Development of the Licensed Product by CASI Sample Clauses

Development of the Licensed Product by CASI. (a) Except to the extent otherwise set forth in this Agreement, CASI shall have the sole responsibility to Develop the Licensed Product and to conduct (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) all Clinical Trials and non-clinical studies CASI believes appropriate to obtain Regulatory Approval for the Licensed Product in the Territory. The Licensed Product will be developed in the Territory as an imported product through the Import Drug Registration pathway and/or domestically as a locally manufactured product. Cleave or any of its Affiliates will provide all reasonable assistance and support necessary for CASI to effectuate the Development and registration of the Licensed Product for clinical trial approval and marketing approval in the Territory. If the Licensed Product is to be registered as an imported product, the NMPA regulations and process require that Cleave remain the Sponsor and Market Authorization Holder on record in the product submissions and CASI will be on record as Cleave’s agent and licensee. In furtherance of the foregoing, Cleave or any of its affiliates will provide CASI reasonable assistance and cooperation as necessary for CASI to serve as Cleave’s agent and licensee of the Licensed Product in the Territory. Should the law in China change to permit CASI to hold the clinical trial approval and/or marketing authorization, CASI will apply for such transfer at Cleave’s request. Within ninety (90) days after the Effective Date, the JSC will approve a CASI clinical development plan and timelines for the Development of CB-5339 in the Territory (the “CASI Development Plan”). The CASI Development Plan will be reviewed and agreed upon by the CB-5339 Joint Project Team established by the Parties as a subcommittee of the JSC and will be based on the PRC import drug registration requirements. The initial CASI Development Plan, with respect to acute myeloid leukemia (AML) and multiple myeloma (MM) indications, will be based on the CB-5339 Global Development Plan, attached hereto as Exhibit D. The requirements of the NMPA (including a potential Phase 1 Trial dose escalation study, a pharmacokinetics study and any analytical testing in the PRC on patient samples from Chinese citizens) will be built into the CASI Development Plan. Without limiting and subject to CASI’s diligence obligations under Section 4.2, the following timeframes are generally required: (i) for CASI to file the first CTA for the License...
Sample 1
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Development of the Licensed Product by CASI. (a) Except to the extent otherwise set forth in Section 3.4, CASI shall have the exclusive right and sole responsibility to Develop the Licensed Product and to conduct (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) all Clinical Trials and non-clinical studies CASI believes appropriate to obtain Regulatory Approval for the Licensed Product in the Territory [***]. As XXXX xxxxx appropriate, CASI may Develop the Licensed Product in the PRC as an imported drug using the import drug registration pathway, or as a locally manufactured product using the domestic drug registration pathway. The Development of each Licensed Product shall be governed by a development plan that accurately describes the proposed overall program of Development (the “CASI Development Plan”), which CASI Development Plan will be updated by CASI at least once annually and communicated to the JSC regarding the Development activities pursuant to Section 3.2(ii). The initial CASI Development Plan is attached hereto as Exhibit C. CASI shall make necessary amendments in accordance with any change in local regulatory requirements with respect to the Development of the Licensed Products in the Territory. (b) The CASI Development Plan shall describe in reasonable detail the Development activities within their corresponding estimated timelines to be performed as well as corresponding decision points and milestones to further the Development process and to obtain Regulatory Approval for the Licensed Product in each Region in the Territory. For clarity, CASI Development Plan shall include (i) significant Clinical Trials to be undertaken by CASI, including, if applicable the engagement of a CRO for the Clinical Trials, (ii) estimated timelines for carrying out the Clinical Trials and the envisaged endpoints of such Clinical Trials, (iii) regulatory pathway and major regulatory activities and their timelines including meetings with Regulatory Authorities and expected market entry, and (iv) only if CASI exercises its option under Section 5.2, a manufacturing plan, as such manufacturing plan may be amended from time to time and communicated to the JSC. Notwithstanding the foregoing, a CASI Development Plan shall be deemed ​ ​ to be in compliance with this Section 4.1(b) if it contains content at a level of detail consistent with the Global Development Plan. (c) Key decisions made by CASI with respect to the Development of the Licensed Product including but not limited...
Sample 1

Related to Development of the Licensed Product by CASI

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • 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).

  • Research Collaboration 3.7.1 Aarvik shall carry out the activities of each Work Item and deliver the required Data Package and/or deliverables in accordance with the applicable SOW. Without limiting the generality of the foregoing, Aarvik shall, in accordance with the applicable SOWs and the timeline approved by JRC, apply the Aarvik IP to (i) design and synthesize Collaboration Compounds, and (ii) by itself or through subcontractor(s), [***]. During the Research Term, if any Party identifies any Third Party Patent or Know-How that is necessary or reasonably useful for any activity under the SOWs but has not been included in the Aarvik IP, then such Party shall immediately inform the other Party and the Parties shall discuss in good faith the need of obtaining a license from such Third Party. 3.7.2 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver the Data Packages and all other deliverables required under the [***], as well as the results of the Patentability and FTO Analysis as described in Section 3.2.3, to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Axxxxx of its decision in writing. If AxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1. 3.7.3 If, upon completion of the [***] for the Collaboration Program, AxxxXxxx decides not to advance the Collaboration Program to [***], ArriVent may terminate the Collaboration Program. If AxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1. 3.7.4 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Axxxxx of its decision in writing. 3.7.5 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent. 3.7.6 Within [***] ([***]) days after completion of the [***], Aarvik shall deliver to ArriVent a full report on all key results and findings of the Collaboration Program, and such other data, results and information as ArriVent may deem necessary for it to determine whether or not to exercise the Option (the “Full Report”).

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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