1
EXHIBIT 10.16C
AMENDED AND RESTATED LICENSE AGREEMENT
This Amended and Restated License Agreement, is made and entered
into as of the date of the last signature on the signature page below (the
"EFFECTIVE DATE"), between The Xxxxx Xxxxxxx University, a Maryland
corporation, having a principal place of business at 000 Xxxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxx 00000 ("JHU"), and Guilford Pharmaceuticals Inc., a
Delaware corporation ("GPI"), having an address at 0000 Xxxxxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxx 00000, and its indirect, wholly-owned subsidiary, GPI NIL
Holdings, Inc., a Delaware corporation ("HOLDINGS," and together with GPI, the
"COMPANY"), having an address at 000 Xxxxxxxx Xxxxxx, Xxxxxxxxxx, Xxxxxxxx,
00000.
WITNESSETH:
WHEREAS, GPI and JHU entered into a License Agreement dated
January 2, 1996 (the "1996 AGREEMENT") relating to (a) * and the invention
disclosed and claimed therein; (b) * and the invention disclosed and claimed
therein; (c) all continuations, divisions, and reissues based on the
above-cited applications and any corresponding foreign patent applications; and
(d) any patents, patents of addition, or other U.S. or equivalent foreign
patent rights issuing, granted or registered thereon (collectively, the "1996
NIL PATENT RIGHTS");
WHEREAS, GPI and JHU entered into an Amended and Restated
License Agreement dated June 26, 1997 (the "1997 AGREEMENT") relating to
certain patents and patent rights including, among others, (a) *; (b) all
continuations, divisions, and reissues based on the above-cited applications
and any corresponding foreign patent applications; and (c) any patents, patents
of addition, or other U.S. or equivalent foreign patent rights issuing, granted
or registered thereon (collectively, the "1997 NIL PATENT RIGHTS");
WHEREAS, JHU has filed the following patent applications: (a) *;
(b) *; and (c) * (collectively, the "1997 JHU NIL PATENT FILINGS").
WHEREAS, pursuant to assignment agreements dated August 1, 1997,
GPI assigned its rights to the 1996 NIL PATENT RIGHTS and the 1997 NIL PATENT
RIGHTS under the 1996 AGREEMENT and the 1997 AGREEMENT, respectively, to its
AFFILIATED COMPANY, HOLDINGS;
WHEREAS, as a center for research and education, JHU is
interested in licensing patent rights in a manner that will benefit the public
by facilitating the distribution of useful products and the utilization of new
methods, but is itself
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
2
without capacity to commercially develop, manufacture and distribute any such
products or methods;
WHEREAS, the COMPANY desires to commercially develop,
manufacture, use and distribute such products and methods based on such
inventions throughout the world; and
WHEREAS, the COMPANY and JHU desire to amend and restate the
1996 AGREEMENT in its entirety, and to amend the 1997 AGREEMENT to the extent
it relates to the 1997 NIL PATENT RIGHTS, and to effect the exclusive worldwide
license from JHU to HOLDINGS of the 1997 JHU NIL PATENT FILINGS;
NOW THEREFORE, in consideration of the foregoing premises and
the following mutual covenants, and other good and valuable consideration, the
receipt of which is hereby acknowledged, and intending to be legally bound
hereby, the parties agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 "AFFILIATED COMPANY" or AFFILIATED COMPANIES" shall mean
any corporation, company, partnership, joint venture or other entity which
controls, is controlled by, or is under common control with, the COMPANY. For
purpose of this Paragraph 1.1, control shall mean the direct or indirect
ownership of at least fifty percent (50%) of the outstanding voting securities
or partnership interests, as applicable, of such corporation, company,
partnership, joint venture or other entity.
1.2 "CONTROL" or "CONTROLLED" shall mean possession of the
right to grant a license or sublicense without violating the terms of any
agreement or other arrangements with a third party.
1.3 "EXCLUSIVE LICENSE" shall mean an exclusive, worldwide
grant by JHU to the COMPANY of JHU's entire right and interest in the JHU
NEUROIMMUNOPHILIN PATENT RIGHTS, subject to rights, if any, retained by the
United States government under applicable law, and subject to the retained
right of JHU to make, have made, provide and use for its and the Xxxxx Xxxxxxx
Health Service's non-profit internal research purposes LICENSED PRODUCT(S) and
LICENSED SERVICE(S).
1.4 "FIELD" shall mean indications involving the use of
NEUROIMMUNOPHILIN TECHNOLOGY to the extent such technology relates to inducing
neurite extension or other neuronal effects. By way of illustration, but not
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
3
limitation, the FIELD includes all Category One Indications and all Category
Two Indications, but does not include Category Three and Category Four
Indications (as such categories are defined as of December 15, 1997 in the
Amgen Agreement) unless the therapeutic activity of such compounds for such
Category Three or Category Four Indication relates to inducing neurite
extension or other neuronal effects.
1.5 "FDA" shall mean the United States Food and Drug
Administration or successor agency having responsibility for regulation of
pharmaceutical products.
1.6 "IND" shall mean an Investigational New Drug Application
or its equivalent.
1.7 "LICENSED PRODUCT(S)" shall mean any material,
composition, drug, or other product, the manufacture, use, sale or importation
of which would constitute, but for HOLDINGS' joint ownership interest therein
or the license granted to HOLDINGS pursuant to this Agreement, an infringement
of a valid, issued claim of JHU NEUROIMMUNOPHILIN PATENT RIGHTS owned by JHU
(infringement shall include, but is not limited to, direct, contributory, or
inducement to infringe).
1.8 "LICENSED SERVICE(S)" shall mean the performance on
behalf of a third party of any service which would constitute, but for
HOLDINGS' joint ownership interest therein or the license granted to HOLDINGS
pursuant to this Agreement, an infringement of a valid, issued claim of JHU
NEUROIMMUNOPHILIN PATENT RIGHTS owned by JHU (infringement shall include, but
not be limited to, direct, contributory or inducement to infringe).
1.9 "NDA" shall mean a New Drug Application, a Product
License Application or its equivalent.
1.10 "NET SALES", subject to Paragraph 4.5 below, shall mean
gross sales revenues and fees (but not royalty payments) received by the
COMPANY, AFFILIATED COMPANIES or SUBLICENSEES, as the case may be, from the
sale of ROYALTY PRODUCT(S) to third parties in arms length transactions, less
trade discounts allowed, refunds, returns and recalls, transportation charges,
and sales, use, value added, withholding and other taxes. In the event that the
COMPANY, an AFFILIATED COMPANY or SUBLICENSE sells a ROYALTY PRODUCT(S) in
combination with other active ingredients or substances, the NET SALES for
purposes of royalty payments shall be based on the sales revenues and fees
received with respect to the sales price of the components consisting of
ROYALTY
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
4
PRODUCT(S), and if such active components are not priced separately, based on
such sales price as the COMPANY, AFFILIATED COMPANY or SUBLICENSEE may
reasonably allocate to the ROYALTY PRODUCT(S) included in such combination,
subject to the reasonable approval of JHU.
1.11 "NET SERVICE REVENUES", subject to Paragraph 4.5 below,
shall mean actual xxxxxxxx by the COMPANY, AFFILIATED COMPANIES or
SUBLICENSEES, as the case may be, for the performance of ROYALTY SERVICE(S)
less sales, use, value added, withholding or other taxes imposed upon and with
specific reference to the ROYALTY SERVICE(S) (excluding tax measured and
assessed solely on the net income of the COMPANY).
1.12 "JHU NEUROIMMUNOPHILIN PATENT RIGHTS" shall mean (i) the
1996 NIL PATENT RIGHTS; (ii) the 1997 NIL PATENT RIGHTS; (iii) the 1997 JHU NIL
PATENT FILINGS; and (iv) all claims of parent, continuing, continuation-in-part
(if and to the extent the new matter in the CIP supports claims originally
filed in the parent application or the claims in the CIP are supported by the
original disclosure in the parent application), reissue and reexamination
applications and patents, foreign and domestic, which are directed to the
subject matter specifically described in the patent applications set forth in
clauses (i) through and including (iii) above and all resulting patents.
1.13 "NEUROIMMUNOPHILIN TECHNOLOGY" shall mean technology
relating to compounds that bind to immunophilins and/or modify rotamase
activity of an immunophilin (including but not limited to FK506 binding
proteins and cyclophilins) or any downstream signalling pathways, including,
without limitation, the COLLABORATION TECHNOLOGY as that term is defined as of
December 15, 1997 in the Collaboration and License Agreement of same date among
GPI, HOLDINGS, and Amgen Inc. (the "Amgen Agreement").
1.14 "PARTNERSHIP PROCEEDS" shall mean all signing and
licensing fees and rights, milestones and other payments received by the
COMPANY or any AFFILIATED COMPANY pursuant to any agreement with any
SUBLICENSEE related to the research, development and/or commercialization of
NEUROIMMUNOPHILIN TECHNOLOGY, but excluding any amounts received by the COMPANY
or any AFFILIATED COMPANY (i) in consideration for issuance of any SECURITIES
except to the extent that the amount paid for such SECURITIES exceeds 150% of
the fair market value of any such SECURITY; (ii) which are dedicated, pursuant
to express written agreement between the COMPANY or any AFFILIATED COMPANY and
a SUBLICENSEE, to support or pay for research, development and/or
commercialization of NEUROIMMUNOPHILIN TECHNOLOGY at, or under the direction
of, the COMPANY or an AFFILIATED
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
5
COMPANY; (iii) specifically directed to reimburse or prepay the COMPANY or any
AFFILIATED COMPANY for expenses or expenditures made or to be incurred as part
of the research, development and/or commercialization of NEUROIMMUNOPHILIN
TECHNOLOGY; (iv) if the COMPANY retains or assumes responsibility or pays for
manufacture of a supply of product or product candidate, any transfer price for
supply of such product or product candidate; or (v) as NET SALES or NET
SERVICES or running royalties paid thereon. The foregoing exceptions to
PARTNERSHIP PROCEEDS contained in clauses (ii) and (iii) extend only to
payments from SUBLICENSEES to the COMPANY or any AFFILIATED COMPANY which,
consistent with industry custom and practice, are to be applied to, or are to
reimburse, costs incurred in commercializing NEUROIMMUNOPHILIN TECHNOLOGY, and
in clause (iv) above in order to exclude bona fide consideration, within a
range consistent with industry custom and practice, that a SUBLICENSEE may
agree to pay the COMPANY or an AFFILIATED COMPANY for the supply of product or
product candidates. Such exceptions shall not be construed to afford the
COMPANY an opportunity to minimize the amount of PARTNERSHIP PROCEEDS payable
by the COMPANY to JHU under this Agreement by unfairly recharacterizing the
nature of such payments. In the event any dispute arises among the parties as
to whether proceeds received by the COMPANY or any AFFILIATED COMPANY from a
SUBLICENSEE qualify for the exceptions set forth in any of clauses (ii) through
(iv) above, the parties agree that such dispute shall be resolved in such a
manner as to give effect to the illustrative characterization agreed by the
parties in SCHEDULE 4.9 attached to this Agreement, industry custom and
practice, and the mutual intention of the parties expressed in the preceding
two sentences.
1.15 "PATENTED ROYALTY PRODUCT" shall mean any material,
composition, drug, or other product (including without limitation any LICENSED
PRODUCT), the manufacture, use, sale or importation of which would constitute
infringement of a claim of a valid, issued patent in the TERRITORY included
within the NEUROIMMUNOPHILIN TECHNOLOGY that is owned by or under the CONTROL
of JHU (to the extent such patent has been licensed by JHU to the COMPANY under
this Agreement), the COMPANY, an AFFILIATED COMPANY or a SUBLICENSEE (provided
in the latter case that the COMPANY or an AFFILIATED COMPANY has a right to
receive consideration from such SUBLICENSEE in respect of such patent) were it
not for such ownership or CONTROL of said patent.
1.16 "PATENTED ROYALTY SERVICE" shall mean the performance of
any service or the manufacture of any product or the use of any product
(including any LICENSED SERVICE), on behalf of a third party which would
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
6
constitute infringement of a claim of a valid, issued patent in the TERRITORY
included within the NEUROIMMUNOPHILIN TECHNOLOGY that is owned by or under the
CONTROL of JHU (to the extent such patent has been licensed by JHU to the
COMPANY under this Agreement), the COMPANY, an AFFILIATED COMPANY or a
SUBLICENSEE (provided in the latter case that the COMPANY or an AFFILIATED
COMPANY has a right to receive consideration from such SUBLICENSEE in respect
of such patent) were it not for such ownership or CONTROL of said patent.
1.17 "ROYALTY PRODUCT(S)" shall mean PATENTED ROYALTY
PRODUCT(S) and UNPATENTED ROYALTY PRODUCT(S).
1.18 "ROYALTY SERVICE(S)" shall mean PATENTED ROYALTY
SERVICE(S) and UNPATENTED ROYALTY SERVICE(S). For the avoidance of doubt, for
purposes of this Agreement, ROYALTY SERVICES shall not include services
rendered by third party vendors engaged by the COMPANY, an AFFILIATED COMPANY
and/or a SUBLICENSEE to the extent such vendors are merely performing services
or supplying product in support of the research, pre-clinical or clinical
development and/or manufacture or supply of ROYALTY PRODUCTS or ROYALTY
SERVICES.
1.19 "SECURITIES" shall mean any equity, debt or other
securities (including, without limitation, any option, warrant, convertible
equity or debt, or other derivative security) issued by the COMPANY.
1.20 "SUBLICENSEE" shall mean any and all entities (other than
the COMPANY) that are authorized by the COMPANY to make, have made, use, sell,
import, export, or provide any ROYALTY PRODUCT or ROYALTY SERVICE.
1.21 "TERRITORY" shall mean each country or other distinct
national jurisdiction, taken separately, around the world.
1.22 "UNPATENTED ROYALTY PRODUCT" shall mean a product in the
FIELD encompassing ligands that bind to immunophilins which is not a PATENTED
ROYALTY PRODUCT in respect of which the COMPANY or any AFFILIATED COMPANY
receives NET SALES or receives a royalty from a SUBLICENSEE.
1.23 "UNPATENTED ROYALTY SERVICE" shall mean the performance
on behalf of a third party of any service that includes the making, use or sale
of an UNPATENTED ROYALTY PRODUCT and in respect of which the COMPANY or any
AFFILIATED COMPANY receives NET SERVICE REVENUES or receives a royalty from a
SUBLICENSEE.
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
7
ARTICLE 2 - GRANTS
2.1 Subject to the terms and conditions of this Agreement,
JHU hereby grants to HOLDINGS an EXCLUSIVE LICENSE to make, have made, use,
lease, sell and import in all cases for any purpose the LICENSED PRODUCT(S) and
to provide the LICENSED SERVICE(S) in the TERRITORY under the JHU
NEUROIMMUNOPHILIN PATENT RIGHTS.
2.2 HOLDINGS may sublicense others under this Agreement and
shall provide a copy of each such sublicense agreement to JHU promptly after it
is executed. Each sublicense shall be consistent with the terms of this
Agreement. JHU acknowledges prior receipt of the Amgen Agreement and the
sublicenses granted thereunder respecting certain of the JHU NEUROIMMUNOPHILIN
PATENT RIGHTS.
ARTICLE 3 - PATENT INFRINGEMENT
3.1 In the event JHU or the COMPANY shall learn of the
substantial infringement of any patent included within JHU NEUROIMMUNOPHILIN
PATENT RIGHTS, the party who learns of the infringement shall promptly notify
the other party in writing and shall provide the other party with all available
evidence of such infringement. HOLDINGS and JHU shall use commercially
reasonable efforts to eliminate such infringement without litigation. If the
efforts of the parties are not successful in eliminating the infringement
within ninety (90) days after the infringer has been formally notified of the
infringement by HOLDINGS, HOLDINGS shall have the right, but not the
obligation, to commence suit against such infringement on its own account;
provided that, HOLDINGS may elect to commence any such suit prior to said
ninety (90) day period.
3.2 Subject to Paragraph 3.1 above, JHU may bring suit on its
own account and at its cost, but only if HOLDINGS elects not to commence suit,
either by formal notice or by failure by HOLDINGS to act within ninety (90)
days following the end of the initial ninety (90) day period referenced in
Paragraph 3.1 above. The COMPANY shall retain the right to join any suit
initiated by JHU.
3.3 If JHU is made a party through the actions of HOLDINGS to
an infringement suit brought by HOLDINGS, any costs, expenses or fees incurred
by JHU as a result of such action shall be reimbursed by HOLDINGS, provided
that nothing herein shall be deemed to require HOLDINGS to reimburse JHU for
any such costs incurred by JHU as a result of JHU's suit on its account
pursuant to Paragraph 3.2 above.
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
8
3.4 Legal action to eliminate infringement and/or recover
damages brought pursuant to this ARTICLE 3 shall be at the full expense of the
party by whom suit is brought. All such damages actually recovered by a party
hereto ("LITIGATION PROCEEDS") shall first be used to reimburse each party for
its expenses in connection with such legal action (in proportion to the
expenses of each party, if recovery is insufficient to cover all such expenses)
and the remainder of such LITIGATION PROCEEDS (the "REMAINDER") shall be
allocated 85% to the party hereto taking the lead in representing the interests
of the owners of the JHU NEUROIMMUNOPHILIN PATENT RIGHTS in the action, and 15%
to the other party hereto.
3.5 Each party agrees to cooperate with the other in
litigation proceedings. Either party may be represented at its own expense by
counsel of its choice in any suit.
ARTICLE 4 - ROYALTY AND OTHER PAYMENTS
4.1 HOLDINGS shall pay to JHU:
(a) As a running royalty, for each PATENTED ROYALTY
PRODUCT sold for one or more indications within the FIELD, and for each
PATENTED ROYALTY SERVICE relating to the FIELD provided, by the COMPANY or by
any AFFILIATED COMPANY, * of NET SALES and NET SERVICE REVENUES relating to
such PATENTED ROYALTY PRODUCTS sold and such PATENTED ROYALTY SERVICES provided
for the term of this Agreement;
(b) As a running royalty, for each PATENTED ROYALTY
PRODUCT sold for one or more indications within the FIELD, and for each
PATENTED ROYALTY SERVICE relating to the FIELD provided, by any SUBLICENSEE
other than an AFFILIATED COMPANY, * of NET SALES and NET SERVICE REVENUES
relating to such PATENTED ROYALTY PRODUCTS sold and such PATENTED ROYALTY
SERVICES provided for the term of this Agreement;
(c) As a running royalty, for each PATENTED ROYALTY
PRODUCT sold exclusively for indications outside the field, and for each
PATENTED ROYALTY SERVICE unrelated to the FIELD provided, by the COMPANY, any
AFFILIATED COMPANY or any SUBLICENSEE, * of NET SALES and NET SERVICE REVENUES
relating to such PATENTED ROYALTY PRODUCTS sold and such PATENTED ROYALTY
SERVICES provided for the term of this Agreement.
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
9
(d) As a running royalty, for each UNPATENTED ROYALTY
PRODUCT sold, and for each UNPATENTED ROYALTY SERVICE provided, by the COMPANY
or by any AFFILIATED COMPANY * of NET SALES and NET SERVICE REVENUES relating
to such UNPATENTED ROYALTY PRODUCTS sold and UNPATENTED ROYALTY SERVICES
provided for the term of this Agreement; and
(e) In the event the COMPANY or any AFFILIATED COMPANY
receives royalty payments from a SUBLICENSEE with respect to an UNPATENTED
ROYALTY PRODUCT or an UNPATENTED ROYALTY SERVICE, then a running royalty, for
each such UNPATENTED ROYALTY PRODUCT sold, and for each such UNPATENTED ROYALTY
SERVICE so provided, equal to * of the of NET SALES and NET SERVICE REVENUES
relating to such UNPATENTED ROYALTY PRODUCTS sold and UNPATENTED ROYALTY
SERVICES provided during the term of this Agreement.
All such royalty payments shall be made quarterly as
provided in Paragraph 4.3 below. In determining royalties, it will be assumed
that the status of a ROYALTY PRODUCT (i.e., whether it is a PATENTED ROYALTY
PRODUCT or an UNPATENTED ROYALTY PRODUCT) at the end of the applicable quarter
was in effect for the entire period.
4.2 (a) In addition to the royalty payments outlined in
Paragraph 4.1 above, HOLDINGS shall pay to JHU * of all PARTNERSHIP PROCEEDS
paid on or after the EFFECTIVE DATE no later than forty-five (45) days
following the end of the calendar quarter in which the COMPANY (or any
AFFILIATED COMPANY) receives amounts constituting PARTNERSHIP PROCEEDS.
(b) In respect of the exclusive licenses granted hereby
and the other mutual agreements, covenants and consideration contained herein,
simultaneously with the execution and delivery of this Agreement the COMPANY
shall pay to JHU by check or wire transfer, as JHU shall instruct the COMPANY
in writing no less than three (3) business days prior to such date of
execution, *. In reliance upon the COMPANY's representations in Paragraph 4.9
below, JHU acknowledges and agrees that the COMPANY, on or prior to the
EFFECTIVE DATE, has paid to JHU all amounts that may be due to JHU under the
1996 AGREEMENT, and all amounts that may be due to JHU under the 1997 AGREEMENT
insofar as they relate to the 1997 NIL PATENT RIGHTS.
4.3 Following the first commercial sale of a ROYALTY PRODUCT
or ROYALTY SERVICE, HOLDINGS shall provide to JHU within sixty (60) days of the
end of each March, June, September and December, a written report to JHU
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
10
stating the amount of ROYALTY PRODUCT(S) and ROYALTY SERVICE(S) sold, the total
NET SALES and NET SERVICE REVENUES of such ROYALTY PRODUCT(S) and ROYALTY
SERVICE(S), and the running royalties due to JHU as a result of NET SALES and
NET SERVICE REVENUES by the COMPANY, AFFILIATED COMPANIES and SUBLICENSEES.
Payment of any such royalties due shall accompany such report. The parties
understand and agree that in the event such products or services are sold,
whether pursuant to a sublicense, marketing and sales agreement or other
contract, by a party other than the COMPANY or an AFFILIATED COMPANY, HOLDINGS
may base its reports of NET SALES and payments of royalty to JHU under this
Paragraph 4.3 on information as and when received from such other party,
provided in no event will HOLDINGS be required to report and pay royalty on a
given due date under this Paragraph 4.3 based on a report or payment received
less than ten (10) business days prior to such due date under this Paragraph
4.3. By way of example and without limitation, if a third party markets and
sells a ROYALTY PRODUCT and reports to HOLDINGS a certain quarter's domestic
sales by the 45th day following such quarter, and international sales by the
60th day following such quarter, HOLDINGS will report and make a royalty
payment to JHU with respect to such domestic sales by the 60th day following
such quarter, and a royalty payment with respect to such international sales at
the next report due date under this Paragraph 4.3. Until the COMPANY, an
AFFILIATED COMPANY or a SUBLICENSEE has made the first commercial sale of a
ROYALTY PRODUCT(S) pursuant to FDA commercial approval, HOLDINGS shall cause to
be submitted to JHU a report at the end of every June and December after the
EFFECTIVE DATE of this Agreement describing the COMPANY's direct and indirect
technical efforts towards meeting the milestones set forth in ARTICLE 6.
4.4 The COMPANY shall make and retain, for a period of three
(3) years following the period of each report required by Paragraph 4.3 above,
true and accurate records, files and books of account containing all the data
reasonably required for the full computation and verification of sales and
other information required in Paragraph 4.3. Such books and records shall be in
accordance with generally accepted accounting principles consistently applied.
The COMPANY shall permit the inspection and copying of such records, files and
books of account by JHU or its agents during regular business hours upon ten
(10) business days' written notice to the COMPANY. Such inspection shall not be
made more than once each calendar year. JHU's election from time to time not to
conduct such inspection shall not be deemed to constitute a waiver of its right
to conduct future inspections under this Paragraph 4.4. All costs of such
inspection and copying shall be paid by JHU, provided that if any such
inspection shall reveal that an error has been made in the amount equal to ten
percent (10%) or more of such payment, such
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
11
costs shall be borne by HOLDINGS. The COMPANY shall include in any agreement
with its AFFILIATED COMPANIES or its SUBLICENSEES which agreement permits such
party to make, use or sell the ROYALTY PRODUCT(S) or provide ROYALTY
SERVICE(S), a provision requiring such party to retain records of sales of
ROYALTY PRODUCT(S) and records of ROYALTY SERVICE(S) and other information as
required in Paragraph 4.3 and permit JHU to inspect such records as required by
this Paragraph 4.4.
4.5 In order to insure JHU the full royalty payments
contemplated hereunder, the COMPANY agrees that in the event any ROYALTY
PRODUCT is sold to an AFFILIATED COMPANY, a SUBLICENSEE or to a corporation,
firm or association with which COMPANY has a business relationship (such as,
among other things, an option to purchase stock or actual stock ownership, or
an arrangement involving division of profits or special rebates or allowances)
(collectively, "Affiliated Purchasers"), the royalties to be paid hereunder for
such ROYALTY PRODUCT(S) shall be based upon the greater of: (1) the net selling
price at which such Affiliated Purchasers of ROYALTY PRODUCT(S) resell such
product to the end user; (2) the Net Service Revenue such Affiliated Purchasers
receive from using the ROYALTY PRODUCT(S) in providing a service; (3) the fair
market value of the ROYALTY PRODUCT(S) being sold at that level of
distribution; or (4) the net price paid by such Affiliated Purchasers for
ROYALTY PRODUCT(S); provided, however, that, subject to the following sentence,
the foregoing shall not apply in the event that a ROYALTY PRODUCT or a ROYALTY
SERVICE is supplied at no charge or below fair market value for bona fide
business reasons such as supply for clinical trials, distributions for
compassionate use, an indigent program and the like, or for advertising and
promotion (collectively, "DISCRETIONARY USES"). In the event that the COMPANY
receives any revenues from an Affiliated Purchaser as a result of such
Affiliated Purchaser's DISCRETIONARY USES, any such amounts paid to the COMPANY
shall be considered PARTNERSHIP PROCEEDS for purposes of Paragraph 4.2(a)
above.
4.6 It is the sole responsibility of JHU to distribute to the
JHU inventors of the JHU NEUROIMMUNOPHILIN PATENT RIGHTS such portion of the
amounts paid pursuant to this ARTICLE 4 as JHU may be required to distribute
pursuant to its internal policies.
4.7 All payments due under this Agreement shall be made in
U.S. Dollars.
4.8. GPI hereby guarantees the payment obligations of HOLDINGS
under this ARTICLE 4.
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
12
4.9 Except for the amounts set forth in Schedule 4.9 hereto,
COMPANY represents that as of the EFFECTIVE DATE it has received no payments
from any third party respecting the NEUROIMMUNOPHILIN TECHNOLOGY. Further,
COMPANY represents that as of the EFFECTIVE DATE: (i) other than the Amgen
Agreement, the COMPANY has not entered into a sublicense with any third party
for the JHU NEUROIMMUNOPHILIN PATENT RIGHTS respecting the research,
development and/or commercialization of NEUROIMMUNOPHILIN TECHNOLOGY; and (ii)
HOLDINGS, GPI and Amgen have not entered into any amendment of the Amgen
Agreement.
4.10 In the event that PARTNERSHIP PROCEEDS, royalties or
other payments would be due JHU under both this Agreement and any other license
agreement existing between JHU and GPI and/or HOLDINGS in respect of the sale
of any particular product or service or the sublicensing of any
NEUROIMMUNOPHILIN TECHNOLOGY, the COMPANY's aggregate liability to JHU for such
payments nevertheless shall not exceed the amount due under any single
agreement.
ARTICLE 5 - JHU NEUROIMMUNOPHILIN PATENT RIGHTS AND
CONFIDENTIAL INFORMATION
5.1 HOLDINGS will, at its expense, take lead responsibility
for, and have final authority with respect to, the preparation, filing,
prosecution, and maintenance of the JHU NEUROIMMUNOPHILIN PATENT RIGHTS, using
competent and experienced patent counsel. Unless JHU and HOLDINGS specifically
consent in writing in particular cases, counsel for HOLDINGS shall not have
authority to act as counsel for JHU in connection with patent matters, and JHU
shall be free to appoint its own counsel at its own expense. HOLDINGS will use
commercially reasonable efforts to: (i) diligently prepare, file, prosecute and
maintain patents and patent applications specified under the JHU
NEUROIMMUNOPHILIN PATENT RIGHTS; (ii) seek the allowance of broad generic
claims, consistent with HOLDINGS' good faith determinations of enforceability,
business considerations and other factors; (iii) provide JHU and its patent
counsel with copies of patent applications and other substantive patent
prosecution documents pertaining to the JHU NEUROIMMUNOPHILIN PATENT RIGHTS
prior to filing in the United States or foreign patent offices so as to afford
JHU a reasonable opportunity to review and comment; (iv) consider JHU's input
in the formulation and execution of HOLDINGS' strategy with respect to filings
constituting the JHU NEUROIMMUNOPHILIN PATENT RIGHTS; provided however, that
HOLDINGS shall have the right to make the final determination in all matters
relating to the JHU NEUROIMMUNOPHILIN PATENT RIGHTS. Title to all patents and
patent applications constituting JHU NEUROIMMUNOPHILIN PATENT RIGHTS which are
solely owned by JHU shall reside in JHU, and, in the case of patents and patent
applications constituting JHU
-12-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
13
NEUROIMMUNOPHILIN PATENT RIGHTS which are jointly owned by JHU and the COMPANY,
title shall reside jointly in JHU and HOLDINGS. HOLDINGS will use commercially
reasonable efforts to provide timely notice of actions or omissions which to
its knowledge would result in JHU NEUROIMMUNOPHILIN PATENT RIGHTS being
irrevocably lost, so that JHU may if it so desires take appropriate action to
preserve the JHU NEUROIMMUNOPHILIN PATENT RIGHTS. In any TERRITORY where
HOLDINGS elects not to have a patent application filed or to pay expenses
associated with filing, prosecuting, or maintaining a patent application or
patent encompassed by the NEUROIMUNOPHILIN PATENT RIGHTS, JHU may file,
prosecute, and/or maintain a patent application or patent at its own expense.
In the event JHU files, prosecutes, and/or maintains a patent application or
patent at its own expense pursuant to this Paragraph 5.1(b), the COMPANY shall
not thereafter be licensed hereunder with respect to JHU's interest in such
patent or patent application in such jurisdiction. Attached as Schedule 5.1
hereto is a current list of jurisdictions in which the COMPANY is pursuing
patent rights with respect to JHU Matter No. DM-9986. Except as JHU may
specifically give written notice to the COMPANY, JHU does not expect to pursue
patent rights in jurisdictions not pursued by the COMPANY, except in North
America, Europe, Australia, or Japan.
5.2 The COMPANY agrees to use commercially reasonable efforts
to xxxx all packaging containing individual LICENSED PRODUCT(S) sold by the
COMPANY, AFFILIATED COMPANIES and SUBLICENSEES of COMPANY with the number of
the applicable patent(s) licensed hereunder in accordance with each TERRITORY's
patent laws.
5.3 From time to time in the course of performing under this
Agreement or developing a ROYALTY PRODUCT or ROYALTY SERVICE, each of JHU, on
the one hand, and the COMPANY, on the other, may disclose confidential
information to the other. The recipient of such information agrees to employ
all reasonable efforts to maintain any such information as secret and
confidential, such efforts to be no less than the degree of care employed by
the recipient to preserve and safeguard its own confidential information. Such
confidential information shall not be disclosed or revealed to anyone except
inventors or employees who have entered into a secrecy agreement with the
recipient under which such inventors or employees are required to maintain
confidential the proprietary information of the recipient (including
confidential information received by the recipient) and such inventors or
employees shall be advised by the recipient of the confidential nature
-13-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
14
of the information and that the information shall be treated accordingly. The
recipient's obligations under this Paragraph 5.3 shall not extend to any
information:
a. that can be demonstrated to have been in the public
domain or publicly known and readily available to the trade or the public prior
to the date of the disclosure;
b. that can be demonstrated, from written records, to have
been in the recipient's possession or available to the recipient from another
source not under obligation of secrecy to the disclosing party prior to the
disclosure;
c. that becomes part of the public domain or publicly known
by publication or otherwise, not due to any unauthorized act by the recipient;
d. that is received by the recipient in good faith from a
third party who is not, directly or indirectly, under an obligation of
confidentiality to the disclosing party with respect to same; or
e. that can be demonstrated is independently discovered or
developed by the recipient without reference to any information or material
disclosed hereunder.
The COMPANY shall have the right to disclose confidential
information received from JHU hereunder to AFFILIATED COMPANIES, SUBLICENSEES
and/or professional advisors, provided that such persons or entities are
subject to substantially similar obligations of confidentiality as are
contained in this Paragraph 5.3. Upon any termination of this Agreement, all
copies of any confidential information in the recipient's possession shall
promptly be returned to the disclosing party or destroyed; provided, however,
that a recipient may retain one copy of such information in the office of its
legal counsel for archival purposes. The obligations set forth in this
Paragraph 5.3 shall apply during the term of this Agreement and shall extend
for a period of five (5) years from the date this Agreement is terminated.
ARTICLE 6 - TERM, MILESTONES AND TERMINATION
6.1. This Agreement shall expire in each TERRITORY on the date
the last patent directed to JHU NEUROIMMUNOPHILIN PATENT RIGHTS expires in that
TERRITORY, or twenty (20) years from the EFFECTIVE DATE of this Agreement,
whichever is later; provided, however, that in no event shall royalty payments
due under this Agreement extend beyond the time period permitted by local law.
-14-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
15
6.2 The COMPANY (either directly or through AFFILIATED
COMPANIES or SUBLICENSEES) shall spend at least One Hundred Thousand dollars
($100,000) in each calendar year period (or a pro rata portion thereof for any
period less than a year) to research, develop or test the ROYALTY PRODUCT(S),
until such time as the COMPANY (either directly or through AFFILIATED COMPANIES
or SUBLICENSEES) has filed and received approval of the first NDA with the FDA
for a ROYALTY PRODUCT. Such required expenditures (in each case a "Minimum
Annual Expenditure") shall be inclusive of internal expenses, such as salaries
and overhead of COMPANY employees prorated for the percent of time worked on
developing ROYALTY PRODUCT(S) and external expenses, such as sponsored research
funding provided by the COMPANY to a third party to develop ROYALTY PRODUCT(S).
No later than March 31st of each calendar year during the term of this
Agreement, HOLDINGS shall provide JHU with a certificate signed by an officer
of the COMPANY certifying as to whether the COMPANY has spent in the preceding
calendar year at least the Minimum Annual Expenditure for such year. If
requested by JHU, the COMPANY shall also provide JHU a written accounting of
the expenditures. In the event the COMPANY (either directly or through
AFFILIATED COMPANIES or SUBLICENSEES) fails to spend the full amount of the
Minimum Annual Expenditure in a given year, the COMPANY (either directly or
through AFFILIATED COMPANIES or SUBLICENSEES) shall be obligated to spend in
the research, development or testing of the ROYALTY PRODUCT(S) in the
succeeding year period both the amount of such shortfall and the Minimum Annual
Expenditure for such succeeding year. If at the conclusion of such succeeding
year the COMPANY (either directly or through AFFILIATED COMPANIES or
SUBLICENSEES) has failed to meet the foregoing expenditure obligation, JHU
shall have the option of terminating this Agreement upon sixty (60) days prior
written notice to the COMPANY. However, if the actual expenditure in any given
year is less than seventy five percent (75%) of the required Minimum Annual
Expenditure in that year, JHU shall have the option of terminating this
Agreement upon sixty (60) days prior written notice to COMPANY.
6.3 The COMPANY must meet the following milestones relative
to a ROYALTY PRODUCT:
-15-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
16
MILESTONE ANNIVERSARY FROM
JUNE 26, 1997
Candidate ROYALTY PRODUCT identified Fourth year
IND filed for first candidate ROYALTY PRODUCT Seventh year
NDA filed for first ROYALTY PRODUCT Twelfth year
Initial Commercial Sale of FDA approved first Six (6) months following
ROYALTY PRODUCT as part of a nationwide approval of NDA
sales effort
Failure to meet any milestone set forth above shall be
grounds for termination of this Agreement by JHU upon sixty (60) days prior
written notice to the COMPANY; provided, however, that failure to meet the
milestone above shall not be grounds for termination if the delay results from
additional time needed for clinical trials or for the FDA to review the
COMPANY's NDA, so long as the COMPANY exercises commercially reasonable efforts
to meet the milestones as promptly as practicable.
6.4 After FDA commercial approval has been granted, the
COMPANY (either directly or through AFFILIATED COMPANIES or SUBLICENSEES) shall
exercise commercially reasonable efforts to market a ROYALTY PRODUCT(S) in the
U.S. and worldwide, conditioned upon obtaining regulatory approval in the
relevant foreign nation or region. The COMPANY shall also exercise commercially
reasonable efforts to develop other ROYALTY PRODUCT(S) suitable for different
indications, so that the JHU NEUROIMMUNOPHILIN PATENT RIGHTS can be
commercialized as broadly and as speedily as good scientific and business
judgment dictate, such determination to be made in good faith by the COMPANY.
6.5 Upon any material breach or default of any of the terms
and conditions of this Agreement, the defaulting party shall be given written
notice of such default in writing and a period of sixty (60) days after receipt
of such notice to correct the default or breach. If the default or breach is
not corrected within said sixty (60) day period, the party not in default shall
have the right to terminate this Agreement. Notwithstanding the foregoing,
wherever an uncured default or right to terminate arises under this Agreement
which relates solely to obligations relating to one or more but not all of the
JHU NEUROIMMUNOPHILIN PATENT RIGHTS covered by this Agreement, any such
termination may, at the election of the party whose rights are being terminated
pursuant thereto, be limited to a termination of the license relating to such
one or more but not all of the JHU
-16-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
17
NEUROIMMUNOPHILIN PATENT RIGHTS covered by this Agreement. By way of example
and without limitation, (i) if HOLDINGS fails to timely deliver a required
report on the progress of research with respect to a single NEUROIMMUNOPHILIN
PATENT RIGHT, but timely delivers required reports with respect to other JHU
NEUROIMMUNOPHILIN PATENT RIGHTS, and JHU elects to seek termination of the
Agreement pursuant to the terms of this ARTICLE 6, the COMPANY may elect to
limit such termination solely to termination of the license under this
Agreement with respect to that single NEUROIMMUNOPHILIN PATENT RIGHT, so long
as HOLDINGS continues to be in compliance with other terms of this Agreement;
and (ii) if JHU elects to seek termination of the Agreement pursuant to this
ARTICLE 6 because of the COMPANY's failure to timely make the Minimum Annual
Expenditure, the COMPANY may not elect to limit such termination to the license
for any one or more of the JHU NEUROIMMUNOPHILIN PATENT RIGHTS under this
Agreement, because the COMPANY's breached obligation does not relate solely to
a specific single NEUROIMMUNOPHILIN PATENT RIGHT.
6.6 Termination shall not affect JHU's right to recover
unpaid royalties or fees accrued prior to termination.
6.7 Termination shall not affect JHU's and the COMPANY's
respective joint ownership interest in the 1996 NIL PATENT RIGHTS, and each
party may following any termination exercise its respective 1996 NIL PATENT
RIGHTS as a joint owner thereof.
ARTICLE 7 - MISCELLANEOUS
7.1 All notices pertaining to this Agreement shall be in
writing and sent by: (i) certified mail, postage prepaid and return receipt
requested, (ii) recognized national express courier service such as Federal
Express, DHL or UPS, (iii) hand delivery, or (iv) facsimile (against receipt of
answer-back confirming delivery), to the parties at the following addresses or
such other address as such party shall have furnished in writing to the other
party in accordance with this Paragraph 7.1:
FOR JHU: Office of Technology Licensing
The Xxxxx Xxxxxxx University School of Medicine
0000 X. Xxxxxxxx Xxxxxx
Xxxxx 0-000
Xxxxxxxxx, XX 00000
Attention: Director
Fax: 410/000-0000
-17-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
18
FOR GPI: Guilford Pharmaceuticals Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: General Counsel
Fax: 410/000-0000
FOR HOLDINGS: GPI NIL Holdings, Inc.
000 Xxxxxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
Attention: Secretary
Fax: 302/000-0000
In the case of notices given by facsimile transmission, a
confirmation copy shall also be sent by first class mail but such notice shall
be deemed given upon receipt of the facsimile transmission.
7.2 All written progress reports, royalty and other payments,
and any other related correspondence shall be in writing and sent to:
Office of Technology Licensing
The Xxxxx Xxxxxxx University School of Medicine
0000 X. Xxxxxxxx Xxxxxx
Xxxxx 0-000
Xxxxxxxxx, XX 00000
Attention: Director
or such other addressee which JHU may designate in
writing form time to time. Checks are to be made payable to "The Xxxxx Xxxxxxx
University."
7.3 This Agreement is binding upon and shall inure to the
benefit of the parties hereto and their respective successors and assignees and
shall not be assignable to another party without mutual written consent, such
consent not to be unreasonably withheld, except that the COMPANY shall have the
right to assign this Agreement without the consent of JHU to a third party in
the case of the sale or transfer by the COMPANY of all, or substantially all,
of its assets relating to its neuroimmunophilin program to such third party.
Any assignment not in accordance with this Paragraph 7.3 shall be void, and no
assignment of this Agreement by any party hereto shall be effective unless and
until the assignee delivers to the other party hereto a binding written
agreement to assume all duties and obligations of the assignor.
-18-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
19
7.4 In the event that any one or more of the provisions of
this Agreement should for any reason be held by any court or authority having
jurisdiction over this Agreement, or over any of the parties hereto, to be
invalid, illegal or unenforceable, such provision or provisions shall be
reformed to approximate as nearly as possible the intent of the parties, and if
unreformable, shall be divisible and deleted in such jurisdictions. The
invalidity or unenforceability of any provisions hereof shall in no way affect
the validity or enforceability of any other provision.
7.5 The construction, performance, and execution of this
Agreement shall be governed by the laws of the State of Maryland (without
giving effect to conflict of law provisions that might otherwise look to the
substantive law of a jurisdiction other than the State of Maryland). Each of
the parties hereto irrevocably consents that any legal action or proceeding
against it or any of its property related to or arising out of this Agreement
or any other agreement executed in connection herewith may be brought in any
court of the State of Maryland or any Federal Court of the United States of
America in the State of Maryland, and by the execution and delivery of this
Agreement each party hereto hereby accepts with regard to any such action or
proceeding, generally and unconditionally, the jurisdiction and venue of the
aforesaid courts.
7.6 The COMPANY shall not use the name of THE XXXXX XXXXXXX
UNIVERSITY, THE XXXXX XXXXXXX HEALTH SYSTEM or the NATIONAL INSTITUTES OF
HEALTH or any of their constituent parts, such as the Xxxxx Xxxxxxx Hospital or
any contraction thereof (a "XXXXXXX ENTITY") in any advertising, promotional,
sales literature or fund-raising documents without prior written consent of the
appropriate officer of JHU, such consent not to be unreasonably withheld. The
foregoing notwithstanding, the COMPANY will not be required to obtain the
aforementioned consent of JHU: (a) if such disclosure is required by applicable
law, rule or regulation; (b) to the extent the COMPANY simply states that it
and JHU are joint owners of the applicable JHU NEUROIMMUNOPHILIN PATENT RIGHTS
and that the COMPANY is the exclusive licensee from JHU under one or more
patents and/or applications comprising the JHU NEUROIMMUNOPHILIN PATENT RIGHTS;
or (c) where the affiliation of a JHU inventor is disclosed solely for
identification purposes, provided, however, that the COMPANY shall provide JHU,
reasonably contemporaneously, representative samples of any such uses or
disclosures for advertising, promotional, sales literature, or fundraising
purposes.
7.7 Subject to Schedule 7.7, JHU warrants, as of the
EFFECTIVE DATE, that: (i) it has good and marketable title to its interest in
the inventions claimed under the JHU NEUROIMMUNOPHILIN PATENT RIGHTS with the
-19-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
20
exception of the retained rights, if any, of the United States Government and
HOLDINGS' joint ownership right therein; (ii) it has the full right and
authority to enter into this Agreement and to grant the rights and licenses
granted herein; and (iii) there are no pending or, to JHU's knowledge,
threatened actions, suits or claims against JHU or others with respect to the
JHU NEUROIMMUNOPHILIN PATENT RIGHTS. JHU does not warrant the validity of any
patents or that practice under such patents shall be free of infringement.
EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 7.7, THE COMPANY, AFFILIATED
COMPANIES AND SUBLICENSEES AGREE OR WILL AGREE, AS APPROPRIATE THAT THE JHU
NEUROIMMUNOPHILIN PATENT RIGHTS ARE PROVIDED "AS IS", AND THAT JHU MAKES NO
REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF THE LICENSED
PRODUCT(S) AND LICENSED SERVICE(S) INCLUDING THEIR SAFETY, EFFECTIVENESS, OR
COMMERCIAL VIABILITY. JHU DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCT(S)
AND SERVICES LICENSED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL
WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY
PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISIONS OF THIS AGREEMENT, JHU
ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF JHU, OR
THE JHU INVENTORS, FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT,
INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS' AND EXPERTS' FEES, AND
COURT COSTS (EVEN IF JHU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES,
FEES, OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE OR
SALE OF THE PRODUCT(S) AND SERVICES LICENSED UNDER THIS AGREEMENT. THE COMPANY,
AFFILIATED COMPANIES AND SUBLICENSEES ASSUME, OR WILL ASSUME, AS APPROPRIATE
ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT AND
SERVICE MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEES AND AFFILIATED
COMPANIES WHICH IS A LICENSED PRODUCT OR LICENSED SERVICE AS DEFINED IN THIS
AGREEMENT.
7.8 JHU and the JHU inventors of the LICENSED PRODUCT(S) and
LICENSED SERVICE(S) will not, under the provision of this Agreement or
otherwise, have control over the manner in which the COMPANY, its AFFILIATE
COMPANIES, its SUBLICENSEES, those operating for its account or third parties
who purchase LICENSED PRODUCT(S) or LICENSED SERVICE(S) from any of the
foregoing entities, practice the invention of LICENSED PRODUCTS) or LICENSED
SERVICE(S). The COMPANY shall defend and hold JHU, The Xxxxx Xxxxxxx Health
Systems, their present and former regents, trustees, officers, JHU
-20-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
21
inventors, agents, faculty, employees and students harmless as against any
judgments, fees, expenses, or other costs arising from or incidental to any
product liability or other lawsuit, claim, demand or other action brought as a
consequence of the practice of said inventions by any of the foregoing
entities, whether or not JHU, or the inventors, either jointly or severally, is
named as a party defendant in any such lawsuit; provided that the COMPANY shall
have sole control of the defense and settlement of any such lawsuit. Practice
of the inventions covered by LICENSED PRODUCT(S) or LICENSED SERVICE(S) by an
AFFILIATED COMPANY, an agent or a SUBLICENSEE, a third party on behalf of or
for the account of the COMPANY or by a third party who purchases LICENSED
PRODUCT(S) or LICENSED SERVICE(S) from the COMPANY, shall be considered the
COMPANY's practice of said inventions for purposes of this Paragraph 7.8. The
obligation of the COMPANY to defend and indemnify as set out in this Paragraph
7.8 shall survive any termination of this Agreement.
7.9 Prior to initial human testing or first commercial sale
of any LICENSED PRODUCT(S) or LICENSED SERVICE(S) as the case may be in any
particular TERRITORY, HOLDINGS shall cause to be established and maintained, in
each TERRITORY in which COMPANY, an AFFILIATE COMPANY or SUBLICENSEES shall
test or sell LICENSED PRODUCT(S) or LICENSED SERVICES(S), product liability or
other appropriate insurance coverage appropriate to the risks involved in so
testing or selling LICENSED PRODUCT(S) or LICENSED SERVICE(S) and will, upon
the request of JHU but no more than once annually, present evidence to JHU that
such coverage is being maintained. Upon JHU's request, HOLDINGS will cause to
be furnished to JHU a Certificate of Insurance of each product liability
insurance policy obtained and agree to increase or change the kind of insurance
pertaining to the LICENSED PRODUCT(S) or LICENSED SERVICE(S) at the reasonable
request of JHU. JHU shall be listed as name insured in COMPANY's said insurance
policies.
7.10 JHU may publish manuscripts, abstracts or the like
describing the JHU NEUROIMMUNOPHILIN PATENT RIGHTS and inventions contained
therein provided confidential information of the COMPANY, as defined in
Paragraph 5.3, is not included, or is not published without first obtaining
prior written approval from the COMPANY to include such confidential
information. Otherwise, JHU, and the JHU inventors shall be free to publish
manuscripts and abstracts or the like directed to the work done at JHU related
to LICENSED PRODUCT(S) or LICENSED SERVICE(S) without prior approval, provided,
however, that the JHU inventors will provide copies of such manuscripts and
abstracts to the COMPANY at least sixty (60) days prior to publication. If the
COMPANY has not been given an opportunity to review such materials for the full
-21-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
22
sixty (60) day period, JHU will upon the COMPANY's request delay publication of
such materials in order to offer the COMPANY the full benefit of such sixty
(60) day review period. During this period, the parties will confer in good
faith and cooperate with each other with respect to any patent applications
which may be filed in order to protect the intellectual property rights of JHU
or the COMPANY prior to publication.
7.11 This Agreement (including the Schedules hereto, which are
incorporated by reference and made part hereof) constitutes the entire
understanding between the parties with respect to the obligations of the
parties with respect to the subject matter hereof, and amends, restates and
supersedes all prior agreements, understandings, writings, and discussions
between the parties relating to said subject matter, including, but not limited
to, the 1996 AGREEMENT and, to the extent relating to the 1997 NIL PATENT
RIGHTS, the 1997 AGREEMENT.
7.12 This Agreement may be amended and any of its terms or
conditions may be waived only by a written instrument executed by the
authorized officials of the parties or, in the case of a waiver, by the party
waiving compliance. The failure of either party at any time or times to require
performance of any provision hereof shall in no manner affect its right at a
later time to enforce the same. No waiver by either party of any condition or
term in any one or more instance shall be construed as a further or continuing
waiver of such conditions or term or of any other condition or term.
7.13 This Agreement shall be binding upon and inure to the
benefit of and been enforceable by the parties hereto and their respective
successors and permitted assigns.
7.14 Upon termination of this Agreement for any reason,
Paragraphs 5.3, 6.6, 6.7, 7.6, 7.7, 7.8 and 7.9 shall survive termination of
this Agreement.
7.15 JHU covenants that it will caused a true and complete
copy of the prosecution history and all patent filings constituting the JHU
NEUROIMMUNOPHILIN PATENT RIGHTS through the EFFECTIVE DATE to be delivered to
HOLDINGS's outside patent counsel on or prior to the date that is five (5)
business days following the EFFECTIVE DATE, and JHU further covenants to cause
to be delivered to the COMPANY, simultaneously with the execution and delivery
of this Agreement, a document in form and substance reasonably acceptable to
the COMPANY signed by JHU and/or its patent counsel transferring lead
responsibility for prosecution of the JHU NEUROIMMUNOPHILIN PATENT RIGHTS to
HOLDINGS' outside patent pursuant to Section 5.1 of this Agreement
-22-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
23
from and after the EFFECTIVE DATE. JHU further agrees to keep he COMPANY fully
informed, and to consult with the COMPANY on a regular basis, with respect to
any action, suit and/or claim by any third party with respect to the JHU
NEUROIMMUNOPHILIN PATENT RIGHTS and the licenses granted hereunder to the
COMPANY. JHU shall promptly inform the COMPANY in writing in the event JHU
shall receive a written notice of any such action, suit and/or claim from a
third party.
7.16 The COMPANY covenants that, in the event (1) the COMPANY
and Amgen hereafter agree to any modification of the Amgen Agreement having the
effect of reducing the amount of any milestone payments to be made by Amgen in
consideration (at least in part) of an increase in any royalty payments to be
made by Amgen, and (2) JHU does not consent in writing to such modification,
the COMPANY shall continue to make payments to JHU pursuant to Paragraph 4.2(a)
above as if such milestone provisions had not been modified and Amgen had made
the specified payments to HOLDINGS in accordance with their original terms.
-23-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
24
IN WITNESS WHEREOF, the respective parties hereto have executed
this Agreement by their duly authorized officers on the date appearing below
their signatures.
THE XXXXX XXXXXXX UNIVERSITY GUILFORD
PHARMACEUTICALS INC.
By: By:
------------------------- -------------------------
Name: Xxxxx X. Xxxxx, M.D.
----------------------- President and Chief Executive
Title: Officer
----------------------
Date: , 1998 Date: , 1998
------------------ -------------------
GPI NIL HOLDINGS, INC.
By:
-------------------------
Xxxxxx X. XxXxxxxx
Vice President and Secretary
Date: , 1998
-------------------
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
25
SCHEDULE 4.9
LIST OF PAYMENTS FROM AMGEN UNDER AMGEN AGREEMENT
As of the EFFECTIVE DATE, the following describes all amounts paid by
Amgen to the COMPANY pursuant to the Amgen Agreement:
1) $15 million Signing Fee in August 1997.
2) $15 million for the purchase of 640,095 shares of GPI common stock in
October 1997.
3) $5 million for purchase of warrants to purchase up to 700,000 shares of
GPI common stock in October 1997.
4) $4.5 million in Research Program Funding through the period ending
September 30, 1998.
5) $1 million as a milestone payment related to the initiation of Lead
Selection in September 1998.
6) Reimbursement of miscellaneous COMPANY expenses, including certain
foreign patent counsel costs, and payment for the purchase of certain
laboratory animals, and for reimbursement of third-party vendor costs
incurred by the COMPANY.
For the purpose of illustration only, the parties acknowledge that,
were the payments set forth above in items 1) through 6) above made after,
rather than prior to, the EFFECTIVE DATE, the proceeds received by the COMPANY
from Amgen above would have given rise to payment obligations to JHU under this
Agreement as follows:
a. The $15 million Signing Fee would have constituted PARTNERSHIP PROCEEDS
under Section 4.2(a) of the Agreement;
b. No amounts would have been due and owing to JHU with respect to the $15
million payment for GPI common stock or the $5 million payment for
warrants because of Section 1.13(i);
c. No amounts would have been due and owing to JHU with respect to the $4.5
million in Research Program Funding because of Section 1.13(ii);
d. The $1 million milestone amount would have constituted PARTNERSHIP
PROCEEDS under Section 4.2(a); and
-25-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
26
e. No amounts would have been due and owing to JHU with respect to the
amounts reimbursed to the Company as described in item 6) above because
of Section 1.13(iii).
-26-
*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
27
SCHEDULE 5.1
*
[1 page omitted]
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
28
SCHEDULE 7.7
*
[2 pages omitted]
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*The asterisk denotes that confidential portions of this exhibit have been
omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The
confidential portions have been submitted separately to the Securities and
Exchange Commission.
