Exhibit 10.7
"CONFIDENTIAL TREATMENT REQUESTED BY ACTIVBIOTICS, INC."
LICENSE AGREEMENT
between
Merlin Technologies, Inc.
and
Kaneka Corporation
September 27, 2001
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AMENDED AND RESTATED LICENSE AGREEMENT
THIS AMENDED AND RESTATED LICENSE AGREEMENT is dated and entered into
as of September 27, 2001, between Kaneka Corporation, a Japanese corporation
having its principal place of business at 0-0, Xxxxxxxxxxx 0-Xxxxx, Xxxx-Xx,
Xxxxx 000-0000, Xxxxx ("Licensor"), and Merlin Technologies, Inc., a Delaware
corporation having its principal place of business at 0 Xxxxxx Xxxxxx, 0xx
Xxxxx, Xxxxxx, XX 00000, X.X.X. ("Licensee"), and is effective as of July 24,
2001 ("the Effective Date").
WITNESSETH:
WHEREAS, Licensor has developed a certain Compound as hereinafter defined
and possesses certain patents, know-how and confidential technical information
relating thereto, and
WHEREAS, Licensee desires to acquire from Licensor an exclusive license, on
the terms set forth herein, to make, use and sell Compound and Products, as
hereinafter defined, and
WHEREAS, subject to all the terms and conditions of this Agreement,
Licensor is willing to grant to Licensee such exclusive license, and
WHEREAS, the parties entered into a License Agreement as of July 24, 2001
and desire to amend and restate such Agreement to read in full and as set forth
in this amended and restated License Agreement (as amended and restated, "this
Agreement").
NOW, THEREFORE, IT IS AGREED AS FOLLOWS:
ARTICLE 1. DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "Analog Product" or "the Analog Product" shall mean any pharmaceutical
product manufactured from a Compound Analog.
1.2 "Commercial Production" shall mean production of a Product for the
purpose of commercial sales.
1.3 "Compound" shall mean KRM-1648, which is described in Appendix 1
attached hereto.
1.4 "Compound Analog" shall mean any analogs of Compounds developed by
Licensor or covered by Licensor's Patents listed in Appendix 3.
1.5 "Trademark" shall mean any trademarks or names or registered names or
generic names with respect to Compound and Compound Analogs that is owned by
Licensor or as to which Licensor otherwise has a transferable interest.
1.6 "FDA" shall mean the United States Food and Drug Administration or any
successor to that agency.
1.7 "Field" shall mean any and all possible indications and uses of the
Compound for
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
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prevention, treatment or diagnosis of disease in humans or animals, subject to
the terms of Section 2.1(b) hereof with respect to veterinary applications.
1.8 "IND" shall mean designations by the FDA of a product as an
Investigational New Drug.
1.9 "Intellectual Property" means:
(a) the Patents; and
(b) the Technical Information
1.10 "NDA" shall mean a New Drug Application to the FDA or a relevant
procedure in a Country in the Territory in respect of a Product.
1.11 "Net Sales" shall mean the amounts received by Licensee and/or its
sub-icensee(s), or Licensor and/or its sub-licensee(s), as the case may be,
from independent customers who are not affiliates of Licensee, Licensor or their
respective Sub-licensees, for the sale of a Product or Analog Product, less(a)
trade, cash and/or quantity discounts actually allowed and taken; (b) excises,
sales taxes, value added taxes, duties and the like paid by the buyer in
addition to the sales price of the goods; (c) amounts repaid or credited by
reason of purchase charge backs, recalls, rebates (including government mandated
rebates), rejections defects or returns; and (d) freight, postage and
transportation insurance paid for and separately identified on the invoice or
other documentation maintained in the ordinary course of business.
1.12 "Option Country" shall mean any of Japan, Korea, People's Republic of
China (including Hong Kong SAR), India, Taiwan and the Philippines.
1.13 "Patents" shall mean Licensor's United States, European and other
countries issued patents and applications for patents relating to the Compound,
now or hereafter issued or applied for, the inventions which are described and
claimed therein, any reissues, divisions, substitutions, continuations,
continuations-in-part, re-examinations and improvements thereon and extensions
thereof, and any corresponding patent rights in any other country. All Patents
heretofore issued and any pending applications are set forth in Appendix 2
attached hereto.
1.14 "Products" or "the Product" shall mean any pharmaceutical product
manufactured from the Compound.
1.15 "Technical Information" shall mean any know-how, technical, scientific
and medical facts, data, advice or other information, written (in the form of
reports, drawings, specifications and the like) or oral, tangible or intangible,
which is now or hereafter controlled or possessed by Licensor and which Licensor
has the right to license (a) relating to a Product or for conversion of the
Compound to a Product, (b) relating to the manufacture of the Compound, provided
such information is required for application of IND or NDA for the Product, (c)
relating to marketing of a Product, or (d) required to comply with applicable
laws or regulations. Technical information shall include, but not be limited to,
patent files, manufacturing know-how, clinical tests and test results,
regulatory submissions and correspondence files, and any other proprietary or
trade secret information concerning the Compound and Intellectual Property
subject to the confidentiality provisions hereof.
1.16 "Territory" shall mean all the countries of the world, subject to
certain rights retained by Licensor to Option Countries pursuant to Section 2.1
(a) hereof.
1.17 "Follow On License" shall mean license agreements for Products based
on Compound analogs described in Patents listed in Appendix 3 of this Agreement.
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
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ARTICLE 2. GRANT OF LICENSE
2.1 Grant. (i) Licensor hereby grants to Licensee a license to the Compound
and Intellectual Property (a) to research, develop, make, have made, use and
sell Compound and (b) to develop, make, have made, import, export, use,
distribute for sale, promote, market, offer for sale, import, export and sell
(on a royalty basis only, except in the case of compassionate use or in the case
of clinical trials prior to the issuance of a United States NDA approval)
Products in the Field in the Territory in accordance with the terms of this
Agreement. This License shall be an exclusive license, with the right to
sublicense, except to the extent Licensor has retained certain rights to the
Option Countries as set forth below and, further, to the extent Licensor has
retained the right to manufacture the Compound pursuant to Article6 hereof.
(ii) Licensor hereby grants to Licensee a license to the Compound
Analogs and Intellectual Property (a) to research, develop, make, have made, use
and sell Compound Analog and (b) to develop, make, have made, import, export,
use, distribute for sale, promote, market, offer for sale, import, export and
sell (on a royalty basis only, except in the case of compassionate use or in the
case of clinical trials prior to the issuance of a United States NDA approval)
Analog Products in the Field in the Territory in accordance with the terms of
this Agreement. This License shall be an exclusive license, with the right to
sublicense, except to the extent Licensor has retained certain rights to the
Option Countries as set forth below and, further, to the extent Licensor has
retained the right to manufacture the Compound Analogs.
(iii) Licensor agrees to assign and hereby assigns to Licensee all
right, title and interest in and to the Trademarks, subject to the condition
that in the event that Licensor executes the option to sell Product or Analog
Product in any Option Country in accordance with this Agreement, Licensee shall
grant to Licensor a license to use such trademark(s) in such Option Country.
(a) When Licensee applies for an NDA for a Product or Analog Product
in any country in the Territory, Licensee shall notify Licensor thereof in
writing as soon as practically possible. For a period of three (3) months from
Licensor's receipt of the notice from Licensee, Licensor may execute an option
to an exclusive license, to develop, make, have made, use and sell such Product
or Analog Product in any or all of the Option Countries, by a written notice to
Licensee. If Licensor properly exercises the option, Licensee shall grant to
Licensor such license upon the same terms applied to the Licensee from the
Licensor in this agreement, and Licensor shall use its best efforts to develop,
make, have made and sell the Product or Analog Product in the selected Option
Countries and Licensor shall pay to Licensee a counter-royalty equivalent to the
royalty owing from Licensee to Licensor pursuant to Section 3.1 (d) of this
Agreement. If Licensor properly exercises the option, it may be terminated upon
written notice from Licensee to Licensor upon same terms as described from
Licensee to Licensor in Section 7.4 of this Agreement. If Licensor declines or
fails to exercise the option with respect to an Option Country in such
three-month period, Licensor shall have no further rights to develop, use, make,
have made or sell the Product or Analog Product in such Option Country.
(b) Should Licensor or Licensee receive from a third party a formal
inquiry for sublicense in one or more countries of the Option Countries,
Licensor or Licensee shall notify Licensee or Licensor thereof in writing, and
Licensor and Licensee shall negotiate in good faith in order to decide how to
treat such inquiry within three (3) months from such notice by Licensor or
Licensee.
(c) Licensee shall use reasonable good faith efforts to develop
Product or Analog Product for veterinary uses during the term of this Agreement.
Licensee shall inform Licensor (not less than annually) of the status of such
development. In the event Licensor reasonably determines that Licensee has not
made significant progress toward market introduction of Product or Analog
Product for veterinary uses, Licensor shall inform Licensee in writing of such
fact and the basis for Licensor's determination. Licensee shall then have three
months in which to cure or to initiate a cure of the default. In the event
Licensee has not affected a cure or not made significant progress in good faith
to effect a cure
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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within three months from Licensor's written notice, at Licensor's election, the
"Field" as used in this Agreement shall be limited to non-veterinary uses.
(d) Licensee shall periodically report, semiannually, to the Licensor
the progress of projects using the Product or Analog Product for non-veterinary
use.
2.2 Technical Information and Support. Within three (3) months after the
execution of this Agreement, Licensor shall disclose and furnish to Licensee all
Patent actions and prosecutions as well as Technical Information in the
possession of Licensor at the date hereof. In addition, to the extent deemed
necessary by Licensee and subject to the agreement of Licensor, Licensor shall
provide such technical support necessary or desirable to enable Licensee to
develop, market and sell Product and Analog Product. Immediately upon execution
of this Agreement, Licensor shall undertake all necessary and appropriate
actions to assign all IND's and related files at any regulatory agency within
the Territory to Licensee. Licensor shall provide all Technical Information
obtained from any prior licensee(s), to the extent that Licensor has the right
to do so, with particular emphasis on information related to regulatory and
clinical matters. Licensor shall provide a list of all third parties who were
provided with Compound for research purposes and shall provide introductions to
those parties if so requested by Licensee.
2.3 Sub-licenses. Licensee may grant sublicenses hereunder to third parties
("Sub-licenses"), provided however that (i) for Sub-licenses to manufacture
Compound and Compound Analog in the Territory, and (ii) for Sublicense to market
Product and Analog Product within the Option Countries, Licensee shall inform
the outline of such Sub-license Agreement to Licensor for its consent, who's
consent shall not be unreasonably withheld, and (iii) for Sub-license to market
Product and Analog Product in the Territory excluding Option Countries, Licensee
does not need to inform Licensor for its consent. Promptly following execution
of a Sub-license, Licensee shall give Licensor a copy of the Sub-license.
Licensee shall not grant a Sub-license unless Licensee's rights thereunder are
no less favorable to Licensee than Licensor's rights under Section 3.1 (d) of
this Agreement are to Licensor. Licensee shall require each Sub-licensee
hereunder to comply with its Sub-license, and shall take such action as may be
reasonably necessary to obtain such compliance, including, without limitation,
the institution of legal proceedings.
2.4 Termination of Sub-license. Any Sub-license granted by Licensee under
Section 2.3 shall provide that either (a) such sub-license will terminate no
later than the date of termination of this Agreement; or (b) upon any
termination of this Agreement, such sub-license shall automatically be assigned
to Licensor provided that (i) the sub-licensee agrees in writing that Licensor
may enforce the terms of such sub-license directly against the sub-licensee,
(ii) the sub-license is subordinate to this Agreement, and (iii) the Licensor
shall have no obligation as a result of such assignment except to keep the
sub-license in effect.
2.5 Territorial Limitation on Sub-licenses, Sub-licensee shall not directly
or indirectly sell the Product or Analog Product to a person where Sub-licensee
is aware, or ought reasonably to be aware, that the person is proposing to use,
make or sell the Product or Analog Product outside the sub-licensed territory.
2.6 Extension of Patent Term. Upon the request of Licensee, Licensor will
execute and file any appropriate application to extend the term of any Patent
and any other document related to such application for extension.
2.7 Use of Compound Limited to Product. Licensee will use the Compound only
in connection with the development, manufacture and sale of the Product.
2.8 Right to Compound Analogs. In consideration of the license granted
under Section 2.1(ii), Licensee shall pay Licensor [***] dollars
($[***] USD), which payment shall be made by
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
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October 24, 2001.
2.9 Improvement. In the event that either of the party develops new
technology, patentable or not, which may significantly improve the production
efficiency or quality of Compound or Product or Compound Analog or Analog
Product, the party shall notify thereof to the other party in writing, and if
the notified party be interested in the licensing of such technology, the
parties hereto shall have a first refusal right to negotiate such licensing in
good faith.
ARTICLE 3. CONSIDERATION, METHOD OF PAYMENT AND RECORD KEEPING
3.1 Consideration and Method of Payment. In consideration for the license
granted by Licensor hereunder and as the fee for furnishing Technical
Information, Licensee shall pay to Licensor, the payments set forth in this
Section 3.1, less all applicable withholding taxes or other taxes equivalent
thereto which Licensee shall remit directly to the appropriate taxing
authorities. Licensor acknowledges that Licensor has been paid ninety thousand
dollars as of the signing of this Amended and Restated License Agreement.
(a) Initial Payment. Upon execution hereof, Licensee shall pay [***]
dollars ($[***]) to Licensor, which shall include (i) [***] dollars ($[***])
in cash and (ii) either [***] dollars ($[***]) in cash or [***] dollars
($[***]) in the form of common stock of the Licensee (such stock to be valued at
a price per share equal to that paid by Licensee's then most recent equity
investor) at the sole option of the licensee. Within three months of the
Effective Date of this Agreement, Licensee shall pay an additional [***] dollars
($[***]) in cash to Licensor.
(b) First Milestone Payment. Licensee shall pay Licensor [***] dollars
($[***]) which shall include (i) ([***]) dollars [$***] in cash and (ii) [***]
dollars ($[***]) in cash or [***] dollars ($[***]) in the form of common stock
of the Licensee (such stock to be valued at a price per share equal to that paid
by Licensee's then most recent equity investor), such form of payment to be
determined by the Licensee and the Licensor through discussions and upon
reaching a reasonable agreement, upon demonstration of human clinical efficacy
of a Product by Licensee or its Sub-licensee (i.e,. transition from Phase II to
Phase III trials, which shall be indicated by enrollment of the first five
patients in a pivotal Phase III trial) in at least one indication of the
following indications: MAC in AIDS patients, M. tuberculosis, H. Pylori in
Peptic ulcer patients, Chlamydia pneumoniae in Multiple Sclerosis or
Atherosclerosis, Chlamydia trachomatis in Sexually Transmitted Disease or
Community acquired pneumonia patients or Staphylococcus aureus infection.
(c) Final Milestone Payment. Upon NDA approval obtained by Licensee or
its Sub-licensee in the United States, Europe or Japan, Licensee shall pay
Licensor [***] ($[***]) which shall include (i) [***] dollars ($[***]) in cash
and (ii) [***] dollars ($[***]) in cash or [***] dollars ($[***]) in the form of
common stock of the Licensee (such stock to be valued at a price per share equal
to that paid by Licensee's then most recent equity investor) at the sole option
of the Licensee.
(d) Royalties. Licensee shall pay to Licensor royalties payment based
on the Net Sales of the Product. The royalty shall be paid quarterly within
sixty (60) days of the close of Licensee's fiscal quarter and shall be equal to
[***] percent ([***]%) of the Net Sales of Product, [***] percent ([***]%) in
the case of combination product(s) containing Compound as an active component
wherein Licensee must pay a royalty to a third party or already acquired it from
a third party with no royalty payments or developed it internally de novo, and
[***] percent ([***]%) for a combination product containing Compound as one of
the
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active components where Licensee does not pay a royalty to a third party. In the
case of a Product for veterinary use, where Compound is the only active
ingredient for which the royalty is paid, the royalty shall be equal to [***]
percent ([***]%) of the Net Sales, and [***] percent (***%) in the case of
combination Product(s) wherein Licensee must pay a royalty to a third party.
(e) Due Diligence. Licensor may elect to convert this Agreement to a
non-exclusive license agreement with the same terms and conditions upon thirty
(30) days prior written notice to Licensee if (a) an NDA has not been approved
in the United States as of a date seven (7) years from the Effective Date of
this Agreement, or (b) Licensee has not marketed a Product or Analog Product
within twenty-four (24) months following NDA approval. Notwithstanding the
foregoing, this Agreement shall remain as an exclusive license for two years
following the date set forth in clause (a) or clause (b) above, as applicable,
if Licensee pays Licensor during such two-year period a minimum annual royalty
of [***] the difference between the actual royalties paid during each year of
such minimum royalty period and such [***] minimum to be payable within 90
days of the end of Licensee's fiscal year during each year of such minimum
period (and such [***] minimum to be prorated to account for any portion of
Licensee's fiscal year during which such minimum royalty obligation is not
applicable)
(f) Analog Royalties. Licensee shall pay to Licensor royalties payment
based on the Net Sales of the Analog Product. The royalty shall be paid
quarterly within sixty (60) days of the close of Licensee's fiscal quarter and
shall be equal to [***] percent ([***]%) of the Net Sales of Analog Product,
[***] percent ([***]%) in the case of combination product(s) containing [***]
Compound Analog as an active component wherein Licensee must pay a royalty to a
third party or already acquired it from a third party with no royalty payments
or developed it internally de novo, and [***]% for a combination product
containing Compound Analog as one of the active components where Licensee does
not pay a royalty to a third party. In the case of a Analog Product for
veterinary use, where Compound Analog is the only active ingredient for which
the royalty is paid, the royalty shall be equal to [***] percent ([***]%) of the
Net Sales, and [***] percent [***] in the case of combination Analog Product(s)
wherein Licensee must pay a royalty to a third party.
(g) With respect to Analog Product, upon approval of a New Drug
Application therefor in the United States or the equivalent thereof in Europe or
Japan, Licensee shall pay Licensor [***] dollars ($[***]), and no other
milestone payments.
3.2 Officer's Certificate. With each payment made pursuant to Section
3.1(d) hereof, Licensee shall provide Licensor with a certificate signed by an
officer of Licensee which states the total amount due and payable and the manner
in which that amount was calculated and which certifies that the information so
provided is true and correct.
3.3 Books and Records. Licensee shall, and shall use its reasonable
endeavors to require that its sub-licensees shall, keep full, true and accurate
books of accounts and records which truly and accurately disclose the number of
the Product and Analog Product sold by it or its sub-licensees in the Territory
and all matters relating to those sales which are relevant for the purposes of
determining the royalty to be paid by Licensee to Licensor. Such books and
records shall be retained for three (3) years following the occurrence of such
sales and shall be in the form which enables speedy and accurate checks to be
made thereof and shall be supported by all relevant vouchers, invoices, work
orders, delivery notes, receipts and the like, all of which shall be
cross-referenced.
3.4 Inspection. Licensee shall, and shall require that its sub-licensees
shall, not more frequently than once per calendar year, make the aforesaid books
of accounts and records available for inspection by Licensor or its authorized
representative at any reasonable time during business hours upon reasonable
request at no charge by Licensee to Licensor. Licensor or its duly authorized
representative shall be entitled to take copies of or extracts from any such
account or record. Licensor and its authorized
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representative shall hold any such information in strict confidence except to
the extent necessary to enforce Licensor's rights under this Agreement.
ARTICLE 4. REPRESENTATIONS AND WARRANTIES
4.1 Representations of Licensor. Licensor represents and warrants that it
owns the Compound and the Intellectual Property exclusive of any and all rights
of any other person or entity. Licensor agrees that it shall not enter into any
agreement or arrangement that would limit Licensor's right to license the
Patents to Licensee pursuant to this Agreement.
4.2 Patent Defense. Each party hereto shall be responsible for maintenance
and defense of its patent portfolios relating to the Compound or Compound Analog
or Product or Analog Product. However, if Licensor elects not to defend in a
given country, then Licensee shall have the right to defend at its expense. If
Licensee desires to maintain a certain patent or prosecute a certain application
in a Country in the Territory, which Licensor will not maintain or prosecute, by
written request by Licensee, Licensor will, on behalf of Licensee, pay
maintenance or prosecution fees therefore. Licensee shall reimburse Licensor for
such maintenance or prosecution fees plus administrative charge (five percent -
5 % - of such maintenance or prosecution fees incurred by Licensor for each
patent or patent application in each country in the Territory. If this Agreement
terminates, each party has no responsibility for maintenance of the patents
listed in Appendix 2, Appendix 3 and Appendix 4. Licensor and Licensee agree
that the patents and designated countries, described in Appendix 4, are really
required and valuable for maintenance, as part of this Agreement. Licensor will
keep Licensee informed of all patent ongoing actions and prosecutions listed as
Patents and Countries requiring maintenance listed in Appendix 4. In addition,
to the extent Licensor refuses to maintain or abandons a Patent that Licensee
desires to maintain, Licensor shall assign such Patent to Licensee at Licensee's
expense. As to the pending European Patent Application(s) at the European Patent
Office on the execution of this Agreement, Licensor shall be responsible for the
prosecution of such application(s). After such application(s) will be patented,
if Licensee desires to maintain such patent(s) in certain countries of EC and
Licensor will not maintain such patent(s) in such countries, Licensor shall
assign such patent(s) to Licensee at Licensee's expenses incurred by Licensor
after the execution of this Agreement.
4.3 Right to Grant License. Licensor represents and warrants that it has
the right to grant the license as set forth in Section 2.1.
4.4 Patents. Licensor represents and warrants that it is unaware of any
information that would adversely affect the validity or enforceability of the
Patents. To the best of Licensor's knowledge, actual and constructive, there are
no pending or threatened claims of litigation brought by a third party under any
third party patent, trade secret or other third party right regarding the
Intellectual Property. Except as set forth in the preceding sentences, Licensor
does not give any warranty that the manufacture, sale or use of the Product or
Analog Product will not infringe the intellectual property rights of any third
party.
4.5 Name of Licensor. Licensor represents and warrants that Kaneka
Corporation is the English language name of Kanegafuchi Kagaku Kogyo
Kabushiki Kaisha and both names refer to the same corporation.
4.6 Licensor represents and warrants that it is unaware of any
regulatory information that would adversely affect the development and
registration of the Product or any Analog Product other than as contained in
Technical Information to be provided to Licensee in accordance with Section
2.2.
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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ARTICLE 5. INFRINGEMENT
5.1 Notification. If any Patent is infringed by a third party, either party
hereto learning of such infringement shall promptly inform the other party
hereto. In the event that Licensor shall not promptly take and diligently pursue
action to enjoin the infringement, Licensee shall have the right to take legal
action to enjoin the infringement in its own name or jointly with Licensor.
5.2 Action by Both Parties. If either of the parties hereto files an
infringement action, then the other party may join in the lawsuit, in which case
each party hereto shall pay fifty percent (50%) of the expenses of the
litigation. Except as provided in Section 5.3 below, the net amount of any
recovery from a third party by judgment or settlement with respect to a claim of
infringement of any Patent shall be paid to the parties in the same proportion
as they have shared the expenses of conducting the suit.
5.3 Action by One Party. If the other party hereto does not join such suit,
other than as a nominal plaintiff, then the party filing such suit shall pay all
expenses related to such suit and shall retain the entire net amount of any
settlement or judgment award as an extraordinary gain outside of this Agreement.
If it is the Licensee who successfully defend the Patent in a country in the
Territory, then Licensor shall assign the Patent in that country to Licensee.
5.4 Cooperation. Licensor and Licensee will cooperate with each other in
connection with any claim or litigation involving a third party involving
alleged infringement by or with respect to any Patent.
5.5 Abandonment. In the event that Licensor elects not to file a patent
application or decides to abandon any pending application or granted patent in
any country, Licensor shall provide adequate notice to Licensee and give
Licensee the opportunity to file or maintain such application or patent at its
own expense; provided, however, that except for the right to file and maintain
such patent rights, the ownership rights of Licensor to such patent rights shall
not be affected by reason of this paragraph.
5.6 Maintenance upon Termination. If this Agreement terminates in
accordance with Article 7, neither party shall be obligated to maintain the
Patents listed in Appendix 2 attached hereto.
ARTICLE 6. SUPPLY OF COMPOUND
6.1 Product Development. Licensor shall supply, from its current stock bulk
batch on hand, quantities of Compound required for Product development and for
use during the development of registration dossiers within the Territory at no
charge to Licensee. The precise amount and timing of supply shall be defined
within twelve (12) months from the Effective Date of this Agreement and agreed
by both parties. Licensee shall be responsible for the costs of shipping,
insurance and duties directly incurred from this supply obligation. Licensor
shall supply Licensee Compound Analog, which Licensor reserves.
6.2 Commercial Supply. Notwithstanding the terms of Section 6.1, Licensor
has elected to terminate the production of new batches of commercial material of
Compound. Licensor will facilitate and expedite the transfer of technology and
know-how required to produce Compound through two independent companies (leading
and secondary manufacturers) designated by Licensee. The transfer of technology
and know-how means:
(a) Licensor will furnish Licensee with the documents on
technology and know-how required to produce Compound, which Licensor possesses.
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
9
(b) The technology and know-how is based on the pilot scale
Compound manufacturing (7-15kg production per batch).
(c) Licensee will dispatch the chemists to Japan to receive the
lectures of the technology and know-how for the production of Compound at the
expense of Licensee.
(d) Licensor has no responsibility if the Compound which Licensee
or such two independent companies produce meets registration requirements within
the Territory.
Licensor and Licensee will bear respective costs for such technology transfer
based on the discussion of the cost-sharing between the parties. Notwithstanding
any technology transfer, Licensor shall retain the right to manufacture Compound
pursuant to this Section 6.2 in the future. Licensor authorizes Licensee to
maintain Licensor as producer of record for Compound supply in the current FDA
clinical trials dossier and subsequent registration dossiers to be filed
elsewhere (referring to the current stock bulk batch and releasing test records
of Compound GMP supply, which will be used for Licensee's clinical trials and
registration dossiers with the FDA). Licensee will not maintain Licensor as an
alternate source of commercial material.
6.3 Liability. Licensor shall have no obligation or liability for any
claim, loss or damage arising out of or in relation to the supply of Compound to
Licensee, and/or any use of Compound or any Product containing Compound made by
Licensee or Licensee's sub-licensee, or designated companies referred to in
Section 6.2.
ARTICLE 7. TERM AND TERMINATION
7.1 Term. Unless otherwise terminated earlier pursuant to this Article 7,
this Agreement shall continue in full force and effect until the fifteenth
(15th) anniversary of first sale of a Product or Analog Product by Licensee.
7.2 Termination for Breach. Either party may terminate this Agreement in
the event the other party shall have materially breached or defaulted in the
performance of any of its material obligations hereunder, and such default shall
have continued for one hundred twenty (120) days after written notice thereof
was provided to the breaching party by the non-breaching party. Any termination
shall become effective at the end of such one hundred twenty (120) day period
unless the breaching party (or any other party acting on its behalf) has cured
any such breach or default prior to the expiration of the one hundred twenty
(120) day period.
7.3 Termination for Insolvency. If voluntary or involuntary proceedings by
or against a party are instituted in bankruptcy under any insolvency law, or a
receiver or custodian is appointed for such party, or proceedings are instituted
by or against such party for corporate reorganization or the dissolution of such
party, which proceedings, if voluntary, shall not have been dismissed within
sixty (60) days after the date of filing, or if such party makes an assignment
for the benefit of creditors, or substantially all of the assets of such party
are seized or attached and not released within sixty (60) days thereafter, the
other party may immediately terminate this Agreement effective upon notice of
such termination.
7.4 Clinical Studies, Product Development and Abandonment. This Agreement
may be terminated upon written notice from Licensor to Licensee if:
(a) Licensee fails to begin a clinical study with respect to a Product
or Analog Product
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
10
within one year after FDA approval of the Licensee's IND for the first Product
or Analog Product; or
(b) Licensee fails to engage in and continue further stages of a
clinical study of a Product or Analog Product within one year after FDA approval
of the first Licensee protocol for a clinical study; or
(c) Licensee does not develop, or has no intention to develop the
Compound or a Compound Analog, as determined at the discretion of Licensor, or
Licensee does not initiate the development of the Compound or any Compound
Analog as a human drug within one (1) year after the execution of this
Agreement, or as an animal drug within two (2) years after the Effective Date of
this Agreement.
7.5 Effect of Breach or Termination.
7.5.1. Paid Up License. Upon expiration of this Agreement as provided
in Section 7.1, the license hereunder shall revert to a fully paid, royalty free
license with the terms and conditions effective then, other than royalty payment
obligation.
7.5.2 Accrued Obligations. Termination of this Agreement for any
reason shall not release any party hereto from any liability which, at the time
of such termination, has already accrued to the other party or which is
attributable to such termination, nor shall it preclude either party from
pursuing all rights and remedies it may have hereunder or at law or in equity
with respect to any breach of this Agreement.
7.5.3 Stock on Hand. In the event this Agreement is terminated for any
reason, Licensee shall have the right to sell or otherwise dispose of the stock
of any Product or Analog Product subject to this Agreement then on hand or in
the process of manufacture at the time of termination, subject to the right of
Licensor to receive royalties thereon.
7.6 Assignment. Neither party shall assign its rights or obligations under
this Agreement, in whole or in part, by operation of law or otherwise, without
the prior written consent of the other party; provided however, that either
party may, without such consent, assign this Agreement and its rights and
obligations thereunder in connection with the transfer or sale of all or
substantially all of its business, or in the event of its merger, consolidation,
change in control or similar transaction; provided further that, in the event of
any such transaction, intellectual property rights of any person or entity,
other than Licensor or Licensee or their affiliates, that is an acquiring party
in such transaction shall not be included in the intellectual property licensed
hereunder. Any purported assignment in violation of this Section 7.6 shall be
void. This Agreement shall inure to the benefit of and be binding upon the
parties hereto and their respective successors and permitted assigns.
7.7 Survival. Section 6.3 and Articles 7, 8 and 9 shall survive any
termination of this Agreement for any reason.
ARTICLE 8. CONFIDENTIALITY
8.1 Confidential Information. Except as expressly provided herein, the
parties agree that, for the term of this Agreement and for seven (7) years
thereafter, the receiving party shall keep confidential and shall not publish or
otherwise disclose and shall not use for any purpose other than the purposes
contemplated by this Agreement any information and data furnished to it by the
disclosing party hereto pursuant to this Agreement (hereinafter referred to as
"Confidential Information"), except that to the extent that it can be
established by competent proof by the receiving party that such Confidential
Information:
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
11
(a) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure, as evidenced by its
written records; or
(b) was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving party; or
(c) became generally available to the public or otherwise became part of
the public domain after its disclosure, other than through any act or omission
of the receiving party in breach of this Agreement; or
(d) was independently developed by the receiving party, as demonstrated by
documented evidence prepared contemporaneously with such independent
development; or
(e) was subsequently lawfully disclosed to the receiving party by a person
other than a party hereto.
8.2 Oral Disclosure. Information or data which is orally disclosed shall
constitute Confidential Information if disclosing party, within thirty (30) days
after such disclosure, delivers to the receiving party a written notice
describing such Confidential Information and referring the place and date of
such oral disclosure and the names of the employees or officers of the receiving
party to whom such disclosure was made.
8.3 Permitted Use and Disclosure. Each party hereto may use or disclose
information disclosed to it by the other party to the extent such use or
disclosure is reasonably necessary in filing or prosecuting patent
applications contemplated hereby, prosecuting or defending litigation, complying
with applicable governmental regulations or otherwise submitting information to
tax or other governmental authorities, conducting clinical trials contemplated
hereby, or making a permitted sublicense or otherwise exercising its rights
hereunder, provided that if a party is required to make any such disclosure of
another party's Confidential Information, other than pursuant to a
confidentiality agreement, it will give reasonable advance notice to the latter
party of such disclosure and, save to the extent inappropriate in the case of
patent applications, will use its best efforts to secure confidential treatment
of such information prior to its disclosure (whether through protective orders
or otherwise).
8.4 Public Disclosure. Except as otherwise required by law, neither party
shall issue a press release or make any other public oral or written disclosure
of the terms of this Agreement without the prior approval of such press release
or other public disclosure by the other party. Each party shall submit any such
press release or public disclosure to the other party, and the receiving party
shall have reasonable time and up to two (2) weeks to review and approve or
disapprove any such press release or public disclosure. If the receiving party
does not respond within such two (2) weeks period, the press release or public
disclosure shall be deemed approved. In addition, if a public disclosure is
required by law, including without limitation in a filing with the Securities
and Exchange Commission, the disclosing party shall provide copies of the
disclosure reasonably in advance of such filing or other disclosure for the
non-disclosing party's prior review and comment.
8.5 Return of Confidential Information. Upon any termination, but not
expiration, of this Agreement, all licenses and rights under such licenses shall
terminate, and Licensor and Licensee shall promptly return to the other party
all Confidential Information received from the other party (except one copy of
which may be retained for archival purposes), and neither party shall be
entitled to use any such Confidential Information of the other party for any
purpose following such termination.
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
12
Article 9. Miscellaneous
9.1 Governing Law. This Agreement and any disputes arising from the
performance or breach hereof shall be governed by and construed and enforced in
accordance with the laws of the Commonwealth of Massachusetts, without reference
to conflict of law principles.
9.2 Entire Agreement. This Agreement, which includes the Appendices hereto,
contains the entire agreement between Licensor and Licensee with respect to the
transactions contemplated by this Agreement and supersedes all prior
arrangements or understandings with respect thereto including the License
Agreement between the parties dated and entered into as of July 24, 2001.
9.3 Notices. All notices or other communications, which are required or
permitted hereunder, must be in writing and must be mailed (registered postage
prepaid), or sent by confirmed facsimile, to the appropriate party addressed
as follows:
If to Licensor: Xxxxxx Xxxxxxxxxxx
0-0, Xxxxxxxxxxx 0-xxxxx, Xxxx-Xx
Xxxxx 530-8288, Japan
Attention: General Manager
Life Science RD Center
Fax: +81(794)45-2459
If to Licensee: Merlin Technologies, Inc.
0 Xxxxxx Xxxxxx, 0xx Xxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000, XXX
Attention: Chief Executive Officer
Fax: x0(000) 000-0000
If any notice or other communication, which is required or permitted hereunder,
is given by airmail, it will be effective on seventh (7th) day after it is
deposited in the mails; if given by confirmed facsimile, when delivered. Any
party may by such notice change the address to which notice of other
communications to it is to be delivered or mailed.
9.4 Waivers and Amendments. Any waivers of any term or condition of this
Agreement, or any amendment or supplementation of this Agreement, shall be
effective only if in writing signed by the parties. A waiver of any breach or
failure to enforce any of the terms or conditions of this Agreement shall not in
any way affect, limit or waive a party's rights hereunder at any time to enforce
strict compliance thereafter with every term or condition of this Agreement.
9.5 Severability. In the event that any provision contained in this
Agreement shall be determined to be invalid, illegal or unenforceable in any
respect for any reason, the validity, legality, and enforceability of any such
provision in every other respect and the remaining provision of this Agreement
shall not, at the election of the party for whose benefit the provision exists,
be in any way impaired.
9.6 Section Headings. The section headings contained herein are for the
purpose of convenience and are not intended to define or limit the contents of
such sections.
9.7 Arbitration. Any controversy arising out of or in relation to this
Agreement, or the breach
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
13
thereof shall be settled mutual consultation and negotiation between the parties
hereto, but if failed, the claim brought against Licensor shall be settled
exclusively by arbitration to be held in Osaka, Japan, in accordance with the
rules of the Japan Commercial Arbitration Association, and the claim brought
against Licensee shall be settled exclusively by arbitration to be held in
Boston, Massachusetts, USA, in accordance with the Commercial Arbitration Rules
of the American Arbitration Association. Any judgment upon, the award rendered
by the arbitrators may be entered in any court having jurisdiction.
9.8 Counterparts. This Agreement may be signed 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.
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
14
IN WITNESS WHEREOF, the parties hereby have executed this Agreement by their
duly authorized representatives as of the Effective Date.
KANEKA CORPORATION
By: /s/ Xxxxxxxx Xxxxxx
------------------------------------
Name: Xxxxxxxx Xxxxxx, PhD
Title: General Manager
Life Science RD Center
MERLIN TECHNOLOGIES, INC
By: /s/ Xxxxxx Xxxxxx
------------------------------------
Name: Xxxxxx Xxxxxx, PhD, MD
Title: President and Chief
Executive Officer
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
15
APPENDIX 1
CHEMICAL STRUCTURE
[GRAPHIC]
CODE NO.: KRM-1648
GENERAL NAME: Rifalazil
CAS NO.: 129791-92-0
CHEMICAL NAME: 5,12-Dihydroxy-2,4-dimethyl-10-[4-(2-methyl- propyl)-l-
piperazinyl]-2,7-[oxy(5-acetoxy-7, 9-dihydroxy-3-methoxy-4,6,8,10,14-
pentamethyl-15-oxo-l,ll,13-pentadecatriene-l,15-diyl)imino]-6H-benzofuro
[4,5-a]phenoxazine-l(2H),6-dione
or
3'-Hydroxy-5'-(4-isobutyl-l-piperazinyl)benzoxazinorifamycin
MOLECULAR FORMULA: C(51)H(64)N(4)O(13)
MOLECULAR WEIGHT:
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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
16
APPENDIX 2
LIST OF THE PATENTS RELATED TO THE RIFAMYCIN DERIVATIVE
1. "3'- Hydroxybenzoxazinorifamycin derivative, process for preparing the same
and antibacterial agent containing the same"
U.S.: Patent No. 4,983,602 Expiration Date: February 5, 0000
Xxxxxx: Patent No. 1,304,363 Expiration Date: June 30, 2009
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Patent No. 0366914 Expiration Date: September 14, 2009
Patent No. (DE) 68919650.4
China: Patent No. 24,993 Expiration Date: September 16, 2004
Singapore: Patent No. 9,790,350-4 Expiration Date: September 14, 0000
Xxxxx Patent No. 0000000 Expiration Date: November 1, 2008
2. "3'-alkyl, -arylsiryloxybenzoxazinorifamycin derivatives"
China: Patent No. 39,298 Expiration Date: August 16, 2006
Taiwan: Patent No. 60,726 Expiration Date: January 20, 2008
Korea: Patent No. 203615 Expiration Date: August 3, 2011
Patent No. 203729 Expiration Date: Xxxxxx 0, 0000
Xxxxx Patent No. 0000000 Expiration Date: August 10, 2010
3. "Production method for fine granules"
U.S.: Patent No. 5,547,683 Expiration Date: October 6, 2013
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Patent No. 0616841 Expiration Date: October 6, 2013
Patent No. (DE) 69322764.8
Canada: Appl. No. 2,124,568 Filed: October 6, 1993
(under examination)
China: Appl. No. 93,118,594.7 Filed: October 6, 1993
Expiration Date: October 6, 2013
Korea: Appl. No. 701,971-94 Filed: October 6, 1993
(under examination)
Japan: Appl. No. P04-297905 Filed: October 9, 1992
(under examination)
4. "Treatment of chlamydia infectious diseases by rifamycin derivative"
US: Patent No. 5,786,349 Expiration Date: December 9, 0000
Xxxxxx: Appl. No. 2,192,255 Filed : December 6, 1996
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Patent No. 0778022 Expiration Date: December 6, 2016
Xxxxxx Xx. (XX) 00000000.0
Xxxxx: Appl. No. P08-002634 Filed: January 10, 1995
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
17
5. "Treatment of disease caused by infection of Helicobacter"
US: Patent No. 5,981,522 Expiration Date : August 29, 0000
Xxxxxx: Appl. No. 2,204,007 Filed: August 29, 1996
Appl. No. 2,230,649 Filed: February 27, 1998
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Appl. No. 96928723.4 Filed: August 29, 1996
Appl. No. 98103481 Filed: February 27, 0000
Xxxxxx: Patent No. 113445 Expiration Date : September 5, 2016
Appl. No. 85110867.1 Filed: February 27, 1998
Korea: Appl. No. 702,879-97 Filed: August 29, 1996
Appl. No. 6,462-98 Filed: February 27, 0000
Xxxxx: Appl. No. P10-038590 Filed: February 20, 1998
6. "Method for treating mastitis in a domestic animal"
US: Appl. No. 463580 Filed: July 29, 1997
CA: Appl. No. 2297012 Filed: July 29, 1998
EPC (DE, GB, FR, IT, CH, NL, SE) :
Appl. No. 98,937,047.3 Filed: July 29, 0000
Xxxxxx: Appl. No. 88,100,078 Filed: January 5, 1999
Korea: Appl. No. 00-7,000,601 Filed: July 29, 0000
Xxxxxxxxx: Appl. No. 85844-98 Filed: July 29, 0000
Xxx Xxxxxxx: Appl. No. 503,027 Filed: July 29, 0000
Xxxxx: Appl. No. 98,807,682.9 Filed: July 29, 0000
Xxxxx: Appl. No. P2000-504.861 Filed: July 29, 1998
7. "Antimicrobial compositions with synergistic effect, drugs and remedies for
digestive diseases containing the same, process for the production thereof
and preparations associated therewith"
PCT (US, CA, DE, GB, FR, IT, CH, BE, ES, JP, KR):
Appl. Xx. XXX/XX00-00000 Filed: February 17, 0000
Xxxxxx: Appl. No. 88,102,542 Filed: February 22, 1999
8. "Method for treatment of bacterial infections with once or twice-weekly
administered rifalazil"(PathoGenesis assigned to Kaneka, 2000)
US: Appl. No. 112,921 Filed: December 18, 1998
PCT ( CA, DE, ES, FR, GB, IT, AT, BE, CH, DK, GR, FI, LU, NL, PT, SE, KR,
CN, JP):
Appl. No. PTC/WO00/35408, Filed: December 18, 1998
9. "Benzoxazinorifamycin derivative, process for preparing the same and
antibacterial agent containing the same"
US Patent No. 4,690,919 Expiration Date February 5, 2006
Canada Patent No. 1,256,430 Expiration Date June 27, 2006
EPC (BE, CH, FR, GB, IT, LI, NL, SE, DE)
Patent No. 0,190,709 Expiration Date February 4, 2006
China Patent No. 24,976 Expiration Date May 31, 0000
Xxxxx Patent No. 1,854,546 Expiration Date January 20, 2006
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HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED
18
10. "Alkyl-substituted benzoxazinorifamycin derivative, process for preparing
the same and antibacterial agent containing the same"
US: Patent No. 4,859,661 Expiration Date: July 13, 2007
11. "Substituted benzoxazinorifamycin derivative and antibacterial agent
containing the same"
US Patent No. 4,965,261 Expiration Date: March 16, 2009
Canada Patent No. 1,293,503 Expiration Date: December 23, 2008
EPC (BE, CH, ES, FR, GB, IT, LI, DE):
Patent No. 0,333,176 Expiration Date: Xxxxx 00, 0000
Xxxxxx Xx. (XX) 68924722.2
China Patent No. 20,729 Expiration Date: Xxxxx 00, 0000
Xxxxx Patent No. 0000000 Expiration Date: September 14, 2009
Note: Request the Patent Office to proceed the validity of patent 10 and 11 to
be recovered
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
19
APPENDIX 3
1*. "3'- Hydroxybenzoxazinorifamycin derivative, process for preparing the same
and antibacterial agent containing the same"
2. "3'-alkyl, -arylsiryloxybenzoxazinorifamycin derivatives"
4. "Treatment of chlamydia infectious diseases by rifamycin derivative"
5. "Treatment of disease caused by infection of Helicobacter"
6. "Method for treating mastitis in a domestic animal"
8. "Method for treatment of bacterial infections with once or twice-weekly
administered rifalazil" (PathoGenesis assigned to Kaneka, 2000)
9. "Benzoxazinorifamycin derivative, process for preparing the same and
antibacterial agent containing the same"
10. "Alkyl-substituted benzoxazinorifamycin derivative, process for preparing
the same and antibacterial agent containing the same"
11. "Substituted benzoxazinorifamycin derivative and antibacterial agent
containing the same"
* Serial numbers are the same as shown in Appendix 2
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
20
APPENDIX 4
PATENTS AND COUNTRIES REQUIRING MAINTENANCE
1*. "3'- Hydroxybenzoxazinorifamycin derivative, process for preparing the same
and antibacterial agent containing the same"
US, CA, DE, ES, FR, GB, IT, Singapore, Japan
2. "3'-alkyl, -arylsiryloxybenzoxazinorifamycin derivatives"
China, Taiwan, Korea, Japan
3. "Production method for fine granules"
US, CA, DE, ES, FR, GB, IT, CN, Japan, KR
4. "Treatment of chlamydia infectious diseases by rifamycin derivative"
US, CA, DE, ES, FR, GB, IT, Japan
5. "Treatment of disease caused by infection of Hehcobacter"
US, CA, DE, ES, FR, GB, IT, Taiwan, Korea, Japan
6. "Method for treating mastitis in a domestic animal"
US, CA, DE, GB, FR, IT, NL, Taiwan, Australia, New Zealand, China, Japan
8. "Method for treatment of bacterial infections with once or twice-weekly
administered rifalazil"
US, CA, DE, ES, FR, GB, IT, Korea, China, Japan
9. "Benzoxazinorifamycin derivative, process for preparing the same and
antibacterial agent containing the same"
US, CA, FR, GB, IT, DE, Japan
* Serial numbers are the same as shown in Appendix 2
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
21
SECOND AMENDMENT AGREEMENT
This AMENDMENT is made on this day of September 18th, 2002, by and between
Kaneka Corporation, a Japanese corporation, having its principal place of
business at 0-0, Xxxxxxxxxxx 0-Xxxxx, Xxxx-Xx, Xxxxx 000-0000, Xxxxx
("Licensor") and ActivBiotics, Inc. (formerly known as Merlin Technologies,
Inc.), a Delaware corporation, having its principal place of business at 000
Xxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000, X.X.X. ("Licensee").
WHEREAS, the Licensor and the Licensee have entered into the License Agreement,
as of July 24th, 2001;
WHEREAS, the Licensor and the Licensee have entered into the Amended and
Restated License Agreement, as of September 27th, 2001 (the "Agreement"); and
WHEREAS, in response to the Licensee's request and inquiry, the Licensor has
decided to definitively not to keep any rights to execute at any time its option
to an exclusive license in the Option Country, as provided in Section 2.1 (a) of
the Agreement.
NOW, THEREFORE, the parties hereto have agreed as follows:
Article 1. Defined Terms
The terms defined in the Agreement and not otherwise defined herein shall
have the respective meanings set forth in the Agreement.
Article 2. Amendments to the Agreement
2.1 The Licensor and the Licensee agree to add the followings to Section 3.1 of
the Agreement:
(h) Initial Payment. The Licensee shall pay [***] dollars ($[***]) in cash
to the Licensor, within sixty (60) days from the date of the execution
hereof.
(i) First Milestone Payment. The Licensee shall pay the Licensor [***]
dollars ($[***]) in the form of shares of a new series of preferred
stock of the Licensee (such shares of such new series of preferred
stock to be specific for this milestone payment and equivalent to the
Common Stock in all respects except that such series of preferred
stock will rank senior to the common stock and that the per share
price of each share of such new series of preferred stock shall
be equal to that paid by the licensee's then most recent equity
investor), such form of payment to be determined by the Licensee
and the Licensor
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
2
through discussions and upon reaching a reasonable agreement, upon
demonstration of human clinical efficacy of a Product by the Licensee
or its Sub-licensee (i.e., transition from Phase II to Phase III
trials in the Option Country, which shall be indicated by enrollment
of the first five patients in a pivotal Phase III trial) in at least
one indication of the following indications: MAC in AIDS patients, M.
tuberculosis, H. Pylori in Peptic ulcer patients, Chlamydia pneumoniae
in Multiple Sclerosis or Atherosclerosis, Chlamydia trachomatis in
Sexually Transmitted Disease or Community acquired pneumonia patients
or Staphylococcus aureus infection.
(j) Final Milestone Payment. Upon NDA approval in the Option Country
(except [***]; [***] shall still be subjected to the terms and
conditions of Section 3.1(c) in the Agreement) obtained by the
Licensee or its Sub-licensee, the Licensee shall pay the Licensor
[***] dollars ($[***]) in the form of shares of a new series of
preferred stock of the Licensee (such shares of such new series
of preferred stock to be specific for this milestone payment and
equivalent to the Common Stock in all respects except that such
series of preferred stock will rank senior to the Common Stock
and that the per share price of each share of such new series of
preferred stock shall be equal to that paid by the Licensee's
then most recent equity investor) or in cash, at the sole option
of the Licensee.
2.2 The Licensor and the Licensee agree to amend Section 2.9 of the Agreement
as follows:
2.9 Improvement. In the event that either of the party develops new
production or manufacturing technology, patentable or not, which may
significantly improve the production efficiency or the production
quality of Compound or Product or Compound Analog or Analog Product,
the party shall notify thereof to the other party in writing, and if
the notified party be interested in the licensing of such production
or manufacturing technology, the parties hereto shall have a first
refusal right to negotiate such licensing in good faith.
2.3 The Licensor and the Licensee agree to amend Sections 3.1(b), 3.1(c),
3.1(d) and 3.1(f) of the Agreement as follows:
(b) First Milestone Payment. Licensee shall pay Licensor [***] dollars
($[***]) which shall include (i) [***] dollars ($[***]) in cash and
(ii) [***] dollars ($[***]) in cash or [***] dollars ($[***]) in the
form shares of a new series of preferred stock of the Licensee (such
shares of such new series of
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3
preferred stock to be specific for this milestone payment and
equivalent to the Common Stock in all respects except that such series
of preferred stock will rank senior to the Common Stock and that the
per share price of each share of such new series of preferred stock
shall be equal to that paid by the Licensee's then most recent equity
investor), such form of payment to be determined by the Licensee and
the Licensor through discussions and upon reaching a reasonable
agreement, upon demonstration of human clinical efficacy of a Product
by Licensee or its Sub - licensee (i.e., transition from Phase II to
Phase III trials, which shall be indicated by enrollment of the first
five patients in a pivotal Phase III trial) in at least one indication
of the following indications: MAC in AIDS patients, M. tuberculosis,
H. Pylori in Peptic ulcer patients, Chlamydia pneumoniae in Multiple
Sclerosis or Atherosclerosis, Chlamydia trachomatis in Sexually
Transmitted Disease or Community acquired pneumonia patients or
Staphylococcus aureus infection.
(c) Final Milestone Payment. Upon NDA approval obtained by Licensee or
its Sub - licensee in the United States, Europe or Japan, Licensee
shall pay Licensor [***] dollars ($[***]) which shall include (i)
[***] dollars ($[***]) in cash and (ii) [***] dollars ($[***]) in cash
or [***] dollars ($[***]) in the form of shares of a new series of
preferred stock of the Licensee (such shares of such new series of
preferred stock to be specific for this milestone payment and
equivalent to the Common Stock in all respects except that such series
of preferred stock will rank senior to the Common Stock and that the
per share price of each share of such new series of preferred stock
shall be equal to that paid by the Licensee's then most recent equity
investor) at the sole option of the Licensee.
3.1(d) Royalties. The Licensee shall pay to the Licensor royalties based on
the Net Sales of the Product. The royalty shall be paid quarterly
within sixty (60) days of the close of the Licensee's fiscal quarter.
In the case of a product for Human use, where Compound is the only
active ingredient for which the royalty is paid, the royalty shall be
equal to [***] percent ([***]%) of the Net Sales of Product for a
combination product containing Compound as one of the active component
where the Licensee does not pay a royalty to third party, or [***]
percent ([***]%) in the case of combination product(s) containing
Compound as an active component wherein the Licensee must pay a
royalty to a third party, or already acquired the additional patented
combined technology from a third party even with no royalty payments,
or developed the new patented combined technology internally de novo.
In the case of a Product for veterinary use, where Compound is the
only active ingredient for which the royalty is paid, the royalty
shall be equal to [***] percent
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4
([***]) of the Net Sales, or [***] percent ([***]) in the case of
combination Product(s) wherein the Licensee must pay a royalty to a
third party.
3.1 (f) Analog Royalties. The Licensee shall pay to the Licensor
royalties based on the Net Sales of the Analog Product. The royalty
shall be paid quarterly within sixty (60) days of the close of the
Licensee's fiscal quarter. In the case of a product for Human use,
where Compound Analog is the only active ingredient for which the
royalty is paid, the royalty shall be equal to [***] percent ([***]%)
of the Net Sales of Analog Product for a combination product
containing Compound Analog as one of the active components where the
Licensee does not pay a royalty to third party, or [***] percent
([***]%) in the case of combination product(s) containing Compound
Analog as an active component wherein the Licensee must pay a royalty
to a third party, or already acquired the additional patented combined
technology from a third party even with no royalty payments, or
developed the new patented combined technology internally de novo. In
the case of a Analog Product for veterinary use, where Compound Analog
is the only active ingredient for which the royalty is paid, the
royalty shall be equal to [***] percent ([***]%) of the Net Sales, or
[***] percent ([***]%) in the case of combination Analog Product(s)
wherein the Licensee must pay a royalty to a third party.
Article 3. Exchange of Stock
Licensor and Licensee hereby agree to convert the one hundred twenty
thousand common stocks issued to Licensor by Licensee on October 15th,
2001, pursuant to the provision in the Agreement, to one hundred twenty
thousand Preferred A Shares, equivalent in all respects to the Series A
round Preferred A Shares issued in October 2001 as part of the Series A
round of financing.
Article 4. No Other Amendments or Waivers
Except as expressly provided in this Amendment, all the terms and
conditions of the Agreement are hereby ratified and confirmed and remain in
full force and effect.
Article 5. Execution in Counterparts
This Amendment may be executed in any number of counterparts, each of which
shall be deemed an original, but which together shall constitute one
instrument.
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5
This Amendment shall be effective upon execution and delivery of this
Amendment by the parties hereto, and shall be governed by the applicable
law specified in Section 9.1 of the Agreement.
Signed and delivered by a duly authorized representative of each party.
KANEKA CORPORATION
/s/ Xxxxxxxx Xxxxxx
----------------------------------------
Xxxxxxxx Xxxxxx, PhD
General Manager, Life Science RD Center
ACTIVBIOTICS, INC.
/s/ Xxxxxx Xxxxxx
----------------------------------------
Xxxxxx Xxxxxx, PhD, MD
President and Chief Executive Officer
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THIRD AMENDMENT AGREEMENT
This THIRD AMENDMENT AGREEMENT ("Amendment") is made on this 29th day of
August, 2004, by and between Kaneka Corporation, a Japanese corporation, having
its principal place of business at 0-0, Xxxxxxxxxxx 0-Xxxxx, Xxxx-Xx, Xxxxx
000-0000, Xxxxx ("Licensor") and ActivBiotics, Inc. (formerly known as Merlin
Technologies, Inc.), a Delaware corporation, having its principal place of
business at 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX, 00000, X.X.X. ("Licensee").
WHEREAS, the Licensor and the Licensee have entered into the License
Agreement, as of July 24, 2001;
WHEREAS, the Licensor and the Licensee have entered into the Amended and
Restated License Agreement, as of September 27, 2001 (the "Amended and Restated
Agreement");
WHEREAS, the Licensor and the Licensee have entered into the Second
Amendment Agreement, as of September 18, 2002 (the "Second Amendment
Agreement"), pursuant to which Licensor and Licensee have agreed to amend the
Amended and Restated Agreement to, among other things, terminate any and all
rights that Licensor retained under the Amended and Restated Agreement with
respect to the Option Countries;
WHEREAS, Licensor and Licensee acknowledge that there is no First Amendment
Agreement to the Amended and Restated Agreement and that, upon execution and
delivery by the parties of this Amendment, the Second Amended Agreement and this
Amendment shall be the only amendments in effect to the Amended and Restated
Agreement; and
WHEREAS, in response to the Licensee's request and inquiry, the Licensor
has decided to assign to the Licensee certain patents or patent applications of
the Licensor as further provided in this Amendment.
NOW, THEREFORE, the parties hereto have agreed as follows:
ARTICLE 1. DEFINED TERMS
The term "Current Agreement" as used in this Amendment shall mean the
Amended and Restated Agreement as amended and modified by the Second
Amendment Agreement Capitalized terms used in this Amendment without
definition and that are defined in the Amended and Restated Agreement
shall have the meaning ascribed to such terms in the Amended and
Restated Agreement. From and after the date of this Amendment, the
term "Agreement" as used throughout the Amended and Restated Agreement
and/or this Amendment shall mean the Amended and Restated Agreement as
amended and modified by the Second Amendment Agreement and this
Amendment.
ARTICLE 2. OPTION COUNTRY
The Licensor and Licensee hereby acknowledge, ratify, confirm and
agree that, pursuant to the Second Amendment Agreement, Licensor and
Licensee agreed to amend the Amended and Restated Agreement to, among
other things, terminate any and all rights that Licensor had
previously retained under the Amended and Restated Agreement with
respect to the Option Countries. Accordingly, consistent with such
agreement, Licensor and Licensee hereby agree that the obligations of
Licensee under clause (ii) of Section 2.3 of the Current Agreement
have been terminated effective as of the date of the Second Amendment
Agreement.
Signature Page to Third Amendment
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ARTICLE 3. PATENTS ASSIGNMENT
3.1 The Licensor hereby assigns to Licensee all of the Licensor's right, title
and interest in and to those patents and patent applications that are
listed as items number 3, 6, 7, 10 and 11 of the new Appendix 2 attached
hereto, and to all rights and claims relating to or arising from such
patents and patent applications. Licensor shall execute and deliver such
additional documents and instruments of assignment as may be reasonably
requested by Licensee from time to time to perfect or evidence the
foregoing assignment.
3.2 Any procedures, including but not limited to the applications to or
registrations at the relevant authorities in the Territory, necessary to
complete the foregoing assignment shall be performed by Licensee.
3.3 The reasonable costs and expenses incurred by Licensor arising out of, or
in connection with, the assignment of patents and patent applications
contemplated under Section 3.1 of this Amendment shall be borne by
Licensee.
ARTICLE 4. CONSIDERATION, ETC.
4.1 In consideration for the assignment of patents and patent applications
pursuant to Section 3.1 of this Amendment, Licensee shall pay to Licensor
[***] United States Dollars (US$[***]) in cash within thirty (30) days from
the date Licensor executed and delivered such additional documents and
instruments of assignment as may be reasonably requested by Licensee to
perfect or evidence the assignment of patents and patent applications
pursuant to Section 3.1 of this Amendment.
4.2 For the avoidance of doubt, the amount payable by Licensee pursuant to
Section 4.1 of this Amendment is consideration only for the assignment of
patents and patent applications pursuant to Section 3.1 of this Amendment,
and no milestone payment or royalty to be paid to Licensor by Licensee
under the Current Agreement shall be affected in any way notwithstanding
the assignment of patents and patent applications pursuant to Section 3.1
of this Amendment.
4.3 In the event that Licensee sells, transfers or assigns any part or all the
right, title and/or interest in and to the patents and patent applications
assigned to Licensee by Licensor hereunder to any third party, Licensee
shall cause such third party to agree in writing to become bound by all of
the terms and provisions of this Agreement applicable to such patents and
patent applications to the same extent that Licensee is then bound under
the Agreement, and Licensee shall provide Licensor with a copy of the
documents and agreements signed by such third party for purposes of
enabling Licensor to confirm that such third party is bound by all of the
terms and provisions of this Agreement applicable to such patents and
patent applications to the same extent that Licensee is then bound. This
Section 4.3 shall survive the termination of the Agreement pursuant to
Section 7.2, 7.3 and/or 7.4.
ARTICLE 5. AMENDMENTS TO THE CURRENT AGREEMENT
5.1 The terms of the Current Agreement will remain unchanged except to the
extent that the Current Agreement is amended and modified pursuant to the
provisions set forth in this Amendment.
5.2 Appendix 2 to the Current Agreement shall be replaced by the new Appendix 2
attached hereto.
5.3 The definitions set forth in the Current Agreement are hereby amended as
follows:
Signature Page to Third Amendment
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Sections 1.1, 1.4, 1.7, 1.8, 1.11, 1.12, 1.13, 1.14, 1.15 and 1.16 of the
Current Agreement are hereby amended to read in their entirety as set forth
below; and seven new definitions numbered as Sections 1.18, 1.19, 1.20,
1.21, 1.22, 1.23 and 1.24 are hereby added as set forth below:
1.1 "Analog Product" or "the Analog Product" shall mean any pharmaceutical
product containing a Compound Analog as the active
pharmaceutical ingredient of such pharmaceutical product.
1.4 "Compound Analog" shall mean those analogs of Compound whose chemical
structures are covered by composition of matter claims under any of
the patents or patent applications listed in Appendix 2 attached
hereto.
1.7 "Field" shall mean any and all possible indications and uses of the
Compound, any Compound Analog, any Derivative, any Product, any Analog
Product and any Derivative Product, for prevention, treatment or
diagnosis of disease in humans or animals, subject to the terms of
Section 2.1(c) of this Agreement with respect to veterinary
applications.
1.8 "IND" shall mean designation by FDA of a Product as an Investigational
New Drug.
1.11 "Net Sales" shall mean the amounts received by the Licensee and/or its
sub-licensee(s) from independent customers who are not affiliates of
the Licensee or its sub-licensee, for the sale of Product, Analog
Product or Royalty Bearing Derivative Product, as the case may be,
less: (a) trade, cash and/or quantity discounts actually allowed and
taken; (b) excises, sales taxes, value added taxes, duties and like
received from the buyer in addition to the sales price of the goods;
(c) amounts repaid or credited by reason of purchase charge backs,
recalls, rebates (including government mandate rebates), rejections
due to defects or returns; and (d) freight, postage and transportation
insurance paid for and separately identified on the invoice or other
documentation maintained in the ordinary course of business.
1.12 "[INTENTIONALLY OMITTED]"
1.13 "Patents" shall mean all of the Original Patents other than those of
the Original Patents that are assigned by Licensor to Licensee
pursuant to Section 3.1 of the Third Amendment
1.14 "Products" or "the Product" shall mean any pharmaceutical product
containing the Compound as the active pharmaceutical ingredient of
such pharmaceutical product.
1.15 "Technical Information" shall mean any know-how, technical, scientific
and medical facts, data, advice or other information, written (in the
form of reports, drawings, specifications and the like) or oral,
tangible or intangible, which is now or hereafter controlled or
possessed by Licensor and which Licensor has the right to license (a)
relating to a Product or for conversion of the Compound to a Product,
(b) relating to any Compound Analog or for the conversion of any
Compound Analog into any Analog Product, (c) relating to the
conversion of any Compound, Compound Analog, Product or Analog Product
into any Derivative or any Derivative Product, (d) relating to any
Derivative or any Derivative Product, or the conversion of any
Derivative into any other Derivative or any Derivative Product, (e)
relating to the manufacture of the Compound or any Compound Analog;
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Derivative, Product, Analog Product or Derivative Product, (f)
relating to marketing of any Product, Analog Product or Derivative
Product, or (g) required to comply with applicable laws or
regulations. Technical Information shall include, but not be limited
to, patent files, manufacturing know-how, clinical tests and test
results, regulatory submissions and correspondence files, and any
other proprietary or trade secret information concerning the Compound
or any Compound Analog, Derivative, Product, Analog Product or
Derivative Product subject to the confidentiality provisions hereof.
1.16 "Territory" shall mean all countries of the world.
1.18 "Derivatives" shall mean (i) new compounds or chemical entities that
are discovered, invented, developed, synthesized, made or manufactured
using Compound or any Compound Analog, Analog Product or Product,
whether as a raw material, intermediate or otherwise, and (ii) new
compounds or chemical entities that are discovered, invented,
developed, synthesized, made or manufactured using any composition of
matter structures, compounds, processes, technology or other items of
any kind covered by any of the Original Patents or any of the
Technical Information. For the avoidance of doubt, and notwithstanding
anything express or implied in the foregoing definition to the
contrary, the term "Derivatives" shall not include Compound or any
Compound Analog, Analog Product or Product.
1.19 "Derivative Product" shall mean any pharmaceutical product containing
a Derivative as the active pharmaceutical ingredient of such
pharmaceutical product.
1.20 "Original Patents" shall mean (i) Licensor's United States, European
and other countries issued patents and applications for patents
relating to the Compound or any of the Compound Analogs, whether
previously, currently or hereafter issued to, or applied for, by
Licensor, (ii) the inventions which are described and claimed therein,
(iii) any reissues, divisions, substitutions, continuations,
continuations-in-part, re-examinations and improvements thereon and
extensions thereof, and (iv) any corresponding patent rights in any
other country. Licensor represents and warrants to Licensee that all
of the patents and patent applications set forth in Appendix 2
attached hereto are included within the Original Patents and that
there are no other patents or patent applications within the Original
Patents that are not set forth in Appendix 2 attached hereto.
1.21 "Royalty Bearing Derivatives" shall mean (i) new compounds or chemical
entities that are synthesized or manufactured in [***]or [***] using
Compound or the compound designated KRM-1158, whether as a raw
material, intermediate or otherwise, and (ii) new compounds or
chemical entities that are synthesized or manufactured in [***] or
[***] using processes covered by any valid claim of the Second Listed
Patents.
1.22 "Royalty Bearing Derivative Product" shall mean any pharmaceutical
product or composition containing or manufactured from any Royalty
Bearing Derivative.
1.23 "Second Listed Patents" shall mean the patents listed as item 2 on
Appendix 2 hereto.
1.24 "Third Amendment" shall mean that certain Third Amendment Agreement,
dated as of August [27], 2004 by and between Licensor and Licensee for
purposes of amending this Agreement.
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5.4 The last sentence of Section 2.l(i) of the Current Agreement is hereby
deleted and the following two sentences are hereby inserted therein in lieu
thereof:
"This license shall be an exclusive license, with the right to
sub-license. Nothing in this Section 2.l(i) shall limit Licensor's
rights under Section 2.10 of this Agreement."
5.5 The last sentence of Section 2.l(ii) of the Current Agreement is hereby
deleted and the following two sentences are hereby inserted therein in lieu
thereof:
"This license shall be an exclusive license, with the right to
sub-license. Nothing in this Section 2.1(ii) shall limit Licensor's
rights under Section 2.10 of this Agreement."
5.6 Section 2.l(iii) of the Current Agreement is hereby renumbered as Section
2.l(iv) and the text thereof is hereby amended to read in its entirety as
follows:
"(iv) Licensor agrees to assign and hereby assigns to Licensee all
right, title and interest in and to the Trademarks."
5.7 A new Section 2.1 (iii) is hereby added as follows:
"(iii) Licensor hereby grants to Licensee a license to the Compound,
the Compound Analogs and the Intellectual Property to research,
develop, make, have made, import, export, use, distribute for
sale, promote, market, offer for sale and sell (on a royalty
basis only, except in the case of compassionate use or in the
case of clinical trials prior to the issuance of a United States
new drug application approval) Derivatives and Derivative
Products in the Field in the Territory in accordance with the
terms of this Agreement. This license shall be an exclusive
license with the right to sublicense. The license granted by
Licensor pursuant to this Section 2.1(iii) shall have retroactive
effect to the date on which Licensor first granted to Licensee a
license pursuant to Section 2.l(i) of this Agreement"
5.8 The text of each of Section 2.l(a) and Section 2.l(b) of the Current
Agreement is hereby deleted and replaced with the following text:
"[Intentionally Omitted]"
5.9 The first sentence of Section 2.3 of the Current Agreement shall be amended
to read as follows:
"Licensee may grant sublicenses hereunder to third parties (the
"Sublicensees"), provided however that, if any of such
sublicenses includes the right to manufacture Compound and/or
Compound Analog-in the Territory, then (A) Licensee shall inform
the outline of such Sub-license agreement to Licensor and (B) the
terms of any such sublicense shall require that the sublicensee
thereunder shall be subject to all of Licensee's obligations
under Section 2.10 of this Agreement. In the event that Licensee
intends to grant a sublicense hereunder to a third party that
includes the right to manufacture Compound and/or Compound Analog
in the Territory and such third party is not a
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Competitor, then no consent of Licensor shall be required in order for
Licensee to grant such sublicense. In the event that Licensee intends
to grant a sublicense hereunder to a third party that includes the
right to manufacture Compound and/or Compound Analog in the Territory
and such third party is a Competitor, then, prior to Licensee granting
such sublicense to such Competitor, Licensee shall have obtained
Licensor's written consent to such sublicense, which consent shall not
be unreasonably withheld or delayed by Licensor. For purposes of this
Section 2.3, the term "Competitor" shall mean any third party that
derives substantially all of its revenues from the business of
contract manufacturing of bulk pharmaceutical products."
5.10 Section 2.7 of the Agreement shall be amended to read in its entirety as
follows:
"2.7 Permitted Uses of Compound, Compound Analogs and Derivatives.
Notwithstanding anything expressed or implied in this Agreement to the
contrary and without limiting the rights granted to Licensee pursuant
to Section 2.1 above, (i) Licensee may use the Compound, any of the
Compound Analogs or any Intellectual Property to research, develop,
make, have made, manufacture, have manufactured, use, import, export,
distribute, promote, market, offer for sale, sell or otherwise
commercialize any Derivative or any Derivative Product anywhere in the
Territory, and (ii) Licensee may use any Derivative to research,
develop, make, have made, manufacture, have manufactured, use, import,
export, distribute, promote, market, offer for sale, sell or otherwise
commercialize any other Derivative or any Derivative Product anywhere
in the Territory. For the avoidance of doubt, the parties hereby
acknowledge and agree that the rights of Licensee under this Section
2.7 shall be deemed to be within the scope of the rights licensed by
Licensor to Licensee pursuant to Section 2.1 hereof and, accordingly,
the lights of Licensee under this Section 2.7 are exclusive license
rights with the light to sublicense."
5.12 A new Section 2.10 shall be added to the Current Agreement as follows:
"2.10 The Licensor and Licensee hereby acknowledge, ratify, confirm
and agree that, effective as of the date of the License Agreement,
Licensor and Licensee have agreed to terminate any and all rights that
Licensor had under the Amended and Restated Agreement to manufacture
the Compound or any of the Compound Analogs, Products or Product
Analogs. Accordingly, consistent with such agreement, Licensor and
Licensee hereby agree that Licensee has exclusive worldwide rights to
manufacture Compound, Compound Analogs, Derivatives, Products, Analog
Products and Derivative Products. Licensor retains the right to
negotiate with Licensee, for the manufacture and supply of Compound on
terms that are competitive with Licensee's requirements, including,
without limitation, competitive with Licensee's requirements on price
and quality. Licensee shall be free to accept or reject Licensor's
proposals."
Signature Page to Third Amendment
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5.13 A new Section 3.1(k) will be added to the Current Agreement as
follows:
"(k) Royalties on Certain Derivative Products Subject to Section
3.1(1) hereof, the Licensee shall pay to Licensor royalties based
on the Net Sales of any Royalty Bearing Derivative Product. The
royalty shall be paid quarterly within sixty (60) days of the
close of the Licensee's fiscal quarter. In the case of a Royalty
Bearing Derivative Product for human use where a Royalty Bearing
Derivative is the only active pharmaceutical ingredient, the
royalty shall be equal to [***] percent ([***]%) of the Net Sales
with respect to such Royalty Bearing Derivative Product In the
case of a combination product for human use where such
combination product consists of any Royalty Bearing Derivative
Product or any Royalty Bearing Derivative as one of the active
pharmaceutical ingredients of such combination product, the
royalty shall be equal to (i) [***] percent ([***]%) of the Net
Sales for such combination product if Licensee is not required to
pay a royalty to a third party in connection with such
combination product and (ii)[***] percent ([***]%) of the Net
Sales for such combination product if Licensee is required to pay
a royalty to a third party in connection with such combination
product, or if Licensee previously acquired such combination
product or any active pharmaceutical ingredient of such
combination product from a third party with or without royalty
payment obligations to such third party, or if Licensee developed
such combination product or any active pharmaceutical ingredient
of such combination product internally de novo. In the case of a
Royalty Bearing Derivative Product for veterinary use where a
Royalty Bearing Derivative is the only active pharmaceutical
ingredient, the royalty shall be equal to [***] percent ([***]%)
of the Net Sales with respect to such Royalty Bearing Derivative
Product. In the case of a combination product for veterinary use
where such combination product consists of any Royalty Bearing
Derivative Product or any Royalty Bearing Derivative as one of
the active pharmaceutical ingredients of such combination
product, the royalty shall be equal to (i) [***] percent ([***]%)
of the Net Sales for such combination product if Licensee is not
required to pay a royalty to a third party in connection with
such combination product and (ii) [***] percent ([***]%) of the
Net Sales for such combination product if Licensee is required to
pay a royalty to a third party in connection with such
combination product, or if Licensee previously acquired such
combination product or any active pharmaceutical ingredient of
such combination product from a third party with or without
royalty payment obligations to such third party, or if Licensee
developed such combination product or any active pharmaceutical
ingredient of such combination product internally de novo."
5.14 Anew Sections 3.1(1) will be added to the Current Agreement as follows:
"(l) Royalty Payment Obligation Notwithstanding anything expressed or
implied in this Agreement to the contrary, the obligation of
Licensee and its sublicensees to make payment of royalties to
Licensor under this Agreement in connection with sales by
Licensee or its sublicensees of any Royalty Bearing Derivative
Product shall apply only if and for so long as the synthesis or
manufacture of such Royalty Bearing Derivative Product by
Licensee or any of its sublicensees would, absent an assignment
of, or a license to, the Second Listed Patents, infringe an
Signature Page to Third Amendment
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
unexpired valid claim of the Second Listed Patents."
5.15 Section 3.2 of the Current Agreement shall be amended to read in its
entirety as follows:
"3.2 Officer's Certificates. With each payment made pursuant to
Section 3.1(d), (f) and (k) hereof, Licensee shall provide
Licensor with a certificate signed by an officer of Licensee
which states the total amount due and payable and the manner in
which that amount was calculated and which certifies that the
information so provided is true and correct."
5.16 Section 7.1 of the Current Agreement shall be amended to read in its
entirety as follows:
"7.1 Term. Unless otherwise terminated earlier pursuant to this
Article 7, this Agreement shall continue in full force and effect
until the fifteenth (15th) anniversary of first sale of a
Product, an Analog Product or a Derivative Product, whichever is
earlier, by Licensee or its sublicensees, notwithstanding any
patent assignment to Licensee by Licensor hereunder or in the
future nor any expiration or termination of Patents"
5.17 The addressees set forth in Section 9.3 of the Current Agreement shall be
amended to read as follows:
"If to Licensor: Kaneka Corporation
Life Science RD Center
1-8, Miyamae-machi, Takasago-cho
Takasago-shi, Hyogo 676-8688, Japan
Attention: General Manager
Life Science RD Center
Fax: +81(794) 45-2459
If to Licensee: ActivBiotics, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
XXX
Attention: Chief Executive Officer
Fax: x0 (000) 000-0000"
ARTICLE 6. NO OTHER AMENDMENTS OR WAIVERS
Except as expressly provided in this Amendment, all the terms and
conditions of the Current Agreement are hereby ratified and confirmed and
remain in full force and effect.
ARTICLE 7. EXECUTION IN COUNTERPARTS, ETC.
7.1 This Amendment may be executed in any number of counterparts, each of which
shall be deemed an original, but which together shall constitute one
instrument.
7.2 This Amendment shall be effective upon execution of this Amendment by the
parties hereto, and shall be governed by the applicable law specified in
Section 9.1 of the Agreement.
Signature Page to Third Amendment
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
This Amendment has been executed by a duly authorized representative of
each party as of the date first above written.
KANEKA CORPORATION
/s/ Xxxxxxxx Xxxx
----------------------------------------
Name: Xxxxxxxx Xxxx, MS
Title: General Manager, Life Science RD
Center
ACTIVBIOTICS, INC.
/s/ Xxxxxx X. Xxxxxx
----------------------------------------
Name: Xxxxxx X. Xxxxxx, Ph D.
Title: President and Chief Executive
Officer
Signature Page to Third Amendment
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
APPENDIX 2
List of the patents related to the Rifamycin derivative:
1. "'3'- Hydroxybenzoxazinorifamycin derivative, process for preparing the
same and antibacterial agent containing the same"
US: Patent No. 4,983,602 Expiration Date: February 5, 0000
Xxxxxx: Patent No. 1,304,363 Expiration Date: June 30, 2009
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Patent No. 0366914 Expiration Date: September 14, 2009
Patent No. (DE) 68919650.4
China: Patent No. 24,993 Expiration Date: September 16, 2004
Singapore: Patent No. 38437 Expiration Date: September 14, 0000
Xxxxx: Patent No. 0000000 Expiration Date: November 1, 2008
THIS PATENT WILL BE RETAINED BY KANEKA.
2. "'3'-alkyl, -arylsiryloxybenzoxazinorifamycin derivatives"
China: Patent No. 39,298 Expiration Date: August 16, 2006
Taiwan: Patent No. 60,726 Expiration Date: January 20, 2008
Korea: Patent No. 203615 Expiration Date: August 3, 2011
Patent No. 203729 Expiration Date: Xxxxxx 0, 0000
Xxxxx: Patent No. 0000000 Expiration Date: August 10, 2010
THIS PATENT WILL BE RETAINED BY KANEKA.
3. "Production method for fine granules"
U.S.: Patent No. 5,547,683 Expiration Date: October 6, 2013
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Patent No. 0616841 Expiration Date: October 6, 2013
Patent No (DE) 69322764 8
Canada: Patent No. 2,124,568 Expiration Date: Xxxxxxx 0, 0000
Xxxxx: Patent No. 1091628 Expiration Date: October 6, 2013
Korea: Patent No. 294525 Expiration Date: Xxxxxxx 0, 0000
Xxxxx: Patent No. 00000000 Expiration Date: October 9, 2012
THIS PATENT HAS BEEN ASSIGNED TO ACTIVBIOTICS.
4. "Treatment of chlamydia infectious diseases by rifamycin derivative"
US: Patent No. 5,786,349 Expiration Date: December 9, 0000
Xxxxxx: Appl. No. 2,192,255 Filed: December 6, 1996
(decision of patent)
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Patent No. 0778022 Expiration Date: December- 6, 2016
Xxxxxx Xx. (XX) 00000000.0
Xxxxx: Appl. No. 08-002634 Filed January 10, 1995
THIS PATENT WILL BE RETAINED BY KANEKA.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
5. "Treatment of disease caused by infection of Helicobacter"
U.S.: Patent No. 5,981,522 Expiration Date: August 29, 0000
Xxxxxx:
Appl. No. 2,230,649 Filed: February 27, 1998
(decision of patent)
EPC (BE, CH, DE, ES, FR, GB, IT, LI):
Appl. No. 969287234 Filed: August 29, 1996
(decision of patent)
Appl. No. 98103481 Filed: February 27, 0000
Xxxxxx: Patent No. 113445 Expiration Date: February 26, 2018
Korea: Patent No. 407849 Expiration Date: August 29, 2016
Patent No. 407851 Expiration Date: Xxxxxxxx 00, 0000
Xxxxx: Appl. No. 10-038590 Filed: February 20, 1998
THIS PATENT WILL BE RETAINED BY KANEKA.
6. "Method for treating mastitis in a domestic animal"
U.S.: Patent No. 6486161 Expiration Date: July 28, 2017
CA: Appl. No. 2297012 Filed: July 29, 1998
(on abandonment)
EPC (DE, XX, XX, X, XX, XX, SE):
Patent No. 1001778 Expiration Date: July 28,
(on abandonment)
Taiwan: Appl. No. 88,100,078 Filed: January 5, 1999
(on abandonment)
Korea: Appl. No. 00-7,000,601 Filed: July 29, 1998
(on abandonment)
Australia: Patent. No. 756367 Expiration Date: July 28,2018
(on abandonment)
New Zealand: Patent No. 503027 Expiration Date: July 28, 2018
(on abandonment)
China: Appl. No. 98,807,682.9 Filed: July 29, 1998
(on abandonment)
Japan: Appl. No. 2000-504,861 Filed: July 29, 1998
THIS PATENT HAS BEEN ASSIGNED TO ACTIVBIOTICS
7. "Antimicrobial compositions with synergistic effect, drugs and remedies for
digestive diseases containing the same, process for the production thereof
and preparations associated therewith"
U.S.: Patent. No. 6362169 Expiration Date: February 16, 2019
EP: Appl. No. 99905227.7 Filed; February 17, 1999
CA: Appl. No. 2321265 Filed; Xxxxxxxx 00, 0000
XX: Appl. No 00-7008855 Filed; February 17, 0000
Xxxxxx: Appl. No. 88,102,542 Filed; February 22, 1999
JP: Appl. No. 2000-533123 Filed; February 17, 1999
THIS PATENT HAS BEEN ASSIGNED TO ACTIVBIOTICS
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
8. "Method for treatment of bacterial infections with once or twice-weekly
administered rifalazil" (PathoGenesis assigned to Kaneka, 2000).
U.S.: Patent No. 6316433 Expiration Date: December 15, 2019
Patent No. 6566354 Expiration Date: February 28, 2020
Appl. No. 10/243141 Filed: November 14, 2002
CA: Appl. No. 2355283 Filed: December 16, 1998
EPC: Appl. No. 99968906.0 Filed: December 16, 1998
(under examination)
KR: Appl. No. 00-0000000 Filed: December 16, 1998
(under examination)
CN: Appl. No. 99815782.1 Filed: Xxxxxxxx 00, 0000
XX: Appl. No. 2000-587729 Filed: December 16, 1998
THIS PATENT WILL BE RETAINED BY KANEKA.
9. "Benzoxazinorifamycin derivative, process for preparing the same and
antibacterial agent containing the same"
U.S.: Patent No. 4,690,919 Expiration Date: February 5, 0000
Xxxxxx: Patent No. 1,256,430 Expiration Date: June 27, 2006
EPC (BE, CH, FR, GB, IT, LI, NL, SE, DE)
Patent No. 0,190,709 Expiration Date: February 4, 2006
China: Patent No. 24,976 Expiration Date: May 31, 0000
Xxxxx: Patent No. 1,854,546 Expiration Date: January 20, 2006
THIS PATENT WILL BE RETAINED BY KANEKA.
10. "Alkyl-substituted benzoxazinorifamycin derivative, process for preparing
the same and antibacterial agent containing the same"
U.S.: Patent No. 4,859,661 Expiration Date: July 13, 2007
THIS PATENT HAS BEEN ASSIGNED TO ACTIVBIOTICS.
11. "Substituted benzoxazinorifamycin derivative and antibacterial agent
containing the same"
U.S.: Patent No. 4,965,261 Expiration Date: March 16, 0000
Xxxxxx: Patent No. 1,293,503 Expiration Date: December 23, 2008
EPC (BE, CH, ES, FR, GB, IT, LI, DE):
Patent No. 0,333,176 Expiration Date: March 15, 2009
Patent No. (DE) 68924722 2
China: Patent No. 20,729 Expiration Date: Xxxxx 00, 0000
Xxxxx: Patent No. 0000000 Expiration Date: March 17, 2009
(on abandonment)
THIS PATENT HAS BEEN ASSIGNED TO ACTIVBIOTICS.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
