Item 1.01
|
Entry Into Material Definitive Agreement
.
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On September 2, 2016, Biodel Inc.
(
Biodel
), Unilife Corporation (
Unilife
) and Unilife Medical Solutions, Inc. (
UMS
and, together with Unilife, the
Unilife Parties
) entered into an Asset Purchase and License
Agreement (the
Agreement
) pursuant to which (i) the Unilife Parties granted Biodel an option to purchase assets and a license to intellectual property relating to Biodels glucagon emergency management
(
GEM
) product candidate; (ii) the parties granted to each other a mutual general release; (iii) Biodel agreed to withdraw with prejudice its pending litigation against UMS (the Existing Lawsuit defined below); and
(iv) Biodel and UMS agreed to dismiss with prejudice their pending arbitration proceeding (the Arbitration defined below).
Asset
Purchase Option
. Pursuant to the Agreement, the Unilife Parties granted Biodel an exclusive option to purchase certain enumerated assets owned by Unilife that are used or useful in the manufacture of Unilifes dual-chamber automatic
reconstitution device intended for use with Biodels GEM product candidate, as well as copies of all records in Unilifes possession that are used or useful in connection with the operation of such assets.
Biodel must exercise the asset purchase option, if at all, within six months of the effective date of the Agreement. To exercise the option,
Biodel must deliver to Unilife written notice that Biodel intends to purchase all of the enumerated assets for the predetermined sum of $1.5 million and to extend the term of the intellectual property license, as described below. If Biodel exercises
its option, upon transferring title and delivering the purchased assets to Biodel, the Unilife Parties shall have no further liabilities, responsibilities or other obligations whatsoever arising out of or relating to the purchased assets.
License
. Pursuant to the Agreement, the Unilife Parties granted to Biodel an exclusive, worldwide, sub-licensable license to certain
enumerated intellectual property assets owned by the Unilife Parties that are necessary or useful to develop, modify, improve, make, use, import, sell, offer for sale, and market a product using Unilifes dual-chamber automatic reconstitution
device with Biodels GEM product candidate for the treatment of hypoglycemia. The intellectual property assets are comprised of patents and patent applications relating to Unilifes dual-chamber automatic reconstitution device, as well as
related know-how, technology and existing supplier agreements. The Unilife Parties will be primarily responsible for maintaining all patent rights with respect to the licensed intellectual property assets.
The initial term of the license is six months from the effective date of the Agreement. Biodel may extend the initial term, at its option, by
delivering to Unilife written notice that Biodel intends to exercise the asset purchase option described above and by paying a license fee. If Biodel exercises its option, the total amount of the license fee shall be equivalent to the aggregate
prosecution and maintenance costs actually incurred by the Unilife Parties during the license term and prosecuting in maintaining the licensed intellectual property assets. If extended, the license term shall continue until the earlier of:
(i) the expiration of the last intellectual property asset to expire; (ii) the 15th calendar day following Biodels delivery of written notice of termination of the license; (iii) termination by the mutual written consent of the
parties; and (iv) termination by either party as a result of the other partys material breach of the Agreement.
2
During the license term, the Unilife Parties shall not develop, manufacture, use, import, sell,
offer for sale, or market a dual-chamber mixing injection system for use as a glucagon rescue device. Furthermore, any modifications, improvements or developments made by Biodel to the dual-chamber automatic reconstitution device shall be owned by
Biodel, and Biodel shall be entitled to pursue intellectual property protection for the same at its own cost.
Assignment
. Under
the Agreement, Biodel may sell or assign its rights or obligations to a third-party that is agreed upon in writing in advance by the parties (which agreement shall not be unreasonably withheld, conditioned or delayed by Unilife), provided that the
transfer of rights or obligations must be an assignment or sale of all of Biodels rights and obligations under the Agreement.
Services
. During the term of the Agreement, Unilife shall establish, maintain and make accessible, free of charge, an electronic data
room which may be accessed from time to time by Biodel. The contents of the electronic data room shall be of a nature to permit Biodel to determine with a reasonable degree of accuracy: (i) the scope of the development work required to
establish commercial manufacturing of Unilifes dual-chamber automatic reconstitution device; (ii) the timelines and costs associated with such development work; (iii) the stage of such development work; and (iv) the unit pricing
for the commercial manufacture of the device. Also during the term, at Biodels election, Unilife shall permit and facilitate up to two separate on-site diligence audits of the assets that are subject to Biodels purchase option. For each
such audit, if any, Biodel shall pay to Unilife a services fee on a time and material basis, not to exceed $40,000.
Term
. The
Agreement became effective on September 2, 2016. It shall survive for a period of six months following the effective date, subject to earlier termination by its terms. Either party may terminate the Agreement upon a material breach by the other
party by delivering written notice of the material breach or upon mutual consent of the parties.
Former Agreement and Mutual
Release
. Pursuant to the Agreement, the parties agreed to terminate, as of the Agreements effective date, the Customization and Commercial Supply Agreement, dated April 8, 2013, as amended, between Biodel and UMS (the
Former
Agreement
). Neither Biodel nor the Unilife Parties have any further rights or obligations whatsoever under the Former Agreement. Furthermore, as of the effective date of the Agreement, each of Biodel, on one hand, and the Unilife Parties,
on the other hand, have unconditionally released the other party from any and all causes of action, rights, obligations, damages, losses, liabilities, demands, debts, contracts, agreements, actions, and claims of any kind or nature whatsoever, at
law or in equity, including any and all of the foregoing that in any way arise out of or relate to: (i) the Former Agreement or any other agreement between the parties, excluding only the Agreement; (ii) the lawsuit pending in the
Connecticut Superior Court under the caption
Biodel Inc. v. Unilife Medical Solutions, Inc
., at docket number DBD-CV-15-6018082 (the
Existing Lawsuit
); or (iii) the arbitration filed with the American Arbitration
Association under the caption
Biodel Inc. v. Unilife Medical Solutions, Inc.
, at case number 01-15-0005-5882 (the
Arbitration
). In connection with the release of claims, Biodel has agreed to withdraw with prejudice the
Existing Lawsuit, and the parties have agreed to dismiss the Arbitration with prejudice.
3
The foregoing description is qualified in its entirety by reference to the complete text of the
Agreement, which is attached to this current report on Form 8-K as
Exhibit 10.1
and is incorporated herein by reference.