Exhibit 10.31
CERTAIN CONFIDENTIAL INFORMATION CONTAINED
IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934, AS AMENDED.
SUPPLY AGREEMENT
Between
ASH STEVENS, INC.
and
PHARMION CORPORATION
Dated: March 31,
2005
TABLE OF CONTENTS
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Sec.
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Page
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Essential Terms and
Conditions
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1
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Supply and Purchase of
Compound
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2
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Rolling Forecast;
Safety Stock
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4
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Shipment of
Compound
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5
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Termination;
Licenses
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7
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Compound Changes;
Starting Materials
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10
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Regulatory
Responsibilities
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12
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Quality
Assurance
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14
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Health and Safety
Procedures
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15
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Warranties and
Indemnifications
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15
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Insurance
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17
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Confidentiality and
Proprietary Rights
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18
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Compliance With
Law
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20
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Other
Provisions
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20
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Table of
Exhibits
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24
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SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (the “ Agreement ”)
is made effective as of March 31, 2005 (“ Effective
Date ”) between:
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(1)
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ASH STEVENS, INC. , a Michigan corporation with its
principal place of business at 5861 John C. Lodge Freeway, Detroit,
Michigan 48202-3398 USA (“ Ash Stevens ”);
and
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(2)
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PHARMION CORPORATION
, a Delaware corporation
with its principal office at 2525 28th St., Suite 200,
Boulder, CO 80301 USA (“ Pharmion ”).
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Pharmion and Ash Stevens are
sometimes individually referred to herein as a “ Party
” and collectively as the “ Parties
”.
In consideration of the mutual
agreements set forth herein, and other good and valuable
consideration the receipt and sufficiency of which are
acknowledged, the Parties, intending to be legally bound, hereby
agree as follows:
ESSENTIAL TERMS AND
CONDITIONS
The following are contractual
essential terms and conditions collected together here solely for
the convenience of the Parties:
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A.
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General . Ash Stevens desires to manufacture
and supply to Pharmion the compound azacitidine (“
Compound ”, which is also known as
5-azacitidine ) in accordance with the specifications
referenced in Exhibit A hereto (the “
Specifications ”). Pharmion desires to purchase
Compound from Ash Stevens for use or for inclusion in human
pharmaceutical products for development, sale or other
commercialization by Pharmion and its affiliates and
licensees.
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B.
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Prices and Payment
. Prices for Compound
are as specified in Exhibit B hereto. Terms of payment
are net 30 days from delivery to Pharmion of Compound and Ash
Stevens’ invoice.
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C.
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Term and Termination
. The initial term of
this Agreement (the “ Initial Term ”) begins on
the Effective Date and ends on May 31, 2011 (the “
Initial Term Expiration Date ”), unless earlier
terminated by either Party pursuant to the provisions of this
Agreement. The Term of this Agreement shall automatically be
renewed for additional periods of two (2) years (each an
“ Automatic Extension Period ”) unless either
Party provides notice of its desire for this Agreement to expire at
least one (1) year in advance of the relevant expiration date
(a “ Notice of Termination ”). Upon the request
of either Party made during the last year of the Initial Term, the
Parties shall discuss in good faith their plans and intent for the
renewal of this Agreement for any Automatic Extension Period. This
Agreement may be terminated as provided in Section 4(b)
hereof.
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SUPPLY AGREEMENT
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Page 1 of 25
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D.
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The
Parties are also parties to that certain Process Development and
Validation Agreement dated as of October 15, 2001, as amended
by the First Amendment to Confidentiality Agreement and Process
Development and Validation Agreement dated May 28, 2003 (the
“ Process Agreement ”) and that certain
Confidentiality Agreement dated as of October 15, 2001, as
amended by the First Amendment to Confidentiality Agreement and
Process Development and Validation Agreement dated May 28,
2003 (the “ Confidentiality Agreement
”).
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TERMS AND CONDITIONS
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1.
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SUPPLY AND PURCHASE OF
COMPOUND
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(a)
General . Subject to and in accordance with the provisions
of this Agreement, Ash Stevens shall manufacture and supply
Compound to Pharmion (and Pharmion’s affiliates and
licensees, as authorized and directed in writing by Pharmion from
time to time subject to the rights of Ash Stevens under
Section 1(g), hereinafter “ Pharmion Designees
”), as ordered by Pharmion pursuant to this Section 1.
As authorized and directed by Pharmion, Pharmion Designees may
exercise the rights of Pharmion pursuant to this Agreement
pertaining to the supply of Compound. All sales of Compound to
Pharmion and Pharmion Designees shall be subject to the terms and
conditions of this Agreement.
(b)
Exclusivity .
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(i)
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Supplies by Ash Stevens
. Ash Stevens shall
exclusively manufacture and supply Compound to Pharmion and
Pharmion Designees pursuant to this Agreement. Ash Stevens shall
not during the Term of this Agreement (both during and after the
Exclusivity Period (as defined below)) and for a period of five
(5) years after expiration of the Term or termination pursuant
to an uncured material breach by Ash Stevens of this Agreement,
sell or provide Compound to any other person or entity anywhere in
the world (the “ Territory ”).
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(ii)
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Purchases by Pharmion
. Pharmion and Pharmion
Designees shall exclusively purchase its requirements of the
Compound for the Territory from Ash Stevens from the Effective Date
until the Initial Term Expiration Date (the “ Exclusivity
Period ”). After the Exclusivity Period and during any
Automatic Extension Period, Pharmion and Pharmion Designees in
their sole discretion may either (i) purchase from Ash Stevens all
of its requirements of Compound for the Territory, or
(ii) purchase a portion, or none of, its requirements of
Compound for the Territory. Notwithstanding the foregoing, the
Exclusivity Period shall terminate in the event that a Supply
Shortage (as defined in Section 2(c) below) has occurred and Ash
Stevens has failed to remedy the Supply Shortage as provided in
Section 4(e) of this Agreement.
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(c)
Orders . Pharmion and Pharmion Designees may order Compound
from Ash Stevens by placing written purchase orders during the Term
of this Agreement (“ Orders ”). During the Term
Ash Stevens shall accept all such Orders which are for quantities
which are not
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SUPPLY AGREEMENT
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Page 2 of 25
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more than 120% of the quantities
specified by Pharmion and Pharmion Designees in the then-current
Rolling Forecast (as defined in Section 2(a) hereof) for the
relevant period, and shall acknowledge promptly (and in any event
within ten (10) business days) each Order in writing and
confirm the delivery dates and the destinations specified in the
relevant Order. During the Term, Ash Stevens shall timely make
delivery on Orders for which the delivery date specified is at
least [... *** ...] after the date of the Order. In the event of
any inconsistencies between the terms of this Agreement and any
Order issued by Pharmion and Pharmion Designees hereunder or any
acceptance thereof by Ash Stevens, the terms of this Agreement
shall govern.
(d)
Force Majeure . Neither Party shall be considered in default
of the performance of any obligation hereunder to the extent that
the performance of such obligation is prevented or delayed by fire,
flood, earthquake, explosion, strike, acts of terrorism, war,
insurrection, embargo, government requirement, civil or military
authority, act of God, or any other event, occurrence or condition
which is not caused, in whole or in part, by that Party, and which
is beyond the reasonable control of that Party (each a “
Force Majeure Event ”); provided, however, that Ash
Stevens shall notify Pharmion promptly of anticipated delivery
delays and shall use commercially reasonable efforts to fill
delayed Orders as soon as possible. Pharmion may cancel any Order,
in whole or in part, which is delayed more than thirty
(30) days after the delivery date in such Order, but only if
Ash Stevens has performed no work on such Order. For the avoidance
of doubt, any failure by suppliers to Ash Stevens to timely deliver
starting materials, ingredients, resources and services used to
make the Compound when properly ordered by Ash Stevens shall be
considered a Force Majeure Event.
(e)
Purchase Prices and Payment . Prices for Compound are as
specified in Exhibit B hereto. Ash Stevens shall invoice
Pharmion for the purchase price of all quantities of Compound
purchased hereunder concurrently with Ash Stevens’s shipment
thereof to Pharmion, or for the safety stock of Compound specified
in Section 2(b) hereof, when such Compound is placed in such safety
stock for Pharmion by Ash Stevens. All amounts properly invoiced by
Ash Stevens hereunder shall be due and payable thirty
(30) days from Pharmion receipt of such invoices. Payment may
be made by corporate check or by wire transfer of funds to such
account in the name of Ash Stevens as Ash Stevens may designate by
notice to Pharmion. Unless otherwise agreed by Ash Stevens in
writing, all payment for Compound purchased by Pharmion Designees
shall be charged and invoiced to the account of Pharmion and
Pharmion shall pay all such invoices in accordance with the terms
set forth herein.
(f)
No Diligence Requirement for Pharmion . Nothing in this
Agreement or any other agreement between the Parties shall obligate
Pharmion to commence or continue manufacture of products
incorporating Compound, or otherwise commercialize the Compound or
such products. If Pharmion permanently discontinues the manufacture
of products incorporating Compound, then Orders which have been
issued by Pharmion and accepted by Ash Stevens shall not be deemed
to be cancelled, and the Parties shall fulfill their respective
obligations related to such Orders as provide herein unless
otherwise agreed in writing.
(g) Pharmion
shall be the guarantor of, and be fully responsible for, all
payment and other obligations incurred by Pharmion Designees for
Orders. Upon any failure by any Pharmion Designee to pay amounts
owing to Ash Stevens or otherwise fail to perform its
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SUPPLY AGREEMENT
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Page 3 of 25
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*** Confidential Treatment Requested
obligations hereunder, Ash
Stevens shall be entitled to full and prompt compensation by
Pharmion for all outstanding payment and other obligations incurred
by Pharmion Designees for Orders. In consideration for the right of
Pharmion Designees to have Orders filled by Ash Stevens hereunder,
Pharmion hereby agrees to indemnify and hold harmless Ash Stevens
from and against any and all losses, obligations, liabilities and
expenses (including attorneys’ fees) for claims, demands,
actions and proceedings arising in connection with Orders by any
Pharmion Designee if such losses, obligations, liabilities and
expenses would be indemnified by Pharmion pursuant to Section 9(c)
hereof if Pharmion were the purchaser of the Compound.
Notwithstanding anything herein to the contrary, Ash Stevens may in
its sole discretion require that each Pharmion Designee that is not
an affiliate of Pharmion enter into a supply agreement on
substantially the same terms as this Agreement as a condition to
submitting any Order hereunder.
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2.
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ROLLING FORECAST; SAFETY
STOCK
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(a)
Rolling Forecast . Pharmion shall provide Ash Stevens with a
twelve (12) month rolling delivery forecast of the quantity of
Compound that Pharmion and Pharmion Designees intends to purchase
from Ash Stevens in the periods specified (the “ Rolling
Forecast ”). The first six months of the Rolling Forecast
(the “ Firm Period ”) shall be binding, subject
to the next sentence, and the last six months of the Rolling
Forecast (the “ Estimate Period ”) shall be
non-binding. Pharmion shall update the Rolling Forecast every three
(3) months; provided, however, in each such update, Pharmion
may (i) revise (increase or decrease) the Rolling Forecast for
the Estimate Period, and (ii) increase the Rolling Forecast
for the Firm Period by a maximum of [... *** ...] from the
quantities specified in the most recent prior Rolling Forecast but
may not decrease such forecast quantities, unless otherwise agreed
to in writing by Ash Stevens. Pharmion shall inform Ash Stevens as
soon as possible if Pharmion reasonably expects that Orders for
Compound would vary significantly (more than 20%) from the Rolling
Forecast but while Ash Stevens will endeavor to satisfy
Pharmion’s increased demand using commercially reasonable
efforts, it is understood and agreed that Ash Stevens shall in no
event be obligated to deliver quantities of Compound in excess of
those quantities properly forecast in accordance with this
Section 2(a).
(b)
Safety Stock . During the Term of this Agreement, as
directed by Pharmion in its Orders, Ash Stevens shall manufacture
and maintain a “safety stock” of Compound. Pharmion
shall have discretion to determine the quantity of such safety
stock from time to time, which shall become the property of
Pharmion upon payment in full therefor in accordance with this
Agreement. For the avoidance of doubt, quantities of Compound
Pharmion wishes to have maintained as a safety stock shall be
subject to the forecasting procedures set forth in
Section 2(a). Ash Stevens, when shipping Compound to Pharmion
in accordance with this Agreement, shall manage such safety stock
with its own inventories of Compound on a “first in, first
out” basis to maximize shelf life and minimize spoilage. Ash
Stevens shall properly store all inventories of Compound (including
such safety stock) prior to delivery pursuant to Section 3
hereof in accordance with the Specifications, cGMPs and the
instructions of Pharmion; such storage shall be at Ash
Stevens’ cost, except for the storage of such safety stock
(for time periods after the date the relevant quantities of the
Compound are released into safety stock until delivered to
Pharmion) for which Pharmion shall pay Ash Stevens [... *** ...].
Title to such safety stock shall pass to Pharmion upon payment
by
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SUPPLY AGREEMENT
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Page 4 of 25
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*** Confidential Treatment Requested
Pharmion for such safety stock
pursuant to Section 1(e) hereof. Ash Stevens shall segregate from
other inventory and clearly mark such safety stock as the property
of Pharmion, and shall not permit any lien, claim or encumbrance to
apply to such safety stock. Risk of loss for such safety stock
shall pass to Pharmion when actually delivered in accordance with
Section 3 hereof. Pharmion may require Ash Stevens to ship
such safety stock as directed by Pharmion at any time, at
Pharmion’s expense pursuant to Section 3. Ash Stevens
shall be entitled to invoice Pharmion for such safety stock storage
charges and Pharmion shall pay all such invoices net 30 days
from delivery of Ash Stevens’ invoice. In addition to the
quantities of Compound held as safety stock as directed by Pharmion
as contemplated by the foregoing, to further protect against
shortages, Ash Stevens shall at its own expense maintain its own
safety stock of Compound corresponding to not less than the greater
of (i) [... *** ...], and (ii) [... *** ...] of the
aggregate quantities ordered by Pharmion in the immediately
preceding twelve (12) month period, with [... *** ...] of such
additional safety stock levels to be achieved not later than nine
(9) months after the Effective Date, and the full requirements of
such additional safety stock levels to be achieved not later than
eighteen (18) months after the Effective Date.
(c) A
“ Supply Shortage ” shall occur if, at any time
during the Term, the quantities of Compound supplied by Ash Stevens
to Pharmion or Pharmion Designees, as applicable, are less than
(i) [... *** ...] of the quantities specified in Orders
accepted by Ash Stevens over a period of three (3) consecutive
months (the “[... *** ...] Trigger”); or (ii) [...
*** ...] of the quantities specified in Orders accepted by Ash
Stevens over a period of four (4) consecutive months (the
“[... *** ...] Trigger”), or (iii) [... *** ...]
of the quantities specified in Orders accepted by Ash Stevens over
a period of six (6) consecutive months (the “[... ***
...] Trigger), where in each case such quantities were properly
forecast and ordered by Pharmion or Pharmion Designees in
accordance with this Section 2. In the event of a Supply
Shortage, the provisions of Section 4(e) shall apply.
(a)
Shipment . Deliveries of Compound shall be EXW (“Ex
Works”, INCOTERMS 2000) Ash Stevens shipping dock. Upon the
request of Pharmion, Ash Stevens shall at Pharmion’s expense
ship Compound to such location in the United States of America as
may be specified by Pharmion in the relevant Order. Pharmion may
not specify delivery locations outside of the United States of
America without the prior written agreement of Ash Stevens. Ash
Stevens shall ship the Compound via carriers which have mutually
agreed upon. Unless otherwise agreed to in writing, Pharmion shall
pay all freight charges. Ash Stevens shall include a packing list
in each shipment of the Compound providing the following
information: (i) Purchase Order No.; (ii) Compound Code;
(iii) Quantity; and (iv) Ash Stevens Lot Number; and the
shipment shall include the Certificate of Analysis and Certificate
of Compliance (confirming that the Compound has been manufactured
in accordance with cGMPs). Ash Stevens shall also mail a copy of
each packing list to the destination and to Pharmion (to the
address specified by Pharmion, which may be different from the
destination) for each shipment at the time of shipment. Ash Stevens
shall comply with Pharmion’s or its designee’s
Receiving Requirements,
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SUPPLY AGREEMENT
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Page 5 of 25
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*** Confidential Treatment Requested
as further described in
Exhibit C hereto without additional charge. Risk of
loss for Compound shall pass to Pharmion when Compound is received
by the carrier at Ash Stevens’ shipping dock.
(b)
Short Quantities . After receipt of each shipment of the
Compound, Pharmion or its authorized representatives shall conduct
a quantity count of such shipment. Pharmion shall notify Ash
Stevens in writing of any obvious shortage in quantity of any
shipment of the Compound within thirty (30) days after such
receipt (a “ Notice of Short Quantity ”). A
shipment of the Compound is to be considered to have fulfilled the
quantity specified in the relevant Order if Pharmion or its
representatives does not notify Ash Stevens about any objections
within such time periods.
(c)
Defects . Pharmion and its representatives shall have the
right, but not the obligation, to inspect and test the quality of
any shipment of the Compound pursuant to Section 7(b) (Pharmion
Inspection) hereof. Ash Stevens acknowledges and agrees that
(i) each shipment of the Compound shall be tested and
inspected by Ash Stevens prior to release in accordance with the
Specifications and cGMPs pursuant to Section 7(a) (Release by Ash
Stevens) hereof, (ii) Ash Stevens shall provide Pharmion with
a certificate of analysis and other proper release documentation
for each shipment of the Compound, (iii) Pharmion and Pharmion
Designees may rely upon such certificate of analysis and other
release documentation related to each shipment of the Compound,
(iv) Ash Stevens at its cost shall make and retain
“retention samples” for each shipment of the Compound,
as required by Section 6(f) (Retention) hereof, and (v) Ash
Stevens shall not be released of its obligations under this
Agreement related to any shipment of the Compound which has not
been inspected or tested by Pharmion or its representatives. If
Pharmion or Pharmion Designee at any time rejects a shipment of
Compound, written notice thereof shall be provided to Ash
Stevens.
(d)
Disputes . If there is a dispute as to whether any portion
of any shipment of the Compound is not in compliance with the
requirements of this Agreement, such dispute shall be resolved by
having a representative of Pharmion observe the performance of the
analytical testing by Ash Steven’s personnel or by having Ash
Stevens observe the performance of the analytical testing by
Pharmion’s personnel. If the discrepancy results cannot be
resolved in this manner, the testing shall be performed by an
independent, mutually acceptable, qualified third party. If
analytical testing results from Ash Stevens retention samples are
different from analytical testing results from Pharmion retention
samples when contemporaneously obtained in the same laboratory,
then the results from the Ash Stevens retention samples shall
govern and control.
(e)
Replacements; Refunds; Exclusive Remedies for Quantities .
If a shipment is properly rejected by Pharmion, Ash Stevens will
schedule another production run as soon as commercially reasonable
thereafter and will deliver a new shipment if so requested in
writing by Pharmion. In the event that Ash Stevens is unable to
deliver a replacement shipment of Compound that conforms to the
Specification, Ash Stevens shall refund any money paid by Pharmion
for such shipment. Notwithstanding anything in this Agreement to
the contrary, this Section 3(e) and Sections 4(b)(iii), 4(e)
and Section 6(e) are the sole and exclusive remedies available to
Pharmion and Pharmion Designees for any failure by Ash Stevens to
supply Compound that meets the Specification, including, without
limitation, any breach of the warranties and covenants provided by
Ash Stevens in Section 9(a), or for a Supply
Shortage,
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SUPPLY AGREEMENT
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Page 6 of 25
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however, the foregoing shall not
be construed to limit the indemnification obligations of either
Party.
(a)
Term . The term of this Agreement (the “ Term
”) shall be the Initial Term, together with any applicable
Automatic Extension Period(s), unless earlier terminated pursuant
to Section 4(b) hereof.
(b)
Termination . This Agreement may be terminated prior to the
expiration of the Initial Term or the current Automatic Extension
Period, as relevant, as follows, but for no other
reason:
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(i)
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For Cause . Either Party may terminate this
Agreement for any material breach by the other Party ninety
(90) days after a written notice containing details of the
breach has been provided to the other Party, if the breach remains
uncured at the end of the notice period; provided however, that the
foregoing shall not apply to Supply Shortages (for which separate
provision has been made hereunder).
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(ii)
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For Bankruptcy
. Either Party may
terminate this Agreement effective immediately with written notice
to the other Party if the other Party shall file for bankruptcy,
shall be adjudicated bankrupt, shall take advantage of applicable
insolvency laws, shall make an assignment for the benefit of
creditors, shall be dissolved or shall have a receiver appointed
for its property.
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(iii)
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For Quality Concerns
. Pharmion shall have
the right to terminate this Agreement immediately if Ash Stevens
has been determined under the procedures in Section 3(d) to be in
material breach of any of its warranties contained in
Section 9 and such breach has not been corrected in the manner
provided in this Agreement to the reasonable satisfaction of
Pharmion.
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(iv)
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Termination for
Disbarment .
Either Party may terminate this Agreement effective immediately
upon notice if at any time during the Term the Other Party becomes
debarred. Each Party shall notify the other Party immediately if at
any time during the Term the Party or any of its officers or
employees becomes debarred, or receives notice of action or threat
of action with respect to its, his, or her debarment.
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(c)
Fulfillment of Orders . If this Agreement is terminated as
provided above by Pharmion, then (i) Pharmion may cancel
without liability all outstanding Orders for which delivery has not
been completed, as determined by Pharmion in its sole discretion,
and (ii) such termination will not relieve Ash Stevens of its
obligation to deliver Compound ordered by Pharmion prior to the
effective date of termination (except to the extent Orders are so
cancelled by Pharmion).
(d)
Survival . Upon the expiration or termination of this
Agreement for any reason, the following provisions of this
Agreement shall survive in accordance with their terms:
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SUPPLY AGREEMENT
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Page 7 of 25
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Sections 2(b) (Safety
Stock), 3(c) (Defects), 3(d) (Disputes), 3(e) (Replacements;
Refunds), 4(c) (Fulfillment of Orders), 4(e) (Back-up Supply and
Licenses), 6(b) (Regulatory Filings), 6(e) (Recalls), 6(f)
(Retention), 6(g) (Further Cooperation), 7(b) (Pharmion Inspection)
(such inspections after the expiration or termination of this
Agreement and shall be at mutually agreeable times, with Pharmion
paying Ash Stevens a fee of $200 per hour during such inspections
(as such fee may be increased annually by Ash Stevens by not more
than 5% per year)), 7(c) (Complaints), 8 (Health and Safety), 9
(Warranties and Indemnifications), 11 (Confidentiality and
Proprietary Rights), 12 (Compliance with Law) and 13 (Other
Provisions). The provisions of the Quality Agreement, as expressly
specified therein to survive, shall also survive the expiration or
termination of this Agreement and the Quality Agreement.
(e)
Back-up Supply and Licenses . If a Supply Shortage occurs
under Section 2(c) and written notice of same by Pharmion to Ash
Stevens has been given, then Ash Stevens shall have the opportunity
to correct the Supply Shortage by supplying those quantities of
Compound specified in Orders (which Orders had been properly
forecast and submitted by Pharmion or Pharmion Designees and duly
accepted by Ash Stevens) which quantities Ash Stevens had failed to
supply and which failure resulted in triggering one of three
alternative definitions of “Supply Shortage” as set
forth in Section 2(c). From the date that the notice of a
Supply Shortage is given, Ash Stevens shall have the following
periods of time as applicable to correct the Supply Shortage:
(i) [... *** ...] if due to the [... *** ...] Trigger,
(ii) [... *** ...] if due to the [... *** ...] Trigger, and
(iii) [... *** ...] if due to the [... *** ...] Trigger. If
Ash Stevens has failed to correct the Supply Shortage within the
applicable time period, then the Exclusivity Period shall terminate
and Pharmion shall be entitled to exercise back-up supply rights
under this Section 4(e) (the “Back-up Supply Rights”)
and Pharmion shall thereafter be free to establish and utilize one
or more alternative suppliers for the Compound. Upon failure by Ash
Stevens to correct the Supply Shortage within the applicable time
period, the Exclusivity Period shall terminate and shall not be
considered to be reinstated merely because Ash Stevens manages to
correct the Supply Shortage after the applicable time
period for so doing has expired.
Upon termination
of the Exclusivity Period pursuant to this Section 4(e) and subject
to the conditions and limitations set forth below in this
Section 4(e), at the request of Pharmion, Ash Stevens shall
provide such cooperation and assistance to Pharmion as reasonably
required to establish such supplier(s) designated by Pharmion by
written notice to Ash Stevens (each a “ Back-up
Supplier ”). Any third party supplier who has received
Ash Stevens’ process trade secrets or proprietary
confidential information pertaining to the Compound (as disclosed
for example in Ash Steven’ development report for the
Compound, any batch production record for the Compound or within
the CMC sections of the relevant NDA submissions to the FDA) from
Pharmion or an affiliate of Pharmion, either directly or
indirectly, shall for the purpose of payment of the Fee be deemed
also to be a “Back-up Supplier”. Such cooperation and
assistance may include reasonable assistance to facilitate the
preparation of registrations, permits, qualifications and approvals
from the relevant regulatory authorities so that such Back-up
Supplier(s) shall be enabled to satisfy regulatory requirements
necessary to commence manufacture and supply of Compound to
Pharmion. Ash Stevens shall be responsible for all of its own
reasonable costs and expenses incurred in association with
rendering such cooperation and assistance. Upon termination of the
Exclusivity Period pursuant to this Section 4(e) and subject to the
provisions of this Section 4(e), at the request of Pharmion,
Ash Stevens shall
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SUPPLY AGREEMENT
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Page 8 of 25
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*** Confidential Treatment Requested
transfer to the Back-up
Supplier(s) designated by Pharmion all Ash Stevens know-how or
other confidential information within Ash Stevens’ possession
that is necessary for the manufacture of Compound, provided that
such Back-up Supplier(s) shall have entered into a confidentiality
agreement with Ash Stevens in form and substance reasonably
satisfactory to Ash Stevens for purposes of appropriately and
reasonably protecting the confidentiality and restricting the use
of any such Ash Stevens know-how or other confidential
information.
Ash
Stevens hereby grants to Pharmion the following licenses (which
together with the balance of this Section 4(e) shall survive the
expiration or termination of this Agreement for any reason),
subject to Pharmion’s compliance with the terms and
conditions of this Agreement which pertain to the rights granted in
such licenses (the “Licenses”):
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(i)
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From and after the Effective Date, a
nonexclusive, royalty free license for the Territory, with the
right to sublicense, to use all information and intellectual
property rights owned or licensed by Ash Stevens, including Ash
Stevens’ Inventions, to research, develop, make, have made,
use, distribute, sell and otherwise commercialize products which
include Compound.
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(ii)
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From and after the earlier of
(A) the expiration or earlier termination of the Exclusivity
Period, or (B) the expiration or earlier termination of this
Agreement for any reason, a nonexclusive, royalty-free (except for
any Fee payable hereunder) license for the Territory, with the
right to sublicense, to use all information and intellectual
property rights owned or licensed by Ash Stevens, including Ash
Stevens’ Inventions, to research, develop, make, have made,
use, distribute, sell and otherwise commercialize
Compound.
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Except as
expressly provided below, during the Fee Period (as defined below),
Pharmion shall pay to Ash Stevens a fee of [... *** ...] of
Compound (the “ Fee ”) for all quantities of
Compound purchased or otherwise received from any Back-up
Supplier(s) by Pharmion, its affiliates (including Pharmion
Designees which are affiliates of Pharmion) and Pharmion Designees,
and each of their respective licensee, sublicensees and any other
third parties which derive their right to market and sell products
containing the Compound from Pharmion or a Pharmion affiliate or a
licensee of either of the foregoing (collectively, the “
Covered Compound Purchasers ”), either directly or
indirectly. The Fee payable for any calendar quarter (or portion
thereof) during the Fee Period shall be paid within ninety
(90) days after the end of such calendar quarter and be
accompanied by a report detailing the quantities of Compound
sourced from third parties during such quarter and the calculation
of the Fee payable for such quarter. The Fee will be payable during
the period beginning immediately following any early termination of
the Exclusivity Period (i.e. before its scheduled expiry on
May 31, 2011) and ending on May 31, 2011 (the “
Fee Period ”), except as expressly provided
below.
The
obligation to pay the Fee shall be suspended for a period two years
immediately following any early termination of the Exclusivity
Period (i.e. before its scheduled expiry on May 31, 2011) due
to a Supply Shortage pursuant to this Section 4(e) that Ash Stevens
has failed to correct within the applicable time period herein
provided for so doing.
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*** Confidential Treatment Requested
The
Fee shall not be payable if Ash Stevens has materially breached its
obligations under this Section 4(e), and failed to promptly
cure such breach upon notice thereof, to transfer to the Back-up
Supplier(s) the necessary know-how and confidential information and
to provide cooperation and assistance as reasonably required, it
being understood however that Ash Stevens shall be considered not
to be in material breach of such obligations where the Back-up
Supplier(s) has been unable or unwilling to receive or to make
effective use of the information or assistance offered by Ash
Stevens.
The
Fee shall not be payable in the event that the uncorrected Supply
Shortage or uncured material breach of this Agreement by Ash
Stevens is demonstrably due to Ash Stevens’ intentional
breach of its obligations to manufacture and supply quantities of
the Compound as properly forecasted, ordered and accepted hereunder
(for example, because of Ash Stevens decides to allocate production
capacity reserved for the production of the Compound for Pharmion
to a different compound for another of its customers or fails to
order necessary supplies). For the avoidance of doubt, the Fee
shall remain payable for any termination of this Agreement under
circumstances other than as set forth in the foregoing
sentence.
The
Fee shall not be payable in respect of any Compound purchased after
May 31, 2011.
Notwithstanding
any provision in this Agreement to the contrary, Ash Stevens shall
be entitled to suspend (during any period of payment default) the
Licenses under clause (ii) above, if sixty (60) days
after written notice has been given to Pharmion of any failure to
pay any amount on account of the Fee that is due and owing, such
amount remains unpaid, provided that Pharmion may avoid such
suspension if the Fee amounts disputed in good faith are deposited
in escrow and supplemented as appropriate pending resolution of the
dispute following the audit process provided in Section 13(o)
hereof.
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5.
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COMPOUND CHANGES; STARTING
MATERIALS
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(a)
Compound Changes .
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(i)
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Approval Rights
. Pharmion, in its sole
discretion, shall have the sole right and authority to make and
approve changes in the Specifications or the Compound; provided,
however, that Ash Stevens shall have limited rights as provided in
clause 5(a)(iii) to change suppliers of certain starting materials
which do not have a supplier specified in the Specifications. As
used in this Section 5, “ Change Expenses ”
shall mean the costs to both Parties of making changes in the
Specifications or the Compound, including, but not limited to,
validation and development costs, capital expenditure costs and
costs for any packaging components or other materials rendered
unusable as a result of such changes; to the extent possible, the
Parties shall agree upon the amount of Change Expenses in advance
of the implementation of any such change. For purposes of Change
Expenses, each Party shall account for the value of the time of its
personnel at the rate of Two Hundred Dollars (US$200) per hour (as
such fee may be increased annually by each Party by not more than
5% per year).
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Page 10 of 25
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(ii)
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Required Changes
. Ash Stevens shall
promptly (and in any event within the time period specified by the
applicable regulatory authority, or if no such time period is
specified, within thirty (30) calendar days unless another
suitable time period is mutually agreed by the Parties) make any
change in the Specifications or the Compound required to address
the requirements of regulatory authorities approved by Pharmion.
Change Expenses for changes required to address the requirements of
regulatory authorities shall be (i) paid for by Pharmion
pursuant to clause 5(a)(iv) hereof if directed to the Compound
specifically, or (ii) paid for by Ash Stevens pursuant to
clause 5(a)(iii) hereof if directed to the operations of Ash
Stevens generally ( i.e. , such modifications or changes are
applicable to both the Compound and one or more other products
manufactured by Ash Stevens). Any net cost decreases per kilogram
for the Compound (after deduction of all Change Expenses) resulting
from such changes shall be allocated as follows: [... ***
...].
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(iii)
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Discretionary Changes Requested by
Ash Stevens . Ash Stevens shall notify Pharmion
in advance and in writing, by submitting to Pharmion the form
substantially as attached as Exhibit D , of any
proposed change that Ash Stevens desires to make in the
Specifications or the Compound or its components. No such change
shall be made without Pharmion’s prior written approval
pursuant to clause 5(a)(i), which approval (i) shall not be
unreasonably withheld to change suppliers of certain starting
materials which do not have a supplier specified in the
Specifications or to make other changes that create no regulatory
consequence for Pharmion, or (ii) may be withheld in
Pharmion’s sole discretion for any other change. Change
Expenses for any such changes requested by Ash Stevens (including
costs to Pharmion) shall be paid by Ash Stevens without an increase
in the prices for the Compound. Any net cost decreases per kilogram
for the Compound resulting from such changes (after Ash Stevens has
first fully recovered all of its investment in Change Expenses)
shall be allocated as follows: [... *** ...].
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(iv)
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Discretionary Changes Requested by
Pharmion .
Pharmion may require that Ash Stevens make changes to the
Specifications, materials, fabrication, manufacturing or packaging
processes, provided that Pharmion shall consult with Ash Stevens
prior to any such change regarding the feasibility and Change
Expenses, to confirm among other things that such changes may be
safely implemented at Ash Stevens’ facilities and are changes
permitted under applicable law. Change Expenses for any such
changes requested by Pharmion (including costs to Ash Stevens)
shall be paid by Pharmion. In the event that raw materials costs or
conversion costs are materially increased (as shall be documented
and established by Ash Stevens) by such change, then the prices for
the Compound shall be increased by an equal amount of such cost
increases. Any net cost decreases per kilogram for the Compound
resulting from such changes (after Pharmion has first fully
recovered all of its investment in Change Expenses) shall be
allocated as follows: [... *** ...].
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*** Confidential Treatment Requested
(b)
Second Sources for Key Starting Materials . The Parties
acknowledge that as of the Effective Date there is only once source
of the following two (2) starting materials for the Compound:
5-Azacytosine and tetra-O-acetyl—D-ribofuranose (the “
Key Starting Materials ”). In the event that either
such source for a Key Starting Material, for whatever reason,
ceases to be available during the
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