Development Milestone Payments TriSalus shall pay (or cause to be paid) to Dynavax, in accordance with and subject to the terms of this Section 2.3, Section 2.4 and Section 6.4 (each such milestone, a “Development Milestone”, and each payment in respect thereof, a “Development Milestone Payment”):
(i) Upon the successful completion by a Milestone Obligor after the Closing of a [**] study with respect to a Product using PEDD, a payment of [**] US Dollars ($[**]), with such Development Milestone Payment being payable only once (for purposes of the foregoing, successful completion means completion of such study in accordance with the plan for such study);
(ii) For the first patient Dosed by a Milestone Obligor in each Phase 1 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor;
(iii) For the first patient Dosed by a Milestone Obligor in each Phase 2 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor;
(iv) For each Phase 2 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 2 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 2 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor;
(v) For each Phase 3 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 3 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 3 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor;
(vi) Upon receipt by a Milestone Obligor of each Regulatory Approval for any Product for any Indication in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval;
(vii) Upon receipt by a Milestone Obligor for each Regulatory Approval of any Product for any Indication in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval;
(viii) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vi) for receipt of such Regulatory Approval), regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; and
(ix) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vii) for receipt of such Regulatory Approval), regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval.
Joint Commercialization Committee Upon a decision by the JSC to activate the joint Commercialization committee, but in no case later than eighteen (18) months prior to the projected First Commercial Sale (the “Joint Commercialization Committee” or “JCC”), the Parties shall establish the JCC. The JCC shall hold its initial meeting within thirty (30) days of its establishment. Following its initial meeting, the JCC will meet in person, by teleconference or by video-teleconference at least [***] per [***] to review and discuss material decisions and key activities that relate to the matters set forth below. The JCC will be responsible for the communication, review and discussion of the Commercialization Plan and other Commercialization matters, including marketing strategy and planning, pricing, commercial manufacture, and [***], in each case in the Territory. Without limiting the foregoing, the JCC shall be responsible for: (a) reviewing and consulting with Coherus on the Commercialization Plan prior to adoption of the Commercialization Plan or changes by Licensee; (b) recommending the Commercialization Plan for approval by the JSC prior to adoption of the Commercialization Plan; (c) communicating with the JDC regarding the interrelationship between Development activities and potential Commercialization activities; (d) reviewing and monitoring the activities and progress against the Commercialization Plan; (e) monitoring and reporting on the competitive landscape for the Product in the Territory; (f) establishing appropriate processes for coordinating review of promotional materials for the Territory to ensure compliance with Applicable Laws and industry best practices; (g) overseeing the trademark and publication strategies for the Territory; and (h) communicating with the Parties regarding all of the foregoing.
Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
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).
Particular Methods of Procurement of Goods Works and Services (other than Consultants’ Services)