Manufacturing. Notwithstanding that Axsome’s grant of the license to Licensee under Section 2.1 is not conditioned on Licensee electing to have Axsome manufacture Licensed Product for Licensee, Licensee shall have the option to have Axsome Manufacture or have Manufactured the Licensed Compound and any Licensed Products for use by Licensee. If Licensee makes such election it shall notify Axsome immediately after the Effective Date and thereafter the Parties, within thirty (30) days after the Effective Date, shall negotiate and enter into such supply agreement that contains the terms in the manufacturing term sheet attached hereto as [Schedule 3.6] the together with other material and non-material terms typically included in agreements of such type and scope (the “Supply Agreement”). In the event Licensee exercises such option and the Parties enter into the Supply Agreement, Licensee shall purchase from Axsome all requirements of any such Licensed Products at the price set forth therein.
The Transition Agreement will require the Opt-Out Party or its Affiliate to enter into a supply and quality agreement to supply or have supplied the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product to the Continuing Party until such time as the Continuing Party provides written notice to the Opt-Out Party of its decision, in its sole discretion, to cease permanently the Research, Development, and Commercialization of such Reversion Product. The cost to the Continuing Party for such supply will be the Manufacturing Costs plus a markup for the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product.
The Parties shall negotiate in good faith the terms of, and shall seek to enter into, separate clinical and commercial manufacturing agreements, and/or amendments to existing manufacturing agreements, under which WuXi would manufacture and supply Licensed Products for Arcus in the Territory (the Manufacturing Agreements). The Parties intend to enter into such Manufacturing Agreements # no later than prior to the Initiation of Phase I Clinical Studies for the first Licensed Product (for the clinical manufacturing agreement) and # no later than prior to the anticipated date of Regulatory Approval of the first Licensed Product (for the commercial manufacturing agreement).
Manufacturing. Arcus shall use Commercially Reasonable Efforts to manufacture or otherwise obtain supply of the requirements of formulated, packaged and labeled Patented Products in connection with its Development and Commercialization obligations hereunder, in accordance with all Applicable Laws, GMP (as applicable) and this Agreement.
Manufacturing Fee. Provided that has not breached its obligations under this Agreement, shall order sufficient quantities of Product over the course of the Term such that the manufacturing fee due and owing over the Term
Manufacturing Problems. The Parties will inform each other promptly after it becomes aware of any problems or delays of any nature in performing their contractual obligations that have the potential to adversely affect the Manufacturing of the ACTR T-cells or SGI Antibodies, as the case may be. Each Party will inform the other Party of the reason for such delay and of the expected duration of its inability to Manufacture and deliver the ACTR T-cells or SGI Antibodies, as the case may be, and will keep the other Party informed on a timely basis of any developments during any such period of time.
Net Sales - with respect to any Compound or Product, the gross invoiced sales price of such Compound or Product sold by Ovid, its Affiliates or Sub-licensees (the Selling Party), in bulk form or finished product form in arms-length transactions to Third Parties, less deductions allowed to the Third Party customer by the Selling Party, to the extent actually taken by such Third Party customer, on such sales for:
Manufacturing Responsibility. Licensee will be responsible for the manufacturing of the Licensed Compound and Licensed Product for use by Licensee, its Affiliates, and its sublicensees in the Field in the Territory.
Subsequent Manufacturing Technology Transfer. Without limiting the foregoing, if makes any invention, discovery, or improvement relating to the Manufacture of a Licensed Compound or a Licensed Product during the Term, shall promptly disclose such invention, discovery, or improvement to [[Organization A:Organization]], and shall, at [[Organization A:Organization]]s request, perform a technology transfer with respect to such invention, discovery, or improvement in the same manner as provided in Section 4.7.2.
Subsequent Manufacturing Technology Transfer. Without limiting the foregoing or the licenses and other rights granted by each Party to the other under this Agreement, in the event that # any Allergan RTGel Improvement is made by or on behalf of Allergan or any of its Affiliates or # any RTGel Improvement is made by or on behalf of UroGen or any of its Affiliates, in each case relating to, or that is otherwise necessary or useful for, the Manufacture of the RTGel Product during the Term (New Manufacturing Technology), such Party shall promptly disclose such New Manufacturing Technology to the other Party and shall, at the other Partys request, perform technology transfer with respect to such New Manufacturing Technology in the same manner as provided in Section 5.2 (applied mutatis mutandis to Allergan, as applicable).
Joint Manufacturing Committee. The JMC will act as an information-sharing forum with respect to the Manufacture of clinical and commercial supplies of ACTR T-cells and SGI Antibodies for a Reversion Product. The Continuing Party will provide such information and data regarding the Manufacture of the Reversion Product as the JMC would customarily receive regarding a Product to the extent that it specifically relates to, if Unum is the Opt-Out Party, ACTR T-cells or the INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
Joint Manufacturing Plan. All Manufacturing of ACTR T-cells and SGI Antibodies in the Territory will be conducted pursuant to a joint manufacturing plan to be prepared as follows: # SGI will be responsible for preparing the portions of the joint manufacturing plan relating to SGI Antibodies, and # Unum will be responsible for preparing the portions of the joint manufacturing plan relating to ACTR T-cells.
Sublicensee Manufacturing Rights. The Manufacturing Agreements shall permit Arcus sublicensees to place orders for such Licensed Products on the same terms and conditions applicable to Arcus; provided that # prior to expiration of Manufacturing Exclusivity Period, each Arcus sublicensee shall be free to manufacture up to CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Performance of Manufacturing. WuXi ATU will perform all Services at the Qualified Facility, provide all staff necessary to perform the Services in accordance with the terms of the applicable Work Order, this Agreement and the Quality Agreement (as applicable), and hold at such Qualified Facility all Graphite Equipment and Graphite Materials and other items used in the Services. For Manufacturing Services performed, WuXi ATU will not use any additional facility (other than the Qualified Facility or the facilities of Permitted Subcontractors) for the performance of Services under this Agreement without timely (meaning with regard to the agreed manufacturing schedule) prior written notice to, and prior written consent from, Graphite, which consent will not be unreasonably withheld or delayed (it being understood and agreed that Graphite may withhold consent
Transitional Manufacturing Period. For a period of no less than six (6) months following the date of this Agreement, and continuing for so long as the Parties mutually agree in good faith thereafter, Assignor shall, at the request of the Assignee, manufacture the Subject IP for Assignee pursuant to the applicable terms and conditions of the Original Distribution Agreement, with the price per gallon of INFINIGUARD to be , and # no territorial restrictions as to where the Assignee may sell INFINIGUARD..
Manufacturing and Supply. Denali shall be responsible for manufacturing Licensed Products for clinical use and commercial sale, using due care and commercially sound approaches.
Manufacturing Technology Transfer. Upon Allergans request, initiated no earlier than after the Effective Date and no later than the completion of the first Phase II Clinical Trial for a Licensed Product conducted by Allergan or its authorized designee, UroGen shall effect a full transfer to Allergan or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all UroGen Know-How relating to the then-current process for the Manufacture of the RTGel Component (the Manufacturing Process) and to implement the Manufacturing Process at facilities designated by Allergan. The transfer of the Manufacturing Process from UroGen shall be deemed complete when Allergan is able to, either itself or via its designee, Manufacture Licensed Products that meet established specifications. Following completion of the transfer of the Manufacturing Process in accordance with this [Section 5.2], as between the Parties, # Allergan shall be responsible for securing the manufacture of its future needs of RTGel Components not then subject to an outstanding purchase order including, for the avoidance of doubt, any Phase I or Phase II Clinical Trials conducted by Allergan after the completion of such transfer, and # except with respect to purchase orders placed by Allergan in accordance with [Section 5.1.1] for RTGel Component prior to the completion of transfer, [Section 5.1.1] and [Section 5.1.3] shall cease to apply in their entirety. Upon Allergans reasonable request following the transfer of the Manufacturing Process for the RTGel Component, UroGen shall provide # up to hours of reasonable technical assistance following the transfer of the Manufacturing Process to enable Allergan (or its Affiliate or designated Third Party manufacturer, as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Allergan and # such additional technical assistance (including access to its technical personnel) as may be requested by Allergan for compensation at the rate of per hour, in each case of [(i) and (ii)])] subject to reimbursement of UroGens documented travel and other out-of-pocket expenses incurred in providing such assistance within days of invoice therefor. Notwithstanding the anything to the contrary, Allergan shall be responsible at all times during the Term for manufacture of all of the Licensed Product.
Development, Manufacturing and Commercialization. Regeneron shall have the right to grant one or more sublicenses under the licenses granted to Regeneron under [Section 4.1], in full or in part, by means of written agreement to Affiliates or Third Parties (with the right to sublicense through multiple tiers), without the prior written consent of CytomX, for the performance of Regeneron’s Development, Manufacturing and Commercialization activities related to Licensed Products or for the performance of any other activities related to the Exploitation of a Licensed Product. As a condition precedent to and requirement of any such sublicense: # Regeneron shall furnish a redacted copy of such sublicense agreement to CytomX; # any such permitted sublicense shall be consistent with and subject to the terms and conditions of this Agreement (including for the avoidance of doubt, that if sales by such Sublicensee are included in Net Sales hereunder, such Sublicensee shall permit audit rights with respect to its reporting of Net Sales that are consistent with those given by Regeneron hereunder with respect to its sales included in Net Sales); # Regeneron will continue to be responsible for full performance of its obligations under this Agreement and will be responsible for all actions of such Sublicensee as if such Sublicensee were Regeneron hereunder; and # Regeneron’s grant of any sublicense will not relieve Regeneron or its Affiliates from any of its obligations under this Agreement.
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.
Manufacture shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.
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