Exhibit 10.1

Braeburn Pharmaceuticals Sprl

c/o Apple Tree Partners

51 East 12th Street, 5th Flr.

New York, NY 10003

July 2, 2013

Titan Pharmaceuticals, Inc.

400 Oyster Point Blvd., Suite 505

South San Francisco, CA 94080-1921

Reference is made to the License Agreement (the “Original License”) dated
December 14, 2012 between Titan Pharmaceuticals, Inc. (“Titan”) and Braeburn
Pharmaceuticals Sprl (“Braeburn”) (each a “Party” and collectively “Parties”),
as amended by written agreement dated May 28, 2013 (the “First Amendment”)
(together the Original License and First Amendment constitute the “Agreement”).
This is to confirm our agreement as follows:

 

  1. Section 4.1 of the Agreement is hereby amended to add the following clause
(c):

“(c) The Parties hereby establish a committee (the “CRL Response Committee”)
comprised of Marc Rubin and Sunil Bhonsle (the “Titan Representatives”) and Seth
Harrison, Garry Neil and a third individual to be named by Braeburn (the
“Braeburn Representatives”). Notwithstanding anything to the contrary, including
the provisions of Section 4.2(a), the CRL Response Committee shall be
responsible for and have the authority to make all decisions regarding the
development and implementation of a strategic plan for FDA approval of
Probuphine for subdermal use in the maintenance treatment of adult patients with
opioid dependence, including, but not limited to developing the strategy for all
written and oral communications with the FDA and responding to any complete
response letter (“CRL”) issued by the FDA (the “Project”). The CRL Response
Committee shall operate as follows:

(i) The CRL Response Committee shall meet in person or by conference telephone
call twice monthly on a regularly scheduled basis on dates mutually agreeable to
all members, except that individual meetings may be cancelled where mutually
agreeable to both Braeburn and Titan. Additional meetings may be called by any
member with at least 48 hours’ notice (unless such notice requirement is waived
by all members) at a time mutually agreeable to all members, provided that the
member calling for the meeting has provided a reasonably sufficient rationale
for the need for a meeting, and that the stated need for the meeting cannot be
sufficiently addressed at the next regularly scheduled meeting of the CRL
Response Committee or through more informal communications.

(ii) Drafts of written communications to the FDA, as well as scripts for
telephonic or in-person meetings with the FDA, prepared by or on behalf of
either Party shall be provided contemporaneously to all of the committee
members. Any comments from the Titan Representatives and the Braeburn
Representatives will be considered in good faith.

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(iii) The CRL Response Committee may designate, on a case -by -case basis, one
or more representatives of the Parties, including consultants or agents of Titan
and Braeburn, to attend telephonic or in-person meetings with the FDA, which
designee(s) shall be in addition to the Parties’ respective representatives for
such meetings pursuant to Section 4.2(xii) below.

(iv) The Titan Representatives and the Braeburn Representatives shall seek to
reach consensus regarding the Project after due consideration of advice from
Braeburn’s regulatory advisors and other outside consultants, as appropriate.
However, in the event the Parties cannot agree, the Braeburn Representatives
shall have final decision-making authority regarding all Project matters
considered by the CRL Response Committee.

(v) The CRL Response Committee shall be automatically disbanded upon the NDA
Transfer Date.

 

  2. Section 4.2(a) of the Agreement is hereby amended by adding the following
new clauses (xi) through (xiii):

“(xi) Notwithstanding the foregoing provisions of this Section 4.2(a), Titan
shall authorize Braeburn to designate a person or persons who shall serve as the
primary contact with the FDA with respect to the Project. The initial designee
of Braeburn is its Head of Research and Development, Garry Neil. Braeburn shall,
with the guidance of regulatory counsel, at the direction of the CRL Response
Committee, determine when and how to meet with the FDA, and who should attend
such meetings in order to obtain the desired outcome.

(xii) Braeburn shall provide advance notice to Titan of any scheduled meetings,
and substantive discussions or other communications with the FDA regarding the
Project. Each of the Parties shall be entitled to have at least one
representative selected by it present at such meetings with FDA, whether in
person or by conference telephone call. Notwithstanding the immediately
preceding sentence, the CRL Response Committee may determine in good faith that
certain interactions with the FDA can reasonably be expected to produce the best
outcome without representatives of either Braeburn or Titan, or with outside
consultants and without representatives of both Braeburn and Titan.

(xiii) Any written communications from the FDA to Braeburn shall be provided to
Titan on the same day as receipt. Any substantive oral communications from the
FDA to Braeburn shall be conveyed to Titan Representatives as soon as possible,
but in no event later than 48 hours following receipt.

In all other respects, the License Agreement shall remain in full force and
effect and shall be unaffected by this Amendment.

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BRAEBURN PHARAMACEUTICALS SPRL By:  

/s/ Seth L. Harrison

  Seth L. Harrison Agreed: TITAN PHARMACEUTICALS, INC. By:  

/s/ Sunil Bhonsle

  Sunil Bhonsle, President