First Amendment to Letter Agreement Between Affymax, Inc. and American Peptide Company, Inc. for Manufacture and Supply of Hematide

Summary

Affymax, Inc. and American Peptide Company, Inc. have amended their original agreement regarding the manufacture and supply of Hematide, a proprietary peptide product. Under this amendment, APC will manufacture and deliver specified quantities of Hematide with a particular polyethylene glycol (PEG) component, using materials supplied by Affymax. The amendment sets delivery schedules, pricing, and procedures for unused materials. Both parties agree to the updated terms to expedite the development and supply of clinical-grade Hematide for clinical trials.

EX-10.24 28 a2171549zex-10_24.htm EXHIBIT 10.24

[*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Exhibit 10.24

First Amendment to Letter of Intent

        This First Amendment (the "Amendment") to the letter agreement by and between the Affymax, Inc. ("Affymax"), a Delaware corporation located at 4001 Miranda Avenue, Palo Alto California, and American Peptide Company, Inc. ("APC") a California corporation with registered offices at 777 Evelyn Avenue, Sunnyvale, California, and dated of even date herewith ("Letter Agreement") is entered into this 9th day of October 2003.

BACKGROUND

        Affymax and APC have entered into the Letter Agreement, which is incorporated herein by reference, whereunder Affymax and APC agreed to certain terms with respect to a process development and supply relationship in which APC will manufacture and supply Affymax with Affymax's requirements for Affymax's proprietary peptide product Hematide through Phase II clinical trials. The terms of the Letter Agreement relate to Hematide having a [*] polyethylene glycol ("[*] PEG").

        For the purpose of enhancing the commercial potential of Hematide at an expedited pace, both parties desire to cooperate further in conducting manufacture, testing and release of clinical grade (cGMP) Hematide which incorporates a [*]polyethylene glycol ("[*] PEG") under the same terms as the Letter Agreement except as specifically modified herein.

        Now, therefore, in consideration of the mutual obligations set forth herein and of other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Affymax and APC agree as follows:

AGREEMENT

        The parties agree that the following terms and modifications shall supercede the corresponding provisions in the Letter Agreement:

        Affymax and APC have decided to substitute Hematide containing [*] PEG ("[*] PEG Hematide") and designated as [*] which shall be manufactured in place of Hematide containing [*] PEG [*]. The [*] PEG Hematide shall be manufactured using [*] PEG obtained from Nektar per Affymax's request and shipped directly to APC. If APC receives at least 75-80 grams of [*] PEG from Nektar prior to October 3, 2003, then APC shall release and deliver to Affymax on or before November 28, 2003 a minimum of thirty (30) grams of Early Stage Drug Substance comprising gross weight of [*] PEG Hematide. The Specifications for this Early Stage Drug Substance is described in the attached Exhibits A and B which supercede the corresponding Exhibits in the Letter Agreement.

        Affymax shall cause to be delivered to APC an additional shipment of Nektar PEG and, if delivered to APC by October 31, 2003, APC shall release and deliver a second batch of Early


Stage Drug Substance fulfilling the Affymax order for a total of one-hundred (100) grams total nine (9) weeks after APC's QA release of the [*] PEG which shall result in product release and shipment no later than twelve (12) weeks subsequent to October 31, 2003. The cost per gram for Early Stage Drug Substance for the two batches totaling one-hundred (100) grams shall be [*] for Early Stage Drug Substance conforming to the Specifications. Affymax shall supply [*] PEG to APC at a cost of [*] to be credited against any future invoice from APC payable by Affymax. APC shall return any unused portion of the [*] PEG to Affymax after conjugation is complete and shall receive a reciprocal credit from Affymax of $100 per gram for the unused PEG.

        Affymax agrees to reimburse APC for up to [*] of unused [*] PEG (Sunbrite) and APC shall ship said [*] PEG to Affymax prior to October 31, 2003.

        This document serves as authorization from Affymax for APC to utilize the Nektar [*] PEG as specified in the current BPR for manufacture of the Early Stage Drug Substance.

        IN WITNESS THEREOF, the parties hereto have caused this Amendment to be executed by their respective duly authorized officers or representatives on the date first above written.

"AFFYMAX"
Affymax, Inc.
  "APC"
American Peptide Company

By:

/s/  ARLENE MORRIS      

 

By:

/s/  SHAWN LEE      
Name: Arlene M. Morris
  Name: Shawn Lee
Title: President and CEO
  Title: Chief Operating Officer
Date: October 9, 2003
  Date: October 9, 2003

[*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.


Exhibits A and B attached following

Exhibit A

Product

Product
Number

  Sequence
  Purity By
HPLC

  Quantity
Gross

  Price
(US$)

  Delivery (wks)
323012   [*]   = or [*]   2 batches
total min 75g
to max 100g
  [*]   [*]

Exhibit B

Specifications for Release [*] Intermediate:

Attribute

  Specifications
  Test Methods
[*]   [*]   [*]

Specifications for GMP Release [*]:

Attribute

  Specifications
  Test Methods
[*]   [*]   [*]

Additional Specifications for [*] for Information Only:

Attribute

  Specifications
  Test Methods
  Cost
[*]   [*]   [*]   [*]

[*] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.