Territory Development Plan Sample Clauses
The Territory Development Plan clause outlines the requirements and expectations for developing a specific geographic area or market under an agreement. Typically, it details the steps, milestones, and timelines that a party must follow to establish or expand operations, such as opening new locations, achieving sales targets, or implementing marketing strategies within the designated territory. This clause ensures that both parties have a clear understanding of development obligations, helping to drive growth and prevent disputes over performance or unmet expectations.
Territory Development Plan. Except for the activities allocated to Zai under the Global Development Plan pursuant to Section 5.3, all Development by Zai of Licensed Products in the Territory under this Agreement shall be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory Development Plan”), which Territory Development Plan shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. contain in reasonable detail all major Development activities (including all Clinical Trials) for Licensed Products in the Territory and the timelines for achieving such activities. Attached hereto as Exhibit C is an initial draft of the Territory Development Plan and attached hereto as Exhibit B is a NMPA Submission Timeline for the indications of recurrent and newly diagnosed GBM. From time to time as needed thereafter, Zai shall propose amendments to the Territory Development Plan in consultation with NVCR and submit such proposed updated or amended Territory Development Plan to the JSC for review, discussion and approval. Once approved by the JSC, the amended Territory Development Plan shall become effective. For clarity, the Territory Development Plan and amendments thereto must be consistent with the Global Development Plan and the Global Development Plan shall take precedent in case of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan.
Territory Development Plan. Except for the activities allocated to Zai under the Global Development Plan pursuant to Section 5.3, all Development by Zai of Licensed Products in the Territory under this Agreement shall be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 5.2 and Section 3.2, the “Territory Development Plan”). Following the Effective Date, and at least [***] prior to Zai’s planned initiation of Development activities in the Territory, Zai shall provide to Five Prime an initial draft of the Territory Development Plan for Five Prime’s review and comment, which Territory Development Plan shall contain in reasonable detail all major Development activities (including all Clinical Trials) and the timelines for achieving such activities. Zai shall take such comments into consideration in good faith and incorporate such comments where appropriate prior to finalizing the initial Territory Development Plan. From time to time thereafter, but at least every [***], Zai shall propose amendments to the Territory Development Plan in consultation with Five Prime and submit such proposed updated or amended Territory Development Plan to the JSC for review, discussion and approval. Once approved by the JSC, the amended Territory Development Plan shall become effective. For clarity, the Territory Development Plan and amendments thereto must be consistent with the Global Development Plan and the Global Development Plan shall take precedent in case of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan.
Territory Development Plan. Except for the activities to be conducted by Zymeworks pursuant to Sections 5.1(b) and 5.2, as between the Parties, all Development of Licensed Products in the Territory shall be conducted by Jazz. Promptly after Jazz prepares[***] a written plan for its Development of Licensed Products in the Territory and, if applicable, outside the Territory (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory Development Plan”), Jazz shall provide Zymeworks with a copy of such plan. From time to time thereafter[***] Jazz shall propose amendments to the Territory Development Plan in consultation with Zymeworks and submit such proposed updated or amended Territory Development Plan to the JSC for review and discussion. Once reviewed by the JSC, the amended Territory Development Plan shall become effective. The Territory Development Plan must include, without limitation, [***].
Territory Development Plan. Except for the activities assigned to Partner under a Global Development Plan for a Licensed Product pursuant to Section 5.3 (Global Development Plan) all Development by or on behalf of Partner of Licensed Products and any Companion Diagnostic to be used in connection therewith designed to generate data that is intended to be used for the purposes of obtaining Regulatory Approval in the Territory will be conducted pursuant to a written development plan agreed by the JDC and approved by the JSC (as updated from time to time in accordance with this Section 5.2 (Territory Development Plan) and Section 3.2 (Joint Steering Committee), the “Territory Development Plan”), and Partner will be primarily responsible for all Territory Development activities for the Licensed Products. An outline of the initial Territory Development Plan for the Licensed Products is set forth on Schedule 5.2 (Territory Development Plan) attached hereto. The Territory Development Plan and all updates thereto will contain [***] (a) all major Territory Development activities for the Licensed Products (including all non-clinical and preclinical studies and Territory-Specific Clinical Trials and the trial design thereof) to be conducted solely in furtherance of obtaining and maintaining Regulatory Approval of the Licensed Products in each Indication in the Territory and any Territory Development activities to be conducted for a Licensed Product solely for use in the Territory, (b) the estimated timelines for performing and completing such activities, including Development of Companion Diagnostics for Licensed Products that are to be used with one or more Licensed Products, and (c) an outline of the key elements involved in obtaining Regulatory Approval of such Licensed Product in each Indication from all applicable Regulatory Authorities throughout the Territory as further described in Section 6.1 (Regulatory Strategy), including the estimated timelines for Regulatory Submissions for the Licensed Products in each country or region in the Territory. In addition, [***], the JDC will propose updates to each Territory Development Plan and submit such proposed updated Territory Development Plan to the JSC. The JSC will review, discuss, and determine whether to approve any and all such updates to the Territory Development Plan. Once approved by the JSC, each update to the Territory Development Plan will become effective and supersede the then-current Territory Development Plan. Notwithstanding...
Territory Development Plan. Except for the activities allocated to Zai under the Global Development Plan pursuant to Section 5.3, all Development by Zai of Licensed Products in the Territory under this Agreement shall be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory Development Plan”), which Territory Development Plan shall contain in reasonable detail all major Development activities (including all Clinical Trials) for Licensed Products in the Territory and the timelines for achieving such activities. Attached hereto as Exhibit C is an initial draft of the Territory Development Plan and attached hereto as Exhibit B is a NMPA Submission Timeline for the indications of recurrent and newly diagnosed GBM. From time to time as needed thereafter, Zai shall propose amendments to the Territory Development Plan in consultation with NVCR and submit such proposed updated or amended Territory Development Plan to the JSC for review, discussion and approval. Once approved by the JSC, the amended Territory Development Plan shall become effective. For clarity, the Territory Development Plan and amendments thereto must be consistent with the Global Development Plan and the Global Development Plan shall take precedent in case of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan.
Territory Development Plan. Except for the activities allocated to BeiGene under the Global Development Plan pursuant to Section 5.2, all Development of Licensed Products in the Territory under this Agreement shall be conducted by BeiGene pursuant to a written development plan (as amended from time to time in accordance with this Section 5.3 and Section 3.2, the “Territory Development Plan”). The initial Territory Development Plan is 43 Competitive Information – Commercially Sensitive Terms. 44 Competitive Information – Discovery Information and Commercially Sensitive Terms. 45 Competitive Information – Discovery Information and Commercially Sensitive Terms. 46 Competitive Information – Discovery Information and Commercially Sensitive Terms. attached hereto as Exhibit 5.3. […***…].47
Territory Development Plan. Prior to ZLAB’s performance of any Development of the Product in the Territory (other than a Global Trial), the JSC must agree to a Territory Development Plan governing such Development and, for clarity, such Development shall be limited to the Approved Product for an Approved Indication that is specific to the Territory. If ZLAB desires to conduct any such Development during the Term, it shall submit to Regeneron, through the JDC, for review and revision, if applicable, a proposed Territory Development Plan including all of the detail set forth in the last sentence of this Section 5.2, and the JDC shall submit such updated Territory Development Plan to the JSC for approval. ZLAB will review and update the Territory Development Plan at least once annually and will present an updated Territory Development Plan to the JDC for review and revision, if applicable, at least […***…] prior to the end of each Calendar Year (starting in 2020), and the JDC shall submit the Territory Development Plan to the JSC for approval. The Parties will use good faith efforts to cause any updates to the Territory Development Plan to be approved by the JSC at least […***…] prior to the end of each Calendar Year. Each Territory Development Plan will set forth, in a reasonable level of detail, the plan for ZLAB’s Development of the Approved Product for the Approved Indications that is […***…] and will include all details set forth on Schedule 5.2, as well as strategies and timelines for Developing and obtaining and maintaining Regulatory Approvals for the Approved Product for the Approved Indications in the Territory.
Territory Development Plan. The initial Territory Development Plan for the initial Product in the Field is set forth in Exhibit 1.115. Ajinomoto will direct, coordinate and manage the Development of the initial Product in the Field in the Territory in accordance with the Territory Development Plan. The Territory Development Plan will include, among other things, the indications in the Field for which each Product is to be Developed and other exploratory indications in the Field for which a Product may be developed, critical activities to be undertaken, timelines, Go/No Go decision points and relevant decision criteria and allocations of responsibilities between the Parties for the various activities to be undertaken under the Territory Development Plan. During the Term, Ajinomoto will amend the Territory Development Plan on an ongoing basis as necessary, any amendments (other than amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities) being subject to review by the JDC, and any amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities being subject to report to the JDC, provided that the Territory Development Plan will at all times contain terms that reflect the use of Commercially Reasonable Efforts to Develop the Product to obtain Regulatory Approval in the Field in Japan and, after the first patient is dosed in a Phase III trial of the Product in Japan, in the other countries throughout the Territory as soon as practicable and provided further that Ajinomoto will not assign any Development activities to Albireo beyond those set forth in the initial Territory Development Plan without Albireo’s prior consent, such consent not to be unreasonably withheld.
Territory Development Plan. Except for the activities allocated to BeiGene under the Global Development Plan pursuant to Section 5.2, all Development of Licensed Products in the Territory under this Agreement shall be conducted by BeiGene pursuant to a written development plan (as amended from time to time in accordance with this Section 5.3 and Section 3.2, the “Territory Development Plan”). The initial Territory Development Plan is attached hereto as Exhibit 5.3. […***…].45
Territory Development Plan. Except for the activities [***] pursuant to Section 5.3, all Development by Zai of Licensed Products in the Territory under this Agreement shall be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory Development Plan”), which Territory Development Plan shall contain in reasonable detail all major Development activities (including all Clinical Trials) for Licensed Products in the Territory and the timelines for achieving such activities. Attached hereto as Exhibit C is an initial draft of the Territory Development Plan and attached hereto as Exhibit B is a NMPA Submission Timeline for the indications of recurrent and newly diagnosed GBM. From time to time as needed thereafter, Zai shall propose amendments to the Territory Development Plan in consultation with NVCR and submit such proposed updated or amended Territory Development Plan to the JSC for review, discussion and approval. Once approved by the JSC, the amended Territory Development Plan shall become effective. For clarity, the Territory Development Plan and amendments thereto must be consistent with the [***] Plan and the [***] Plan shall take precedent in case of any conflict or inconsistency between the Territory Development Plan and the [***] Plan.