Initial Formulation definition

Initial Formulation means the pharmaceutical product in solid, oral tablet form containing 10mg of the Compound as its sole active pharmaceutical agent as described in the Initial Product NDA as of the Effective Date.

Initial Formulation means the formulation of the Lead Compound set forth on Exhibit C.

Initial Formulation means the formulation of the Licensed Product for the Initial Indication (a) intended to be used for the first Phase 3 Clinical Trial immediately following Acucela’s exercise of its Opt-In Right, if Acucela exercises the * Opt-In Right, or (b) intended to be used for purposes of filing the first NDA, if Acucela exercises the P3 Opt-In Right.

Examples of Initial Formulation in a sentence

• Formulation Development (Programme Extension Data) Auditing and Assessment Performance Validation (Final ACEA Performance Dataset) Initial Formulation (Candidate Data Package) Define engine lubricant requirements (ACEA OilSequences)The key steps for engine lubricants meeting ACEA Oil Sequences and the corresponding sections of the Code are shown in Figure 1.

• If Acucela exercises an Opt-In Right under Section 3.1, the Parties shall Co-Promote the Licensed Product for the Initial Indication in the Initial Formulation in the Territory in accordance with the Commercialization Plan and the Co-Promotion Agreement.

• The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”).

• In accordance with this Section 3.1, Acucela shall have an opt-in right to co-Develop and Co-Promote with Otsuka (and its Affiliates) the Licensed Compound and Licensed Products for the Initial Indication in the Initial Formulation in the Territory pursuant to Development Plans, Commercialization Plans and the terms of this Agreement.

• As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory.

More Definitions of Initial Formulation

Initial Formulation means the oral formulation of a Product in non-enteric coated soft gel capsules which is specified in each NDA application for the Product for Constipation and C-IBS indications in the Initial Territory.

Initial Formulation shall have the meaning as such term is defined in Clause 2.3 of the JDOA.

Initial Formulation means the oral formulation of a Product in non-enteric coated soft gel capsules which is specified in each NDA application for the Product for Constipation and C-IBS indications in the Initial Territory. “Initial Indications” shall mean all gastroenterology indications, including but not limited to, Constipation and C-IBS for the Product. “Initial Territory” shall mean the United States and Canada. “JCC” shall have the meaning set forth in Section 5.1(a). “JDC” shall have the meaning set forth in Section 4.1(a). “JMC” shall have the meaning set forth in Section 6.1(a). “JSC” shall have the meaning set forth in Section 3.1(a). “Labeling Changes” shall have the meaning set forth in Section 4.2 (b)(iii). “Liability” shall have the meaning set forth in Section 10.1. “Licensed Know-How” shall mean all information and data, regardless of form, which is owned by or licensed (with right of sublicense) to SPI as of the Effective Date or at anytime during the

Initial Formulation means the oral formulation of Drug Product in soft gelatin capsules as of the Effective Date.

Initial Formulation shall have the meaning as such term is defined in Clause 2.3.

Initial Formulation means the pharmaceutical product in solid, oral tablet form containing 10mg of the Compound as its sole active pharmaceutical agent as described in the Initial Product NDA as of the 2nd Amendment Effective Date.

Initial Formulation has the meaning ascribed thereto in Section 1.44 of the License Agreement.