GUILFORD PHARMACEUTICALS INC
8-K, 1998-10-02
PHARMACEUTICAL PREPARATIONS
Previous: PACKAGED ICE INC, S-1/A, 1998-10-02
Next: PAUL SON GAMING CORP, DEF 14A, 1998-10-02



<PAGE>   1

                       SECURITIES AND EXCHANGE COMMISSION

                             Washington, D.C. 20549



                                    FORM 8-K




                 Current Report Pursuant to Section 13 or 15(d)
                     of the Securities Exchange Act of 1934



                               September 25, 1998
                -------------------------------------------------
                Date of Report (Date of earliest event reported)




                          Guilford Pharmaceuticals Inc.
             ------------------------------------------------------
             (Exact name of registrant as specified in its charter)




          Delaware                     0-23736                  52-1841960
- --------------------------------------------------------------------------------
(State or other jurisdiction of    (Commission File          (I.R.S. Employer
incorporation or organization)         Number)               Identification No.)




6611 Tributary Street            Baltimore, Maryland                21224
- --------------------------------------------------------------------------------
                    (Address of principal executive offices)       (Zip Code)



                                 (410) 631-6300
               --------------------------------------------------
               Registrant's telephone number, including area code



- --------------------------------------------------------------------------------
          (Former name or former address, if changed since last report)

- --------------------------------------------------------------------------------
                           Exhibit Index is on page 5.


                                      -1-
<PAGE>   2

                          GUILFORD PHARMACEUTICALS INC.

ITEM 5.     OTHER EVENTS.

            On September 25, 1998, Guilford Pharmaceuticals Inc. (the "Company")
entered into Amendment No. 1 (the "Marketing Rights Amendment") to its
Marketing, Sales and Distribution Rights Agreement (the "Marketing Rights
Agreement") dated June 13, 1996 with Rhone-Poulenc Rorer Pharmaceuticals Inc.
("RPR") and GPI Polymer Holdings, Inc. (formerly named GPI Holdings, Inc.,
"Holdings"). On September 25, 1998, the Company also entered into Amendment No.
1 (the "Stock Purchase Amendment") to its Stock Purchase Agreement (the "Stock
Purchase Agreement") dated June 13, 1996 with RPR. The Marketing Rights
Agreement granted to RPR the worldwide (excluding Scandinavia) rights to market,
sell and distribute GLIADEL(R) wafer ("GLIADEL"), a novel treatment for
malignant glioma, the most common and rapidly fatal form of primary brain
cancer. The Stock Purchase Agreement provided the terms under which RPR made an
initial $7.5 million equity investment in the Company, as well as the terms for
an additional $7.5 million investment upon the achievement of certain goals and
representation on the Company's Board of Directors following such second
investment. The U.S. Food and Drug Administration ("FDA") cleared GLIADEL for
marketing in September 1996 for use as an adjunct to surgery to prolong survival
in patients with recurrent glioblastoma multiforme for whom surgical resection
is indicated. In February 1997, RPR commercially launched GLIADEL in the United
States, and in December 1997 RPR commenced a multi-center Phase III clinical
trial in Europe, the United States and Israel for GLIADEL in patients undergoing
initial surgery for malignant glioma (the "First Surgery Trial").

            Pursuant to the terms of the Marketing Rights Amendment, RPR will
use commercially reasonable efforts to conduct the First Surgery Trial, for
which the Company will pay one-half of the costs, not to exceed $3 million. In
addition, the Marketing Rights Amendment provides that RPR shall reimburse the
Company for certain costs incurred after September 25, 1998 relating to work
performed by the Company at the request of RPR to the extent that the work
exceeds requests made by the FDA and other government regulators. The terms of
the Marketing Rights Amendment also confirm that all rights to market GLIADEL in
Japan have reverted to Holdings, and provides for adjustments to the milestone
payments provided for in the Marketing Rights Agreement.

            The Stock Purchase Amendment deletes a term in the Stock Purchase
Agreement which would have entitled RPR to representation on the Company's Board
of Directors following any FDA approval for commercial sale of GLIADEL for the
treatment of primary forms of malignant glioma and investment by RPR of its
second $7.5 million tranche.

                                      -2-
<PAGE>   3

            There can be no assurance that RPR will be able to achieve any of
the milestones set forth in the Marketing Rights Amendment, and accordingly
there can be no assurance that the Company will receive the related milestone
payments. For a description of these and other risks, readers should review
"Item 4A. Risk Factors" set forth in the Company's annual report on Form 10-K
for the year ended December 31, 1997, filed with the Securities and Exchange
Commission on March 27, 1998.

ITEM 7.     FINANCIAL STATEMENTS AND EXHIBITS.

10.63*      Amendment No. 1 to Marketing, Sales and Distribution Rights
            Agreement

10.64       Amendment No. 1 to Stock Purchase Agreement
- -------------
*The registrant has requested confidential treatment of certain portions of this
agreement from the Securities and Exchange Commission.


                                      -3-
<PAGE>   4

                                   SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.

                                    GUILFORD PHARMACEUTICALS INC.


Date  October 2, 1998               By:   /s/  Craig R. Smith, M.D.
                                          -------------------------------------
                                          Craig R. Smith, M.D.
                                          President and Chief Executive Officer

                                      -4-
<PAGE>   5

                                INDEX TO EXHIBITS

EXHIBIT
NUMBER                        EXHIBIT DESCRIPTION                       PAGE
- -------                       -------------------                       ----

10.63*                  Amendment No. 1 to Marketing, Sales
                        and Distribution Rights Agreement

10.64                   Amendment No. 1 to Stock Purchase Agreement
- -------------
*The registrant has requested confidential treatment of certain portions of this
agreement from the Securities and Exchange Commission.


                                      -5-

<PAGE>   1

              AMENDMENT NO. 1 TO MARKETING, SALES AND DISTRIBUTION
                                RIGHTS AGREEMENT


      Amendment No. 1 is made and entered into as of the date of the last
signature on the signature page below ("Amendment No. 1"), by and among
Rhone-Poulenc Rorer Pharmaceuticals Inc. ("RPR"), GPI Polymer Holdings, Inc.
(previously named GPI Holdings, Inc., "Holdings") and Guilford Pharmaceuticals
Inc. ("GPI"; Holding and GPI, collectively, "Guilford"), to Marketing, Sales and
Distribution Rights Agreement, dated as of June 13, 1996.

      WHEREAS, RPR, GPI and Holdings are parties to a Marketing, Sales and
Distribution Rights Agreement, dated as of June 13, 1996 (the "Rights
Agreement"), and GPI and Rhone-Poulenc Rorer Inc. ("RPR Inc.") are parties to a
Stock Purchase Agreement, dated as of June 13, 1996 (the "Stock Agreement"), and
RPR and GPI are parties to a Manufacturing and Supply Agreement, dated as of
June 13, 1996 (the "Supply Agreement"), and GPI and RPR Inc. are parties to a
Loan Agreement, dated as of June 13, 1996 (the "Loan Agreement"; the Rights
Agreement, the Stock Agreement, the Supply Agreement and the Loan Agreement,
collectively, the "Transaction Agreements"), all in connection with a
transaction pursuant to which RPR has become the worldwide marketer and
distributor (except in Scandinavia) for Guilford's biodegradable polymer
oncology product, GLIADEL(R) Wafer; and

      WHEREAS, RPR and Guilford now desire to amend certain provisions of the
Rights Agreement as set forth herein and to amend certain provisions of the
Stock Agreement as set forth in Amendment No. 1 to that Agreement, of even date
herewith, to reflect further agreements between them;

      NOW, THEREFORE, the parties hereto, intending to be legally bound, agree
as follows:

      1. GLIADEL First Surgery Phase III Clinical Trial. (a) Notwithstanding
anything to the contrary in Article III.B.1. of the Rights Agreement, RPR will
use commercially reasonable efforts to conduct the First Surgery Trial (as
defined below), subject to the terms contained in this Amendment No. 1. The
"First Surgery Trial" is the international multi-center Phase III clinical trial
for the GLIADEL Product in first surgery for malignant glioma (the "First
Surgery Indication"), commenced by RPR in December 1997 pursuant to a protocol
entitled "Phase III Multicenter Randomized Double-Blind Placebo-Controlled Trial
of Polifeprosan 20 with Carmustine Implant 3.85% in Patients Undergoing Initial
Surgery for Newly-Diagnosed Malignant Glioma," Protocol No. RPR 132596/T-301,
attached hereto as Exhibit A (the "First Surgery Protocol").

         (b) Guilford will pay for half the costs of the First Surgery Trial,
up to a limit of $3 million, subject to the terms contained in this Amendment
No. 1. The budget for the First Surgery Trial is attached hereto as Exhibit B
(with such 

<PAGE>   2

variances thereto from time to time as RPR may reasonably deem necessary in
order to carry out the First Surgery Trial, the "First Surgery Trial Budget").
Guilford will pay for half the costs of the First Surgery Trial, substantially
as contemplated by the First Surgery Trial Budget, if and to the extent such
costs are reasonably incurred by RPR, provided that in no event will Guilford
pay RPR under this Section 1(b) in excess of $3 million in the aggregate.
Guilford shall make payments for its share of the First Surgery Trial as
follows: (1) Guilford shall pay $500,000 in cash upon the execution of this
Amendment No. 1; and (2) Guilford shall make additional payments in cash,
quarterly, at the rate of $250,000 per quarter, over the next 10 calendar
quarters, commencing on October 1, 1998 and thereafter on each successive
January 1, April 1, July 1 and October 1 (or if such day is not a business day,
then on the first business day immediately following such day); provided,
however, that Guilford's quarterly payments will continue beyond such next 10
calendar quarters if and for so long as its contributions to the cost of the
First Surgery Trial as described above are less than one-half of such costs,
always subject to the $3 million limit set forth above. Each such payment shall
be made against an itemized invoice, together with reasonable supporting
documentation, delivered by RPR. Each such invoice from RPR shall constitute a
certification by RPR that the costs incurred by RPR on the First Surgery Trial
Budget for the First Surgery Trial in the aggregate to date are at least twice
the aggregate amounts invoiced to date to Guilford for the First Surgery Trial.
Notwithstanding any contrary provision of this Section 1(b), in the event the
First Surgery Trial is terminated early for any reason (other than sufficiently
demonstrated efficacy), Guilford shall owe an amount under this Section 1(b) for
its share of the First Surgery Trial equal to $3 million, multiplied by the
fraction A over B, where A equals the aggregate, cumulative number of patients
enrolled (as defined in the First Surgery Protocol) in the First Surgery Trial
at the time of early termination and B equals 200, provided that in no event
will the fraction A/B exceed one. If at the time of an early termination of the
First Surgery Trial Guilford has paid more or less than such amount, Guilford or
RPR, as the case may be, shall promptly make a payment to the other party in
such amount as to cause Guilford's aggregate, cumulative payments with respect
to the First Surgery Trial under this Section 1(b) to equal such amount. For
purposes hereof, the First Surgery Trial shall be deemed to be terminated early
if and at such time as RPR as the sponsor of First Surgery Trial (a) notifies
the FDA of the official termination of the First Surgery Trial prior to its
completion, or (b) suspends patient enrollment in the First Surgery Trial and
such suspension continues for a period of ninety (90) days or more. All direct
and indirect costs incurred by RPR in conducting the First Surgery Trial above
the amount of Guilford's contribution as provided in this Section 1(b) with
respect to the First Surgery Trial shall be for the account of RPR. All direct
and indirect costs incurred by Guilford in support of RPR's conduct of the First
Surgery Trial shall be for the account of Guilford (and shall not be included in
calculating the $3 million limit described above), including overhead for
project management to monitor the progress of the First Surgery Trial and costs
to manufacture and supply, in accordance with the terms of the

                                       2
<PAGE>   3

Supply Agreement, the GLIADEL Product for use in the First Surgery Trial
pursuant to the First Surgery Trial Protocol, subject however to Section 2
below.

         (c) GPI shall have the right to review and comment in advance on all
material aspects of the First Surgery Trial, including any amendments to the
First Surgery Protocol, and shall be afforded access to all data and results
thereof under and in accordance with the terms of the Rights Agreement. RPR and
GPI shall establish a First Surgery Trial steering committee (the "First Surgery
Trial Steering Committee"), which shall be comprised of the two representatives
of RPR and the two representatives of GPI set forth on Exhibit C attached
hereto, plus one independent expert to be mutually agreed to by such RPR and GPI
representatives. Except as set forth in the last sentence of this Section 1(c),
RPR shall not suspend enrollment in the First Surgery Trial without first
consulting with the First Surgery Trial Steering Committee and obtaining and
considering its views with respect to the proposed suspension; provided,
however, that: (i) in cases where medical or scientific concerns require prompt
action, RPR shall be entitled to convene an emergency meeting of the First
Surgery Trial Steering Committee (by teleconference if necessary) on no more
than twenty-four hours notice, and (ii) after having obtained and considered the
views of the First Surgery Trial Steering Committee as set forth in this
paragraph 1(c), RPR, as the sponsor of the First Surgery Trial, shall be
entitled, in its sole discretion, to take whatever action with respect to the
First Surgery Trial as it deems appropriate, including without limitation
suspending patient enrollment. Notwithstanding any contrary provision herein, if
the First Surgery Trial Steering Committee is unable or fails to meet on an
emergency basis as set forth herein, or if in RPR's judgment significant medical
or scientific issues require it, RPR shall be entitled to suspend patient
enrollment in the First Surgery Trial without first consulting with the First
Surgery Trial Steering Committee, provided RPR convenes a meeting of the First
Surgery Trial Steering Committee as promptly thereafter as practicable and
obtains and considers its views with respect to such action.

      2. Prospective Reimbursement of Certain Costs Incurred by Guilford. Since
the execution and delivery of the Rights Agreement, direct and indirect costs
have been incurred by Guilford due to additional work performed and data
generated by Guilford at RPR's request relating to the GLIADEL Product. In
consideration of this Amendment No. 1, the parties agree that all such costs
incurred by Guilford prior to the date hereof, and all such costs incurred by
Guilford on or after the date hereof to (i) supply Gliadel Product in accordance
with the terms of the Supply Agreement; and/or (ii) respond to written inquiries
or requests from the FDA or any other regulatory authority in the Territory,
shall be for the account of Guilford. The parties further agree that, subject to
the proviso of the final sentence of this Section 2, all costs reasonably
incurred by Guilford from and after the date hereof in performing work (other
than that covered by the immediately preceding sentence) that relates to
chemistry, manufacturing and controls, quality or compliance and that is
undertaken in response to requests from RPR that are above and beyond those of
the FDA and/or other regulatory 

                                       3
<PAGE>   4

authorities in the Territory shall be for the account of RPR. In determining
what work shall be undertaken to respond to written inquiries or requests from
the FDA or other regulatory authorities in the Territory, the parties shall have
a full and fair exchange of their views with respect to the matter, and each
party shall give good faith consideration to the other's views. RPR shall
reimburse Guilford for all such costs that under the terms of this Section 2 are
for RPR's account within thirty (30) days of receipt of Guilford's itemized
invoice for such costs, together with reasonable supporting documentation. If
there should arise any dispute among the parties over the appropriate amount of
such reimbursement, RPR shall timely pay that amount which is not in dispute,
and any amount in dispute shall be subject to the dispute resolution terms of
Article VI.L. of the Rights Agreement. Notwithstanding the terms of this Section
2, Guilford will supply additional data and other information relating to the
GLIADEL Product requested by RPR which already exist and are in Guilford's
possession or control without cost to RPR.

      3. Rights in Japan. The parties hereto confirm that all rights in Japan to
the GLIADEL Product (as defined in Article III.C.1. of the Rights Agreement)
have reverted to Holdings, and the definition of "Territory" set forth in
Article I.AB. of the Rights Agreement is hereby amended and restated as follows:

            "AB.  "Territory" shall mean the entire world, excluding Denmark,
            Finland, Norway, Sweden and Japan."

The reversion to Holdings of all rights in Japan to the GLIADEL Product has been
in full satisfaction of all of GPI's, Holdings and RPR's rights and obligations
under Article III.C.1. of the Rights Agreement. In consideration of such
reversion, each of GPI and Holdings, on the one hand, and RPR, on the other,
irrevocably releases, discharged and waives any other rights or remedies it may
have or have had against the other with respect to the matters set forth in
Article III.C.1. of the Rights Agreement.

      4. Milestones in Europe, Canada and Australia. (a) Article III.C.2. of the
Rights Agreement sets forth certain deadlines for filing Regulatory Filings of
the GLIADEL Product for Regulatory Approval outside the United States. RPR filed
Regulatory Filings for Regulatory Approval for the GLIADEL Product for the First
Surgery Indication in Canada on December 20, 1996 and for Regulatory Approval
for the GLIADEL Product for the recurrent surgery indication in France on March
23, 1998. In addition, RPR submitted an application for Orphan Drug status for
the GLIADEL Product for the First Surgery Indication in Australia on March 19,
1998. RPR has informed Guilford that RPR intends to file Regulatory Filings for
Regulatory Approval of the GLIADEL Product for the recurrent surgery indication
in Europe through the European mutual recognition procedure based on RPR's
initial filing in France, as Reference Member State. RPR shall use commercially
reasonable efforts to obtain French Regulatory Approval as promptly as possible,
and further shall use commercially reasonable efforts to make as promptly as
possible such additional filings as are required for 

                                       4
<PAGE>   5

Regulatory Approval for the recurrent surgery indication in Germany, Italy,
Spain and the United Kingdom under the European mutual recognition procedure
based on the French filing. Subject to the foregoing and the other terms of this
Amendment No. 1, RPR's time period under Article III.C.2. for filing Regulatory
Filings for Regulatory Approval of the GLIADEL Product in each of Germany,
Italy, Spain, and the United Kingdom shall be extended until 90 days following
the French regulatory authority's dispatch to the regulatory authorities in
Germany, Italy, Spain and the United Kingdom, as the case may be, of its
assessment report of the Regulatory Filing for the GLIADEL Product that was
submitted on March 23, 1998. In addition, RPR's deadline under Article III.C.2.
of the Rights Agreement for filing a Regulatory Filing for Regulatory Approval
for the GLIADEL Product in Australia is hereby extended until the sooner of 90
days following RPR's receipt of the Australian authorities' approval of Orphan
Drug status for the GLIADEL Product in Australia or March 31, 1999. If any
Regulatory Filing for Regulatory Approval for the GLIADEL Product in any of the
foregoing countries is not timely made as aforesaid (unless otherwise
unanimously agreed in advance in writing by the Governance Committee), rights to
the GLIADEL Product in such of those countries where the Regulatory Filing for
Regulatory Approval was not timely made in accordance with the Rights Agreement,
as amended by this Amendment No. 1, shall revert back to Holdings.

            (b)  Subject to the terms of this Amendment No. 1, Article III.D.6.
of the Rights Agreement is amended and restated as follows:

                        "6. The respective sums set forth below opposite each of
            the following countries on the first business day after RPR's
            receipt of the Regulatory Approval of the GLIADEL Product in such
            country, depending on whether Regulatory Approval obtained is for a
            recurrent indication, or the First Surgery Indication:

<TABLE>
<CAPTION>
<S>  <C>           <C>               <C>                <C>    
                                     Milestone upon     Milestone if
                   Milestone if      receipt of         initial
                   initial           subsequent         Regulatory
                   Regulatory        Regulatory         Approval
                   Approval is for   Approval for       includes First
                   recurrent         First Surgery      Surgery
                   indication only   Indication         Indication

(a)  France        $2.5 million      $2.5 million       $5 million


(b)  Germany       $2 million        $2 million         $4 million
(c)  Italy         $1.5 million      $1.5 million       $3 million
(d)  Spain         $1 million        $1 million         $2 million
(e)  Canada        $2 million        --                 $2 million
(f)  U.K.          $1 million        $1 million         $2 million
(g)  Australia     $1 million        $1 million         $2 million
</TABLE>

            RPR shall not be obligated to make any milestone payment upon the
            issuance of any other Regulatory Approval.

                                       5
<PAGE>   6

            Notwithstanding the foregoing, RPR shall not be obligated to make
            any of the foregoing milestone payments if at the time of the
            issuance of any such Regulatory Approval in an applicable country
            and the grant of such a reimbursement price in such country, RPR's
            rights under this Agreement with respect to such country have
            reverted back to GPI Holdings or otherwise terminated."

      5.    Right of First Offer.  (a)  Subject to the terms of this Amendment
No. 1, Article III.J.1. and III.J.2. of the Rights Agreement are amended and
restated as follows:

            "1. From and after the Effective Date during the term of this
      Agreement, RPR shall have the exclusive right of first offer with respect
      to worldwide rights (except in Japan) to any Guilford product candidate
      based on cancer chemotherapeutics in conjunction with polymers, whether
      such product candidate is developed, owned or controlled prior to or after
      the Effective Date provided that the following two conditions are met:

            (i)         the product candidate is being developed (or proposed to
                        be developed) directly by Guilford (and not pursuant to
                        a corporate collaboration with another party)
                        specifically for the indication of brain cancer; and

            (ii)        Guilford either owns or has license rights to the
                        intellectual property rights covering the active
                        chemotherapeutic agent which would be incorporated in
                        the polymer, or the agent is non-proprietary and in the
                        public domain.

      Any such product candidate satisfying both of the foregoing conditions
      shall be termed a "Qualifying Product Candidate." Notwithstanding anything
      to the contrary in this Article III.J., any collaboration between RPR and
      Guilford pursuant to RPR's exercise of its right of first offer under this
      Article III.J.1. shall, except as may otherwise be specifically agreed in
      writing by Guilford, be limited to product candidates meeting both of the
      foregoing two conditions.

            2. Upon a determination by Guilford of the existence of a Qualifying
      Product Candidate, and the completion of the preliminary animal studies
      referred to below (any such Qualifying Product Candidate referred to
      herein as an "Offered Technology"), GPI shall give written notice thereof
      to RPR, together with (i) all data available to Guilford on physical
      product characteristics as well as all data from any preliminary animal
      studies of the Offered Technology conducted by Guilford, and (ii) 

                                       6
<PAGE>   7

      all of Guilford's available records and data relating to the Offered 
      Technology (the "Offer Notice")."

For the avoidance of doubt, Guilford has previously offered, and RPR has
declined to exercise such right of first offer with respect to, docetaxel
(TAXOTERE(R)), paclitaxel (TAXOL(R)) or IL-2 in Guilford's polyphosphoester
polymer platform for cancers.

                  (b) The "six month period" referred to in Article III.J.3. of
the Rights Agreement constituting the Offer Period as defined therein is hereby
amended to read the "90 day period."

      6.    No Waiver.  Except to the extent resulting from the specific terms
and conditions of this Amendment No. 1, this Amendment No. 1 does not constitute
a waiver by any party hereto of any of its rights under any of the Transaction
Agreements.

      7.    Headings.  The section headings contained in this Amendment No. 1 
are for reference purposes only and shall not affect in any way the meaning or
interpretation of this Amendment No. 1.

      8.    Capitalized Terms. Capitalized terms not otherwise defined in this
Amendment No. 1 are used herein as defined in the Rights Agreement.

      9.    Continuing Effect.  Except as specifically amended by this Amendment
No. 1, all other terms and conditions of the Rights Agreement remain in full
force and effect.

                                       7
<PAGE>   8
 
      IN WITNESS WHEREOF, duly authorized representatives of the parties hereto
have duly executed this Amendment No. 1 as of the date hereof.

<TABLE>
<CAPTION>
<S>                                     <C>
RHONE-POULENC RORER
  PHARMACEUTICALS INC.                  GUILFORD PHARMACEUTICALS INC.

By:    /s/ CLAUDE P. DUPUIS             By:    /s/ CRAIG R. SMITH, M.D.
       --------------------                    ------------------------
Name:  Claude P. Dupuis                 Name:  Craig R. Smith, M.D.
       --------------------                    ------------------------
Title: Corporate Vice President         Title: Chairman of the Board,
       Worldwide Business Development          President and Chief 
       and Licensing                           Executive Officer
       --------------------                    ------------------------

Date:  9/25/98                          Date:  9/25/98
       --------------------                    ------------------------

                                        GPI POLYMER HOLDINGS, INC.
                                        (formerly named GPI Holdings, Inc.)


                                        By:    /s/ DANIEL P. MCCALLOM
                                               -----------------------  
                                        Name:  Daniel P. McCallom
                                               -----------------------             
                                        Title: Vice President
                                               -----------------------  
                                        Date:  9/25/98
                                               -----------------------  
</TABLE>
                                       8
<PAGE>   9
                                   EXHIBIT A


***Confidential treatment of 47 pages has been requested.***



<PAGE>   10
                                   EXHIBIT B


***Confidential treatment has been requested.***



<PAGE>   11
                                   EXHIBIT C


                            Guilford Representatives

Dana Hilt, M.D. V.P. Clinical

Bill Vincek, V.P. Corporate Quality



                              RPR Representatives

Thomas Honohan, V.P. Worldwide Research and Development Quality Assurance

Jean-Pierre Bizzari, M.D., V.P. Clinical Oncology


<PAGE>   1

                 Amendment No. 1 to Stock Purchase Agreement

      Amendment No. 1, dated as of September 25, 1998 ("Amendment No. 1") by
and between Rhone-Poulenc Rorer Inc. ("RPR") and Guilford Pharmaceuticals
Inc. ("GPI") to Stock Purchase Agreement, dated as of June 13, 1996.

      WHEREAS, Rhone-Poulenc Rorer Pharmaceuticals Inc. ("RPRPI"), GPI and GPI
Polymer Holdings, Inc. (previously named GPI Holdings, Inc., "Holdings"; GPI and
Holdings, collectively, "Guilford") are parties to a Marketing, Sales and
Distribution Rights Agreement, dated as of June 13, 1996 (the "Rights
Agreement"), and GPI and RPR are parties to a Stock Purchase Agreement, dated as
of June 13, 1996 (the "Stock Agreement"), and RPRPI and GPI are parties to a
Manufacturing and Supply Agreement, dated as of June 13, 1996 (the "Supply
Agreement"), and GPI and RPR are parties to a Loan Agreement, dated as of June
13, 1996 (the "Loan Agreement"; the Rights Agreement, the Stock Agreement, the
Supply Agreement and the Loan Agreement, collectively, the "Transaction
Agreements"), all in connection with a transaction pursuant to which RPRPI has
become the worldwide marketer and distributor (except in Scandinavia) for
Guilford's biodegradable polymer oncology product, GLIADEL(R) Wafer; and

      WHEREAS, RPR and Guilford now desire to amend certain provisions of the
Stock Agreement as set forth herein and to amend certain provisions of the
Rights Agreement as set forth in the Amendment No. 1 to that agreement, of even
date herewith, to reflect further agreements between them;

      NOW, THEREFORE, the parties hereto, intending to be legally bound, agree
as follows:

      1. RPR Representation on GPI Board. In consideration of this Amendment No.
1 and the Amendment No. 1 to the Rights Agreement, of even date herewith,
Section 6.03 of the Stock Agreement, providing RPR with representation on the
GPI Board on and after the Second Closing Date, is deleted from the Stock
Agreement, and Section 6.04 is renumbered Section 6.03.

      2.    No Waiver.  Except to the extent resulting from the specific
terms and conditions of this Amendment No. 1, this Amendment No. 1 does not
constitute a waiver by any party hereto of any of its rights under any of the
Transaction Agreements.

<PAGE>   2

      3.    Headings.  The section headings contained in this Amendment No. 1
are for reference purposes only and shall not affect in any way the meaning
or interpretation of this Amendment No. 1.

      4. Capitalized Terms. Capitalized terms not otherwise defined in this
Amendment No. 1 are used herein as defined in the Stock Agreement.

      5.    Continuing Effect.  Except as specifically amended by this
Amendment No. 1, all other terms and conditions of the Stock Agreement remain
in full force and effect.

      IN WITNESS WHEREOF, duly authorized representatives of the parties hereto
have duly executed this Amendment No. 1 as of the date hereof.

RHONE-POULENC RORER INC.                GUILFORD PHARMACEUTICALS INC.

By /s/ JAMES P. WEYGANDT                By /s/ THOMAS C. SEOH
  --------------------------               ---------------------------------
Name:  James P. Weygandt                Name:  Thomas C. Seoh
Title: Secretary                        Title: Vice President, General Counsel
                                               & Secretary

                                       


© 2022 IncJournal is not affiliated with or endorsed by the U.S. Securities and Exchange Commission