicable,
international, national, state or local statues, laws, ordinances, rules,
regulations, or other governmental orders ("Laws") of any country in which the
Product is either manufactured or sold which affect the manufacture, processing,
packaging, shipment, or storage of the Product; provided that Alliance shall
only be required to comply in all material respects with those Laws of countries
other than the United States upon specific written notice by PFC of such Laws
and inclusion in the Specifications, if applicable.
11.2 Injunctive Relief. Both parties hereto acknowledge that a breach of
this Agreement may give rise to irreparable injury to the non-breaching party
and acknowledge that remedies other than injunctive relief may not be adequate.
Accordingly, both parties have the right to equitable and injunctive relief to
prevent or enjoin violations of this Agreement.
11.3 Right of Set Off. Alliance shall be entitled at all times to set off
any amount owing from PFC or any of its Affiliates to Alliance against any
amount due or owing from PFC.
11.4 Relationship of Parties. The relationship between Alliance and PFC is
that of vendor and vendee and under no circumstances shall either party, its
agents, employees or representatives, be deemed agents, employees or
representatives of the other party, or have the right to enter into any
contracts or commitments in the name of or on behalf of the other party in any
respect.
11.5 Governing Law and Jurisdiction. All aspects this Agreement, and the
contract embodied herein, including, but not limited to, its validity,
formation, content, performance or nonperformance, breach, damages and
construction, shall be governed by the internal laws of the State of Illinois,
excluding its conflicts of law provisions.
11.6 Entire Agreement; Parol Evidence; Amendment. This Agreement, the
Exhibits attached hereto and the other agreements referenced in this Agreement
constitute the entire
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Agreement between the parties and supersede all written and oral agreements
between the parties regarding the subject matter hereof, and are intended as a
complete and exclusive statement of the terms of their agreement. This Agreement
may not be released, discharged, charged, amended or modified except by an
instrument in writing signed by a duly authorized representative of each of the
parties.
11.7 Titles and Headings. Titles and headings of sections of this
Agreement are for convenience of reference only and shall not affect the
construction or interpretation of any provision of this Agreement.
11.8 Attorneys' Fees. Should any party institute any action or proceeding
to enforce this Agreement or any provision hereof, or for damages by reason of
any alleged breach of this Agreement or of any provision hereof, or for a
declaration of rights hereunder, the prevailing party in any such action or
proceeding shall be entitled to receive from the other party all costs and
expenses, including attorneys' fees, incurred by the prevailing party in
connection with such action or proceeding.
11.9 No Third Party Beneficiaries. This Agreement is for the benefit of
the parties hereto and not for any other person, except as specifically provided
herein.
11.10 Severability. In any provision or provisions of this Agreement is
found to be invalid by any court, the invalidity of such provision or provisions
shall not affect the validity of the remaining provisions hereof.
11.11 Notices. Any notice, request, instruction or other document deemed
by PFC or Alliance to be necessary or desirable to be given to the other party
hereto shall be in writing and shall be telefaxed, delivered by messenger, air
courier (such as Federal Express, DHL or UPS), or mailed by certified mail,
postage prepaid, to the following addresses:
If to PFC: Xxxxxx Healthcare Corporation
Xxxxx 000 & Xxxxxx Xxxx
Xxxxx Xxxx, Xxxxxxxx 00000
Attention: General Manager, Global Anesthesia
Facsimile: (000) 000-0000
with a copy to: Xxxxxx Healthcare Corporation
Xxx Xxxxxx Xxxxxxx
Xxxxxxxxx, XX 00000
Attention: General Counsel
Facsimile: (000) 000-0000
with a copy to: Xxxxxx, Xxxx & Xxxxxxxx LLP
0 Xxxx Xxxxx, Xxxxx 0000
Xxxxxx, XX 00000-0000
Attention: Xxxxxx X. Xxxxxx, Esq.
Facsimile: (000) 000-0000
12
If to Alliance: Alliance Pharmaceutical Corp.
0000 Xxxx Xxxxxxxxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxxxx X. Xxxx
President and Chief
Operating Officer
Xxxxx X. Xxxxxxx
Vice President and General Counsel
Facsimile: (000) 000-0000
with a copy to: Stroock & Stroock & Xxxxx LLP
000 Xxxxxx Xxxx
Xxx Xxxx, XX 00000
Attention: Xxxxxx Xxxxxxx, Esq.
Facsimile: (000) 000-0000
11.12 Assignment. Alliance may assign or delegate any of its rights,
obligations or interests under this Agreement only upon obtaining the prior
written consent of Baxter. PFC may assign or delegate any of its rights,
obligations or interests under this Agreement (except PFC's obligation for
payment of the transfer price) to all persons or entities which repurchase the
Product directly from PFC.
11.13 Force Majeure. No failure or omission by the parties hereto in the
performance of any obligation of this Agreement shall be deemed a breach of this
Agreement nor create any liability if the same shall arise from any cause or
causes beyond the control of the parties, including but not limited to the
following which, for the purposes of this Agreement, shall be regarded as beyond
the control of the party in question; act of God, acts or omissions of any
government or any rules, regulations or orders of any governmental authority or
any officer, department, agency or instrument thereof; fire, storm, flood,
earthquake, accident, acts of the public enemy, war, rebellion, insurrection,
riot, invasion, strikes, or lockouts.
11.14 Survivability. Notwithstanding anything else in this Agreement to
the contrary, the parties agree that Article X shall survive the termination or
expiration of this Agreement, as the case may be.
11.15 Counterparts. This Agreement may be executed in counterparts, each
of which shall be deemed an original and all of which taken together shall
constitute one and the same instrument.
[Signatures to follow.]
13
IN WITNESS THEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the day and year first above
written.
Alliance Pharmaceutical Corp.: PFC Therapeutics, LLC:
By: _____________________________ By: ____________________________________
Name: ___________________________ Name: _________________________________
Title: __________________________ Title: ________________________________
EXHIBIT AA
The price of Product * .
*
