[***] CONFIDENTIAL TREATMENT REQUESTED
REDACTED FOR CONFIDENTIALITY
AMENDMENT NUMBER ONE
TO AGREEMENT BETWEEN
NEUROCRINE BIOSCIENCES, INC. AND
XXXXXXX PHARMACEUTICA, N.V.
AMENDMENT NUMBER ONE dated September 24, 1999 (this "Amendment") to the
Agreement effective as of January 1, 1995 (the "Original Agreement") by and
between Neurocrine Biosciences, Inc., a Delaware corporation with principle
offices located at 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000
("Neurocrine") and Xxxxxxx Pharmaceutica, N.V., a corporation organized under
the laws of Belgium with principle offices located at Xxxxxxxxxxxxx 00, 0000
Xxxxxx, Xxxxxxx ("Xxxxxxx").
WHEREAS, pursuant to the Original Agreement, Xxxxxxx and Xxxxxxxxxx have
conducted a collaborative research program in the field of
corticotropin-releasing factor (CRF) Receptor Antagonists (as defined below) and
have developed certain technology in this field.
WHEREAS, the Research (as defined below) conducted by Xxxxxxxxxx and Xxxxxxx
pursuant to the Original Agreement has led to filing of patents and the
identification of certain CRF Receptor Antagonist pre-clinical and clinical
development candidate compounds.
WHEREAS, Research Term (as defined in the Original Agreement) expired on January
1, 1998 and Xxxxxxx and Xxxxxxxxxx now wish to conduct an additional program of
collaborative research (the "Back-up Program") designed to identify new CRF
Receptor Antagonist which will be subject to the terms of the Original Agreement
as amended hereby.
NOW, THEREFORE, in consideration of the promises and mutual covenants contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereto agree as
follows:
ARTICLE 1
DEFINITIONS
Defined Terms. Capitalized terms used herein that are not defined herein shall
have the meanings assigned to such terms in the Original Agreement.
1.1 "Amendment Effective Date" shall mean April 15, 1999.
1.2 "Back-up PCC" shall mean any composition of matter that (or, in the case of
prodrugs, an active ----------- metabolite of which):
(a) demonstrates CRF Receptor Antagonist activity
****************************** ****************; and
(b) demonstrates CRF Receptor Antagonist activity at a dosage of
***************************************************************************
**************************************************************************,
provided that at the request of Neurocrine, such activity is confirmed in
the ******** by repeating the experiment; and
(c) is within the scope of the Back-up Program Patents; and
(d) is discovered, identified, synthesized, developed or acquired by or on
behalf of Neurocrine or Xxxxxxx within the scope and during the Back-up
Program Term and is recognized by either Party to meet the conditions of
(a) and (b) hereof, prior to the first anniversary of the end of the
Back-up Program Term.
1. 3 "Back-up Program" shall mean all work performed by the Parties or on their
behalf directed towards or in connection with the discovery, identification and
synthesis of Back-up PCCs during the Back-up Program Term, but shall not include
work performed by Xxxxxxx on the PCCs of the Original Agreement without the
direct cooperation or assistance of Neurocrine.
1. 4 "Back-up Program Patents" shall mean the Patents ****************
************ which consist of **********************************************
***************** ****************** and the Neurocrine Back-up Patents.
1.5 "Back-up Program Term" shall mean the term beginning on April 15, 1999 and
ending February 15, 2001 or such earlier date as Xxxxxxx shall terminate the
Back-up Program in accordance with section 2a.13.
1.6 "Neurocrine Back-up Patents" shall mean *************************** filed by
Neurocrine, excluding any genus thereof outlicensed to a Third Party with the
knowledge of Xxxxxxx.
1.7 "Preliminary Back-up Candidate" shall mean a PCC, including Back-up PCC,
that meets the following criteria:
(i) demonstrates ************************* in Exhibit B; and
(ii) demonstrates the ******************** in Exhibit B; and
(iii) demonstrates no **************** as set forth in Exhibit B; and
(iv) falls within the scope of the claims of a Program Patent, including
Back-up Program Patent, or is licensed to Xxxxxxx and Neurocrine by
DuPont Pharmaceuticals Company under the executed Settlement Proposal,
and on the basis of review of published applications appears to be free
of published Patent claims of Third Parties.
1.8 "Settlement Proposal" shall mean the settlement proposal among Xxxxxxx,
Neurocrine and a Third Party (DuPont Pharmaceuticals Company),
****************************.
4
ARTICLE 2
AMENDMENT OF CERTAIN DEFINITIONS.
2.1 The definition of Collaboration Tangible Research Product is hereby revised
to read as set forth below: ---------------------------------------
"Collaboration Tangible Research Product" means any composition of
matter or other tangible asset, including but not limited to compounds,
natural products or fermentation broths and/or extracts or factions
thereof, immunoglobulin molecules, including active fragments thereof
and monoclonal antibodies, cells and cell lines, DNA and RNA molecules,
plasmids, proteins, peptides, receptors, receptor fragments, research
tools, materials for use in screening methods and techniques made or
synthesized by either Party in the course of the Research or Back-up
Program, or acquired by Xxxxxxxxxx in the course of the Research or
Back-up Program with funds provided by Xxxxxxx under 2.5(c) or
2a.7(iii) as mutually agreed.
2.2 The definition of Non-Collaboration Tangible Research Product is hereby
revised to read as set forth below:
"Non-Collaboration Tangible Research Product" means any composition of
matter or other tangible asset, including but not limited to compounds,
natural products or fermentation broths and/or extracts or factions
thereof, immunoglobulin molecules, including active fragments thereof
and monoclonal antibodies, cells and cell lines, DNA and RNA molecules,
plasmids, proteins, peptides, receptors, receptor fragments, research
tools, materials for use in screening methods and techniques made or
synthesized by either Party outside of the Research or Back-up Program
before, during or after the Research Term and Back-up Program Term and
actually utilized by such Party in conducting the Research or Back-up
Program, respectively.
2.3 The definition of Primary Collaboration Compounds or PCC is hereby amended
so that subparagraphs (c)(i) and (c)(ii) shall read as set forth below:
(i) is (A) discovered, identified, synthesized or
acquired by or on behalf of Neurocrine or Xxxxxxx
prior to the end of the Research Term and is
recognized by either Party to meet the conditions of
(a) and (b) hereof, prior to the first anniversary of
the end of the Research Term or (B) is a Back-up PCC;
or
(ii) is (A) first discovered, identified, synthesized or
acquired by or on behalf of Xxxxxxx during the period
beginning with the end of the Research Term and
ending on the Amendment Effective Date and recognized
by Xxxxxxx to meet the condition of (b) hereof prior
to the third anniversary of the end of the Research
Term, or (B) first discovered, identified,
synthesized or developed by Xxxxxxx or by a Third
Party directly or indirectly on behalf of Xxxxxxx
during the period beginning on the Amendment
Effective Date and ending on the third anniversary of
the end of the Research Term and
recognized by Xxxxxxx to meet the condition of (b)
hereof during such period if the discovery,
identification, synthesis or development (whether by
Xxxxxxx or a Third Party) would, but for any licenses
granted hereunder or pursuant to the Settlement
Proposal, infringe any Neurocrine Patent; or
2.4 The definition of Program Patents is hereby amended to read as set forth
below:
"Program Patents" shall mean on a genus by genus basis, the genuses in
any Patent (or pending application for a Patent) the subject of which
is an invention that (i) was conceived (in a writing provided to the
other Party) or reduced to practice by Xxxxxxx or Neurocrine in the
course of the Research or within the scope and during the term of the
Back-up Program and (ii) that comprises a PCC or SCC or a formulation,
method of use or method of manufacture thereof.
ARTICLE 3
OTHER AMENDMENTS
3.1 Amendment of Paragraph 9.1. Paragraph 9.1 of the Original Agreement is
hereby amended so that the second sentence shall read as set forth below:
Title to all other Patents claiming inventions made solely by an
employee of a Party in the course of performing Research or the Back-up
Program shall be owned by such Party.
3.2 Amendment of Paragraph 9.2. Paragraph 9.2 of the Original Agreement is
hereby amended so that the first sentence shall read as set forth below:
Each Party shall provide to the other any invention disclosure
submitted in the normal course and disclosing an invention arising in
the course of the Research or Back-up Program.
3.3 Amendment of Paragraph 10.3. Paragraph 10.3 of the Original Agreement
is hereby amended to read as set forth below:
10.3 Exclusivity/ Non-Competition. During the Research Term and
thereafter until the Amendment Effective Date, Neurocrine shall not
conduct, have conducted or fund any research, development, regulatory,
manufacturing or commercialization activity directed to the discovery,
development or commercialization of CRF Antagonists for use in anxiety,
depression or drug abuse except as permitted pursuant to this
Agreement.
3.4 Amendment of Paragraph 11.6. The first sentence of Paragraph 11.6 of the
Original Agreement is hereby revised to read as set forth below:
11.6 Termination for Convenience. Xxxxxxx may terminate this
Agreement for any reason without cause at any time with further
obligations of payment on the part of Xxxxxxx being limited to amounts
expected by Neurocrine under Paragraph 2.5 (including
without limitation 2.5(b)), Paragraph 6.1 above and paragraph 2a.7,
which Neurocrine would have received if the Agreement had not been
terminated under this Paragraph 11.6.
3.5 Amendment of Paragraph 15.8. Paragraph 15.8 of the Original Agreement is
hereby amended to read as set forth below.
----------------------------
15.8 Notices. All notices hereunder shall be in writing and shall be
deemed given if delivered personally or by facsimile transmission
(receipt verified), telexed, mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by express courier
service, to the Parties at the following address (or at such other
address for a party as shall be specified by like notice; provided,
that notices of a change of address shall be effective only upon
receipt thereof.
If to Neurocrine,
addressed to: Neurocrine Biosciences, Inc.
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Attention: President & CEO
Telephone: 000-000-0000
Telecopy: 000-000-0000
If to Xxxxxxx,
addressed to: Xxxxxxx Pharmaceutica,X.X.
Xxxxxxxxxxxxx 00
0000 Xxxxxx, Xxxxxxx
Attention: President, JRF
Telephone: (32 + 14) 60-21-11
Telecopy: (32 + 14) 60-28-41
With a copy to: Office of General Counsel
Xxxxxxx & Xxxxxxx
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Each of the Parties consent to the personal jurisdiction of the U.S.
Federal Courts and agree to accept any legal process served upon such
Party at the addresses specified above for such Party.
ARTICLE 4
ADDITION OF NEW ARTICLE II A
The Original Agreement is hereby amended by the addition of the following new
article covering the terms and conditions under which the parties have agreed to
conduct the Back-up Program.
13
[***] CONFIDENTIAL TREATMENT REQUESTED
ARTICLE II A
BACK-UP PROGRAM
2a.1 Back-up Program. Xxxxxxx and Xxxxxxxxxx agree to conduct a
collaborative Back-up Program under the terms and conditions set forth
in this Article II A.
(i) Scope. The scope of the Back-up Program will be limited to
identification, characterization and pre-clinical development
of CRF Antagonist compounds within the scope of the Back-up
Program Patents. The Parties acknowledge that a number of CRF
Antagonist Compounds identified in the scope of the Research
have been designated PCCs. It is anticipated that the Back-up
Program will focus on the discovery of new PCCs but to the
extent the JRC elects to conduct further characterization and
development of PCCs identified in the course of the Research
as part of the Back-up Program, the characterization and
development of such PCCs shall be subject to the terms of this
Article II A.
(ii) Goal. It is the goal of the Back-up Program to********
*************************************************************
**************************************************************
********************************.
The Parties will in good faith use commercially reasonable
efforts to meet the goals of the Back-up Program. For
clarification, there is no obligation on the part of Xxxxxxx
to file an IND or any equivalent thereof on any PCC, including
Back-up PCC, imposed by the operation of this Amendment except
as provided in 2a.8(ii).
2a.2 The JRC.
(i) Formation. Xxxxxxx and Xxxxxxxxxx will establish a Joint
Research and Development Committee ("JRC") to oversee, review
and co-ordinate the Back-up Program and the implementation
thereof. The JRC will consist of at least three (3) members
from each of Xxxxxxx and Xxxxxxxxxx (with Xxxxxxx and
Xxxxxxxxxx having equal representation).
(ii) Decisions. Each Party shall have one consolidated vote on
any issue and decisions of the JRC shall be by unanimous vote.
If the JRC fails to resolve any matter before it for
consideration, the matter shall be resolved pursuant to the
dispute resolution provisions of Paragraph 13.1.
(iii) FTE use. The JRC will use reasonable efforts to allocate
work under the Plan to supply Neurocrine with Neurocrine's
expected utilization rate of approximately ******/calendar
quarter. The JRC may provide that FTE utilization be moved
from one quarter to another where such is in the best interest
of the Plan and convenient to Neurocrine.
(iv) Subcommittees. From time to time the JRC may establish
subcommittees to oversee particular projects or activities
(such as separate committees to manage
the research phase and pre-clinical phase of the Back-up
Program) and such committees will be constituted as the JRC
agrees.
(v) Meetings. The JRC will meet regularly according to a
mutually agreed schedule.
2a.3 Research Plan.
(i) Agreement on Research Plan. Promptly after the Amendment
Effective Date, the Parties shall meet and mutually agree on
a plan for the conduct of the Back-up Program (the "Plan").
The Plan will outline the Back-up Program objectives and
timeline and describe the activities to be conducted by each
Party. The JRC shall review the Plan on an ongoing basis and
approve changes thereto as the JRC deems appropriate. The
Plan shall be consistent with this paragraph 2a.3 and
consistent with each Party's available resources. An initial
Plan is outlined in Exhibit B.
(ii) Efforts. The Plan will include general responsibilities of
Neurocrine and Xxxxxxx FTEs devoted to the Back-up Program.
Neurocrine will commit to devote approximately
*************** FTEs in total to the conduct of the Back-up
Program. Xxxxxxx will play an active role in both the
research phase and pre-clinical phase of the Back-up Program
and commit resources accordingly.
(iii) Responsibilities.
(A) Neurocrine. The Parties have agreed that Neurocrine
will be responsible for the initial identification,
synthesis and pharmacological and toxicological
profiling of PCCs, including Back-up PCCs, during
the Back-up Program. This will include medicinal
chemistry, synthesis scale up, in vitro CRF
receptor studies, in vivo pharmacological studies
related to depression, anxiety and substance abuse,
pharmacokinetics, non-GLP toxicology and
teratogenicity screening.
(B) Xxxxxxx. The Parties have agreed that Xxxxxxx will
be responsible for testing of PCCs, including
Back-up PCCs, which are suitably scaled up in the
***************************************************
and for GLP toxicology. Subject to the obligations
imposed by sub-Paragraph 2a.1(ii) and regardless of
2a.2(ii), Xxxxxxx shall have final say of which
compounds are scaled up for further testing at any
point where scale up from the initial synthesis is
necessary. Any decision on which Xxxxxxx has final
say will be consistent with the objective of the
Plan and with timelines contained therein.
2a.4 Identification of Preliminary Back-up Candidate. The determination
of whether a Preliminary Back-up Candidate has been identified will be
based upon the good faith results of the above mentioned animal models.
In the case of the *****************
****************************************, the model may be run a second
time and the average result will be determinative. In the case of the
******************** **************, the first results will be
determinative.
2a.5 Collaboration Tangible Research Products. During the Back-up
Program Term each Party shall use reasonable efforts to make available
to the other, Collaboration Tangible Materials to the extent such
transfer shall be reasonably necessary for a party to conduct their
responsibilities under the Plan.
2a.6 Reports. Xxxxxxx and Neurocrine will use reasonable efforts to
make available and disclose to one another Information known by Xxxxxxx
or Neurocrine on the Amendment Effective Date that directly relates to
the scope of the Back-up Program. During the Back-up Program Xxxx
Xxxxxxx and Neurocrine will use reasonable efforts to disclose to one
another Information regarding compounds synthesized or discovered,
initial leads, activities of leads, derivatives, and results of in
vitro and in vivo studies arising in the course of the conduct of the
Back-up Program. Notwithstanding the foregoing, the Parties agree that
Information disclosed during the course of the Back-up Program will be
limited to Information within the scope of the Back-up Program the
disclosure of which is reasonably necessary for the Parties to conduct
the Back-up Program in accordance with the Plan. Consistent with the
above, each Party will provide the other with raw data for work
conducted in the course of the Back-up Program to the extent reasonably
requested by the other Party.
2a.7 Funding.
(i) Prior Efforts. In consideration of research conducted and data
and information generated prior to the Effective Date, Xxxxxxx
will pay to Neurocrine
**************************************** within thirty (30)
days of the Amendment Effective Date.
(ii) FTEs. Xxxxxxx will reimburse Neurocrine for costs
associated with the conduct of the Back-up Program by
Neurocrine personnel by providing funding equal
************************************************** per
calendar quarter for the Back-up Program Term or until the
total sum ***************
**************************************************** is paid.
Such funding shall be provided in advance in quarterly
installments. The payments for the first and last quarters
shall be prorated to reflect the April 15, 1999 effective date
for the Back-up Program Term with the first such payment being
due and payable within thirty (30) days after the Amendment
Effective Date and the first payment shall include past due
amounts for calendar 1999 as well as the advance payment for
the fourth quarter of 1999.
(iii) Outside Costs. Xxxxxxx will be responsible for all
outside and third party costs associated with Back-up Program
activities approved by the JRC in the Plan including the costs
associated with third party contractors retained to perform
tasks approved by the JRC. In addition, Xxxxxxx may elect to
have third party
contractors reasonably acceptable to Xxxxxxxxxx perform some
of Xxxxxxx'x obligations under the Plan to the extent Xxxxxxx
is unable to perform the task internally within the approved
timeline or when Xxxxxxx otherwise deems it appropriate
consistent with the goals of the Back-up Program. Similarly,
Neurocrine may elect to use third party contractors for
certain toxicology, manufacturing and other tasks approved by
the JRC. Xxxxxxx will be responsible for all such third party
costs. Regardless of 2a.2(ii), Xxxxxxx shall have final say as
to all outside and third Party Costs associated with Back-up
Program activities, including the costs associated with Third
Party contractors retained to perform tasks approved by the
JRC. Any decision on which Xxxxxxx has final say will be
consistent with the objectives of the Plan and with timelines
contained therein.
(iv) Records. Neurocrine will maintain complete and accurate
records relevant to the expenditure of Back-up Program funding
hereunder. Such records shall be open during reasonable
business hours for a period of three (3) years from the date
of creation of such records for the sole purpose of allowing
Xxxxxxx to verify payments hereunder.
2a.8 Milestones
(i) Payments. Within thirty (30) days following the first
occurrence of the events set forth below, Xxxxxxx shall make
the following one-time milestone payments to Neurocrine:
Event Payment
Identification of Preliminary Back-up Candidate,
which Preliminary Back-up Candidate ******
*******************************************
***********************************
Filing and acceptance for review of an IND or equivalent in a
country of the European Union of a PCC, including Back-up PCC,
discovered, identified or synthesized or developed
in the Back-up Program *************
In the event the event that the milestone on acceptance for
review of an IND is paid, then the milestone for
identification of a Preliminary Back-up Candidate will be paid
where it was previously unpaid. The milestones of this
Paragraph will be paid in total only once. Milestone payments
based on further post IND development of a PCC developed in
the scope of the Back-up Program will be subject to any unpaid
milestones under Paragraph 6.3.
(ii) Diligence. In the event that Xxxxxxx has not incurred the
obligation to pay the milestone for
*********************************************, then upon the
later of six (6) months following
********************************** or
nine (9) months following ************************************
**************************************************************
**************************************************************
agrees to either (A) pay such milestone *****************
******************************, or (B) on a compound by
compound basis *****************************************
**************************************************************
**************************************************************
**************************************************************
***********************************************.
The return of rights under this sub-Paragraph will include
rights to all data and information and be free of any royalty
obligation to Xxxxxxx.
(iii) In the event that the milestone for
**************************************************************
**************************************** and the Milestone For
**************************************************************
*************************************************************
*************************************************************,
then Xxxxxxx agrees to pay such milestone for identification
of a Back-up Preliminary Candidate at the time the milestone
is paid pursuant to 2a.8(i) or 2a.8(ii).
2a.9 Royalties. Xxxxxxx will pay to Neurocrine Royalties on Net Sales
of PCCs developed in the scope of the Back-up Program as set forth in
Article VI.
2a.10 Clinical Development and Commercialization.
(i) Clinical Development. Clinical development of PCCs developed
in the course of the Back-up Program will be conducted in
accordance with Article III.
(ii) Commercialization. Commercialization of PCCs developed in
the course of the Back-up Program will be conducted in
accordance with Article IV.
(iii) Manufacture. Xxxxxxx shall be responsible for the
manufacture of PCCs developed in the scope of the Back-up
Program consistent with Article VII.
(iv) Indemnification. For the purposes of Article XII, the
conduct of the Back-up Program shall be considered a
Research and Development activity.
2a.11 Licenses and Patents.
(i) Back-up Program. Xxxxxxx hereby grants to Neurocrine a
non-exclusive license under the Xxxxxxx Patents and Program
Patents as shall be reasonably necessary or useful for
Neurocrine to conduct the Back-up Program. Neurocrine hereby
grants to Xxxxxxx a non-exclusive license under the
Neurocrine Patents (including Neurocrine Back-up Patents)
and Program Patents as shall be reasonably necessary or
useful for Xxxxxxx to conduct the Back-up Program.
(ii)
Xxxxxxx. Xxxxxxx will receive rights and assume obligations
consistent with Article IX for any back-up Program Patents
that are determined during the Back-up Program Term to
actually contain a PCC to the extent Xxxxxxx did not
previously have such rights and obligations. Upon the
determination that all or a portion of a Neurocrine Back-up
Patent is a Program Patent, Xxxxxxx will reimburse
Neurocrine for past fees and expenses incurred with respect
to all or part of such Patent, as the case may be, prior to
such determination. Thereafter, Xxxxxxx will assume
responsibility for such Program Patent consistent with
Article IX.
2a.12 Exclusivity/ Non-Competition. Xxxxxxx acknowledges that
Xxxxxxxxxx has informed Xxxxxxx that during the period between the end
of the Research Term and the Amendment Effective Date, Neurocrine has
conducted an internal research program directed to the discovery and
characterization of CRF Antagonist compounds which do not fall within
the scope of the Program Patents ("Neurocrine Compounds") with the
intention of developing these compounds for stroke and other
indications that would not be categorized as anxiety, depression and/or
drug abuse within the time periods dictated by Paragraph 10.3 and,
following the expiration of the limitations imposed by Paragraph 10.3,
expanding the development of these compounds to anxiety, depression and
drug abuse should the compounds demonstrate activity in such
indications. Xxxxxxxxxx has also informed Xxxxxxx that Xxxxxxxxxx's
willingness to conduct the Back-up Program is conditioned on Xxxxxxx'x
recognition of Xxxxxxxxxx's continued right to conduct independent
research and development of CRF Antagonist compounds. It is understood
that **************************************************************
************************** entitles the Parties to use
******************** ******************* for any purpose subject to
obligations of confidentiality in Article VIII. This would include the
use of ****************************** in the development of the
********************.
2a.13 Termination.
(i) Convenience. In the event Xxxxxxx shall elect to terminate
this Agreement under Paragraph 11.6, Xxxxxxx shall pay to
Neurocrine all amounts that would have been payable under
Paragraphs 2a.7(ii) (up to ********************) and reimburse
Neurocrine for all noncancelable obligations incurred by
Neurocrine for JRC approved activities.
(ii) Breach. Notwithstanding the provisions of paragraph 11.2, in the event
either Party shall default in --------------- the performance of any material
obligation set forth in this Article II A, the sole remedy of the other Party
shall be termination of the Back-up Program. In the event the Back-up Program
shall be terminated by reason of a default by Xxxxxxx, Xxxxxxx shall pay to
Neurocrine all amounts that would have been payable under paragraph 2a.7(ii) and
(iii), grant to Neurocrine an exclusive license under the Program Patents to
make, use and sell Back-up PCCs which are Preliminary Back-up Candidates and
reimburse Neurocrine for all noncancelable obligations incurred by Neurocrine
for JRC approved activities. In the event the (iii)
Back-up Program shall be terminated by reason of a default by
Xxxxxxxxxx, Neurocrine will return to Xxxxxxx the initial
payment and any milestone payments made by Xxxxxxx hereunder
and any Neurocrine Back-up Patent and Back-up Program Patent
that contains a Preliminary Back-up Candidate will be
considered a Program Patent which contains in each chemical
genus thereof at least one member which is a PCC meeting the
requirements of Paragraph 1.38 (c)(i).
(iii) Early Termination. Xxxxxxx shall have the right to
terminate the Back-up Program as **************** upon
delivering notice of its intention to do so by *************.
Upon such termination, Xxxxxxx will reimburse Neurocrine for
noncancelable obligations incurred by Neurocrine for JRC
approved activities and thereafter shall have no further
obligation to fund the conduct of the Back-up Program by
Neurocrine. Xxxxxxx will retain all rights, patent or
otherwise, to PCCs which are such by the terms of the Original
Agreement except that any development of such a PCC by Xxxxxxx
which was discovered, identified, synthesized or developed in
the Back-up Program will be subject to the milestone payments
herein. Upon such termination, Neurocrine will retain all its
rights, patent or otherwise, to any compound which, except for
the terms of this Amendment would not be a PCC. The definition
of Program Patent would return to that of the Original
Agreement. Xxxxxxxxxx's retained rights under this
sub-Paragraph will be free of any royalty obligation to
Xxxxxxx and include all rights to data.
ARTICLE V
MISCELLANEOUS
5.1 Assignment. Either Party may assign this Amendment or its ownership interest
in jointly owned Program Patents: (i) to a party that succeeds to substantially
all of the business or assets of such Party by reason of a merger or similar
reorganization or the sale of substantially all of its business or assets, or
(ii) otherwise with the prior written consent of the other Party. This Amendment
shall be binding upon and inure to the benefit of the successors and permitted
assigns of the Parties. Any assignment not in accordance with this Amendment
shall be void.
5.2 Force Majeure. Neither Party shall lose any rights hereunder or be liable to
the other Party for damages or losses on account of failure of performance by
the defaulting Party if the failure is occasioned by government action, war,
fire, explosion, flood, strike, lockout, embargo, act of God, or any other
similar cause beyond the control of the defaulting Party, provided that the
Party claiming force majeure has exerted all reasonable efforts to avoid or
remedy such force majeure; provided, however, that in no event shall a Party be
required to settle any labor dispute or disturbance.
5.3. Further Actions. Each Party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Amendment
5.4 Waiver. Except as specifically provided for herein, the waiver from time to
time by either of the Parties of any of their rights or their failure to
exercise any remedy shall not operate or be construed as a continuing waiver of
same or of any other of such Party's rights or remedies provided in this
Amendment.
5.5 Severability. If any term, covenant or condition of this Amendment or the
application thereof to any Party or circumstance shall, to any extent, be held
to be invalid or unenforceable, then (i) the remainder of this Amendment, or the
application of such term, covenant or condition to Parties or circumstances
other than those as to which it is held invalid or unenforceable, shall not be
affected thereby and each term, covenant or condition of this Amendment shall be
valid and be enforced to the fullest extent permitted by law; and (ii) the
Parties hereto covenant and agree to renegotiate any such term, covenant or
applicable thereof in good faith in order to provide a reasonably acceptable
alternative to the term, covenant or condition of this Amendment or the
application thereof that is invalid or unenforceable, it being the intent of the
Parties that the basic purposes of this Agreement are to be effectuated.
5.6 Counterparts. This Amendment may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
5.7 Entire Agreement. The Original Agreement as amended hereby, the accompanying
Stock Purchase Agreement ***************************************************
****** set forth all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties hereto and
supersede and terminate all prior agreements and understanding between the
Parties. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties other than as set forth herein and therein. No subsequent
alteration, amendment, change or addition to this Amendment shall be binding
upon the Parties hereto unless reduced to writing and signed by the respective
authorized officers of the Parties.
5.8 Relationship of Parties. Nothing herein shall be construed to create any
relationship of employer and employee, agent and principal, partnership or
joint venture between the Parties. Each Party is an independent contractor.
Neither Party shall assume, either directly or indirectly, any liability of or
for the other Party. Neither Party shall have the authority to bind or
obligate the other Party and neither Party shall represent that it has such
authority.
14
IN WITNESS WHEREOF, the Parties have executed this Amendment as of the date
first written above.
NEUROCRINE BIOSCIENCES, INC.
/s/Xxxx Xxxxx
By: Xxxx Xxxxx
President & CEO
XXXXXXX PHARMACEUTICA, N.V.
/s/Xx. Xxxx Xxxxxx
By: Xx. Xxxx Xxxxxx
President
[***] CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT A
*******************
EXHIBIT B
*******************
