Exhibit 10.33
CLOFARABINE MARKETING & DISTRIBUTION AGREEMENT
THIS CLOFARABINE MARKETING & DISTRIBUTION AGREEMENT (this
"Agreement"),
effective as of the 24th day of March, 2006 (the "Effective Date")
is between
Bioenvision, Inc., a Delaware corporation with its principal
offices located at
345 Park Avenue, 41st Floor, New York, New York 10154
("Bioenvision") and Mayne
Pharma Limited, an Australian corporation with its principal
offices located at
Level 21, 390 St. Kilda Road, Melbourne Victoria 3004 Australia
(the
"Distributor").
WITNESSETH
WHEREAS, Bioenvision is engaged in the development and manufacture
of
certain pharmaceutical products and the Distributor is engaged in
the business
of marketing and selling certain pharmaceutical products; and
WHEREAS, Bioenvision has the exclusive right to market and sell
the
Product (as hereinafter defined) in certain territories, including
the Territory
(as hereinafter defined); and
WHEREAS, the Distributor has substantial knowledge, experience
and
expertise in obtaining regulatory approvals and reimbursement
authorizations,
and making and selling therapeutic drugs in the Territory; and
WHEREAS, Bioenvision desires to engage the Distributor to seek
registration and, as required, reimbursement approval of the
Product in the
Territory; and
WHEREAS, Bioenvision desires to appoint the Distributor as the
exclusive
distributor of the Product in the Territory, and the Distributor
desires to
accept such appointment;
WHEREAS, Bioenvision desires to grant exclusive marketing rights
to
Distributor in the Territory, and the Distributor desires to accept
such grant;
NOW, THEREFORE, in consideration of the foregoing and the mutual
terms,
conditions and agreements set forth herein, Bioenvision and the
Distributor
hereby agree as follows:
1.
DEFINITIONS
As used in this Agreement, the singular includes the plural and
the
plural includes the singular, wherever so required by fact or
context. Titles
used in the Sections hereof shall be only for convenience and shall
not be
regarded as part of this Agreement. Schedule shall mean any
schedule to this
Agreement, each of them being made a part hereof. As used in this
Agreement, and
unless otherwise provided, the following terms shall have the
following
meanings:
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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"Act of Insolvency" means (1) filing a petition in voluntary
bankruptcy
or making an assignment for the benefit of creditors or consenting
to the
appointment of a receiver of all or any substantial part of the
property of a
party, or filing a petition to take advantage of any debtors act;
(ii) the
commencement against a party of any case, proceeding or other
action seeking the
adjudication of such party as bankrupt by a court of competent
jurisdiction or
the appointment by such a court of a trustee or receiver or
receivers of such
party or of all or any substantial part of the property of such
party upon the
application of any creditor in any insolvency or bankruptcy
proceeding or other
creditor's suit, which case, proceeding or other action is not
dismissed within
sixty (60) days of its commencement; or (iii) any event or act
analogous to any
of these.
"Affiliates" of a party means persons or entities that directly,
or
indirectly through one or more intermediaries, control or are
controlled by or
are under common control with such party. The term "control" means
the
possession, directly or indirectly, of the power to direct or cause
the
direction of the management and policies of an entity, whether
through the
ownership of voting securities, by contract or otherwise.
"Competitive Products" means any products, other than the Products,
that
contain clofarabine as their active ingredient.
"Distributor's Warehouse" means the warehouse of the Distributor
located
at 1 Lexia Place, Mulgrave, Victoria, Australia, or such other
place as the
Distributor determines that is acceptable to Bioenvision.
"Dossier" means the then-current EU Common Technical Document for
a
Product;
"Effective Date" means the date the last party properly executes
this
Agreement.
"EMEA" means the European Medicines Agency or any successor body
or
organization.
"Event of Default" means (the party with respect to which such an
event
relates being referred to herein as a "Defaulting Party") any
failure of the
Defaulting Party (except where such failure is caused by or a
direct result of
an Event of Default by the other party) to observe and perform any
material
covenant or agreement contained in this Agreement for a period of
thirty (30)
days after receipt by the Defaulting Party of notice thereof from
the other
party.
"Extension Term(s)" means the period or periods, if any, during
which
the Initial Term is extended by the Distributor in accordance
herewith.
"Generally Accepted Accounting Principles" or ("GAAP") means
the
principles, basic concepts and conventions used and set by the
Financial
Accounting Standards Board in the United States of America.
"GMP" has the meaning provided under the GMP Agreement.
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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"GMP Agreement" means an agreement in relation to the quality
issues
relating to the Product.
"Gross Sales" means the gross amount invoiced by the Distributor
for
Sales of Product, other than amounts invoiced by the Distributor to
its
Affiliates, but such amount shall include the subsequent sale to
Third Parties
by any such Affiliate.
"Indication" means any one of the Initial Indications or the
Optional
Indications for which Distributor has exercised its option under
Section 3.2(a),
and "Indications" means more than one of either or both of the
Initial
Indications and such Optional Indications.
"Initial Indication" means use of the Product for treatment of
acute
lymphoblastic leukemia, acute myeloid leukemia in children and
adults, and as
first-line treatment for acute myeloid leukemia in adults.
"Initial Term" means the period beginning on the Effective Date
and
continuing until the [****] anniversary of the Effective Date,
unless terminated
earlier in accordance with the provisions of Section 14.
"Marketing Plan" has the meaning ascribed to it in Section
10.1(a).
"Net Sales" means Gross Sales less the sum of (i) credits or
allowances
given or made for rejection or return of previously sold Products,
(ii) sales,
use, value-added and similar retail taxes charged to the purchaser
and
specifically identified on the invoice or other documentation
related to the
Sale and (iii) charges for freight and insurance directly related
to the
distribution of Products to the extent reflected on the invoice
issued by
Distributor.
"New Indication" means any indication for the Product other than
those
that are included within the Indication.
"Optional Indications" means use of the Product for treatment of
any of
the following conditions or diseases: chronic lymphoblastic
leukemia, chronic
myeloid leukemia, acute promyelocytic leukemia, myeloproliferative
and
myelodysplastic syndromes, multiple myeloma and non-hodgkins
lymphoma.
"Pharmacovigilance Agreement" means an agreement in relation to
the
pharmacovigilance issues relating to the Product.
"Product" means clofarabine supplied to the Distributor by
Bioenvision
under this Agreement, in oral and injectable formulations, as
further described
in the Specifications.
"Registration Approval" means the approval for each Product issued
by
the Regulatory Authorities that is required for the commercial sale
of such
Product in the Territory. Registration Approval shall not include
Reimbursement
Approval.
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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"Regulatory Authorities" means the Therapeutic Goods Administration
in
Australia and Medsafe in New Zealand, in each case, including any
successor or
equivalent authority thereto, if applicable.
"Reimbursement Approval" means the approval of the Reimbursement
Price
for each Product as established by the Australian Pharmaceutical
Benefits
Scheme. Reimbursement Approval shall not include Registration
Approval.
"Reimbursement Price" means the government reimbursement price
established, approved and as modified from time to time by the
Australian
Pharmaceutical Benefits Scheme for the Product within
Australia.
"Sale(s)" (or "Sold") means any gift, grant, sale, assignment,
transfer,
conveyance or other disposition of the Product by the Distributor
or any of its
Affiliates to another party (other than for quality assurance or
control
purposes); provided however, that Sales shall not include
distribution of
samples of the Product without charge to physicians, hospitals or
clinics for
promotional or research purposes as set forth in the Marketing
Plan.
"Sales Reports" has the meaning ascribed to it in Section
10.1(c).
"Specifications" means the specifications for Product set forth
in
Schedule A as amended from time to time in accordance herewith.
"Term" means the Initial Term plus any Extension Term(s), if
applicable.
"Territory" means Australia and New Zealand.
"Third Party" means any person other than the parties to this
Agreement
and their Affiliates.
"Trademarks" means the trademarks, service marks, trade names and
logos
used on or in connection with the identification or marketing of
the Product
listed on Schedule B hereto and any additional trademarks, service
marks, trade
names and logos that are approved by the Parties.
"Unit of Product" means the standard outer package for the
Territory
labeled in accordance with applicable laws and the Registration
Approval,
initially containing four (4) vials of Product, a package insert
and the
components contained in Bioenvision's standard package for markets
outside North
America (and such other components as the parties may mutually
agree to include
due to regulatory requirements in the Territory).
1A.
EARLY TERMINATION
This Agreement shall be subject to termination by Distributor, by
written notice
to Bioenvision provided within sixty (60) days following the
Effective Date, if
Distributor is not satisfied with
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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the results of its due diligence efforts conducted during such
period, or if the
GMP Agreement and Pharmacovigilance Agreements are not executed by
both parties
during such period.
2. PROJECT
MANAGEMENT
2.1 Project Managers. No later than thirty (30) days after the
Effective
Date, Bioenvision and the Distributor shall each appoint a project
manager to be
responsible for coordinating between the parties all issues related
to
regulatory affairs, medical affairs, marketing, logistics,
distribution,
forecasting, and any other activities contemplated in relation to
the
commercialization of the Product in the Territory. Each party shall
ensure that
its project manager is well informed about all relevant
Product-related
activities within its organization and shall delegate to its
project manager
authority to, and responsibility for, identifying and resolving
within such
party's organization all issues related to the marketing and
distribution of the
Product as contemplated by this Agreement.
2.2
Meetings. The
Project Managers shall:
(a) review
and advise on the Marketing Plans submitted by the
Distributor, and review and comment on sales and marketing
strategies for the Product (including launch plans for the
Product);
(b) review
and comment on the overall strategy for training,
advertising and promotional materials to be used in the
Territory;
(c) review
and advise on the publications to be used in the
Territory;
(d)
discuss appropriate medical conferences and meetings in
the Territory at which the Product should be represented;
(e)
discuss any improvements to the Product planned to be made
by Bioenvision, including new formulations or dosage
regimens, but excluding new indications; and
(f)
perform such other functions as the parties may decide are
appropriate to further the commercial success of the
Product in the Territory and the purposes of this
Agreement, including the periodic evaluation of actual
performance against performance objectives.
The Project Managers shall meet at such times and places as it may
determine,
but no less frequently than once per calendar year commencing with
the second
calendar year after the Effective Date. The Project Managers may
meet in person
or by video or teleconference (if practical), and individual
members may
participate in any of the foregoing ways. All costs of
participation by each
Project Manager shall be borne by the party appointing such
person.
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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3.
REGISTRATION APPROVAL; REIMBURSEMENT APPROVAL.
3.1 Registration Approval; Reimbursement Approval. Distributor has
the
exclusive right and obligation to apply for, obtain and maintain
(subject to
Section 3.5(a) below), on trust for the benefit of Bioenvision, the
Registration
Approval and Reimbursement Approval for the Initial Indications,
and, to the
extent it exercises its option hereunder to any Optional
Indications, then for
such Optional Indications as well, for the Product in the
Territory. Subject to
the terms and conditions hereof, the Distributor shall make all
required
submissions for Registration Approval and Reimbursement Approval
for the Initial
Indications in the Territory provided that the Distributor has no
obligation to
make the first submission for Registration Approval until it has
received
Dossiers under Section 3.2(a) for both pediatric Acute
Lymphoblastic Leukemia
and adult Acute Myeloid Leukemia, and if such approvals are granted
by the
Regulatory Authorities, during the Term of this Agreement, maintain
in effect
such Registration Approval and Reimbursement Approval. Distributor
shall seek
such Registration Approval and Reimbursement Approval for each type
of cancer
within the Optional Indications at its own option and will notify
Bioenvision in
writing if it chooses to exercise such option. Distributor must
notify
Bioenvision whether it chooses to exercise such option over the
Optional
Indications within ninety (90) days of receipt of the relevant
Dossier from
Bioenvision as set out in section 3.2(a). In the event that
Distributor
exercises option, then the relevant Optional Indication shall be
deemed to be
included with the "Indications" for all purposes hereunder. In the
event the
Distributor does not exercise such option within the period
referred to above,
Bioenvision shall be free to seek such Registration Approval and
Reimbursement
Approval through its Affiliate, or to discuss with, and grant to, a
Third Party
rights to import, promote, market, distribute and sell Products for
the Optional
Indication in the Territory, provided that it shall not enter into
such a deal
with a Third Party on payment terms that are more favourable to the
Third Party
than the terms last offered to the Distributor.
3.2 Bioenvision Obligations. Bioenvision shall perform the
following
obligations following the Effective Date:
(a)
Bioenvision shall provide the Distributor with copies of
the Dossier assembled to obtain or update regulatory
approval by, and submitted to, the EMEA by Bioenvision for
each Indication no later than thirty (30) days after such
submission has taken place;
(b)
Bioenvision shall, in June and December of each year,
provide the Distributor with clinical and marketing
updates from major markets outside the Territory as
reasonably necessary to support marketing of the Product
and applications for Registration Approval and
Reimbursement Approval; and
(c)
Bioenvision shall provide additional information regarding
the Product that it may possess, to the extent useful in
connection with marketing of the Product and obtaining or
maintaining the Registration Approval or Reimbursement
Approval; provided however, that Bioenvision shall have
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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no obligation to perform additional pre-clinical or
clinical studies or data analysis in connection with this
obligation.
(d) Prior
to the submission by Distributor of an application
for Registration Approval by Distributor within the
Territory, Bioenvision is free to alter the Specification
or Dossier in relation to the Product or any Indication in
the Territory, provided that Bioenvision shall provide
reasonably prompt notice of same, and an updated Dossier
reflecting such changes, to Distributor after making such
alteration. After the submission by Distributor of an
application for Registration Approval within the Territory
but prior to approval of such application, Bioenvision
shall not alter the Specification or Dossier in relation
to the Product or any Indication in the Territory, except
that it may improve the Specification or Dossier during
such period provided it gives reasonable prior notice to
Distributor. After the submission by Distributor of an
application for Registration Approval within the Territory
and the approval of such application, Bioenvision shall
not alter the Specification or Dossier in relation to the
Product or any Indication in the Territory, without the
prior written approval of the Distributor, which approval
shall not be unreasonably withheld.
(e) If
Bioenvision applies for registration approval or any
amendment to any registration approval for an improvement
to the Product, including new formulations or dosage
regimens, but excluding new indications, in any country
outside the Territory, Bioenvision will immediately notify
the Distributor and provide the Distributor with the
option, which the Distributor may exercise at its own
discretion, to apply for or amend the Registration
Approval and
sell such improved version of the Product,
and in which case the parties will amend the
Specifications as required.
3.3 Costs. Distributor shall pay all costs and fees incurred in
connection with obtaining and maintaining the Registration Approval
and
Reimbursement Approval for the Product in the Territory, including
without
limitation, regulatory evaluation fees, maintenance fees and costs,
and costs of
local expert reports, but excluding expenses incurred by
Bioenvision for
performing the obligations described in Section 3.2 above.
3.4
[****]
3.5 Regulatory Support Services. The Distributor shall apply for
the
Registration Approval and the Reimbursement Approval (and, if
necessary in New
Zealand, in the name of such Affiliate) subject to the following
conditions.
(a) The
Distributor hereby agrees to transfer, or cause to be
transferred, the Registration Approval and Reimbursement
Approval obtained by it in respect of the Product in
written form and by means of providing, or
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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causing to be provided, to Bioenvision (or its designee)
an assignment of all of Distributor's right, title and
interest in and to all such Registration Approvals and
Reimbursement Approvals, as well as any applications
therefor,and all submitted data including without
limitation all data on Specifications, toxicology, AME,
clinical investigations etc, and all other documents,
undertakings, authorizations and approvals necessary for
the importation into and sale of the Product in the
Territory., within sixty (60) days from the date of
termination or expiration of this Agreement, but not
before the Distributor has disposed of all Product in its
possession to the extent provided under Section 14.5 and,
furthermore, agrees to provide free of charge full
cooperation to Bioenvision or its duly qualified designee.
If such termination is by Distributor under Section
14.4(c), and the effective date of such termination occurs
before the end of the second year of the Term, then
Bioenvision shall reimburse Distributor for all reasonable
out-of-pocket costs and fees it incurred in obtaining such
Registration Approvals and Reimbursement Approvals. If
such termination is by Distributor under Section 14.4(c),
and the effective date of such termination occurs before
the end of the third year of the Term, then Bioenvision
shall reimburse Distributor for fifty percent (50%) of all
reasonable out-of-pocket costs and fees it incurred in
obtaining such Registration Approvals and Reimbursement
Approvals. If such termination is by Distributor under
Section 14.4(c), and the effective date of such
termination occurs before the end of the fourth year of
the Term, then Bioenvision shall reimburse Distributor for
twenty-five percent of all reasonable out-of-pocket costs
and fees it incurred in obtaining such Registration
Approvals and Reimbursement Approvals. Under all other
circumstances, such transfer of rights shall be promptly
conducted by the Parties at their own expense; and
(b) The
Distributor shall provide, or cause to be provided, to
Bioenvision: (i) notice and a prior written copy of any
material filings in connection with the Registration
Approval or the Reimbursement Approval, (ii) prompt notice
of any other filings so made, (iii) immediate notice and a
copy of all material correspondence from the Regulatory
Authorities concerning the Registration Approval or
Reimbursement Approval, and (iv),a complete copy of each
application for Registration Approval prepared for
submission by or on behalf of the Distributor for a
Product and ten (10) business days to make comments
regarding such application prior to filing, which comments
shall be considered in good faith by the Distributor, and
(v) a complete copy of each application for Reimbursement
Approval prepared for submission by or on behalf of the
Distributor for
a Product, and twenty (20) business days
to make comments regarding such application prior to
filing, which comments shall be considered in good faith
by the Distributor.
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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3.6 Plant Inspection. Bioenvision shall use commercially
reasonable
efforts to obtain for the Distributor and/or its designee, the
right, upon
reasonable notice and during normal business hours, to inspect
Bioenvision's or
its contract manufacturer's facilities and operations where Product
is
manufactured and stored, at the Distributor's cost and expense.
Bioenvision and
Distributor acknowledge that Bioenvision cannot provide the
Distributor with
such rights under current agreements with Bioenvision's contract
manufacturers.
Bioenvision shall also provide Distributor with copies of such
inspection
reports (whether prepared by a Regulatory Authority, Bioenvision or
a Third
Party), relating to such facilities, as it shall have the right to
disclose to
Distributor during the Term.
4.
DISTRIBUTION AND MARKETING RIGHTS
4.1 Appointment. Subject to the terms and conditions hereof,
Bioenvision
hereby appoints the Distributor as its exclusive distributor, on a
royalty-free
basis, and grants the Distributor the exclusive right to market,
sell and
distribute the Product in the Territory for the Indications, and
the Distributor
hereby accepts such appointment during the Term.
4.2 Resale Restrictions. During the Term, the Distributor and
its
Affiliates shall not, directly or indirectly, through one or a
series of
transactions, market, sell or promote for sale Product: (i) outside
of the
Territory, (ii) obtained from any source other than Bioenvision, or
(iii) with
the use of any trademark or brand other than one of the Trademarks.
During the
Term, the Distributor and its Affiliates shall not, directly or
indirectly,
market or promote for sale Product for any indication other than
the
Indications.
4.3 Resale Pricing. Distributor shall set the price and terms for
resale
of the Product within the Territory provided that Distributor and
its Affiliates
shall not: (i) discount the price charged for the Products in order
to promote
the sale of other products, or (ii) sell the Products for
consideration other
than valid currency. Distributor and its Affiliates shall conduct
all price
negotiations, and make all sales, on an arm's-length basis and
shall not resell
the Product to its Affiliates or agents, for the purpose of
decreasing the
amount payable hereunder, or otherwise, other than any sales that
are necessary
to its Affiliate in New Zealand in order to effect sale and
distribution in that
country.
**** Material omitted pursuant to a request for confidential
treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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4.4 Appointment of Subdistributors; Wholesalers. Distributor shall
not
sell the Product through subdistributors, other than an Affiliate
in New Zealand
(and only so long as such party remains an Affiliate of
Distributor), without
the prior written consent of Bioenvision. If Bioenvision consents
to such sales,
Distributor shall be and remain fully liable and responsible to
Bioenvision for
the activities of the subdistributor. Notwithstanding the
foregoing, Distributor
shall be entitled to enter into such agreements with drug
wholesalers, on an
arm's-length basis, in order to distribute and sell the Products in
the
Territory, it being understood that the designation of such
wholesalers shall be
the sole responsibility of the Distributor. Bioenvision shall not
have any
obligations towards such wholesalers either during the Term of this
Agreement or
after its termination.
4.5 Sale of Competitive Products. In consideration of, and as a
continuing condition of, the grant and retention of the rights
granted under
Section 4.1 to the Distributor, the Distributor and its Affiliates
shall not
import, sell and/or distribute in the Territory any Competitive
Products during
the Term.
4.6 New Indications; Right of First Offer. During the Term of
this
Agreement, if Bioenvision obtains regulatory approval from the EMEA
for a New
Indication for the Products, then Bioenvision shall, within thirty
(30) days of
such filing, notify the Distributor of such New Indication, such
notification to
include a copy of the Dossier submitted to the EMEA, and shall
offer to discuss
with the Distributor the grant of exclusive import, promotion,
marketing,
distribution and sale rights to the Distributor in the Territory
for such New
Indication, prior to discussing the same with any Third Parties.
Any grant of
rights to the Distributor shall be subject to agreement between
Bioenvision and
the Distributor of mutually satisfactory terms and conditions. In
the event the
Distributor is not interested in, or unable to reach agreement with
Bioenvision
within ninety (90) days following notification from Bioenvision as
referred to
above on the terms and conditions for the grant of exclusive rights
to the New
Indication, Bioenvision shall be free to discuss with, and grant
to, a Third
Party rights to import, promote, market, distribute and sell
Products for the
New Indication in the Territory.
5.
SALES, ORDERS AND
SHIPMENTS OF PRODUCT
5.1 Sales. Subject to the grant of Registration and
Reimbursement
Approvals, Bioenvision shall deliver the Product to the Distributor
for sale in
Units of Product, and the Distributor shall order the Product
exclusively from
Bioenvision in Units of Product.
5.1A Samples. Prior to the grant of Registration Approval
Distributor
shall be entitled to order, on an as needs basis, Product labeled
in accordance
with the relevant requirements of the EMEA ("EU Labeled Product"),
and
Bioenvision will deliver such EU Labeled Product to the Distributor
within
thirty (30) days of receipt of such order. The price for EU Labeled
Product will
be as set out in section 6.2, except that the Distributor will
reimburse
Bioenvision the cost of transport to the Distributor's
Warehouse.
5.2 Forecasts; Orders. Except as provided in Section 5.1A, the
Distributor shall order the Product from Bioenvision no more than
once per
calendar quarter, and subject to the
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treatment under
Rule 24b-2 of the Exchange Act of 1934. Material filed separately
with the
Securities and Exchange Commission.
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limitations set forth below, Bioenvision shall supply the Units of
Product to
the Distributor, in such quantities as are ordered by the
Distributor. On or
before the fourth day of each month immediately preceding the
commencement of a
new calendar quarter during the Term, Distributor shall provide a
twelve (12)
month, rolling quarterly forecast of the Distributor's forecast
requirements for
each Product that is then for sale in the Territory or that the
Parties
anticipate will be launched in the Territory in the next twelve
(12) months,
such forecasts to be developed by the Distributor in good faith
using the best
available information ("Forecasts"). Such Forecasts shall be
communicated in
writing to Bioenvision. Such Forecasts shall cover the next four
full
consecutive calendar quarters and shall be updated quarterly by the
Distributor
on a rolling basis. The first six months of each Forecast shall be
considered as
the firm forecast ("Firm Forecast"). Total Units forecast for the
second quarter
of any Firm Forecast shall not deviate by more than [****] from the
immediately
preceding Forecast for such calendar quarter. Purchase orders shall
provide for
at least ninety (90) days before requested delivery, unless the
Parties are able
to agree upon an early delivery date if requested by the
Distributor ("Delivery
Date") of the Units of Product ordered.
5.3 Shipment. Bioenvision shall ship such quantities of the Product
to
the Distributor as the Distributor shall order by the requested
Delivery Date,
subject to the limitations set forth below. If due to an force
majeure event as
described in Section 15.6, Bioenvision is unable to supply Product
to meet the
needs of all of its customers and distributors, including orders
placed by
Distributor in accordance with this Agreement, then Bioenvision
reserves the
right to allocate to the Distributor such portion of the available
supplies as
Bioenvision shall determine in its sole discretion to minimize
patient safety
concerns. Bioenvision acknowledges that the Distributor shall be
released from
any obligations hereunder to maintain minimum stock of the Product,
if
Bioenvision does not supply sufficient quantities of the Product to
enable the
Distributor to discharge such obligations.
5.4 Delivery Shipments of the Product to the Distributor's
Warehouse
shall be by CIP Incoterms 2000. Shipments shall be accompanied by a
legible
certificates of analys
