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AMENDMENT NO. 1 TO THE COLLABORATION AGREEMENT

Collaboration Agreement

AMENDMENT NO. 1

                                     TO THE

                             COLLABORATION AGREEMENT
 | Document Parties: VIACELL INC | AMGEN INC. You are currently viewing:
This Collaboration Agreement involves

VIACELL INC | AMGEN INC.

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Title: AMENDMENT NO. 1 TO THE COLLABORATION AGREEMENT
Governing Law: New York     Date: 11/14/2005

AMENDMENT NO. 1

                                     TO THE

                             COLLABORATION AGREEMENT
, Parties: viacell inc , amgen inc.
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<PAGE>

                                                                    EXHIBIT 10.1

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS

([**]), HAS BEEN OMITTED AND FILED SEPARATELY WTH THE SECURITIES AND EXCHANGE

COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS

AMENDED

 

                                 AMENDMENT NO. 1

                                     TO THE

                             COLLABORATION AGREEMENT

 

THIS AMENDMENT NO. 1 TO THE COLLABORATION AGREEMENT (this "Amendment") is made

effective as of August 29, 2005 (the "Amendment Effective Date") by and between

AMGEN INC., a Delaware corporation having its principal place of business at One

Amgen Center Drive, Thousand Oaks, California 91320-1799 ("Amgen"), and VIACELL,

INC., a Delaware corporation having its principal place of business at 245 First

Street, Cambridge, Massachusetts 02142 ("ViaCell"). Amgen and ViaCell are

sometimes referred to herein individually as a "Party" and collectively as the

"Parties".

 

WHEREAS, Amgen and ViaCell entered into that certain Collaboration Agreement

dated December 23, 2003 (the "Agreement"), pursuant to which ViaCell obtained

supplies of and a license under Amgen's intellectual property rights in SCF and

Flt3-L for use in ViaCell's research and development activities relating to cell

therapy products and services;

 

WHEREAS, the Agreement dictates how the Parties may collaborate in the future

with respect to late stage clinical trials and commercialization of ViaCell's

cell therapy products;

 

WHEREAS, ViaCell wishes to obtain a supply of G-CSF and a license under Amgen's

intellectual property rights in G-CSF for use in ViaCell's research and

development activities relating to cell therapy products and services; and

 

WHEREAS, concurrently with the execution of this Amendment the Parties are

entering into a Warrant Purchase Agreement whereby Amgen is acquiring a warrant

to purchase the common stock of ViaCell.

 

NOW, THEREFORE, in consideration of the mutual promises and covenants

hereinafter set forth, the parties hereto agree to amend the Agreement as

follows:

 

                             ARTICLE 1 - AMENDMENTS

 

1.1 AMENDMENT TO SECTION 1.8. Section 1.8 of the Agreement shall be replaced in

its entirety and read as follows:

 

 

                                        1

 

<PAGE>

 

                                                                    EXHIBIT 10.1

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS

([**]), HAS BEEN OMITTED AND FILED SEPARATELY WTH THE SECURITIES AND EXCHANGE

COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS

AMENDED

 

     "1.8 "CELL THERAPY PRODUCT(S)" SHALL MEAN ANY TREATMENT, WHETHER A PRODUCT

     OR A SERVICE, THAT UTILIZES CELLS OR TISSUES [**] INCLUDING, WITHOUT

     LIMITATION, CB001, PRIOR TO THE EARLIER OF THE EXERCISE OF THE OPTION OR

     THE EXPIRATION OF THE OPTION PERIOD WITH RESPECT TO SUCH TREATMENT;

     PROVIDED, HOWEVER, THAT NO PRODUCT OR SERVICE WHICH INCLUDES OR IS PRODUCED

     USING G-CSF SHALL BE A CELL THERAPY PRODUCT, UNLESS SUCH PRODUCT OR SERVICE

     MEETS THE DEFINITION OF A G-CSF PRODUCT. FOR THE AVOIDANCE OF DOUBT, ONCE

     AMGEN EXERCISES ITS OPTION WITH RESPECT TO A CELL THERAPY PRODUCT, SUCH

      CELL THERAPY PRODUCT SHALL BE DEEMED A COLLABORATION PRODUCT AND SHALL

     CEASE TO BE CONSIDERED A CELL THERAPY PRODUCT. FOR THE AVOIDANCE OF DOUBT,

     ONCE THE OPTION PERIOD EXPIRES WITH RESPECT TO A CELL THERAPY PRODUCT FOR

     AN INDICATION WITHOUT AMGEN HAVING EXERCISED ITS OPTION WITH RESPECT

     THERETO SUCH CELL THERAPY PRODUCT FOR THAT INDICATION SHALL BE DEEMED AN

     UNOPTIONED CELL THERAPY PRODUCT AND SHALL CEASE TO BE CONSIDERED A CELL

     THERAPY PRODUCT."

 

1.2 AMENDMENT TO SECTION 1.18. Section 1.18 of the Agreement shall be replaced

in its entirety and read as follows:

 

     "1.18 "CONTRIBUTED PRODUCT" shall mean (a) SCF, (b) Flt3-L, (c) G-CSF and

     (d) [**] that Amgen Controls and which Amgen has, [**], chosen to make

     available to ViaCell under this Agreement, and which ViaCell has expressly

     accepted for use in connection with Unoptioned Cell Therapy Products, Cell

     Therapy Products and/or Collaboration Products under this Agreement, as

     listed on Exhibit D, as updated from time to time by mutual agreement of

     the Parties."

 

1.3 AMENDMENT TO SECTION 1.64. Section 1.64 of the Agreement shall be replaced

in its entirety and read as follows:

 

     "1.64 "UNOPTIONED CELL THERAPY PRODUCT(S)" shall mean any Cell Therapy

     Product for an indication for which the Option Period has expired without

     Amgen having exercised its option with respect thereto."

 

1.4 AMENDMENT TO ARTICLE 1. Article 1 of the Agreement shall be amended to

include a new Section 1.69 as follows:

 

     "1.69 "G-CSF" shall mean Amgen's granulocyte colony-stimulating factor, an

     early-acting hematopoietic growth factor, having the amino acid sequence

     which is set forth in Exhibit I [**]."

 

1.5 AMENDMENT TO ARTICLE 1. Article 1 of the Agreement shall be amended to

include a new Section 1.70 as follows:

 

 

                                        2

 

<PAGE>

 

                                                                    EXHIBIT 10.1

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS

([**]), HAS BEEN OMITTED AND FILED SEPARATELY WTH THE SECURITIES AND EXCHANGE

COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS

AMENDED

 

     "1.70 "G-CSF PRODUCT" shall mean any treatment, whether a product or a

     service, that utilizes [**]. For the purposes of this Agreement, any G-CSF

     Product shall be deemed a Cell Therapy Product with the same effect and

     consequences with respect to Collaboration Products and Unoptioned Cell

     Therapy Products (other than with respect to royalty payments provided for

     under Section 8.4)."

 

1.6 AMENDMENT TO ARTICLE 1. Article 1 of the Agreement shall be amended to

include a new Section 1.71 as follows:

 

     "1.71 "UNOPTIONED G-CSF PRODUCT" shall mean any Unoptioned Cell Therapy

     Product that is a G-CSF Product."

 

1.7 AMENDMENT TO ARTICLE 1. Article 1 of the Agreement shall be amended to

include a new Section 1.72 as follows:

 

     "1.72 "PHASE II TRIAL(S)" shall mean those clinical trials on sufficient

     numbers of patients that, i


 
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