Exhibit 10.41
S UPPLY A GREEMENT
This Supply Agreement is effective as of
December 22, 2005 (“Effective Date”) by and
between Dendreon Corporation, a corporation organized under the
laws of the State of Delaware, and having a place of business at
3005 First Avenue, Seattle, Washington 98121
(“DENDREON”), and Diosynth RTP, a corporation organized
under the laws of the State of Delaware and having a place of
business at 101 J. Morris Commons Lane, Morrisville, NC 27560
(“DIOSYNTH”) (each individually a “Party”
and collectively the “Parties”).
W ITNESSETH :
Whereas, DENDREON and DIOSYNTH are parties to that
certain Bioprocessing Services Agreement dated March 16, 2001,
as amended by the First Amendment to Bioprocessing Services
Agreement dated May 8, 2003 and the Second Amendment to
Bioprocessing Services Agreement dated October 27, 2004 (as
amended, the “BSA”) for the provision of services for
the production of the Ancillary Component, which is used in the
manufacture of Drug Product; and
Whereas, DENDREON wishes to continue to purchase
Ancillary Component from DIOSYNTH, and DIOSYNTH wishes to continue
to sell and manufacture Ancillary Component for DENDREON under the
following terms of this Supply Agreement.
Now, Therefore , in consideration of the mutual covenants and
promises set forth herein, the parties agree as follows:
All defined terms used in this Agreement have
the meanings assigned to them in Schedule 1 .
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2.
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Supply of
Ancillary Component
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2.1.
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During the term
of this Agreement, DIOSYNTH will manufacture Ancillary Component
for DENDREON at the Facility and in the quantities required under
this Agreement.
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2.2.
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DIOSYNTH will
manufacture the Ancillary Component for DENDREON only at its
facility located in Research Triangle Park, North Carolina (the
“Facility”).
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2.3.
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During the
Term, DENDREON will order a minimum of one [***] Campaign in
accordance with the requirements of Section 6 (Forecasts/Orders).
DIOSYNTH shall produce at least the following Campaign Quantities
of Ancillary Component during each Campaign (as increased under
Section 2.4, the “Minimum Gram Guarantee”):
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[***]
(Each of the above amounts are the
“Original Minimum Gram Guarantees”).
For purposes of determining whether
the Minimum Gram Guarantee is satisfied, the mass of Ancillary
Component produced shall be determined with respect to final,
purified bulk Ancillary Component that is dispositioned, and shall
include from each
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 1 of 27
Campaign samples pulled during
filling. The mass is calculated by multiplying the Ancillary
Component concentration by the volume of Ancillary Component. The
Joint Operating Committee will maintain a register of mass of
Ancillary Component for each Campaign.
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2.4.
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If in any
Campaign (“First Campaign”) DIOSYNTH produces and
DENDREON Accepts more than the Minimum Gram Guarantee applicable to
the First Campaign (such additional amount being referred to as
“Additional Production”), other than as a result of
extension of the First Campaign to meet the Minimum Gram Guarantee,
the Minimum Gram Guarantee for the next Campaign shall be increased
as follows: The Minimum Gram Guarantee shall equal the greater of
(i) the Minimum Gram Guarantee applicable to the immediately
prior Campaign of equal length (or if no such Campaign has
occurred, the Original Minimum Gram Guarantee for that length
Campaign) or (ii) [ *** ] of the total production of Accepted
Ancillary Component during the First Campaign (proportionally
adjusted, where the First Campaign was not of equal length, by
multiplying [ *** ] of the total production of Accepted Ancillary
Component during the First Campaign by the Appropriate Adjustment
Ratio). For clarity, the following examples demonstrate the
intended application of the provisions of this Section
2.4:
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a)
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Example of
Consecutive Campaigns of the Same Lengths:
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Campaign #1 = [ *** ]
months.
Minimum Gram Guarantee = [ *** ]
grams.
[ *** ] grams Accepted.
Campaign #2 = [ *** ]
months.
Minimum Gram Guarantee = Greater of
(i) [ *** ] grams and (ii) [ *** ] grams = [ *** ] grams.
Thus, the Minimum Gram Guarantee is now [ *** ] grams.
[ *** ] grams Accepted (As the [ ***
] month Campaign yielded less than [ *** ] grams, the Campaign was
extended to produce at least [ *** ] grams, [ *** ] actually
Accepted).
Campaign #3 = [ *** ]
months.
Minimum Gram Guarantee = Greater of
(i) [ *** ] grams and (ii) [ *** ] x [ *** ] grams. Thus,
the Minimum Gram Guarantee is still [ *** ] grams.
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b)
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Example of
Consecutive Campaigns of Different Lengths :
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Campaign #1 = [ *** ]
months.
Minimum Gram Guarantee = [ *** ]
grams.
[ *** ] grams Accepted
Campaign #2 = [ *** ]
months.
Minimum Gram Guarantee = Greater of
(i) [ *** ] grams and (ii) [ *** ] grams x the
Appropriate Adjustment Ratio [ *** ] grams.
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2.5.
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Process
Consumables required in connection with the production and testing
of Ancillary Component under this Agreement shall be acquired as
set forth in Schedule 2 , which sets forth each of the
Parties’ roles and responsibilities with respect to the
Process Consumables.
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 2 of 27
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2.6.
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For
clarification purposes, except as set forth in the first sentence
of Section 0, nothing in this Agreement shall be construed as
creating a “requirements” contract or otherwise to
limit DENDREON’s right to manufacture Ancillary Component for
itself or to obtain Ancillary Component from third
parties.
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3.1.
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The term of
this Agreement shall commence on the Effective Date and shall
continue for a term of [ *** ] with automatic renewal for
additional [ *** ] terms unless either Party gives written notice
at least [ *** ] months prior to the expiration of such year term,
or unless terminated sooner pursuant to Sections 3.2, 3.3 or 3.4
below (“Term”).
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3.2.
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This Agreement
may be terminated by either Party in the event of the material
breach or default by the other Party of the terms and conditions
hereof; provided however, that the other Party shall first give to
the defaulting Party written notice of the proposed termination or
cancellation of the Agreement, specifying the grounds therefor.
Upon receipt of such notice, the defaulting party shall have [ ***
] days to cure such breach or default, except with respect to
DIOSYNTH’S failure to meet the minimum gram guarantee or
production of non-conforming Product, which shall be governed by
Sections 8.1 and 8.4 of this Agreement. If the defaulting Party
fails to cure such breach or default within the time set forth
above, then the other Party may immediately terminate this
Agreement. Termination of this Agreement pursuant to this Article
3.2 shall not affect any other rights or remedies which may be
available to the non-defaulting Party subject to the limitations
contained in Article 15.
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3.3.
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This Agreement
may be terminated by either Party if the other Party makes an
assignment for the benefit of its creditors, or is placed in
receivership, liquidation, or bankruptcy.
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3.4.
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This Agreement
may be terminated immediately at DIOSYNTH’S option if
DENDREON fails to place an Order for at least a [ *** ] -month
Campaign and purchase the Ancillary Component from that [ *** ]
month Campaign in any [ *** ] month period following the first
Order.
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3.5.
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It is
anticipated that approval of the current Ancillary Component
manufacturing process will be sought by Biologics License
Application (“BLA”) with the FDA in the third quarter
of 2006. This Agreement assumes the BLA will be accepted for
review, and approved by the FDA using the current Ancillary
Component manufacturing process as defined in the batch records and
deliverables from the BSA. Should the FDA require material changes
to the process, the parties will negotiate appropriate amendments
to this Agreement in good faith.
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3.6.
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The right of
either Party to terminate this Agreement as provided in Sections
3.2, 3.3 or 3.4 shall not be affected in any way by its waiver of,
or failure to take action with respect to, any other
default.
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 3 of 27
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3.7.
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Termination of
this Agreement for any reason shall not relieve the other Party of
any liability or from any obligations which have accrued under this
Agreement prior to such termination; provided that DENDREON may, at
its option, cancel any outstanding orders for Ancillary Component
without charge or other liability upon termination of this
Agreement by DENDREON for DIOSYNTH’S material breach or
default under Section 3.2.
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3.8.
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The following
Sections shall survive expiration or termination of this Agreement:
Sections 3.7, 3.8 and 5.2, and Articles 9 through 17 and
21.
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4.
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Price,
Invoicing and Payment
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4.1.
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The price per
Campaign to produce Ancillary Component manufactured hereunder
shall be determined as set forth in Schedule 3 attached
hereto, which is incorporated herein by reference. If DIOSYNTH
produces Additional Production during any Campaign, DENDREON shall
purchase [ *** ] of such Additional Production at a price per gram
equal to the Additional Production Price. Effective for all
invoices issued for Accepted Product on or after January 1,
2008 and each year thereafter, the price per Campaign and the price
for Additional Production shall be increased annually by the
percentage equal to the percentage increase in the Producer Price
Index from the previous calendar year.
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4.2.
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Following
receipt of an Order that complies with the terms of this Agreement,
DIOSYNTH may invoice DENDREON as follows:
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(a)
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[ *** ] percent
[ *** ] of the Campaign Base Price (as set forth in Schedule
3 , based on the assumption of delivery of the then-current
Minimum Gram Guarantee) upon the later of (i) receipt of the
order, or (ii) the date which is [ *** ] months before the
Order Campaign Start Date; provided that for the first Order
DIOSYNTH may invoice DENDREON this amount as of April 1,
2006;
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(b)
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[ *** ] percent
[ *** ] of the Estimated Consumables Payment (each as set forth in
Schedule 2 , based on the assumption of delivery of the
then-current Minimum Gram Guarantee) upon the later of
(i) receipt of the order, or (ii) the date which is [ ***
] months before the Order Campaign Start Date;
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(c)
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A further [ ***
] of the Campaign Base Price and the remaining [ *** ] percent [
*** ] of the Estimated Consumables Payment (as set forth in
Schedules 2 and 3 , based on the assumption of delivery of
the then-current Minimum Gram Guarantee) upon the Campaign Start
Date; and
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(d)
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The remaining [
*** ] percent [ *** ] of the Campaign Base Price shall be paid by
DENDREON on a per-gram basis, until the Minimum Gram Guarantee is
met as such Ancillary Component is Accepted by DENDREON under this
Agreement, at a price equal to [ *** ] percent [ *** ] of the ratio
of the Campaign Base Price divided by the Minimum Gram
Guarantee.
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(e)
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After the
Minimum Gram Guarantee is met, subsequent Additional Production
will be invoiced on a per-gram basis as such Ancillary Component is
Accepted by DENDREON at the Additional Production Price.
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(f)
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As Process Consumables are
purchased, DIOSYNTH will issue a statement to DENDREON reconciling
such purchases against the Estimated Consumables
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 4 of 27
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Payment pursuant to Schedule
2 and section 4.2(b). The reconciliation against Actual
Consumables Payment will result in either: (i) a credit for
overpayment compared to the Estimated Consumables Payment which
DIOSYNTH will credit against the Campaign Base Price, or
(ii) an invoice to DENDREON for the additional costs compared
to the Estimated Consumables Payment.
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(g)
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For the first [
*** ] months of manufacturing under this Agreement, DIOYSNTH will
invoice DENDREON on a monthly basis for manufacturing support by
DIOSYNTH’S process development group. Such manufacturing
support will be priced at the Manufacturing Support Price per month
as specified in Schedule 3 . For clarity, the following
example demonstrates the intended application of the provisions of
this Section:
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i.
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DENDREON’s Initial Order is for a [ *** ]
month Campaign: DIOSYNTH will invoice DENDREON at the Manufacturing
Support Price at the Campaign Start Date and for the subsequent [
*** ] monthly invoices
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ii.
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DENDREON’s next Order is for a [ *** ]
month Campaign: DIOSYNTH will invoice at the Manufacturing Support
Price at the Campaign Start Date and for the subsequent [ *** ]
monthly invoices.
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4.3.
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DENDREON shall
pay DIOSYNTH in U.S. dollars within thirty (30) days from the
date of invoice. Invoiced amounts not paid within such thirty
(30) day period, and not disputed under Section 4.7, are
subject to interest at the lesser rate of one percent (1%) per
month, or the maximum rate amount permitted by law.
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4.4.
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Any Ancillary
Component stored by DIOSYNTH for more than sixty (60) days
after Acceptance by DENDREON is subject to a storage charge of [
*** ] per Lot per day.
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4.5.
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Except as
provided in Section 4.7, any amounts owed for more than sixty (60)
days past due, and not disputed under Section 4.7, constitute a
material breach of this Agreement.
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4.6.
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Notwithstanding
the DENDREON Process Consumables Payment Percentage set forth in
Schedule 2 , DENDREON shall bear 100% of the costs related
to changes in availability or catalog/custom status of the cell
culture medium (currently Sf900II) or chromatography
resins.
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4.7.
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DENDREON shall
notify DIOSYNTH in writing of any good faith dispute with respect
to any invoice within thirty (30) calendar days after the date
of such invoice, and the Parties shall promptly attempt in good
faith to amicably resolve such disagreement. In the event that
DENDREON disagrees with part of any invoice pursuant to this
Section 4.7 DENDREON shall pay the part of that invoice not subject
to disagreement.
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5.
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Title and
Risk of Loss
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5.1.
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DIOSYNTH shall
deliver Ancillary Component to DENDREON FCA (according to INCO
Terms 2000) the Facility. Delivery of Ancillary Component by
DIOSYNTH shall be deemed to have taken place upon delivery to a
DENDREON-designated carrier at the Facility.
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 5 of 27
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5.2.
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Title and risk
of loss to the Ancillary Component sold hereunder shall pass to
DENDREON upon delivery of Ancillary Component to a
DENDREON-designated carrier at DIOSYNTH’S facility consistent
with Section 5.1.
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6.1.
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Within ten
(10) business days after the Effective Date, and thereafter
within ten (10) business days after the start of each Quarter
during the Term, DENDREON shall submit to DIOSYNTH a [ *** ]
rolling forecast for its anticipated requirements for Ancillary
Component for the succeeding [ *** ] Quarters (beginning with the
Quarter in which the forecast is due). Notwithstanding the
provisions of this Section 6.1, the forecasts that DENDREON is to
provide hereunder need not extend beyond this Agreement’s
Term.
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6.2.
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DENDREON shall
submit to DIOSYNTH a binding Order for the first Campaign by
January 1, 2006. DENDREON does not anticipate placing an
additional Order until[ *** ]; accordingly, DIOSYNTH shall be free
to fill its intermediate scale cell culture facility with other
customers from[ *** ]. In addition, following DENDREON’s
placement of any Order for a [ *** ] month Campaign, DIOSYNTH shall
be free to fill its intermediate scale cell culture facility with
other customers for the [ *** ] month period beginning [ *** ]
months after the Order Campaign Start Date for that [ *** ] month
Campaign and following DENDREON’s placement of any Order for
a [ *** ] -month Campaign, DIOSYNTH shall be free to fill its
intermediate scale cell culture facility with other customers for
the [ *** ] -month period beginning [ *** ] months after the Order
Campaign Start Date for that [ *** ] month Campaign.
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6.3.
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DENDREON’s first Order for a Campaign
under Section 6.2, and all subsequent Orders, shall be submitted to
DIOSYNTH at least [ *** ] months prior to the requested Campaign
Start Date that is specified in the Order (such specified Campaign
Start Date, the “Order Campaign Start
Date”).
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6.4.
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Each Order
shall be for a [ *** ] month Campaign and shall specify
(i) the Order Campaign Start Date; (ii) the length of the
Campaign; and (iii) the designated carrier for delivery of
Ancillary Component.
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6.5.
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DIOSYNTH shall
respond to a written Order from DENDREON within ten
(10) business days (an “Order Acceptance”) to
accept the Order and confirm an estimated Campaign Start Date,
which shall be no later than the Order Campaign Start Date, and
which shall be confirmed in writing at least six (6) month
prior to the Order Campaign Start Date, and the Estimated Campaign
Completion Date, and which shall include the applicable Minimum
Gram Guarantee for the Campaign.
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6.6.
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After receiving an Order for a
Campaign, DENDREON shall have the right and option to extend the
Campaign for up to an additional [ *** ] months; provided that
DIOSYNTH has available manufacturing capacity and raw materials. If
the Campaign is extended from a [ *** ] month Campaign to a [ *** ]
month Campaign,
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 6 of 27
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then DIOSYNTH may invoice
DENDREON as if the extension was a new Order for a [ *** ] month
Campaign (provided that DENDREON shall receive a credit for any
amounts previously paid by DENDREON on the original Order for the [
*** ] month Campaign). Likewise, if the Campaign is extended from
either a [ *** ] month Campaign to a[ *** ] month Campaign, then
DIOSYNTH may invoice DENDREON as if the extension was a new Order
for a [ *** ] month Campaign (provided that DENDREON shall receive
a credit for any amounts previously paid by DENDREON on the
original Order for the [ *** ] month Campaign).
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6.7.
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The Parties
recognize that this Agreement is for the manufacturing and delivery
of Ancillary Component and that there is an interval of
approximately [ *** ] weeks between completion of manufacture of
Ancillary Component and Disposition of Ancillary
Component.
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6.8.
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Once an Order
has been placed, it shall be binding on both Parties (except as
provided in Section 3.7) and (i) DENDREON shall be responsible
for payment of the price of such Order as set forth in Section 4.2,
subject to DENDREON’s cancellation rights under Section 6.9,
and (ii) DIOSYNTH shall be responsible to fulfill the Order by
the dates set forth therein.
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6.9.
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With the
exception of the first Order, DENDREON shall have the right to
cancel any Orders submitted hereunder, subject to the
following:
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(a)
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If the
cancellation occurs [ *** ] months or more before the Order
Campaign Start Date, the cancellation shall be without charge or
other liability to DENDREON.
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(b)
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If the
cancellation occurs at least [ *** ] months, but no more than [ ***
] months, before the Order Campaign Start Date, DENDREON shall be
responsible for a percentage of the Campaign Base Price of the
Campaign specified in the Order (as set forth in Schedule 2
, based on the assumption of delivery of the then-current Minimum
Gram Guarantee) and one hundred percent (100%) of the Actual
Consumables Payment. The cancellation fee will be determined as
follows:
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i.
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[ *** ] month
Campaign –[ *** ] of the Campaign Base Price will be paid by
DENDREON.
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ii.
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[ *** ] Month
Campaign [ *** ] of the Campaign Base Price will be paid by
DENDREON.
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iii.
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[ *** ] Month
Campaign [ *** ] of the Campaign Base Price will be paid by
DENDREON.
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(c)
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If the
cancellation occurs before the Order Campaign Start Date, but no
more than [ *** ] before the Order Campaign Start Date, DENDREON
shall be responsible for a percentage of the Campaign Base Price of
the Campaign specified in the Order (as set forth in Schedule
2 , based on the assumption of delivery of the then-current
Minimum Gram Guarantee) and one hundred percent (100%) of the
Actual Consumables Payment. The cancellation fee will be applied as
follows:
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i.
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[ *** ] month
Campaign –[ *** ] of the Campaign Base Price will be paid by
DENDREON.
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 7 of 27
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ii.
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[ *** ] Month
Campaign [ *** ] of the Campaign Base Price will be paid by
DENDREON.
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iii.
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[ *** ] Month
Campaign [ *** ] of the Campaign Base Price will be paid by
DENDREON.
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(d)
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If the
cancellation occurs on or after the Order Campaign Start Date,
DENDREON shall be responsible for [ *** ] of the Campaign Base
Price plus the higher value of the Estimated Consumables Payment or
the Actual Consumables Payment.
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(e)
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DIOSYNTH shall
use all reasonable efforts to mitigate its losses where DENDREON
cancels an Order, including, among other things, using the Process
Consumables for other customers of DIOSYNTH and returning Process
Consumables for cash or credit wherever possible. DIOSYNTH shall
promptly notify DENDREON of any losses it is able to mitigate, and
DENDREON’S payment obligations under this Section 6.9 shall
be reduced to the extent that DIOSYNTH mitigates its losses in this
regard.
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(f)
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Any amounts
paid by DENDREON for a Campaign under Section 4 shall be fully
credited against amounts due under this Section 6.9. To the extent
amounts paid under Section 4 exceed amounts payable under this
Section 6.9, DIOSYNTH shall promptly refund the difference to
DENDREON.
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6.10.
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DENDREON shall
have the right to reduce any Order submitted hereunder, subject to
the following:
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(a)
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DENDREON may
not change the Order Campaign Start Date.
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(b)
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DENDREON may
reduce any Order to a shorter Campaign without penalty no less than
[ *** ] months prior to the Order Campaign Start Date.
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(c)
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DENDREON may
reduce any Order from [ *** ] months prior to the Order Campaign
Start Date through the Campaign Start Date, subject to the
following:
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i.
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Campaign
reduction fees to be paid by DENDREON will be calculated based on
reduced Campaign length in increments of [ *** ] months.
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ii.
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For a reduction
of [ *** ] months from a [ *** ] month to a [ *** ] month Campaign,
DENDREON shall pay to DIOSYNTH [ *** ] [ *** ] of the difference in
Campaign Base Prices (as set forth in Schedule 2 , based on
the assumption of delivery of the then-current Minimum Gram
Guarantee).
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iii.
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For a reduction
of [ *** ] months from a [ *** ] month to a[ *** ] month Campaign,
DENDREON shall pay to DIOSYNTH [ *** ] of the difference in
Campaign Base Prices (as set forth in Schedule 2 , based on
the assumption of delivery of the then-current Minimum Gram
Guarantee.
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iv.
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For a reduction
of [ *** ] months from a [ *** ] month to a [ *** ] month Campaign
DENDREON shall pay to DIOSYNTH a reduction fee equal to [ *** ] of
the difference in the Campaign Base Prices (as set forth in
Schedule 2 , based on the assumption of delivery of the
then-current Minimum Gram Guarantee).
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v.
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DENDREON shall
pay to DIOSYNTH the Actual Consumables Payment for the reduced
Order, including payment for any surplus consumable irrevocably
committed by DIOSYNTH for the Original Order Campaign.
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 8 of 27
DENDREON shall have the right to
visit DIOSYNTH’S facilities in accordance with the guidelines
set forth in Schedule 5 attached to this Agreement. DENDREON
agrees to comply with these guidelines and shall bear
responsibility for any failure of its representatives to so
comply.
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8.
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Non-Conforming Ancillary
Component
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8.1.
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If during the
performance of a Campaign DIOSYNTH reasonably anticipates that the
Campaign Quantity of Acceptable Ancillary Component that will be
produced in such Campaign may not meet the applicable Minimum Gram
Guarantee, DIOSYNTH shall promptly notify DENDREON in writing and
shall extend the Campaign as reasonably necessary to meet the
Minimum Gram Guarantee, unless DENDREON otherwise notifies DIOSYNTH
in its discretion. In the event that DIOSYNTH reasonably
anticipates during the Campaign that the Campaign Quantity of
Acceptable Ancillary Component will meet the Minimum Gram
Guarantee, but the Campaign does not actually produce sufficient
Acceptable Ancillary Component to meet the Minimum Gram Guarantee,
then DIOSYNTH shall promptly produce, at its sole cost, such
additional Ancillary Component as is necessary to meet the Minimum
Gram Guarantee[ *** ] The remedies set forth in this Section 8.1
shall be DENDREON’s sole remedy in the case of failure to
meet the Minimum Gram Guarantee.
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8.2.
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Subject to
Section 6.7, after the completion of a Lot, DIOSYNTH shall use
commercially reasonable efforts to Disposition the Ancillary
Component to DENDREON along with the certificate of analysis, other
associated manufacturing, testing and process documentation, and
supporting data, required to be provided by DIOSYNTH under the
Quality Agreement.
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8.3.
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Ancillary
Component shall be considered non-conforming, and may be rejected
by DENDREON, if it fails to conform to the warranties set forth in
section 16.1.
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8.4.
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In the event
that any Ancillary Component is Dispositioned by DIOSYNTH and not
Accepted by DENDREON pursuant to written notification, DIOSYNTH
shall not ship such Ancillary Component. In such case, and if
DIOSYNTH concurs with DENDREON’s basis for not Accepting the
Ancillary Component, DIOSYNTH shall replace the non-conforming
Ancillary Component up to the Minimum Gram Guarantee[ *** ] The
replacement of non-conforming Ancillary Component as provided in
this paragraph shall constitute DENDREON’S sole remedy for
the production of non-conforming Ancillary Component, subject to
Sections 4.2(d) and (e) (pursuant to which certain DENDREON
payment obligations that are conditioned upon Acceptance of
Ancillary Component), and without limiting DIOSYNTH’s
obligations or DENDREON’s rights under Sections 9 (Recall of
Marketed Drug Product), and 12 (Indemnification).
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8.5.
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If DENDREON and
DIOSYNTH are unable to agree as to whether such Ancillary Component
meets the warranties set forth in Section 17.1(a), then the matter
shall be[ *** ] If DENDREON and DIOSYNTH are unable to agree as to
whether such Ancillary Component meets the warranties set forth in
Section 17.1(b)-(e), then[ *** ]
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[***]
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION
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Page 9 of 27
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9.
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Recall of
the Marketed Drug Product
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Each party shall promptly notify the
other party (in any event within 48 hours) of obtaining knowledge
of any information that might reasonably result in the recall,
seizure or other enforcement action relating to the Drug Product.
If Drug Product must be recalled by reason of failure to meet any
regulatory requirement, or DENDREON reasonably determines that all
or specified quantities of the Drug Product should be recalled,
DENDREON shall have the sole responsibility to effect the recall.
However, DIOSYNTH shall cooperate as reasonably requested by
DENDREON. DENDREON shall reimburse DIOSYNTH for any costs
reasonably expended by DIOSYNTH unless the recall is due to
negligent or intentionally wrongful act or omission of DIOSYNTH, or
a failure of DIOSYNTH to conform in all material respects to the
Specifications or the provisions of this Agreement or the Quality
Agreement, then DIOSYNTH shall reimburse DENDREON for all costs
reasonably expended by DENDREON to effect the removal of Drug
Product from the supply chain.
EXCEPT FOR EXPRESS WARRANTIES
PROVIDED IN THIS AGREEMENT, DIOSYNTH HEREBY EXPRESSLY DISCLAIMS ANY
WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD TO THE SERVICES AND
PRODUCTS PROVIDED UNDER THIS AGREEMENT AND THE MANUFACTURE OF
ANCILLARY COMPONENT, INCLUDING, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
EXCEPT FOR EXPRESS WARRANTIES DESCRIBED IN SECTION 17.1 , DIOSYNTH
FURTHER DISCLAIMS ANY WARRANTY THAT THE ANCILLARY COMPONENT
SUPPLIED TO DENDREON HEREUNDER WILL SATISFY THE REQUIREMENTS OF ANY
REGULATORY AGENCY AT THE TIME OF A REGULATORY SUBMISSION TO SUCH
AGENCIES.
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