Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)
Commercialization Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].
Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.
Commercialization Plans 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. 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”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:
Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.
Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.
Research Program Term The Research Program shall be conducted during the period of five years commencing as of the Agreement Date ("Research Program Term"). Upon not later than seventy-five (75) days' prior written notice JT may, in its sole judgment, terminate the Research Program at the end of the third (3/rd/) year and fourth (4/th/) year of the Research Program. The RMC may terminate the Research Program any time during the Research Program Term if it unanimously determines the Research Program is no longer scientifically useful or that all potential Products would not be commercially viable. In case of such an early termination by JT or the RMC, JT shall be exempt from any payment(s) under Section 10(a) that would have become due and payable after the effective date of such early termination. Following any termination of the Research Program (i) that occurs simultaneously with the termination of this Agreement in accordance with Section 13 (i.e., no compound or Lead Compound has been designated previously a Collaboration Lead Compound in accordance with Section 3(b) and no Independent Lead Compound is being developed in accordance with Section 3(m)) or (ii) that is followed at some future date by the termination by JT of Development or co-promotion of any Collaboration Lead Compound and/or Product pursuant to Sections 3(l) or 5(c), respectively, or development of an Independent Lead Compound in accordance with Section 3(m) (A) any licenses granted by Tularik to JT will terminate, (B) JT will grant to Tularik an exclusive, sublicensable, worldwide license, to make, use and sell compounds, Collaboration Lead Compounds or Products under JT's interest in Program Patents and Program Know-How and (C) under the terms and conditions to be separately agreed, JT will also grant to Tularik a nonexclusive, sublicensable, worldwide license under any JT Patent Rights and Know-How to the extent necessary to practice the license granted under the Program Patents and Program Know-How in (B) (including, with respect to compounds, a limited number of JT's library compounds approved by JT); provided, however, that in the event the Research Program terminates but the Agreement has not terminated with respect to designated Collaboration Lead Compounds, Independent Lead Compounds and/or Products as provided in Section 2(g)(ii), Sections 2(g)(A), (B) and (C) shall apply only to those compounds, Collaboration Lead Compounds, Independent Lead Compounds and Products for which Development or co-promotion shall have been terminated and/or to those compounds or Lead Compounds that have not been designated previously a Collaboration Lead Compound in accordance with Section 3(b) or an Independent Lead Compound in accordance with Section 3(m); provided further that in the event that JT elects to pursue a Discontinued Compound or a Non-Proposed Compound on or before the first anniversary of the expiration or termination of the Research Program Term pursuant to Section 3(b)(iii) or 3(b)(iv), respectively, Sections 2(g)(A), (B) and (C) shall not apply to such Discontinued Compound or Non-Proposed Compound until such time as JT shall have terminated the Development or co-promotion of such Discontinued Compound or Non- Proposed Compound. Tularik will then be free to pursue clinical development and registration of such compounds, Lead Compounds and/or Products without obligation to JT except as provided in Section 4(f) or Section 5(c), as appropriate.
Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.
