Common use of Manufacturing Clause in Contracts

Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need ***Confidential Treatment Requested for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.

Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need ***Confidential Treatment Requested for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.

Manufacturing. Bellicum shall All manufacturing of Ivory for all indications and uses in accordance with applicable product specifications and GMP, including labeling, fill/finish, packaging, selection of presentations and manufacturing-related regulatory activities (including regulatory inspections). GSK will have the right to audit Amgen’s manufacturing facilities and any Third Party manufacturing facilities used for the manufacture of Ivory in the Collaboration Scope on a periodic basis, not to exceed once every eighteen (18) months for routine audits (“Routine Audits”) or have manufactured as defined below with respect to for-cause audits (“For Cause Audits”) (provided such quantities request is made within sixty (60) days of any Dimerizer as it may require GSK being informed of or becoming aware of an event that would permit a For Cause Audit in order GSK’s reasonable opinion). GSK will bear the cost of all Routine Audits and For Cause Audits of Amgen manufacturing facilities conducted by GSK and such costs will not be subject to develop and commercialize any Licensed Product pursuant to cost-sharing between the terms of Parties under this Agreement. Bellicum The costs of any Routine Audits and For Cause Audits of any Third Party manufacturing facility requested by GSK will be included in GSK Costs and will be subject to the cost-sharing principles under this Agreement, unless otherwise provided below. GSK will notify ARIAD Amgen in writing if GSK desires to conduct any manufacturing audit, and the Parties will mutually agree upon reasonable audit agendas in advance and reasonably cooperate in the conduct of its intent such audit. If GSK notifies Amgen that GSK desires to manufacture (conduct either a For Cause Audit or have manufactured by Routine Audit of a Third Party) any Dimerizer at least […***…] prior Party manufacturer, Amgen will notify GSK if Amgen’s contract with such Third Party manufacturer permits GSK to commencement of manufacture by itself or through a conduct such audit, in which case Amgen will allow GSK to conduct such audit (with Amgen’s participation, if it chooses). If Amgen’s contract with such Third PartyParty manufacturer does not permit GSK to conduct audits, then Amgen will conduct such audit and share the results with GSK to the extent permitted under Amgen’s contract with such Third Party manufacturer. Upon ARIAD’s request at any timeNotwithstanding the foregoing, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts cooperate to coordinate and achieve reasonable efficiencies with respect to audits of its anticipated need ***Confidential Treatment Requested for such Dimerizer Third Party manufacturers as follows: (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (bi) if GSK requests a Routine Audit of a Third Party manufactures manufacturer, and Amgen has conducted a Routine Audit of such Dimerizer for Bellicummanufacturer in the previous [*], then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees Amgen will share with GSK the right to purchase results of any Routine Audit of such Dimerizers from the Third Party on terms no less favorable than those granted (to Bellicumthe extent permitted under Amgen’s contract with such Third Party manufacturer), giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant if after sharing the results described under (i), GSK would like to proceed with a Routine Audit of such Third Party, then, to the extent permitted under Amgen’s contract with such Third Party all licenses manufacturer, GSK may conduct such Routine Audit (or, to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to the extent permitted under Amgen’s contract with such Third Party licensors of Bellicum) as may be required in order for manufacturer, Amgen will conduct such Routine Audit if GSK is not permitted to do so under the applicable Third Party manufacturing contract) and the costs of such Routine Audit will be borne by GSK and will not be subject to supply ARIAD and ARIAD’s licensees with such Dimerizerscost-sharing under this Agreement. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Any audit of a Third Party manufacturer will transfer be subject to ARIAD or its designee the terms and conditions of Amgen’s contract(s) with such manufacturer and GSK will cooperate and coordinate with Amgen to comply with all technology reasonable terms and conditions communicated by Amgen in connection with the performance of such audit. Any audit of an Amgen manufacturing facility will comply with Amgen’s reasonable policies and procedures. GSK’s Routine Audits will be limited in scope to what is reasonably necessary to manufacture confirm that Amgen or a Third Party manufacturer has complied with all applicable product specifications, GMP or GDP requirements in manufacturing Ivory. GSK’s For Cause Audits will be limited in scope to what is reasonably necessary to confirm that the cause for such Dimerizer audit has been or is being remedied. Any information disclosed to GSK in the course of any audit may only be used for the purposes of such audit. Any audit conducted under this Agreement, the Expansion Agreement or the relevant Ivory supply agreement between Amgen and GSK will grant be considered an audit conducted under all necessary licenses such agreements. For the purposes of this Section 3.14.4 (Manufacturing), the following will give GSK the right to ARIAD or its designee on conduct a royalty fee basisFor Cause Audit: [*]. The JSC will review events that may give rise to the right to conduct a For Cause Audit if so requested by either Party.

Manufacturing. Bellicum shall All manufacturing of Ivory for all indications and uses in accordance with applicable product specifications and GMP, including labeling, fill/finish, packaging, selection of presentations and manufacturing-related regulatory activities (including regulatory inspections). GSK will have the right to audit Amgen’s manufacturing facilities and any Third Party manufacturing facilities used for the manufacture of Ivory in the Collaboration Scope on a periodic basis, not to exceed once every eighteen (18) months for routine audits (“Routine Audits”) or have manufactured as defined below with respect to for-cause audits (“For Cause Audits”) (provided such quantities request is made within sixty (60) days of any Dimerizer as it may require GSK being informed of or becoming aware of an event that would permit a For Cause Audit in order GSK’s reasonable opinion). GSK will bear the cost of all Routine Audits and For Cause Audits of Amgen manufacturing facilities conducted by GSK and such costs will not be subject to develop and commercialize any Licensed Product pursuant to cost-sharing between the terms of Parties under this Agreement. Bellicum The costs of any Routine Audits and For Cause Audits of any Third Party manufacturing facility requested by GSK will be included in GSK Costs and will be subject to the cost-sharing principles under this Agreement, unless otherwise provided below. GSK will notify ARIAD Amgen in writing if GSK desires to conduct any manufacturing audit, and the Parties will mutually agree upon reasonable audit agendas in advance and reasonably cooperate in the conduct of its intent such audit. If GSK notifies Amgen that GSK desires to manufacture (conduct either a For Cause Audit or have manufactured by Routine Audit of a Third Party) any Dimerizer at least […***…] prior Party manufacturer, Amgen will notify GSK if Amgen’s contract with such Third Party manufacturer permits GSK to commencement of manufacture by itself or through a conduct such audit, in which case Amgen will allow GSK to conduct such audit (with Amgen’s participation, if it chooses). If Amgen’s contract with such Third PartyParty manufacturer does not permit GSK to conduct audits, then Amgen will conduct such audit and share the results with GSK to the extent permitted under Amgen’s contract with such Third Party manufacturer. Upon ARIAD’s request at any timeNotwithstanding the foregoing, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts cooperate to coordinate and achieve reasonable efficiencies with respect to audits of its anticipated need ***Confidential Treatment Requested for such Dimerizer Third Party manufacturers as follows: (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (bi) if GSK requests a Routine Audit of a Third Party manufactures manufacturer, and Amgen has conducted a Routine Audit of such Dimerizer for Bellicummanufacturer in the previous eighteen (18) months, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees Amgen will share with GSK the right to purchase results of any Routine Audit of such Dimerizers from the Third Party on terms no less favorable than those granted (to Bellicumthe extent permitted under Amgen’s contract with such Third Party manufacturer), giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant if after sharing the results described under (i), GSK would like to proceed with a Routine Audit of such Third Party, then, to the extent permitted under Amgen’s contract with such Third Party all licenses manufacturer, GSK may conduct such Routine Audit (or, to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to the extent permitted under Amgen’s contract with such Third Party licensors of Bellicum) as may be required in order for manufacturer, Amgen will conduct such Routine Audit if GSK is not permitted to do so under the applicable Third Party manufacturing contract) and the costs of such Routine Audit will be borne by GSK and will not be subject to supply ARIAD and ARIAD’s licensees with such Dimerizerscost-sharing under this Agreement. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Any audit of a Third Party manufacturer will transfer be subject to ARIAD or its designee the terms and conditions of Amgen’s contract(s) with such manufacturer and GSK will cooperate and coordinate with Amgen to comply with all technology reasonable terms and conditions communicated by Amgen in connection with the performance of such audit. Any audit of an Amgen manufacturing facility will comply with Amgen’s reasonable policies and procedures. GSK’s Routine Audits will be limited in scope to what is reasonably necessary to manufacture confirm that Amgen or a Third Party manufacturer has complied with all applicable product specifications, GMP or GDP requirements in manufacturing Ivory. GSK’s For Cause Audits will be limited in scope to what is reasonably necessary to confirm that the cause for such Dimerizer audit has been or is being remedied. Any information disclosed to GSK in the course of any audit may only be used for the purposes of such audit. Any audit conducted under this Agreement, the Expansion Agreement or the relevant Ivory supply agreement between Amgen and GSK will grant be considered an audit conducted under all necessary licenses such agreements. For the purposes of this Section 3.14.4 (Manufacturing), the following will give GSK the right to ARIAD conduct a For Cause Audit: (a) receipt of a warning letter pertaining to manufacturing concerns or its designee issues for Ivory from the relevant Governmental Agency; (b) a recall of Ivory in the Collaboration Scope based on manufacturing concerns or issues; (c) product complaints evidencing material manufacturing concerns or issues for Ivory; and (d) more than one (1) lot failure or stability failure of Ivory in any calendar year that indicates a royalty fee basislikely manufacturing concern or issue. The JSC will review events that may give rise to the right to conduct a For Cause Audit if so requested by either Party.

Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need ***Confidential Treatment Requested for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.