Common use of Agreed Activities Clause in Contracts

Agreed Activities. (a) The parties acknowledge and agree that, in order to comply with current FDA manufacturing standards, production of Licensed Products with the existing master cell bank (“Established MCB”) must be re-validated with synthetic culture media that does not contain animal-derived products such as Bovine Serum Albumin (“BSA”). The currently implemented GMP process (“Established Process”) uses BSA in the culture media. (b) Within [**] of the Effective Date, Telix will enter into a contract with one or more qualified contract manufacturing organisations (“CMOs”) to provide the following “Initial Development Services”: (i) [**]; and (ii) [**]. (c) Telix will provide Wilex with a complete set of documentation related to the New Process. (d) Following delivery of the Initial Development Services by the CMO(s) engaged by Telix pursuant to Section 4.2(b), Telix will conduct analytical comparability studies between: [**] (“Comparability Study”) including but not limited to [**]. (e) Following completion of the Comparability Study, Telix will determine and provide notice to Wilex of the outcome of the Comparability Study and its decision whether: (i) to proceed to GMP Production stage, either using the Established Process, using the Established MCB or using the New Process, using the Established MCB, in which case Telix will make a one-time payment to Wilex of US$[**] within [**] of submission of Comparability Study to Wilex in order to proceed with GMP production, at its own cost, using the Established Process or the New Process (as applicable). (ii) to proceed to GMP Production stage using the [**] to develop a new master cell bank (“New MCB”), in which case Telix will make a one-time payment to Wilex of US$[**] within [**] of submission of the Comparability Study to Wilex in order to proceed with GMP production, at its own cost, using the New MCB. (iii) not to proceed to GMP Production stage on the basis that the Comparability Study indicates that either the New Process development was unsuccessful or the [**] development yields material that would be insufficiently comparable and not commercially viable for use as a Diagnostic Product, in which case, Telix will terminate the agreement with immediate effect by giving notice to Wilex.