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SUPPLY AGREEMENT

Supply Agreement

SUPPLY AGREEMENT | Document Parties: DENDREON CORP | Diosynth RTP You are currently viewing:
This Supply Agreement involves

DENDREON CORP | Diosynth RTP

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Title: SUPPLY AGREEMENT
Governing Law: New York     Date: 12/28/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

SUPPLY AGREEMENT, Parties: dendreon corp , diosynth rtp
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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:

 

1.

Definitions

 

All defined terms used in this Agreement have the meanings assigned to them in Schedule 1 .

 

2.

Supply of Ancillary Component

 

 

2.1.

During the term of this Agreement, DIOSYNTH will manufacture Ancillary Component for DENDREON at the Facility and in the quantities required under this Agreement.

 

 

2.2.

DIOSYNTH will manufacture the Ancillary Component for DENDREON only at its facility located in Research Triangle Park, North Carolina (the “Facility”).

 

 

2.3.

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”):

 

[***]

 

(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

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

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.

 

 

2.4.

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:

 

 

a)

Example of Consecutive Campaigns of the Same Lengths:

 

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.

 

 

b)

Example of Consecutive Campaigns of Different Lengths :

 

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.

 

 

2.5.

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.

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 2 of 27


 

2.6.

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.

 

3.

Term and Termination

 

 

3.1.

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”).

 

 

3.2.

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.

 

 

3.3.

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.

 

 

3.4.

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.

 

 

3.5.

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.

 

 

3.6.

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.

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 3 of 27


 

3.7.

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.

 

 

3.8.

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.

 

4.

Price, Invoicing and Payment

 

 

4.1.

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.

 

 

4.2.

Following receipt of an Order that complies with the terms of this Agreement, DIOSYNTH may invoice DENDREON as follows:

 

 

(a)

[ *** ] 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;

 

 

(b)

[ *** ] 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;

 

 

(c)

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

 

 

(d)

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.

 

 

(e)

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.

 

 

(f)

As Process Consumables are purchased, DIOSYNTH will issue a statement to DENDREON reconciling such purchases against the Estimated Consumables

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 4 of 27


 

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.

 

 

(g)

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:

 

 

i.

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

 

 

ii.

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.

 

 

4.3.

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.

 

 

4.4.

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.

 

 

4.5.

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.

 

 

4.6.

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.

 

 

4.7.

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.

 

5.

Title and Risk of Loss

 

 

5.1.

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.

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 5 of 27


 

5.2.

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.

 

6.

Forecasts/Orders

 

 

6.1.

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.

 

 

6.2.

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.

 

 

6.3.

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”).

 

 

6.4.

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.

 

 

6.5.

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.

 

 

6.6.

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,

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 6 of 27


 

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).

 

 

6.7.

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.

 

 

6.8.

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.

 

 

6.9.

With the exception of the first Order, DENDREON shall have the right to cancel any Orders submitted hereunder, subject to the following:

 

 

(a)

If the cancellation occurs [ *** ] months or more before the Order Campaign Start Date, the cancellation shall be without charge or other liability to DENDREON.

 

 

(b)

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:

 

 

i.

[ *** ] month Campaign –[ *** ] of the Campaign Base Price will be paid by DENDREON.

 

 

ii.

[ *** ] Month Campaign [ *** ] of the Campaign Base Price will be paid by DENDREON.

 

 

iii.

[ *** ] Month Campaign [ *** ] of the Campaign Base Price will be paid by DENDREON.

 

 

(c)

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:

 

 

i.

[ *** ] month Campaign –[ *** ] of the Campaign Base Price will be paid by DENDREON.

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 7 of 27


 

ii.

[ *** ] Month Campaign [ *** ] of the Campaign Base Price will be paid by DENDREON.

 

 

iii.

[ *** ] Month Campaign [ *** ] of the Campaign Base Price will be paid by DENDREON.

 

 

(d)

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.

 

 

(e)

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.

 

 

(f)

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.

 

 

6.10. 

DENDREON shall have the right to reduce any Order submitted hereunder, subject to the following:

 

 

(a)

DENDREON may not change the Order Campaign Start Date.

 

 

(b)

DENDREON may reduce any Order to a shorter Campaign without penalty no less than [ *** ] months prior to the Order Campaign Start Date.

 

 

(c)

DENDREON may reduce any Order from [ *** ] months prior to the Order Campaign Start Date through the Campaign Start Date, subject to the following:

 

 

i.

Campaign reduction fees to be paid by DENDREON will be calculated based on reduced Campaign length in increments of [ *** ] months.

 

 

ii.

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).

 

 

iii.

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.

 

 

iv.

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).

 

 

v.

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.

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 8 of 27


7.

Facilities Visits

 

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.

 

8.

Non-Conforming Ancillary Component

 

 

8.1.

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.

 

 

8.2.

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.

 

 

8.3.

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.

 

 

8.4.

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).

 

 

8.5.

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[ *** ]

 

[***]

DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

 

Page 9 of 27


9.

Recall of the Marketed Drug Product

 

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.

 

10.

DIOSYNTH Disclaimer

 

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.

 

11.

Confidentiality

 

 

11.1. 

Except


 
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