March 4, 2005 Kevin Cox Vice President, Biotechnology Avecia Limited Hexagon House, Blackley Manchester M9 8ZS England
Exhibit 10.40
March 4, 2005
Xxxxx Xxx
Vice President, Biotechnology
Avecia Limited
Xxxxxxx Xxxxx, Xxxxxxxx
Xxxxxxxxxx X0 0XX
Xxxxxxx
| Re: | Agreement between Corgentech Inc. and Avecia Limited, Dated December 27, 2004 |
Dear Xxxxx:
This letter will modify the programme of work (the “Programme”) to be carried our under Schedule 1, Part B, of the Agreement dated December 27, 2004 (the “Agreement”) between Corgentech Inc. (“Corgentech”) and Avecia Limited (“Avecia”). Except as expressly set forth in this letter, all other terms of the Agreement shall remain unmodified and in full force and effect.
Under the Programme, Avecia shall perform the work set forth below.
| 1. | E2F Decoy Technical assistance |
Perform activities to support CGT regulatory filling, support rapid resumption of E2F Decoy SSI and duplex production, prepare the facility for a FDA Pre Approval Inspection (PAI) and commercial production as outlined on the attached Schedule 1
| 2. | NFkappaB Decoy Technical assistance |
Perform activities to support CGT knowledge of the NFkappaB Decoy as outlined in the attached Schedule 1.
| 3. | General Assistance |
Provide summary cost monthly breakdowns between NFkappaB Decoy manufacturing, E2F Decoy technical assistance and NFkappaB technical assistance allocated by Manufacturing, QA/QC, R&T, SG&A and depreciation.
Notwithstanding anything to the contrary in Paragraphs 7 and 8 of the Programme, the only amount Corgentech shall pay to Avecia under the Programme for raw materials or Milestones, beyond amounts already paid to Avecia as of the date of this letter, shall be USD $304,000 as described in the attached letter from Avecia to CGT dated January 5, 2005.
| By: |
/s/ Xxxx X. Xxxxx | |
| Xxxx X. Xxxxx | ||
| Vice President, Manufacturing | ||
| Accepted and agreed, | ||
| Avecia Limited | ||
| By: |
/s/ Xxxxx Xxx | |
| Name: |
Xxxxx Xxx | |
| Title: |
Vice President, Biotechnology | |
January 5, 2005
Xxxxx Xxxxxxxxxx
Senior Director, Manufacturing
Corgentech
000 Xxxxxxx Xxxx.
Xxxxx Xxx Xxxxxxxxx, XX 00000
Re: Raw Material Requirements for NFkB Q1 runs
Dear Xxxxx:
Thanks for your call on Monday as a follow up on the information you were still waiting on us for the NFKB campaigns. As requested, here is the information you needed as a more complete breakdown of the raw material requirement for the Quarter 1 NFkappaB campaigns.
On the original schedule, when we were planning for E2F Cleaning Validation manufacture in Quarter 1, we agreed a $500,000 up-front payment to cover raw material purchase. Those material have been ordered. Many of them can be used in NFkappaB manufacture and we have redirected them in order to minimise the material costs for the NFkappaB campaign.
In addition, part of the $500,000 E2F payment has been used to partially underwrite the strategic stock of tetrazole required to support E2F manufacture through 2005/06 (as agreed in e.mail exchanges between Andy and Matt November 17).
The detailed raw material costs are embedded below. In summary the headline figures are:
| $000 |
|||
| Material requirement for 3 x E2F |
440 | ||
| Tetrazole strategic stock |
90 | ||
| Material requirement for 4 x NFkappaB |
590 | ||
| E2F stock unusable for NFkappaB |
214 | ||
| Balance of material cost for NFkappaB |
304 | * |
| * | 304 = 590 (NFkappaB cost) – 500 (E2F payment) + 214 (E2F unusable) |
These costs only encompass the external spend Avecia has borne to secure the raw materials – ie they do not take account of the Avecia internal effort required to order, receive, quarantine, test, clear, store and transfer the materials. This approach is most appropriate under these circumstances because the internal fixed costs are being covered through an alternative payment mechanism.
With this approach Corgentech will remain the named owner of the strategic stock of tetrazole and the CPG –T and Primer Support 30 HL G which was purchased under the $500,000 up-front payment for E2F cleaning validation.
If you require any further information or explanation please do not hesitate to ask.
Assuming everything has been explained to your satisfaction it is our intention to proceed with raising an invoice for $304,000 in the next few days.
Thanks so much.
Sincerely-
| /s/ Xxxxxx Xxxxx |
| Xxxxxx Xxxxx |
| Director North American Sales |
Q1 2005 Avecia Requirements
| In Scope to complete |
Progress as possible | |||
| NFkB DECOY
|
• Campaign 2, as detailed through March
• Campaign 1 - second duplex run
• Qualification of cleaning methods(complete)
• Routine stability testing Campaign 1
• Close out complaint for particulate deviation, CGT to provide information on particulate identitiy
• Collect in-process fraction samples
• D7000/001/04K split down/release |
• Initiate Campaign 2 stability (CGT to request)
| ||
| E2F DECOY
|
• D1700 Restart Plan including generation/approval of all required cleaning documentation and schedule for dedicated equipment installation
• IEX study for D1700 stress/photostability studies
• Routine stability testing
• Insure raw material supply to support a minimum of 2 runs of D1702 &1 run of D1701(CGT to authorize orders)
• Close out cleaning failure investigation
• Incorporate vendor COA’s in PDF’s for solid support
• SOP and PI Sheet revisions
• Trial both SSI and IP revised RP-HPLC methods and initiate SSI method qualification |
• Validate D1700 cleaning methods
• Complete all technical reports including process validation
• Generate and finalize a 300mmol Scale-up Plan
• Support for Drug Product degradation studies –LCMS(scope in development)
• Complete the stability moisture failure investigation (scope tbd) | ||
| HIF |
• * Hold inventory |
|||
|
GENERAL |
• Update Intertek Quality Agreement
• Monthly Inventory Reports (all products)
• PAI readiness
• Address major observations from pre-audit
• Control of dedicated equipment |
• Scientific Publication assistance | ||
