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 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 19 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. 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. 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 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 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. 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 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. 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 allocated to BeiGene under the Global Development Plan pursuant to Section 5.3, 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 5.4 and Section 3.2, the “Territory Development Plan”). BeiGene shall provide the first Territory Development Plan for JDC review and discussion [***] after exercise of the Option by BeiGene. From time to time after the Effective Date, but not [***], BeiGene shall propose amendments to the Territory Development Plan in consultation with Leap and submit such proposed updated or amended Territory Development Plan to the JDC for review and discussion. For clarity, the Territory Development Plan and amendments thereto shall 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.39 34 Competitive Information – Discovery Information and Commercially Sensitive Terms. 35 Competitive Information – Discovery Information and Commercially Sensitive Terms. 36 Competitive Information – Discovery Information and Commercially Sensitive Terms. 37 Competitive Information – Discovery Information and Commercially Sensitive Terms. 38 Competitive Information – Discovery Information and Commercially Sensitive Terms.
Territory Development Plan. Without limiting the generality of the other provisions in this Article 4, an initial, mutually agreed Territory Development Plan is attached hereto as Exhibit D (the “Initial Development Plan”). Within [***] after the Effective Date, Kaken (in conjunction with assistance from Spruce) will prepare and submit to the JSC a high level plan concerning the Development of the Licensed Compound and Licensed Products in the Field in the Kaken Territory (the “First Supplemental Development Plan,” and together with the Initial Development Plan and any subsequent updates pursuant to this Section 4.2, the “Territory Development Plan”). The First Supplemental Development Plan shall include among other things, all material non-clinical studies, Phase 1 Clinical Trial, CMC Activities and regulatory activities with respect to the Licensed Compound and Licensed Products to be conducted by or on behalf of Kaken or its Affiliates or their respective Sublicensees in the Kaken Territory and include target timelines for: [***]. From time to time during the Term (but at least [***] per Kaken Fiscal Year), Kaken shall prepare amendments and updates, as appropriate, to the then-current Territory Development Plan, and shall submit such amendments and updates to the JSC in accordance with Section 4.3. For clarity, if there are no amendments or updates to the then-current Territory Development Plan that are applicable in a Kaken Fiscal Year, Kaken’s sole responsibility under this Section 4.2 during such Kaken Fiscal Year shall be to inform Spruce that the then-current Territory Development Plan is up to date.
