Document:

Exhibit 10.70

 

AMENDMENT NO. 2 TO LICENSING AGREEMENT

 

THIS AMENDMENT
NO. 2 (“the Second Amendment”) is entered into as of December 4, 2001, by and
between EyeTech Pharmaceuticals, Inc. a Delaware corporation (“EyeTech”) and
Gilead Sciences, Inc., a Delaware corporation (“Gilead”), to amend that certain
Licensing Agreement dated as of March 31, 2000, as amended by Amendment No. 1
to Licensing Agreement dated as of May 9, 2000 (the “Agreement”) by and between
EyeTech and Gilead (as successor in interest to NeXstar Pharmaceuticals, Inc.).
Capitalized terms used and not otherwise defined herein shall have the meanings
given them in the Agreement.

 

WHEREAS,
EyeTech desires to obtain access to notebooks of Gilead relating or potentially
relating to the compound NX1838;

 

WHEREAS,
Gilead is willing to provide such access to EyeTech personnel if the
information in such notebooks is kept confidential by EyeTech and its personnel
under the terms of the Agreement;

 

WHEREAS, in
support of EyeTech’s activities under the Agreement, Gilead would like to
provide to EyeTech, and EyeTech would like to receive from Gilead, certain of
Gilead’s inventory of VEGF aptamer and potentially a reference standard
possessed by Gilead, as determine by Gilead (“Materials”).

 

NOW, THEREFOR,
in consideration of the foregoing and the covenants herein, EyeTech and Gilead
hereby agree, and the Agreement is hereby amended, as follows:

 

1.               All information
learned, received, extracted or copied by EyeTech from notebooks or other
documents or records of Gilead, or excerpts thereof, that Gilead provides or
makes available to EyeTech after the date hereof shall be deemed to be
Proprietary Information of Gilead and subject to provisions in the Agreement
pertaining to Proprietary Information of Gilead.

 

2.               Nothing in this
Second Amendment shall be construed as creating any obligation of Gilead to
provide or make available to EyeTech any notebooks or other documents or
records of Gilead, or excerpts thereof, beyond any such obligation of Gilead
currently existing under the Agreement.

 

3.               Gilead will deliver
the materials to EyeTech within fifteen (15) days after the date hereof.

 

4.               EyeTech shall not
and shall not permit any person or entity to (a) administer any Materials to
humans under any circumstances; or (b) administer any Materials to animals
except in compliance with U.S. National Institutes of Health guidelines and all
other applicable laws, rules, and regulations.

 

5.               Nothing in this
Amendment shall be construed to grant either Party any right or license beyond
those set forth in the Agreement.

 

 

6.               GILEAD PROVIDES THE
MATERIALS “AS IS”, WITH NO WARRANTY, EXPRESS, IMPLIED OR STATUTORY, INCLUDING
WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, TITLE, NON-INFRINGEMENT,
EXCLUSIVITY, OR FITNESS FOR A PARTICULAR PURPOSE.

 

7.               Solely for purposes
of Section 7.1(b) of the Agreement, the Materials will deemed to included
within NX1838.

 

8.               The Agreement, as
amended by this Second Amendment, shall remain in full force and effect
according to its terms.

 

9.               This Second
Amendment may be executed in any number of counterparts, each of which shall be
deemed an original, and all of which taken together shall constitute one and
the same instrument.

 

10.         This Second Amendment
shall be effective as of the date first written above.

 

IN WITNESS
WHEREOF, the parties hereto have duty executed this Second Amendment effective
as of the date first written above.

 

 

	
  EYETECH
  PHARMACEUTICALS, INC.

  	
  GILEAD
  SCIENCES, INC.

  
	
   

  	
   

  
	
  By:

  	
  /s/  Harsha
  Murthy

  	
   

  	
  By:

  	
  /s/  Nicole
  Onetto

  	
   

  
	
   

  	
   

  
	
  Name:  Harsha Murthy

  	
  Name:  Nicole Onetto

  
	
   

  	
   

  
	
  Title: V.P.
  - Business Development & General Counsel

  	
  Title: SVP
  Medical AffairsExhibit 10.71

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

 

AMENDMENT
NO. 3 TO LICENSING AGREEMENT

 

 

This Amendment No. 3 to Licensing Agreement (the
“Third Amendment”) amends, effective August 30, 2002, the LICENSING AGREEMENT,
itself effective as of March 31, 2000 and previously amended first as of May 9, 2000 and second as of December 4, 2001  (as
so twice amended, the “Agreement”) originally by and among GILEAD SCIENCES,
INC., a Delaware corporation with its principal office located at 333 Lakeside
Drive, Foster City, CA 94404 (“Gilead”), and its wholly-owned subsidiary,
NEXSTAR PHARMACEUTICALS, INC., a Delaware corporation, on the one hand, and
EYETECH PHARMACEUTICALS, INC., a Delaware corporation with its principal office
as of the date hereof located at 500 Seventh Avenue, 18th Floor, New
York, New York 10018 (“EyeTech”), on the other hand, and currently between
Gilead and EyeTech.  All capitalized
terms used herein and not otherwise defined shall have the meanings given in
the Agreement.  All references to
“Sections” and “Articles” are to sections and articles of the Agreement unless
otherwise specified below.

 

The Parties hereby amend the Agreement as follows:

 

1.               The definition of
Net Sales is deleted in its entirety and replaced with the following:

 

“‘Net Sales’ shall mean, with respect to the Product, the gross
amount billed or invoiced by EyeTech, its Affiliates or sublicensees to Third
Parties for Products and Combination Products (defined below), less the
following deductions to the extent included in such billed or invoiced or
credited amounts:

 

(a)          trade, quantity and cash
discounts allowed, but expressly excluding discounts or allowances offered as
part of a package of products that includes a Product sold by EyeTech, its
Affiliates or sublicensees;

 

(b)         refunds, chargebacks and
any other allowances which effectively reduce the net selling price;

 

(c)          actual product returns,
credits and allowances allowed to customers;

 

(d)         rebates actually paid or
credited to any governmental agency (or branch thereof) or to any Third Party
payor, administrator or contractee;

 

(e)          discounts mandated by,
or granted to meet the requirements of, applicable state, provincial or federal
law, wholesaler, including required chargebacks and retroactive price
reductions;

 

(f)            transportation,
freight, postage charges and other charges such as insurance, relating thereto,
in each case included as a specific line item on an invoice to such Third
Parties; and

 

(g)         taxes, excises or other
governmental charges upon or measured by the production, sale, transportation,
delivery or use of goods, in each case included as a specific line item on an
invoice to such Third Parties.

 

If any such sales to Third Parties are made in transactions that are
not at arm’s length between the buyer and the seller, then the gross amount to
be included in the calculation of Net Sales shall be the amount that would have
been invoiced had the transaction been conducted at arm’s length.  Such amount that would have been invoiced
shall be determined, wherever possible, by reference to the average selling
price of the relevant Product in arm’s-length transactions in the relevant
country.

 

 

If EyeTech, its Affiliate or sublicensee sells a Product in unfinished
form to a Third Party for resale, then the gross amount to be included in the
calculation of Net Sales arising from such sale shall be the amount invoiced by
the Third Party upon resale, in lieu of the amount invoiced by EyeTech, its
Affiliates or sublicensee when selling the Product in unfinished form.  Otherwise, where EyeTech, its Affiliate or
sublicensee sells a Product in finished form to a Third Party that does not
require a sublicense under the Licensed Patents for further resale (a
distributor) (each such Third Party hereinafter a “Distributor”), the amount to
be included in the calculation of Net Sales shall be the price invoiced from
EyeTech or its Affiliate or sublicensee to the Third Party, not the amount
invoiced by the Third Party upon resale.

 

If, in addition to or in lieu of a transfer price paid for quantities
of Product supplied, any Distributor provides consideration to EyeTech, its
Affiliate or sublicensee in connection with any Product or the Distributor’s
rights or relationship with EyeTech, its Affiliate or sublicensee in relation
thereto, then such consideration shall be included in the calculation of Net
Sales in the calendar quarter in which it becomes due to EyeTech or its
Affiliate or sublicensee (as applicable).

 

Notwithstanding the foregoing, amounts received by EyeTech, or its
Affiliates or sublicensees, for the sale of Products among EyeTech and its
Affiliates or sublicensees for resale shall not be included in the computation
of Net Sales hereunder.

 

Net Sales shall be determined from books and records maintained in
accordance with GAAP, consistently applied throughout the organization and
across all products of the entity whose sales of Product are giving rise to Net
Sales.

 

If any Product (i) contains or is sold with a therapeutically active
ingredient other than NX1838 (such therapeutically active ingredient an “Other
Active”), regardless of whether they are coformulated or physically packaged
together, or (ii) is sold with a mechanical or pharmacological delivery system
for the delivery of such Product (such system, a “Delivery System), (such a
Product including and together with the Other Active or Delivery System, a
“Combination Product”) then Net Sales from the Combination Product shall be
determined by multiplying the Net Sales of the Combination Product (as
determined without reference to the calculations of this paragraph) by the fraction A/(A+B), where A is the
average sale price of a Product of the same formulation and dosage when not
sold as part of a Combination Product, and B is the average sale price of the
Other Active or Delivery System when sold separately, or, only if the value of
B cannot be determined, where A+B is the average sales price of the Combination
Product.  If A and B can be determined,
in no event will the sales price of the Combination Product be less than the
sum of A and B.  If both A and B, and
A+B, cannot be determined, then C/(C+D) shall be substituted for A/(A+B) in
such calculation, where C is EyeTech’s cost of goods of the Product and D is
EyeTech’s cost of goods for the Other Active or Delivery System, determined in
accordance with the method of accounting normally employed by EyeTech in
computing cost of goods sold (which must be in accordance with GAAP
consistently applied throughout EyeTech), provided,
however, that the minimum value of such fraction as used in the
calculation of Net Sales shall be 0.9. 
All average prices, for purposes of this paragraph, shall be determined
on a country-by-country and product-by-product basis.

 

For clarity and without limiting the generality of the foregoing, the
inclusion of  PEG (polyethylene
gylcol)  in a Product, because PEG is
not a therapeutically active molecule, will not in itself be deemed to result
in a Combination Product for purposes of the foregoing paragraph.”

 

2.               The phrase “with a
right to sublicense to its Affiliates or (subject to Section 2.4) to any other
Person” in Section 2.1 is deleted and replaced with the following: “with a
right (subject to Section 2.4) to sublicense to its Affiliates or to any other
Person.”

 

3.               In Section 2.5, the
phrase “EyeTech Know-How and EyeTech Patents” in the nineteenth (19th)
line is deleted and replaced with the following:  “EyeTech Rights.”

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.

 

 

4.               The following words
are included in the sentence that is the text of Section 2.3, at the end of the
sentence:  “within the scope of the
license granted EyeTech in Section 2.1.”

 

5.               Section 3.3(b) is
deleted in its entirety and replaced with the following:

 

“Offset. 
Notwithstanding the foregoing, on a country-by-country and
Product-by-Product basis, EyeTech may credit against Royalties otherwise due
hereunder on Net Sales of such Product in such country [*] percent in any calendar quarter ([*]%) of any royalties it must pay to any
Third Party on sales of such Product in such country in such calendar quarter:
(1) pursuant to any licenses necessary to practice the License; or (2) resulting
from any litigation (including settlement thereof) under Section 6.16; provided, however, for purposes of this
Section 3.3(b) that the applicable royalty rates used for calculation of
Royalties payable to Gilead shall not be reduced to less than [*] percent ([*]%) of the royalty rate(s) otherwise applicable pursuant to
Section 3.3(a).”

 

6.               The following is
inserted between the first and second sentences of Section 3.7:  “EyeTech shall promptly remit any amounts so
withheld to the appropriate governmental authority and provide Gilead with
written evidence of such payment.”

 

7.               Section 4.6 is
deleted in its entirety and replaced with the following:

 

“Accrued Rights and Obligations; Survival.  Termination or expiration of this Agreement
for any reason shall be without prejudice to any rights which shall have
accrued to the benefit of either Party prior to such termination or expiration,
including damages arising from any breach hereunder.  The following provisions of this Agreement shall survive any
expiration or termination of this Agreement: 
Sections 2.3, 3.6, 4.2, 4.6, 5, 6.3, 6.4, 6.5, 6.9, 6.11(a), 6.12, 6.18,
7, and 8.  In addition, the following
provisions of this Agreement shall survive the expiration of this Agreement to
the extent that the license granted to EyeTech pursuant to Section 4.2 is in
effect: Sections 3.4  through 3.9, 4.3,
4.5, 6.2, 6.7(c)-(e), 6.8, 6.9,  6.11(b),
6.11(c), 6.11(d), 6.13, 6.16 and 6.17(a).”

 

8.               The last sentence
of Section 6.13 is deleted in its entirety and changed to read as follows:
“Except as otherwise permitted by this Agreement or required by law, Gilead
shall refrain from granting any right to any Third Party relating to NX1838,
the Licensed Patents or the Transferred Assets that would, in any manner,
violate the terms of or conflict with the rights granted to EyeTech pursuant to
this Agreement.

 

9.               The phrase
“distribution,” is inserted immediately prior to “administration” in the second
(2nd) line of Section 7.1(b)(3).

 

10.         Section 8.2, “Notices” is
changed to show EyeTech’s address as follows: 
EyeTech Pharmaceuticals, Inc., 500 Seventh Avenue, 18th
Floor, New York, New York  10018,
Facsimile:  212-997-9251, attn:  Chief Executive Officer.

 

11.         The Agreement, as amended
by this Third Amendment, remains in full force and effect according to its
terms.

 

12.         Article 18 shall apply to
this Third Amendment as if set forth herein in its entirety.

 

IN WITNESS WHEREOF, the Parties have caused this Third
Amendment to be duly executed and delivered as of the day and year first above
written.

 

 

	
  GILEAD SCIENCES, INC.

  	
  EYETECH PHARMACEUTICALS, INC.

  
	
   

  	
   

  
	
  By:

  	
  /s/ Gregg Alton

  	
   

  	
  By:

  	
  /s/ David Guyer

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Gregg Alton

  	
   

  	
  David Guyer

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Vice President and General Counsel

  	
   

  	
  Chief Executive Officer

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