EXHIBIT 10.9(B)
AMENDMENT NO. 2 TO RESEARCH, LICENSE AND ROYALTY AGREEMENT
This Amendment No. 2 to Research, License and Royalty Agreement (the
"Amendment") effective as of June 30, 1997, is entered into by and between
Pharmacopeia, Inc. ("Pharmacopeia") and Berlex Laboratories, Inc. ("Berlex"),
and amends that certain Research, License and Royalty Agreement entered into by
Pharmacopeia and Berlex effective as of February 15, 1995 (the "Agreement"), as
amended by Amendment No. 1 to Research, License and Royalty Agreement effective
as of November 27, 1996.
1. All capitalized terms not defined in this Agreement shall have the meanings
given to them in the Agreement.
2. Section 1.3 is amended to read in its entirety as follows:
1.3 "Additional Berlex Target" shall mean [***].
3. Section 1.17 is amended to read in its entirety as follows:
1.17 "Field" means the use for the prevention, mitigation, or cure of
diseases of any substance which [***].
4. Section 1.36 is amended to read in its entirety as follows:
1.36 "Other Product" means any drug with activity with respect to the
Initial Berlex Target approved for human or animal use that is not a
Product (i.e., not based on a Development Compound accepted as an Accepted
Development Compound in accordance with Section 6.1(b)) and is within the
scope of a Live Claim. It is understood that a drug meeting the criteria of
the preceding sentence and that also has biological activity outside the
Field (i.e. via a different mechanism of action) shall be an Other Product
only if such drug has an activity (Ki) in the Field of less than [***].
5. Section 1.39 is amended to read in its entirety as follows:
1.39 "Product" means any drug with activity within the Field approved for
human or animal use based on a Development Compound that has received
Acceptance in accordance with Section 6.1(b) and is within the scope of a
Live Claim, or a Derivative thereof. It is understood that a drug meeting
the criteria of the preceding sentence which also has biological activity
outside the Field (i.e., via a different mechanism of action) shall be a
Product.
*Information omitted and filed separately with the Commission under Rule 24b-2.
6. Section 2.2 is amended to read in its entirety as follows:
2.2 Number of Scientists. Berlex is making the payments described in
Section V based on the requirement that Pharmacopeia shall provide an
average of [***] full-time equivalent ("FTE") research positions.
7. In Section 3.5, the phrase "Chief Scientific Officer for Pharmacopeia"
shall be replaced with "Senior Vice President of Drug Discovery for
Pharmacopeia."
8. In Section 3.7, the phrase "Chief Scientific Officer for Pharmacopeia"
shall be replaced with "Senior Vice President, Chemistry, of Pharmacopeia."
9. Section 4.8 is amended to read in its entirety as follows:
4.8 Random Libraries.
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(a) For a period of [***] under the Research Plan with respect to the
Initial Berlex Target, Pharmacopeia shall not knowingly screen
Random Libraries with respect to the Initial Berlex Target, nor
shall Pharmacopeia knowingly (i) design Random LIbraries for the
purpose of identifying compounds with activity for the Initial
Berlex Target, (ii) make such Random Libraries, or (iii) use or
sell such Random Libraries to Third Parties or, (iv) use any
structure-function data learned as a result of the research under
the Research Plan for the purposes of subsections (i)-(iii)
above.
(b) For a period of [***} years from the end of the Term, or in the
event research under the Research Plan with respect to the
Additional Berlex Target does not proceed until [***],
until[***], Pharmacopeia shall not knowingly screen Random
Libraries with respect to the Additional Berlex Target, nor shall
Pharmacopeia knowingly (i) design Random Libraries for the
purpose of identifying compounds with activity for the Additional
Berlex Target, (ii) make such Random Libraries, or (iii) use or
sell such Random Libraries to Third Parties or, (iv) use any
structure-function data learned as a result of the research under
the Research Plan for the purposes of subsections (i)-(iii)
above.
(c) It is understood that at any time Pharmacopeia may otherwise make
and provide Random Libraries to Third Parties who may screen such
Random Libraries against any targets, including without
limitation, the Initial Berlex Target and Additional Berlex
Target without the knowledge of Pharmacopeia.
*Information omitted and filed separately with the Commission under Rule 24b-2.
10. Section 4.14 is amended to read in its entirety as follows:
4.14 Commercialization Status. If Berlex is developing a Product or
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Other Products, for a period from the end of the Term to the First
Commercial Sale of a Product or Other Product, Berlex shall keep
Pharmacopeia informed of its development activities with respect to
Products and Other Products, including without limitation, the
achievement of the milestones set forth in Section 6.1 and 6.2 and
the commercialization of Products and Other Products, by semi-
annually providing Pharmacopeia with a written report stating the
status of development of each such Product and Other Product. If
research under the Research Plan with respect to the Additional
Berlex Target does not proceed until [***] and if, at any time,
Berlex fails to use diligent efforts to actively develop and
commercialize any Product having activity with respect to the
Additional Berlex Target, or does not cure any breach with respect
to such Product noticed by Pharmacopeia pursuant to Section 14.2(a)
herein within the time permitted thereunder, thereafter Berlex's
rights under Sections 4.5 and 4.9 herein shall terminate worldwide
with respect to such Product, as well as with respect to any Focused
Libraries, Lead Compounds, and Development Compounds from which such
Product was developed. However, notwithstanding the preceding
sentence, Berlex can maintain such rights under Section 4.5 and 4.9
(i.e., such rights shall not terminate) for successive twelve-month
periods by paying to Pharmacopeia a license maintenance fee of [***]
per twelve-month period, payable no later than thirty (30) days
after the commencement of each such twelve-month period.
11. Section 5.1 is amended to read in its entirety as follows:
5.1 Term.
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(a) Subject to Article XIV and Sections 3.2 and 3.5 (as amended
herein), the Term of the research activities under the
Research Plan shall extend until [***] from the Effective
Date. The Term may be further extended with the written
agreement of the Parties.
(b) Berlex shall, at least [***] prior to the end of the Term,
notify Pharmacopeia in writing whether Berlex wishes to
negotiate an extension of the Term. Such written notice
shall include at least the following information: (i)
whether Berlex wishes to continue conducting research in the
Field or wishes to conduct research with respect to
additional or different targets, (ii) an indentification of
any such proposed additional or different targets, (iii) the
length of the proposed extended Term, and (iv) the proposed
amount of funding for such extending Term.
*Information omitted and filed separately with the Commission under Rule 24b-2
(c) (i) Berlex shall make a payment to Pharmacopeia, in addition
to the payments due under Section 5.2, on or before the last
day of the Term (the "Wind-Down Payment"). The amount of the
Wind-Down Payment shall be [***]. In the event Berlex fails
to provide Pharmacopeia written notice as provided under
Section 5.1(b), then the amount of the Wind-Down Payment
shall be increased to [***].
(ii) In exchange for the Wind-Down Payment, Pharmacopeia shall provide such
number of FTEs as the Research Committee reasonably agrees,
in order to complete certain activities previously commenced
pursuant to the Research Plan.
12. Section 5.2 is amended to read in its entirety as follows:
5.2 Payment. Subject to the delivery of each quarterly written report from
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Pharmacopeia to Berlex referred to in Section 3.1 pursuant to the Research
Plan, Berlex shall pay Pharmacopeia research payments as follows:
(a) [***] on the Effective Date.
(b) [***] within [***] of the Effective Date.
(c) [***] within [***] of the Effective Date.
(d) [***] within [***] of the Effective Date.
(e) [***] within [***] of the Effective Date.
(f) [***] within [***] of the Effective Date.
(g) [***] within [***] of the Effective Date.
(h) [***] within [***] of the Effective Date.
(i) [***] within [***] of the Effective Date.
(j) [***] within [***] of the Effective Date.
(k) [***] within [***] of the Effective Date.
(l) [***] within [***] of receipt of the final written report on the
research done pursuant to the Research Plan.
*Information omitted and filed separately with the Commission under Rule 24b-2.
All payments made pursuant to this Section 5.2 shall be non-refundable, but
payments under Section 5.2(k) and (l) may be creditable against the Wind-
Down Payment [***].
13. Section 6.1(a)(ii) is amended to read in its entirety as follows:
(ii) [***] upon the initiation of GLP toxicity studies for each
Development Compound for which Berlex decides to develop a Separate
Indication and which is a Distinct Molecule from other Accepted
Development Compounds; provided, however, that the Milestone Payment
provided in this Section 6.1(a)(ii) is not due and payable for a given
Development Compound if (i) with respect to a Development Compound
having activity against the Additional Berlex Target, research under
the Research Plan with respect to the Additional Berlex Target has
proceeded until at least [***], and (ii) with respect to a Development
Compound having activity against either the Initial Berlex Target or
the Additional Berlex Target, at least one Accepted Development
Compound has not been provided to Berlex by Pharmacopeia so as to
enable Berlex to initiate GLP toxicity studies within [***] from the
start of research by Pharmacopeia with respect to the applicable
Berlex target (the "Start Date"). The Start Date will be determined by
the Research Committee with respect to the Initial Berlex Target and
the Additional Berlex Target, respectively, and stated in the first
quarterly research report following such Start Date.
14. Section 6.1(b) is amended to read in its entirety as follows:
(b) Acceptance of Development Compounds. The "Acceptance" of each
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Development Compound to become an "Accepted Development Compound"
shall be determined by the Research Committee in good faith based on
criteria set forth in the Research Plan. Notwithstanding the above, in
the event that research under the Research Plan with respect to the
Additional Berlex Target does not proceed until [***] or the Research
Committee no longer exists, then "Acceptance" for a particular
Development Compound shall be deemed to have occurred on the date when
Berlex initiates [***] based on the applicable Lead Compound or
Development Compound.
15 The first nine (9) lines of Section 6.2 (comprising the introductory
paragraph thereof) are deleted and replaced with the following:
*Information omitted and filed separately with the Commission under Rule 24b-2.
6.2 Milestones on Other Products. If Pharmacopeia fails to provide Berlex
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a Development Compound having activity against the Initial Berlex Target
within [***] years of the Start Date, but provides Berlex with a Lead
Compound within the Term, and Berlex initiates GLP toxicity studies on such
Lead Compound or a compound Derived therefrom after the Effective Date, and
such Lead Compound or a compound Derived therefrom becomes an intended
Other Product or an Other Product, then Berlex shall pay to Pharmacopeia
Milestone Payments with respect to such Other Product or intended Other
Product as follows:
16. Section 6.5 is amended to read in its entirety as follows:
6.5 No Obligations for Non-Products. It is understood that Berlex is in
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the Business of developing products for the prevention, treatment, cure and
mitigation of diseases in animals and that Berlex has extensive research
programs independent of Pharmacopeia. Pharmacopeia acknowledges that Berlex
has no obligations to pay Pharmacopeia royalties for a product in the Field
which Berlex independently researched, developed and commercialized, either
alone or in conjunction with Third Parties, without the use of or reliance
on Developed Technology or Pharmacopeia Base Technology, as shown by
written records kept in the ordinary course of business consistent with
pharmaceutical industry standards (a "Non-Product"). Unless, with respect
to a particular putative Non-Product, Berlex has not initiated GLP
toxicity studies within the periods set forth in Sections 6.1(a) or 6.2(b)
if applicable, within thirty (30) days of the filing of an IND with respect
to each Non-Product for which Berlex believes no royalties and/or Milestone
Payments are due Pharmacopeia, Berlex shall notify Pharmacopeia of such
filing, and shall, to the extent it may do so without breaching any
contractual or other legal obligation, provide Pharmacopeia with a
statement explaining why Berlex believes the Non-Product was independently,
researched, developed and commercialized, either alone or in conjunction
with Third Parties without the use of or reliance on Developed Technology
or Pharmacopeia Base Technology and is independent of Berlex's activities
under the Research Plan. Berlex is not required to provide written records
referred to above at the time providing such statement, but may have to
provide such records pursuant to Section 15.19. Such Information shall be
deemed Berlex confidential Information pursuant to this Agreement.
17. The first ten (10) lines of Section 7.3 (comprising the introductory
paragraph thereof) are deleted and replaced with the following:
7.3 Royalties on Other Products. If Pharmacopeia fails to provide Berlex
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an Accepted Development Compound having activity against the Initial Berlex
Target within [***] years of the Start Date, but provides Berlex with a
Lead Compound within the Term, and Berlex initiates GLP toxicity studies on
such Lead Compound or a compound Derived therefrom after the Effective
Date, and such Lead Compound or a compound Derived
therefrom becomes an Other Product, then Berlex shall pay to
Pharmacopeia royalties with respect to such Other Product for a
Separate Indication and which is a Distinct Molecule from any other
Products or Other Products, as set forth below:
18. Section 14.2 is amended by the deletion of subsection 14.2(d).
19. Except as specifically modified or amended hereby, the Agreement shall
remain in full force and effect and, as modified or amended, is hereby
ratified, confirmed and approved. No provision of this Amendment may
be modified or amended except expressly in a writing signed by both
parties nor shall any terms be waived except expressly in a writing
signed by the party charged therewith. This Amendment shall be
governed in accordance with the laws of the State of Delaware, without
regard to principles of conflicts of laws.
IN WITNESS WHEREOF, each of the parties has executed this Amendment as
of the date indicated on this Amendment.
BERLEX LABORATORIES, INC. PHARMACOPEIA, INC.
By:______________________ By:_____________________
Name:____________________ Name:___________________
Title:___________________ Title:__________________
Date:____________________ Date:___________________
