Exhibit 10.11
FIRST AMENDMENT TO LICENSE AGREEMENT
THIS FIRST AMENDMENT TO THE LICENSE AGREEMENT (the "AMENDMENT") is entered
into as of July 16, 2003 (the "AMENDMENT EFFECTIVE DATE"), between PENINSULA
PHARMACEUTICALS, INC., a Delaware corporation with a principal place of business
at 0000 Xxxxxx Xxxx, Xxxxxxx, XX 00000 XXX ("PENINSULA"), and SHIONOGI & CO.,
LTD., a Japanese corporation with a principal place of business at 1-8
Xxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx 000-0000, Xxxxx ("SHIONOGI"). Shionogi and
Peninsula may be referred to individually as a "PARTY", and collectively as the
"PARTIES".
RECITALS
WHEREAS, Peninsula and Shionogi have entered into a License Agreement
dated July 11, 2002, as amended effective as of September 30, 2002 by that
certain Memorandum concerning the License Agreement (the "LICENSE AGREEMENT"),
pursuant to which Shionogi has granted to Peninsula exclusive rights to develop
and commercialize Licensed Products in the Territory;
WHEREAS, the Parties have entered into a Supply Agreement of even date
herewith (the "SUPPLY AGREEMENT"), pursuant to which Peninsula will purchase
from Shionogi, and Shionogi will supply to Peninsula, Peninsula's requirements
of Licensed Products for commercial sale;
WHEREAS, the Parties desire to amend the License Agreement to modify
certain terms under which Shionogi is providing clinical supply of Licensed
Products to Peninsula, to clarify that the supply of Licensed Products to
Peninsula for commercial sale shall be governed by the terms of the Supply
Agreement, and to conform certain provisions in the License Agreement to the
Supply Agreement.
NOW, THEREFORE, Peninsula and Shionogi hereby agree that the License
Agreement shall be amended, effective as of the Amendment Effective Date, as
provided below:
1. All capitalized terms used but not otherwise defined herein shall have
the meanings ascribed to such terms in the License Agreement.
2. Section 1.14 of the License Agreement shall be amended to include
Puerto Rico as part of the Territory.
3. Article 9 and all Sections thereof of the License Agreement shall be
deleted, in their entirety, and replaced with the following Article 9:
ARTICLE 9 COMMERCIAL SUPPLY
The supply by Shionogi of Licensed Products to Peninsula for
commercial sale in the Territory shall be governed by the terms and
conditions of the Supply Agreement.
4. Article 11 of the License Agreement shall be deleted in its entirety
and replaced with the following new Article 11:
1.
ARTICLE 11. ADVERSE DRUG EXPERIENCE REPORTING.
Peninsula shall be responsible for receiving, investigating, and
documenting all adverse drug experiences relating to the use of the
Licensed Products in the Territory of which it becomes aware.
Peninsula will be solely responsible for filing all post-marketing
reports of such adverse drug experiences required by Regulatory
Authorities in the Territory or as required by applicable laws or
regulations. In the event that either Party receives a report of an
adverse drug experience relating to the use of Licensed Products or
the Compound anywhere in the world, it shall immediately notify the
other in writing. The Parties shall periodically exchange a summary
of all adverse drug reactions of Licensed Products or the Compound
during the term of this Agreement, and shall agree on a detailed
procedure for exchanging and reporting the information.
5. A new Section 16.3 shall be added to the License Agreement as follows:
16.3 Injunctive Relief
The Parties expressly acknowledge and agree that any breach or
threatened breach of this Article 16 may cause immediate and
irreparable harm to the disclosing Party which may not be
adequately compensated by damages. Each Party therefore agrees
that in the event of such breach or threatened breach and in
addition to any remedies available at law, the disclosing
Party shall have the right to secure equitable and injunctive
relief, without bond, in connection with such a breach or
threatened breach.
6. Section 17.7 of the License Agreement shall be deleted in its entirety
and replaced with the following new Section 17.7:
17.7 Survival
Any provisions of Article, Sections or Subsections 3.3(e),
12.1, 12.3, 12.5, 14, 16, 17.6, 17.7, 20.10, and 21 of this
Agreement shall survive the termination or expiration of this
Agreement.
7. Section 20.1 of the License Agreement shall be deleted in its entirety
and replaced with the following new Section 20.1:
20.1 Notices
Any notice required or permitted to be given under this Agreement
shall be in writing, in English, shall specifically refer to this
Agreement, and shall be addressed to the appropriate Party at the
address specified in this Section 20.1 or such other address as may
be specified by such Party in writing in accordance with this
Section 20.1, and shall be deemed to have been sufficiently given
for all purposes (a) when received, if hand-delivered, sent by a
reputable overnight delivery service, or by facsimile (provided that
such facsimile is later confirmed
2.
in writing), or (b) five (5) business days after mailing, if mailed
by first class certified or registered mail, postage prepaid, return
receipt requested.
For Shionogi: Shionogi & Co., Ltd.
0-0, Xxxxxxxxxx 0-xxxxx, Xxxx-xx
Xxxxx 000-0000, Xxxxx
Attn: General Manager, International Business
Division
Fax: x00-0-0000-0000
With copy to: Shionogi & Co., Ltd.
0-0, Xxxxxxxxxx 0-xxxxx, Xxxx-xx
Xxxxx 000-0000, Xxxxx
Attn: General Manager, Legal Affairs Dept.
Fax: x00-0-0000-0000
For Peninsula: Peninsula Pharmaceuticals, Inc.
0000 Xxxxxx Xxx Xxxxxxx
Xxxxxxx, XX 00000
Attn: Office of the President
Fax: x0-(000) 000-0000
With a copy to: Cooley Godward LLP
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attention: Xxxxxxx Xxxxx Xxxx, Esq.
Fax: x0-(000) 000-0000
8. Section 20.4 of the License Agreement shall be deleted in its entirety
and replaced with the following new Section 20.4:
20.4 Severability
If any one or more of the provisions of this Agreement is held
to be invalid, illegal, or unenforceable by any court of
competent jurisdiction from which no appeal can be or is
taken, the provision shall be considered severed from this
Agreement and shall not serve to invalidate any remaining
provisions hereof. The Parties shall make a good faith effort
to replace any invalid or unenforceable provision with a valid
and enforceable one such that the objectives contemplated by
the Parties when entering this Agreement may be realized.
9. The following new Sections shall be added to Article 20 of the License
Agreement as follows:
3.
20.9 No Strict Construction
This Agreement has been prepared jointly and shall not be
strictly construed against either Party. Ambiguities, if any,
in this Agreement shall not be construed against any Party,
irrespective of which Party may be deemed to have authored the
ambiguous provision.
20.10 No Waiver
Any delay in enforcing a Party's rights under this Agreement
or any waiver as to a particular default or other matter shall
not constitute a waiver of such Party's rights to the future
enforcement of its rights under this Agreement, excepting only
as to an express written and signed waiver as to a particular
matter for a particular period of time.
20.11 Further Actions
Each Party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes
and intent of this Agreement.
10. Except as amended hereby, the License Agreement shall remain in full
force and effect.
11. This Amendment may be executed in one or more counterparts, each of
which shall be an original, and all of which shall constitute together the same
document.
IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed:
SHIONOGI & CO., LTD. PENINSULA PHARMACEUTICALS, INC.
By: /s/ Xxxxxxxx Xxxx By: /s/ Xxxx X. Xxxxx
-------------------------- --------------------------
Name: Xxxxxxxx Xxxx Name: Xxxx X. Xxxxx
Title: General Manager, Title: President
International Business Division
4.
