Common use of Program Performance Clause in Contracts

Program Performance. (a) Gallus shall use its commercially reasonable efforts to provide the Facility, Process Consumables and staff necessary to complete the Program in accordance with the terms of this Agreement. In the event of any conflict between the terms and provisions of this document and the terms of a Work Statement, the terms of this document shall control, unless expressly provided otherwise in the applicable Work Statement. (b) Customer acknowledges that the work to be performed hereunder is by its nature developmental and that the Program involves biological processes that are, by their nature, unpredictable such that Gallus does not guarantee to Customer the achievement of a successful outcome. For the avoidance of doubt, it shall not be considered a breach of this Agreement by Gallus if an objective of the Program is not achieved so long as Gallus has complied with its obligations set forth herein. Gallus shall not be responsible for any loss of a Batch in crude or purified form unless it is a Defective Batch caused by a Gallus Failure. Customer’s sole and exclusive remedy for a Gallus Failure shall be as set forth in Section 20(h) below. (c) Gallus will appoint a Gallus representative (the “Program Manager”) to be responsible for overseeing the completion of the Program by Gallus. The Program Manager will coordinate performance of the Services with a representative designated by Customer (the “Customer Representative”), which representative shall have responsibility over all matters relating to performance of the Services on behalf of Customer. Unless otherwise agreed in the Work Statement, or mutually agreed to by the Parties, all communications between Gallus and the Customer regarding the conduct of the Services pursuant to the Work Statement shall be addressed to or routed through the Program Manager and Customer Representative. The Program Manager is named in the Work Statement and Gallus may, at its option, substitute the Program Manager during the course of the Program. The Customer Representative is named in the Work Statement and Customer may, at its option, substitute the Customer Representative during the course of the Program. (d) Promptly following the execution of this Agreement, the Parties will negotiate and enter into a detailed agreement specifying the quality and regulatory procedures and responsibilities of the Parties with respect to the manufacture of Product (the “Quality Agreement”). (e) Customer may cancel one or more Batches subject to Gallus retention of any deposit or advance payment with respect to that Batch, provided that Gallus will credit any such deposit or advance payment to future Services for the Customer to the extent that Gallus is able, using commercially reasonably efforts, to fill a manufacturing slot for which the deposit or advance payment was made. Notwithstanding the foregoing, if Customer cancels a majority of remaining Batches, the Agreement shall be deemed to have been terminated by Customer under Section 23(b), unless the Parties agree otherwise in writing.

Program Performance. (a) Gallus Laureate shall use perform the Program as provided in the Scope, as it may be modified as provided herein, at its Facility using commercially reasonable efforts to provide the Facility, Process Consumables and employing staff having appropriate training and skill necessary to complete the Program Program, in accordance with the terms of this Agreement. Laureate will maintain an appropriate, secure work site for conducting the Program in its Facility. Laureate will cause its research team performing the Program to keep detailed contemporaneous records and data in connection with the Scope, and to prepare reports detailing work to date, which will be furnished to Customer in a timely manner in accordance with the Scope or as otherwise agreed between the Parties. Any Laureate personnel working on the Program will be obligated under his/her terms and conditions of employment to (i) assign his/her entire worldwide right, title, and interest in and to any discovery, invention, improvement, or technological advance, including any Process Invention or Product Invention, and any associated intellectual property, to Laureate, and (ii) comply at all times with the confidentiality obligations imposed on Laureate under this Agreement. In the event of any conflict between the terms and provisions of this document and the terms of a Work StatementScope, the terms of this document shall control, unless expressly provided otherwise in the applicable Work Statement. (b) Customer acknowledges that the work to be performed hereunder is by its nature developmental and that the Program involves biological processes that are, by their nature, unpredictable such that Gallus does not guarantee to Customer the achievement of a successful outcome. For the avoidance of doubt, it shall not be considered a breach of this Agreement by Gallus if an objective of the Program is not achieved so long as Gallus has complied with its obligations set forth herein. Gallus shall not be responsible for any loss of a Batch in crude or purified form unless it is a Defective Batch caused by a Gallus Failure. Customer’s sole and exclusive remedy for a Gallus Failure shall be as set forth in Section 20(h) below. (c) Gallus Laureate will appoint a Gallus Laureate representative (the “Program Manager”) to be responsible for overseeing the completion of the Program by GallusLaureate. The Program Manager will coordinate performance of the Services Program with a representative designated by Customer (the “Customer Representative”), which representative shall have responsibility over all matters relating to performance of the Services Program on behalf of Customer. Unless otherwise agreed in the Work StatementScope, or mutually agreed to by the Parties, all communications between Gallus Laureate and the Customer regarding the conduct of the Services Program pursuant to the Work Statement Scope shall be addressed to or routed through the Program Manager and Customer Representative. The Program Manager is named in the Work Statement and Gallus Laureate may, at its optionoption and upon notice to and after consultation with Customer, substitute the Program Manager during the course of the Program. The Customer Representative is named in the Work Statement and Customer may, at its optionoption and upon notice to Laureate, substitute the its Customer Representative during the course of the Program. (dc) Promptly following Within thirty (30) days after the execution of this AgreementEffective Date, or such longer period as the Parties agree in writing, and prior to Laureate commencing the Program in any event, the Parties will negotiate and enter into prepare a detailed agreement document (“Quality Agreement”) specifying the quality and regulatory procedures and responsibilities of the Parties hereunder with respect to the manufacture of Product Drug Substance and Drug Product. (d) Customer’s representatives may visit the “Quality Facility at appropriate times consistent with the Program to observe the progress of the Program or to audit the Program, subject to the limitations provided in Appendix 6 to this Agreement”). (e) Customer may cancel one During the term of the Program, Laureate will maintain a commercially reasonable program consistent with standard industry practice and/or applicable cGMP to regularly monitor and test the Facility, and undertake such precautions and procedures as are commercially reasonable so as to minimize the risks of contamination from or more Batches subject to Gallus retention the Facilities and/or Materials as well as any damage that occur in the event of an incident of contamination. Upon reasonable prior request and during business hours, Laureate will provide access to Customer, in accordance with the terms set forth in Appendix 6, to review documentation detailing the procedures and testing used by Laureate for such purposes. In the event Laureate becomes aware of any deposit or advance payment with respect incident of contamination at the Facility that could have an impact on the Program, Laureate will (i) immediately implement such commercially reasonably steps as are necessary to that Batch, provided that Gallus will credit any such deposit or advance payment to future Services for the Customer minimize and mitigate damage to the extent Facility, Materials, and Third Party property that Gallus is able, using commercially reasonably efforts, to fill a manufacturing slot for which may then be present in the deposit or advance payment was made. Notwithstanding Facility and (ii) so notify Customer within two (2) business days after the foregoing, if Customer cancels a majority date Laureate becomes aware of remaining Batches, the Agreement shall be deemed to have been terminated by Customer under Section 23(b), unless the Parties agree otherwise in writingcontamination.

Program Performance. (a) Gallus shall use its commercially reasonable efforts to provide the Facility, Process Consumables and staff necessary to complete the Program in accordance with the terms of this Agreement. In the event of any conflict between the terms and provisions of this document and the terms of a Work Statement, the terms of this document shall control, unless expressly provided otherwise in the applicable Work Statement.. Development and Manufacturing Services Agreement CONFIDENTIAL (b) Customer acknowledges that the work to be performed hereunder is by its nature developmental and that the Program involves biological processes that are, by their nature, unpredictable such that Gallus does not guarantee to Customer the achievement of a successful outcome. For the avoidance of doubt, it shall not be considered a breach of this Agreement by Gallus if an objective of the Program is not achieved so long as Gallus has complied with its obligations set forth herein. Gallus shall not be responsible for any loss of a Batch in crude or purified form unless it is a Defective Batch caused by a Gallus Failure. Customer’s sole and exclusive remedy for a Gallus Failure shall be as set forth in Section 20(h) below. In the event Customer’s actions or inactions cause a delay in the schedule that is within Customer’s reasonable control, and such delay requires additional Gallus expenses or the idling of Gallus’s resources, then Customer shall be responsible to compensate Gallus accordingly for such additional expenses and idled resources. (c) Gallus will appoint a Gallus representative (the “Program Manager”) to be responsible for overseeing the completion of the Program by Gallus. The Program Manager will coordinate performance of the Services with a representative designated by Customer (the “Customer Representative”)) and as set forth in the Work Statement, which representative shall have responsibility over all matters relating to performance of the Services on behalf of Customer. Unless otherwise agreed in the Work Statement, or mutually agreed to by the Parties, all communications between Gallus and the Customer regarding the conduct of the Services pursuant to the Work Statement shall be addressed to or routed through the Program Manager and Customer Representative. The Program Manager is named in the Work Statement and Gallus may, at its option, substitute the Program Manager during the course of the Program. The Customer Representative is named in the Work Statement and Customer may, at its option, substitute the Customer Representative during the course of the Program. (d) Promptly following the execution of this Agreement, the Parties will negotiate and enter into a detailed agreement document specifying the quality and regulatory procedures and responsibilities of the Parties with respect to the manufacture of Product (the “Quality Agreement”). (e) Customer may cancel one or more Batches subject to retention by Gallus retention of any deposit or advance payment manufacturing suite reservation fee with respect to that Batch, provided that Gallus will credit any such deposit or advance payment to future Services for the Customer to the extent that Gallus is able, using commercially reasonably efforts, to fill a manufacturing slot for which the deposit or advance payment was madecancelled Batch(es). Notwithstanding the foregoing, if Customer cancels a majority of remaining Batches, the Agreement shall be deemed to have been terminated by Customer under Section 23(b), unless the Parties agree otherwise in writing.