Manufacturing Right Sample Clauses
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Manufacturing Right. Prior to Roche’s exercise of its Option Right for a Collaboration Target, the JRC will determine which Party has responsibility for the manufacture of Collaboration Compounds and Products, subject to the oversight of the JRC, in accordance with the applicable Research Plan and Phase I Plan for such Collaboration Target. If requested by a Party, the other terms under which a Party will manufacture and supply Collaboration Compounds and Products to the other Party will be set forth in one or more manufacturing and supply agreements to be entered into between the Parties (each a “Supply Agreement”). Such Supply Agreements will contain customary terms and conditions, including quality and supply failure remedies, and otherwise be consistent with this Agreement and Roche quality standards. If the Parties cannot agree to the terms of a Supply Agreement within ninety (90) days of initiation of discussions, such matter will be decided by the Expert Committee in accordance with the terms and conditions set forth in Section 12.9.4, mutatis mutandis. After Roche’s exercise of its Option Right for a Collaboration Target, subject to the oversight of the JDC, Roche shall have the right to manufacture all Licensed Products for such Collaboration Target throughout the Territory, subject to this Section 9.1. For Licensed Products in the BPM Territory pursuant to Program 2 and Program 4, (i) Roche, at its option, can elect to transfer the manufacturing process to BPM (or a CRO that is reasonably acceptable to Roche) whereby BPM (or such CRO) would then have responsibility to manufacture its own supply of such Licensed Product at its own costs; or (ii) BPM, at its option, can elect to use a CRO that is acceptable to Roche to perform such manufacturing activities on behalf of BPM in the BPM Territory if such CRO provides a price that is at least […***…] lower than the per unit cost for a Licensed Product than offered by Roche taking into account projected supply volume discounts. The costs of any such manufacturing process transfer pursuant to clause (i) of the preceding sentence shall be shared equally by the Parties, and pursuant to clause (ii) of the preceding sentence shall be borne solely by BPM. For Licensed Products supplied to BPM by Roche in the United States pursuant to Program 2 and Program 4, Roche shall supply such Licensed Products for clinical supply at […***…] and for commercial supply at […***…][…***…]. The other terms under which Roche will manufacture and s...
Manufacturing Right. Hyseq shall be responsible for manufacturing and supplying Licensed Products for Development and Commercialization in the Territory and for making all decisions with respect thereto in its sole discretion, including without limitation, decisions relating to process development work to support quality assurance, improving manufacturing/cost efficiency and commercial scale-up manufacturing. For the avoidance of doubt, Hyseq shall have final decision making authority to fulfill its regulatory responsibilities over all steps of the manufacturing process (including bulk, finish and fill, labeling and packaging, lot release and management of subcontractors).
Manufacturing Right. Subject to Section 5.4, Licensor shall have the sole right and, subject to the terms of this Agreement, any pre-clinical or clinical supply agreement, and the Commercial Supply Agreement, responsibility to Manufacture and supply Licensee’s requirements of the Licensed Compound and Licensed Products.
Manufacturing Right. In the event of Failure to Supply, Synthes shall have the right, following written notice to KNC, for the balance of the then-present Initial Term or Renewal Term, to manufacture, or have manufactured by a third party, any Product in the applicable Product category set forth on Exhibit 1.7 (the “Manufacturing Right”). KNC shall provide reasonable assistance to Synthes in establishing an alternative source of supply. The parties agree that the remedy set forth in this Section 2.8.3 shall be Synthes’ sole remedy with respect to a Failure to Supply, and Synthes shall not be permitted to terminate this Agreement as a result of any such Failure to Supply.
Manufacturing Right. Without limiting any other right of Cypress under this Agreement, Cypress shall have the right, but not the obligation, to make itself, or have made by any Third Party, API in order to satisfy Cypress' and its sub-licensees' requirements of Bulk API (the "Manufacturing Right"), all pursuant to the license granted under Section 8.11(d), if one of the following events occurs:
(i) If Cypress exercises its rights in respect of a Shortfall pursuant to Section 8.9(c); or
(ii) If Cypress terminates the Restated License Agreement pursuant to Section 14.2(a)(i) or (ii) thereof or under the circumstances described in Section 10.3(e) of this Agreement. In the event Cypress or its sub-licensee wishes to exercise the Manufacturing Right, Cypress shall provide ▇▇▇▇▇▇ ▇▇▇▇▇ with written notice thereof no fewer than 30 days in advance of the effective date of such exercise (the "Exercise Date").
Manufacturing Right. (1) HealthTronics shall have the exclusive right to manufacture the OssaTron OSA 120 and other subsequent models related thereto, as well as accessories, spare parts, consumables and disposables related thereto.
(2) HMT shall, within thirty days after receiving a written request, provide HealthTronics, Inc. with all drawings, technical descriptions, suppliers and all other matters requested by HealthTronics, Inc. related to manufacturing the OssaTron OSA 120 so as to enable HealthTronics, Inc. to manufacture the OssaTron OSA 120.
(3) HealthTronics, Inc. shall pay to HMT a one time fee of $1,000,000 for the manufacturing know-how, technical drawings, descriptions and other paperwork and associated documents described in section number III ss.13
Manufacturing Right. From and after the Effective Date, Amylin shall have the right and responsibility (subject to the terms of this Section 3.2 and Exhibit H) to manufacture and supply Licensed Products for development and Commercialization in the Territory within the Product Field and to make all decisions with respect thereto in its sole discretion, including without limitation, decisions related to process development work to support quality assurance, improving manufacturing cost/efficiency and commercial scale-up manufacturing.
Manufacturing Right. JVC shall have a non-exclusive right to after-process material glass sheets for LCD Glass in Paju.
Manufacturing Right. At any time after the Transition Event, upon written notice to Nuo, Nuo shall grant to Boyalife an exclusive license, with limited right to sublicense, to use Nuo Technology for manufacturing, or having third-party manufacture devices which are covered by Nuo Patent or embodied by Nuo Know How, such as the New Devices and Centrifuge of current and future version, for the Territory. Upon request of Boyalife, Nuo shall provide Boyalife with reasonably sufficient information for Boyalife to manufacture or have manufactured such devices. For avoidance of doubt, in such case Boyalife shall assemble Product for the Territory, and sales amount of such Boyalife’s assembled Product as a whole shall be the base of Net Sale for Distribution Fee payment set forth in Section 4 (c) of this Agreement.
Manufacturing Right. Without limiting any other right of Forest under this Agreement, Forest shall have the right, but not the obligation, to make itself, or have made by a Third Party, Compound in order to satisfy Forest’s and its sublicensees’ requirements of Bulk Compound (the “Manufacturing Right”), all pursuant to the license granted under Section 7.11(d), if one of the following events occurs:
(i) If it appears substantially likely that Forest will exercise its rights in respect of a Shortfall pursuant to Section 7.9(c) or Forest in fact exercises such rights;
(ii) If Forest terminates the License Agreement pursuant to Section 10.3 (Breach of ▇▇▇▇▇▇ ▇▇▇▇▇) or 10.4 (Bankruptcy of ▇▇▇▇▇▇ ▇▇▇▇▇) thereof (and in accordance with Section 10.5(c) thereof) or this Agreement pursuant to Section 9.2(a) hereof; or
(iii) If this Agreement expires and the provisions of Section 9.3(c) hereof are applicable in connection with such expiration. In the event Forest to exercise the Manufacturing Right, Forest shall provide ▇▇▇▇▇▇ ▇▇▇▇▇ with written notice thereof no fewer than [***] in advance of the effective date of such exercise (the “Exercise Date”).