Additional Development Activities. If, following the Effective Date, the Lead Party in the US Territory or the ROW Territory, as applicable (any such Party, the “Proposing Party”) wishes (i) to conduct a Clinical Trial or other study (including to repeat any Clinical Trial previously conducted under the Development Plan that failed to meet its primary endpoints) of Shared Products not contemplated by the Development Plan, (ii) to Develop Shared Products for a territory in which it is the Lead Party for any Indication in the Field other than an Indication for which such Shared Products are being Developed pursuant to the Development Plan, (iii) to Develop a dosage form or formulation of Shared Products for a territory for which the Proposing Party is the Lead Party other than that being studied in the Development Plan, or (iv) to conduct any other Clinical Trial of a Shared Product in the Field for a territory for which the Proposing Party is the Lead Party, or any Clinical Trial or study that is not otherwise set forth in the Development Plan, or any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval in the Proposing Party’s territory, including any Phase IV Study or any combination of pharmaceutical products (each such study or activity in (i)-(iv) not already included in the then-current Development Plan, an “Additional Study”), then Parties understand and agree that this Section 3.3 shall apply and, accordingly, (A) the Proposing Party shall first provide the proposed trial design and protocol for such Additional Study to the other Party (the “Non-Proposing Party”), through its members on the JSC for review and approval as to the clinical and regulatory aspects of such Additional Study, and shall incorporate reasonable comments from the Non-Proposing Party’s JSC members into such Additional Study design and protocol, and (B) following such review by the Non-Proposing Party’s JSC members, the Proposing Party shall provide the final proposed design and projected costs of such Additional Study to the Non-Proposing Party’s JSC members. In any such case the following shall apply:
Additional Development Activities. (a) Santarus shall have the sole right and responsibility to conduct (or have conducted) all Development, including post-marketing Phase IV studies and any label enhancement studies for the Product, and any Development in support of an Additional Product.
Additional Development Activities. If the JDC is unable to reach agreement on the inclusion in the Global Development Plan of (i) additional Development activities relating to the Development of a Product Candidate that are not critical to obtaining Regulatory Approval for the Desired Label, or (ii) that constitute an Out-of-Budget Proposal (“Additional Development Activities”), then the Party wishing to conduct those activities may do so at its own expense, but only after review and approval of the Additional Development Activities with the JSC and, failing approval by the JSC, subject to the provisions of Sections 14.2 and 14.3 hereof. If the results of any such activities are included by the other Party in a filing with a Regulatory Authority (other than a required submission for safety purposes) to support a label claim or a change in an approved label in that other Party’s territory, then the other Party using that data [***]
Additional Development Activities. Each Party shall be permitted to undertake Development activities for an Optioned Product within a particular Collaboration Program for [***] (such activities, the “Additional Development Activities”); provided that such Party complies with the provisions of this Section 4.2.4.
Additional Development Activities. Subject to Section 2.12, each Party shall be permitted (i) to undertake Development activities (including Clinical Trials) not contemplated by the Development Plan (for example, a Clinical Trial for an Indication not included in such plans) or (ii) to repeat any Clinical Trial previously conducted under the Development Plan that failed to meet its primary endpoints (collectively, “Additional Development Activities”); provided that such Party complies with the provisions of this Section 3.3.
Additional Development Activities. If, following the Effective Date, Celgene wishes (i) to conduct a Clinical Trial (including to repeat any Clinical Trial previously conducted under the Development Plan that failed to meet its primary endpoints) of Shared Products not contemplated by the Development Plan, (ii) to Develop Shared Products in a country in the Territory for any Indication in the Field other than an Indication for which such Shared Products are being Developed pursuant to the Development Plan, (iii) to Develop a dosage form or formulation of Shared Products in a country in the Territory other than that being studied in the Development Plan, or (iv) to conduct any other Clinical Trial of a Shared Product in the Field in a country, including any Clinical Trial or study that is not otherwise set forth in the Development Plan, or any Clinical Trial that Celgene believes may have utility to support Regulatory Approval on a global basis (each such study or activity in (i)-(iv) not already included in the then-current Development Plan, an “Additional Study”), then Parties understand and agree that this Section 3.4 shall apply and, accordingly, (A) Celgene shall first provide the proposed trial design and protocol for such Additional Study to the JSC for review and approval as to the clinical and regulatory aspects of such Additional Study, and shall incorporate reasonable comments from the JSC into such Additional Study design and protocol, and (B) following such review by the JSC, Celgene shall provide the final proposed design and projected costs of such Additional Study to the JSC. In any such case the following shall apply:
Additional Development Activities. If a Party (the “Proposing Party”) wishes to conduct Development Activities that are not covered by an approved Product Work Plan (“Additional Development Activities”), then the Proposing Party shall provide the JSC with a proposal for such Additional Development Activities, including a description of, and rationale for, the activities, timelines for the activities and a projected budget for such activities, for review and approval, and shall incorporate reasonable comments from the JSC. If the JSC approves such Additional Development Activities, then such Additional Development Activities shall be incorporated into the existing Product Work Plan (thereby becoming Development Activities), and the costs of such Additional Development Activities [***] pursuant to Section 4.2(a)(i).
Additional Development Activities. If the Development Plan is amended to include additional development activities in the Territory other than the Initial Study, the Parties shall agree in writing on the allocation of costs and expenses with respect thereto. For clarity, neither Party shall be obligated to perform additional activities under an amended Development Plan unless and until the Parties have agreed in writing on the allocation of such costs and expenses. Notwithstanding the foregoing, Section 4.4.1 sets forth the Parties’ agreement on the allocation of costs and expenses with respect to a global Registration Enabling Clinical Trial for RX-3117 for the Lead Indication and no further written agreement with respect thereto shall be required.
Additional Development Activities. Except for the 611 Study, 612 Study and **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. BCG Refractory Study, nothing in this Agreement shall prevent Allergan from developing and performing any clinical trials with respect to the Licensed Product in the Field of Use in the Allergan Territory unilaterally and at its own expense. If Allergan requests that Spectrum assist in such trials, and Spectrum agrees to do so and agrees to assist in funding such trials, the Parties shall amend the JDP to govern such trials and the Development Costs incurred in such clinical trials shall be paid as set forth in Section 6.6. Spectrum shall not conduct any development activities with respect to the Licensed Product in the Allergan Territory other than pursuant to this Article 3 or as permitted in Section 2.5(b).
Additional Development Activities. Subject to this Section 4.2.4 (Additional Development Activities) and Section 3.8.2(b) (Licensor Final Decision-Making Authority), Licensor will have the right, in its sole discretion and at its sole cost, to conduct any Clinical Trials or other Development activities in or outside the Territory with respect to any Licensed Compound or Licensed Products which are not specified in the Development Plan.
