Third Party CMO definition
Examples of Third Party CMO in a sentence
Genevant may conduct such Manufacturing activities itself or through a Third Party CMO under Genevant’s control, subject to Section 4.9 (Subcontractor).
For avoidance of doubt, Genmab shall not be required to obtain the prior consent of CureVac before engaging a Third Party CMO as allowed for under Section 6.2 and Section 6.4 if such Third Party CMO is not comprised by (i) or (ii) above.
If such Third Party CMO is (i) a direct competitor of CureVac within the field of development of mRNA-based products (such as, but not limited to, [*****]); or (ii) located inside [*****] at the time when Genmab wishes to engage such Third Party CMO, then Genmab’s engagement of such Third Party CMO to Manufacture Products requires CureVac’s prior written consent not to be unreasonably withheld.
As used above, “Process Transfer” means a technology transfer of Sutro’s know-how and information as is necessary or useful for the Third Party CMO to Manufacture in its own facilities Extract that meets SutroVax’ requirements, including any such information and know-how as would be needed for such CMO to scale up such Manufacture to the requested commercial volumes.
If under Section 6.2 or Section 6.4 Genmab wishes to engage a Third Party CMO to Manufacture Products it must provide notice of such intent and the identity of the CMO to CureVac.
Each Party agrees that, in its CMO Supply Agreement with a Third Party CMO, such Party shall not include any limitations on such Third Party CMO’s ability to supply the other Party with such CoDev Product, and upon the request of the other Party, such Party shall facilitate initial business discussions between the other Party and such Third Party CMO.
Upon Genmab’s request, in the event of (i) or (ii) above, CureVac shall within [*****] of receipt of such request notify Genmab if CureVac opposes to Genmab’s engagement of such Third Party CMO and otherwise CureVac shall be deemed to have consented to such engagement.
The cost of any CoDev Product supplied for clinical purposes prior to commercial scale Manufacturing or on a commercial scale with a Third Party CMO will be shared equally by the Parties and will be included in Shared Costs pursuant to Section 1.234, except for supply for any Unsponsored Work, which shall be fully paid by the Proposing Party.
If, in the event of (i) or (ii) above, CureVac consents to the appointment of such CMO nominated by Genmab, such consent may be conditional upon the Third Party CMO entering into direct undertakings with CureVac for the protection of Confidential Information and Know-How within CureVac Manufacturing Technology.
In the event of a CMO Supply Agreement directly with the Third Party CMO, the Parties will use good faith efforts to coordinate the activities under this Section 5.3.2.1(b) and to take advantage of any volume discounts or economies of scale.