Supply Agreement (the
dated January 14, 2008 by and between Alfacell
Delaware corporation with its principal place of business at 300 Atrium Drive,
Somerset, New Jersey 08873 (“Alfacell”),
Delaware corporation with its principal place of business at 300 Tice Blvd,
Woodcliff Lake, NJ 07677, USA (“Par”).
Alfacell and Par may be referred to herein individually as a “Party”,
together as the “Parties”.
Capitalized terms not defined herein shall have the meanings ascribed to them
the License Agreement (as defined below).
Alfacell are entering into a License Agreement on even date herewith (the
which Par is receiving a license to, among other things, promote, market, have
marketed, distribute, offer for sale, sell and have sold the Product in the
Field in the Territory; and
desires to supply Product to Par in connection with the License Agreement and
the terms and conditions set forth herein.
consideration of the foregoing premises and the mutual covenants contained
herein and other good and valuable consideration, the receipt and sufficiency
which are hereby acknowledged, the Parties agree as follows:
“adverse drug experience” as such term is defined at 21 C.F.R. 310.305(b) (as
such definition may be amended, supplemented or replaced from time to time)
includes any adverse event associated with the use of a drug in humans, whether
or not considered drug related, including any failure of expected
pharmacological action and any adverse event occurring (i) in the course of
use of a drug product in professional practice; (ii) from drug overdose, whether
accidental or intentional; (iii) from drug abuse or (iv) from drug
meaning provided in the Preamble.
meaning provided in the Preamble.
meaning provided in Section 12.2.
each respective period of three consecutive months ending on March 31,
June 30, September 30 or December 31.
meaning provided in Section 6.1.
meaning set forth in the License Agreement.
uses for cancer in humans.
refer to such labels and other written, printed or graphic matter (i)
vials of Product and boxes of vials
accompanying the Product, including package inserts.
have correlative meaning.
meaning provided in Section 3.1.
meaning provided in the Recitals.
meaning provided in Section 12.1.
all activities related to the manufacturing of a pharmaceutical product, or
ingredient thereof, including to manufacturing Product or supplies for
development, manufacturing of Product for commercial sale, Packaging, Labeling,
in-process and finished product testing, release of product or any component
ingredient thereof, quality assurance activities related to the manufacturing
and release of product, ongoing stability tests and regulatory activities
related to any of the foregoing. “Manufactured”
have correlative meaning.
meaning provided in Section 7.3.
meaning provided in Section 6.2.3.
all primary containers, cartons and shipping cases, used in packaging or
accompanying the Product for delivery to Par hereunder. “Packaged”
have correlative meaning.
meaning provided in the Preamble.
meaning provided in Section 12.1.
specifications for the Product contained in the applicable Regulatory Approval
and any specifications mutually agreed upon by the Parties, such agreement
to be unreasonably withheld, conditioned or delayed, established in connection
with the Product and any changes to such specifications made at the request
the FDA or by mutual agreement of the Parties from time to time, including
specifications set forth in Exhibit
meaning provided in Section 6.3.
meaning provided in Section 11.1.
(i) either Scientific Protein Laboratories LLC or Ben Venue Laboratories, Inc.
or any of their respective Affiliates or (ii) such other
Party as Alfacell shall contract to Manufacture Product under this Agreement,
subject in respect of this clause (ii) to Par’s prior written consent, such
consent not to be unreasonably withheld.
by Alfacell. Subject
to the terms and conditions of this Agreement, Alfacell shall Manufacture and
supply, or cause its Third Party Manufacturer to Manufacture and supply to
such quantities of Product, in finished form, as are ordered by Par in
accordance with the requirements of this Agreement of its total commercial
requirements for Product. Alfacell shall not supply any Third Party with Product
for sale in the Territory. Alfacell shall not be required to provide samples
Product to Par. Par shall only purchase Product from Alfacell and from no other
and Purchase Orders.
shall notify Alfacell at least twelve (12) months in advance of the anticipated
date of the Initial Commercial Sale, which notification shall include a
preliminary estimate of the quantity of Product needed for the Initial
Commercial Sale. Par may change the estimated date of the Initial Commercial
Sale and the estimated quantity of Product needed for such Initial Commercial
Sale at any time by notifying Alfacell in writing; provided,
Par shall notify Alfacell of the minimum amount of Product that Par will require
for the Initial Commercial Sale at least six (6) months (or at least nine (9)
months, if such amount is less than or greater than the initial estimate by
than twenty-five percent (25%)) prior to the anticipated date of the Initial
Commercial Sale (the “Launch
month, Par shall provide Alfacell with a written twelve (12)-month rolling
estimated orders and delivery dates for Product in the Territory (each a
volume forecasted for the first five (5) months of each Forecast shall be
binding upon Par. The remainder of each Forecast shall not be
shall order Product as set forth in the binding portions of the Forecast by
submitting to Alfacell written purchase orders, in such form as the Parties
shall agree from time to time, specifying the quantities of Product ordered
the desired delivery dates for such Product. Par shall submit each purchase
order to Alfacell at least three (3) months in advance of the delivery date
specified in the Forecast. Alfacell
shall, or shall cause its Third Party Manufacturer to, make each delivery of
Product in the quantity and on the delivery date specified on Par’s purchase
order. Any purchase orders for Product submitted by Par to Alfacell shall
reference this Agreement and shall be governed exclusively by the terms
contained herein. The Parties hereby agree that the terms and conditions of
Agreement shall supersede any term or condition in any order, confirmation
other document furnished by Par or Alfacell that is in any way inconsistent
these terms and conditions.
of Orders. The
Parties agree that Forecasts and orders of Product will be expressed by multiple
boxes of Product in a unit size to be mutually agreed to by the Parties, subject
to Section 13.1.
Manufacture of the Product, Par shall pay Alfacell a price equal to the Transfer
Price. The Parties shall cooperate in good faith and use Commercially Reasonable
Efforts to reduce the Direct Cost of Product. Subject to Section 6, Par shall
responsible for shipping and related insurance costs.
shall, or shall cause its Third Party Manufacturer to, invoice Par for the
aggregate Transfer Price of each delivery of Product at the time of such
payments due hereunder to Alfacell shall be paid to Alfacell in U.S. Dollars
later than thirty (30) days following applicable delivery.
Notwithstanding anything else to the contrary herein, Par shall not be obligated
to take ownership or to
payment to Alfacell for any Launch Quantities until Regulatory Approval for
Product is obtained.
period of three (3) years after the calendar year to which the records relate
such longer period as may be required by applicable law, Alfacell shall, and
shall cause the Third Party Manufacturer to, keep records pertaining to any
that are components of Direct Costs in
sufficient detail to permit Par to confirm the
accuracy of the amounts
shall have the right to cause an independent, certified public accountant
reasonably acceptable to Alfacell to audit such records solely to
confirm the amounts
such auditor shall not disclose Alfacell’s Confidential Information or
Party Manufacturer’s confidential
except to the extent such disclosure is necessary to verify the amount of any
overpayments made by Par to Alfacell, and such auditor shall enter into a
non-disclosure agreement reasonably acceptable to Alfacell. Such audits may
exercised once per year on reasonable advance notice and during normal business
hours, within three (3) years after the date of payment to which such records
relate, upon notice to Alfacell and during normal business hours; provided,
Alfacell may cause an independent, certified public accountant reasonably
acceptable to Par to participate with Par’s accountant in such audit of any
Third Party Manufacturer. Any amounts shown to be owing by such audits shall
paid promptly. Par shall bear the cost of such audit unless such audit discloses
an overpayment by Par of more than five percent (5%) as compared to the amount
of payments and/or reimbursements actually owed to Alfacell for the period
audited. In such case, Alfacell shall bear the reasonable cost of such
payments due under this Agreement by either Party that are not paid by the
such payments are due shall bear interest at one
percent (1%) per month from the date such payments are due. The foregoing
interest shall be due from the
owing the payment amount without any special notice and shall be in addition
any other remedies that the Party entitled to such payment may have pursuant
to compliance with Section 3.1, the Launch Quantities shall be delivered to
Par at least two (2) weeks before the anticipated Initial Commercial Sale.
Deliveries shall be made EXW (Incoterms 2000) at Alfacell’s manufacturing
facility or that of its Third Party Manufacturer as designated by Alfacell.
delivered to Par shall be appropriately Labeled and Packaged by Alfacell at
expense in fully finished form for supply to the ultimate consumer in accordance
with law and all applicable Regulatory Approvals. Products supplied by Alfacell
shall have a shelf life of at least twenty (20) months from the date of
Assurance Control -
of Analysis and Compliance. Alfacell
shall provide Par with a copy of the certificate of analysis and a certificate
of compliance (together, the “Certificates”),
or at the same time of, each delivery of Product supplied hereunder. In the
event Par requires additional documentation due to a change in the law or a
Regulatory Approval without which the release into commerce and selling of
Product in the Field in the Territory under any Regulatory Approval would be
impossible or impracticable, Alfacell will use Commercially Reasonable Efforts
to supply (unless such documentation is required from all manufacturers of
pharmaceutical products, in which case Alfacell shall supply or cause its Third
Party Manufacturer to supply) such documentation with each delivery of Product.
Subject to variations agreed to in the Quality Agreement, such Certificates
shall certify, with respect to each shipment and batch (identified by batch
number): (i) the quantity of the shipment, (ii) that the Product
delivered conforms to, and was handled in compliance with, the Product
Specifications and (iii) that the Product was Manufactured in accordance with
cGMP and any applicable Regulatory Approval, as well as any further information
required by the relevant regulatory authorities that Par may have previously
notified Alfacell is necessary. Par shall be under no obligation to accept
shipment of Product without the accompanying Certificates.
Control Problem. If
Alfacell identifies a quality problem with respect to any batch of the Product,
then it shall promptly notify Par.
reject any delivery of Product if the Product does not conform to the Product
Specifications or if it fails to conform to any Product warranty set forth
this Agreement. In addition, Par will visually inspect each delivery of Product
upon receipt and shall, within forty five (45) days from receipt of delivery,
notify Alfacell in writing (i) of any defects discovered by such visual
inspection and (ii) that it is rejecting the delivery and the reasons for such
rejection. If Par fails to
such notice to Alfacell within the forty five (45)-day period, Par shall be
deemed to have accepted such delivery; provided,
other than with respect to defects or other non-compliance plainly observable
from a visual inspection, any such acceptance, or deemed acceptance, shall
operate to limit the warranties of Alfacell set forth in this Agreement relating
to such Product shipment and shall not preclude a subsequent rejection by Par
such shipment due to the discovery of latent defects in such Product (including
discovery of any substance that would cause Product to be adulterated within
meaning of the United States Food, Drug, and Cosmetic Act); and provided,
Par notifies Alfacell in writing within five (5) business days of its discovery
of such latent defect.
of Product and Dispute Procedure. If
Alfacell believes that Product was wrongly rejected, it shall notify Par in
writing, within twenty (20) days of receipt by Alfacell of Par’s written notice
of rejection, that Alfacell disagrees with such basis for rejection (an
Par and Alfacell cannot agree, within twenty (20) days after receipt by Par
the Objection Notice, whether Product rejected by Par is defective,
representative samples of the batch of Product in question shall be submitted
a mutually-acceptable independent laboratory or consultant for analysis and/or
review. The results of such evaluation shall be binding upon the Parties. The
Party that is determined to have been incorrect in its determination of whether
the Product should be rejected shall pay the costs of any such evaluation and
reimburse the other Party for any amounts previously paid by the other Party
the independent laboratory or consultant in connection with such evaluation.
such evaluation is inconclusive as to whether the Product rejected is defective,
or if it is conclusive as to the fact that the Product rejected is defective
it cannot be determined which Party is responsible for such defect, then the
Parties shall each be responsible for one-half of the costs related to such
evaluation and Par may, in its discretion, purchase replacement Product when
available for delivery. The Parties may also mutually agree in their discretion
to further testing.
of Replacement of Rejected Product. If
delivery or portion thereof is rejected by Par, unless already paid, Par’s
obligation to pay all amounts payable to Alfacell in respect of the rejected
delivery or portion thereof shall be suspended until there is agreement between
the Parties or a determination by the independent laboratory or consultant
regarding whether the respective delivery or portion thereof should be rejected.
If such agreement or determination is in support of Alfacell’s Objection Notice,
Par shall pay the amount due under the respective invoice for such improperly
rejected delivery or portion thereof. If no agreement can be reached or the
determination as to whether the delivery or portion thereof should be rejected
is inconclusive, or if it is determined or agreed that the Product rejected
defective but it cannot be determined or agreed which Party is responsible
such defect, as the case may be, Par shall only be obligated to pay one-half
the outstanding amount applicable to the rejected delivery or portion thereof,
as the case may be, less one-half of Ex-U.S. Shipping Costs or domestic shipping
and insurance costs related to such Product, as applicable. If such agreement
determination is in favor of Par, Par shall not be obligated to pay any amount
applicable to the rejected delivery or portion thereof, as the case may be,
Alfacell shall reimburse Par for the Ex-U.S. Shipping Costs or domestic shipping
costs related to such Product, as applicable, within thirty (30) days of Par's
providing to Alfacell reasonable documentation of such costs.
delivery or portion thereof is rejected by Par pursuant to the provisions of
this Section 6.2, after determination that the rejection is legitimate in
accordance with this Agreement, Par shall return to Alfacell at Alfacell’s
request and expense (or, at the election of Alfacell, destroy and provide
evidence of such destruction to Alfacell) any such rejected Product. If the
Product was rightly rejected, Alfacell shall (i) credit the original invoice
respect of the rejected Product and (ii) adjust such invoice so that it includes
only Product not rejected. Payment in respect of such adjusted invoice shall
due thirty (30) days after receipt by Par of such adjusted invoice.
the pendency of any rejection discussions, Alfacell shall, or shall use its
Commercially Reasonable Efforts to cause its Third Party Manufacturer to, supply
Par with the same amount of Product as is subject to rejection discussions
Par shall purchase such amount on the same terms as such rejected Product.
Notwithstanding Section 7.5, Alfacell shall, or shall use its Commercially
Reasonable Efforts to cause its Third Party Manufacturer to, make the supply
such replacement Product Alfacell's first supply priority and shall ship via
courier such replacement Product to Par at Alfacell’s expense. Shipping costs
related to such replacement Product shall be borne by Alfacell, unless the
evaluation as to whether the Product rejected is defective, or if conclusive
to the fact that the Product rejected is defective but it cannot be determined
which Party is responsible for such defect, in which event Par and Alfacell
shall each be responsible for one-half of such shipping costs. Any replacement
Product that replaces rejected Product shall have a shelf life, at the time
delivery, equal to or greater than the remaining shelf life of the rejected
Product at the time Par delivered notice of rejection in respect
sixty (60) days following the date that the first NDA is submitted to the FDA
Alfacell, the Parties shall enter into an agreement that details the quality
assurance obligations of each Party on mutually agreeable and customary terms
Parties shall notify each other within seventy-two (72)
hours of any new instructions or specifications required by the FDA or by other
Governmental Authorities. The Parties shall confer with each other with respect
to any response regarding such instruction or specification and the best means
to comply with such requirements and Alfacell shall bear the costs for
implementing such changes.
Labels and Packaging of Product shall specify Par as the distributor and display
the logo of Par and the artwork, text, and SKU numbers and other necessary
supplied by Par to Alfacell. The Labels and Packaging shall also include
references to the Third Party Manufacturer in accordance with applicable law
all Regulatory Approvals. All Labels and Packaging or trade dress shall comply
with applicable laws and Regulatory Approvals, and the presentation of the
Trademark thereon shall comply
provisions regarding the Trademark under the License Agreement. Except for
information and services provided to Alfacell by Par, Alfacell shall be
responsible for ensuring the accuracy of all information contained on all Labels
and Packaging of the Product and for the compliance of all such Labels and
Packaging with the law and all Regulatory Approvals. Should Par desire or be
required pursuant to applicable law and any Regulatory Approvals to make any
change in any such Labels or Packaging, Alfacell shall be responsible for
procuring the updating of all artwork and text associated with such change
for providing such changes to Par. Upon approval by Par, Alfacell shall make
necessary arrangements for such changed Labels or Packaging to be printed and
shall provide Par with agreed artwork documents for Par’s review. Par shall,
within one (1) week of receipt of agreed artwork documents, either provide
Alfacell with any necessary corrections thereto or notify Alfacell of its
approval of such agreed artwork documents. Par shall supply Alfacell with all
Par’s necessary artwork, text, SKU numbers and other necessary items by the
dates reasonably requested by Alfacell so that Alfacell can prepare the Labels
and Packaging for the Launch Quantities. Alfacell’s obligations to supply Par
and its Affiliates with Product, including the Launch Quantities by the
specified delivery dates, shall be contingent upon Alfacell’s timely receipt of
the foregoing artwork, text, and SKU numbers and other necessary items from
to the Product Specifications or to the Manufacturing Process.
shall obtain the prior written consent of Par, which consent shall not be
unreasonably withheld, conditioned or delayed, with respect to any proposed
revision to the Product Specifications, site of manufacture and any change
the Raw Materials, equipment, process or procedures used to Manufacture the
Product (the “Manufacturing
would require approval of or notification to the FDA, or other applicable
Governmental Authority, in the Territory. The corresponding costs of
implementing any changes to the Product Specifications or to the Manufacturing
Process shall be borne by Alfacell.
and Reworking of Product.
reprocessing or reworking of any batch or lot of Product shall be made in full
compliance with the procedures described in the Regulatory Approvals for the
Product, or, if not made in compliance with the procedures described in the
Regulatory Approvals for the Product, Alfacell shall obtain the prior written
consent of Par, not to be unreasonably withheld, delayed or
shall, or shall cause its Third Party Manufacturer to, use Commercially
Reasonable Efforts to avoid shortfalls in supply of Product based on the
Forecasts provided by Par. In the event Alfacell is unable to supply to Par,
whole or in part, Product requested for any reason (except to the extent caused
by Par), then, in addition to other rights or remedies available to Par,
Alfacell shall promptly notify Par in writing of such shortage, or potential
shortage, or inability to timely supply Product and, if possible, the date
Alfacell will again be able to supply Product. Alfacell shall make efforts
cause its Third Party Manufacturer to use commercially reasonable efforts to
remedy any shortfall of the Product as soon as practicable and to promptly
allocate its available production capacity for the production of Product.
Notwithstanding anything contained herein to the contrary, during Product
shortfalls, Product will be allocated on a pro rata basis among the worldwide
Product distributors and partners of Alfacell based on estimated market,
on the basis of quantities of Product ordered in the two fiscal quarters
immediately preceding the Product shortfall.
Event Reporting; Product Complaints.
the Term, the Parties shall keep each other promptly and fully informed of
of their pharmacological, toxicological and clinical trials, investigations
findings relating to the Product relevant to the Territory or the activities
the other Party. To
end, Alfacell and Par shall enter into a pharmacovigilance agreement to
coordinate the flow of safety information. Par shall forward all Adverse Events
reports or ISCRs received for the Product to Alfacell within five (5) calendar
days after receipt by Par. Format for Adverse Events reporting from Par to
Alfacell shall be a copy or facsimile of the source documentation. All event
information will be transmitted via fax or secure electronic mail. The
regulatory reporting time clock for submitting Adverse Events reports or ICSRs
to Alfacell is deemed to start on the date when any individual within Par is
first notified of a case report that fulfills the minimum criteria for a case
regard to the Product, Alfacell is responsible for preparing and submitting
aggregate and individual case regulatory safety reports within the Territory
required by any Governmental Authority. Alfacell shall also hold and maintain
reports of all Adverse Events, both serious and non-serious, in a database
the Product for preparing and submitting aggregate and single case reports
the FDA for the Product.
shall reasonably cooperate at its own expense.
shall be responsible for screening published scientific and medical literature
for Adverse Events or ICSRs. Par
responsible for notifying Alfacell of any relevant Adverse Events or ICSRs
may come to its attention in the Territory via local scientific or medical
journals, or unpublished scientific or conference papers. A copy of any such
documentation shall be provided at the same time as the report.
notify Alfacell within five (5) calendar days of any customer complaints that
relate to the Manufacture, Labeling or Packaging of the Product.
Compliance and QA Audits.
written request to Alfacell by Par or otherwise upon the reasonable request
Par and subject to the consent of Alfacell, not to be unreasonably withheld,
delayed or conditioned, Par may accompany Alfacell to a Third Party
Manufacturer’s Manufacturing facilities during normal business hours to discuss
any issues regarding Manufacturing and management personnel, and to review
inspect (i) the Manufacturing and storage facilities, (ii) the quality control
procedures, and/or (iii) any records and reports pertinent to the Manufacture,
disposition or transport of Product as may be necessary to evidence the Third
Party Manufacturer’s compliance with all applicable Regulatory Approvals for the
Manufacture of Product supplied to Par hereunder, including
with cGMP. Par may make such visits with Alfacell to the Third Party
Manufacturer’s Manufacturing facilities once per calendar year unless Par
identifies, during any such visit or as a result of any Form 483 received by
such Third Party Manufacturer, any defects or deficiencies provided in any
the foregoing clauses (i), (ii) or (iii) above, in which case Par may make
many subsequent visits to such facilities as are reasonably required to
determine whether such defects or deficiencies have been cured.
extent practicable, Alfacell shall notify Par within two (2) business days
to any inspection (of which Alfacell is aware) by the FDA or other regulatory
agency relating to Product or any Product-related facility that is involved
the supply of Product to Par hereunder and, within twenty-four (24) hours after
such inspection, shall furnish Par with a copy of all documentation, including
any Form 483 and the Third Party Manufacturer’s response thereto, relating to
such inspection. In addition, Alfacell shall notify Par within five (5) business
days of its receipt of any other written regulatory actions or communications
(other than ministerial, non-substantive communications) relating to the Product
or any Product-related facility that is involved in the supply of Product to
hereunder. The Parties shall confer with each other with respect to any response
regarding such action or communication and the best means to comply with such
action or communication, but the final response shall be within Alfacell’s final
of Product. In
event either Party believes a recall, field alert, product withdrawal or field
correction, may be necessary with respect to Product provided under this
Agreement, such Party shall immediately notify the other Party in writing.
Neither Party shall act to initiate a recall, field alert, Product withdrawal
field correction, without the express prior written approval of the other Party,
unless required by applicable law. Both Parties shall cooperate with one another
with respect to such recall, field alert, product withdrawal or field
correction. Alfacell shall be responsible for conducting any recall, field
alert, product withdrawal or field correction; provided,
the cost of any such recall, field alert, product withdrawal or field correction
shall be borne equally by the Parties, except to the extent such recall, field
alert, Product withdrawal or field correction is caused by a breach by either
Alfacell or Par of its respective warranties, representations or obligations
under this Agreement, the License Agreement or applicable law or its gross
negligence or willful misconduct, in which case such cost shall be borne by
responsible Party. For purposes hereof, such cost shall be limited to
reasonable, actual and documented costs incurred by the Parties for such recall,
field alert, product withdrawal or field correction, and for the replacement
the Product to be recalled. In the event of a recall, Par shall provide to
Alfacell copies of distribution records in its control and shall otherwise
reasonably cooperate with Alfacell in respect of any such recall.
require the Third Party Manufacturer to, comply
with all applicable present and future orders, regulations, requirements and
laws of any and all Governmental Authorities, including all laws and regulations
of such territories applicable to the transportation, storage, use, handling
disposal, of hazardous materials. Alfacell represents and warrants to Par that
it has and will maintain during the Term all governmental permits (including
health, safety and environmental permits) necessary for the conduct of the
actions and procedures that it
pursuant to this Agreement;
Alfacell or the Third Party Manufacturer ceases to hold such permits, licenses,
registrations and other forms of governmental authorizations, Alfacell or the
Third Party Manufacturer shall have a reasonable time to regain compliance
the foregoing requirements so long as during such time Alfacell is able to
supply Product to Par in accordance with this Agreement.
three (3) years after the termination of this Agreement, Alfacell shall keep
complete, accurate and authentic accounts, notes, data and records of the work
performed under this Agreement (including batch records), including by the
Party Manufacturer. Each Party shall maintain complete and adequate records
pertaining to the methods and facilities used for the Manufacture, processing,
testing, packing, Labeling, holding and distribution, of the Product in
accordance with all applicable domestic and foreign laws and regulations so
such Product may be used in humans.
shall retain samples of Product for the period and in quantities agreed by
Parties in the Quality Agreement.
represents and warrants that Product delivered hereunder will: (i) be
Manufactured in accordance with all applicable Regulatory Approvals (to the
extent applicable at the time of Manufacturing), relevant cGMPs and other
applicable U.S. laws, rules and regulations, as then in effect;
(ii) conform to the Product Specifications at the time of delivery; (iii)
be capable of maintaining conformity to said Product Specifications and
requirements when handled and stored in accordance with the Labeling until
applicable expiry date of such Product (assuming such expiry date is based
the accurate shelf life for Product); and (iv) not be misbranded or adulterated
under the law. WITHOUT LIMITING ALFACELL’S INDEMNIFICATION OBLIGATIONS UNDER
SECTION 12.1 WITH RESPECT TO THIRD-PARTY CLAIMS AND EXPENSES ARISING OUT
OF, OR RESULTING FROM, ALFACELL’S BREACH OF THE PRODUCT WARRANTY IN THIS SECTION
9.1, EXCEPT FOR WILLFUL MISCONDUCT OR GROSS NEGLIGENCE BY ALFACELL, ITS
AFFILIATES OR ITS THIRD PARTY MANUFACTURER OR ANY OF THEIR RESPECTIVE EMPLOYEES
OR AGENTS, ALFACELL’S EXCLUSIVE LIABILITY FOR ALFACELL’S SUPPLY OF DEFECTIVE
PRODUCT SHALL BE REPLACEMENT OF SUCH PRODUCT OR CREDIT THEREFOR.
WARRANTY SET FORTH IN THIS SECTION 9.1 IS VOID TO THE EXTENT PRODUCT FAILURE
DEFICIENCIES ARE ATTRIBUTABLE TO AN ACT OR OMISSION OF PAR, ITS AFFILIATES,
EMPLOYEES, AGENTS OR PERMITTED SUB-DISTRIBUTORS, OR ANY OF THEIR RESPECTIVE
EMPLOYEES OR AGENTS.
Debarred or Disqualified Persons.
and Par shall
not, and Alfacell shall require that the Third Party Manufacturer not,
employ, contract with or retain, any person, directly or indirectly, to perform
any services under this Agreement if such person: (a) is under investigation
the FDA for debarment or is presently debarred by the FDA pursuant to 21 U.S.C.
§ 335a or its successor provisions, or (b) has a disqualification hearing
pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70 or
provisions. In addition, Alfacell and Par each represents and warrants that
has not engaged in any conduct or activity which could lead to any of the
above-mentioned disqualification or debarment actions. If, during the Term,
Alfacell, Par or any person employed or retained by them, or employed or
retained by the Third Party Manufacturer, to perform under this Agreement
(i) comes under investigation by the FDA or other Governmental Authority
for a debarment action or disqualification, (ii) is debarred or
disqualified or (iii) engages in any conduct or activity that could lead to
any of the above-mentioned disqualification or debarment actions, Alfacell
Par, as the case may be, shall immediately notify the other Party of
Parties’ Representations and Warranties. Each
Party represents and warrants to the other that: (a) it is duly organized
and validly existing under the laws of its jurisdiction of incorporation, and
has full corporate or other power and authority to enter into this Agreement
to carry out the provisions hereof; (b) it is duly authorized to execute
and deliver this Agreement and to perform its obligations hereunder, and the
person or persons executing this Agreement on its behalf has been duly
authorized to do so by all requisite corporate actions; (c) this Agreement
is legally binding upon it, enforceable in accordance with its terms, and does
not conflict with any agreement, instrument or understanding, oral or written,
to which it is a party or by which it may be bound, nor violate any material
or regulation of any court, governmental body or administrative or other agency
having jurisdiction over it; and (d) it will conduct all of its activities
related to this Agreement in accordance with applicable laws, rules, regulations
and guidelines, including in respect of the commercialization of
of Liability. EXCEPT
RESPECT OF (A) ANY CLAIM RELATED TO THE WILLFUL MISCONDUCT OR GROSS NEGLIGENCE
OF A PARTY OR, INTENTIONAL BREACH OF A REPRESENTATION, WARRANTY OR OBLIGATION
A PARTY UNDER THIS AGREEMENT OR (B) ANY THIRD PARTY CLAIMS UNDER SECTION 12,
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE
INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL
ADVISED, SHALL HAVE OTHER REASON TO KNOW OR IN FACT SHALL KNOW OF THE
POSSIBILITY OF THE FOREGOING.
EXCEPT THE EXPRESS WARRANTIES SET FORTH IN SECTION 9, ALFACELL MAKES
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
STATUTE OR OTHERWISE, AND ALFACELL SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY
OF QUALITY, WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE OR WARRANTY OF NONINFRINGEMENT WITH RESPECT TO THE PRODUCT.
Party agrees to retain in strict confidence and not to disclose, divulge or
otherwise communicate to any Third Party any Confidential
of the other Party, whether received prior to or after the date hereof and
further agrees not to use any such Confidential Information for any purpose,
except pursuant to, and in order to carry out, the terms and objectives of
Agreement, except that each Party may disclose Confidential Information of
other Party to the officers, directors, employees, agents, accountants,
attorneys, consultants, subcontractors or other representatives of the receiving
Party or its Affiliates (the “Representatives”),
in each case, (a) need to know such Confidential Information for purposes
of the implementation and performance by the receiving Party of this Agreement
and (b) will use the Confidential Information only for such limited
purposes. Each Party hereby agrees to use at least the same standard of care
complying with its confidentiality obligations hereunder as it uses to protect
its own Confidential Information of comparable sensitivity and to exercise
reasonable precautions to prevent and restrain the unauthorized disclosure
such Confidential Information by any of its Representatives. Each Party warrants
that each of its Representatives to whom any Confidential Information is
revealed shall previously have been informed of the confidential nature of
Confidential Information and shall have agreed to maintain its confidentiality
under terms no less restrictive than those set forth in this Article 10.
Without limiting the generality of any of the foregoing, the Parties agree
to make any disclosure of Confidential Information that would be reasonably
likely to impair the Parties’ ability to obtain U.S. or foreign patents on any
patentable invention or discovery described or otherwise embodied in such
Confidential Information. The Confidential Information of each Party includes
information from Third Parties disclosed by one Party to this Agreement to
other Party to this Agreement.
Party may disclose Confidential Information belonging to the other Party to
extent such disclosure is reasonably necessary in the following
filings for Product as contemplated by the License Agreement;
to the Third Party Manufacturer to enable it to perform under this Agreement;
the Third Party Manufacturer agrees to be bound by terms of confidentiality
non-use comparable in scope to those set forth in this Article 10;
or defending litigation as permitted by the License Agreement;
extent necessary to perform its obligations under this Agreement and/or the
License Agreement; and
with applicable court orders or governmental regulations or inquiries, including
the listing standard of any national or international securities exchange.
the foregoing, in the event a Party is required to make a disclosure of the
other Party’s Confidential Information pursuant to Section 10.2.2 or 10.2.3, it
shall give, except
impracticable, reasonable advance notice to the other Party of such disclosure
and use efforts to secure confidential treatment of such information at least
diligent as such Party would use to protect its own confidential information,
but in no event less than reasonable efforts. In any event, the Parties agree
take all reasonable actions to avoid disclosure of Confidential Information
hereunder. The Parties shall consult with each other on the provisions of this
Agreement to be redacted in any filings made by the Parties with any regulatory
authority (such as the Securities and Exchange Commission) or as otherwise
required by law.
of this Agreement (the “Term”)
commence on the effective date of the License Agreement (the “Effective
shall end upon the expiration or
termination of the License Agreement (or upon earlier termination of this
Agreement, if such termination occurs before the expiration or termination
the License Agreement).
for Uncured Material Breach. Each
Party shall have the right to terminate this Agreement, upon written notice
the other as a result of a material breach of this Agreement by the other Party
that is not cured by the breaching Party within sixty (60) days (twenty (20)
business days in the event of an undisputed payment default) following written
notice of such breach by the non-breaching Party.
Expiration or Termination; Surviving Obligations.
expiration of the Term or the earlier termination of this Agreement pursuant
Section 11.1 or 11.2, all rights and obligations of the Parties under this
Agreement shall terminate, except as provided in this Section 11.3.
Expiration or termination of this Agreement shall not relieve the Parties of
obligation accruing prior to such expiration or termination. For a twenty-four
(24)-month period following the termination or expiration of this Agreement,
Alfacell’s obligations under Sections 8.1, 8.3, 8.4 and 8.6 shall remain in full
force and effect. Except as set forth below or elsewhere in this Agreement,
obligations and rights of the Parties under the following provisions of this
Agreement shall survive expiration or termination of this
– Financial Audit
– Effect of Expiration or Termination; Surviving Obligations
13 – Dispute Resolution
– General Provisions
by Alfacell. Alfacell
agrees to defend, indemnify and hold harmless Par
directors, officers and employees (each, a “Par
and against any and all claims, suits, actions, demands, liabilities, expenses
and/or loss, including reasonable legal expense and attorneys’ fees
which any Par Indemnitee may become subject as a result of any claim, demand,
action or other proceeding by any Third Party to the extent such Losses arise
directly or indirectly from (i) any material breach of this Agreement by
Alfacell (including any material breach of any of its warranties hereunder),
including any material breach of any warranty made by Alfacell on behalf of
Third Party Manufacturer; (ii) any mishandling of the Product by Alfacell or
Third Party Manufacturer before delivery of the Product to Par or (iii) the
gross negligence or willful misconduct of Alfacell, Alfacell Indemnitee or
Third Party Manufacturer, except, in each case, to the extent such Losses are
subject to indemnification pursuant to Section 12.2.
hereby agrees to defend, indemnify and hold harmless Alfacell and its directors,
officers and employees (each, an “Alfacell
and against any and all Losses to which any Alfacell Indemnitee may become
subject as a result of any claim, demand, action or other proceeding by any
Third Party to the extent such Losses arise directly or indirectly from (i)
material breach of this Agreement by Par (including any material breach of
of its warranties hereunder), including any material breach by a permitted
Sub–distributor of any obligation of Par hereunder, (ii) any mishandling of
the Product by Par or any act or omission of Par that causes the Product not
meet the Product warranties set forth herein after delivery to Par or
(iii) the gross negligence or willful misconduct of Par or a Par
Indemnitee, except, in each case, to the extent such Losses are subject to
indemnification pursuant to Section 12.1.
Alfacell Indemnitee or a Par Indemnitee (the “Indemnitee”)
intends to claim indemnification under this Article 12, it shall promptly
notify the other Party (the “Indemnitor”)
writing of any such alleged Losses promptly after it becomes aware of the basis
for such indemnification. The Indemnitor shall have the right to control the
defense thereof with counsel of its choice; provided,
such counsel is reasonably acceptable to Indemnitee; and, provided,
any Indemnitee shall have the right to retain its own counsel at its own
expense, for any reason, including if representation of any Indemnitee by the
counsel retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between such Indemnitee and any other Party
reasonably represented by such counsel in such proceeding. The Indemnitee,
employees and agents, shall reasonably cooperate with the Indemnitor and its
legal representatives in the investigation of any Losses covered by this
Article 12. The obligations of this Section 12.3 shall not apply to
amounts paid in settlement of any claim, demand, action or other proceeding
such settlement is effected without the consent of the Indemnitor, which consent
shall not be withheld, conditioned or delayed unreasonably. The failure to
deliver prompt written notice to the Indemnitor shall relieve the Indemnitor
any obligation to the Indemnitee of liability under this Section 12.3 to
the extent it is prejudiced thereby. It is understood that only Alfacell or
may claim indemnity under this Article 12
own behalf or on behalf of its Indemnitees), and other Indemnitees may not
directly claim indemnity hereunder.
shall require that the Third Party Manufacturer maintain, at its own expense,
general liability coverage appropriate to its activities with reputable and
financially secure insurance carriers to cover its activities related to this
Agreement. In addition, such insurance coverage shall include product liability
coverage in an amount not less than that commensurate with industry standards
for similar products, to be in place prior to the Initial Commercial Sale and
for the remainder of the Term. The Third Party Manufacturer shall provide a
certificate of insurance (or evidence of self-insurance) evidencing such
coverage to the other Party upon request. In addition, Alfacell shall have
maintain, at its own expense, general liability insurance coverage for the
manufacture, supply, use and sale of the Product as is reasonable, normal and
customary in the pharmaceutical industry generally and otherwise consistent
Article XII of the License Agreement.
Parties recognize that a bona fide
as to certain matters may, from time to time, arise during the Term that relates
to a Party’s rights and/or obligations hereunder. In the event of the occurrence
of such a dispute, either Party may, by written notice to the other Party,
such dispute referred to the respective officers designated below, or their
successors, for attempted resolution by good faith negotiation within thirty
(30) days after such notice is received. Such designated officers are as
MacPhee, President, Strativa Pharmaceuticals (a division of
event that the designated officers are not able to resolve the dispute within
such thirty (30)-day period, or such other period of time as the Parties
may mutually agree to in writing, the Parties shall attempt in good faith to
resolve such dispute in a voluntary, amicable and expeditious manner
through non-binding mediation in
York, New York under the International Institute for Conflict Prevention and
Resolution Mediation Procedure then currently in effect. Unless the Parties
agree otherwise, the mediator will be selected from the JAMS panel of
each Party shall bear its own costs.
dispute is not resolved within sixty (60) days from a Party’s written request
for mediation, there is no further obligation to mediate. If the
Parties are unable to resolve any dispute through mediation as set
forth in this Section 13.1, each Party shall have the right to pursue any
and all remedies available at law or in equity.
Law; Waiver of Jury Trial.
Agreement shall be governed by, and construed in accordance with, the laws
the State of New York without reference to any rules of conflicts of laws.
Parties hereby consent to the exclusive jurisdiction of the Federal and State
courts of New York and hereby waive any objection to venue or forum laid
therein. The Parties hereby agree that service of process by certified mail,
shall constitute personal service for all purposes hereof. The Parties expressly
reject the application of the United Nations Convention on Contracts for the
International Sale of Goods and all implementing legislation thereunder. EACH
PARTY HEREBY WAIVES ITS RIGHT TO A TRIAL BY JURY OF ANY CLAIM OR CAUSE OF ACTION
BASED UPON, ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS
CONTEMPLATED HEREBY, IN ANY ACTION, PROCEEDING OR OTHER LITIGATION OF ANY TYPE
BROUGHT BY ANY PARTY AGAINST THE OTHER, WHETHER WITH RESPECT TO CONTRACT CLAIMS,
TORT CLAIMS OR OTHERWISE. THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS,
RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT.
Agreement, together with the Exhibits attached hereto and incorporated herein,
constitutes the entire understanding and agreement of the Parties with respect
to the subject matter hereof and cancels and supersedes any and all prior
negotiations, correspondence, understandings and agreements, whether verbal
written, between the Parties with respect to the subject matter hereof. No
modification or amendment of any provision of this Agreement shall be valid
effective unless made in writing and signed by a duly authorized officer of
making and performing this Agreement, Par and Alfacell act and shall act at
times as independent contractors and nothing contained in this Agreement shall
be construed or implied to create an agency, partnership, joint venture or
employer and employee relationship between Alfacell and Par. Neither Party
legal representative of the other Party and at no time shall one Party make
commitments, create any obligations or incur any charges or expenses for or
the name of the other Party.
one (1) or more of the provisions of this Agreement are held by any court
or authority having jurisdiction over this Agreement or either of the Parties
be invalid, illegal or unenforceable, such provision or provisions shall be
validly reformed to as nearly as possible approximate the intent of the Parties
and, if unreformable, shall be divisible and deleted in such jurisdiction;
elsewhere, this Agreement shall not be affected so long as the Parties are
able to realize the principal benefits bargained for in this Agreement. The
failure of a Party to insist upon strict performance of any provision of this
Agreement or to exercise any right arising out of this Agreement shall neither
impair that provision or right nor constitute a waiver of that provision or
right, in whole or in part, in that instance or in any other instance. Any
waiver by a Party of a particular provision or right shall be in writing, shall
be as to a particular matter and, if applicable, for a particular period of
and shall be signed by such Party.
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their successors and permitted assigns; provided,
neither Party shall assign any of its rights and obligations hereunder without
the prior written consent of the other Party except to an Affiliate or as
incident to the merger, consolidation, reorganization or acquisition of stock
assets affecting substantially all of the assets or actual voting control of
assigning Party. Any assignment or attempted assignment by either Party in
violation of the terms of this Section 14.5 shall be null and void. In the
Change of Control of Par or Alfacell, the surviving entity shall promptly
confirm to Alfacell or Par, as applicable, in writing its obligation to abide
the terms and conditions of this Agreement, and shall meet with Alfacell or
as applicable, within thirty (30) days of such Change of Control to discuss
review continued performance under this Agreement.
Third Party Beneficiaries. This
Agreement is neither expressly nor impliedly made for the benefit of any party
other than those executing it other than as expressly provided in
notices given under this Agreement shall be in writing, addressed to the Parties
at the following addresses, and delivered by person, by facsimile followed
U.S. Mail, return receipt requested, or by FedEx or other reputable national
courier service. Unless specified otherwise herein, any such notice shall be
deemed to have been given as of the day of personal delivery, one (1)
business day after the date sent by facsimile service or on the day of delivery
to the other Party confirmed by the courier service.
the case of Alfacell:
Chief Executive Officer
a copy (which shall not
Kevin T. Collins, Esq.
the case of Par:
Lake, NJ 07677
General Counsel’s Office
a copy (which
Herrington & Sutcliffe LLP
R. King Milling, Jr., Esq.
Party may change its address for communications by a notice to the other Party
in accordance with this Section 14.7.
& Headings. The
captions and headings of clauses contained in this Agreement preceding the
of the articles, sections, subsections and paragraphs hereof are inserted solely
for convenience and ease of reference only and shall not constitute any part
this Agreement, or have any effect on its interpretation or
& Plural. All
references in this Agreement to the singular shall include the plural where
applicable, and all references to gender shall include both genders and the
Sections & Subsections. Unless
otherwise specified, references in this Agreement to any article shall include
all sections, subsections, and paragraphs in such article; references in this
Agreement to any section shall include all subsections and paragraphs in such
sections; and references in this Agreement to any subsection shall include
paragraphs in such subsection.
references to days in this Agreement shall mean calendar days, unless otherwise
and uncertainties in this Agreement, if any, shall not be interpreted against
either Party, irrespective of which Party may be deemed to have caused the
ambiguity or uncertainty to exist.
Agreement has been prepared in the English language and the English language
shall control its interpretation. In addition, all notices required or permitted
to be given hereunder, and all written, electronic, oral or other communications
between the Parties regarding this Agreement, shall be in the English
the context of this Agreement otherwise requires, (a) the terms “hereof,”
“herein,” “hereby” and other similar words refer to this entire Agreement; (b)
the terms “include,” “includes” or “including” shall be deemed to be followed by
the words “without limitation”; (c) the terms “US,” “U.S.,” “USA” and “United
States” refer to the United States of America and (d) references in this
Agreement to “Dollars” or “$” shall mean the legal tender of the
monetary amounts referenced in this agreement shall be denominated in United
States dollars or other legal currency of the United States.
Agreement may be executed in two (2) or more counterparts, each of which
shall be an original and all of which shall constitute together the same
document. Counterparts may be signed and delivered by facsimile, each of which
shall be binding when sent.
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WITNESS WHEREOF, the Parties hereto have caused this Supply Agreement to be
executed by their duly authorized representatives as of the Effective