manufacture and
supply to Janssen of all Product(s), and component bioabsorbable polymers
utilized in such Product(s). Medisorb will have a period of thirty (30) days
following written notice from Janssen of terms it is offering to, or prepared to
accept from, a third party manufacturer to notify Janssen of its intention to
exercise its right of first refusal to supply Product and/or component
bioabsorbable polymers thereof to Janssen, its Affiliates and Licensees on terms
no less favorable to Janssen than those offered by such third party
manufacturer. Such third party manufacturer cannot be an in-kind competitor to
Medisorb and must be reasonably acceptable to Medisorb with respect to
confidential protection of
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5
Medisorb's Technical Information. In the event that at any time during the term
of this Agreement Medisorb is unable for any reason whatsoever to supply the
Medisorb Polymers required by Janssen for use in Products, then the right of
first refusal under this paragraph respecting the supply of the
component bioabsorbable polymers shall be eliminated. For the purposes of this
section, an "in-kind" competitor shall mean any organization which regularly
engages in the contract development and/or contract manufacture of injectable
controlled release drug delivery systems comprising a polymeric excipient based
on lactic and/or glycolic acids and/or other closely related monomers. This
Section 4(b) specifically supercedes Section 7(B) of the Development Agreement,
which Section 7(B) shall be of no further force or effect.
(c) The right of first refusal granted to Medisorb pursuant to Section 4(b)
above shall be contingent upon: (i) Medisorb and Janssen reaching an agreement
concerning the financing, scheduling and construction in Europe of a Medisorb
manufacturing facility within twelve (12) months of the date first above written
or the initiation of Phase III human clinical trials, whichever is later, and
(ii) prior to the qualification of Medisorb's European manufacturing facility,
Medisorb using reasonable efforts to supply from its United States manufacturing
facilities all of Janssen's commercial requirements for Product pursuant to the
Product Supply Agreement anticipated by Section 7(A) of the Development
Agreement.
(5) Proprietary Rights
(a) Medisorb will retain title to and ownership of all technology (including,
without limitation, all patents, inventions, and data relating thereto) relating
to absorbable polymers, controlled release of active agents, and/or
manufacturing methods or processes relating to such polymers and the controlled
delivery systems for active agents based on such polymers previously owned by
Medisorb or developed by Medisorb as a result of the Development Program or
otherwise. Medisorb will pay its own costs and expenses in connection with the
protection of any such technology, including all patent application and
maintenance costs and Janssen agrees to provide Medisorb with any necessary
utility information.
Medisorb shall inform Janssen of any patent application it wishes to file to
protect proprietary rights defined in Article 5, resulting from either the
Development Program