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
000 Xxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000 ("Bioenvision") and Mayne
Pharma Limited, an Australian corporation with its principal offices located at
Xxxxx 00, 000 Xx. Xxxxx Xxxx, Xxxxxxxxx Xxxxxxxx 0000 Xxxxxxxxx (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:
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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 0 Xxxxx Xxxxx, Xxxxxxxx, Xxxxxxxx, Xxxxxxxxx, 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.
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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-xxxxxxxx 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.
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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
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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.
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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
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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
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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.
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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.
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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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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 analysis and documents showing the origin of the Products
shipped. The Distributor shall be responsible for paying all costs associated
with storage and handling of the Products at the Distributor's Warehouse and
handling and transportation costs associated with transportation to other
warehouses.
5.5 Quality Control and Storage. Upon delivery, Distributor shall
promptly cause the Products to be unloaded and inspected. Distributor shall
store and transport the Products in accordance with the procedures specified by
Bioenvision and the Registration Approvals. In all cases, the Distributor shall
comply with the information and recommendations communicated in writing by
Bioenvision to the Distributor and with all applicable laws, rules and
regulations concerning the labeling, packaging, warehousing and distribution of
Products.
6. PAYMENTS
6.1 Milestone Payments. Distributor shall give prompt notice to
Bioenvision of the achievement of each of the following milestone events,
following which Bioenvision shall issue.
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the Distributor with an invoice for the applicable milestone payment. Both
parties acknowledge that nothing in this Agreement obliges the Distributor to
achieve any or all of Milestones 6 to 11, and that any attempt to achieve such
Milestone(s) is solely at the Distributor's discretion. In consideration of the
rights granted herein, in particular the rights granted under clause 4.1 herein,
Distributor shall pay the following amounts to Bioenvision within thirty days
after receipt of the invoice for each applicable milestone payment referred to
above.
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Milestone Event Milestone Payment
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1 [****] [****]
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2 [****] [****]
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3 [****] [****]
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4 [****] [****]
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5 [****] [****]
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6 [****] [****]
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7 [****] [****]
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8 [****] [****]
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9 [****] [****]
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10 [****] [****]
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11 [****] [****]
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[****]
6.2 Purchase Price for Product. After the first sale by Distributor of
Product, Distributor shall commence making quarterly payments to Bioenvision of
the purchase price for the Product as set forth in this Section 6.2. Not later
than each May 31, August 31, November 30 and February 28, the Distributor shall
pay to Bioenvision [****] as payment for the Products sold hereunder by
Bioenvision to Distributor. Such payment shall be made in Australian Dollars and
by wire transfer of immediately available funds in accordance with instructions
to be provided by Bioenvision.
Bioenvision shall have the right to audit the records to be
retained and that support the reports to be provided under this Agreement by
Distributor to Bioenvision, including without limitation, the Sales Reports, on
an annual basis, at Bioenvision's sole cost and expense,
**** 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.
12
provided, however, if any such audit shall reveal that Distributor has underpaid
Bioenvision amounts due hereunder for any period by in excess of five percent,
(5%), then the costs of such audit shall be reimbursed by Distributor to
Bioenvision along with the amount that was due and owing and interest thereon.
6.3 Terms of Payment. Bioenvision and Distributor agree that GST on any
taxable supply made by Bioenvision under this Agreement will be payable by
Distributor pursuant to Section 83 of the A New Tax System (Goods and Services)
Xxx 0000. All payments due under this Agreement are to be made without reduction
for taxes (except withholding taxes or other taxes for which the recipient party
may claim any tax credit or other double tax relief), duties and such other
amounts that are or may be imposed by any national, municipal or other
government agency or authority. If any such reduction is required to be made,
the gross payment due to Bioenvision shall be increased such that the net amount
received after the required reduction shall equal the amount specified herein.
Any late payments shall bear interest at the rate of one percent (1%) per month
compounded annually. Payment of such interest shall be in addition to any other
remedies available hereunder to Bioenvision.
7. OBLIGATIONS REGARDING SALES OF PRODUCT
7.1 Distributor Obligations. The Distributor hereby agrees to use
commercially reasonable efforts to market, sell and distribute the Products in
the Territory, including without limitation the following:
(a) promote the sale of the Product in the Territory, in
particular in hospitals and clinics and prepare
promotional materials and advertising in all relevant
local languages;
(b) establish and maintain a well-trained sales force for the
Product (together with a well-trained support staff)
adequate to service all of the Distributor's customers and
to promote the sale of the Product in the Territory; and
keep the sales force knowledgeable and fully informed as
to the Products and Bioenvision's policies as communicated
to the Distributor in writing;
(c) enable a prompt delivery service compatible with good
business practice, the nature of the Products, and the
requirements of its customers;
(d) ensure that the transportation and storage of the Product
shall preserve the quality of the Products;
(e) maintain a permanent stock of the Product of at least
three (3) months supply (based on Distributor's forecast
pursuant to Section 5.2 above);
(f) sell the Product in the Territory only in containers
approved by Bioenvision, with labels and packaging
approved by Bioenvision;
**** 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.
13
(g) promptly advise Bioenvision in writing of all material
laws, rules and regulations of the Territory of which the
Distributor has knowledge and which are relevant to
Bioenvision for the performance of its obligations under
this Agreement;
(h) obtain and maintain all material licenses, appraisals and
permits necessary for the Distributor to perform its
obligations under this Agreement;
(k) notify Bioenvision immediately upon its becoming aware of
any material occurrence of disparagement of any of the
Products or infringement of any rights relating to the
Product in the Territory;
(l) comply with all applicable anti-corruption laws in effect
in the Territory;
(m) make no safety or performance claim in respect of the
Product which has not been previously approved by the
Regulatory Authorities;
(n) establish and maintain suitable systems and records
(including lot numbers of the Products sold and the
purchasers of the Products) to enable a recall of Products
in a timely, efficient and accurate manner and otherwise
in accordance with applicable laws and regulations.
(p) obtain and maintain during the term of this Agreement
product liability insurance to cover all its potential
liabilities under this Agreement and in connection with
the distribution of Products, in an amount which shall
exceed [****] per incident and provide to Bioenvision, no
later than thirty (30) days following the Effective Date,
a certificate of its current product liability insurance
policy(is) providing such coverage; and
7. 1A Distributor Representation and Warranty. Distributor represents
and warrants that (i) it has the authority and right to enter into and perform
this Agreement, (ii) no authorization, consent or approval of, or any filing or
registration with, any governmental authority or regulatory body (other than as
contemplated by this Agreement) is required for the execution, delivery and
performance of this Agreement, and (iii) the execution, delivery and performance
of this Agreement will not conflict with the terms of any other agreement to
which it is or becomes a party or by which it is or becomes bound.
7.2 Commencement of Sales. The Distributor shall commence the sale of
the Product in the Territory within three (3) months following the date on which
the Reimbursement Approval for the Product is granted in the Territory and no
later than five (5) years following the Effective Date, and in the event the
Distributor fails to do so, Bioenvision shall be entitled to terminate this
Agreement pursuant to Section 14.4, such right to terminate to expire as soon as
the Distributor commences the sale of the Product in the Territory.
**** 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.
14
7.3 Bioenvision Obligations; Warranties; Limitation of Liability.
(a) Bioenvision warrants that all of the Products sold to the
Distributor hereunder:
(i) shall be manufactured in accordance with GMP (as
evidenced by a certificate of analysis or other comparable
document accompanying shipments of Products from
Bioenvision, or its contract manufacturer, to the
Distributor), the GMP Agreement, and in accordance with
all applicable laws and regulations in the country of
manufacture and the Territory;
(ii) shall be of merchantable quality and manufactured at
a facility approved by a competent authority (including
the United States Food and Drug Administration or EMEA)
that is recognized by the Regulatory Authorities;
(iii) with respect to the remaining shelf life of Product
at the time of delivery: (A) Bioenvision will use
commercially reasonable efforts to ensure that, if
delivered prior to Registration Approval is granted,
Product shall have at least six (6) months of remaining
shelf life; (B) Bioenvision will use commercially
reasonable efforts to ensure that, if delivered during
calendar year 2007 (provided Registration Approval has
been granted) shall have at least eighteen (18) months of
remaining shelf life; and (C) Product delivered after
calendar year 2007 (provided Registration Approval has
been granted) shall have at least twenty four (24) months
of remaining shelf life;
(iv) shall for the duration of shelf life meet all of the
Specifications, except to the extent such failure to meet
such Specifications arose out of a failure by Distributor,
its Affiliates or their customers to use proper handling
and storage procedures with respect to the Product.
(b) Bioenvision shall comply with the Foreign Corrupt
Practices Act of 1977, as amended, of the United States of
America and all applicable laws in effect in the
Territory. The Distributor will respond to inquiries from
Bioenvision regarding compliance with this Act.
(c) Bioenvision shall provide the Distributor with sample form
of promotional materials and educational materials
relating to the Product from time to time during the Term.
(d) Bioenvision shall obtain and maintain during the term of
this Agreement product liability insurance to cover all
its potential liabilities under this Agreement and in
connection with the manufacture and supply of the
**** 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.
15
Products to the Distributor, in an amount which shall
exceed [****] per incident and provide to the Distributor,
no later than thirty (30) days following the Effective
Date, a certificate of its current product liability
insurance policy(is) providing such coverage.
(e) Bioenvision represents and warrants that (i) it has the
authority and right to enter into and perform this
Agreement, (ii) no authorization, consent or approval of,
or any filing or registration with, any governmental
authority or regulatory body (other than as contemplated
by this Agreement) is required for the execution, delivery
and performance of this Agreement, (iii) the execution,
delivery and performance of this Agreement will not
conflict with the terms of any other agreement to which it
is or becomes a party or by which it is or becomes bound
and (iv) Bioenvision has sufficient right, title and
interest (through ownership, license grant or otherwise)
to the copy rights and trade secrets covering the
information in the Dossier and the patent rights listed on
Schedule C to grant the rights granted hereunder to
Distributor.
Except as expressly set forth in Section 7.3(a), Bioenvision does not
make and shall not be liable to the Distributor for any warranty whatsoever,
express or implied, in respect of the Products, including without limitation any
warranties of fitness for a particular use or purpose. Subject to Bioenvision's
indemnification obligations under Section 12.1, Bioenvision's liability to the
Distributor for breach of the warranty set forth in Section 7.3(a) shall be
limited to replacement of nonconforming Product pursuant to Section 7.5(a).
7.3A Joint Obligations
Each party shall use its best endeavors to separately execute a
GMP Agreement and Pharmacovigilance Agreement within sixty (60) days of the
Effective Date.
7.4 Use of the Products In Clinical Studies. The Distributor shall not
use the Product, or knowingly provide the Product to any Third Party for use, in
any clinical study without the prior written consent of Bioenvision.
7.5 Quality Assurance; Nonconforming Products.
(a) Failure to Meet Product Warranty. Any claim by the
Distributor that any batches of the Product when shipped
did not meet the warranty set out in Section 7.3(a) must
be made in writing to Bioenvision within (i) fifteen (15)
days of receipt of shipment by the Distributor at the
Distributor's Warehouse in the event such non-compliance
is or would have been discoverable by the Distributor when
or if the inspection and testing procedures called for
under the GMP Agreement and under Distributor's policies
and standard operating procedures as of the Effective Date
were conducted, and (ii) within fifteen (15) days of
discovery of any other non-
**** 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.
16
conformity. The Distributor shall have the right to cause
analytical testing on the Product by an independent
laboratory reasonably acceptable to Bioenvision for
purposes of determining conformity with the product
warranty and the findings of such laboratory shall be
binding on both parties. Any batches of the Product
failing to meet the product warranty set out in Section
7.3(a) shall be destroyed or returned by the Distributor
to Bioenvision at Bioenvision's option and expense and
Bioenvision shall replace as promptly as possible such
batches of the Product with Product meeting the product
warranty set out in Section 7.3(a). Except as described in
the preceding sentence, no shipment or portion of a
shipment of any quantity of the Product shall be returned
to Bioenvision for replacement without Bioenvision's prior
written consent.
(b) Specifications. The Distributor shall not be obligated
under any circumstances to accept delivery of the Product
unless the Product meets the Specifications.
9. SUSPENSION OF DISTRIBUTION; RECALL
9.1 Suspension of Distribution. If requested by Bioenvision as a result
of a problem with the quality or safety of the Products or otherwise, or if it
reasonably determines that in the interest of patient safety it is necessary to
do so, the Distributor will immediately suspend sales and distribution of the
Products.
9.2 Product Recall. Bioenvision shall promptly notify the Distributor of
any recalls initiated by Bioenvision or required by any Regulatory Authorities
in respect of any Product in the Territory. Distributor shall promptly (but in
no event less than one working day prior to any recall) notify Bioenvision of
any recall it reasonably deems necessary in the Territory due to the Product not
meeting the Specification. Such recall shall be implemented and administered by
the Distributor in a manner that is appropriate and reasonable under the
circumstances and in conformity with any requests or orders of the applicable
Regulatory Authority or Bioenvision. Bioenvision will cooperate with the any
reasonable request from the Distributor in connection with any such recall.
Bioenvision shall be responsible for the mailing, shipping and reasonable
administrative expenses incurred by the Distributor in connection with such a
recall as well as the cost of replacement Products for the Distributor and its
customers; provided that the reason for the recall does not arise from (i) the
negligence or misconduct of, or a breach of this Agreement by, the Distributor
or any of its directors, officers, employees or agents or (ii) the failure of
the Distributor to comply with the procedures for the proper storage and
transportation of the Products. The Distributor shall cooperate in any such
recall by providing to Bioenvision the information in respect of sales of the
Products maintained by the Distributor pursuant to Section 9.3 hereof.
9.3 Record Retention; Audit. The Distributor and its Affiliates shall
maintain for two (2) years after the termination or expiration of this Agreement
such information as shall reasonably be required to effect a recall of the
Products, and shall make such information
**** 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.
17
available to Bioenvision, if necessary, in the event of such a recall.
Furthermore, the Distributor and its Affiliates shall cooperate with Bioenvision
in investigating any product failure which results in the need for a recall.
10. PROMOTION AND ADVERTISING
10.1 Marketing Plan and Sales Reports.
(a) The Distributor, at its expense, shall submit a reasonably
detailed marketing plan (the "Marketing Plan") to
Bioenvision's Project Manager no later than sixty (60)
days prior to the beginning of June and January (the
latter plan to be an update of the June plan only) during
the Term, provided that the Distributor shall submit the
initial Marketing Plan (which shall provide the launch
plans for the Product) to Bioenvision's Project Manager
nine (9) months prior to the estimated launch date of the
Product (launch date being the date the Product is first
sold with both Registration and Reimbursement Approval).
As soon as the Distributor can reasonably establish said
launch date, the Distributor will so notify the Project
Manager. The Marketing Plan shall be designed to optimize
sales of the Product in the Territory. Distributor shall
give good faith consideration to implementing any comments
that Bioenvision timely provides with respect to such
plans.
(b) Not later than May 31, August 31, November 30 and February
28 of each year during the Term, the Distributor shall
submit to Bioenvision a marketing report for the preceding
calendar quarter ending March 31, June 30, September 30
and December 31, respectively (the "Sales Reports"). The
Sales Reports shall include the following information: (i)
number of Units of Product purchased by the Distributor
from Bioenvision, (ii) Units of Product Sold by the
Distributor and its Affiliates, (iii) the Gross Sales and
the Net Sales for such period (including an itemization of
all deductions from Gross Sales to determine such Net
Sales), and (iv) number and value of Units of Product
maintained in inventory at the Distributor and its
Affiliates on the last day of the calendar quarter
calculated on the basis of projected prices for Sales. In
addition, the Sales Reports shall contain such other
information in the Distributor's possession concerning the
Distributor's and its Affiliates' promotional and
marketing activities during the preceding quarter as may
be reasonably requested by Bioenvision.
10.2 Advertising and Promotional Materials. All advertising and
promotional materials related to the Product shall be prepared by the
Distributor. Written and visual promotional or educational materials will
indicate, where required to do so by the Regulatory Authorities, that the
Product is sold under authorization from Bioenvision. As permitted by applicable
laws and regulations all documentary information, promotional material and oral
**** 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.
18
presentations (where practical) promoting the Product in the Territory shall
display the Trademarks in a manner that promotes the Product and each of the
parties in an appropriate manner and shall display the tradename and one or more
logos or trademarks of Distributor in an appropriate manner to identify it as
the Distributor of the Product. Bioenvision shall have the right to reproduce,
distribute and otherwise use outside the Territory during the Term, and inside
and outside the Territory after the Term, all Product-related advertising and
promotional materials prepared by the Distributor.
Distributor shall have the right to reproduce, distribute and otherwise
use in the Territory during the Term, all Product-related advertising and
promotional materials prepared by Bioenvision outside the Territory.
10.3 Training. Bioenvision will provide annual training sessions for
Distributor's sales personnel at either Bioenvision's or Distributor's facility,
as Distributor shall choose, and Distributor shall pay all expenses incurred by
Bioenvision in connection with such training sessions (other than salary and
benefits for personnel conducting such training sessions).
11. TRADEMARKS
11.1 Use of Trademarks. The Distributor acknowledges and agrees that the
Trademarks are the sole and exclusive property of Bioenvision and that nothing
herein shall be construed as transferring any right, title or interest of any
kind or nature whatsoever thereto to the Distributor. The Distributor further
agrees not to use any trademarks other than the Trademarks, or its corporate
trademark (being the words "MAYNE", "MAYNE PHARMA" and its red dot logo), in
connection with its distribution of the Products and not to register the
Trademarks for its own account or use a xxxx, name or logo which is confusingly
similar to the Trademarks to identify other Products manufactured, distributed
or sold by the Distributor. The Distributor shall have the exclusive and
royalty-free right and licence to use the Trademarks in the Territory; provided
however, that such use (i) shall be limited to the Term of this Agreement, (ii)
shall be solely in connection with the import, promotion, marketing, sale and
distribution of the Product for an Indication or any New Indication, if any, in
each case, in the Territory and (iii) shall be subject to the following
conditions:
(a) such use shall be in accordance with the shape, form and
color of the Trademarks as communicated or authorized by
Bioenvision;
(b) such use shall clearly indicate that the Trademarks are
owned and/or registered by Bioenvision, Inc., e.g., by
using the appropriate TM or (R) symbol and by stating that
the Trademarks are owned by Bioenvision or used under
licence from Bioenvision;
(c) all rights arising from the use of the Trademarks in the
Territory shall inure solely to Bioenvision's benefit, it
being understood that nothing contained herein shall give
the Distributor any right or interest in the Trademarks;
**** 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.
19
(d) the Distributor shall notify Bioenvision promptly of any
infringement by Third Parties of which it becomes aware in
the Territory with regard to the Trademarks and give
Bioenvision all reasonable assistance; and
(e) the Distributor hereby waives any rights it may have with
respect to the Trademarks under the Trade Marks Act of
1995; provided however, that if Bioenvision fails to
enforce its rights in the Trademarks against a material
infringement in the Territory after receipt of notice of
same from Distributor, Distributor shall have the right to
enforce such rights and Bioenvision shall provide
reasonable support and cooperation in connection with such
enforcement action.
11.2 Maintenance of Trademarks. Bioenvision shall seek and maintain the
registration of the Trademarks in the Territory throughout the Term of this
Agreement.
11.3 Inactive or Abandoned Trademarks. Bioenvision shall have no
obligation to defend and maintain any Trademarks which it considers, in its sole
discretion, inactive and/or abandoned. Bioenvision, to the extent reasonably
practicable, shall consult with the Distributor concerning any Trademark which
Bioenvision considers to be inactive or abandoned prior to taking action to
abandon such Trademark.
12. INDEMNIFICATION
12.1 Indemnification by Bioenvision. Bioenvision shall indemnify the
Distributor, its Affiliates, and their respective directors, officers, employees
and agents from and against all liabilities, penalties, costs, losses, damages
and expenses (including reasonable attorney fees and expenses) ("Liabilities")
to the extent incurred and arising out of or resulting of (i) the breach of this
Agreement by Bioenvision, including [****] The provisions of this Section 12.1
shall survive [****].
12.2 Indemnification by Distributor. The Distributor shall indemnify
Bioenvision, its Affiliates, and their respective directors, officers, employees
and agents, from and against all liabilities, penalties, costs, losses, damages
and expenses (including reasonable attorneys fees and expenses) to the extent
incurred and arising out of [****]. The provisions of this Section 12.2 shall
survive [****].
12.3 Defense of Claim. Each party hereto agrees to give the other
parties (i) prompt written notice of the institution of any claims asserted or
made, including any claims asserted or made by any governmental authority having
jurisdiction, for which the other parties might be liable under the foregoing
indemnification obligations, or for which the notifying party will be liable
under the foregoing indemnification obligations (such as a patent or trademark
claim against Bioenvision); (ii) to the extent the other party is so obligated,
the opportunity to defend, negotiate and settle such claims; and (iii)
reasonable assistance in the defense of such claims.
**** 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.
20
12.3A Notification of Claims outside the Territory. Bioenvision will
promptly notify the Distributor of any claim asserted or made outside the
Territory in relation to the Product, that may reasonably be anticipated to
affect supply of the Product to the Territory.
12.4 Settlements. The indemnifying party may not settle a claim or
action covered by this Article 12 without the consent of the indemnified party,
if such settlement would impose any monetary obligation on the indemnified party
or require the indemnified party to submit to an injunction, make an admission
of liability, or assume an obligation. Any payment made by an indemnifying party
to settle any such claim or action shall be at its own cost and expense.
12.5 Limitation of Liability. With respect to any claim by one party
against the other arising out of the performance or failure of performance of
the other party under this Agreement, the parties expressly agree that the
liability of such party to the other party for such breach shall be limited
under this Agreement or otherwise at law or equity to direct damages, lost
profits directly related to the Products, attorney's fees and the like, and in
no event shall a party be liable to the other party for indirect, incidental,
special or consequential damages, including without limitation, lost profits not
related to the Products. Anything herein to the contrary notwithstanding,
neither Party intends to limit or exclude any liability or warranty that cannot
be limited or excluded under applicable laws.
13. CONFIDENTIALITY
13.1 Each party agrees and shall undertake to keep confidential, and not
to use except as expressly provided hereunder, the confidential information of
the other Party disclosed hereunder , including without limitation, information
concerning the manufacture, development, testing and marketing of the Product,
shall refrain from disclosing it to any Third Party unless compelled to disclose
by judicial or administrative process or, in the opinion of such party's
counsel, by the requirements of law, and except by the Distributor as required
to carry out its rights or obligations hereunder. [****] Notwithstanding the
foregoing, the parties shall issue a joint press release disclosing the
existence and general nature of this Agreement, the text of which first shall
have been reviewed and approved by each party, provided further that such press
release shall not disclose any proprietary information of the either party. The
provisions of this Section 13.1 shall survive the termination or expiration of
this Agreement.
14. TERM AND TERMINATION
14.1 Term. This Agreement shall become effective on the Effective Date
and, unless terminated earlier in accordance with this Agreement, shall continue
in effect for the Initial Term. The term shall automatically be renewed for
successive two (2) year periods ("Extension Terms"), unless one party elects to
terminate this Agreement upon expiration of the then existing term by giving
notice to the other party in writing at least six (6) months prior to the
expiration of the then existing term.
**** 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.
21
14.2 Termination by Bioenvision. Bioenvision, in its sole discretion,
may, upon ninety (90) days written notice to the Distributor, terminate this
Agreement in the event that [****].
14.3 Termination by the Distributor. The Distributor may terminate this
Agreement upon ninety (90) days written notice to Bioenvision in the event
[****].
14.4 Termination by Either Party. If one of the following events shall
occur
(a) the parties shall have mutually agreed in writing to
terminate this Agreement;
(b) an Act of Insolvency of either Bioenvision or the
Distributor shall have occurred;
(c) an Event of Default (other than one described in Section
14.2) has occurred and such Event of Default has not been
remedied by the defaulting party within thirty (30) days
of receipt of a written notice by the non-defaulting
party; or
(d) either party has ceased to conduct business.
then, upon such mutual agreement or upon the giving of notice in writing by (A)
the nondefaulting party in the event of an Event of Default, (B) the
non-insolvent party in the event of an Act of Insolvency, or (C) the
non-business impaired party in the circumstances described in the foregoing
Section 14.4(d), this Agreement shall terminate upon the expiration of thirty
(30) days from the date thereof or such earlier date as the parties may mutually
agree in writing. Anything herein to the contrary notwithstanding, during this
period, it will be at the sole discretion of Bioenvision as to whether it shall
provide Products to the Distributor.
14.5 Rights and Obligations Upon Termination.
(a) Upon the termination of this Agreement for any reason, at
the option of Bioenvision (subject to what may be legally
permissible) and upon receipt of Bioenvision's written
instructions, the Distributor shall either (i) continue to
distribute the Products then in its possession, in which
case the provisions of this Agreement shall fully apply to
such distribution of the Products unless otherwise
notified by Bioenvision to the Distributor, (ii) deliver
to Bioenvision, or to such other persons as may be
specified by Bioenvision, at the Distributor's Warehouse
and in accordance with Bioenvision's written instructions,
all the Product in the Distributor's possession, or (iii)
destroy all Product then in the Distributor's possession
(any such destruction to be accomplished in conformity
with all applicable laws and regulations). Unless
otherwise agreed between the Parties, the option set out
in Section 14.5(a)(i) above will automatically apply for
the first six (6) months following termination unless such
termination resulted
**** 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.
22
from an Event of Default of the Distributor.
Notwithstanding the foregoing, the Parties agree to
reasonably cooperate with each other to limit their
respective liability to third parties in connection with
such a termination, to ensure a continuity of supply of
Product to the Territory during any transition or to
conduct any market withdrawal in a commercially reasonable
manner. In the cases where the Product is returned or
destroyed in accordance with Bioenvision's instructions,
Bioenvision shall pay to the Distributor the following sum
of monies within thirty (30) days following receipt by
Bioenvision of the Products or notice of their
destruction: [****].
(b) Following termination of this Agreement for any reason and
disposal by the Distributor of all Product in its
possession, at Bioenvision's option and cost and in
accordance with Bioenvision's written instructions, the
Distributor shall either deliver to Bioenvision or
Bioenvision's designee at the address indicated by
Bioenvision, or destroy, all display, point-of-sale,
advertising and promotional materials then in the
Distributor's possession bearing the Trademarks or other
indicia of origin or quality, pertaining to the Products.
The Distributor shall also promptly remove all signs,
advertising, and similar materials bearing the Trademarks
and other indicia of origin or quality of the Products
from the Distributor's buildings, stationery and other
property and advertising.
(c) Following termination of this Agreement for any reason and
disposal by the Distributor of all Product in its
possession and to the extent legally permissible, the
Distributor shall deliver to Bioenvision an accurate and
complete copy (including without limitation address and
telephone number, contact name and purchase history) of
the Distributor's list of hospital and clinical customers
for the Products.
(d) The termination for any reason whatsoever of this
Agreement shall not release the Distributor from the
obligation to pay any sums then owing to Bioenvision or
from the obligation to perform any other duty or to
discharge any other liability that the Distributor has
incurred prior thereto, and shall not release Bioenvision
for the obligation to pay any sums then owing to the
Distributor or from the obligation to perform any other
duty or to discharge any other liability that Bioenvision
has incurred prior thereto. Except as otherwise
specifically set forth in Section 14.5(f) or elsewhere in
this Agreement, Bioenvision shall not, by reason of the
expiration or termination of this Agreement for any reason
whatsoever, be liable to the Distributor for compensation
or damage on account of loss of present or prospective
profits on sales or anticipated sales, or expenditures,
investments or commitments made in connection
**** 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.
23
therewith or in connection with the establishment,
development or maintenance of the Distributor's business
or goodwill.
(e) Upon termination for any reason whatsoever, Bioenvision or
its new distributor shall be entitled to market and sell
Product to the Distributor's customers in the Territory.
15. MISCELLANEOUS
15.1 Entire Agreement. This Agreement, together with the Schedules
hereto, sets forth the entire agreement and understanding between the parties as
to the subject matter hereof. Except as otherwise provided expressly herein, no
modification, amendment or supplement to this Agreement or to such Schedules
shall be effective for any purpose unless in writing and signed by the parties
hereto.
15.2 Binding Effect; Assignments. This Agreement shall inure to the
benefit of and be binding upon the parties hereto and their respective
successors and permitted assigns. Neither this Agreement nor the rights granted
or obligations assumed hereunder shall be assigned or otherwise transferred by
either party without the prior written consent of the other party; provided
however, that either party may assign this Agreement without the consent of the
other party to any of its Affiliates. An assignment by a party to any of its
Affiliates shall, in no event, release such party of any of its obligations
hereunder.
15.3 Governing Law. This Agreement shall be governed by, and construed
in accordance with, the laws of [****] and, to the extent it may be applicable,
the parties intend that the [****] shall not apply. Each party submits to the
non-exclusive jurisdiction of the courts of the United Kingdom in relation to
any suit arising out of or based upon this Agreement.
15.4 No Waiver; Remedies. No failure on the part of either party hereto
to exercise, and no delay in exercising, any right hereunder shall operate as a
waiver thereof; nor shall any single or partial exercise of any such right
preclude any other future exercise thereof or the exercise of any other right.
The remedies herein are cumulative and not exclusive of any remedies provided by
law.
15.5 No Warranties, Liability. Except as expressly set forth in this
Agreement, NEITHER PARTY MAKES ANY REPRESENTATIONS AND EXTENDS NO WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT OR OTHERWISE, NEITHER
PARTY WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER
ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL THEORY FOR ANY
INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR COST
OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES.
**** 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.
24
15.6 Force Majeure. Any violation of this Agreement resulting from an
event beyond the reasonable control of the party affected thereby, such as
fires, flood, earthquakes, accidents, explosions, sabotage, strikes, or other
labor disturbances (regardless of the reasonableness of the demands of labor),
civil commotions, riots, invasions, wars, acts, restraints, requisitions,
regulations, or directions of governmental authorities, shortages of labor,
fuel, power, or raw material, inability to obtain equipment or supplies,
inability to obtain or delays in transportation, acts of God, peril of the sea,
or any other cause beyond the reasonable control of the party affected thereby,
shall not be considered a breach of this Agreement, provided that the party
affected thereby uses its commercially reasonable efforts to promptly remedy the
situation. In the event any violation of this Agreement as a result of a case of
force majeure continues for more than two months, the party not affected thereby
shall have the right to terminate this Agreement with immediate effect by
written notice sent to the other party.
15.7 Notices. All notices, reports and communications permitted or
required by this Agreement shall be in writing, shall be in English and shall be
deemed given when delivered personally or transmitted by facsimile (and
telephonically confirmed), four business days after being mailed by registered
or certified mail with postage prepaid and returned receipt requested, or when
received, if sent by commercial overnight courier with fees prepaid (if
available; otherwise, by the next best class of service available), to the
parties at the following addresses:
(a) To Bioenvision Bioenvision, Inc.
000 Xxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Xxxxxx Xxxxxx of America
Attention: General Counsel
Telephone: x0-000-000-0000
With a copy to: Xxxxxxx Procter
Exchange Place
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Xxxxxx Xxxxxx of America
Attention: Xxxxxxxxxxx Xxxx, Esq.
Telephone: x0-000-000-0000
(b) To Distributor: Mayne Pharma Limited
Xxxxx 00, 000 Xx. Xxxxx Xxxx
Xxxxxxxxx Xxxxxxxx 0000
Xxxxxxxxx
Attention: Company Secretary
Telephone : x00-0-0000-0000
**** 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.
25
15.8 Severability. Any provision of this Agreement that is invalid or
unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective
to the extent of such invalidity or unenforceability without invalidating the
remaining provisions hereof, to the extent that the purpose of this Agreement is
not materially altered, or affecting the validity or enforceability of such
provision in any other jurisdiction.
15.9 Relationship of Parties. The Distributor shall act as an
independent contractor which purchases the Products and resells them for its
account. Nothing in this Agreement shall constitute or be deemed to constitute
either party as the legal representative or agent of the other, nor shall either
party have the right or authority to assume, create, or incur any liability or
any obligation of any kind, expressed or implied, in the name or on behalf of
the other party.
15.11 Dispute Resolution.
(a) Any matter that cannot be resolved amicably by the Project
Managers, and any other dispute, controversy or claim
arising out of or relating to this Agreement, or the
entering into, breach, termination, or invalidity of this
Agreement, shall be submitted in the first instance to the
Chief Executive Officer of Bioenvision and the regional
President of the Distributor.
(b) If the matter or dispute cannot be resolved by the
individuals designated in Section 15.11(a) within sixty
days after such submission, it shall be settled by
arbitration as provided herein. The number of arbitrators
shall be three, one of whom is selected by the
Distributor, one of whom is selected by Bioenvision and
one of whom is selected by Bioenvision and the Distributor
(or by the other two arbitrators if the parties cannot
agree within thirty (30) days of selecting the other two
arbitrators). The arbitration proceeding shall be
conducted in the English language. [****] unless the
parties agree in writing to conduct the arbitration in
another location and under different arbitration rules.
(c) The arbitration decision shall be binding upon the
parties. The decision of the arbitrators shall be
executory, and the prevailing party may enter such
decision in any court having competent jurisdiction. Each
party shall have the right to institute judicial
proceedings against the other party or anyone acting by,
through or under such other party (including the right to
seek and to obtain injunctive relief) solely to enforce
the instituting party's arbitration rights or the decision
of the arbitrators.
(d) Nothing in this Agreement shall be deemed as preventing
either Party from seeking injunctive relief (or other
provisional remedy) from any court having jurisdiction
over the Parties and the subject matter of the dispute as
necessary to protect either Party's interests.
**** 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.
26
15.12 No Other Rights. Except as expressly set forth herein, no rights
or licenses to intellectual property rights are granted herein, whether by
implication or otherwise.
15.13 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original and all of which, when
taken together, shall constitute one and the same agreement.
15.14 Interpretation. By executing this Agreement both parties
acknowledge and accept that the final draft of this Agreement was reached by
negotiation and initial consent and the Agreement shall be deemed drafted by
both parties and shall not be interpreted against any one party.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized officer, as of the date first above written.
BIOENVISION, INC. MAYNE PHARMA LIMITED
/s/ Xxxxxxxxx
/s/ Xxxxx X. Xxxxxxxxxxxx
By: Luci By: Kiriacoulacos
------------------- -------------------------
Print Print Name:
Name:
Xxxxx X. Xxxxxxxxx
Xxxx Xxxxxxxxxxxx
Xxxxxxxxxxxxx
Title: CFO Title:
and
General General
Counsel Counsel and
Company
Secretary
/s/ Xxxxxxx /s/ Xxxxxxxx
Witness: Xxxxxx Witness Xxxxxx
------------------- -------------------------
Print Print Name:
Name:
Xxxxxxx Xxxxxxxx
Xxxxxx Xxxxxx
Date: Date:
3/31/06 3/24/06
**** 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.
27
SCHEDULE A
SPECIFICATIONS
[****]
**** 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.
28
SCHEDULE B
TRADEMARKS. SERVICEMARKS, TRADE NAMES AND LOGOS
[****]
**** 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.
29
SCHEDULE C
INTELLECTUAL PROPERTY RIGHTS
[****]
**** 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.
30
