Exhibit 10.51
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.
AMENDED AND RESTATED WORLDWIDE
AGREEMENT
This Amended and Restated Worldwide
Agreement is entered into as of October 1, 2003 (the
“Effective Date” ), by and among, on the one
hand, HOFFMANN-LA ROCHE INC., a New Jersey corporation having
offices at 340 Kingsland Street, Nutley, New Jersey 07110 (
“Roche-Nutley” ) and F. HOFFMANN-LA ROCHE LTD of
Basel, Switzerland ( “F. Roche ”) (Roche-Nutley
and F. Roche are hereinafter individually and collectively
referred to as “Roche ”) and, on the other hand,
PROTEIN DESIGN LABS, INC., a Delaware corporation having offices at
34801 Campus Drive, Fremont, California 94555 (
“PDL” ).
RECITALS
Roche and PDL were originally parties to
agreements dated January 31, 1989, as amended (the
“1989 Agreements” ) pertaining to humanized and
chimeric antibodies against the interleukin-2 receptor (
“IL-2R” ).
Under the 1989 Agreements, PDL exclusively
licensed to Roche rights to a humanized antibody now known as
Daclizumab (as defined below).
Roche is currently marketing Daclizumab under
the trademark Zenapax® for the prevention of acute organ
rejection in patients receiving kidney transplants.
In 1999, Roche and PDL replaced the 1989
Agreements with two new agreements (as amended, known separately as
the “1999 PDL/Roche Agreement” and the
“F. Roche Agreement,” respectively, and
collectively as the “1999 Agreements” ) which
provided PDL with rights to develop and, if successful, promote
Daclizumab in autoimmune indications for increased compensation
from the 1989 Agreements.
Roche and PDL now desire to replace the 1999
Agreements with this Amended and Restated Worldwide Agreement that
(1) reverts to PDL all IL-2R antibody rights licensed to Roche
by PDL under the 1999 Agreements, subject to Roche’s
continuing exclusive license to market and sell Daclizumab for
Transplant Indications in the Roche Territory and develop and
commercialize products based on [*] that [*] to the
[*] of [*] ; (2) grants to PDL the sole and
exclusive worldwide rights under Roche’s relevant
intellectual property to develop, and, if successful, market and
sell Daclizumab for Autoimmune Indications and Other Indications;
and (3) grants PDL the right to purchase all of Roche’s
remaining rights to Daclizumab, subject to Roche’s right to
retain its exclusive license from PDL to develop and commercialize
products based on [*] that [*] to the [*] of
[*] .
1
NOW, THEREFORE, in consideration of
the premises and the mutual promises and covenants set forth below,
PDL and Roche mutually agree to amend and restate the 1999
Agreements in this single Amended and Restated Worldwide Agreement
as follows:
I. DEFINITIONS
For the purposes of this Amended and
Restated Worldwide Agreement, the following terms, when written
with an initial capital letter, shall have the meaning ascribed to
them below. All references to particular Appendices, Articles
and Sections shall mean the Appendices to, and Articles and
Sections of, this Amended and Restated Worldwide Agreement, unless
otherwise specified.
1.1
“AAGS”
shall mean the average annualized
Roche Adjusted Gross Sales of Daclizumab calculated according to
the following:
[*]
where [*] is the [*]
for the period from [*] through the most recent [*]
ended [*] the [*] of (i) the date of [*]
that [*] the [*] ; or (ii) the date of
[*] that [*] the [*] ;
[*] is that portion of [*] that [*] ,
to [*] reasonable satisfaction, to be [*] to
[*] for [*] in [*] or [*] ;
and
[*] is the [*] of [*] from (and
including) [*] through the end of the [*] ended
[*] to the [*] of (i) the date of [*]
that [*] the [*] ; or (ii) the date of
[*] that [*] the [*] .
By way of illustration and without
limitation, [*]
1.2
“Acting
Party” has the
meaning set forth in Section 12.1(c).
1.3
“Affiliates” means any corporation or other business entity
controlled by, controlling, or under common control with another
entity, with “control” meaning direct or indirect
beneficial ownership of more than fifty percent (50%) of the voting
stock of, or more than a fifty percent (50%) interest in the income
of, such corporation or other business entity. Anything to
the contrary in this paragraph notwithstanding,
[*]
1.4
“AI
Trademarks” means
all trademarks used in connection with the marketing, promotion,
and sale of Daclizumab by PDL or its sublicensee(s) and all
trademark registrations and applications therefor, and all goodwill
associated therewith.
1.5
“Application”
means a new application, or a
supplement or an amendment to an existing application, for
marketing approval for an Autoimmune Indication in the
Territory.
1.6
“Autoimmune
Indications” or
“AI” means all indications that involve
pathogenic consequences, including tissue injury, produced by
autoantibodies or autoreactive T lymphocytes interacting with self
epitopes, i.e., autoantigens. Autoimmune Indications
shall
2
include, without limitation, asthma, psoriasis,
rheumatoid arthritis, systemic lupus erythematosus, scleroderma,
juvenile rheumatoid arthritis, polymytosis, Type I diabetes,
sarcoidosis, Sjogrens syndrome, chronic active non-pathogenic
hepatitis, non-infectious uveitis (Behcets), aplastic anemia,
regional non-pathogenic enteritis (including ulcerative colitis,
Crohn’s Disease and inflammatory bowel disease),
Kawasaki’s disease, post-infectious encephalitis, multiple
sclerosis, and tropic spastic paraparesis.
1.7
“Change of
Control” means a
transaction in which Roche either (a) sells, conveys or
otherwise disposes of all or substantially all of its property or
business; or (b) either (i) merges or consolidates with
any other entity (other than a wholly-owned subsidiary of Roche);
or (ii) effects any other transaction or series of
transactions, in each case of clause (i) or (ii), such that
the voting stockholders of Roche immediately prior thereto, in the
aggregate, no longer own, directly or indirectly, beneficially or
legally, at least fifty percent (50%) of the outstanding voting
securities or capital stock of the surviving entity following the
closing of such merger, consolidation, other transaction or series
of transactions.
1.8
“Combination
Product” means any
product containing both an ingredient that causes it to be
considered a Licensed Product and one or more other therapeutically
active ingredients.
1.9
“Commercialization
Term” means the
period commencing on the Effective Date and ending on the earliest
of (a) the Reversion Effective Date; (b) the Put Right
Effective Date; and (c) if Roche does not exercise the Roche
Put Right and the Exercise Period ends without PDL exercising the
Transplant Reversion, the date Roche ceases to sell Daclizumab in
every country in the Roche Territory, as permitted under this
Amended and Restated Worldwide Agreement.
1.10
“Controlled” means, with respect to any intellectual property
right, that the party has a license to such intellectual property
right and has the ability to grant to the other party a sublicense
to such intellectual property right as provided for herein without
violating the terms of any agreement or other arrangements with any
Third Party existing at the time such party would be first required
hereunder to grant the other party such sublicense.
1.11
“Cost of
Goods” means the
manufacturing cost of either (a) unformulated bulk Daclizumab,
or (b) finished Daclizumab product made from unformulated
bulk, as the case may be, calculated in accordance with internal
cost accounting methods consistently applied by a party for its
other biologics pharmaceutical products, provided that such methods
comply with [*] . Cost of Goods shall include
[*] . As used in this Amended and Restated Worldwide
Agreement, the Cost of Goods shall not exceed [*]
1.12
“Cover”
(including variations thereof such
as “Covering” or “Covered”), means that the
manufacture, use, sale, offer for sale, or importation of a
particular product would infringe a Valid Claim of a patent in the
absence of rights under such patent. The determination of
whether a particular product is Covered by particular Valid Claims
shall be made on a country-by-country basis.
3
1.13
“Daclizumab” means any product that contains humanized
anti-Tac (as defined under “Field”).
1.14
“Daclizumab
Assets” means all
assets owned by Roche or its Affiliates and relevant solely to the
development or commercialization of Daclizumab, other than the
Trademarks and the Roche Owned Patents. Daclizumab Assets
include, without limitation:
(a)
domain names used in connection with
the sale or promotion of Daclizumab;
(b)
all then current promotional
materials, including brochures, leave-behind materials, product
fact sheets, advertisements in all media;
(c)
all then current packaging art copy,
and all trade dress rights thereto;
(d)
rights to any “look and
feel” of any materials referenced in (a) through
(c) above and used in connection with the marketing, sale or
promotion of Daclizumab and any and all copyrights or other
intellectual property rights appurtenant thereto;
(e)
all then current sales training
materials and medical education materials;
(f)
copies of market research surveys,
analyses, and reports;
(g)
then current customer lists, sales
records, lists of distributors;
(h)
regulatory filings, INDs, agreements
related to physician sponsored INDs (to the extent assignable),
CTXs, BLAs, and foreign equivalents of the foregoing, and all
associated communications with regulatory authorities in the Roche
Territory (excluding manufacturing approvals); and
(i)
then current contracts with managed
care groups, hospitals, transplant centers, pharmaceutical benefit
managers, distributors and other similar Third Parties.
1.15
“Excluded
Field” means
[*] that (a) [*] to the [*] of
[*] , (b) [*] the [*] of [*] ,
and (c) may also [*] . The Parties agree that
Daclizumab is not in the Excluded Field.
1.16
“Excluded
Product” means any
product in the Excluded Field, including any Combination Product,
that contains an [*] that was [*] by [*] on
behalf of [*] pursuant to the [*] . [*]
shall be deemed to be an Excluded Product.
1.17
“Exercise
Period” has the
meaning set forth in Section 5.2(a).
1.18
“FDA”
means the United States Food and
Drug Administration and any successor agency thereto, and/or any
equivalent foreign governmental agency, depending on the
context.
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1.19
“Field”
means any humanized or chimeric
antibody that binds to IL-2R, where “humanized” means a
genetically engineered combination of a substantially human
framework region and constant region, and complementarity
determining regions from non-human antibodies, and where
“chimeric” means a genetically engineered combination
of human constant region and non-human variable region.
“Antibodies in the Field ” means humanized and
chimeric antibodies that bind to IL-2R. It is believed that
these Antibodies in the Field may be useful for therapeutic,
diagnostic, imaging and similar purposes. It is understood
that the Field includes, but is not limited to, that certain
humanized murine monoclonal antibody prepared against the p55
component of IL-2R ( “humanized anti-Tac” ).
Furthermore, the Field includes, but is not limited to, all
improvements relating to humanized anti-Tac, including without
limitation modifications in structure introduced by genetic
engineering, or by chemical or enzymatic cleavage. Also
included within the Field shall be alternate hosts for producing
humanized anti-Tac, methods for purification, formulations
incorporating humanized anti-Tac, and uses and methods of use for
humanized anti-Tac in human medicine.
1.20
“Joint
Inventions” means
any inventions in the Field, whether patented or not, that are
jointly made during the period beginning on January 31, 1989
and continuing until the end of the Commercialization Term by at
least one (1) PDL employee or person contractually required to
assign or license patent rights covering such inventions to PDL and
at least one (1) Roche-Nutley or F. Roche employee or person
contractually required to assign or license patent rights covering
such inventions to Roche-Nutley or F. Roche.
1.21
“Licensed
Product” means any
product, other than an Excluded Product, in the Field, including
any Combination Product, the making, importation, use, offer for
sale, or sale of which utilizes Roche Know-How, Roche Patents, or
Joint Inventions or would, in the absence of this Amended and
Restated Worldwide Agreement, infringe a Valid Claim of a Roche
Patent. Daclizumab shall be deemed to be a Licensed
Product.
1.22
“Major
Country” means the
United States, United Kingdom, France, Italy and
Germany.
1.23
“Other
Indications” means
all indications other than Transplant Indications and Autoimmune
Indications.
1.24
“ Other Licensed
Products” means all Licensed Products other than
Daclizumab.
1.25
“PDL Adjusted Gross
Sales” means the
gross invoice price of Daclizumab sold or otherwise disposed of for
consideration in the Roche Territory by PDL, its Affiliates or
sublicensees (other than Roche and its Affiliates hereunder) to
independent Third Parties not an Affiliate of the seller, reduced
by the following amounts: (a) the amounts actually allowed as
volume or quantity discounts, rebates, price reductions, returns
(including withdrawals and recalls); and (b) sales, excise and
turnover taxes imposed directly on and actually paid by PDL, its
Affiliates or sublicensees.
5
When calculating the PDL Adjusted
Gross Sales, the amount of such sales in foreign currencies shall
be converted into U.S. dollars at the average rate of exchange at
the time for the applicable calendar quarter in accordance with
PDL’s then-current standard practices.
In the case of Combination Products
for which Daclizumab and each of the other therapeutically active
ingredients contained in the Combination Product have established
market prices when sold separately, PDL Adjusted Gross Sales shall
be determined by multiplying the PDL Adjusted Gross Sales for each
such Combination Product by a fraction, the numerator of which
shall be the established market price for the form and formulation
of Daclizumab contained in the Combination Product, and the
denominator of which shall be the sum of the established market
prices for such form and formulation of Daclizumab plus the other
active ingredients contained in the Combination Product. When
such separate market prices are not established, then the parties
shall negotiate in good faith to determine the method of
calculating PDL Adjusted Gross Sales for Combination
Products.
If PDL or its Affiliates or
sublicensees receive non-cash consideration for Daclizumab sold or
otherwise transferred to an independent Third Party not an
Affiliate of the seller or transferor, the fair market value of
such non-cash consideration on the date of the transfer as known to
PDL, or as reasonably estimated by PDL if unknown, shall be deemed
the PDL Adjusted Gross Sales for such Daclizumab sold or otherwise
transferred.
1.26
PDL Know-How”
means, except as otherwise set forth
in this Section 1.26, all inventions, discoveries, trade
secrets, information, experience, data, formulas, procedures and
results in the Field, and improvements thereon, including any
information regarding the physical, chemical, biological,
toxicological, pharmacological, clinical, and veterinary data,
dosage regimens, control assays and specifications of Daclizumab
(collectively, “Know-How in the Field” ), that
is owned or Controlled by PDL or its Affiliates as of the Effective
Date or that is developed or Controlled by PDL or its Affiliates
during the term of this Amended and Restated Worldwide Agreement,
and which Know-How in the Field is reasonably required or useful
for manufacturing, using or selling Daclizumab; provided, however,
that PDL Know-How excludes any Know-How in the Field of any kind
concerning generic methods of manufacturing, designing, developing
or preparing antibodies including, but not limited to, methods of
humanizing antibodies, methods of reducing the immunogenicity of
antibodies, and methods of increasing the affinity of
antibodies.
1.27
“PDL Net
Sales” means the
amount determined by deducting [*] from PDL Adjusted Gross
Sales to cover all other expenses or discounts, including but not
limited to cash discounts, custom duties, transportation and
insurance charges and other direct expenses, to the extent not
already deducted from the amount invoiced.
1.28
“PDL
Patents” means all
patent applications owned or Controlled by PDL alone or with a
Third Party ( “Sole PDL Patents” ) and all
patent applications resulting from Joint Inventions (
“Joint Roche-PDL Patents” ) Covering Daclizumab,
which are filed prior to or during the term of the 1989 Agreements,
the 1999 Agreements or this Amended and Restated Worldwide
Agreement in the United States or any foreign jurisdiction,
including any addition,
6
continuation, continuation-in-part or division
thereof or any substitute application therefor; any patent issued
with respect to such patent application, any reissue, extension or
patent term extension of any such patent, and any confirmation
patent or registration patent or patent of addition based on any
such patent; and any other United States or foreign patent or
inventor’s certificate covering products in the
Field.
1.29
“ PDL Sole Territory
” means all countries of the world, as listed in Appendix C
(which the parties may agree to update from time to time), with
respect to which Roche has granted an exclusive license to PDL, in
connection with the previous return or reversion of Roche’s
rights under the 1999 Agreements.
1.30
“Product Operating
Committee” or
“POC” has the meaning set forth in
Section 6.2(a).
1.31
“Put Exercise
Fee” has the
meaning set forth in Section 5.3(b).
1.32
“Put Right Effective
Date” has the
meaning set forth in Section 5.3(a).
1.33
“Queen et al.
Patents” means
those Sole PDL Patents in the Territory claiming priority under 35
USC 120 to U.S. Patent Application Serial No. 290,975, filed
December 28, 1988.
1.34
“Reasonable
Diligence” means
the same level of effort used by Roche in developing, registering,
marketing and selling its own protein-based products that must be
approved by the FDA before they can be sold in the Roche
Territory. The parties acknowledge that Roche does not
develop, register, market and sell its own protein-based products
in every country within the Roche Territory, and it is understood
that the exercise by Roche of reasonable diligence shall be
determined by judging its efforts in the Roche Territory taken as a
whole.
1.35
“Regulatory
Approval” means the
granting of all governmental regulatory approvals required, if any,
for the sale of a Licensed Product in a given country or
jurisdiction within the Territory.
1.36
“Reversion Effective
Date” has the
meaning set forth in Section 5.2(b).
1.37
“Reversion Exercise
Fee” has the
meaning set forth in Section 5.2(c).
1.38
“Roche Adjusted Gross
Sales” means the
gross invoice price of Daclizumab sold or otherwise disposed of for
consideration by Roche, its Affiliates or sublicensees (other than
PDL and its Affiliates hereunder) to independent Third Parties not
an Affiliate of the seller, reduced by the following amounts:
(a) the amounts actually allowed as volume or quantity
discounts, rebates, price reductions, returns (including
withdrawals and recalls); and (b) sales, excise and turnover
taxes imposed directly on and actually paid by Roche, its
Affiliates or sublicensees.
7
When calculating the Roche Adjusted
Gross Sales, the amount of such sales in foreign currencies shall
be converted into U.S. dollars at the average rate of exchange at
the time for the applicable calendar quarter in accordance with
Roche’s then-current standard practices.
In the case of Combination Products
for which Daclizumab and each of the other therapeutically active
ingredients contained in the Combination Product have established
market prices when sold separately, Roche Adjusted Gross Sales
shall be determined by multiplying the Roche Adjusted Gross Sales
for each such Combination Product by a fraction, the numerator of
which shall be the established market price for the form and
formulation of Daclizumab contained in the Combination Product, and
the denominator of which shall be the sum of the established market
prices for such form and formulation of Daclizumab plus the other
active ingredients contained in the Combination Product. When
such separate market prices are not established, then the parties
shall negotiate in good faith to determine the method of
calculating Roche Adjusted Gross Sales for Combination
Products.
If Roche or its Affiliates or
sublicensees receive non-cash consideration for Daclizumab sold or
otherwise transferred to an independent Third Party not an
Affiliate of the seller or transferor, the fair market value of
such non-cash consideration on the date of the transfer as known to
Roche, or as reasonably estimated by Roche if unknown, shall be
deemed the Roche Adjusted Gross Sales for such Daclizumab sold or
otherwise transferred.
1.39
“Roche Commercialization
Activities” has the
meaning set forth in Section 4.1(a).
1.40
“Roche Controlled
Patents” means all
patent applications Controlled by Roche or its Affiliates and not
Controlled by PDL or its Affiliates Covering inventions in the
Field that are filed prior to or during the term of this Amended
and Restated Worldwide Agreement in the United States or any
foreign jurisdiction, including any addition, continuation,
continuation-in-part or division thereof or any substitute
application therefor; any patent issued with respect to such patent
application, any reissue, extension or patent term extension of any
such patent, and any confirmation patent or registration patent or
patent of addition based on any such patent; and any other United
States or foreign patent or inventor’s certificate covering
inventions in the Field. Roche Controlled Patents are,
specifically, those listed on Schedule 2.8(b).
1.41
“Roche
Inventions” means
any inventions in the Field that are made prior to or during the
term of this Amended and Restated Worldwide Agreement by employees
of Roche or persons contractually required to assign or license
patent rights covering such inventions to Roche.
1.42
“Roche
Know-How” means all
Know-How in the Field that is owned or Controlled by Roche or its
Affiliates as of the Effective Date, or that is developed or
Controlled by Roche or its Affiliates during the Commercialization
Term and which Know-How in the Field is reasonably required or
useful for seeking registration of, manufacturing, using or selling
Daclizumab, as the case may be, provided, however, that this
portion of Roche Know-How excludes any Know-How in the Field of any
kind concerning generic methods of manufacturing,
8
designing, developing or preparing antibodies
including, but not limited to, methods of humanizing antibodies,
methods of reducing the immunogenicity of antibodies, and methods
of increasing the affinity of antibodies. For clarity, Roche
Know-How includes all Know-How in the Field provided to PDL by
Roche or its Affiliates under the 1989 Agreements and 1999
Agreements.
1.43
“ Roche Licensed
Know-How” means that portion of Roche Know-How that is
reasonably required or useful for seeking registration of,
manufacturing, using or selling Daclizumab for Autoimmune
Indications or any Other Indication, but shall not include
[*] .
1.44
“Roche Licensed
Patents” means
those Roche Patents that Cover in whole or in part the manufacture,
importation, offer for sale or sale of Daclizumab or any Other
Licensed Products, or the use of Daclizumab or any Other Licensed
Products in Autoimmune Indications or Other Indications.
1.45
“Roche Net
Sales” means the
amount determined by deducting [*] from Roche Adjusted Gross
Sales to cover all other expenses or discounts, including but not
limited to cash discounts, custom duties, transportation and
insurance charges and other direct expenses, to the extent not
already deducted from the amount invoiced. Notwithstanding
the foregoing, “Roche Net Sales of Excluded
Products” shall be calculated in the same manner as Roche
Net Sales, except that for the purpose of such calculation, Roche
Adjusted Gross Sales shall be based on the gross invoice price of
Excluded Products.
1.46
“Roche Owned
Patents” means all
patent applications owned by Roche or its Affiliates (
“Sole Roche Patents” ) alone or with a Third
Party, and all patent applications resulting from Joint Inventions
( “Joint Roche-PDL Patents” ) covering
inventions in the Field that are filed prior to or during the term
of this Amended and Restated Worldwide Agreement in the United
States or any foreign jurisdiction, including any addition,
continuation, continuation-in-part or division thereof or any
substitute application therefor; any patent issued with respect to
such patent application, any reissue, extension or patent term
extension of any such patent, and any confirmation patent or
registration patent or patent of addition based on any such patent;
and any other United States or foreign patent or inventor’s
certificate covering inventions in the Field. Roche Owned
Patents as of the Effective Date are, specifically, those listed on
Schedule 2.8(a).
1.47
“Roche
Patents” means both
the Roche Owned Patents and the Roche Controlled
Patents.
1.48
“Roche
Products” means
Daclizumab and any Excluded Products.
1.49
“Roche Put
Right” has the
meaning set forth in Section 5.3(a).
1.50
“Roche
Territory” means,
collectively, (a) the United States of America (“
U.S. ” or “ U.S.A. ” or “
United States ”) and its territories and possessions
where the patent laws of the
9
United States are in force and (b) all
other countries in the Territory, excluding the PDL Sole Territory
(the “ Roche ROW Territory ”).
1.51
“Territory” means all the countries of the world.
1.52
“Third
Party” means any
person or entity other than PDL, Roche, and their respective
Affiliates.
1.53
“Third Party
License” means
(a) any of the license agreements set forth on Appendix B that
were entered into by either party, prior to the Effective Date, in
order for Roche or PDL to manufacture, use, import, offer for sale
or sell Daclizumab or (b) any license agreement entered into
with a Third Party by either party in accordance with
Section 7.4(b).
1.54
“Trademarks
” means the trademark
“Zenapax®,” and all trademark registrations and
applications therefor, and all goodwill associated therewith, and
all other trademarks owned by Roche (except for any Roche
housemarks or trade names) and used in connection with the sale or
promotion of Daclizumab in the Roche Territory.
1.55
“Transplant Foreign Filing
Expenses” means ex
parte out-of-pocket expenses (a) incurred by PDL after
January 31, 1989, but prior to the Effective Date, in
connection with the prosecution and maintenance in the Roche ROW
Territory of patent applications and patents included within the
PDL Patents or Joint Roche-PDL Patents and (b) reimbursed by
Roche pursuant to Section 7.2(a) of the 1999 PDL/Roche
Agreement or Section 5.3(a) of the F. Roche
Agreement.
1.56
“Transplant
Indications” means
all indications that involve the suppression of rejection of
transplanted organs, bone marrow or other tissue, including,
without limitation, solid organ transplantation (including
tolerance induction and xenotransplantation), bone marrow
transplantation, graft versus host disease and cell
transplantation. In any event, if a given indication
satisfies the criteria for both an Autoimmune Indication and a
Transplant Indication, such indication shall be deemed a Transplant
Indication and not an Autoimmune Indication, provided that an
Autoimmune Indication shall not be deemed a Transplant Indication
merely because it may cause the need for a transplant (e.g., Type I
diabetes, even if it causes the need for an organ
transplant).
1.57
“Transplant
Reversion” has the
meaning set forth in Section 5.2(a).
1.58
“Valid
Claim” means a
claim in any issued patent that has not been disclaimed or held
unenforceable or invalid by a decision of a court or governmental
agency of competent jurisdiction by a decision beyond right of
review.
II. LICENSE GRANTS
2.1
License Grant to PDL On Effective
Date.
10
(a)
Subject to the terms and conditions
of this Amended and Restated Worldwide Agreement, Roche grants to
PDL and to PDL’s Affiliates the worldwide right and license
under the Roche Licensed Know-How and Roche Licensed Patents, to
(i) develop, use, market, promote, and detail Daclizumab in
the Territory solely for use in Autoimmune Indications and/or the
Other Indications, and (ii) sell and offer for sale Daclizumab
in the Territory, under the AI Trademarks.
(b)
The licenses set forth in Sections
2.1(a)(i) and 2.1(a)(ii) shall be exclusive (even as to
Roche) with respect to the Roche Licensed Know-How and Roche
Licensed Patents that Roche or its Affiliate solely owns or has an
exclusive license. With respect to the Roche Licensed
Know-How and Roche Licensed Patents to which Roche or its Affiliate
has a non-exclusive license, such licenses shall be sole,
non-exclusive licenses. With respect to the Roche Licensed
Know-How and Roche Licensed Patents that Roche or its Affiliate
jointly owns, such licenses shall be sole licenses under
Roche’s interest in such Roche Licensed Know-How and Roche
Licensed Patents. As used in this Section 2.1(b) a
“sole” license means that the Roche will not grant to
any Third Party a license that overlaps with the scope of the
licenses granted to PDL under Section 2.1(a).
(c)
Roche grants to PDL and to
PDL’s Affiliates, the nonexclusive right under the Roche
Licensed Know-How and Roche Licensed Patents to make, have made,
and import Daclizumab.
(d)
PDL and its Affiliates may
sublicense the rights and licenses granted to them under Sections
2.1(a) and (c) to any Affiliate or Third Party, with the
right to further sublicense; provided, however, that without
Roche’s written consent, PDL shall not have the right to
sublicense, during the Commercialization Term, any of the
[*] rights or licenses in Section 2.1(a) to any
other entity, that is, as of the time of such sublicensing,
[*] in the [*] (in at least one [*] with
[*] ), or [*] in the [*] any [*] for
the [*] of [*] in any [*] . It is
expressly understood and agreed by Roche that PDL shall have the
right to sublicense its rights under Sections 2.1(a) and
(c) to [*] . Notwithstanding the preceding
limitation on sublicensing, PDL and its Affiliates may use Third
Party distributors in accordance with their customary
practices.
(e)
Subject to the terms and conditions
of this Amended and Restated Worldwide Agreement, Roche grants to
PDL and to PDL’s Affiliates a worldwide right and license (or
sublicense, as the case may be) under the Roche Licensed Know-How
received by PDL pursuant to the 1989 Agreements, 1999 Agreements or
Section 2.4 hereof, the Roche Controlled Patents and only
those Roche Owned Patents listed in Schedule 2.8(a), to
(i) develop, use, market, promote, and detail Other Licensed
Products in the Territory solely for use in Autoimmune Indications
and/or the Other Indications; (ii) sell and offer for sale
Other Licensed Products in the Territory; and (iii) to make,
have made, and import Other Licensed Products in the
Territory.
(f)
The license set forth in
Section 2.1(e) shall be exclusive (even as to Roche) with
respect to the Roche Controlled Patents that Roche or its Affiliate
solely owns or has an exclusive license. With respect to the
Roche Controlled Patents to which Roche or its Affiliate has a
non-exclusive license, such license shall be a sole, non-exclusive
license. With respect to
11
the Roche Owned Patents that Roche
or its Affiliate jointly owns, such license shall be a sole license
under Roche’s interest in such Roche Owned Patents. PDL
and its Affiliates shall have the right freely to sublicense,
through multiple tiers, the rights and licenses granted to them
under Section 2.1(e). Notwithstanding anything to the
contrary in Section 2.1(e), the license to Roche Licensed
Know-How shall be non-exclusive. Roche hereby covenants that,
until the termination, pursuant to Section 2.2(a), of the
license set forth in Section 2.1(e), it will not grant to any
Third Party any right or license under the (i) Roche
Controlled Patents to which Roche or its Affiliate has a
non-exclusive license or (ii) Roche Owned Patents that Roche
or its Affiliate jointly owns , to (A) develop, use, market,
promote, and detail Other Licensed Products in the Territory for
use in Autoimmune Indications and/or the Other Indications;
(B) sell and offer for sale Other Licensed Products in the
Territory; and (C) make, have made, and import Other Licensed
Products in the Territory.
(g)
If PDL wishes to receive a license
with respect to Other Licensed Products in Autoimmune Indications
and/or Other Indication, under any Roche Owned Patents that are not
listed in Schedule 2.8(a), it shall [*] and Roche shall
[*] .
2.2
License Grant to PDL On Reversion
Effective Date or Put Right Effective Date.
(a)
Effective only on the Reversion
Effective Date or the Put Right Effective Date, Roche hereby grants
the following license to PDL: subject to the terms and conditions
of this Amended and Restated Worldwide Agreement, Roche grants to
PDL and to PDL’s Affiliates a worldwide right and license
under the Roche Know-How and Roche Patents, to develop, use,
manufacture, have manufactured, market, promote, import, offer for
sale, sell and have sold Daclizumab and all Other Licensed Products
in the Field and in the Territory. On the effectiveness of
the license set forth in this Section 2.2(a), the licenses
granted in Section 2.1(a), (c) and (e) shall
terminate. PDL and its Affiliates shall have the right freely
to sublicense, with the right to further sublicense, the right and
license granted to them under this Section 2.2(a).
(b)
For Daclizumab, the license set
forth in Section 2.2(a) shall be exclusive (even as to
Roche) with respect to the Roche Know-How and Roche Patents that
Roche or its Affiliate solely owns or has an exclusive
license. With respect to the Roche Know-How and Roche Patents
to which Roche or its Affiliate has a non-exclusive license, the
license set forth in Section 2.2(a) shall be a sole,
non-exclusive license. With respect to the Roche Know-How and
Roche Patents that Roche or its Affiliate jointly owns, the license
set forth in Section 2.2(a) shall be a sole license under
Roche’s interest in such Roche Know-How and Roche
Patents. Roche hereby covenants that it will not grant to any
Third Party any right or license, under (i) the Roche Know-How
and Roche Patents to which Roche or its Affiliate has a
non-exclusive license or (ii) the Roche Know-How and Roche
Patents that Roche or its Affiliate jointly owns, to develop, use,
manufacture, have manufactured, market, promote, import, offer for
sale and sell Daclizumab in the Field and in the
Territory.
(c)
For Other Licensed Products, the
license set forth in Section 2.2(a) shall be
non-exclusive. Notwithstanding the preceding sentence, Roche
hereby covenants that it will not
12
grant licenses to any Third Party under the
Roche Patents to make, have made, use, sell, offer for sale or
import any Other Licensed Product.
2.3
Certain [*] To PDL of
[*] Intellectual Property. PDL acknowledges and understands that
[*] are [*] as to [*] (a) Roche has
received, prior to the Effective Date, a [*] license under
certain [*] of [*] that [*] cover the
manufacture, use, importation, offer for sale or sale of humanized
antibodies against IL-2R, including Daclizumab and any Other
Licensed Products, and/or (b) [*] Roche has the right
to [*] such licensed [*] , to the extent granted to
Roche. In the event that the parties agree that Roche
is [*] such license [*] , PDL shall be deemed to have
been [*] pursuant to the [*] , as applicable, and
such [*] will be deemed part of the [*] licensed
thereunder. In the event that the parties agree that Roche
[*] such rights, and/or that Roche [*] such rights to
PDL as part of the [*] , Roche agrees to use diligent
efforts to itself secure or assist PDL in securing from [*]
, a license to such [*] from [*] , which license
rights will be documented under a separate agreement from this
Amended and Restated Worldwide Agreement. If [*]
obtains [*] consent to the terms of such separate agreement,
then it shall be deemed a [*] and [*] shall
[*] the costs of such license rights, in the manner and as
set forth in Section 7.4, [*] the [*] the costs
and royalties owed to [*] shall be as follows: [*]
shall bear [*] of the cost of such license rights and
[*] shall bear [*] of the costs of such license
rights; and provided, however, that this addition or offset shall
not cause the amount to be paid by PDL to Roche pursuant to
Section 7.2(c), in the aggregate and after payment to
[*] , to be less than [*] of [*] in [*]
. On either the [*] or the [*] , [*]
shall be [*] responsible for paying the prospective costs of
such license from that date forward, as further detailed in
Section 7.4(e). If the Exercise Period expires without
[*] or [*] , then the parties will proceed as
detailed in Section 7.4(f) with respect to Third Party
Licenses.
2.4
Transfer of Roche Licensed
Know-How to PDL .
Promptly after the Effective Date, Roche shall transfer all Roche
Licensed Know-How to PDL in the manner in which and to the extent
to which the parties, prior to the Effective Date, have transferred
know-how under the Joint Development Committee or the Joint
Commercialization Committee under the 1999 Agreements.
Thereafter, and until the Reversion Effective Date or the Put Right
Effective Date, if Roche develops or gains Control of additional
Roche Licensed Know-How, Roche shall promptly provide such
additional Roche Licensed Know-How to PDL through the
parties’ participation in the POC. On either the
Reversion Effective Date or the Put Right Effective Date, Roche
shall transfer to PDL any Roche Know-How not previously transferred
to PDL, including in particular, any Roche Know-How related to the
Transplant Indications.
2.5
License Grants to Roche.
(a)
Subject to the terms and conditions
of this Amended and Restated Worldwide Agreement, PDL grants to
Roche and to Roche’s Affiliates, during the Commercialization
Term, the exclusive (even as to PDL) right and license under the
PDL Know-How and PDL Patents to (i) market, promote, and
detail Daclizumab in the Roche Territory solely for use in the
Transplant Indications, and (ii) to sell and offer for sale
Daclizumab in the Roche Territory under the Trademarks.
In addition, PDL grants to Roche and to Roche’s Affiliates,
the nonexclusive right under the PDL Know-How and PDL Patents to
make, have made and import
13
Daclizumab, but only to the extent reasonably
necessary for Roche to carry out its rights and obligations under
this Amended and Restated Worldwide Agreement. Roche may
sublicense the rights and licenses granted to Roche under this
Section 2.5, subject to PDL’s written consent, which
consent PDL may not unreasonably withhold. It shall be deemed
reasonable for PDL to withhold consent with respect to sublicense
by Roche of any of the rights or licenses to any other entity that
is [*] (in at least one [*] with [*] ), or
[*] in a [*] any [*] for the [*] of any
[*] . Notwithstanding the preceding sentence, Roche
and its Affiliates may use Third Party distributors in accordance
with their customary practices. All sublicenses granted by Roche or
its Affiliates of the licenses set forth in this
Section 2.5(a) shall automatically terminate on the
Reversion Effective Date or Put Right Effective Date.
(b)
Subject to the terms and conditions
of this Amended and Restated Worldwide Agreement, in particular the
restrictions set forth in Section 3.1(b), PDL grants to Roche
and to Roche’s Affiliates the exclusive (even as to PDL)
right and license, including the right to grant sublicenses, under
the PDL Know-How and PDL Patents to use, develop, make, have made,
sell, offer for sale, and import the Excluded Products in the Roche
Territory; provided, however that the license granted under this
Section 2.5(b) under [*] shall be
nonexclusive.
(c)
PDL hereby covenants that, until the
expiration of [*] , it will not make, have made, use, sell,
offer for sale or import any product in the Excluded Field Covered
by [*] in the Roche Territory, and it will not grant to any
Third Party any right or license under [*] the right to
make, have made, use, sell, offer for sale or import any product in
the Excluded Field in the Roche Territory.
(d)
If during the term of this Amended
and Restated Worldwide Agreement, Roche or its Affiliate challenges
the validity or enforceability in any jurisdiction of [*] ,
then PDL shall have the right to [*] to Roche under this
Amended and Restated Worldwide Agreement to PDL Patents that
include [*] .
(e)
Roche hereby covenants that it shall
not, nor shall it cause any Affiliate or sublicensee to:
(i)
knowingly use or practice, directly
or indirectly, any PDL Know-How or PDL Patents for any other
purposes other than those expressly permitted by this Amended and
Restated Worldwide Agreement or any other written agreements in the
Field between the Parties currently in existence and not expressly
superceded by this Amended and Restated Worldwide Agreement, or
which may later be entered into by the Parties;
(ii)
market, promote, detail, sell or
offer for sale Daclizumab, during the Commercialization Term, in
any manner outside the scope of the licenses set forth in
Section 2.5(a), including, in particular, for any use in the
treatment of Autoimmune Indications or Other Indications;
or
(iii)
use, develop, make, have made, sell,
offer for sale or import Excluded Products in any manner outside
the scope of the licenses set forth in
Section 2.5(b).
14
(f)
PDL hereby covenants that it shall
not, nor shall it cause any Affiliate or sublicensee to market,
promote, detail, sell or offer for sale Daclizumab, during the
Commercialization Term, in any manner outside the scope of the
licenses set forth in Sections 2.1 and 2.2.
2.6
Identification of the Queen et al
Patents . Set forth
on Appendix A is a list identifying patents or patent
applications that comprise the Queen et al. Patents in the Roche
Territory as of the Effective Date. If there are any
changes, PDL shall update this list by delivering a supplement to
Roche no less frequently than once per year during the term of this
Amended and Restated Worldwide Agreement.
2.7
Cooperation Regarding Third Party
Licenses. In
the event Roche negotiates and intends to enter into a license
agreement with a Third Party with respect to the right to make,
use, sell, import, offer for sale or sale of any [*] under
such Third Party’s intellectual property, it shall so inform
PDL and provide PDL the opportunity to participate in such
negotiations and enter into such license agreement or take a
sublicense thereunder with respect to [*] , on such terms as
are agreed by the parties.
2.8
Roche Representations, Warranties
and Covenants .
Roche hereby represents and warrants as of the Effective Date as
follows:
(a)
To the best of Roche’s
knowledge, Schedule 2.8(a) identifies the Roche Owned
Patents existing as of the Effective Date. To the extent that
it is not prohibited from doing so, Roche agrees to make available
to PDL copies of such Roche Owned Patents promptly following the
Effective Date. Roche covenants that, to the extent any additional
Roche Owned Patents are identified by Roche subsequent to the
Effective Date and to the extent that it is not prohibited from
doing so, it shall promptly inform PDL, and
Schedule 2.8(a) shall be revised to so reflect such
additional Roche Owned Patents.
(b)
Schedule 2.8(b) identifies
all of the license agreements under which Roche has rights to Roche
Controlled Patents existing as of the Effective Date (other than
the license rights from Genentech referred to in
Section 2.3). Roche agrees to make available to PDL
copies of such license agreements pursuant to which the Roche
Controlled Patents were licensed to Roche promptly following the
Effective Date, to the extent not already in PDL’s possession
and to the extent that Roche has a right to do so. [*]
further covenants that, where it is not [*] to [*] to
[*] such [*] , it will [*] to [*] from
the [*] its [*] to do so. Roche shall not, without
the prior written consent of PDL, terminate any agreement that
grants Roche a license under a Roche Controlled Patent. Roche
covenants that, to the extent any additional licenses under which
Roche has rights to Roche Controlled Patents are identified by
Roche or come into existence subsequent to the Effective Date,
Roche shall promptly inform PDL, and
Schedule 2.8(b) shall be revised to so reflect such
additional licenses; provided, however, that in the event any
royalty or other payment is owed to the licensor of any such Roche
Controlled Patent [*] PDL, [*] shall not be
responsible for any such royalty payments, and [*] shall so
notify [*] in writing and [*] shall have a period of
ninety (90) days to evaluate whether it desires that such
[*] be included within the [*]
15
licensed to [*] under [*] and if
so, the mechanism for payment to the [*] thereunder.
Where [*] elects not to [*] to such Roche Controlled
Patent, it agrees to [*]
(c)
Roche has not granted any Third
Party a license or other right that is currently in effect under
any of the Roche Owned Patents for any purpose.
(d)
To Roche’s knowledge, Roche
has complied with its obligation under 37 CFR §1.56(a) to
disclose to the United States Patent and Trademark Office, during
the pendency of each United States patent application included in
the Roche Owned Patents, information known to Roche to be material
to the patentability of the pending claims in such
application. None of the Roche Owned Patents is involved in
any interference or opposition proceeding, and, to Roche’s
knowledge, no such proceeding is being threatened with respect to
any of the Roche Owned Patents.
(e)
[*]
(f)
[*]
(g)
Roche and its Affiliates have not
granted to any Third Party in any Major Country, any sublicense,
under the license(s) to the PDL Know-How and PDL Patents that Roche
and its Affiliates received pursuant to the 1999 Agreements, to:
(i) promote and sell Daclizumab generally, and/or for use in
Autoimmune Indications or the Other Indications; or
(ii) develop, make, use, import, offer for sale and sell Other
Licensed Products for any indication in the Field. Roche
shall, prior to the [*] , disclose in writing to PDL all
sublicenses that Roche or its Affiliate have granted, under the PDL
Know-How and PDL Patents, to develop, make, use, import, promote,
offer for sale and sell Daclizumab and Other Licensed Products for
any indication in the Field. If any such sublicenses exist at
such time, the parties, through the POC, will work together to
[*] (including [*] , where practicable) such
sublicense.
(g)
Roche covenants that, in the event
that Roche [*] of the [*] of the [*] of
[*] , through whatever means, on PDL’s request, Roche
will within [*] days of such request, meet and discuss with
PDL the impact of such event on the relationship between PDL and
Roche at such time, and modify this Amended and Restated Worldwide
Agreement to the extent deemed appropriate by both
parties.
2.9
Termination of Certain
Sublicenses. If,
prior to the Effective Date, PDL and Roche or an Affiliate of Roche
entered into any agreement(s), other than the 1999 Agreements,
wherein PDL granted Roche or such Affiliate a sublicense with
respect to Daclizumab or Other Licensed Product(s), under any Third
Party intellectual property rights licensed by PDL, then such
sublicenses are hereby terminated and replaced by the licenses set
forth in Section 2.5.
16
III. DEVELOPMENT; REGULATORY ISSUES
3.1
Development by Roche
.
(a)
Development of
Daclizumab .
Following the Effective Date, [*] after the Effective
Date. In addition, to the extent Roche receives any data or
other results of any clinical trials pursuant to ongoing physician
sponsored trials, Roche will update the POC with respect to such
trial results and data. Further, Roche shall promptly forward
to PDL any requests for new [*] studies involving Daclizumab
that Roche receives after the Effective Date.
(b)
Development of Excluded
Products . Roche
shall be solely responsible, at its sole cost and expense and at
its sole discretion, for the non-clinical, clinical, and regulatory
development of any Excluded Product. Notwithstanding the
foregoing, it is understood and agreed that [*] for any
indication other than [*] without the written consent of
PDL, such consent not to be unreasonably withheld. The
Parties recognize that it may be desirable to develop the Excluded
Products for [*] , in which case the POC shall discuss and
recommend to the parties whether [*] . Following the
Effective Date, Roche shall use Reasonable Diligence in proceeding
with the development and registration of Excluded Products in the
Roche Territory, to the extent permitted under this
Section 3.1(b). If Roche fails to exercise such
diligence, PDL may terminate the license granted to Roche under
Section 2.5(b), but shall not be obligated to do
so.
3.2
Development by PDL
.
(a)
General . Following the Effective Date, PDL shall
be solely responsible, at its sole cost and expense and at its sole
discretion, for the non-clinical, clinical, and regulatory
development of Daclizumab for all indications in the Territory,
other than those trials referenced in Section 3.1(a), subject
to the restrictions set forth in Section 3.2(b). All
data and information generated by PDL development activities
pursuant to this Section 3.2(a) shall be PDL
Know-How.
(b)
Restriction on PDL
Development .
During the period commencing on the Effective Date and ending at
the end of the Commercialization Term, PDL agrees not to pursue the
clinical or regulatory development of Daclizumab for use in the
[*] in the Roche Territory.
3.3
Assistance by Roche
. At no cost to PDL (except as
provided in the following sentence), Roche will allow PDL to
cross-reference Roche regulatory filings and clinical data with
respect to Daclizumab and will grant PDL reasonable access during
normal business hours to such regulatory filings and clinical
data. To the extent Roche is required under applicable law,
rule or regulation, Roche, at PDL’s cost, shall promptly
make all filings reasonably required or useful to permit the use of
the clinical materials, if any, supplied pursuant to
Section 4.5(a) (e.g., preparation and filing of required
technical reports, data summaries, or a regulatory
dossier).
3.4
Adverse Event
Reporting . Each
party shall notify the other of all information coming into its
possession concerning any and all side effects, injury, toxicity,
pregnancy or sensitivity event associated with commercial or
clinical uses, studies, investigations or tests with Daclizumab,
throughout the world, whether or not determined to be attributable
to Daclizumab ( “Adverse Event Reports” ).
The parties shall each identify a person to coordinate the exchange
of Adverse Event Reports ( “Report Coordinators”
) so as to enable timely reporting of such Adverse Event Reports to
appropriate governmental and regulatory authorities consistent with
all
17
laws, rules and regulations. The parties,
through their Report Coordinators, have agreed in writing on formal
procedures for such exchange, which are embodied in the PDL-Roche
Procedure for the Exchange of Daclizumab Adverse Event Reports,
dated December 2000 ( “Pharmacovigilance
Agreement” ). Promptly after the Effective Date,
Roche and PDL agree to cause their Report Coordinators (a) to
review the Pharmacovigilance Agreement and (b) to negotiate in
good faith an amendment to the Pharmacovigilance Agreement to
reflect the terms of this Amended and Restated Worldwide Agreement,
if the Report Coordinators agree that such an amendment is
required. Such Pharmacoviligance Agreement (as amended, if
applicable) shall survive the end of the Commercialization
Term.
3.5
Copies of Responses
. Within a reasonable time
frame prior to submission of responses to any regulatory authority
on product safety issues regarding Daclizumab, a copy of a near
final draft response will be provided to the other party for
review. Final copies of responses submitted to any regulatory
authority will be provided to the other party within five
(5) business days of document finalization.
3.6
Regulatory Actions
. The party responsible to
interact with regulators on a specific safety issue regarding
Daclizumab must communicate action requested by regulators to the
other party without delay. Such actions may include, for
example, change in label, Dear Doctor letter, trial on hold for
clinical safety reasons and the like.
3.7
Other Safety Issues
. Either party may request
that specific safety issues be discussed, and the parties will
establish a Joint Safety Committee ( “JDSC” ),
consisting of an equal number of representatives from each party,
for such purpose. JDSC discussion on such issues will be for the
purpose of advising each party concerning the collection and
evaluation of safety data, and responding to any significant safety
issues raised, or requests made, by regulatory
authorities.
3.8
Registration
. PDL shall notify Roche in
writing if PDL determines that clinical trial results for
Daclizumab justify filing an Application. Roche shall provide
cross reference letters reasonably required or useful to allow PDL
to make any such filing and to allow PDL to carry out without delay
any related clinical trial in the Territory. PDL shall be
responsible for preparing periodic reports required by the FDA
related to any such Applications and for timely filing such
periodic reports with the FDA. Through the POC, each party
shall advise and consult with the other with respect to any
significant issues or questions raised by any regulatory
authorities with respect to Daclizumab.
IV. COMMERCIALIZATION AND
MANUFACTURING
4.1
Commercialization By
Roche.
(a)
Commercialization of Daclizumab
by Roche . The
parties intend that, following the Effective Date, Roche will
continue to market and sell Daclizumab in the Transplant
Indications in the Roche Territory for the duration of the
Commercialization Term, under the Trademarks. In particular,
and without limitation, during the Commercialization
Term
18
and in the Roche Territory, Roche shall be
responsible, at its sole cost and as permitted by applicable law,
for (i) the marketing, promotion, and detailing of Daclizumab
for use in the Transplant Indications; (ii) accepting and
filling orders for Daclizumab received by it or its Affiliates,
including the distribution of Daclizumab to fill such orders;
(iii) booking all sales of Daclizumab attributable to such
orders; and (iv) any other activities reasonably related to
Daclizumab that are permitted under the license granted in
Section 2.5(a) (the “Roche Commercialization
Activities” ). As provided in Article VII,
Roche shall pay royalties to PDL on Roche Net Sales.
(b)
Commercialization of Excluded
Products by Roche .
Roche, its Affiliates, or sublicensees shall be solely responsible
for, at its or their sole cost and as permitted by law, all aspects
of the commercialization of Excluded Products in the Roche
Territory, including but not limited to the booking of all sales of
Excluded Products in the Roche Territory. Roche shall use
commercially diligent efforts to develop and commercialize such
Excluded Products. Following receipt of regulatory approval, Roche
shall use Reasonable Diligence in proceeding with the marketing,
promotion and sale of Excluded Products in the Roche
Territory. If Roche fails to exercise such diligence,
PDL may terminate the license granted to Roche under
Section 2.5(b), but shall not be obligated to do so. As
provided in Article VII, Roche shall pay royalties to PDL on
Roche Net Sales of Excluded Products.
4.2
Commercialization by PDL.
(a)
Commercialization by PDL During
Commercialization Term . In the Roche Territory, PDL, its
Affiliates, or sublicensees shall have the right, but not the
obligation, at its or their sole cost and as permitted by law, to
pursue all aspects of the commercialization of Daclizumab and any
Other Licensed Products, excluding the Roche Commercialization
Activities. Without limiting the generality of the foregoing,
in the Roche Territory and during the Commercialization Term, PDL,
its Affiliates, or sublicensees shall have the right, but not the
obligation, to commercialize Licensed Products in Autoimmune
Indications and Other Indications and to commercialize Other
Licensed Products in any indication. In particular, in the
Roche Territory, PDL shall be responsible, at its sole cost and as
permitted by applicable law, for (i) the marketing, promotion,
and detailing of Daclizumab for use in the Autoimmune Indications
or Other Indications; (ii) accepting and filling orders for
Daclizumab received by it or its Affiliates, including the
distribution of Daclizumab to fill such orders; (iii) booking
all sales of Daclizumab attributable to such orders; and
(iv) any other activities reasonably related to Daclizumab
that are permitted under the license granted in
Section 2.1. As provided in Article VII, PDL shall
pay royalties to Roche on PDL Net Sales during the
Commercialization Term.
(b)
Commercialization by PDL
Following Reversion Effective Date or Put Right Effective
Date . Following
the Reversion Effective Date or the Put Right Effective Date, PDL,
its Affiliates, or sublicensees shall have the right, but not the
obligation, to pursue, at its or their sole cost and as permitted
by law, all aspects of the commercialization of Daclizumab for all
indications and for all Other Licensed Products. Following
the Reversion Effective Date or the Put Right Effective Date, in no
event shall PDL owe any royalties or any other compensation
to
19
Roche on sales of Daclizumab under
Section 7.2(c) in the Territory, whether by PDL, its
Affiliates, or their sublicensees.
4.3
Commercialization in the PDL Sole
Territory . PDL,
its Affiliates, or sublicensees shall have the right, but not the
obligation, to pursue, at its or their sole cost and as permitted
by law, all aspects of the commercialization of Licensed Products
in the PDL Sole Territory, including but not limited to the booking
of all sales of Licensed Products in the PDL Sole
Territory.
4.4
Pricing . As between the parties, PDL has the sole
right to determine the price for Daclizumab or any Other Licensed
Product that it sells and distributes. As between the
parties, Roche has the sole right to determine the price for any
Excluded Product that it sells and distributes, and the sole right
during the Commercialization Term to determine the price for
Daclizumab that it sells and distributes; provided, however, that
until the earlier of (a) [*] or (b) PDL’s
receipt of a [*] from [*] having the power to grant
[*] , stating that [*] will grant [*] for
Daclizumab in [*] , Roche shall provide PDL with [*]
of any [*] in the [*] of Daclizumab and shall give
[*] to any [*] or [*] by PDL regarding the
[*] of Daclizumab whether [*] . It is expressly
understood that following the date which is the earliest of
(i) [*] , (ii) the receipt of [*] for
Daclizumab in [*] , or (iii) the Reversion Effective
Date or Put Right Effective Date, the obligations of either party
in the foregoing sentence shall terminate, and PDL shall have sole
control regarding the price of Daclizumab that it sells and
distributes.
4.5
Manufacturing
. References to Roche in
Sections 4.5(a) and 4.5(b) shall include Roche, its
Affiliates [*] and any sublicensees manufacturing Daclizumab
for Roche or its Affiliates.
(a)
Clinical Manufacturing
.
(i)
Supply . Subject to
Section 4.5(a)(ii) and until [*] , Roche shall use
commercially reasonable efforts to supply to PDL, [*]
Daclizumab and placebo [*] for the development of Daclizumab
for AI in the [*] and [*] specified by PDL.
Notwithstanding the above, Roche shall not be obligated to
[*] (A) any amount of Daclizumab or placebo not in
accordance with the AI Development plan, (B) a number of units
of placebo in excess of the units of Daclizumab supplied by Roche,
or (C) any form or formulation of Daclizumab [*] for
the [*] . In the event PDL requests Daclizumab in a
form or formulation [*] for the [*] , Roche shall be
obligated to supply to PDL [*] All Daclizumab for the
development of Daclizumab for AI, regardless of form or
formulation, shall be manufactured in accordance with cGMPs and any
other applicable regulatory or legal requirements. Through
the POC, the parties shall meet periodically and discuss the
availability and timing of delivery of Daclizumab hereunder.
[*] . At PDL’s cost, PDL shall perform any
bridging studies that are necessary to enable PDL to use
PDL-manufactured Daclizumab to satisfy its clinical development
requirements. On [*] , and any time thereafter, PDL
shall have the sole responsibility for the manufacture of all
Daclizumab and placebo required by PDL for the development of
Daclizumab for AI.
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(ii)
Limitations
. From the Effective Date
until [*] , Roche shall supply to PDL [*] up to
[*] of Daclizumab and an equivalent number of units of
placebo. For supplies in excess of such maximum amount
[*] , PDL shall pay to Roche for such additional supplies an
amount equal to [*] of [*] (including for
[*] ) for such supplies up to [*] of [*] per
gram]. Notwithstanding anything to the contrary herein, from
the Effective Date until [*] , the [*] of Daclizumab
that Roche shall be obligated to supply to PDL shall be [*]
of Daclizumab.
(iii)
Procedures
. During the period commencing
on the Effective Date and ending on [*] , PDL shall provide
Roche with [*] purchase orders, or such other procedures as
the POC determines, each setting forth the amount of Daclizumab and
placebo to be supplied by Roche to PDL. To the extent that
such purchase orders are consistent with the terms and conditions
of this Section 4.5, Roche agrees to honor all such purchase
orders and to deliver to PDL the amount of Daclizumab and placebo
specified therein as soon as practicable but in any event not later
than [*] days following Roche’s receipt of each such
purchase order, or under such other procedures as the POC
determines.
(b)
Commercial
Manufacturing .
Effective on the Effective Date and subject to
Section 4.5(c) and this Section 4.5(b), each party
shall each be solely responsible for the manufacturing of all
Daclizumab necessary to satisfy the commercial requirements of
itself, its Affiliates and its sublicensees. [*] shall
keep [*] reasonably informed, via the POC, regarding its
progress in [*] for its [*] to [*] for
[*] . As needed, the parties shall discuss and agree
upon a plan of action to address, among other things, [*]
that could arise if [*] progress in [*] is delayed,
which plan could include for [*] to supply commercial
requirements to [*] on a [*] basis.
(c)
Commercial Manufacturing
Following Exercise of the Roche Put Right . In the event that Roche exercises the
Roche Put Right, [*] shall [*] to supply [*]
for Daclizumab in the Territory for the period commencing on
[*] and ending on [*] unless PDL has not, despite
[*] to [*] for [*] to [*] Daclizumab
for sale in the United States, [*] at such time, in which
case such period shall end on [*] of such [*] .
In the event that Roche exercises the Roche Put Right, the parties
shall negotiate in good faith a separate supply agreement that
shall provide for procedures for PDL to submit to Roche [*]
for Daclizumab and Roche supplying Daclizumab thereafter at a price
equal to [*] . Such procedures shall include PDL
providing (i) [*] of [*] and (ii) firm
purchase commitments no less than [*] prior to the time the
order must be delivered to [*] by [*] .
4.6
Roche Diligence
. Following the Effective
Date, Roche shall use Reasonable Diligence in proceeding with the
manufacturing, marketing and sale of Daclizumab for use in the
Transplant Indications in the Territory as contemplated by this
Amended and Restated Worldwide Agreement, and in a manner
comparable to its conduct of the manufacturing, marketing and sale
of Daclizumab [*] during the [*] prior to the
Effective Date. If Roche fails to exercise such diligence,
PDL may exercise its rights hereunder pursuant to Section 13.3
below, but shall not be obligated to do so. Roche’s diligence
obligations under this Section 4.6 shall expire on,
(i) if PDL exercises the Transplant Reversion or Roche
exercises the Roche Put Right, the completion of all activities and
undertakings set forth in Sections 5.4(b), (c), (e) and (f),
or (ii) if the Exercise Period expires without PDL exercising
the Transplant Reversion. In the event of a dispute as to
whether Roche has used Reasonable Diligence, the party that loses
on this issue
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in an arbitration brought pursuant to
Article XV shall reimburse all of the other party’s
arbitration expenses, including reasonable attorneys’ fees
relating to such arbitration.
V. PDL RIGHT TO ACQUIRE TRANSPLANT BUSINESS
FROM ROCHE
5.1
General . The parties intend that, subject
to the terms and conditions of this Amended and Restated Worldwide
Agreement, the commercialization of Daclizumab in the Transplant
Indications in the Roche Territory will continue to be an exclusive
Roche responsibility unless and until PDL decides to undertake
commercialization of Daclizumab in the Transplant Indications under
the terms provided in this Article V. Subject to the
limitations set forth below, PDL shall have the option to terminate
Roche’s rights with respect to Daclizumab, which, if
exercised, would allow PDL to replace Roche as the party
responsible for the promotion, sales, distribution and
manufacturing of Daclizumab for use in the Transplant Indications
in the Roche Territory. In the ev