Cephalon, Inc.
000 Xxxxxxxxxx Xxxxxxx
Xxxx Xxxxxxx, XX 00000-0000
(000) 000-0000 Ext. 480
Fax (000) 000-0000
June 28, 1996
TAP Holdings Inc.
Bannockburn Lake Office Plaza
0000 Xxxxxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: President
Re: Amendment of Agreement dated May 17, 1994
-----------------------------------------
Ladies and Gentlemen:
This is to confirm our understanding concerning certain modifications and
clarifications to be made with respect to the Agreement between TAP Holdings
Inc. (formerly TAP Pharmaceuticals Inc.)("TAP") and Cephalon, Inc. ("Cephalon"),
dated May 17, 1994 (the "Agreement"). All terms not otherwise defined herein
are used as defined in the Agreement.
This letter will document our agreement as to certain principles which,
effective upon your acceptance, will supersede any conflicting terms of the
Agreement and govern our collaboration going forward. In all other respects the
terms of the Agreement will remain in force.
Our governing principles are set forth below:
1. Access to and Selection of Molecules for Development. TAP shall be
----------------------------------------------------
entitled to have access, through the Development Committee, to the
following molecules (collectively, the "Subject Compounds") which may
be selected for development during the Research Term:
(a) [xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxx] (metabolites inclusive), and salts and esters
of any of the foregoing (the "[xxxxxxxxxxxxxx]"); and
(b) all [xxxxxxxxxxxxxxxxxxxxx] discovered and/or synthesized by
Cephalon under the Development Plan, during the Research Term,
which meet the criteria for activity set forth on Attachment A
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June 28, 1996
Page 2
hereto, as amended from time to time by the Development Committee
(collectively, the "Required Criteria"); and for which, in each
case, the composition, manufacture and/or use of such compound is
covered by one or more claims contained in any of the following
patent and patent applications (the "[xxxxxxxxxxxxxxxxxxxxxx]"):
U.S. Patent No. Issue Date Description
-------------- ---------- -----------
[xxxxxxxxx] [xxxxxxxxxxxxxxx] [xxxxxxxxxxxxxxxxxxxxxxxx]
U.S. Serial No. Filing Date Description
[xxxxxxxxx] [xxxxxxxxxxxx] [xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xx]
[xxxxxxxxx] [xxxxxxxxxxxx] [xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xx]
[xxxxxxxxx] [xxxxxxxxxxxx] [xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xx]
--------------------------------------------------------------------
; and
(c) all other compounds discovered and/or synthesized by Cephalon under the
Development Plan, during the Research Term, which meet the Required
Criteria, subject in all respects to Cephalon's then-existing obligations
to third parties and excluding any compounds then being developed by
Cephalon for any indications outside the Field (the "Other Subject
Compounds").
* * *
Exhibit A to the Agreement is hereby amended to include the above-listed patent
and patent applications for the [xxxxxxxxxxxxxxxxxxxxx] and will continue to be
amended as needed during the term of the Agreement. Schedule I to the Agreement
is hereby amended, as attached hereto ("First Amended Schedule I"). First
Amended Schedule I sets forth the Subject Compounds identified to date. The
specific [xxxxxxxxxxxxxxxxxxx] and the Other Subject Compounds, as determined
from time to time in
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June 28, 1996
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accordance with subparagraphs (b) and (c) above, shall be added to Schedule I by
the Development Committee in accordance with paragraph 7 below.
Subject Compounds means only the [xxxxxxxxxxxxxx], as identified in subparagraph
(a) above, and the [xxxxxxxxxxxxxxxxxxxxx] and the Other Subject Compounds
hereafter set forth on Schedule I in accordance with this paragraph 1.
"Development Compounds" means all of the Subject Compounds selected for
development by the Development Committee during the Research Term. As of the
date of this amendment, [xxxxxxxxxxxxxxxxxx] are the only Development Compounds.
"Excluded Compounds" means all of the Subject Compounds that are rejected for
development, and all of the Development Compounds that are rejected for further
development, by the Development Committee. Except as otherwise provided
hereinafter in this paragraph 1, TAP shall not have any rights in or to the
Excluded Compounds.
(i) At any time during the Research Term, if the Development Committee
identifies a new screen or assay from which the Development Committee
derives additional criteria for activity to include in the Required
Criteria and which screen or assay was not available at the time when
a specified Excluded Compound was rejected for development or further
development by the Development Committee, the Development Committee
may request Cephalon to test such Excluded Compound in such new screen
or assay. Cephalon shall test such Excluded Compound in such screen or
assay unless Cephalon has a then-existing enforceable, contractual
obligation to any third party(ies) with respect to such Excluded
Compound and/or Cephalon is then itself developing such Excluded
Compound for one or more indications outside the Field. If the results
of such test, together with the results ofthe other screens or assays
then included in the Required Criteria indicate that the Excluded
Compound would be a Subject Compound under the provisions of
subparagraph (b) or (c), such Excluded Compound may, again, be
selected by the
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June 28, 1996
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Development Committee for development in the Field.
(ii) At any time during the Research Term, TAP may request the
Development Committee to reconsider an Excluded Compound for
development in the Field based on existing data, subject in all
respects to Cephalon's then-existing obligations to third
parties and provided that Cephalon is not developing such
Excluded Compound for any indications outside the Field.
(iii) Any Excluded Compound that is permitted to be selected for
development pursuant to clause (i) or (ii) above, and that is
so selected by the Development Committee during the Research
Term, shall, upon such selection, be deemed a Development
Compound and not an Excluded Compound.
The rights and obligations of the parties under Section 3.2(d) (relating to
first negotiation and first offer) are hereby terminated.
2. Field. The Field is expanded to mean the prophylactic and/or therapeutic
-----
treatment of any type of cancer in humans and/or of any noncancerous
prostate disorders (including, without limitation, benign prostatic
hypertrophy), subject to the provisions of subparagraph 11(c)(ii)(C) below.
3. Section 2.1. The last sentence of Section 2.1 is amended and restated as
-----------
follows: During the Research Term, the parties will collaborate
exclusively with each other, in the Territory, in the Field, with respect
to the discovery and development of compounds that meet the Required
Criteria.
4. Section 3.2. Cephalon's obligations to provide information under Section
-----------
3.2(a) of the Agreement shall expire at the end of the Research Term,
except with respect to Development Compounds. TAP's rights to new
indications for Development Compounds outside the Field (excluding
Neurology) under Section 3.2(b) of the Agreement shall continue, subject in
all respects to Cephalon's then-existing obligations to third parties. TAP
shall not have any rights to new indications for the Excluded Compounds,
except for the rights provided in clauses (i) and (ii) of paragraph 1
above. Cephalon shall not have any right to develop, or license any third
party to develop, the Excluded Compounds in the Field
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in the Territory during the Research Term and the nine (9) months
immediately following the termination of the Research Term. Upon the
expiration of such nine (9)-month period, the Development Committee shall
identify, and Cephalon shall not thereafter develop, or license any third
party to develop, any Excluded Compound in the Territory for any
indications specified in [xxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxx] (collectively, the "TAP Indications").
5. Milestone Payments. In recognition of the expansion of the Field provided
------------------
in paragraph 2 above, TAP shall pay to Cephalon the milestone payments set
forth in Section 3.1(g) of the Agreement in respect of each Product in the
Field. Such milestone payments will be required for the original NDA for
each Product, with no additional milestone payments for supplemental-NDA
submissions ("s-NDAs") for any additional indications, salt, ester, amide,
complex, chelate, hydrate, isomer, stereoisomer, crystalline or amorphous
form, prodrug, metabolite, metabolic precursor, and/or formulation changes
in such Product.
If for any reason, a Product is withdrawn during the period commencing
[xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxx],
with respect to such Product, TAP shall receive
[xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxx]
with respect to such Product, which credit may be applied toward TAP's
obligations to Cephalon with respect to a replacement Product for which TAP
files an NDA with the FDA
[xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx].
6. Licenses; Certain Defined Terms. The licenses granted by Cephalon in
-------------------------------
Article 5 of the Agreement apply to the Development Compounds and Products,
as the case may be, and are subject to the provisions of subparagraph 11(c)
below. All references in the Agreement to [xxx xxxxxxxxxx] shall be deemed
references to Subject Compounds. All references in the Agreement to a
Product or Products shall mean any
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June 28, 1996
Page 6
product or products containing a Development Compound, whether alone or
with any other therapeutically- or prophylactically-active ingredients,
which product(s) is/are in finished form, packaged and labelled in the
final commercial package for sale by TAP for use in the Field. All
references in the Agreement to a [xx] Product or [xx] Products shall mean
any product or products manufactured by or for Cephalon that contain a
Development Compound, whether alone or with any other therapeutically-or
prophylactically-active ingredients, which product(s) is/are in finished
form for sale for use in the Field, including the Products supplied by or
for Cephalon pursuant to the Agreement for sale by TAP.
7. Development Committee. The Development Committee shall consist of three
---------------------
members designated by each of TAP and Cephalon, initially:
TAP Cephalon
--- --------
[xxxxxxxxxxxxxxxxxxx] [xxxxxxxxxxxxxxxxxx]
----------------------- ----------------------
[xxxxxxxxxxxxxxxxxxx] [xxxxxxxxxxxxxxxxxx]
----------------------- ----------------------
[xxxxxxxxxxxxxxxxxxx] [xxxxxxxxxxxxxxxxxx]
----------------------- ----------------------
Each party may change its designated members of the Development Committee,
effective upon reasonable notice to the other party, provided, however, that the
consent of the other party shall be required to effect any designation of a
member who is not an employee of the designating party, such consent not to be
unreasonably withheld. Regular meetings of the Development Committee will be
held quarterly. An agenda for each of these meetings will be agreed upon within
an appropriate time prior to the meeting. Issues for discussion at the meetings
may include, but may not necessarily be limited to, the following
responsibilities of the Development Committee:
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June 28, 1996
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. With respect to each Subject Compound, prior to the Development
Committee's determination whether to select such Subject Compound as
a Development Compound or to identify it as an Excluded Compound,
reviewing all data available to either party (subject to its then-
existing obligations to third parties) which profiles such Subject
Compound
. With respect to each Development Compound, reviewing all data
available to either party (subject to its then-existing obligations
to third parties), and all data which either party is then required
to disclose to the FDA, in each case which profiles the Development
Compound
. Preparing, reviewing and recommending changes to the Development
Plan, including the selection of compounds that will be tested under
the Development Plan
. Identifying the [xxxxxxxxxxxxxxxxxxxxx] and the Other Subject
Compounds during the Research Term, in accordance with subparagraphs
1(b) and (c) above
. Reviewing and revising Attachment A hereto, as amended from time to
time, to reflect the selection and development of additional criteria
for activity that become available from new screens and assays, such
that the Required Criteria, as so amended, reasonably identify, from
among the compounds that are otherwise eligible to be Subject
Compounds, those compounds which demonstrate a principal preclinical
activity against cancer and/or any noncancerous prostate disorder
(including, without limitation, benign prostatic hypertrophy)
. Generating and revising, as appropriate, the criteria for the
selection of Development Compounds
. Reviewing all data available to either party which profiles the
Excluded Compounds that are permitted to be selected for development
in the Field pursuant to clauses (i) and (ii) of paragraph 1, above
. Selecting Development Compounds and identifying Excluded Compounds
. Critiquing the activities under the Development Plan to date and
identifying and resolving outstanding issues
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. Reviewing and approving (prior to implementation) all preclinical
and clinical protocols involving the Development Compounds
. Monitoring the implementation of the clinical trials involving any of
the Development Compounds and reviewing the generated data from such
clinical trials
. Reviewing and amending the Timetable (Exhibit B)
. Reviewing status of Development Compounds
* * *
The agenda shall include specific questions and recommendations
that need to be resolved by the Development Committee, as it is
the charter of the Development Committee not only to review the
joint development program but also to resolve issues. Data
scheduled for discussion at the meeting will be distributed to
all members at an appropriate time before the scheduled meeting
date. The decision making process will be agreed to by the
Development Committee, subject to the requirements of Section 2.4
of the Agreement. Teleconferences shall be conducted on those
occasions where it is imperative to address an action item prior
to the next scheduled meeting.
The Development Committee will appoint one member who will be
responsible for taking minutes of the meetings, distributing to
each party copies of the minutes and of any written reports
presented at the meetings, obtaining approval of the minutes by
each party and distributing to each party copies of the approved
minutes. Approval of the minutes shall be indicated by the
signatures thereon of at least two members designated by Cephalon
and at least two members designated by TAP.
The minutes shall include action items assigned at the meeting
with specific dates for addressing the issues involved. The
minutes also shall include two schedules:
Schedule I, setting forth all of the Subject Compounds
identified through the date of such meeting; and
Schedule II, setting forth all of the Development
Compounds and
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June 28, 1996
Page 9
all of the Excluded Compounds as of the date of such meeting.
The person to whom such minutes and reports should be sent shall be:
TAP Cephalon
--- --------
[xxxxxxxxxxxxxxxxxx] [xxxxxxxxxxxxxxxxx]
---------------------- -------------------
Copies of Schedules I and II to all minutes shall be sent to each
party, marked Attention: General Counsel; upon receipt of duly approved
copies Schedules I and II to the minutes by both General Counsel, such
schedules shall constitute amendments to the Agreement. Each party may
change the person or persons to whom minutes and reports, and copies of
schedules, are to be sent, effective upon reasonable notice to the
other party.
8. Technical Information. Promptly after the development of any
---------------------
Technical Information (as defined in Section 3.1(h)(i) of the
Agreement) relating to the Subject Compounds and Products in the Field
developed by or for either party under the Agreement, such party shall
provide to the other party copies of such Technical Information, in
such form (e.g., hard copy, disk, tape) as the other party may
reasonably request.
9. Budget and Billing. The budget included in each Development Plan shall
cover the amounts projected to be paid by TAP for the Cephalon FTE's
assigned by Cephalon to conduct Cephalon's activities under the
Development Plan, at the FTE Rates determined in accordance with
Section 3.1(e)(ii) of the Agreement. In addition, TAP shall reimburse
Cephalon for all amounts payable to [xxxxxxxxxx], as approved in
writing by the Development Committee. Cephalon shall use all
commercially-reasonable efforts to submit to the Development Committee
for pre-approval all such [xxxxxxx] arrangements. All expenses incurred
by TAP for any development activities undertaken by TAP sh all be borne
solely by TAP, and there shall be no adjustment of any amounts due to
Cephalon as a result thereof. Cephalon will xxxx TAP at the end of each
month during the Research Term for the time spent during such month by
the Cephalon FTE's on the Development Plan, together with all amounts
paid during such month by Cephalon to [xxxxxxx]. Cephalon's xxxx for
each month or
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June 28, 1996
Page 6
part thereof during the Research Term shall be accompanied by a
breakdown of the time spent by Cephalon FTE's on the Development
Plan during such month, and shall be paid by TAP within twenty-
one (21) days after TAP receives Cephalon's invoice therefor. TAP
shall have reasonable access, at its own expense and upon
reasonable prior notice, [xxxxxxxxxxxxxxxxxxxxxxxxxxx] to verify
the billing by Cephalon pursuant to this paragraph 9. Such access
shall be limited to [xxxxxxx] in each calendar year and may be
conducted during normal business hours by TAP's outside auditors,
subject to the confidentiality obligations of Section 7.1 of the
Agreement.
10. Clinical and Commercial Supplies of the Development Compounds.
-------------------------------------------------------------
Cephalon shall be responsible for supplying TAP's requirements of
the Development Compounds for clinical trials and other
premarketing development activities and for the Products for
sale. It is anticipated that the [xxxxxxxxxxxxx] will be
manufactured by Kyowa Hakko and the [xxxxxxxxxxxxx] will be
manufactured by Cephalon or a designated third party. If any
Development Compound is to be manufactured by a third party other
than Kyowa Hakko, TAP shall be entitled to participate with
Cephalon in the evaluation of potential third-party
manufacturers, but Cephalon shall have the right to select the
third-party manufacturer, with due consideration of TAP's
recommendations and subject to Cephalon continuing to be
responsible for all supply obligations under the Agreement. If a
third party other than Kyowa Hakko has been selected to
manufacture a Development Compound or Product, inspection and
audit rights shall be included in such third-party contract and
TAP shall be entitled to participate with Cephalon, in accordance
with the terms of the third-party contract, in all inspections
and audits of such third party that are conducted by Cephalon
with respect to the manufacture of the Subject Compound or
Product; in addition, if Cephalon shall not initiate any such
inspections or audits, with reasonable frequency, in accordance
with its rights under any such third-party contract, TAP shall be
entitled to request, in writing, that Cephalon initiate a
specified inspection or audit which is permitted under the terms
of the third-party contract, and Cephalon shall comply with any
such reasonable request. All of the pricing terms with respect to
all Subject Compounds and Products shall continue to apply, with
respect to the Development Compounds and Products, as set forth
in the Agreement.
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June 28, 1996
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11. Termination of Research Term.
----------------------------
(a) The Research Term may be terminated by TAP at the end of
any extension of the Initial Research Term by providing at
least [xxxxxxxxxxxxxxxxx] prior written notice of such
termination to Cephalon.
(b) The Research Term may be terminated by Cephalon at the end
of any extension of the Initial Research Term if, by
[xxxxxxxxx] during such extension, the parties have not
approved the Development Plan (including budget) prepared
by the Development Committee for the next succeeding year.
Cephalon shall effect a termination of the Research Term
under this paragraph 11(b) by providing at least thirty
(30) days' prior written notice thereof to TAP.
(c) A termination of the Research Term under this paragraph 11
shall have the following consequences:
(i) If the Research Term is terminated at a time when no
Development Compound is being developed for
commercialization in the Field, and no Product is
being manufactured, used or sold by or for TAP under
the Agreement, the Agreement shall terminate in
accordance with Section 12.2 of the Agreement.
(ii) If the Research Term is terminated at a time when at
least one Development Compound is being developed for
commercialization in the Field in accordance with
Section 3.4(c) of the Agreement or one Product is
being manufactured, used or sold by or for TAP under
the Agreement:
(A) The responsibilities of Cephalon to conduct
research and preclinical activities under Section
3.1(b) of the Agreement shall terminate.
(B) The responsibilities of TAP to fund such
activities under Section 3.1(c) and (f) shall
terminate.
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TAP Holdings Inc,
June 28, 1996
Page 12
(C) The licenses granted to TAP in Sections 5.1 and 5.2 of the
Agreement shall not apply to the entire Field, and
thereafter, shall be restricted to the TAP Indications and
any indications for which TAP has obtained or is in the
process of obtaining a license from Cephalon under Section
3.2(b) of the Agreement.
(D) Cephalon shall be permitted to develop the Excluded
Compounds in accordance with paragraph 4 above.
(E) The other rights and obligations of the parties under the
Agreement, as amended hereby, shall remain in full force
and effect.
12. 1996 Development Plan. Attached to this letter is the Development Plan
---------------------
for 1996, as approved by the parties.
13. Third Party Requests for Subject Compounds. Each party shall deliver to
------------------------------------------
the Development Committee for consideration all requests received by such
party from third parties relating to the transfer of a Subject Compound.
Any such transfers that are approved by the Development Committee shall
be made by Cephalon under a form of materials transfer agreement approved
by the Development Committee and executed by Cephalon.
14. Reimbursement of Audit Costs. In each case under the Agreement where
----------------------------
the outside auditors of one party have access to the books and records of
the other party to verify the bills or reports of such other party, if
such audit establishes that the party subject to the audit has overbilled
or underpaid the auditing party, in either case by [xxxxxxxxxxxxxx] or
more, the party subject to the audit shall reimburse the auditing party
for the reasonable costs payable to its outside auditors for such audit.
15. Timetable; Exhibit B. The Timetable shall apply in respect of each
--------------------
Development Compound. The Timetable is hereby amended in respect of the
timing for the beginning of Phase III, so that the second row of the
first column of Exhibit B to the Agreement shall read in its entirety as
follows:
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June 28, 1996
Page 13
Within [xxxx] after filing the initial IND; provided, however, that
[xxxxx] after filing the initial IND shall be permitted in a case where,
after filing the initial IND for a Development Compound, an alternative
formulation of the Development Compound is developed under the
Development Plan to permit delivery of the Development Compound by a
delivery method that was not specified in the initial IND
16. Miscellaneous. Certain technical corrections to the Agreement have been
-------------
agreed to by TAP and Cephalon, as set forth below:
(a) On page 9, line 6 of Section 2.5(b) (Notice), delete: "member or"
(b) On page 15, amend and restate Section 3.2(c)(ii) as follows:
(ii) With respect to any Excluded Compound which Cephalon
desires to develop in accordance with the Agreement, as amended, TAP
shall be deemed to have granted to Cephalon a royalty-free,
exclusive license in and to that portion of the TAP Technology, if
any, that shall be made available to the Development Committee for
use during the Research Term in connection with a Subject Compound
and/or Development Compound, to develop, use, market and sell such
Excluded Compound (and products containing such Excluded Compound)
in accordance with the Agreement, as amended.
(c) On page 26, line 12 of Section 4.3(a), insert: "If Cephalon uses as
Trademark with a [xx] Product, TAP shall have the right require that
such [xx] Product complies with the Specifications for the
corresponding Product sold by TAP, and to monitor such compliance by
Cephalon."
(d) On page 37, amend and restate Section 7.1(ii) as follows:
"information that was rightfully known by the Receiving Party (as
evidenced by its written records) prior to the date of disclosure by
the Furnishing Party to the Receiving Party in connection with this
Agreement, or information that is independently developed by or for
the Receiving Party without benefit of the Furnishing Party's
Confidential Information, and such use or disclosure is expressly
permitted by this Agreement;"
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June 28, 1996
Page 14
(e) On page 37, delete Section 7.2 (Injunctive Relief) in its entirety,
without impairing, in any respect, the rights of each party to seek
injunctive or other equitable relief in addition to any and all
remedies available at law or in equity, including, the recovery of
damages and reasonable attorneys fees.
If the foregoing accurately reflects your understanding as to these matters,
please indicate your agreement in the space provided below and return a signed
copy of this letter to me.
Very truly yours,
/s/ Xxxxxx X. Day, Jr.
Xxxxxx X. Day, Jr.
Senior Vice President
Worldwide Business Development
Acknowledged and agreed to by:
TAP Holdings, Inc.
By: /s/ Xxxx Xxxxxxxx
-------------------------
Name: Xxxx Xxxxxxxx
Title: President
Date: 07/08/96
--------------
WLN/sm
Attachments
cc: Xxxxxxx X. Xxxxxxxxx, Esq.
Xxxxx X. Xxxx, Esq.
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AMENDED SCHEDULE I
------------------
Identified Subject Compounds
----------------------------
[xxxxxxxxxx]
[xxxxxxxxxx]
[xxxxxxxxxx]
[xxxxxxxxxx]
[xxxxxxxxxx]
[xxxxxxxxxx]
[xxxxxxxxxx]
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June 28, 1996
Page 16
ATTACHMENT A
Required Criteria
-----------------
For establishing Subject Compounds under subparagraphs 1(b) and (c)
[Charts Deleted]
ATTACHMENT A IS SUBJECT TO AMENDMENT BY THE DEVELOPMENT
--------------------------------------------------------
COMMITTEE
---------
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1996 DEVELOPMENT PLAN
---------------------
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Discovery Flow
[ Charts Deleted
]
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RESOURCE ALLOCATION BY MONTH
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
[
]
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DRUG DEVELOPMENT
FTE ALLOCATION BY QUARTER
[
]
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Attachment 1:96
Total
------
Cephalon, Inc. Costs Vendor 1stQ 2ndQ 3rdQ 4thQ Budget
---- ---- ---- ---- ------
Drug Development [
----------------
Personnel Costs:
Analytical Development
Drug Safety and Disposition
Operations and Technical
Services
VP Pharmaceutical
Development
Chemical Process
Development
Total Drug Development**
Research
--------
Research Personnel*
Total Research
Total Spending ]
[ ]
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