1
EXHIBIT 10.4
AMENDMENT NO. THREE
TO
LICENSE AGREEMENT
THIS AMENDMENT NUMBER THREE TO LICENSE AGREEMENT FOR INTERFERON GAMMA
("Amendment") is entered into effective April 27, 1999 (the "Amendment Effective
Date"), by and between Genentech, Inc. ("Genentech") and Connetics Corporation
("Connetics"). Genentech and Connetics may each be referred to herein as a
"Party" and jointly as the "Parties."
RECITALS
A. The Parties have previously entered into that certain License Agreement
for Interferon Gamma, dated May 5, 1998, as amended on December 23, 1998
and on January 15, 1999 (the "License Agreement").
B. Pursuant to Section 2.3(c) of the License Agreement, Connetics has the
right to sublicense certain of its rights under the Agreement to
InterMune Pharmaceuticals, Inc. ("InterMune"), and has in fact entered
into such sublicense to that effect dated August 21, 1998.
C. The Parties have entered into that certain letter agreement dated
January 5, 1999 and revised on March 1, 1999 (the "Letter Agreement"),
documenting the intent and agreement of Connetics and Genentech with
respect to certain additional rights to be granted to Connetics and its
sublicensees under the Genentech License, pending the preparation of an
amendment to the License Agreement.
D. In consideration of such additional rights, [*].
E. The Parties now desire to enter into a definitive amendment to the
License Agreement, as of the Amendment Effective Date, through which
Genentech shall grant, and Connetics and InterMune shall accept, such
certain additional rights under the License Agreement.
NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants
and conditions herein contained, and intending to be legally bound hereby, the
Parties mutually agree as follows:
1. Terms not otherwise defined in this Amendment shall have the meanings
defined in the License Agreement.
2. A new Section 1.7.1 is hereby added to read in its entirety as follows:
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
2
1.7.1 "Combination Product Adjustment" shall mean the following:
in the event that a Licensed Product is sold in the form of a
combination product containing one or more active ingredients or
components in addition to such Licensed Product, Net Sales for such
combination product will be adjusted by multiplying actual Net Sales of
such combination product by the fraction A/(A + B) where A is the
invoice price of the Licensed Product, if sold separately, and B is the
invoice price of any other active ingredient(s) or component(s) in the
combination, if sold separately. If, on a country-by-country basis, the
other active ingredient(s) or component(s) in the combination are not
sold separately in said country, Net Sales shall be calculated by
multiplying actual Net Sales of such combination product by the fraction
A/C where A is the invoice price of the Licensed Product if sold
separately, and C is the invoice price of the combination product. If,
on a country-by-country basis, neither the Licensed Product nor the
other active ingredient(s) or component(s) of the combination product is
sold separately in said country, Net Sales allocable to the Licensed
Product shall be determined by mutual agreement reached in good faith by
the Parties based on an equitable method of determining such Net Sales
that, among other considerations, takes into account, on a
country-by-country basis, variations in potency, the relative
contribution of each active ingredient or component in the combination
product and the relative value to the end-user of each active ingredient
or component.
3. Section 1.12 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
1.12 "Field of Use" shall mean the administration to humans of
Licensed Protein Product for the treatment or prevention of any human
disease or condition, [*]. Each "indication" listed on Exhibit E
attached hereto shall be referred to herein individually as an "Area of
the Field of Use" and collectively as "Areas of the Field of Use."
4. A new Section 1.15.1 is hereby added to the Agreement to read in its
entirety as follows:
1.15.1 "Gene Therapy Field of Use" shall mean the administration
to humans of Licensed Gene Product for Gene Therapy for the treatment or
prevention of any human disease or condition, [*].
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
2
3
5. Section 1.18 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
1.18 "Genentech Patent Rights" shall mean all patents and patent
applications and any patents issuing therefrom, together with any
extensions, reissues, reexaminations, substitutions, renewals,
divisions, continuations and continuations-in-part thereof:
(a) that are owned or controlled by Genentech presently
or hereafter, during the term of this Agreement, and under which
Genentech is free to license or sublicense; and
(b) to the extent they claim or directly relate to: (i)
Interferon Gamma or the manufacture or use of Interferon Gamma
in the Field of Use, or (ii) IG Nucleotide Sequence or the
manufacture or use of IG Nucleotide Sequence in the Gene Therapy
Field of Use;
including, without limitation, the patent rights granted under
that certain license agreement between Genentech and Children's
Medical Center Corporation, dated July 16, 1990 (the "CMCC
License"), but specifically excluding any rights granted to
Genentech under the Biogen License. Genentech Patent Rights
shall include, without limitation, the patents and patent
applications listed in Exhibit A attached hereto.
Notwithstanding the foregoing, Genentech Patent Rights shall
exclude any rights Genentech acquires after the Effective Date
under third-party license agreements, with the exception of
those rights acquired under the CMCC License, unless and until
the Parties mutually agree on terms and conditions for the
sublicense of such rights from Genentech to Connetics.
6. A new Section 1.20.1 of the License Agreement is hereby added to read in
its entirety as follows:
1.20.1 "IG Nucleotide Sequence" shall mean any DNA or RNA
sequence encoding Interferon Gamma.
7. Section 1.22 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
1.22 "Licensed Product" shall mean, collectively:
(a) Any pharmaceutical formulation containing Interferon
Gamma, whether alone or together with or incorporated into any
other substance or product or material or device, whether active
or not, and which (i) but for the licenses granted hereunder,
the manufacture, use, sale, offer for sale or importation of
which in the Territory would infringe or contribute to the
infringement of the Genentech Patent Rights in the Territory, or
(ii) is based upon or incorporates or utilizes Genentech Knowhow
(a "Licensed Protein Product"); and
3
4
(b) Any pharmaceutical formulation containing the IG
Nucleotide Sequence, whether alone or together with or
incorporated into any other substance or product or material or
device, whether active or not, and which but for the licenses
granted hereunder, the manufacture, use, sale, offer for sale or
importation of which in the Territory would infringe or
contribute to the infringement of the Genentech Patent Rights in
the Territory (a "Licensed Gene Product").
8. The following two sentences are hereby added to the end of Section 1.25:
[*] shall also be deducted from the gross invoiced sales prices
charged for such Licensed Products in determining Net Sales for such
Licensed Products. In the event that a Licensed Product is sold in the
form of a combination product containing one or more active ingredients
or components in addition to such Licensed Product, Net Sales for such
combination product will be calculated in accordance with the
Combination Product Adjustment."
9. Section 1.28 of the License Agreement is hereby deleted and replaced in
its entirely as follows:
1.28 "Territory" shall mean the United States of America, and
its territories and possessions, and Japan.
10. A new Section 1.37 is hereby added to the License Agreement to read in
its entirety as follows:
1.37 "Third Party Product Rights" shall mean any rights licensed
or sublicensed to any third party by Genentech as of the Effective Date
to use, manufacture or sell (a) Interferon Gamma, (b) the IG Nucleotide
Sequence or (c) any pharmaceutical formulation containing either or both
of Interferon Gamma and the IG Nucleotide Sequence, whether alone or
together with or incorporated into any other substance or product or
material or device, whether active or not; [*].
11. Section 2.1 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
2.1 Patent and Knowhow License Grants.
(a) Genentech hereby grants to Connetics an exclusive
license, even as to Genentech, under Genentech Patent Rights and
under Genentech Knowhow to use, sell, offer for sale and import
(but not to make or have made) Licensed Protein Products in the
Field of Use in the Territory (excluding Japan), (excluding,
with respect to the fields of (i) scleroderma and (ii)
infectious disease or condition caused by human papillomavirus,
Licensed Protein Products containing any form of Interferon
Gamma other than
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
4
5
Genentech Gamma Interferon (DELTA)3 (as that term is defined in
the Biogen License)). Notwithstanding the foregoing, Genentech
reserves the right to use (but not to import, offer for sale or
sell) Licensed Protein Products within the Field of Use solely
for non-commercial research purposes.
(b) Genentech hereby grants to Connetics a non-exclusive
license under Genentech Patent Rights and under Genentech
Knowhow to use, sell, offer for sale and import (but not to make
or have made) Licensed Protein Products containing any form of
Interferon Gamma other than Genentech Gamma Interferon (DELTA)3
(as that term is defined in the Biogen License) in the Territory
(excluding Japan) in the fields of: (i) scleroderma and (ii)
infectious disease or condition caused by human papillomavirus.
(c) Genentech hereby grants to Connetics a non-exclusive
sublicense under the Biogen License Rights to use, sell, offer
for sale and import Licensed Protein Products (excluding
Licensed Protein Products containing Biogen Gamma Interferon
(DELTA)0 (as that term is defined in the Biogen License)) in the
Territory (excluding Japan) in the fields of scleroderma and
infectious disease or condition caused by human papillomavirus.
(d) Genentech hereby grants to Connetics a non-exclusive
license under Genentech Patent Rights to make or have made in
the Territory (excluding Japan) Licensed Protein Products for
use or sale in the Field of Use in the Territory (excluding
Japan).
(e) Genentech hereby grants to Connetics a non-exclusive
license under Genentech Patent Rights and Genentech Knowhow to
use non-human animal species derived homologues of Interferon
Gamma ("Non-human Interferon Gamma") solely for non-commercial
research purposes to support the Field of Use in the Territory
(excluding Japan). Genentech hereby grants to Connetics a
non-exclusive license under Genentech Patent Rights to use
non-human animal species derived homologues of IG Nucleotide
Sequence ("Non-human Interferon Gamma-encoding IG Nucleotide
Sequence") solely for non-commercial research purposes to
support the Gene Therapy Field of Use in the Territory
(excluding Japan).
(f) Genentech hereby grants to Connetics a co-exclusive
license under Genentech Patent Rights to use, make, have made,
import, offer for sale and sell Licensed Gene Products in the
Gene Therapy Field of Use in the Territory (excluding Japan).
Notwithstanding the foregoing, Genentech reserves the right to
use (but not to import, offer for sale or sell) Licensed Gene
Products within the Gene Therapy Field of Use solely for
non-commercial research purposes. As used in this subsection
(f), "co-exclusive" shall mean that (i) Genentech shall not
grant a license to any party other than Connetics to use, make,
have made, import, offer for sale or sell Licensed Gene Products
in the Gene Therapy Field in the Territory (excluding Japan) [*]
and (ii) Genentech shall not authorize or approve any grant or
assignment [*].
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
5
6
(g) (i) Genentech hereby grants to Connetics an
exclusive license, even as to Genentech, under Genentech Patent
Rights and under Genentech Knowhow, in Japan to make, have made,
use, sell, offer for sale and import [*].
(ii) Connetics, its Affiliates and sublicensees
hereunder shall [*] to the extent based, in whole or in part,
upon [*] [*] [*] for indications
(including, without limitation, the treatment of [*] shall not
extend to: [*] the manufacture, use or sale [*] for the
treatment of [*]. Connetics' and its Affiliates' and
sublicensees' [*] shall terminate with respect to [*].
(iii) In the event that any Third Party Product
Rights held by a third party [*] revert to Genentech, then
Genentech shall notify Connetics or its designated sublicensee
in Japan of such reversion, and upon such notice Genentech shall
be deemed to have automatically granted to Connetics the license
under Genentech Patent Rights and under Genentech Knowhow to all
such reverted rights, which license shall be exclusive to the
extent that such reverted rights were exclusive. All rights
granted to Connetics pursuant to this subsection (iii) shall be
subject to the terms of this Agreement, including without
limitation subsection (ii) above, Section 3.2(g) and Section
8.3.
(h) In the event that any Third Party Product Rights
(other than those described in subsection (g) above) shall
revert to Genentech, then Genentech shall notify Connetics of
such reversion. For the ninety (90) day period following its
receipt of such notice, Genentech and Connetics shall negotiate
exclusively in good faith the reasonable commercial terms upon
which Genentech would be willing to grant to Connetics the
license to such reverted rights. If the Parties fail to enter a
written agreement for a license to such rights by the end of
such ninety (90) day period, then Genentech shall have no
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
6
7
further obligation to Connetics with respect to such rights;
provided that for six (6) months following such ninety (90) day
period, Genentech shall not enter into an agreement to grant a
license to such rights with a third party on terms that, taken
as a whole, are less favorable to Genentech than those last
offered by Connetics for such rights. [*] Nothing in the
preceding sentence shall imply any [*]. Connetics may not
transfer its rights under this Section 2.1(h) to any party other
than InterMune without Genentech's prior written consent.
Except as expressly granted herein, there are no implied licenses under
the Genentech Patent Rights or any other intellectual property rights owned or
controlled by Genentech.
12. Section 2.3(b) of the License Agreement is hereby deleted and replaced
in its entirety as follows:
(b) Connetics may grant one or more sublicenses under
the rights granted in Sections 2.1(a), (b), (c), (e), (f) and
(g) in the Field of Use and the Gene Therapy Field of Use, on
thirty (30) days prior written notice to Genentech, and subject
to Genentech's prior written approval, which approval shall not
be unreasonably withheld.
13. A new Section 3.2(g) is hereby added to read in its entirely as follows:
(g) In addition to the Clinical Development Milestones
(as set forth in Exhibit E hereto), Connetics shall use its Best
Efforts to develop and commercialize Licensed Products: (i) in
the Field of Use with respect to indications and diseases that,
under the provisions of this Amendment, have been added to the
"Field of Use" as defined in the original License Agreement
executed as of May 5, 1998, and (ii) in the Gene Therapy Field
of Use. Such additional indications and diseases in the Field of
Use, and the Gene Therapy Field of Use, collectively are
referred to in this subsection (g) as the "Additional
Indications." In the event that Connetics is not conducting such
development efforts with respect to any Additional Indication(s)
in a country or countries in the Territory as of the [*] (or if
rights to such Additional Indication were granted to Connetics
pursuant to Section 2.1(g)(iii), then as of the [*] that
Genentech notifies Connetics or its designated sublicensee
regarding such rights as set forth in that Section) or at any
time thereafter, Genentech shall have the right to terminate
this Agreement, and the licenses granted hereunder, with respect
to Licensed Products for such Additional Indication(s) in such
country or countries, upon [*] days prior written notice to
Connetics, unless Connetics can reasonably demonstrate, during
such notice period, by its written records that as of the date
of such notice it is conducting such development efforts with
respect to such Additional Indication(s) in such country or
countries.
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
7
8
14. Sections 8.2(a) and (b) of the License Agreement are hereby deleted and
replaced in their entirety as follows:
(a) [*] within thirty (30) days following the dates on
which the first NDA or BLA, as applicable, for a Licensed
Protein Product is filed with the FDA by Connetics for [*]
provided however, that such milestone payments shall only be
paid once for each of the foregoing indications, and shall not
be paid upon the filing of a NDA or BLA for an osteopetrosis or
any mycobacterial infection indication.
(b) [*] within thirty (30) days following the date
Connetics receives the first FDA approval of [*] provided
however, that such milestone payment shall only be paid once for
each of the foregoing indications, and shall not be paid upon
receipt of FDA approval for commercial sale for an osteopetrosis
or any mycobacterial infection indication.
15. Section 8.3 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
8.3 Royalties. Connetics shall pay Genentech the following
royalties on Net Sales of Licensed Products by Connetics and its
sublicensees:
(a) For annual aggregate Net Sales of all Licensed
Protein Products in the Territory (excluding Japan) [*]
a royalty rate equal to [*] of such Net Sales.
(b) [*] for annual aggregate Net Sales of all Licensed
Protein Products in the Territory (excluding Japan) [*] a
royalty rate equal to [*] of such Net Sales [*].
(c) For Net Sales of all Licensed Protein Products in
Japan, a royalty rate equal to [*] of such Net Sales; provided,
however, that in the event that [*] for an indication for which
InterMune has exclusive rights under Section 2.1(g), the
foregoing royalty rate shall be reduced to [*] for Net Sales of
[*] in Japan for such indication [*]. For the sake of clarity,
Net Sales of Licensed Protein Products to which Connetics
acquires rights pursuant to Section 2.1(g)(iii) shall be subject
to this subsection (c).
(d) (i) For Net Sales of Licensed Gene Product in the
Territory, where such Licensed Gene Product is used in
conjunction with a Licensed Protein Product for the treatment or
prevention of a given indication in a given patient
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
8
9
population, a royalty rate equal to [*] of such Net Sales.
As used in this subsection (d), "indication" shall mean any
particular medical condition within the Field of Use and Gene
Therapy Field of Use, including but not limited to labeling
claims approved by a regulatory agency.
(ii) For Net Sales of Licensed Gene Product in a
country in the Territory, where such Licensed Gene Product is
used in a given patient population for the treatment or
prevention of the same indication for which a given Licensed
Protein Product is used in such patient population, a royalty
rate equal to (A) [*] of such Net Sales during the [*][*] period
following the first commercial sale of such Licensed Gene
Product in such country for the treatment or prevention of such
indication in such patient population by Connetics, or its
Affiliates and sublicensees (the "First Commercial Sale"); (B)
[*] of such Net Sales during the [*][*] period following the
First Commercial Sale; and (C) [*] of such Net Sales beginning
on the [*] anniversary of the First Commercial Sale and
thereafter.
(iii) Notwithstanding the provisions of
subsections (i) and (ii) above, in the event that annual Net
Sales of a Licensed Gene Product for the treatment or prevention
of an indication in a patient population in a country in the
Territory [*] for the treatment or prevention of such indication
in such patient population in such country, the royalty rate
thereafter applicable to Net Sales of such Licensed Gene Product
for the treatment or prevention of such indication in such
patient population in such country shall be [*] of such Net
Sales.
(iv) In the event that Connetics or InterMune
determines at any point following [*] that the above royalty
rates are having or are likely to have an adverse impact on
Connetics' or InterMune's ability to compete effectively in its
sales of such Licensed Gene Product, Connetics or InterMune
shall so notify Genentech, and the Parties shall in good faith
discuss and attempt to reach a reasonable and mutually agreeable
resolution to the situation.
(e) (i) The royalties set forth in subsections (a), (b)
and (c) above shall be payable, on a country-by-country basis,
until the later of: (A) the expiration or revocation of the last
remaining issued patent in such country within the Genentech
Patent Rights that covers Licensed Protein Products, or (B) [*]
years from the Effective Date of this Agreement. Notwithstanding
the foregoing, upon the expiration of the last to expire issued
patent in each country within the Genentech Patent Rights during
the term of this Agreement, thereafter each of the royalty rates
set forth in (a), (b) and (c) above shall be reduced by [*] with
respect to such country.
(ii) The royalties set forth in subsection (d)
above shall be payable, on a country-by-country basis, until the
expiration or revocation of the last remaining issued patent in
such country within the Genentech Patent Rights that covers
Licensed Gene Products.
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
9
10
16. Section 8.4 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
8.4 Third-Party Royalties. If Genentech or Connetics is required
to pay any third party a royalty due to the manufacture, use, sale,
offer for sale or importation of a Licensed Product in the Territory for
or by Connetics or its sublicensees, Connetics shall be responsible for
the payment of [*] of such third-party royalty, provided however, that
Connetics may deduct from the royalties otherwise payable to Genentech
under Section 8.3 above, an amount equal to [*] of such third party
royalties incurred only due to use patents in the Field of Use or in the
Gene Therapy Field of Use in the Territory, provided that the amount
deducted shall not exceed [*] of the royalties otherwise payable by
Connetics to Genentech under Section 8.3. For purposes of clarification,
such deductions shall not apply to [*]. Attached hereto as Exhibit G is
a list of all such royalty obligations to third parties known to
Genentech as of the Effective Date without diligent search. No later
than thirty (30) days from the Effective Date, Genentech shall complete
a reasonable internal investigation of its records and update Exhibit G,
as necessary, to accurately reflect all such royalty obligations to
third parties to the best of Genentech's knowledge; provided however,
Connetics acknowledges that Genentech has no obligation to conduct due
diligence or any investigation with respect to third party patent rights
related to Licensed Products. Genentech shall notify Connetics in
writing during the term of this Agreement if it becomes aware of any
additional Genentech third party royalty obligations.
17. Section 8.5 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
8.5 Royalty Payments.
(a) Royalty payments shall be made to Genentech
quarterly within ninety (90) days following the end of each
calendar quarter for which royalties are due. Each royalty
payment shall be accompanied by a report summarizing the total
Net Sales during the relevant three-month period, and the
calculation of royalties, if any, due thereon pursuant to
Section 8.3.
(b) Notwithstanding subsection (a) above, any royalty
payments which accrue during 1999 on Net Sales of Licensed
Protein Product sold by Connetics' sublicensee InterMune shall
be paid to Genentech in the form of promissory note, in the form
attached hereto as Exhibit I. For each calendar quarter in 1999
for which royalty payments are due, InterMune shall execute and
deliver to Genentech, within ninety (90) days following the end
of each such calendar quarter, a promissory note in the form of
Exhibit I, and in the amount of such royalties due to Genentech
for such quarter. Each such promissory note shall be accompanied
by the report described in Section 8.5(a) above for such
quarter. In the event that any such note is delivered by
InterMune after such 90 day period, nevertheless interest shall
accrue on the date that such note was due.
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
10
11
18. The following provision is hereby inserted as Section 10.4 to the
License Agreement:
10.4 Insurance. At all times during the term of this Agreement,
Connetics and its sublicensees shall provide the following insurance at
its sole cost and expense:
(a) Commercial General Liability, including coverage for
products and completed operations (maintained for a period of at
least [*] after the expiration or termination of this Agreement)
[*]. The policy shall have a limit of no less than [*] dollars.
(b) Foreign Local Coverages: Where required by law,
Connetics and its sublicensees will purchase foreign local
coverages in an amount that, at a minimum, satisfies the legal
requirements of that jurisdiction.
(c) Policy Conditions: All policies under (a) and (b)
above shall:
(i) be written by insurance companies with an
A.M. Best's rating of A:VIII or higher (or if Connetics' or its
sublicensees policies are not subject to the Best rating, then
by carriers who are acceptable to Genentech); and
(ii) add Genentech as an additional insured.
(d) Additionally, Connetics shall use its Best Efforts
to obtain from its insurance carrier for the policies described
in subsections (a) and (b) covenants:
(i) [*]; and
(ii) [*].
Connetics and its sublicensees shall provide Genentech a
certificate of insurance which shall reflect the above coverages and
provisions, with annual renewals as long as the contract continues.
19. Section 11.1 of the License Agreement is hereby deleted and replaced in
its entirety as follows:
11.1 Term. This Agreement shall commence on the Effective Date
of this Agreement and, unless terminated earlier, shall expire:
(a) With respect to Licensed Protein Products, at the
later to occur of (i) the expiration of the last to expire of
any Genentech Patent Rights covering a Licensed Protein Product,
or (ii) twenty (20) years from the Effective Date of this
Agreement; and
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
11
12
(b) With respect to Licensed Gene Products, at the
expiration of the last to expire of any Genentech Patent Rights
covering a Licensed Gene Product;
provided, however, that in the event that either the
CMCC License or the Biogen License is terminated, the licenses
granted by Genentech to Connetics under the CMCC License or the
Biogen License shall also terminate. Genentech shall use its
Best Efforts to keep the CMCC License and the Biogen License in
effect during the term of this Agreement, [*]. One (1) year
before the expiration of this Agreement under Section 11.1(a),
the Parties agree to meet and to discuss in good faith extending
the term of this Agreement with respect to Licensed Protein
Products on terms mutually agreeable to the Parties.
20. Exhibit E of the License Agreement is hereby deleted and replaced in its
entirety with new Exhibit E attached hereto and incorporated herein.
21. In consideration for the rights granted to Connetics and its
sublicensees under this Amendment, [*].
22. This Amendment supersedes the Letter Agreement in its entirety. All
other terms and provisions of the License Agreement, including all
exhibits to that Agreement, will continue in full force and effect as
though fully set forth in this Amendment. Nothing in this Amendment
shall be construed as affecting Connetics' obligations to be liable and
responsible for the performance of all of the obligations of Connetics
and its sublicensees under the License Agreement.
THIS SPACE INTENTIONALLY LEFT BLANK
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
12
13
IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by the
respective duly authorized officers as of the date first written above.
GENENTECH, INC. CONNETICS CORPORATION
By: /s/ Xxxxxxxx Xxxxx By: /s/ X. Xxxxxxx
------------------------------- --------------------------------
Printed Name: Xxxxxxxx Xxxxx Printed Name: Xxxxxx X. Xxxxxxx
---------------------- ----------------------
Title: Title: President & CEO
------------------------------ -----------------------------
Acknowledged and agreed as to InterMune's rights and obligations hereunder as
Connetics' sublicensee under the License Agreement:
INTERMUNE PHARMACEUTICALS, INC.
By: /s/ X. Xxxxxxxx
----------------------------------
Printed Name: W. Xxxxx Xxxxxxxx
------------------------
Title: Chief Executive Officer
-------------------------------
13
14
EXHIBIT E
CLINICAL DEVELOPMENT MILESTONES
[*]
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
14
