On an annual basis, ACADIA shall prepare a Commercialization plan with respect to the Commercialization of each Product in the Field in the Territory pursuant to this Agreement (as may be amended by ACADIA, the “Commercialization Plan”). The Commercialization Plan for the first full year following commercial launch of the first Product for which an NDA is filed with the FDA will be provided to Neuren by ACADIA as soon as it is available but, in any event, no later than […​…] days after the filing of the NDA for such Product with the FDA. Such initial Commercialization Plan shall provide a reasonably detailed plan for ACADIA’s (or its Affiliate’s or Sub-Licensee’s) Commercialization activities with respect to such Product, including pre-launch plans and launch plans, pricing, label expansion and market positioning (which information may be preliminary). ACADIA may amend the Commercialization Plan from time to time in its discretion.

Commercialization Plan. Allergan shall deliver to UroGen a high-level summary of its anticipated Commercialization activities in the United States and ​ the [[Unknown Identifier]] Countries for which Allergan is using Commercially Reasonable Efforts to Commercialize a Licensed Product with respect to a Licensed Product ​ no later than six (6) months prior to the anticipated launch of ​ Licensed Product ​ in the United States or one of the [[Unknown Identifier]] Countries (such summary, the “Commercialization Plan”). On or before each anniversary of the delivery of the first Commercialization Plan, Allergan shall prepare an amendment, as appropriate, to the then-current Commercialization Plan to reflect material changes or additions to the Commercialization of Licensed Product for the First Indication in the United States and the relevant ​ [[Unknown Identifier]] Countries. Allergan shall submit all amendments to the Commercialization Plan to UroGen and, upon such submission, the amended Commercialization Plan will become effective and supersede the previous Commercialization Plan.

As further described in this Section 8.3, the tactics and strategy for the Commercialization of each Product in the Territory will be described in a comprehensive plan (each such plan, a “Joint Commercialization Plan”) that describes the pre-launch, launch and subsequent Commercialization of such Product in the Shared Territory (including anticipated activities relating to messaging, branding, Pricing Matters (to the extent not prohibited by Applicable Law), advertising, planning, marketing, sales force training and allocation, detailing, and Distribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a “Joint Commercialization Budget”).

Joint Commercialization Plan. Any expenses incurred by a Party for Commercialization activities in the Shared Territory related to a Product that do not fall within the definitions of Joint Commercialization Costs will be borne solely by such Party unless the JCC determines otherwise. In addition, any expenditure or cost that exceeds the amount set forth in the applicable Joint Commercialization Plan by more than ​ for a calendar year or any unbudgeted cost that is incurred by either Party will be borne by such Party; provided that the JCC will have the discretion to review such expenditures or costs and propose to the JSC that they be designated as Joint Commercialization Costs.

Commercialization. In connection with this Agreement and the rights granted hereunder,

Commercialization. By ​ of each calendar year during the Term, the Continuing Party will provide to the other Party a report on the Commercialization of the applicable Reversion Product. Such report will describe in reasonable detail the Commercialization efforts for the preceding calendar year for such Reversion Product (including the past calendar year and projected budgets for such Commercialization). Further, the Continuing Party will provide such additional information regarding the Commercialization of such Reversion Product as the other Party may reasonably request, and further will meet (in person at the Continuing Party’s site) with such other Party after providing such report upon such other Party’s request to discuss same. Subject to Applicable Law, all Pricing Matters for Reversion Products will be determined by the Continuing Party, except to the extent they constitute an ACTR Matter, in which event such Pricing Matter will be determined by mutual agreement of the JSC, subject to the dispute resolution process set forth in [Section 4.5(c)]. The Parties will comply with Section 7.3 for each Reversion Product, with the Continuing Party being responsible for the global safety database for such Reversion Product.

Commercialization. Licensee shall promptly give Merck written notice that it has filed an NDA for the Licensed Product and at that time shall further provide Merck with the anticipated date of First Commercial Sale for the Licensed Product in the country of filing. Licensee shall promptly provide Merck with notice of any Marketing Authorization of Licensed Product.

Without limiting any other provision of this Agreement ACADIA (or its Affiliate or Sub-Licensee, as applicable) shall be solely responsible for:

Regulatory, Manufacturing and Commercialization. After the Effective Date, # Zai Lab will be solely responsible for and control (at its own expense) all regulatory matters related to the Development and Commercialization of Compounds and/or Products in the Territory, including, without limitation, taking full responsibility for preparing and filing the relevant applications with the Regulatory Authorities for pre-clinical and clinical studies and for Regulatory Approval; and # Zai Lab will be solely responsible for and control (at its own expense) all aspects of Commercialization of Products and the Manufacturing and supply of Products (including, without limitation, the Manufacture and supply of related Compounds being Developed by Zai Lab) in the Territory and will have sole responsibility for all costs arising therefrom.

Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Patented Products in the Field. Notwithstanding the foregoing, Arcus is obligated to file an IND in the United States on a Patented Product no later than ​ months from the Effective Date; provided that Stage 2 Technology Transfer, as defined in [Section 3.3.1] below, is completed no later than ​ days following the Effective Date. The deadline for Arcus to file an IND in the United States on a Patented Product shall be extended by one (1) day for each day that Abmuno is late in completing Stage 2 Technology Transfer. Any delay or postponement in the filing of an IND in the United States on a Patented Product beyond the deadline for such filing will be subject to approval by Abmuno, which approval shall not be unreasonably withheld, conditioned or delayed.

“Commercialization Plan” has the meaning given to that term in clause 7.4.

“Joint Commercialization Plan” has the meaning set forth in [Section 8.3(a)(i)].

Co-Promotion Budget. The amount budgeted for each Party’s Co-Promotion activities in each Joint Commercialization Budget will be consistent with the Co-Promotion activities assigned to such Party pursuant to the Joint Commercialization Plan.

that the activities contemplated in any Development Plan or Commercialization Plan shall achieve any of the objectives contemplated therein; or

Governance. Subject to [Article 2], the Parties’ Co-Promotion activities for any Product in the Shared Territory will be overseen by the JCC and governed by the Joint Commercialization Plan. The JCC will use reasonable and good faith efforts to allocate the Co-Promotion activities in a manner to give effect to the sales and marketing strategy described in the Joint Commercialization Plan and in the best interests of such Product. The Joint Commercialization Plan will not allocate Co-Promotional activities in a manner that results in sales representatives of both Parties detailing Product to the same prescribers.

Co-Promotion Plan. The Commercialization of the Co-Promotion Product(s) in the Co-Promotion Territory shall be conducted pursuant to a comprehensive multi-year plan (the “Co-Promotion Plan”). At least […​…] prior to the anticipated date of the First Commercial Sale of the Co-Promotion Product, [[Organization A:Organization]] shall propose to the JCC the initial Co-Promotion Plan. The Co-Promotion Plan shall allocate responsibility for such Commercialization activities among the Parties. The JCC shall review and approve the Co-Promotion Plan within […​…] after receipt.

allocate budgeted resources and determine priorities for each Voluntary Phase 4 Clinical Trial included under the Joint Commercialization Plan;

During the Term, ACADIA shall be solely responsible for Commercializing any Product in the Territory for use in the Field, which Commercialization shall be in accordance with the Commercialization Plan and this Agreement. ACADIA shall be responsible for 100% of the expenses (including Pre-Marketing and other Commercialization expenses) incurred by or on behalf of ACADIA (including any expenses incurred by Neuren at the written request of ACADIA) in connection with the Commercialization of any Product in the Territory for use in the Field. Without limiting the foregoing, ACADIA shall use its Commercially Reasonable Efforts to launch and Commercialize any Product for use in the Field in each country in the Territory after the Marketing Authorisation (if applicable) and all other applicable regulatory approvals for that Product have been obtained in that country.