Unilateral Development Clause Samples

Unilateral Development. The Party independently developing a Collaboration Product under Section 3.6.3, in the case of New River, or Section 3.6.4, in the case of Shire (the “Developing Party”), shall have the right unilaterally to conduct the Development of the applicable Collaboration Product (each such Collaboration Product, a “Unilateral Product”); provided, however, that such right shall be subject to the Developing Party conducting such Development in a manner that would not adversely affect in any significant way any then existing Collaboration Product being Developed or Commercialized under this Agreement. For any Unilateral Product, the non-Developing Party shall have the opportunity to opt back into the Development program and participate in the Development upon the [*] for any such Unilateral Product (a “[*] Opt-In Right”). At least [*] prior to [*] of such [*], the Developing Party shall provide to the other Party an updated proposal that contains, at a minimum the information set forth in Section 3.6.1, to enable such other Party to determine if it desires to exercise its [*] Opt-In Right. Such other Party shall have [*] after receipt of such updated proposal to exercise its [*] Opt-In Right. If such other Party exercises its [*] Opt-In Right, then such other Party shall be required to pay the Developing Party, within [*] days after such exercise, an amount equal to [*] in respect of the Development of the applicable Unilateral Product prior to such exercise, and thereafter the [*]. If the non-Developing Party does not exercise its [*] Opt-In Right but Regulatory Approval is obtained in the US Territory for the Unilateral Product, then the non-Developing Party shall be required to pay the Developing Party, within [*] of receipt of such Regulatory Approval, an amount equal to [*] in respect of such Unilateral Product. In order to conform with the definition of [*] in Article 1 above, for purposes of this Section 3.6.5 only, all [*] in connection with the Development of a Unilateral Product will be treated as if such [*] in connection with a Development Plan.

Unilateral Development. In the event the Parties do not determine to co-develop a Hospital Product as provided in Section 4.2(a), each Party shall be responsible for all

Unilateral Development a. If a Party (Non-Interested Party) – through the Joint Research Committee pursuant to Section 2.10 – decides not to develop a Preferred Clinical Candidate as a Collaboration Product and move it to Phase B, the other Party (Interested Party) shall be permitted to unilaterally continue development of the Preferred Clinical Candidate on the pre-defined terms and conditions set forth in Exhibit 1. In such case, the Preferred Clinical Candidate will become a Unilateral Product and Section 14.6 shall apply mutatis mutandis. b. If the Interested Party is not willing to continue development of the Preferred Clinical Candidate on the pre-defined terms and conditions set forth in Exhibit 1, a mandatory joint Divestment of the Preferred Clinical Candidate shall take place and Section 15.9 shall apply mutatis mutandis, unless the Parties decide otherwise. If the mandatory joint Divestment fails, the Preferred Clinical Candidate will be considered a Ceased Product under Section 14.5.

Unilateral Development. During the term of and in connection with the Agreement, if any software, copyrights, patents, trade secrets, intellectual property, including inventions, whether patentable or unpatentable, (each an "Invention") are made by either party or by the employees or contractors of such party, exclusive title to each such Invention and to any resulting patent shall be in the party on whose behalf the employees and/or contractors made the Invention. Such party shall be responsible for the costs of preparing, filing, and prosecuting any resulting patent or copyright applications.

Unilateral Development. 48 3.8 Dropped EDC Compound..........................................................................53 3.9 Back-Up Compounds.............................................................................53 3.10

Unilateral Development. If a Party – through the Joint Research Committee pursuant to Section 2.10 – decides not to develop a Preferred Clinical Candidate as an LCA Product and move it to Phase B, this shall be regarded as an opt-out by such Party in accordance with Section 18 and the process specified in Section 18.1 and 18.3 and the terms and conditions set forth in Sections 18.4 to 18.8 shall apply mutatis mutandis. In such event, the Opt-Out Notice (as specified in Section 18.1) shall be such Party’s declaration of its decision not to develop such Preferred Clinical Candidate as an LCA Product in such Joint Research Committee meeting and the Opt-Out Date (as specified in Section 18.1) shall be the date thirty (30) days after the date of the Joint Research Committee meeting in which such Party declared its decision not to develop such Preferred Clinical Candidate as an LCA Product. If the Parties agree not to advance a certain Clinical Candidate to Phase B, then such Clinical Candidate shall be considered a Ceased Product and Section 18.4 shall apply mutatis mutandis.

Unilateral Development