RESEARCH AND LICENSE AGREEMENT
This Agreement dated 23rd day of December, 1994 is between The Xxxxx
Xxxxxxx University, a corporation of the State of Maryland, having a principal
place of business at 000 Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000 (hereinafter
referred to as "JHU" and Gryphon Pharmaceuticals, Inc., a Delaware corporation
(hereinafter the "Company") having an initial address at 0000 Xxxxxx Xxxxxx,
Xxxxx 000, Xxxxxxxxx, XX 00000.
WITNESSETH:
WHEREAS, as a center for research and education, JHU is interested in
licensing PATENT RIGHTS (hereinafter defined) in a manner that will benefit
the public by facilitating the distribution of useful products and the
utilization of new methods, but is without capacity to commercially develop,
manufacture and distribute any such products or methods; and
WHEREAS, Company desires to commercially develop, manufacture, use and
distribute such products and processes covered by PATENT RIGHTS throughout the
world;
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
purposes of this Paragraph 1.1, control shall mean the direct or indirect
ownership of at least fifty percent (50 %). In addition, for purposes of this
Agreement, Company and Osiris Therapeutics, Inc. ("OSIRIS") are not AFFILIATED
COMPANIES.
1.2 The term "AGREEMENT YEAR" shall mean the twelve month period
beginning on the EFFECTIVE DATE, and each subsequent twelve (12) month period
thereafter.
1.3 The term "BACKGROUND MATERIALS" shall mean the following biological
materials currently existing in the JHU laboratories of PRINCIPAL
INVESTIGATORS: (i) CD34+ cell fractions and (ii) cDNA and other libraries
derived from CD34+ mRNA.
1.4 The term "PATENT RIGHT(s)" shall mean (i) any patent application or
patent or equivalent thereof, anywhere in the world including, but not limited
to any division, continuation, or continuation-in-part re-examination, reissue
or extension issuing thereon, which is owned by JHU and it contains one or
more claims to any RESEARCH TECHNOLOGY and/or BACKGROUND MATERIALS, and (ii)
the patents and patent applications tabulated in Exhibit B.
1.5 "EFFECTIVE DATE" of this License Agreement shall mean the date the
last party hereto has executed this Agreement.
1.6 "EXCLUSIVE LICENSE" shall mean a grant by JHU to Company of its
entire right and interest in the PATENT RIGHTS, subject to rights retained by
the United States government in accordance with P.L. 96-517, as amended by P.L.
98-620, and subject to the retained right of JHU to make, have made, provide
and use LICENSED PRODUCT(S) and LICENSED SERVICES, for its and The Xxxxx
Xxxxxxx Health Systems' non-profit, noncommercial research purposes or with
LICENSED PRODUCT obtained from LICENSEE for the treatment or diagnosis of
patients by JHU or the Xxxxx Xxxxxxx Health System and in such case Company
will exert reasonable efforts to make such LICENSED PRODUCT available to
JHU or in the alternative JHU may produce same if not available from the
Company.
1.7 The term "FIELD OF RESEARCH" shall mean the isolation,
purification and identification of novel hematopoietic and/or mesenchymal
stem/progenitor cell populations, their genes and gene products and other
materials, reagents and biologics (such as, for example, growth factor
receptors, protein kinases and other signal transduction molecules) involved
in the self renewal, proliferation, inhibition or differentiation of
hematopoietic and/or mesenchymal stem/progenitor cells.
1.8 "FOUNDING SCIENTISTS" shall mean, collectively, Drs. Xxxx x. Xxxxx
and Xxxxxx Xxxxx.
1.9 The term "INVESTIGATOR" shall mean PRINCIPAL INVESTIGATORS, JHU
faculty members, graduate students, undergraduate students, fellows or
employees of JHU who shall work under the direction of PRINCIPAL INVESTIGATORS
on the research funded in whole or part by the Company pursuant to this
Agreement.
1.10 The term "LICENSED PRODUCT" shall mean any article, composition,
apparatus, substance, chemical, material, method, process or service the
manufacture, import, sale or use of which is covered by PATENT RIGHTS.
1.11 "LICENSED SERVICE(S)" means the performance on behalf of a third
party of any method or the use of any product or composition, the manufacture,
use or sale of which is covered by PATENT RIGHTS.
1.12 The term "LICENSED TERRITORY" shall mean all countries of the
world.
1.13 "NET SALES" subject to Paragraph 4.9 shall mean gross sales
revenues received by the Company or an AFFILIATED COMPANY from the sale of
LICENSED PRODUCT(S) less trade discounts allowed, refunds, returns and recalls,
rebates, transportation and transportation-related insurance costs, itemized
on a xxxx or invoice, and sales taxes.
In the event that Company, AFFILIATED COMPANY or SUBLICENSEE sells a
LICENSED PRODUCT in combination with other ingredients or components which are
not LICENSED PRODUCT(S) (such other ingredients or components being "Other
Items"), then the NET SALES for purposes of royalty payments on the
combination shall be calculated as follows:
(a) If all LICENSED PRODUCT(S) and Other Items contained in the
combination are available separately, the NET SALES for purposes of royalty
payments will be calculated by multiplying the NET SALES of the combination by
the fraction M(A+B), where A is the separately available price of all LICENSED
PRODUCT(S) in the combination, and B is the separately available price for all
Other Items in the combination.
(b) If the combination includes Other Items which are not sold
separately (but all LICENSED PRODUCT(S) contained in the combination are
available separately), the NET SALES of the combination multiplied by the
fraction A/C, where A is as defined above and C is the invoiced price of the
combination.
(c) If the LICENSED PRODUCTS contained in the combination are
not sold separately, the NET SALES for such combination shall be NET SALES
multiplied by D/C where C is as defined above and D is the fair market value of
LICENSED PRODUCTS in the combination. The fair market value will be determined
by negotiation between the
parties; should the parties fail to reach an agreement, the issue will be
brought to binding arbitration in accordance with the rules of the American
Arbitration Association, as set forth in Paragraph 7.5.
The term "Other Items" does not include solvents, diluents, carriers,
excipients, or the like used in formulating a product.
1.14 "NET SERVICE REVENUES" shall mean actual revenues received for
the performance of LICENSED SERVICE less sales and/or use taxes imposed upon
and with specific reference to the LICENSED SERVICE, trade discounts allowed,
refunds and rebates.
If a LICENSED SERVICE is offered in combination with another service or
services, NET SERVICE REVENUES for purposes of determining royalties on the
LICENSED SERVICE shall be calculated by multiplying the NET SERVICE REVENUES
[as defined above, but applied to the combination services], by the fraction
A/(A+B), where A is the invoice price of the LICENSED SERVICE and B is the
invoice price of the other service or services in the combination if sold
separately.
1.15 The term "PRINCIPAL INVESTIGATOR(S)" shall mean Xx. Xxxx Xxxxx and
Dr. Xxxxxx Xxxxx.
1.16 The term "RESEARCH TECHNOLOGY" shall mean any data, formulas,
process information or other information, material, substance, invention or
discovery, whether or not patentable, conceived or first actually or
constructively reduced to practice during the period when research is being
supported under this Agreement solely or jointly by at least one INVESTIGATOR
while acting as an INVESTIGATOR and in his capacity as a JHU faculty member,
graduate student, undergraduate student, fellow or employee of JHU, which is in
the FIELD OF RESEARCH or which is the direct result of research funded in whole
or in part by the Company pursuant to Paragraph 5.1 of this Agreement.
1.17 The term "SUBLICENSEE" shall mean any non-AFFILIATED COMPANY
licensed by Company to make, have made, import, use or sell any LICENSED
PRODUCT.
1.18 "VALID CLAIM" shall mean a claim of an issued patent which has not
lapsed or become abandoned or been declared invalid or unenforceable by a
court of competent jurisdiction or an administrative agency from which no
appeal can be or is taken.
ARTICLE 2- GRANTS
2.1 Subject to the terms and conditions of this Agreement JHU hereby
grants to the Company an EXCLUSIVE LICENSE under the PATENT RIGHTS and a non-
exclusive license under RESEARCH TECHNOLOGY and BACKGROUND MATERIAL to make,
have made, use and sell the LICENSED PRODUCT(S) and to provide the LICENSED
SERVICE(S) in the LICENSED TERRITORY.
2.2 Company 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 non-financial terms of
this Agreement.
2.3 Company shall have the right to extend its license rights granted
under Paragraph 2.1 to its AFFILIATED COMPANIES; however, such AFFILIATED
COMPANIES must agree in writing to be bound by the terms of this Agreement with
a copy of such agreement promptly sent to JHU after it is executed.
ARTICLE 3- PATENT INFRINGEMENT
3.1 Each party will notify the other promptly in writing when any
infringement of the PATENT RIGHTS by another is uncovered or suspected.
3.2 Company shall have the first right to enforce any patent within
PATENT RIGHTS against any infringement or alleged infringement thereof, and
shall at all times keep JHU informed as to the status thereof. Company may, in
its sole judgment and at its own expense, institute suit against any such
infringer or alleged infringer and control, settle, and defend such suit in a
manner consistent with the terms and provisions hereof and recover, for its
account, any damages, awards or settlements resulting therefrom, subject to
Paragraph 3.4. This right to xxx for infringement shall not be used in an
arbitrary or capricious manner. JHU shall reasonably cooperate in any such
litigation at Company's expense.
3.3 If Company elects not to enforce any patent within the PATENT
RIGHTS, then it shall so notify JHU in writing within six (6) months of
receiving notice that an infringement exists, and JHU may, in its sole judgment
and at its own expense, take steps to enforce any patent and control, settle,
and defend such suit in a manner consistent with the terms
and provisions hereof, and recover, for its own account, any damages, awards
or settlements resulting therefrom.
3.4 Any recovery by Company under Paragraph 3.2 shall be deemed to
reflect loss of commercial sales, and Company after reimbursing JHU out of the
recovery for amounts credited pursuant to the next sentence shall pay to JHU
fifteen percent (15 %) of the recovery net of all reasonable costs and
expenses associated with each suit or settlement. One-half (1/2) of the costs
and expenses incurred by the Company pursuant to Paragraph 3.2 shall be
credited against royalties payable by Company to JHU hereunder in connection
with sales in the country of such legal proceedings, provided, however, that
any such credit under this Paragraph 3.4 shall not exceed fifty percent (50 %)
of the royalties otherwise payable to JHU with regard to sales in the country
of such action in any one calendar year, with any excess credit being carried
forward to future calendar years.
3.5 In the event that litigation against Company is initiated by a
third party charging Company with infringement of a patent of the third party
in a country as a result of the manufacture, use or sale by Company of a
LICENSED PRODUCT or LICENSED SERVICE in that country Company shall promptly
notify JHU in writing thereof. Company's costs as to any such defense in that
country shall be creditable against any and all payments due and payable to
JHU under Paragraph 4.5 of this Agreement with respect to that LICENSED PRODUCT
and/or LICENSED SERVICE in that country. No royalty payment after taking into
consideration any such credit under this Paragraph 3.5 shall be reduced by
more than fifty percent (50%).
3.6 In the event of a judgment in any suit in which a court of
competent jurisdiction rules that the manufacture, use or sale by Company in
a country of a LICENSED PRODUCT or LICENSED SERVICE covered by a PATENT RIGHT,
in that country has infringed on a third party's patent requiring Company to
pay damages or a royalty to said third party in that country, or in the event
of a settlement of such suit requiring damages or back royalty payments to be
made, payments due to JHU under Paragraph 4.5 of this Agreement arising from
the applicable LICENSED PRODUCT or LICENSED SERVICE shall be correspondingly
reduced in that country by the amounts due under the requirement of such
judgment or under the terms of such settlement. The royalty payment after
taking into
consideration any such reduction under this Paragraph 3.6 shall not be
reduced by more than fifty percent (50%).
3.7 In any infringement suit against a third party, either party hereto
may institute to enforce the PATENT RIGHTS pursuant to this Agreement, the
other party hereto shall, at the request of the party initiating such suit,
cooperate in all respects and, to the extent possible, have its employees
testify when requested and make available relevant records, papers,
information, samples, specimens, and the like. All reasonable out-of-pocket
costs incurred in connection with rendering cooperation requested hereunder
shall be paid by the party requesting cooperation.
ARTICLE 4- PAYMENTS. ROYALTY. RESEARCH SUPPORT AND EQUITY
4.1 Company shall reimburse JHU for JHU's past and future costs
associated with preparing, filing, maintaining and prosecuting PATENT RIGHTS in
accordance with Article 6.
4.2 The Company shall reimburse JHU for its costs in outside legal fees
to review the corporate formation and shareholder documents; such reimbursement
shall not exceed [*CONFIDENTIALITY REQUESTED*].
4.3 The Company shall pay to JHU an up front processing fee of
[*CONFIDENTIALITY REQUESTED*]; of which [*CONFIDENTIALITY REQUESTED*] is
due within thirty (30) days from the EFFECTIVE DATE of this Agreement, and
[*CONFIDENTIALITY REQUESTED*] is due on May 30, 1995. For each new invention
in RESEARCH TECHNOLOGY for which an original (i.e., not continuational or
divisional) U.S. Patent application is filed, Company shall pay JHU an
additional [*CONFIDENTIALITY REQUESTED*] processing fee at the time of such
filing.
4.4 The Company shall pay to JHU a [*CONFIDENTIALITY REQUESTED*] annual
maintenance fee due within thirty (30) days of each anniversary of the
EFFECTIVE DATE of this Agreement.
4.5 The Company shall pay to JHU one of the following royalties which
shall be due and payable sixty (60) days after June 30 and December 31 for
LICENSED PRODUCTS sold or LICENSED SERVICES provided in the respective half-
year period:
a. [*CONFIDENTIALITY REQUESTED*] of NET SALES of LICENSED PRODUCTS or
NET SERVICE REVENUE of LICENSED SERVICES which are therapeutics,
and [*CONFIDENTIALITY REQUESTED*] of NET SALES of LICENSED PRODUCTS
or NET SERVICE REVENUE of LICENSED SERVICES in the case of
diagnostics, sold or provided by the Company or an AFFILIATED
COMPANY licensed under this Agreement which in the country where
made, sold or provided are covered by a VALID CLAIM included in
PATENT RIGHTS.
b. The higher of (i) [*CONFIDENTIALITY REQUESTED*] of royalties
received by the Company from a SUBLICENSEE other than Osiris
Therapeutics, Inc. or its affiliates hereunder for LICENSED PRODUCTS
sold or LICENSED SERVICES provided by such SUBLICENSEE which in the
country where made, sold or provided is covered by a VALID CLAIM
included in PATENT RIGHTS or (ii) an amount equal to
[*CONFIDENTIALITY REQUESTED*] of such SUBLICENSEE'S NET SALES from
LICENSED PRODUCTS sold or NET SERVICE REVENUE of LICENSED SERVICES
provided by such SUBLICENSEES and covered by a VALID CLAIM included
in PATENT RIGHTS. However, if Osiris Therapeutics, Inc. or its
affiliates are the SUBLICENSEE, Company shall pay [*CONFIDENTIALITY
REQUESTED*] of NET SALES of LICENSED PRODUCTS or NET SERVICE REVENUE
of LICENSED SERVICES sold or produced by Osiris Therapeutics, Inc.
which in the country where made, sold or provided is covered by a
VALID CLAIM included in PATENT RIGHTS.
4.6 In the event royalties are due hereunder with respect to a LICENSED
SERVICE solely because such service, involves the use of a LICENSED PRODUCT,
for the purposes of calculating royalties hereunder, NET SALES for the
LICENSED PRODUCT and/or NET SERVICE REVENUES for the LICENSED SERVICE shall be
based on the price of the LICENSED PRODUCT, respectively in arm's length
transactions. If no such transactions have taken place, such price shall be
determined by mutual agreement of the parties and if such agreement is not
reached within sixty (60) days, either party shall have the right to submit a
determination of price to binding arbitration according to the rules of the
American Arbitration Association as set forth in Paragraph 7.5.
4.7 The Company shall provide to JHU within sixty (60) days of the end
of each June 30 and December 31, after the EFFECTIVE DATE of this Agreement, a
written report to JHU of the amount of LICENSED PRODUCTS sold, and LICENSED
SERVICES sold, the total NET SALES and NET SERVICE REVENUES of such LICENSED
PRODUCTS and LICENSED SERVICES, and the running royalties due to JHU as a
result of NET SALES and NET SERVICE REVENUES by Company, AFFILIATED COMPANIES
and SUBLICENSEES. Payment of any such royalties due shall accompany such
report. So long as Company, an AFFILIATED COMPANY or a SUBLICENSEE is
developing a LICENSED PRODUCT under this Agreement, a report shall be
submitted at the end of every June 30 and December 31 after the EFFECTIVE
DATE of this Agreement and will include a full written report describing the
Company's, AFFILIATED COMPANIES or SUBLICENSEE'S technical efforts under
Article 7.
4.8 The Company shall make and retain, for a period of three (3) years
following the period of each royalty report required by Paragraph 4.7, 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 royalty related information required in Paragraph 4.7. 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. All costs
of such inspection and copying shall be paid by JHU, provided that if any
such inspection shall reveal that an underpayment error has been made in the
amount equal to ten percent (10%) or more of such payments in a calendar year,
such costs shall be borne by the Company. The Company shall include in any
agreement with its AFFILIATED COMPANIES or SUBLICENSEES which permits
such party to make, use or sell the LICENSED PRODUCT(S) or provide LICENSED
SERVICES, a provision requiring such party to retain records of sales of
LICENSED PRODUCT(S) and records of LICENSED
SERVICES and other information as required in Paragraph 4.7 and permit JHU to
inspect such records as required by this Paragraph 4.8.
4.9 In order to insure JHU the full royalty payments contemplated
hereunder, the Company agrees that in the event any LICENSED PRODUCT shall be
sold to an AFFILIATED COMPANY, then the royalty due hereunder shall be based on
the higher of (i) NET SALES of the LICENSED PRODUCT to the AFFILIATED COMPANY
or (ii) the NET SALES of the AFFILIATED COMPANY from the resale of such
LICENSED PRODUCT.
4.10 In order to insure JHU the full royalty payments contemplated
hereunder, the Company agrees that in the event any LICENSED PRODUCT or
LICENSED SERVICE shall be sold to other than an AFFILIATED COMPANY for partial
or full future compensation then such future compensation when received shall
be included in NET SALES for the purpose of paying royalties hereunder. In
addition, if Company sells LICENSED PRODUCT or LICENSED SERVICES to a person or
entity in whom Company has an ownership interest other than an AFFILIATED
COMPANY and JHU can demonstrate that such sale was other than an arms length
transaction, then NET SALES shall include any additional amount that would have
been paid in an arms length transaction.
4.11 All payments under this Agreement shall be made in U.S. Dollars.
4.12 To the extent royalty is owed to a third party for patents held by
that party covering the making, using or selling of a LICENSED PRODUCT or
LICENSED SERVICE in a particular country, the royalty due to JHU under
Paragraph 4.5 for such LICENSED PRODUCT or LICENSED SERVICE in such country
will be reduced by one-half (1/2) such royalty paid to such third party;
however, in no event shall such royalty due to JHU for such LICENSED PRODUCT or
LICENSED SERVICE be less that [*CONFIDENTIALITY REQUESTED*] of NET SALES or NET
SERVICE REVENUES.
4.13 Any tax required to be withheld by Company under the laws of any
foreign country for the account of JHU, shall be promptly paid by Company for
and on behalf of JHU to the appropriate governmental authority, and Company
shall use its best efforts to furnish JHU with proof of payment of such tax.
Any such tax actually paid on JHU's behalf shall be deducted dollar for dollar
from royalty payments due JHU.
4.14 Only one royalty shall be due and payable for the manufacture, use
and sale of a LICENSED PRODUCT or a LICENSED SERVICE irrespective of the number
of patents or claims thereof which cover {he manufacture, use or sale of such
LICENSED PRODUCT or LICENSED SERVICE.
4.15 The Company shall pay to JHU the following payments which are due
on the occurrence of each of the following milestones:
[*CONFIDENTIALITY REQUESTED*] upon completion of Phase II
or J/II FDA trial for each LICENSED PRODUCT
[*CONFIDENTIALITY REQUESTED*] upon issuance of NDA or PLA
for each LICENSED PRODUCT
ARTICLE 5 - SPONSORED BASIC RESEARCH
5.1 Company shall provide the following research support (full direct
and normal JHU indirect expenses) to JHU to support research in the JHU
laboratories of PRINCIPAL INVESTIGATORS pursuant to Paragraph 5.2; the
research support (full direct and normal JHU indirect expenses) for each
annual period shall be paid quarterly on July 1st, October 1st, January 1st,
April 1st:
Annual Support Period
[*CONFIDENTIALITY REQUESTED*] July 1, 1994 - June 30, 1995
[*CONFIDENTIALITY REQUESTED*] July 1, 1995 - June 30, 1996
[*CONFIDENTIALITY REQUESTED*] July 1, 1996 - June 30, 1997
[*CONFIDENTIALITY REQUESTED*] July 1, 1997 - June 30, 1998
[*CONFIDENTIALITY REQUESTED*] July 1, 1998 - June 30, 1999
Failure to make any of the above quarterly research payments will be a
material breach of this License Agreement.
The parties acknowledge that Company has already advanced
[*CONFIDENTIALITY REQUESTED*] towards the first years payment. Accordingly, it
is agreed that [*CONFIDENTIALITY REQUESTED*] will be paid by Company to JHU on
January 1, 1995 and [*CONFIDENTIALITY REQUESTED*] on April 1, 1995.
5.2 (a) Each quarterly amount provided under Paragraph 5.1 will be
equally ivided between PRINCIPAL INVESTIGATORS and used for basic research
activities in identifying natural or synthesized molecules involved in the
proliferation, commitment differentiation and regulation of hematopoietic stem/
progenitor cells and their progeny. JHU, based on the recommendation of the
Founding Scientists, will prepare a budget for the upcoming year and a
statement of work. The budget and work statement for the first year will be
completed within ninety (90) days after the effective date of this Agreement
and attached hereto as Exhibit D.
(b) If a PRINCIPAL INVESTIGATOR ceases to be employed by JHU, the
research specified above will be reduced one half (1/2) and applied to the
laboratory of the remaining PRINCIPAL INVESTIGATOR; however, if both PRINCIPAL
INVESTIGATOR(S) leave the employment of JHU, the research funding will be
reduced by one hundred percent (100%). The Company agrees to enter into a
written agreement substantially in the form of this Agreement with such
PRINCIPAL INVESTIGATOR'(S) new employing institution relative to continuing
the research funding and licensing of technology provided that such
institution is willing to enter into such agreement, PRINCIPAL INVESTIGATORS
are a third party beneficiary of Company's obligations under this Paragraph
5.2(b).
(c) Within sixty (60) days after the end of each AGREEMENT YEAR,
JHU shall provide Company with an accounting of the expenditure of research
funds for such year in accordance with JHU's standard procedures for such
accounting. Any funds granted hereunder which have not been expended by JHU
within the year shall be continued to be used to fund research under this
Agreement. Any funds which have not been expended upon any termination of the
research funding shall be returned to the Company.
(d) During the period during which Company is funding research
under this Agreement, neither PRINCIPAL INVESTIGATOR may seek or accept funding
from a commercial sponsor in the FIELD OF RESEARCH but may accept funding from
the
government, not-for-profit organizations and other universities. Company
acknowledges that the PRINCIPAL INVESTIGATORS can continue to receive funding
from Ceilco Incorporated, pursuant to a Research Agreement signed March 23,
1994 and that research conducted under such Research Agreement will not be in
violation of any terms and conditions of this Agreement; provided that the
scope of the work currently being performed under that Research Agreement will
not be expanded nor will that Research Agreement be amended without the prior
approval of Company.
(e) Beginning on the effective date of this Agreement and
thereafter unless sooner terminated, JHU shall:
(i) through the PRINCIPAL INVESTIGATORS conduct research, and
apply the funds paid by Company to support the expenses of research and shall
use reasonable efforts and diligence consistent with JHU's professional
standards to achieve the goals for such research;
(ii) promptly and systematically disclose to Company, RESEARCH
TECHNOLOGY and Company shall be entitled to use such RESEARCH TECHNOLOGY
pursuant to Paragraph 2.1;
(iii) for the purpose of facilitating disclosure to Company of
RESEARCH TECHNOLOGY, permit duly authorized employees of or representatives of
Company to visit the PRINCIPAL INVESTIGATORS' laboratories at JHU or other JHU
facilities where research is conducted at reasonable times and with reasonable
notice;
(iv) promptly advise Company of any Invention and adequate
advance notice of the intent to file, filing, allowance and issuance of any
PATENT RIGHT;
(v) at Company's request provide Company with BACKGROUND
MATERIALS and reasonable research quantities of materials produced or derived
from the research conducted herein ("MATERIALS"); and
(vi) JHU shall, on a continuing basis, advise Company of the
results of the research sponsored hereunder and at least once every twelve (12)
months provide Company with written progress reports concerning such research.
A final written report setting forth in detail the results achieved under and
pursuant to such research shall be submitted by JHU to Company within ninety
(90) days of termination of the research. Such final report shall
include (1) a complete summary of the research carried out; (2) a scientific
assessment by the PRINCIPAL INVESTIGATORS of the research; and (3) detailed
experimental protocols of the assays performed in the course of the research.
5.3 The PRINCIPAL INVESTIGATORS will assure that all faculty, students,
fellows or other employees of JHU working in their laboratories on the
research project or collaborating with them on the research funded by Company
hereunder sign the Invention Agreement (Exhibit A).
5.4 (a) During the period in which Company holds a license, JHU and
PRINCIPAL INVESTIGATORS shall not, without Company's prior written approval,
distribute or knowingly allow any materials which are RESEARCH TECHNOLOGY to
be distributed to for-profit entities or persons known to be employed thereby
or consulting or performing research therefor other than under a license
permitted under this Agreement.
(b) JHU and PRINCIPAL INVESTIGATORS shall have the right to
transfer materials which are RESEARCH TECHNOLOGY to (i) not-for-profit entities
or persons known to be affiliated therewith, or (ii) to any person or entity,
if required by a journal in connection with a publication or if required by
Government rules and/or regulations, provided that such entities or persons
sign the Material Transfer Agreement set forth in Exhibit C or a modification
thereto agreeable to JHU and Company. The PRINCIPAL INVESTIGATORS shall notify
Company before any such distribution is made.
(c) Prior to any such distribution of any such MATERIALS, JHU and
Company shall use reasonable efforts to consider the patentability of such
MATERIALS and cooperate to file, where appropriate, PATENT RIGHTS protecting
such MATERIALS prior to their distribution.
5.5 Notwithstanding anything else to the contrary, JHU and PRINCIPAL
INVESTIGATORS agree not to publish or disclose to third parties RESEARCH
TECHNOLOGY without supplying Company with a copy of the material to be
disclosed or published to third parties at time of submission for publication
or disclosure so that Company may evaluate such material to determine whether
the material contains patentable subject matter on which a patent application
should be filed, Company shall review the material within fifteen (15) days of
submission to Company. At Company's request, JHU initially will delay
publication and/or disclosure for an additional thirty (30) days in order to
enable the preparation and filing of a patent application on any such
patentable subject matter. Notwithstanding anything to the contrary, JHU will
not be required to withhold publication of such material for a period which is
more than forty-five (45) days after Company is first provided with the
material to be disclosed or published.
ARTICLE 6 - PATENT RIGHTS AND CONFIDENTIAL INFORMATION
6.1 (a) JHU, at the Company's expense, shall file, prosecute and
maintain all patents and patent applications specified under PATENT RIGHTS upon
authorization of the Company and the Company shall be licensed thereunder.
Tide to all such patents and patent applications shall reside in JHU. JHU
shall have full and complete control over all patent matters in connection
therewith under the PATENT RIGHTS. The Company will provide payment
authorization to JHU at least one (1) month before an action is due, provided
that the Company has received timely notice of such action from JHU. Failure
to provide authorization can be considered by JHU as a Company decision not to
authorize an action. In any country where the Company elects not to have a
patent application filed or to pay expenses associated with filing,
prosecuting, or maintaining a patent application or patent, JHU may file,
prosecute, and/or maintain a patent application or patent at its own expense
and for its own exclusive benefit and the Company thereafter shall not be
licensed under such patent or patent application.
(b) For patent applications in PATENT RIGHTS that are jointly
owned by JHU and the Company, the Company shall file, prosecute and maintain
all such patents and patent applications and the Company shall be licensed
thereunder. Title to all such patents and patent applications shall reside
jointly in JHU and the Company.
(c) The parties shall first consult with each other as to the
preparation, filing, prosecution and maintenance of such applications and
patents. Each party shall keep the other advised as to all developments with
respect to all patent applications and patents included in PATENT RIGHTS and
shall promptly supply the other: (i) copies of all official correspondence from
the U.S. Patent Office or from a patent office in any other country within a
reasonable time after receipt; and (ii) copies of all substantive papers to be
filed in the U.S. Patent Office or a patent office in any other country a
reasonable time prior to filing to provide
sufficient time to comment thereon. In any country where a party elects not
to file a patent application or to pay expenses associated with filing,
prosecuting, or maintaining a patent application or patent, the other party
may file, prosecute, and/or maintain a patent application or patent at
its own expense and for its own exclusive benefit and thereafter the party so
electing shall not have tide to or be licensed under such patent or patent
application.
6.2 Company agrees that all packaging containing individual LICENSED
PRODUCT(S) sold by Company, AFFILIATED COMPANIES and SUBLICENSEES will be
marked with the number of the applicable patent(s) licensed hereunder in
accordance with each country's patent laws.
6.3 If necessary, the parties will exchange information which they
consider to be confidential. The recipient of such information agrees to accept
the disclosure of said information which is marked as confidential at the time
it is sent to the recipient, and to employ all reasonable efforts to maintain
the information 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. The information shall not be disclosed or revealed
to anyone except employees of the recipient who have a need to know the
information and who have entered into a secrecy agreement with the recipient
under which such employees are required to maintain confidential the
proprietary information of the recipient and such employees shall be advised
by the recipient of the confidential nature of the information and that the
information shall be treated accordingly. The recipient's obligations under
this Paragraph 6.3 shall not extend to any part of the 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; or
b. that can be demonstrated, from written records to have been in the
recipient's possession or readily available to the recipient from
another source not under obligation of secrecy to the disclosing party
prior to the disclosure; or
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 can be demonstrated, from written records, to have been developed
by the recipient independently of the disclosed information.
The obligations of this Paragraph 6.3 shall also apply to AFFILIATED COMPANIES
and/or SUBLICENSEES provided such information by Company. JHU's, the
Company's, AFFILIATED COMPANIES, and SUBLICENSEES' obligations under this
Paragraph 6.3 shall extend until three (3) years after the termination of this
Agreement. Notwithstanding the foregoing, Company, AFFILIATED COMPANIES and/or
SUBLICENSEES shall have the right to disclose Confidential Information of JHU
to a third party who undertakes an obligation of confidentiality and non-use
with respect to such information at least as restrictive as the obligations
under this Paragraph 6.3
ARTICLE 7- TERM. MILESTONES AND TERMINATION
7.1 This Agreement shall expire in each country on the date of
expiration of the last to expire patent included within PATENT RIGHTS in that
country or if no patents issue seventeen (17) years from the EFFECTIVE DATE of
this Agreement at which time Company shall have a fully paid up noncancellable
license.
7.2 For each PATENT RIGHT Company agrees to exercise reasonable efforts
and to take effective steps, within a reasonable time to (i) identify product
candidate(s) which are LICENSED PRODUCT(S) (ii) perform pre-clinical animal
and toxicological studies for each identified product candidate, (iii) conduct
clinical studies aimed at obtaining FDA regulatory approval for each
identified product candidate and (iv) develop and commercialize each such
product, provided however, a LICENSED PRODUCT need not be identified and
developed for a PATENT RIGHT if a similar product is being developed under
another PATENT RIGHT. Company's obligations under this paragraph shall take
into account the stage of development thereof and regulatory consideration and
requirements. The efforts of a SUBLICENSEE, an AFFILIATE, a collaborator and
research funded under this Agreement shall be considered as efforts of the
Company.
7.3 (a) As part of the efforts under Paragraph 7.2, Company shall
exercise reasonable efforts to meet the following milestones within the time
set forth below:
(i) within four (4) years from the earlier of (i) the closing
of the Second Round Financing (as defined in the Stock Purchase Agreement
between the parties), or (ii) October 1, 1997 initiate Phase I clinical trials
of a LICENSED PRODUCT.
(ii) within three (3) years from the identification of a
product candidate as set forth in Paragraph 7.2, start the Phase I clinical
study of such LICENSED PRODUCT.
(iii) within seven (7) years from the start of the Phase I
Study of each product candidate, obtain FDA commercial approval (NDA/PLA) of
such LICENSED PRODUCT
(b) JHU will; not unreasonably withhold its consent to Company's
request for a reasonable extension of any of the above milestones if the
Company can demonstrate that its inability to meet such milestone occurred as a
result of reasons beyond the control of Company (including scientific or
regulatory reasons beyond the control of Company).
(c) If, as to a specific LICENSED PRODUCT, Company fails to
exercise reasonable efforts as required by Paragraphs 7.2 or meet milestones
required by 7.3, as its sole and exclusive remedy JHU may terminate Company's
license with respect thereto, provided however, if in good faith Company has
pursued research and development of such LICENSED PRODUCT and in good faith
Company intends to pursue research and development of such LICENSED PRODUCT and
reasonably appears to have the ability to do so and thereafter in good faith
does continue to do so, JHU's sole and exclusive remedy shall be conversion
of the exclusive rights and license for such specifically defined LICENSED
PRODUCT to non-exclusive rights and licenses.
7.4 Company can market and sell LICENSED PRODUCT(S) and LICENSED
SERVICE(S) to third parties at a sales price determined by Company in its sole
discretion.
7.5 Any matter or disagreement arising under Paragraphs 1.13(c), 4.6,
7.2 or 7.3 shall be submitted to a mutually selected single arbitrator to so
decide any such matter or disagreement. The arbitrator shall conduct the
arbitration in accordance with the Rules of the American Arbitration
Association, unless the parties agree otherwise. If the parties are unable to
mutually select an arbitrator, the arbitrator shall be selected in accordance
with the procedures of the American Arbitration Association. The decision by
the arbitrator shall be final and
binding and may be enforced in any court of competent jurisdiction. Any
arbitration pursuant to this section shall be held in Washington, D.C., or
such other place as may be mutually agreed upon in writing by the parties.
7.6 After NDA or PLA has been obtained from the FDA, Company shall
exercise commercially reasonable efforts to market a product included in
LICENSED PRODUCTS in the U.S. and worldwide, provided that Company has obtained
regulatory approval in a particular foreign nation or region.
7.7 In the event that a third party notifies JHU that it desires to
develop and market a LICENSED PRODUCT which is not being researched and/or
developed and/or marketed by Company, an AFFILIATED COMPANY or SUBLICENSEE, JHU
shall notify Company in writing thereof. If Company does not notify JHU within
ninety (90) days of such written notice that Company or an AFFILIATED
COMPANY or SUBLICENSEE intends to research and develop such LICENSED PRODUCT
and does not initiate such research and development in accordance with the
provisions of paragraph 7.2 hereof with a reasonable time thereafter, Company
shall enter into good faith negotiations with such third party for granting a
sublicense for such LICENSED PRODUCT unless the granting of such sublicense
would have a potential adverse commercial effect upon marketing and/or selling
of a LICENSED PRODUCT which is being researched, developed, or sold pursuant
to this Agreement.
7.8 Except as provided in Paragraphs 7.2 and 7.3, upon breach or
default of any of the terms and conditions of this Agreement, the defaulting
xxxxx 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.
7.9 Company may terminate this Agreement or any of the licenses granted
herein under any PATENT RIGHT in any country, for any reason, upon giving JHU
sixty (60) days written notice.
7.10 Termination shall not affect JHU's right to recover unpaid
royalties or fees or reimbursement for patent expenses incurred pursuant to
Paragraph 6.1 prior to termination. Upon termination all rights in and to the
licensed technology (including PATENT RIGHTS) shall revert to JHU at no cost to
JHU.
7.11 Upon any termination of this Agreement Company, at its option,
shall be entitled to finish any work-in-progress which is completed within six
(6) months of termination of this Agreement and to sell any completed inventory
of a LICENSED PRODUCT covered by this Agreement which remains on hand as of the
date of the termination, so long as Company pays to JHU the royalties
applicable to said subsequent sales in accordance with the same terms and
conditions as set forth in this Agreement.
7.12 In the event that this Agreement and/or the rights and licenses
granted under this Agreement to Company are terminated, any sublicense granted
under this Agreement shall remain in full force and effect as a direct license
between JHU and the SUBLICENSEE under the terms and conditions of the
sublicense agreement, subject to the SUBLICENSEE agreeing to be bound directly
to JHU under such terms and conditions of the sublicense as well as all the
relevant duties and obligations of a licensee under this Agreement (other
than royalty and other payment obligations which shall be paid in accordance
with the sublicense provided the JHU receives a royalty of at least two
percent of the SUBLICENSEE's NET SALES) within thirty (30) days after JHU
provides written notice to the SUBLICENSEE of the termination of Company's
rights and licenses under this Agreement, provided further that JHU's
obligations under such sublicense are no greater than currently existing
under this Agreement. At the request of the Company, JHU will acknowledge to a
SUBLICENSEE, JHU's obligations to the SUBLICENSEE under this paragraph.
ARTICLE 8- MISCELLANEOUS
8.1 All notices pertaining to this Agreement shall be in writing and
sent certified mail, return receipt requested, 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 8.1:
FOR JHU: Xx. Xxxxxxx X. Xxxxx
Assistant Xxxx for Technology Licensing
The Xxxxx Xxxxxxx University
School of Medicine
0000 Xxxx Xxxxxxxx Xxxxxx
Xxxxx 0-000
Xxxxxxxxx, XX 00000
FOR COMPANY: Xx. Xxxxx X Xxxxx
President and CEO
Gryphon Pharmaceuticals, Inc.
0000 Xxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxxx, XX 00000
CC: Carella, Byrne, Bain, Gilfillan,
Ceechi, Xxxxxxx & Olstein
0 Xxxxxx Xxxx Xxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attn: Xxxxxx X. Xxxxxxx, Esq.
8.2 All written progress reports, royalty and other payments, and any
other related correspondence shall be in writing and sent to:
FOR JHU: Xxxxxxx 3. Xxxxx, Ph.D.
Assistant Xxxx for Technology Licensing
The Xxxxx Xxxxxxx University
School of Medicine
0000 Xxxx Xxxxxxxx Xxxxxx
Xxxxx 0-000
Xxxxxxxxx, XX 00000
or such other addressee which JHU may designate in writing from time to time.
Checks are to be made payable to "The Xxxxx Xxxxxxx University".
8.3 This Agreement is binding upon and shall inure to the benefit of
Company, its successors and assignees and shall not be assignable to another
party without the written consent of JHU, which consent shall not be reasonably
withheld, except that the Company shall have the right to assign this
Agreement to another party without the consent of JHU in the case of the sale
or transfer or merger or consolidation of the Company or sale or transfer by
the Company to that party of all, or substantially all, of its assets or all
or substantially all of the portion of its assets to which this Agreement
relates, provided the assignee undertakes to be bound by and perform the
obligations of the assignor under this Agreement.
8.4 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; elsewhere, this Agreement shall not be
affected.
8.5 The construction, performance, and execution of this Agreement
shall be governed by the laws of the State of Maryland.
8.6 (a) The Company and its AFFILIATED COMPANIES and its SUBLICENSEES
shall not use the names, likenesses, or logos of JHU or any of its schools or
divisions or The Xxxxx Xxxxxxx Health Systems or any of its constituent parts
and affiliated hospitals and companies, such as The Xxxxx Xxxxxxx Hospital or
any contraction or derivative thereof or the names of JHU's faculty members,
employees, and students in any press releases, general publications,
advertising, marketing, promotional or sales literature without prior written
consent from an authorized official of JHU which consent shall not be
unreasonably withheld. It should be understood that JHU does not allow any
use of its name for the endorsement of products.
(b) Notwithstanding Paragraph 8.6(a), the Company shall have the
right to use the name of JHU in agreements between Company and OSIRIS and in
any SEC filing (including but not limited to 8K statements), fundraising
documents and the like and in any case where such use is required by law, rule
or regulation provided that the Company shall provide JHU with the appropriate
documents and papers which use the name of JHU for JHU's review and comment no
less than three (3) business days prior to the anticipated date of submission
of such documents or papers.
(c) All notifications relating to the use of JHU's name as
required herein shall be made to the person listed below:
Xxxxxxx X. Xxxxx, Ph.D.
Assistant Xxxx of Technology Licensing
Xxxxx Xxxxxxx University
Office of Technology Licensing
0000 Xxxx Xxxxxxxx Xxxxxx
Xxxxx 0-000
Xxxxxxxxx, XX 00000
8.7 JHU warrants that it has good and valid title to its interest in
the inventions claimed under PATENT RIGHTS with the exception of certain
retained rights of the United States government. In addition, JHU warrants that
it has not licensed or assigned any right or interest in or to PATENT RIGHTS to
any third party, and the granting of such rights to Company hereunder does not
require the consent of a third party; and JHU is not aware as of the
EFFECTIVE DATE of this Agreement of any legal or contractual restriction which
would inhibit its ability to perform the terms and conditions imposed on it by
this Agreement. 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 8.7, Company, AFFILIATED COMPANIES AND
SUBLICENSEES AGREE THAT THE PATENT RIGHTS ARE PROVIDED "AS IS", AND THAT JHU
MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF
LICENSED PRODUCT(S) AND LICENSED SERVICES 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 P
MENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART
OF JHU AND INVESTIGATORS, 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), WHICH DAMAGES ARISE OUT OF OR RESULT FROM THE
MANUFACTURE, USE, OR SALE OF THE PRODUCT(S) AND SERVICES LICENSED UNDER THIS
AGREEMENT. Company, AFFILIATED COMPANIES AND SUBLICENSEES A AS DEFINED IN
THIS AGREEMENT.
8.8 The Company shall defend and hold JHU, The Xxxxx Xxxxxxx Health
Systems, their present and former trustees, officers, inventors of PATENT
RIGHTS, agents, faculty, employees and students harmless as against any third-
party 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 the inventions of LICENSED PRODUCTS or
LICENSED SERVICES by Company or its AFFILIATED COMPANIES or its SUBLICENSEES
or those operating for its account or third parties who purchase LICENSED
PRODUCT(S) or LICENSED SERVICES from any of the foregoing entities whether
or not JHU or said inventors, either jointly or severally, is named as a party
defendant in any such lawsuit, except those which arise from the gross
negligence or willful misconduct of any of parties indemnified hereunder.
Practice of the inventions covered by LICENSED PRODUCT(S) and LICENSED
SERVICES, by an AFFILIATED COMPANY or an agent or a SUBLICENSEE or a third
party on behalf of or for the account of the Company or by a third party who
purchases LICENSED PRODUCT(S) and LICENSED SERVICES from the Company, shall
be considered the Company's practice of said inventions for purposes of this
Paragraph 8.8. The obligation of the Company to defend and indemnify as set
out in this Paragraph 8.8 shall survive the termination of this Agreement.
8.9 Prior to initiating first commercial sale of any LICENSED PRODUCT
or LICENSED SERVICE as the case may be in any particular county, the Company
shall establish and maintain, or in the alternative maintain for JHU in each
country in which Company, an AFFILIATED COMPANY or SUBLICENSEE shall test
or sell LICENSED PRODUCT(S) and LICENSED SERVICES, product liability
or other appropriate insurance coverage with respect to LICENSED PRODUCT(S)
and LICENSED SERVICES which coverage shall be similar to that maintained by
Companies at a stage of development similar to Company for similar products
provided that such insurance is available at terms, conditions and costs which
are commercially reasonable and prudent under the circumstances. Upon JHU's
request, the Company will furnish JHU with a Certificate of Insurance of each
product liability insurance policy obtained. JHU shall be listed as an
additional insured in Company's said insurance policies.
8.11 This Agreement constitutes the entire understanding between the
parties with respect to the obligations of the parties with respect to the
subject matter hereof, and
supersedes and replaces all prior agreements, understandings, writings, and
discussions between the parties relating to said subject matter.
8.12 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 instances shall be construed as a further or continuing waiver of
such condition or term or of any other condition or term.
8.13 This Agreement shall be binding upon and inure to the benefit of
and be enforceable by the parties hereto and their respective successors and
permitted assigns.
8.14 Upon termination of this Agreement for any reason, Paragraphs 6.3,
7.1, 7.10, 8.6, 8.7, 8.8, 8.9 (to the extent Company, AFFILIATED COMPANIES and/
or SUBLICENSEES are selling or providing LICENSED PRODUCTS or LICENSED SERVICES
under the licenses granted under this agreement) and 8.14 shall survive
termination of this Agreement.
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 GRYPHON PHARMACEUTICALS, INC.
By: _/s/ Xxxxx X. Blake____________ By: _/s/ Xxxxx X. Burns_______________
Xxxxx X. Xxxxx, Ph.D. Xxxxx X. Xxxxx
Executive Vice Xxxx President and CEO
Date: _12/29/94___________________ Date: _12/23/94____________________
I have read, understand and agree to abide by the terms of this Agreement
By: _/s/ Xxxx X. Civin____ By: _/s/ Xxxxxx Small________
Xxxx X. Xxxxx, M.D. Xxxxxx Xxxxx, M.D., Ph.D.
Date: _12/23/94 Date: _12/23/94
EXHIBIT A
INVENTION AGREEMENT
The following individuals who are employees or students of THE XXXXX
XXXXXXX UNIVERSITY (hereinafter ?'JHU") hereby agree to assign to JHU all their
right and title to all inventions, mprovements and applicable patent rights
conceived and/or made by them during the course of their research at JHU with
respect to which Gryphon Pharmaceuticals, Inc. ("Gryphon") has rights under a
Research and License Agreement with JHU. The following individuals further
acknowledge that the invention will be licensed pursuant to the JHU/Gryphon
Research and License Agreement and that, only if listed as an inventor on an
issued patent, will he or she be entitled to participate in the running
royalties if any received, for such invention as allocated pursuant to
University policy.
Signature: Signature:
Name: Name:
Title: Title:
Date: Date:
Signature: Signature:
Name: Name:
Title: Title:
Date: Date:
Signature: Signature:
Name: Name:
Title: Title:
Date: Date:
Signature: Signature:
Name: Name:
Title: Title:
Date: Date:
EXHIBIT B
[*CONFIDENTIALITY REQUESTED*]
EXHIBIT C
Dear :
Xxxx Xxxxxxx University (JHU) agrees to provide you the material(s)
indicated below, which you requested from __________________________ for your
nonclinical research studies as such studies are described in Appendix A
attached hereto. In order to protect JHU's proprietary rights in the
material(s) or its (their) progeny portions, and derivatives thereof
(hereinafter "Materials"), we request that you and an authorized official of
your institution sign, date, and return this letter agreement to us.
Material(s) identification:
Acceptance of the Material(s) by your institution confirms your agreement
to the following conditions:
1. This agreement and the resulting transfer of the Material(s)
constitute a nonexclusive license to use the Material(s) for
nonprofit, nonclinical research purposes only as described in
Appendix A. The Material(s) will not be used in humans and will be
stored, used, and disposed of in accordance with applicable law and
regulations. The Material(s) will not be used for research for any
commercial purpose or in research sponsored by a commercial entity.
This agreement is not assignable and the Material(s) may not be
transferred to another party.
2. You are free to publish your work involving this Material(s). You
agree to provide JHU with a copy of any publication which contains
results obtained from use of the Material(s).
3. JHU makes no representations whatsoever as to the Material(s). They
are experimental in nature and are provided WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER
WARRANTY, EXPRESS OR IMPLIED. JHU MAKES NO REPRESENTATION OR
WARRANTY THAT THE USE OF THE MATERIAL(S) WILL NOT INFRINGE ANY
PATENT OR OTHER PROPRIETARY RIGHT.
4. Except where precluded by Federal law and to the extent allowed by
State law, you and your institution agree to defend, indemnify, and
hold harmless JHU, its trustees, officers, employees, and agents
from any loss, claim, damage, or liability, of any kind whatsoever,
which may arise from you or your institution's use, storage, or
disposal of the Material(s) or any other material that could not
have been made but for the Material(s), except to the extent such
arise due to the gross negligence of JHU.
To indicate you and your institution's agreement to these conditions,
you and an authorized official should sign and date this letter in the spaces
indicated below and return it to me. If you have any questions concerning
this agreement, you may call me at 000-000-0000.
Sincerely,
Xxxxxxx X. Xxxxx, Ph.D.
Assistant Xxxx for Technology Licensing
FJM:
Signature: ____________________________________
(Recipient Investigator Signature)
Name:
Title:
Date:
RECIPIENT INSTITUTION'S AUTHORIZED OFFICIAL
An Authorized Signature is that of an Institutional Official or Company
Officer specifically authorized to execute documents of this type on behalf
of the Institution.
Institution/Company: ________________________
Signature: __________________________________
Name:
Title:
Date:
