Exhibit 10.103
LICENSE AGREEMENT
-----------------
This License Agreement ("Agreement") effective as of the 24th day of
December 2003 (the "Effective Date"), by and among IGI, Inc., a Delaware
corporation ("IGI"), having its principal place of business at 000 Xxxxxxx
Xxxxxx, Xxxxx, Xxx Xxxxxx 00000, and Xxxxxxx X. Xxxxxx, MD, PhD ("XXXXXX"),
residing at 00 Xxxxxx Xxxx, Xxxxxxx, XX 00000, and A&D Bioscience Inc.
("A&D"), a Massachusetts corporation wholly owned by Xxxxxx, with its
principal place of at 00 Xxxxxx Xxxx, Xxxxxxx, XX 00000.
WITNESSETH
----------
WHEREAS, XXXXXX represents and warrants that he is the sole owner, free
and clear of any and all liens, encumbrances, claims or other impairments, of
and to all rights, title and interest in and to certain intellectual property
and inventions (as described in the patents and patent applications set forth
on Appendix A annexed hereto and made a part of this Agreement), and
information, know-how, data, materials, trade secrets and other proprietary
information relating to Parathyroid Hormone Related Peptide ("PTH") drugs,
formulations, methods, usage and technologies, including but not limited to
the PTH technologies developed by XXXXXX useful in the treatment of psoriasis
and hair loss (designated herein as the "PTH Technologies");
WHEREAS, XXXXXX and A&D represent and warrant that A&D is the sole
owner by assignment of any and all rights, title and interest in and to
certain intellectual property and inventions (as described in the patent
applications set forth on Appendix B annexed hereto and made a part of this
Agreement), and information, know-how, data, materials, trade secrets and
other proprietary information relating to glycoside drugs, formulations,
methods, usage and technologies, including but not limited to the sugar
conjugate platform technology useful for a wide family of drugs (designated
herein as the "Glycoside Technologies");
WHEREAS, A&D further represents and warrants that it is in possession
of a valid and biding Assignment executed by all Inventors which by its terms
and operation fully and permanently assigns to A&D, free and clear of any and
all liens, encumbrances, claims or other impairments, any and all of his
rights, title and interest in and to the Glycoside Technologies and each and
all of the pending patent applications set forth on Appendix B annexed hereto
and made a part of this Agreement; and
WHEREAS, XXXXXX and A&D, respectively, represent and warrant that they
have the sole right to grant an exclusive license for the PTH Technologies
and the Glycoside Technologies under the terms and conditions set forth
herein;
WHEREAS, IGI states that it is in the business of developing,
formulating, producing and manufacturing cosmetics, fragrances, consumer
products, and topical dermatological products, and desires to acquire
exclusive rights from XXXXXX and A&D, respectively, in and to the PTH
Technologies and the Glycoside
1
Technologies, including without limitation the products, and methods and
processes for making and using the PTH Technologies and the Glycoside
Technologies in the Field, and seeks the right to grant sublicenses of the
PTH Technologies and Glycoside Technologies to its Affiliates and to third
parties, and to grant its Affiliates and sublicensees the right to grant
further sublicenses to third parties; and
WHEREAS XXXXXX and A&D, respectively, are willing to grant such an
exclusive license;
NOW, THEREFORE, in consideration of the mutual promises and covenants
herein contained, and other good and valuable consideration, the receipt and
sufficiency of which is acknowledged by the parties hereto, IGI and XXXXXX
and A&D agree as follows:
ARTICLE I - DEFINITIONS
-----------------------
1.1 Licensed Technology. The term "Licensed Technology" shall mean
any and all data, information, technologies, formulations, know-how,
processes, techniques, methods, skill, proprietary information, trade
secrets, developments, discoveries and inventions, and other proprietary
material relating to the PTH Technologies and the Glycoside Technologies,
including, but not limited to the improvements on such inventions in the
Field, which arise during the course of this Agreement .
1.2 Licensed Patent Rights. The term "Licensed Patent Rights" shall
mean each and all United States and foreign patents and patent applications
for any and all patents for the License Technology in the Field, including,
without limitation, each and all United States, Foreign and International
patents and patent applications set forth on Appendix A and Appendix B
annexed hereto and made a part of this Agreement, and all issued divisions,
continuations, continuations-in-part, reexaminations, reissues and extensions
thereof.
1.3 Licensed Products. The term "Licensed Products" shall mean any
and all products, the development, formulation, manufacture, use,
distribution or sale of which is within the scope of the Licensed Patent
Rights.
1.4 Affiliates. The term "Affiliates" shall mean any corporation or
other business entity, directly or indirectly, controlling, controlled by or
under common control with a party.
1.5 Territory. The term "Territory" shall mean all countries in the
world.
1.6 Field. The term "Field" means the any and all uses of the PTH
Technologies and the Glycoside Technologies, including, but not limited to,
the PTH Technologies for cosmetics, consumer products, and topical
dermatological products for treating psoriasis and hair loss, and the
processes for making the same.
1.7 Sublicense Agreement. The term "Sublicense Agreement" shall mean
a valid and enforceable written agreement fully executed by IGI and a third
party pursuant to the terms of which a sublicense is granted
2
by IGI to the third party to make, have made, use and/or sell Licensed
Products in the Field using the Licensed Technology covered by a Licensed
Patent Rights.
1.8 Milestone Payment. The term "Milestone Payment" shall mean only
to include a payment of a fixed lump sum amount that a third party is
required to make to IGI under the terms of a Sublicense Agreement (as defined
in Section 1.7 above) upon either on an exact specified future date that is
at least one (1) year subsequent to the effective date of the Sublicense
Agreement, and/or upon the occurrence or happening of certain specified
events or acts contingent to the requiring that such payment be made (e.g.,
payment of $X due upon receipt of FDA approval for Drug X ), but shall
expressly exclude without limitation (i) any and all lump sum payments made
or received by IGI upon the execution of a Sublicense Agreement or at any
time within one (1) year thereafter, (ii) any and all royalties, commissions
or other payments based on a percentage of sales made to or received at any
time by IGI under a Sublicense Agreement, (iii) payments to IGI in
reimbursement or contribution of fees, expenses, costs or other obligations
incurred at any time under a Sublicense Agreement to protect, promote,
develop, prosecute, oversee and/or register any of the intellectual property
rights related to the development of the Licensed Technology; and (iv) any
and all payments made to or received at any time by IGI as consideration for
or otherwise attributed to any tangible or intangible property, assets,
goods, intellectual property or other rights of any kind acquired, licensed,
assigned, leased, sold or otherwise transferred by IGI to the third party as
part or incident to a Sublicense Agreement.
ARTICLE II - GRANT
------------------
2.1 Exclusive License. XXXXXX and A&D, respectively, hereby grant to
IGI an exclusive license for a term of the longer of twenty (20) years or the
life of each and all patents for the Licensed Technology in the Field,
including, without limitation, the patents and patent applications set forth
on Appendix A and Appendix B annexed hereto and made a part of this
Agreement, with the right to grant sublicenses, as well as the right of its
sublicensees to grant further sublicenses, to make, have made, use,
distribute and sell Licensed Products in the Field using the Licensed
Technology covered by the Licensed Patent Rights throughout the Territory.
ARTICLE III - PAYMENTS AND OPTIONS
----------------------------------
3.1 Payments. In consideration of the exclusive license granted to
IGI hereunder, XXXXXX shall receive payments from IGI, as follows:
i. Non-refundable advance payment of $50,000 was received by
XXXXXX from IGI upon execution of the Memorandum of
Agreement on September 26, 2003;
ii. Within five (5) days of the execution of a Sublicense
Agreement IGI shall make payment to XXXXXX in the amount of
$236,000; provided, however, nothing contained in this
Agreement shall require IGI to sublicense to a third party
any of its rights acquired hereunder to any of the Licensed
Technology covered by the Licensed Patent Rights, and IGI
shall have no obligation to make payment to XXXXXX in the
foregoing sum of
3
$236,000 or any other amount if for any reason whatsoever
IGI does not grant a sublicense to a third party and/or
enter into a Sublicense Agreement.
3.2 Options. As additional consideration hereunder, within thirty
(30) days of the execution of this Agreement, IGI shall grant to XXXXXX
options to purchase up to but not exceeding a total of 300,000 shares of IGI
Common Stock in accordance with and to the extent authorized under the terms
and conditions of the Company's stock options plans. To the extent
permitted by the Company's stock options plans, the options granted to XXXXXX
under this Section 3.2 shall vest at the earliest of the following: (a)
300,000 options upon the execution of a Sublicense Agreement relating to the
PTH Technologies, (b) 300,000 options one year after the date of grant, or
(c) 100,000 options each year after the date of grant during which and
provided Xx. Xxxxxx remains an employee of IGI.
3.3 Right to Terminate As to PTH Technologies. If following 180 days
from the Effective Date of this Agreement set forth above, IGI has not either
(a) entered into or executed a Sublicense Agreement relating to the PTH
Technologies, or (b) otherwise raised sufficient capital to provide the
necessary financial resources to fund the Phase I of the NDS ("New Drug
Study") Human Clinical Trial for Alopecia, XXXXXX shall have the right upon
ten (10) business days written notice to IGI to terminate this Agreement as
it relates to the PTH Technologies revoking all rights granted hereunder
thereto; PROVIDED, HOWEVER, that no such termination under this Section 3.3
shall be effective unless and until XXXXXX returns to IGI in full (i) any and
all payments received by XXXXXX under Section 3.1 of this Agreement, (ii)
any and all unexercised options received by XXXXXX from IGI under Section 3.2
of this Agreement, and (iii) any and all other amounts paid or incurred by
IGI under Sections 5.1 and/or 5.2 of this Agreement.
3.4 Right to Terminate As to Glycoside Technologies. If following 90
days from the Effective Date of this Agreement set forth above, IGI has not
entered into or executed a Sublicense Agreement relating to the Glycoside
Technologies, A&D shall have the right upon ten (10) business days written
notice to IGI to terminate this Agreement as to only the Glycoside
Technologies revoking all rights granted hereunder thereto.
ARTICLE IV -- SUBLICENSE AND ROYALTY PAYMENTS
----------------------------------------------
4.1 Sublicense Milestone Payments. In the event IGI grants a third
party a sublicense to make, have made, use and sell Licensed Products in the
Field using the Licensed Technology covered by a Licensed Patent Right, IGI
shall subject to its right to reimbursement under Section 4.6 of this
4
Agreement pay to XXXXXX and/or A&D, as the case may be relative to the
Licensed Technology at issue, 50% of the gross amount of any Milestone
Payments received by IGI from a third party as consideration for the
sublicense rights granted to such third party under a Sublicense Agreement,
less (i) 50% of any and all transactional fees and expenses incurred by IGI
relating thereto, including attorney fees, brokerage commissions, finder
fees, bonuses and awards to IGI personnel responsible for consummation of the
transaction, accounting fees, filing fees, search fees and other professional
service fees; (ii) any and all taxes; (iii) any and all liabilities and other
obligations assumed by IGI under the terms of the agreement granting the
sublicense; (iv) any and all amounts paid by IGI to XXXXXX under Section 3.1
of this Agreement as of the date of the Milestone Payment at issue which have
not already been otherwise recovered by IGI under this Agreement as of such
date; (v) any and all amounts equal to the value of the unexercised options
received by XXXXXX under Section 3.2 of this Agreement as of the date of the
Milestone Payment at issue which has not already been otherwise recovered by
IGI under this Agreement as of such date; (vi) any and all costs, fees and
other expenses made, paid, assumed or incurred by IGI under Sections 5.1
and/or 5.2 or any other provision of this Agreement as of the date of the
Milestone Payment at issue which has not already been otherwise recovered by
IGI under this Agreement as of such date; and (vii) any and all amounts of
the Milestone Payment received by IGI as consideration for or otherwise
attributed to any and all tangible or intangible property, assets, goods,
intellectual property or other rights of any kind acquired, licensed,
assigned, leased, sold or otherwise transferred by IGI to the third party as
part of or incident to the transaction and/or agreement that granted the
sublicense rights at issue.
4.2 Sublicense Royalty Payments. Subject to IGI's right to
reimbursement under Section 4.6 of this Agreement, IGI shall pay XXXXXX
and/or A&D, as the case may be relative to the License Product sale at issue,
as annual royalties of 50% on the Net Sales Amount received by IGI on the
sale of Licensed Products to sublicensees from the Effective Date hereof
until the expiration of the Licensed Patent Right used to make such Licensed
Product, with no further payments of any kind be being due to XXXXXX and/or
A&D, as the case may be relative to the License Product sale at issue, after
the date thereof. For the purpose of this Agreement, "Net Sales Amount"
shall mean the gross amounts received by IGI from the sale of Licensed
Products to a sublicensee, less the aggregate of the following amounts: (i)
discounts, including cash discounts, off-invoice allowances or rebates
actually allowed or granted, provided that IGI does not receive any payments
or consideration for such discounts, (ii) credits or allowances actually
granted by IGI upon claims or returns; (iii) freight, insurance and
transportation
5
charges; (iv) all sales taxes, excise taxes and other taxes or duties; and
(v) additional delivery charges for "cash-on-delivery" orders. Sales are
considered made for the purposes of this Agreement when invoiced by IGI to
sublicensee.
4.3 Books and Records. IGI shall, and shall maintain complete and
accurate records of sales of all Licensed Products to sublicensees and all
royalty payments due to XXXXXX and/or A&D hereunder, and IGI shall deliver to
XXXXXX and/or A&D, as the case may be, within forty-five (45) days after the
close of each calendar year, a true and accurate written report, certified as
true and correct by an officer of IGI, setting forth the gross dollar amounts
received by IGI for the sales of Licensed Products to sublicensees; the
calculation of the Net Sales Amount; and the computation of the royalties to
be paid to XXXXXX and/or A&D, as the case may be relative to the License
Product sale at issue, by IGI for such period. Simultaneously with providing
the report required in this Section 4.3, IGI shall pay to XXXXXX an/or A&D,
as the case may be, the entire amount of royalties due to XXXXXX and/or A&D,
as the case may be, for the calendar year on account of which such report is
made and submitted.
4.4 Right to Audit. XXXXXX and A&D shall have the right, at his own
expense, to request an audit of any annual period ending not more than two
(2) years prior to the date of such request, and to appoint an independent
accountant to perform such audit. The independent accountant appointed by
XXXXXX and/or A&D shall have access to the business records of IGI which are
necessary or appropriate to verify the royalties payable to XXXXXX and/or
A&D, as the case may be, pursuant to this Agreement. The independent
accountant shall keep confidential all information received from IGI, except
for information necessary for disclosure to XXXXXX and/or A&D, as the case
may be, to report on the accuracy of IGI's reports. In the event that a
deficiency of ten percent (10%) or more is discovered between the actual
royalty payment due to XXXXXX and/or A&D, as the case may be, and the amount
of the royalty payment specified in the written report submitted by IGI to
XXXXXX and/or A&D pursuant to Section 4.3, IGI shall bear the costs of the
audit conducted by XXXXXX and/or A&D, as the case may be.
4.5 Payment by Check. All payments of royalties and other amounts
due to XXXXXX and/or A&D pursuant to any of the provisions of this Agreement
shall be made to XXXXXX and/or A&D, as the case may be, by check to the
address set forth under Section 10.1 herein or other addressed to which IGI
as been notified in accordance with the terms of Section 10.1.
4.6 IGI's Right to Reimbursement It is expressly understood and
agreed by the parties hereto that neither XXXXXX nor A&D shall not receive
payment from IGI for any amount whatsoever under Sections 4.1 and/or 4.2
unless and until such time that IGI has recovered in full by, through or
resulting
6
from operations, transactions or other business opportunities relating to
the Licensed Technology covered by the Licensed Patent Rights (i) any and all
amounts paid by IGI to XXXXXX under Section 3.1 of this Agreement, (ii) an
amount equal to the value any and all options received by XXXXXX from IGI
under Section 3.2 of this Agreement, and (iii) any and all amounts paid or
incurred by XXXXXX and/or A&D, as the case may be, under Sections 5.1 and/or
5.2 of this Agreement.
ARTICLE V - COMMERCIALIZATION
-----------------------------
5.1 Development and Oversight Expenses. IGI shall be responsible for
any and all costs, fees and expense for the prosecution and oversight of any
intellectual property rights related to the development of the Licensed
Technology on a going forward basis, such obligations shall include, but are
not limited to, payment by IGI within thirty (30) days of the execution this
Agreement for the amount of the actual costs and expenses incurred by XXXXXX
the case may be, from January 1, 2003 until the Effective Date of this
Agreement for prosecuting the patents and patent application set fort on
Appendix A annexed hereto and made a part of this Agreement, as follows: (a)
$27,039.00 to Sterne, Kessler, Xxxxxxxxx & Fox; and (b) $458.74 to Xxxxx &
Xxxxxx, LLP.
5.2 Government Approvals. IGI (and its sublicensees) shall be
responsible for all government approvals of Licensed Products, and the rights
in and to said data and any governmental approvals obtained thereof shall be
the property of IGI (or sublicensees as the case may be).
5.3 Right to Manufacture. IGI (together with its sublicensees) shall
have the exclusive right to manufacture, and sublicense for manufacture,
Licensed Products in the Field pursuant to the grant under Section 2.1 above
and otherwise under this Agreement.
5.4 Manufacturing Know-How. To assist IGI (and its sublicensees) in
achieving the aims of Section 5.3, XXXXXX and A&D will supply all of the
manufacturing know-how in his possession or available to him for development
and/or manufacture of Licensed Products in the Field at no cost to IGI. To
further assist in development and/or manufacture of Licensed Products, IGI
(and its sublicensees) may send personnel to XXXXXX'x and/or A&D's offices
and/or other facilities at a time convenient for, and with the prior approval
of, XXXXXX and/or A&D, as the case may be, and XXXXXX and A&D shall provide
the instruction necessary for developing and manufacturing Licensed Products
at no cost to IGI.
5.5 Advertising and Promotion. IGI (and its sublicensees) shall have
the responsibility for the preparation and dissemination of all advertising
and promotional materials, including, without limitation, the choosing and
use of trade names and trademarks in connection with the Licensed Products
and shall pay all
7
costs in connection therewith, and all such trade name and trademarks shall
be the sole and exclusion property of IGI.
ARTICLE VI - PATENTS
--------------------
6.1 Warranty as to Patent Filings. XXXXXX and A&D, respectively,
warrant and represent that all of the patent applications covering the
Licensed Technology for use in making Licensed Products in the Field have
been filed, and that all the patents set forth on Appendix A and Appendix B
annexed hereto and made a part of this Agreement have been issued, and that
all the patents applications set forth on Appendix A and Appendix B have been
filed, and that neither XXXXXX nor A&D, respectively, are not aware of any
valid patents of third parties which would be infringed by IGI's or its
sublicensees', making, using or selling Licensed Products.
6.2 Warrant as to Patent Ownership. XXXXXX and A&D, respectively, as
the case may be relative to the technology at issue, represent and warrant
that they are the sole owner of and have the full authority to grant to IGI
the rights with respect to the Licensed Patent Rights in accordance with this
provision of this Agreement. XXXXXX and A&D, respectively, further represent
and warrant that no written consent or other notice from any third party is
necessary or required under any agreement, arrangement, association,
understanding or other affiliation between or among ether XXXXXX, A&D and/or
any third party to grant to IGI the rights with respect to the Licensed
Patent Rights hereunder.
6.3 Infringement Notice. XXXXXX, A&D or IGI, as the case may be,
shall provide written notice to the other of any infringement known to
XXXXXX, A&D or IGI of a Licensed Patent Right, and shall supply the other
with such details of such infringement as are actually in XXXXXX'x, A&D's or
IGI's possession.
6.4 Infringement by Others. In the event of any infringement of a
Licensed Patent Right in the Field, IGI shall, if consistent with its
business interests, institute such proceedings or other actions as it deems
advisable to prevent such infringement and shall retain all recovery from any
infringer.
6.5 Infringement Proceedings. If IGI does not institute such
proceedings or other actions necessary to prevent such infringement within
three (3) months after it learns of such infringement, XXXXXX and/or A&D,
respectively as the case may be, at their own expense, institute such
proceedings as may be appropriate to prevent such infringement.
Notwithstanding the foregoing, neither XXXXXX, A&D nor IGI has any obligation
to institute any proceedings or other actions to prevent infringement of a
Licensed Patent Right. However, the party who initiates such proceedings or
actions shall be solely entitled to any and all recovery.
6.6 Infringement of Others' Proprietary Rights. XXXXXX and A&D, as
the case may be shall, defend, indemnify and hold harmless IGI (and its
sublicensees) from and against any and all liabilities, losses, damages,
claims, demands, suits, judgments, royalties, actions, causes of action,
costs or expenses of any nature
8
whatsoever arising out of any infringement or alleged infringement of the
proprietary rights of others by a Licensed Product.
ARTICLE VII - IMPROVEMENTS
--------------------------
7.1 Improvements. If at any time during the term of this Agreement
XXXXXX, A&D or IGI shall make or discover any improvement of the Licensed
Products useful in the Field, XXXXXX, A&D and IGI, respectively, shall
communicate all details in respect thereof to the other party. If XXXXXX
and/or A&D make such an improvement, IGI (and its sublicensees) shall be
entitled to use the same in the Field during the term of this Agreement upon
the same terms pursuant to this Agreement neither without payment of any
additional compensation nor without paying any increased or decreased royalty
in respect thereof. If XXXXXX and/or A&D obtain a patent in respect to any
such improvement, it shall be included in the Licenses Patent Rights.
7.2 Joint Inventions. In the event XXXXXX and/or A&D and employees
of IGI are joint inventors as a result of inventions arising out of the
development of Licensed Products, any patent applications filed thereon shall
be jointly owned by XXXXXX and/or A&D and IGI with IGI having the exclusive
right to use in the Field as provided in Section 2.1.
ARTICLE VIII- CONFIDENTIALITY
-----------------------------
8.1 Scope of Confidentiality. Except as expressly provided under
this Agreement, each party agrees that it shall hold in confidence for the
term of this Agreement and for a period of five (5) years thereafter all
confidential information disclosed by or acquired from the other pursuant to
this Agreement and shall not use such for the benefit of third parties, or
disclose such to third parties, without the prior written authorization of
the other party; provided, however, that neither party shall be responsible
for any inadvertent disclosure of confidential information provided it has
exercised the same standard of care as it exercises with respect to its own
information and further provided that the parties may, for the purpose of
development, testing, registration, exploitation and manufacture of Licensed
Products, transmit and disclose such information as is necessary to
affiliated company, subsidiaries, subcontractors, representatives, agents and
governmental authorities.
8.2 Exceptions. The foregoing obligation shall not extend to
information which (i) at the time of disclosure or acquisition is part of the
public knowledge or literature or thereafter becomes part of the public
knowledge or literature otherwise than by unauthorized disclosure by the
receiving party, or (ii) at the time of disclosure or acquisition was in the
receiving party's possession as evidenced by its written records, or (iii)
become available to the receiving party from another source not bound to
secrecy by the disclosing party with
9
respect to such information, (iv) is disclosed to Affiliates, subsidiaries,
subcontractors, representatives, agents and/or governmental authorities as
necessary or required for purposes of developing, testing, registration,
exploitation and/or manufacture of a Licensed Product, and (v) disclosure as
otherwise required by law.
8.3 Press Releases. Except as otherwise required by law, neither
XXXXXX, A&D nor IGI shall issue a press release or other public announcement
concerning, or otherwise disclosing, the execution and/or the financial
terms of this Agreement without the prior specific written consent of the
other party. Notwithstanding the foregoing, IGI may in its sole discretion
disclose in a press release, to potential licensees, or otherwise, the fact
that this Agreement has been executed and entered into on mutually agreeable
terms without disclosing the amount of the payments, the royalty rates
hereunder or any of the other specific financial terms of this Agreement.
ARTICLE IX- TERM AND TERMINATION
--------------------------------
9.1 Term. Subject to XXXXXX'x right to terminate this Agreement
pursuant to Sections 3.3 and A&D's right to terminate this Agreement pursuant
to 3.4 above, this Agreement shall begin on the Effective Date set forth
herein and continue for the longer of twenty (20) years or the life of the
patents for the Licensed Technologies in the Field, including, without
limitation, the patents and patent applications set forth on Appendix A and
Appendix B annexed hereto and made a part of this Agreement. Upon termination
of this Agreement, IGI (and its sublicensees) may thereafter make, use,
distribute and sell the Licensed Products in any country without further
payment of any royalty or other compensation to XXXXXX and/or A&D.
ARTICLE X - NOTICES
-------------------
10.1 Any and all notices and other communications under this Agreement
shall be given in writing and shall be sent to the addresses set forth below,
or at such other address as may be designated in writing hereafter by XXXXXX,
A&D and/or the IGI in accordance with the terms hereof. If mailed, such
notice, demand or request shall be made by certified or registered mail, and
deposited in any post office station or letter-box, enclosed in a postage
paid envelope and shall be deemed to have been made on the third (3rd)
business day following posting as aforesaid. If commercially sent, the party
giving such notice shall use a recognized, overnight commercial courier
service and notice shall be deemed to have been made on the day following
actual delivery of such notice to the commercial carrier. If sent by
facsimile transmission, the party sending the transmission shall send it to
the facsimile number, if any, set forth below, or to such other number as a
party thereto shall direct by written notice given in accordance with this
Section 6. Delivery shall be deemed to have been made on the day that the
facsimile transmission occurred if received prior to 4:00 p.m. on a business
day at the place of receipt, otherwise on the following business day.
10
(a) To XXXXXX and/or A&D
Xx. Xxxxxxx X. Xxxxxx
00 Xxxxxx Xxxx
Xxxxxxx, XX 00000
(b) To the Company
Xxxxx Xxxxxxx
Chairman & Chief Executive Officer
IGI, Inc.
000 Xxxxxxx Xxxxxx
Xxxxx, Xxx Xxxxxx 00000
Fax No.: (000) 000-0000
With a copy to:
Xxxxx X. Xxxxxxxx, Esq.
Xxxxx & Associates, P.C.
1776 On the Green - 8th Floor
00 Xxxx Xxxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
Fax No.: (000) 000-0000
ARTICLE XI - ADDITIONAL PROVISIONS
----------------------------------
11.1 Assignment. The rights granted under this Agreement shall accrue
to XXXXXX and A&D, as the case may be, and their respective successors and
assigns, and to IGI and its successors and assigns. This Agreement if freely
assignable by either party with upon prior written notification of any such
assignment to be given to the other party.
11.2 Warranty of License to Others. XXXXXX and A&D, respectively,
represent and warrant to IGI that no license or right has been or will be
granted during the exclusive term of this Agreement by XXXXXX and/or A&D, as
the case may be, to any third party to manufacture, use or sell the Licensed
Products in the Field, and neither XXXXXX, A&D nor any party their
respective behalves shall use, manufacture or sell the Licensed Products in
the Field.
11.3 Modification and No Waiver. This License Agreement may be
amended, modified, superseded or canceled, and any of the terms and
conditions hereof may be modified, only by a written instrument executed by
all parties hereto. Failure of any party at any time or times to require
performance of any provision hereof shall in no manner affect the right of
such party at a later time to enforce the same, and no waiver of any nature,
whether by conduct or otherwise, in any one or more instances, shall be
deemed to be or considered as a further or continuing waiver of any other
provision of this License Agreement.
11.4 Severability. In the event that any one or more of the
agreements, provisions or terms contained herein shall be declared invalid,
illegal or unenforceable in
11
any respect, the validity of the remaining agreements, provisions or terms
contained herein shall in no way be affected, prejudiced or disturbed
thereby.
11.5 Entire Agreement. This License Agreement contains the entire
agreement between the parties hereto with respect to the subject matter
hereof.
11.6 Governing Law and Jurisdiction. This Agreement shall be governed
by and construed in accordance with the laws of the State of New Jersey.
The parties hereto each expressly submit themselves and consent to the
jurisdiction of the state and federal courts of New Jersey with respect to
any action that may be commenced relating in any way to this Agreement. The
parties hereto each further agree that service of process with respect to any
judicial action between the parties relating to this Agreement shall be
deemed made when sent via ordinary United States mail to the parties at
addresses set forth above in Section 10.1. In the event either party is
required to incur legal fees and costs in seeking enforcement of this
Agreement, the prevailing party shall be entitled to recover from the other
party any and all such legal fees and costs so incurred.
11.7 Headings. Section headings are for convenience only and shall
not be considered a part of the terms and provisions of the Agreement.
11.8. Interpretation
(a) All references in this Agreement to the plural shall also mean
the singular and to the singular shall also mean the plural
unless the context otherwise requires. The words "hereof",
"herein", "hereunder", "this Agreement", "the Agreement" and
words of similar import when used in this Agreement shall refer
to this Agreement as a whole and not any particular provision of
this Agreement unless the context otherwise requires. The word
"including" when used in this Agreement shall mean "including,
without limitation". "And" and "or" as used in this Agreement
shall be interpreted conjunctively and shall not be interpreted
disjunctively to exclude any information otherwise within the
scope thereof.
(b) Any reference in this Agreement to any corporate and/or other
business entity shall include and extend to the benefit of such
corporate and/or other business entities' predecessors,
successors, subsidiaries, affiliates, assigns and/or any and all
of their respective past and present agents, attorneys,
representatives, officers, directors, employees, representatives,
independent contractors, accountants and shareholders, as if same
were named individually herein.
11.9 Neutral Construction. This Agreement is the product of
negotiations between the parties and shall be construed neutrally, without
regard to the identity of the party who drew it.
11.10 Counterpart Execution. This Agreement may be executed in one or
more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
11.11 Cooperation of the Parties. The parties hereto each expressly
acknowledge and agree to cooperate with each other in order to effectuate
this Agreement and the terms hereof, in whole or part, and as such, shall at
the reasonable request of either party hereto execute any additional
necessary documents, consistent with the terms of this Agreement, to
validate, enforce and/or otherwise effectuate the terms hereof.
12
11.12 Legal Advice of Counsel. The parties have obtained legal advice
concerning this Agreement from attorneys of their own choosing and have not
relied on anything the other party or the other party's attorneys have said
in deciding to sign this Agreement.
13
IN WITNESS WHEREOF, the parties hereto have executed this License
Agreement effective as of the day and year first above written.
IGI, INC.
By: /s/ Xxxxx Xxxxxxx
---------------------
Xxxxx Xxxxxxx
Chairman & CEO
A&D BIOSCIENCE INC.
By: /s/ Xxxxxxx X. Xxxxxx, MD, Ph.D.
------------------------------------
Xxxxxxx X. Xxxxxx, MD, Ph.D.
President
/s/ Xxxxxxx X. Xxxxxx, MD, Ph.D.
--------------------------------
Xxxxxxx X. Xxxxxx, MD, Ph.D
Individually.
14
APPENDIX A
----------
I. United States Issued Patents
----------------------------
Regulation of Cell Proliferation and Differentiation Using Peptides
U.S. Patent No. 5,527,772
Appl. No. 281,648
Inventor: Xxxxxxx X. Xxxxxx
Filed: July 28, 1994
Date of Patent: June 18, 1996
Assignee: None
Regulation of Cell Proliferation and Differentiation Using Peptides
(Expanded Claims)
U.S. Patent No. 5,840,690
Appl. No.: 471,576
Inventor: Xxxxxxx X. Xxxxxx
Filed: June 6, 1995
Date of Patent: November 24, 1998
Assignee: None
Regulation of Cell Proliferation and Differentiation Using Peptides
(Expanded Claims)
U.S. Patent No. 6,066,618
Appl. No. 09/191,192
Inventor: Xxxxxxx X. Xxxxxx
Filed: November 13, 1998
Date of Patent: May 23, 2000
Assignee: None
II. International issued Patents
----------------------------
JAPAN -
Title of Invention: Regulation of Cell Proliferation
and Differentiation using
Peptides
Japanese Patent No. 2802084
Date of Publication September 21, 1998
Patent Reg. Date July 10, 1998
Number of Claims Seven (7)
Application No. 509145/88
Application Date October 17, 1998
Domestic Announcement No. 505517/91
Domestic Announcement Date December 5, 1991
International Application No. PCT/US88/03649
International Publication No. WO89/03873
International Publication Date May 5, 1989
Inventor: Xxxxxxx X. Xxxxxx
Patentee: Xxxxxxx X. Xxxxxx
Assignee: None
CANADA
15
Title Of Invention: Regulation of Cell Proliferation
and Differentiation Using
Peptides.
Canadian Patent No. 1,326,469
Date Patent Issued January 25, 1994
Number of Claims: Twenty-three (23)
Inventor Xxxxxxx Xxxxxx
Patentee Xxxxxxx Xxxxxx
EUROPEAN PATENT
Title Of Invention: Regulation of Cell Proliferation
and Differentiation Using
Peptides.
European Patent No. EP 0 415 924 B1
Date Patent Issued May 29, 1996
Number of Claims: Twenty-three (23)
Inventor Xxxxxxx Xxxxxx
Patentee Xxxxxxx Xxxxxx
III. Pending United States Patent Applications
-----------------------------------------
Regulation and Cell Proliferation and Differentiation Using Topically
Applied Peptides
Application No.
Inventor: Xxxxxxx X. Xxxxxx
Filed: June 22, 2000
Assignee: None
16
Regulation of Cell Proliferation and Differentiation Using topically
Applied Nucleic Acid Molecules
Application No. To Be Assigned
Inventor: Xxxxxxx X. Xxxxxx
Filed:
Date of Patent:
Assignee: None
Use of Parathyroid Hormone Peptide Analogs for the Treatment of
Vaginal Atrophy
PCT International Patent Application
Application No.
Inventor: Xxxxxxx X. Xxxxxx
Filed:
Assignee: None
00
XXXXXXXX X
----------
X. Xxxxxxx Xxxxxx Xxxxxx Patent Applications -
Conjugates Comprising an NSAID and a Sugar and Uses Thereof
Application No. 60/391,642
Filing Date: June 27, 2002
Inventors: Xxxxxxx X. Xxxxxx and Xxxxxxx Xxxxxxxxxx
Assignee: A&D Bioscience Inc.
Carboxylic Acid Glycuronides, Glycosamides and Glycosides of
Quinolones, Penicillins, Analogs and Uses Thereof
Application No. 60/365,180
Filed: March 19, 2002
Inventors: Xxxxxxx X. Xxxxxx and Xxxxxxx Xxxxxxxxxx
Assignee: A&D Bioscience Inc.
Conjugates Comprising Cancer Cell Specific Ligands, A Sugar and Cancer
Chemotherapeutic Agents/Boron Neutron Capture Therapy Agents, and Uses
Thereof
Application No. 60/371,674
Filed: April 12, 2002
Inventors: Xxxxxxx X. Xxxxxx and Xxxxxxx Xxxxxxxxxx
Assignee: A&D Bioscience Inc.
Conjugates Comprising Cancer Cell Specific Ligands, A Sugar and
Diagnostic Agents, and Uses Thereof
Application No. 60/371,672
Filed: April 12, 2002
Inventors: Xxxxxxx X. Xxxxxx and Xxxxxxx Xxxxxxxxxx
Assignee: A&D Bioscience Inc.
Conjugates Comprising a Central Nervous System-Active Drug Linked to
Glucuronic Acid or Glucosamine Through an Amide Bond and Uses Thereof
Application No. 60/378,333
Filed: May 7, 2002
Inventors: Xxxxxxx X. Xxxxxx and Xxxxxxx Xxxxxxxxxx
Assignee: A&D Bioscience Inc.
18
Glycoside and Orthoester Glycoside Derivatives of Apomorphine, Analogs,
and Uses Thereof
Application No. 60/365,454
Filed: March 19, 2002
Inventors: Xxxxxxx X. Xxxxxx and Xxxxxxx Xxxxxxxxxx
Assignee: A&D Bioscience Inc.
Glycuronamides, Glycosides and Orthoester Glycosides of Fluoxetine,
Analogs, and Uses Thererof
Application No. 60/359,887
Filed: February 28, 2002
Inventors: Xxxxxxx X. Xxxxxx and Xxxxxxx Xxxxxxxxxx
Assignee: A&D Bioscience Inc.
II. Pending International Patent Applications Under the Paten Cooperation
---------------------------------------------------------------------
Treate (PCT) -
--------------
Conjugates Comprising an NSAID and a Sugar and Uses Thereof
Int'l Application No. PTC/US2003/020188
Int'l Filing Date: June 27, 2003
Int'l Publication No. WO 2004/002457 A2
Int'l Publication Date: January 8, 2004
Inventors: Xxxxxxx X. Xxxxxx and
Xxxxxxx Xxxxxxxxxx
Applicant: A&D Bioscience Inc.
Carboxylic Acid Glycuronides, Glycosamides and Glycosides of
Quinolones, Penicillins, Analogs and Uses Thereof
Int'l Application No. PTC/US03/08260
Int'l Filing Date: March 19, 2003
Int'l Publication No. WO 03/079980 A2
Int'l Publication Date: October 2, 2003
Inventors: Xxxxxxx X. Xxxxxx and
Xxxxxxx Xxxxxxxxxx
Applicant: A&D Bioscience Inc.
19
Conjugates Comprising Cancer Cell Specific Ligands, A Sugar and Cancer
Chemotherapeutic Agents/Boron Neutron Capture Therapy Agents, and Uses
Thereof
Int'l Application No. PTC/US03/11374
Int'l Filing Date April 14, 2003
Int'l Publication No. WO 03/086312 A1
Int'l Publication Date October 23, 2003
Inventors: Xxxxxxx X. Xxxxxx and
Xxxxxxx Xxxxxxxxxx
Applicant: A&D Bioscience Inc.
Conjugates Comprising Cancer Cell Specific Ligands, A Sugar and
Diagnostic Agents, and Uses Thereof
Int'l Application No. PTC/US03/11372
Int'l Filing Date April 14, 2003
Int'l Publication No. WO 03/086475 A1
Int'l Publication Date October 23, 2003
Inventors: Xxxxxxx X. Xxxxxx and
Xxxxxxx Xxxxxxxxxx
Applicant: A&D Bioscience Inc.
Conjugates Comprising a Central Nervous System-Active Drug Linked to
Glucuronic Acid or Glucosamine Through an Amide Bond and Uses Thereof
Int'l Application No. PTC/US03/14050
Int'l Filing Date May 7, 2003
Int'l Publication No. WO 03/094842 A2
Int'l Publication Date November 20, 2003
Inventors: Xxxxxxx X. Xxxxxx and
Xxxxxxx Xxxxxxxxxx
Applicant: A&D Bioscience Inc.
20
Glycuronamides, Glycosides and Orthoester Glycosides of Fluoxetine,
Analogs, and Uses Thererof
Int'l Application No. PTC/US03/06061
Int'l Filing Date February 23, 2003
Int'l Publication No. WO 03/073988 A2
Int'l Publication Date September 12, 2003
Inventors: Xxxxxxx X. Xxxxxx and
Xxxxxxx Xxxxxxxxxx
Applicant: A&D Bioscience Inc.
21