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. 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. 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. 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 Xxxxxx Xxxxx with written notice thereof no fewer than 30 days in advance of the effective date of such exercise (the "Exercise Date").
Manufacturing Right. At any time after the Transition Event, upon written notice to Nuo, Nuo shall grant to Rohto 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 Rohto, Nuo shall provide Rohto with reasonably sufficient information for Rohto to manufacture or have manufactured such devices. For avoidance of doubt, in such case Rohto shall assemble Product for the Territory, and sales amount of such Rohto’s assembled Product as a whole shall be the base of Net Sale for royalty payment set forth in Section 4 (c) of this Agreement.
Manufacturing Right. At any time during the Term, in the event of a Failure to Supply, BioAlliance shall have the right, but not the obligation, to make or have made by any Third Party Licensed Product in order to satisfy BioAlliance’s and its Sublicensees’ requirements of Licensed Product (the “Manufacturing Right”). BioAlliance shall have the Manufacturing Right until such time as NovaDel has resumed and restored its capability to Manufacture and supply BioAlliance’s and its Sublicensees’ requirements of Licensed Product and recommences its Manufacture and supply of Licensed Product, or until such time as BioAlliance reasonably believes that NovaDel is able to supply Licensed Product, or, if longer, for the duration of any commercially reasonable obligation to any Third Party supplier entered into by BioAlliance or its Sublicensees in connection with the exercise of the Manufacturing Right. If BioAlliance and its Sublicensees continue to have obligations to any Third Party supplier entered into in connection with the exercise of the Manufacturing Right after NovaDel has resumed its capability to Manufacture and supply under this Agreement or, as applicable, after BioAlliance reasonably believes that NovaDel is able to supply Licensed Product, BioAlliance and its Sublicensees will purchase such portion, if any, of their requirements of Licensed Product from NovaDel pursuant to this Agreement as can reasonably be purchased given the obligations to such Third Party supplier. When assessing Third Party suppliers in connection with the exercise of the Manufacturing Right, BioAlliance will consider any Third Party suppliers suggested by NovaDel and will in good faith attempt to select a Third Party supplier that will permit NovaDel to resume Manufacture and supply under this Agreement as promptly as possible after it is able to do so, subject to commercially reasonable considerations of material differences in qualification, reliability, pricing, quality and other similar factors, considered as a whole, with respect to such potential Third Party suppliers. NovaDel shall provide BioAlliance with written notice of its ability to recommence Manufacturing and supplying BioAlliance and its Sublicensees with their requirements of Licensed Product no less than six (6) months in advance.
Manufacturing Right. Nuo shall grant to Rohto 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 Rohto, Nuo shall provide Rohto with reasonably sufficient information for Rohto to manufacture or have manufactured such devices. For avoidance of doubt, in such case Rohto shall assemble Product for the Territory, and sales amount of such Rohto’s assembled Product as a whole shall be the base of Net Sale for royalty payment set forth in Section 4 (c) of this Agreement.
Section 4. CONSIDERATION (b) Milestone Payment. of the Original Agreement shall be amended in its entirety to read as follows.
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 Xxxxxx Xxxxx) or 10.4 (Bankruptcy of Xxxxxx Xxxxx) 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 Xxxxxx Xxxxx with written notice thereof no fewer than [***] in advance of the effective date of such exercise (the “Exercise Date”).
