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 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 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 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 Partys site) with such other Party after providing such report upon such other Partys 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:
discuss, prepare and approve for submission to the JSC the Joint Commercialization Plan for each Product, including, in each case, any amendments thereto;
If Unum reasonably believes that a Voluntary Phase 4 Clinical Trial that Unum is conducting at its sole expense for the Shared Territory will also reasonably benefit the Licensed Territory, Unum may propose to SGI that a portion or all of the Joint Commercialization Costs attributable to such Voluntary Phase 4 Clinical Trial be included in the allocation set forth in [[Section 8.3(b), and SGI]I]] will consider that request reasonably and in good faith. Alternatively, SGI may request by written notice to Unum that any Voluntary Phase 4 Clinical Trial that Unum is conducting at its sole expense pursuant to the preceding sentence be included in the Joint Commercialization Plan and the Joint Commercialization Costs attributable to such Voluntary Phase 4 Clinical Trial be allocated on the terms set forth in this [Section 8.3(a)(iv)], including the applicable premium. No such Joint Commercialization Costs may be allocated in whole or in part without the express written consent of SGI and for clarity will not be subject to decision within the JDC or JSC (it being understood that each of the Parties will be deemed to have consented expressly in writing that any such Joint Commercialization Costs included as part of the applicable Joint Commercialization Plan be so allocated to the extent appearing in such plan). Further, such an allocation of such Joint Commercialization Costs incurred with respect to such Voluntary Phase 4 Clinical Trial may be made retrospectively (i.e.,
Unum may use one or more Third Party subcontractors to perform Unums assigned obligations and responsibilities under this Agreement or any Research Plan, Early Clinical Development Plan, Late Clinical Development Plan or Joint Commercialization Plan, provided that such agreements will comply with [Section 5.9], [Section 6.9], or [Section 8.6], as applicable. Under the licenses granted by Unum under [Section 10.2], Unum retains the right to have its Affiliates (for so long as such party continues as an Affiliate of Unum) and Third Party subcontractors perform Unums assigned obligations and responsibilities and exercise its rights under this Agreement or any Research Plan, Early Clinical Development Plan, Late Clinical Development Plan or Joint Commercialization Plan, provided that such agreements will comply with [Section 5.9], [Section 6.9], or [Section 8.6], as applicable. In addition, unless the relevant subcontractor is contemplated by the Research Plan, Early Clinical Development Plan, Late Clinical Development Plan or Joint Commercialization Plan (as applicable), Unum will provide written notice to SGI within days of engaging such subcontractor.
Commercialization Pending Resolution of Disputes. In the event of a dispute relating to Commercialization in the Shared Territory with respect to a Product, and in an effort to avoid economic harm to such Product, the Lead Commercializing Party will be entitled to exercise tie-breaking decision authority pending the resolution of the applicable dispute in accordance with this [Article 4]; provided that # in exercising such authority the Lead Commercializing Party will take into consideration the temporary nature of such authority, # this [Section 4.8] will not apply to Pricing Matters, and # this [Section 4.8] will not apply if the dispute relates to any ACTR Matter.
review and discuss reports from the JDC and JCC and provide guidance thereto, direct the activities of such Committees, and approve each Research Plan, Early Clinical Development Plan, Late Clinical Development Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto;
Overview. On a Product-by-Product basis (but not including a Reversion Product), subject to the oversight of the JSC and JCC, # the Parties will participate in the planning of Commercialization activities with respect to, and the Co-Promotion of, such Product in accordance with this Agreement and the Joint Commercialization Plan for such Product in the Shared Territory, and # SGI will be solely responsible, at its expense, for all Commercialization activities relating to such Product in accordance with this Agreement for such Product in the Licensed Territory.
Lead Commercializing Party means # SGI for the first Product and the third Product for which a Joint Commercialization Plan is approved pursuant to [Section 4.2(c)] and [[Section 8.3(a)(ii), and (b)])]])] Unum for the second Product for which a Joint Commercialization Plan is approved pursuant to [Section 4.2(c)] and [Section 8.3(a)(ii)]. For clarity, a Reversion Product will not have a Lead Commercializing Party (and thus will not count as one of the designations of a Lead Commercializing Party).
Shared Territory. For after commercial launch of a Product in the Shared Territory, each Party may perform any of its Commercialization obligations under the Joint Commercialization Plan through one or more subcontractors, provided # such Party remains responsible for the work allocated to, and payment to, such subcontractors to the same extent it would if it had done such work itself; # the subcontractor undertakes in writing commercially reasonable obligations of confidentiality and non-use regarding Confidential Information that are substantially the same as those undertaken by the Parties with respect to Confidential Information pursuant to [Article 15] hereof; and # the subcontractor undertakes in writing to assign or exclusively license back (with the right to sublicense) all intellectual property with respect to Products developed in the course of performing any such work under the Joint Commercialization Plan to the Party retaining such subcontractor. , either Party may continue to use any such subcontractors only if the other Party and its Affiliates is not able and willing to take on those previously subcontracted obligations under the Joint Commercialization Plan.
Following the termination of this Agreement for any reason each Party will be responsible for an orderly wind-down of this Agreement with respect to such Research Candidate, Development Candidate, Product or Reversion Product (as applicable), in accordance with accepted pharmaceutical industry norms and ethical practices, including any then on-going Clinical Trials hereunder with respect to such Research Candidate, Development Candidate, Product or Reversion Product (as applicable). The Parties will endeavor to effect any such wind-down as expeditiously as possible and subject to Applicable Law and taking in account the then-current applicable Research Plan, Early Clinical Development Plan, Late Clinical Development Plan or Joint Commercialization Plan. In such circumstances, each Party will also continue to bear its share of all Research Costs, Development Costs and Joint Commercialization Costs incurred during any such wind-down period, as well as all committed or otherwise non-cancellable Research Costs, Development Costs and Joint Commercialization Costs for any activities agreed to by the Parties under the then-current applicable Research Plan, Early Clinical Development Plan, Late Clinical Development Plan or Joint Commercialization Plan. By way of example, but not limitation, in the event that the termination of this Agreement occurs in the middle of a Phase 3 Clinical Trial for a Development Candidate, then each Party will continue to bear its share of all Development Costs with respect to such Phase 3 Clinical Trial until it is concluded.
Commercialization [ ]. When used as a verb, to Commercialize and Commercializing means to engage in Commercialization, and Commercialized has a corresponding meaning.
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