License Agreement
Category: License Agreements
ARTICLE II
LICENSE GRANTS
2.1. License Grant from Unigene to Novartis. Subject to the terms and conditions of this Agreement, Unigene hereby grants to Novartis and its Affiliates an exclusive license under the Licensed Technology to develop, manufacture, sell, use, import and export API, Intermediate and Amidating Enzyme in the Territory solely for the purpose of
| (a) | developing, having developed, manufacturing, using, selling, having sold importing and exporting Novartis Drug Products and/or |
| (b) | manufacturing and selling API to Unigene for use in Unigene Drug Products, by Unigene its Affiliates, licensees or distributors. |
2.2. Reservation of Rights to the Licensed Technology.
2.2.1. Unigene’s Oral Product. Notwithstanding the exclusive license granted to Novartis in Section 2.1.1, Unigene shall have the right to
| (a) | manufacture API, Amidating Enzyme and Intermediates for use in Unigene’s Oral Product needed until completion of **; |
| (b) | have manufactured API for use in Unigene’s Oral Product for commercial sale exclusively by Novartis and/or its Affiliates, as per the terms of the Contract Manufacturing Agreement; |
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| (c) | have manufactured API for use in Unigene’s Oral Product by a Third Party, in the event ** according to the terms of this Agreement and/or as contemplated by the Contract Manufacturing Agreement. |
| (d) | In the event that the Parties shall not negotiate and execute the Contract Manufacturing Agreement as contemplated in Section 5.2 below, or such Contract Manufacturing Agreement shall be terminated, the license granted to Novartis in Section 2.1 (b) shall terminate, and Unigene shall be free to manufacture or have manufacture API for use in Unigene’s Oral Product by a Third Party and/or a Joint Venture. |
2.2.2. Other Unigene Products. Notwithstanding the exclusive license granted to Novartis in Section 2.1.1, Unigene shall have the right to
| (a) | develop, manufacture, have manufactured by a Joint Venture, sell, use, import and export API, Intermediates and Amidating Enzyme to the extent it is used in Other Unigene Products, it being understood that such Joint Venture shall have the rights to manufacture API solely for use in Other Unigene Products; |
| (b) | have manufactured API for use in Other Unigene Products by Novartis and/or its Affiliates, as per the terms of the Contract Manufacturing Agreement; |
| (c) | have manufactured API for use in Other Unigene Products by a Third Party, in the event **, or as contemplated by the Contract Manufacturing Agreement, it being understood that such ** shall have the rights to ** solely for use in **; |
| (d) | In the event that the Parties shall not negotiate and execute the Contract Manufacturing Agreement as contemplated in Section 5.2 below, or such Contract Manufacturing Agreement shall be terminated, the license granted to Novartis in Section 2.1 (b) shall terminate, and Unigene shall be free to manufacture or have manufacture API for use in Other Unigene Products by a Third Party and/or a Joint Venture. |
2.2.3. Right of **. Each Party and its Affiliates will, upon reasonable request, provide the other Party with a right of ** related to **, including but not limited to **, other than the ** for **. ** will have the right to ** relating to the **, including ** shall have the right to ** related to **.
2.3. Novartis Sublicensing Rights.
2.3.1. Novartis shall not be permitted to sublicense the manufacture of API, Amidating Enzyme or Intermediates or provide any Third Party with access to the cell lines, cell banks, clones, vectors, cassettes, separations and purifications or any other Unigene Know-How
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included within the Licensed Technology without consent and prior written approval from Unigene, which approval shall be within Unigene’s sole discretion.
2.3.2. Novartis shall have the right to sublicense tableting, filling, packaging, finishing and similar aspects of secondary manufacture, of Novartis Drug Products (but excluding **) without consent or approval from Unigene.
2.4. Improvement License Grants from Novartis to Unigene to manufacture API.
2.4.1. For Novartis Non-Severable Sole Improvements and Non-Severable Joint Improvements.
2.4.1.1. During the term of the Contract Manufacturing Agreement and/or this Agreement. During the term of the Contract Manufacturing Agreement and/or this Agreement Novartis and/or its Affiliate as applicable shall upon implementation of Novartis Non-Severable Sole Improvements or Non-Severable Joint Improvements in its manufacture of API, Intermediates or Amidating Enzyme, grant to Unigene, its Affiliates and/or Joint Ventures a ** (except as to **), ** license, without the right to **, to Novartis Non-Severable Sole Improvements solely to manufacture API, Intermediates or Amidating Enzyme.
2.4.1.2. Upon termination of the Contract Manufacturing Agreement and this Agreement. After both the Contract Manufacturing Agreement and this Agreement have terminated any license granted to Unigene under Section 2.4.1.1 above shall be converted to a ** (even as to **), ** license with the right to **, to Novartis Non-Severable Sole Improvements and Non-Severable Joint Improvements solely to manufacture and have manufactured API, Intermediates or Amidating Enzyme.
2.4.1.3. Novartis and its Affiliates shall not at any time license Novartis Non-Severable Sole Improvements and/or Non-Severable Joint Improvements to any Third Party, and shall only employ Novartis Non-Severable Sole Improvements and/or Non-Severable Joint Improvements to manufacture API, Intermediates or Amidating Enzyme for Novartis Drug Products or for Unigene.
2.4.2. For Novartis Severable Sole Improvements.
2.4.2.1. During the term of the Contract Manufacturing Agreement and this Agreement. During the term of the Contract Manufacturing Agreement and this Agreement Novartis and/or its Affiliate as applicable shall upon implementation of Novartis Severable Sole Improvements in its manufacture of API, Intermediates or Amidating Enzyme, grant to Unigene, its Affiliates a ** license, without the right to **, to Novartis Severable Sole Improvements solely to manufacture API, Intermediates or Amidating Enzyme, said licenses to expire upon termination of the **.
2.4.2.2. Upon termination of the Contract Manufacturing Agreement and/or the term of this Agreement. Upon termination of the Contract Manufacturing Agreement and/or the term of this Agreement the Parties shall negotiate in good faith the terms
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of a ** license, without the right to ** solely to manufacture or have manufactured for Unigene, its Affiliates and/or Joint Ventures API, Intermediates or Amidating Enzyme.
2.4.3. Third Party Manufacturing. Unigene shall have the right to grant the rights granted under ** to a ** and/or ** in case ** for use in ** by a ** is required as per Section ** and/or as contemplated under the terms of the **, provided that such ** and/or ** is bound to confidentiality with respect to any information shared in the implementation of such rights and such ** and/or ** are bound by the terms and limitations of such licenses as set forth herein.
2.5. Improvement License Grants from Novartis to Unigene to manufacture proteins or peptides other than API.
2.5.1. For Novartis Non-Severable Sole Improvements. Upon the request of Unigene, the Parties shall negotiate in good faith the terms of an ** license for ** for use in the production of proteins or peptides other than API. Such licenses will be negotiated on an ** basis, unless agreed to the contrary in writing by the Parties. The right to ** will also be negotiated in good faith on an ** basis.
2.5.2. For Novartis Severable Sole Improvements. Upon the request of Unigene, the Parties shall negotiate in good faith the terms of a ** license for ** for use in the production of proteins or peptides other than API. Such licenses will be negotiated on an ** basis, unless agreed to the contrary in writing by the Parties. The right to ** will also be negotiated in good faith on an ** basis.
2.6. Licensed Technology Facilities. Prior to the commencement thereat, Novartis shall notify Unigene of each location at which Novartis will utilize the Licensed Technology, with respect to the manufacture of API, Amidating Enzyme, Intermediates and/or Novartis Drug Products.
ARTICLE III
PAYMENTS
3.1. Initial Fee to Unigene. In partial consideration for the license to Licensed Technology granted to Novartis under Section 2.1 of this Agreement, Novartis shall pay to Unigene three million five hundred thousand U.S. dollars (U.S. $ 3,500,000) within fifteen (15) days following execution of this Agreement, which amounts shall be non-refundable and not creditable against other amounts due Unigene under this Agreement.
3.2. Milestone Payments to Unigene.
3.2.1. Milestone Schedule for Novartis’ **. In partial consideration for the license to Licensed Technology granted to Novartis under Section 2.1 of this Agreement, Novartis shall pay Unigene the amounts set forth below following the first achievement by Novartis its respective Affiliates or permitted sublicensees, as applicable and as the case may be, of each of the following milestones with respect to the Novartis’ ** (“Milestones”):
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