Exhibit 10.77
FOURTH AMENDMENT TO LICENSE
AGREEMENT
This Fourth Amendment to License Agreement (“Fourth
Amendment”) is effective as of the 19 th day of
April, 2004 (the “Effective Date”), by and among Gilead
Sciences, Inc. (formerly Triangle Pharmaceuticals, Inc.), a
Delaware corporation having its principal place of business at 333
Lakeside Drive, Foster City, CA 94404 (“COMPANY”) and
Emory University, a not-for-profit Georgia corporation with offices
at 1380 South Oxford Road, N.E., Atlanta, Georgia 30322
(“LICENSOR”), and amends certain terms of that certain
License Agreement, dated April 17, 1996, between LICENSOR and
COMPANY, as amended by the First Amendment to License Agreement,
dated May 6, 1999 (“First Amendment”) and as further
amended by the Second Amendment to License Agreement dated July 10,
2000 (“Second Amendment”) and as further amended by the
Third Amendment to the License Agreement dated May 31, 2002 (such
License Agreement as amended by the First, Second and Third
Amendments is referred to herein as the
“Agreement”).
WHEREAS LICENSOR and COMPANY wish to
clarify a fair and equitable formula for Net Selling Price of
Licensed Products which contain as their active ingredients both
Licensed Compounds and compounds other than Licensed
Compounds;
WHEREAS LICENSOR and COMPANY wish to
clarify definitions related to an expanded access program such as
COMPANY’S Global Access Program;
NOW, THEREFORE, for good and valuable consideration, the receipt
and sufficiency of which are acknowledged by each of the parties,
COMPANY and LICENSOR hereby agree as follows:
1.
Definitions.
1.1.
Use of Existing
Definitions . All
terms used in this Fourth Amendment and not otherwise defined
herein shall have the same meanings ascribed to them in the
Agreement.
1.2.
Amendment of
Definitions . The
Agreement is hereby amended to provide that:
1.2.1.
Sections 1.20 and 1.21 and 1.25 are
deleted in their entirety and replaced with the
following:
“1.20
“Net Selling Price” of a product (including a Licensed
Product) shall mean, with respect to a particular fiscal quarter,
the gross invoice price (i.e. the total invoiced price therefore
prior to any deductions made pursuant to clauses (i) through (iv))
paid by a purchaser of such product (including Distributors), to
COMPANY, an Affiliate or sublicensee of COMPANY and their
sublicensees or any other party authorized by COMPANY to sell that
product (which shall not include Distributors) (collectively the
“Sellers”), plus, if applicable, the value of all
properties and services received in consideration of a Sale of such
product, less only:
1
(i)
discounts, including cash and
quantity discounts, charge-back payments and rebates granted to
managed health care organizations or to federal, state and local
governments, their agencies, purchasers and reimbursers or to trade
customers;
(ii)
credits or allowances actually
granted upon claims, damaged goods, rejections or returns of such
Licensed Products, including recalls;
(iii)
freight, postage, shipping,
transportation and insurance charges actually allowed or paid for
delivery of Licensed Products to the extent billed; and
(iv)
taxes (other than income taxes),
duties or other governmental charges levied on, absorbed or
otherwise imposed on sale of such Licensed Products, including
without limitation value-added taxes, or other governmental charges
otherwise measured by the billing, when included in the billing, as
adjusted for rebates and refunds.
(a)
Notwithstanding the foregoing in this Section 1.20, amounts
received by COMPANY, its Affiliates or sublicensees for the sale of
Licensed Products among COMPANY, its Affiliates and sublicensees
for resale shall not be included in the computation of Net Selling
Price hereunder.
(b)
For purposes of this Section 1.20, “Distributor” shall
mean any third party (i) to which a Seller has granted (at any time
during the term) a right to sell or distribute a Licensed Product,
(ii) that sells Licensed Products to hospitals and/or pharmacies
for their sale to or use with patients (rather than to other third
parties for resale to hospitals and/or pharmacies for their sale to
or use with patients), and (iii) that does not make payments to
COMPANY or such COMPANY Affiliate that are calculated on the basis
of a percentage of, or profit share on, such third party’s
sales of Licensed Products. For purposes of calculating Net
Selling Price, no Distributor shall be deemed to be a sublicensee
of COMPANY or its Affiliates. Net Selling Price for the
quantities of License Product sold by Distributors shall be
calculated based on the amount invoiced the Distributors by COMPANY
and/or its Affiliates and/or sublicensees of Affiliates and COMPANY
rather than by the Distributors to their customers.
(c)
Where Licensed Product is sold in the form of a combination product
containing one or more active ingredients in addition to a Licensed
Compound (“Combination Product”), Net Selling Price for
such
2
Combination Product for purposes of
determining royalties payable under this Agreement will be
calculated by multiplying the actual Net Selling Price of such
Combination Product by the fraction A/(A+B) where A is the Net
Selling Price for the stock keeping unit most comparable in
formulation and dosing to that used for the Combination Product of
the Licensed Product containing the relevant Licensed Compound as
the sole active ingredient, if sold separately, in such country
during the relevant fiscal quarter, and B is the Net Selling Price
for the stock keeping unit, most comparable in formulation and
dosing to that used for the Combination Product, of any other
active ingredient, if sold separately, in such country during the
relevant fiscal quarter. For clarity, if there are three or
more active ingredients (including the Licensed Compound),
additional B terms calculated in the same manner, shall be included
in the denominator
