Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Exhibit 10.30
LICENSE AGREEMENT
This Agreement, dated as of the 31st day of December, 1998, is between The
Xxxxx Xxxxxxx University, a corporation of the State of Maryland, having a
principal place of business at 0000 X. Xxxxxxxx Xxxxxx, Xxxxx 0-000, Xxxxxxxxx,
XX 00000 (hereinafter referred to as "JHU") and Xxxxxxx Cellular Therapies,
Inc., a Delaware corporation (hereinafter "CCT"), having an address at 00
Xxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000.
WITNESSETH:
WHEREAS, as a center for research and education, JHU is interested in
licensing PATENT RIGHTS (hereinafter defined) and INVENTIONS (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, valuable inventions entitled "Use of Multivalent Chimeric
Peptide-loaded, MHC/Ig Molecules to Detect, Activate or Suppress
Antigen-Specific T Cell-Dependent Immune Responses" (JHU Ref. DM-3302), U.S.
Provisional Patent Application Serial No. 60/058,573 filed on September 11, 1997
and "Soluble Divalent and Multivalent Heterodimer Analogs of Protein" (JHU
DM-3085), U.S. Provisional Patent Application Serial No. 60/014,367 filed on
March 28, 1996, U.S. Patent Application, Serial No. 08/828,712 and International
PCT Application Serial No. PCT/U597/04694 both filed March 28, 1997 were
developed during the course of research conducted by Drs. Xxxxxxxx Xxxxxxx and
Xxxx Xxxxxxx (all hereinafter, "INVENTORS"); and
WHEREAS, JHU has acquired through assignment all rights, title and
interest, with the exception of certain retained rights by the United States
government, in said valuable PATENT RIGHTS and INVENTIONS; and
1
WHEREAS, CCT desires to commercially develop, manufacture, use and
distribute such products and processes throughout the world; and
WHEREAS, CCT desires to exclusively license and advance the development of
clinically effective technology;
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 "PATENT RIGHTS" shall mean (a) the US provisional patent application
Serial No. 60/058,573 filed on September 11, 1997 and assigned to JHU entitled
"Use of Multivalent Chimeric Peptide-loaded, MHC/Ig Molecules to Detect,
Activate or Suppress Antigen-Specific T Cell-Dependent Immune Responses" (JHU
DM-3302) and U.S. provisional patent application, Serial Number 60/014,367 filed
March 28, 1996 and U.S. patent application Serial Numbers 08/828,712 and
PCT/U597/04694 both filed March 28, 1997 and assigned to JHU entitled "Soluble
Divalent and Multivalent Heterodimer Analogs of Protein" (JHU DM-3085)
(hereinafter the "PATENT APPLICATION"), (b) any invention disclosed and claimed
therein, and all continuations, divisions, reissues and extensions based
thereon, and any corresponding foreign patent applications, and any patents,
patents of addition, or other equivalent foreign patent rights issuing, granted
or registered thereon and (c) all new inventions or improvements conceived and
or reduced to practice by JHU faculty and employees (solely or jointly with
others) while performing Research under the COLLABORATION RESEARCH AGREEMENT and
any other existing or future patent, patent application and provisional
application claiming either any INVENTION or joint INVENTION that is developed
under the COLLABORATIVE RESEARCH AGREEMENT. Improvements made specifically to
CCT's proprietary High Density Microparticles ("HDM") by JHU while performing
Research shall not be considered PATENT RIGHTS or INVENTIONS and at all times
shall vest in CCT, provided, however, that royalty
2
obligations related to PATENT RIGHTS set forth herein shall not decrease because
a HDM is used with or attached to materials or utilizes methods covered by
PATENT RIGHTS.
1.2 "LICENSED PRODUCT(S)" means any material, compositions, drug or device
including IN VIVO THERAPEUTICS and EX VIVO THERAPEUTICS, or other product, the
manufacture, use or sale of which would constitute, but for the license granted
to the CCT pursuant to this Agreement, an infringement of a claim of PATENT
RIGHTS (infringement shall include, but is not limited to, direct, contributory,
or inducement to infringe) and/or utilizing INVENTIONS.
1.3 "LICENSED SERVICE(S)" means the performance on behalf of a third party
of any method including THERAPEUTIC CELL PRODUCT SERVICE or the manufacture of
any product or the use of any product or composition which would constitute, but
for the license granted to the CCT pursuant to this Agreement, an infringement
of a claim of the PATENT RIGHTS, (infringement shall include, but not be limited
to, direct, contributory or inducement to infringe) and/or utilizing INVENTIONS.
1.4 "NET SALES" shall mean gross sales revenues and fees billed by CCT,
AFFILIATED COMPANY or CCT's sublicensees to an unaffiliated third party for the
sale of LICENSED PRODUCT(S) less trade discounts allowed, refunds, rebates,
returns and recalls, sales and use taxes, tariffs, duties and the like, and
shipping costs and insurance actually paid by the seller. In the event that CCT,
AFFILIATED COMPANY or CCT's sublicensee sells a LICENSED PRODUCT(S) in
combination with other ingredients or substances or as part of a kit, the NET
SALES for purposes of royalty payments shall be based on the sales revenues and
fees received from the entire combination or kit.
1.5 "NET SERVICE REVENUES" shall mean actual xxxxxxxx for the performance
of services by CCT, AFFILIATED COMPANY or CCT's sublicensees, to an unaffiliated
third party for the LICENSED SERVICE, less trade discounts allowed, refunds,
rebates shipping costs and insurance actually paid by the seller and sales or
other use taxes imposed upon and with specific reference to the LICENSED
SERVICE.
3
1.6 "LICENSED FIELD" shall mean EX VIVO and IN VIVO THERAPEUTIC PRODUCTS
and THERPAEUTIC CELL PRODUCT SERVICE for the treatment of cancers and infectious
diseases.
1.7 "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 CCT. For purposes of this
Paragraph 1.7, control shall mean the direct or indirect ownership of at least
fifty-percent (50%) of the voting power of such entity.
1.8 "EXCLUSIVE LICENSES" shall mean a grant by JHU to CCT of its entire
right and interest in the INVENTIONS AND 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 solely for its and The Xxxxx Xxxxxxx Health Systems'
non-profit research and education purposes, LICENSED PRODUCT(S) and LICENSED
SERVICES.
1.9 "EFFECTIVE DATE" of this License Agreement shall mean the date set
forth in the first paragraph of this Agreement.
1.10 "COLLABORATIVE RESEARCH AGREEMENT" means that sponsored research
agreement between CCT and JHU for the development of the technology licensed
herein.
1.11 "INVENTIONS" shall mean (i) the inventions claimed in the PATENT
RIGHTS, (ii) any discovery or invention first conceived or first reduced to
practice in the performance of the COLLABORATIVE RESEARCH AGREEMENT and (iii)
any other existing discovery or invention made in the field in the performance
of the ongoing research program under the direction of the INVENTORS. INVENTIONS
shall include discoveries and inventions which are not patentable or patented,
including but not limited to, trade secrets or other protectable intellectual
property.
4
1.12. "COMMERCIAL SALE" shall mean sales to non-affiliated third-party
purchasers after FDA or other applicable regulatory approval, with defined
prices and support through standard sales promotion activities.
1.13. "VALID CLAIM" shall mean any issued, unexpired, valid claim or
pending claim contained in the PATENT RIGHTS issued within seven (7) years of
the filing date of the patent application from which it arose which claim shall
not have been invalidated by a court of competent jurisdiction.
ARTICLE 2 - GRANTS
2.1 Subject to the terms and conditions of this Agreement, JHU hereby
grants to CCT: a) an EXCLUSIVE LICENSE to make, have made, use, and sell the
LICENSED PRODUCT(S) and to provide the LICENSED SERVICE(S) in the United States
and worldwide under the PATENT RIGHTS and INVENTIONS in the LICENSED FIELD and
b) a NON-EXCLUSIVE worldwide license to make, have made, use, and sell IN VITRO
THERAPEUTIC PREDICTIVE ASSAYS covered by PATENT RIGHTS AND INVENTIONS; provided
any such in vitro diagnostic product or service is used in the LICENSED FIELD
and only sold in association with IN VIVO THERAPEUTICS, or EX VIVO THERAPEUTICS
or used in association with THERAPEUTIC CELL PRODUCT SERVICES covered by this
Agreement.
2.2 CCT 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.
ARTICLE 3 - PATENT INFRINGEMENT
3.1 Each party will notify the other promptly in writing when any
infringement by another is uncovered or suspected.
5
3.2 CCT 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. CCT 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 and agrees to allow CCT to include JHU as a party in any suit
with respect to any infringement.
3.3 If CCT 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 CCT, at its sole expense, shall have the right but not the obligation
to determine the appropriate course of action to enforce PATENT RIGHTS or
otherwise xxxxx the infringement thereof in the Field, to take (or refrain from
taking) appropriate action to enforce PATENT RIGHTS in the LICENSED FIELD, to
control any litigation or other enforcement action in the Field and to enter
into, or permit, the settlement of any such litigation or other enforcement
action with respect to PATENT RIGHTS in the LICENSED FIELD, and shall consider,
in good faith, the interests of JHU in so doing and shall at all times keep JHU
informed as to the status thereof. If CCT does not, within one hundred twenty
(120) days of receipt of notice from JHU, xxxxx the infringement or file suit to
enforce the Licensed Patent Rights against an infringing party, JHU shall have
the right to take whatever action it deems appropriate to enforce the Licensed
Patent Rights; provided, however that, within thirty (30) days after receipt of
notice of JHU's intent to such suit, CCT shall have the right to jointly
prosecute such suit and to fund up to one-half (1/2) the costs
6
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
of such suit. The party controlling any such enforcement action shall not settle
the action or otherwise consent to an adverse judgment in such action that
diminished the rights or interests of the non-controlling party without the
prior written consent of the other party. All monies recovered upon the final
judgment or settlement of any such suit controlled by JHU to enforce the PATENT
RIGHTS in the LICENSED FIELD shall be shared, after reimbursement of expenses,
non-punitive damages net legal fees and out-of-pocket costs of the action to
each party, on an equal basis by JHU and CCT. In the event of a recovery by CCT
as a result of an action brought solely at CCT's expense, compensatory (i.e.
non-punitive damages net of legal fees and out-of-pocket costs of the action)
for a royalty-bearing product described under Paragraph 4.4, CCT shall pay to
JHU the applicable royalty rate on infringing net sales. Infringing net sales
shall be determined by and calculated from the amount of infringing sales on
which the award of compensatory damages is based. With respect to any recovery
of punitive damages with respect to royalty-bearing products, CCT shall pay to
JHU an amount equal to 15% thereof. Notwithstanding the foregoing, JHU and CCT
shall fully cooperate with each other in the planning and execution of any
action to enforce the Licensed Patent Rights.
ARTICLE 4 - PAYMENTS AND ROYALTY
4.1 CCT will reimburse JHU for the reasonable costs of preparing, filing,
maintaining and prosecuting PATENT RIGHTS in the United States, Canada, Japan,
Australia, New Zealand, South Korea and the countries of the European Union. CCT
shall reimburse JHU within thirty (30) days of receipt of invoice from JHU. CCT
will be notified, in advance, of the filing and prosecution of all patents and
patent applications. Upon JHU licensing to one or more third parties for other
fields of use in any of the aforementioned countries, CCT will receive a
prorated reimbursement of patent expenses for such countries pertaining to
PATENT RIGHTS that have been incurred up to said time, and from that time
forward future patent costs will be prorated.
4.2(a) CCT shall pay to JHU within thirty (30) days of the EFFECTIVE
DATE of this Agreement a nonrefundable processing fee of ** Dollars ($**) and
(b)
7
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
on the ninetieth day after the EFFECTIVE DATE, unless CCT has terminated this
Agreement pursuant to Section 6.6(b), CCT shall pay a nonrefundable initial
licensing fee of ** Dollars ($**). These payments are nonrefundable and shall
not be credited against royalties or other fees.
4.3 CCT shall pay to JHU a Five Thousand dollar ($5,000) annual
maintenance fee due within thirty (30) days of each anniversary of the EFFECTIVE
DATE of this Agreement. Such fees are nonrefundable and shall not be credited
against royalties or other fees.
4.4 CCT shall pay to JHU, as a running royalty, for each LICENSED
PRODUCT sold, and for each LICENSED SERVICE provided, by CCT, AFFILIATED
COMPANIES and Sublicensees, ** percent (**%) of NET SALES of IN VIVO
THERAPEUTIC(S) and IN VITRO THERAPEUTIC PREDICTIVE ASSAYS covered by a VALID
CLAIM of PATENT RIGHTS and ** percent (**%) of NET SALES on EX VIVO
THERAPEUTIC(S) covered by a VALID CLAIM of PATENT RIGHTS and ** percent (**%)
of NET SERVICE REVENUES for THERAPEUTIC CELL PRODUCT SERVICE(S) covered by a
VALID CLAIM of PATENT RIGHTS for the term of this Agreement. Any LICENSED
PRODUCT or LICENSED SERVICE that is not an EX VIVO THERAPEUTIC or THERAPEUTIC
CELL PRODUCT SERVICE and is covered by a VALID CLAIM of PATENT RIGHTS shall
be subject to the **% royalty payment. As used above NET SALES for an EX VIVO
THERAPEUTIC shall mean an entire kit or system including components for
extracting, growing and harvesting cells requiring use of other technology
(devices). NET SALES shall be calculated based on the entire kit or system.
As used above, NET SALES for a THERAPEUTIC CELL PRODUCT SERVICE shall include
the entire service performed by CCT or an Affiliate or Sublicensee to
extract, grow and harvest cells. NET SALES shall be calculated based on the
entire service. The Royalty rates as used above shall be flat royalties not
reducible by third party royalty fees. Such payments shall be made quarterly
as provided in Paragraph 4.6
4.5 CCT shall pay to JHU the following milestone payments (not creditable
against earned royalty) within thirty (30) days of the events indicated below:
8
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Milestone payments shall be made on the occurrence of the following
events:
Event Payment
----- -------
Issuance of the ** ** Dollars ($**)
Issuance of the ** ** Dollars ($**)
First ** ** Dollars ($**)
First ** ** Dollars ($**)
4.6 CCT shall provide to JHU within forty-five (45) days of the end of
each March, June, September and December 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 CCT, AFFILIATED COMPANIES and
sublicensees thereof. Payment of any such royalties due shall accompany such
report. Until CCT, an AFFILIATED COMPANY or a sublicensee has achieved a first
COMMERCIAL SALE of a LICENSED PRODUCT and received FDA market approval, a report
shall be submitted at the end of every June and December after the
9
EFFECTIVE DATE of this Agreement and will include a full written report
describing CCT's, AFFILIATED COMPANIES' or sublicensees' technical efforts
towards meeting the milestones in Article 6.
4.7 CCT shall make and retain, for a period of three (3) years following
the period of each report required by Paragraph 4.6, 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 4.6. Such books and records shall be in accordance with generally
accepted accounting principles consistently applied. CCT 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 notice to CCT.
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 error has been made in the amount equal to five
percent (5%) or more of such payment, such costs shall be borne by CCT. CCT
shall include in any agreement with its AFFILIATED COMPANIES or its 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 4.6 and permit JHU to inspect such records as required by
this Paragraph 4.7.
4.8 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 or sublicensee or to a corporation, firm or
association with which CCT shall have any agreement, understanding or
arrangement with respect to consideration (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) the royalties to be paid
hereunder for such LICENSED PRODUCTS shall be based upon the greater of: 1) the
net selling price at which the purchaser of LICENSED PRODUCTS resells such
product to the end user, 2) the net service revenue received from using the
LICENSED
10
PRODUCT in providing a service, 3) the fair market value of the LICENSED PRODUCT
or 4) the net selling price of LICENSED PRODUCTS paid by the purchaser to CCT.
4.9 All payments under this Agreement shall be made in U.S. Dollars.
4.10 Stock Participation - CCT will grant JHU an option to purchase
250,000 Common Shares of Xxxxxxx Cellular Therapies, Inc. at an exercise
price of no more than $0.20 per share. The Stock Option will vest according
to the Vesting Schedule ("Appendix A"). JHU shall have 10 years from the
EFFECTIVE DATE of this Agreement in which to exercise such Stock Option
ARTICLE 5 - PATENT RIGHTS AND CONFIDENTIAL INFORMATION
5.1 JHU, at CCT's expense, (subject to pro rata reimbursement and
allocation of expenses as provided in Paragraph 4.1), shall file, prosecute and
maintain all patents and patent applications specified under PATENT RIGHTS upon
request and authorization of CCT and CCT shall be licensed thereunder. Title to
all such patents and patent applications shall reside in JHU. Except as
otherwise provided herein, JHU shall have full and complete control over all
patent matters in connection therewith under the PATENT RIGHTS. JHU shall
consult with CCT, and shall reasonably respond to CCT's requests regarding the
handling of such patent matters. CCT will provide payment authorization to JHU
at least one (1) month before an action is due, provided that CCT has received
timely notice of such action from JHU. Failure to provide authorization can be
considered by JHU as a CCT decision not to authorize an action upon further
notice by JHU. In any country where the CCT elects not to have a patent
application filed or not 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 CCT thereafter shall not be licensed under such patent or
patent application, provided, however, that CCT shall have the first right to
negotiate a license in such countries.
11
5.2 CCT agrees that all packaging containing individual LICENSED
PRODUCT(S) sold by CCT, AFFILIATED COMPANIES and sublicensees of CCT will be
marked with the number of the applicable patent(s) licensed hereunder in
accordance with each country's patent laws.
5.3 If necessary, the parties will exchange information which they
consider to be confidential (hereinafter "CONFIDENTIAL INFORMATION"). The
recipient of such information agrees to accept the disclosure of said
information which is marked or stated as confidential at the time it is provided
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 5.3 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; or
12
d. that is demonstrated from written records to have been developed by or
for the receiving party without reference to CONFIDENTIAL INFORMATION
disclosed by the disclosing party.
The obligations of this Paragraph 5.3 shall also apply to AFFILIATED COMPANIES
and/or Sublicensees provided such information by CCT. JHU's, CCT's, AFFILIATED
COMPANIES, and Sublicensees' obligations under this Paragraph 5.3 shall extend
until five (5) years after the termination of this Agreement.
ARTICLE 6 - TERM, MILESTONES AND TERMINATION
6.1 This Agreement shall expire in each country on the date of expiration
of the last to expire VALID CLAIM of a patent included within PATENT RIGHTS in
that country. At the expiration of this license in any country, CCT shall have a
fully paid up license to the PATENT RIGHTS and INVENTIONS with respect to such
country and no further royalties shall be paid with respect to such country
under this Agreement.
6.2 CCT shall exercise commercially reasonable efforts to develop, seek
registration and sell the LICENSED PRODUCT(S) and LICENSED SERVICE(S) based on
the PATENT RIGHTS and using good scientific judgement. To this end, JHU and CCT
shall reasonably endeavor to meet the milestones as defined in the COLLABORATIVE
RESEARCH AGREEMENT, and incorporated herein by reference as Appendix B
(hereinafter "RESEARCH MILESTONES"). If at any time during the term of this
Agreement either party believes that the other party has failed to exercise
reasonable efforts timely meet any milestone set forth in the RESEARCH
MILESTONES, such party shall give notice to the other party specifically
detailing such failure. Such party shall be given a reasonable amount of time,
not to exceed 180 days, to cure any such failure. If such failure is not
thereafter cured in such time or there is a dispute as to any milestone, then
the parties hereby agree to submit the matter to CCT's President and JHU's
Director, Office of Technology Licensing, for discussions concerning such
matter. If, after a period of ninety days, the parties are unable to resolve the
matter, then either may terminate this Agreement
13
upon notice to the other, provided, however, that no party shall have the right
to terminate this Agreement if the failure of the other party is due to the
terminating party's own action or inaction or circumstances within the
terminating party's own control.
6.3 After FDA or other applicable regulatory approval in a relevant
country listed under Paragraph 4.1, CCT shall exercise commercially reasonable
efforts to market a product included in LICENSED PRODUCTS in such country. CCT
shall also use commercially reasonable efforts to develop other LICENSED
PRODUCTS in the LICENSED FIELD suitable for different indications, so that the
PATENT RIGHTS can be commercialized in the LICENSED FIELD as broadly and as
speedily as good scientific and business judgment would deem possible.
6.4 After clinical or other evidence, provided in writing by JHU, to CCT,
demonstrates the commercial and technical practicality of a particular
therapeutic application in the LICENSED FIELD which is not being developed or
commercialized by CCT, CCT shall either provide JHU with a reasonable
development plan and start development or attempt to reasonably sublicense the
technology for the particular therapeutic application to a third party. If
within six (6) months of such notification by JHU, CCT has not initiated such
development efforts or initiated efforts to sublicense that particular
therapeutic application, JHU may upon thirty (30) days notice terminate this
license for such particular therapeutic application. This Paragraph 6.4 shall
not be applicable if CCT reasonably demonstrates to JHU that commercializing
such LICENSED PRODUCT(S) or granting such a sublicense would have a potentially
adverse commercial effect upon marketing or sales of the LICENSED PRODUCTS
developed and being sold by CCT.
6.5 Upon breach or default of any of the terms and conditions of this
Agreement, the defaulting party shall be given notice of such default 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.
14
6.6 (a) CCT may terminate this Agreement and the license granted herein,
for any reason, upon giving JHU sixty (60) days notice.
(b) Notwithstanding section 6.6(a), CCT may terminate this agreement
upon notice to JHU at any time within ninety (90) days after the EFFECTIVE DATE
without any cost or penalty to JHU, including without limitation any costs
relating to patents or any RESEARCH MILESTONES.
6.7 Termination shall not affect JHU's right to recover unpaid royalties
or fees or reimbursement for patent expenses and other uncancelable obligations
incurred pursuant to Paragraph 4.1 prior to termination. Upon termination, all
rights in and to the licensed technology shall revert to JHU at no cost to JHU.
ARTICLE 6A - REPRESENTATIONS AND WARRANTIES
6A.1 JHU represents to CCT that as of the EFFECTIVE DATE:
(a) Except for any rights of the United States of America as set forth in
Public Laws 96-517 and 98-620, JHU is the owner of the entire right, title and
interest in and to the PATENT RIGHTS;
(b) JHU has not assigned, transferred, licensed, pledged or otherwise
encumbered the PATENT RIGHTS or the INVENTIONS to any other entity or individual
that would restrict the rights granted to CCT hereunder in any way;
(c) JHU has full power and authority to enter into this Agreement and to
grant the EXCLUSIVE LICENSES granted to CCT hereunder;
6A.2. CCT represents and warrants to JHU that:
15
(a) CCT is a corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware and has all requisite corporate
power and authority to carry on its business as now conducted; and
(b) All corporate action on the part of CCT, its officers and directors
necessary for the authorization, execution and delivery of this Agreement and
the performance of all obligations of CCT hereunder has been taken, and this
Agreement constitutes a valid legally binding obligation of CCT.
ARTICLE 7 - MISCELLANEOUS
7.1 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 7.1:
FOR JHU: Xxxxxx Xxxxxxxx, Esq.
Assistant Xxxx and Director
Office of Technology Licensing
The Xxxxx Xxxxxxx University
School of Medicine
0000 X. Xxxxxxxx Xx., Xxxxx. 0-000
Xxxxxxxxx, XX 00000
FOR CCT: Vice President, Business Development
00 Xxxxxxx Xxxxxx
Xxxxxxx, XX 0000.0
7.2 All written progress reports, royalty and other payments, and any
other related correspondence shall be in writing and sent to:
FOR JHU: Xxxxxx Xxxxxxxx, Esq.
Assistant Xxxx and Director,
Office of Technology Licensing
The Xxxxx Xxxxxxx University
School of Medicine
0000 X. Xxxxxxxx Xx., Xxxxx. 0-000
Xxxxxxxxx, XX 00000
16
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".
7.3 This Agreement is binding upon and shall inure to the benefit of JHU,
CCT and their successors and assignees and shall not be assignable to another
party without the written consent of the other party, which consent shall not be
unreasonably withheld, except that CCT shall have the right to assign this
Agreement to another party without the consent of JHU in the case of the sale or
transfer by CCT of all, or substantially all, of its assets relating to the
LICENSED PRODUCT or LICENSED SERVICE, to that party.
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; elsewhere, this Agreement shall not
be affected.
7.5 The construction, performance, and execution of this Agreement shall
be governed by the laws of the State of Maryland.
7.6 CCT shall not use the name of THE XXXXX XXXXXXX UNIVERSITY or THE
XXXXX XXXXXXX HEALTH SYSTEM or any of its constituent parts, such as the Xxxxx
Xxxxxxx Hospital or any contraction thereof or the name of INVENTORS of PATENT
RIGHTS in any advertising, promotional, sales literature or fundraising
documents without prior written consent from an officer of JHU unless required
by law, any such consent not to be unreasonably withheld or delayed. CCT shall
allow at least seven (7) business days notice of any proposed public disclosure
for JHU's review and comment or to provide written consent.
7.7 JHU does not warrant the validity of any patents or that practice
17
under such patents shall be free of infringement. EXCEPT AS EXPRESSLY SET FORTH
IN THIS PARAGRAPH 7.7, AND IN SECTION 6A.1, CCT, 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. EXCEPT AS SET FORTH IN SECTION 6A.1, 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 PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS
AND LIABILITIES ON THE PART OF JHU AND 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 LICENSED PRODUCT(S) AND LICENSED
SERVICES UNDER THIS AGREEMENT. CCT, AFFILIATED COMPANIES AND SUBLICENSEES ASSUME
ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT AND
SERVICE MANUFACTURED, USED, OR SOLD BY CCT, ITS SUBLICENSEES AND AFFILIATED
COMPANIES WHICH IS A LICENSED PRODUCT OR LICENSED SERVICE AS DEFINED IN THIS
AGREEMENT.
7.8 JHU and the INVENTORS of LICENSED PRODUCT(S) and LICENSED SERVICES
will not, under the provisions of this Agreement or otherwise, have control over
the manner in which CCT 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, practice the inventions of
18
LICENSED PRODUCT(S) and LICENSED SERVICES. CCT 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 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 said INVENTORS, either jointly or severally, is
named as a party defendant in any such lawsuit. 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
CCT or by a third party who purchases LICENSED PRODUCT(S) and LICENSED SERVICES
from CCT, shall be considered CCT's practice of said inventions for purposes of
this Paragraph 7.8. The obligation of CCT to defend and indemnify as set out in
this Paragraph 7.8 shall survive the termination of this Agreement.
7.9 Prior to initial human testing or first commercial sale of any
LICENSED PRODUCT or LICENSED SERVICE as the case may be in any particular
country, CCT shall establish and maintain, in each country in which CCT, an
AFFILIATED COMPANY or Sublicensee shall test or sell LICENSED PRODUCT(S) and
LICENSED SERVICES, product liability or other appropriate insurance coverage
appropriate to the risks involved in marketing LICENSED PRODUCT(S) and LICENSED
SERVICES and will annually upon request present evidence to JHU that such
coverage is being maintained. Upon JHU's request, CCT will furnish JHU with a
Certificate of Insurance of each product liability insurance policy obtained and
agrees to increase or change the kind of insurance pertaining to the LICENSED
PRODUCT(S) and LICENSED SERVICES, within reasonable commercial limits, at the
request of JHU. JHU shall be listed as an additional insured in CCT's said
insurance policies.
7.10 The parties agree to use good faith efforts to collaborate on joint
publications. In any case, the publishing party shall provide any proposed
publications to the other party thirty (30) days prior to submission to a
journal or any public disclosure. The non-publishing party shall have such
thirty (30) day period to identify any CONFIDENTIAL
19
INFORMATION or potentially patentable information and provide comments to the
publishing party. Upon the request of the non-publishing party, the publishing
party agrees to delay submission for a ninety (90) days to allow for the filing
of any relevant patent applications. In accordance with scientific custom, the
publishing party agrees to note the contributions of the non-publishing party
through acknowledgment or co-authorship, as appropriate.
7.11 This Agreement and the COLLABORATIVE RESEARCH AGREEMENT constitute
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.
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
instances shall be construed as a further or continuing waiver of such condition
or term or of any other condition or term.
7.13 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.
7.14 Upon termination of this Agreement for any reason, Paragraphs 5.3,
6.7, 7.6, 7.7 and 7.8 and 7.9 shall survive termination of this Agreement.
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IN WITNESS WHEREOF the respective parties hereto have executed this
Agreement by their duly authorized officers.
THE XXXXX XXXXXXX UNIVERSITY XXXXXXX CELLULAR
THERAPIES, INC.
By /s/ Xxxx Xxxxxxx By /s/ Xxxxxx X. Xxxxx
-------------------------------- ------------------------------
Xxxx Xxxxxxx, M.D. Xxxxxx X. Xxxxx
Vice Xxxx for Research & Technology President and CEO
Prof. of Med., Anesthesiology &
Critical Care
Date: Jan. 27, 1999 Date December 28, 1998
-------------------------------- ------------------------------
I have read and agree to abide by the terms of this Agreement.
By /s/ Xxxxxxxx Xxxxxxx
--------------------------------
Xx. Xxxxxxxx Xxxxxxx
Date: 1/28/99
--------------------------------
By /s/ Xxxx Xxxxxxx
--------------------------------
Xx. Xxxx Xxxxxxx
Date: Jan. 28, 1999
--------------------------------
21
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
APPENDIX A
Vesting Schedule
Percentage Number
of Shares of Shares
--------- ---------
Common Share Total 250,000
Vesting Milestones
Issuance of first U.S. Patent 20% 50,000
Issuance of first European
Patent 20% 50,000
Initiation of a Phase I
Human Clinical Trial 20% 50,000
First U.S. Commercial Sale 20% 50,000
First E.U. Commercial Sale 20% 50,000
00
XXXXXXXX X
Research Milestones
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Feasibility Phase **
JHU to transfer ** to CCT, together with
ancillary technology as appropriate
CCT to perform laboratory evaluation of ** as therapeutic agents
CCT to determine appropriate ** for therapeutic products
CCT and JHU to agree to ** and disease targets for development
CCT and JHU to identify ** highest priority disease targets
JHU to develop ** highest priority disease targets
CCT and JHU to engineer a **
CCT and JHU to develop work plan for Development Phase
Development Phase **
JHU to transfer ** highest priority disease targets
CCT to develop ** for highest priority disease target
CCT to produce ** for highest priority disease target
JHU to develop necessary ** for highest priority disease target
CCT to develop ** for highest priority disease target
JHU to initiate development of the ** disease target
CCT and JHU to develop work plan for Optimization Phase
23
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Optimization Phase **
JHU to test ** for highest priority disease target
CCT to produce ** for highest priority disease target
JHU to test ** highest priority disease target
JHU and CCT to develop ** for highest priority disease target
CCT to develop ** disease target
CCT to produce ** disease target
JHU to develop ** disease target
JHU to transfer ** disease target
JHU to develop ** disease target
CCT and JHU to develop work plan for Preclinical Phase
Preclinical Phase **
CCT to produce ** for highest priority disease target
CCT and JHU to test ** for highest priority disease target
CCT and JHU to ** for highest priority disease target
CCT and JHU to prepare and submit ** for highest priority disease target
CCT to produce ** disease target
JHU to test ** disease target
CCT to develop ** disease construct
JHU to develop and transfer ** disease target
CCT and JHU to develop work plan for Clinical Phase
Clinical Phase **
JHU to initiate ** for highest priority disease target
CCT to produce ** disease target
JHU and CCT to develop ** disease target
24
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
CCT and JHU to test ** disease target
CCT and JHU to ** disease target
CCT to produce ** disease target
CCT and JHU to agree to appropriate ** and disease states for development
CCT and JHU to initiate **
25
