Common use of Preclinical and Clinical Supply Clause in Contracts

Preclinical and Clinical Supply. Affymax shall, by itself or through its Third Party contract manufacturers, supply to Takeda all quantities of Bulk API reasonably required by Takeda to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW Development. Takeda shall, by itself or through its Third Party contract manufacturers and by using the Bulk API thus supplied by Affymax, supply to both Parties all quantities of Finished Product reasonably required to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW Development. Such quantities of Bulk API and Finished Product, and the schedule for such supply, shall be confirmed and if necessary updated by the JSC in a manner consistent with the U.S. Development Plan and a plan for the ROW Development. Such supply shall be governed by clinical supply and Bulk API manufacturing agreements that the Parties shall negotiate in good faith promptly within ninety (90) days following the Effective Date. The clinical supply agreement shall, in addition to other terms and conditions agreed upon by the Parties, provide for the following: (a) Affymax shall, before entering into negotiation for an agreement with a Third Party contract manufacturer of Bulk API for supply to Takeda hereunder, notify Takeda of the fact. Thereafter, Takeda shall have the right to provide input regarding the terms of such agreement (as well as any amendments thereof), review and comment on agreement drafts and forms, consult with Affymax regarding the negotiation of such agreement, and participate in person in the negotiation of such agreement, as the Parties may agree, it being understood that Affymax shall retain the final authority over the terms and conditions of any such agreement with such Third Party contractor. The Parties agree that [*] should be qualified to manufacture Bulk API. (b) From time to time, Takeda shall submit to Affymax purchase orders for quantities of Bulk API for such use consistent, as far as reasonably practicable, with such confirmed, or, if applicable, updated quantity and schedule which confirmation or update shall be consistent, as much as reasonably possible, with the then-current U.S. Development Plan and a plan for the ROW Development, and Affymax shall supply or have supplied to Takeda such quantities of Bulk API. All shipments to Takeda of Bulk API shall be made [*]. (c) Affymax shall invoice Takeda for such Bulk API with each shipment, and Takeda shall pay such invoices within thirty (30) days of its receipt of such invoice. The price for supplies from Affymax to Takeda of Bulk API for (non-clinical and clinical) Development of the Product shall be [*] for such Bulk API. The price of Bulk API used for the U.S. Development as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Bulk API shall be included in the Development Expenses. (d) All Bulk API supplied by Affymax to Takeda shall, when delivered, have been manufactured, handled and stored by Affymax or its Third Party contract manufacturer(s) in compliance with all agreed-upon specifications and applicable Laws, including without limitation then-current GMP requirements. (e) Subject to the following Section 7.2(f), the terms described in Sections 7.2(a), (b) and (d) above shall apply, mutatis mutandis, to Takeda's provision of Finished Product to Affymax, it being understood that Affymax shall provide Finished Product to both Parties during such time as Takeda is establishing a source of Finished Product, not to exceed twelve (12) months after the Effective Date, unless mutually agreed upon otherwise by the Parties, and the terms described in Section 7.2(c) above shall apply, mutatis mutandis, to Affymax's provision of Finished Product to Takeda. (f) With regard to the Finished Product manufactured by or on behalf of Takeda and provided to Affymax, Takeda shall not invoice Affymax. The Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus provided to Affymax or used by Takeda for the U.S. Development, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product supplied to Affymax or used by Takeda, shall be included in the Development Expenses. Likewise, the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Affymax with regard to such Finished Product supplied to Affymax by Takeda, shall be included in the Development Expenses. (g) Within ninety (90) days after the Effective Date, the Parties shall discuss and agree upon the terms pursuant to which Affymax shall provide to Takeda reasonable quantities of: (i) reference standard compounds to the extent same are required to exercise methods in Product specifications; and (ii) related substances, both (i) and (ii) to the extent reasonably necessary for Takeda to Develop the Product. Provision of other non-Product synthetic peptides (i.e., placebo) by Affymax to Takeda for Product development purposes shall be discussed by the JSC and Affymax shall supply these at [*] cost of preparation to Takeda as soon as reasonably practicable after approval by the JSC. For the purpose of this Section 7.2, both Parties shall abide by the above-mentioned (a) to (g) prior to the conclusion of a clinical supply agreement.

Preclinical and Clinical Supply. Affymax Rhizen shall, by itself or through its Third Party contract manufacturers, use Diligent Efforts to supply to Takeda TGTX all quantities of Finished Product or Bulk API reasonably required by Takeda TGTX to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW Development. Takeda shall, by itself or through its Third Party contract manufacturers and by using the Bulk API thus supplied by Affymax, supply to both Parties all quantities of Finished Product reasonably required to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW DevelopmentPlan. Such quantities of Bulk API and Finished Product, and the schedule for such supply, shall be confirmed and if necessary updated by the JSC in a manner consistent with the U.S. Development Plan and a plan for the ROW DevelopmentPlan. Such supply shall be governed by the clinical supply and Bulk API manufacturing agreements agreement that the Parties shall negotiate in good faith promptly within ninety one hundred eighty (90180) days following the Effective Date. The clinical supply agreement shall, in addition to other terms and conditions agreed upon by the Parties, provide for the following: (a) Affymax Rhizen shall, before entering into negotiation for an agreement with a Third Party contract manufacturer of Bulk API or Finished Product for supply to Takeda TGTX hereunder, notify Takeda TGTX of the fact. Thereafter, Takeda TGTX shall have the right to provide reasonable input regarding the terms of such agreement (as well as any amendments thereof), review and comment on agreement drafts and forms, consult with Affymax Rhizen regarding the negotiation of such agreement, and participate in person in the negotiation of such agreement, as the Parties may agree, it being understood that Affymax Rhizen shall retain the final authority over the terms and conditions of any such agreement with such Third Party contractor. The Parties agree that [*] should be qualified TGTX shall also have the right to manufacture Bulk APIconduct a general GMP/regulatory inspection of any manufacturing, packaging, labeling or storage facility in advance of the conclusion of any agreement. (b) From time to time, Takeda TGTX shall submit to Affymax Rhizen purchase orders for quantities of Finished Product or Bulk API for such use consistent, as far as reasonably practicable, with such confirmed, or, if applicable, updated quantity and schedule which confirmation or update shall be consistent, as much as reasonably possible, with the then-current U.S. Development Plan and a plan for the ROW Development, and Affymax Rhizen shall supply or have supplied to Takeda TGTX such quantities of Finished Product. It shall not be a breach of this Agreement by Rhizen if it is unable to supply such quantities of Finished Product or Bulk APIAPI to the extent the quantities ordered were in excess of 120% of the quantities forecasted in the then-current Development Plan. All shipments to Takeda TGTX of Bulk API Finished Product shall be made [*]“Delivered Duty Paid” (Incoterms 2010) to a secondary packager or distribution center of TGTX’s choice. (c) Affymax shall invoice Takeda for such Bulk API with each shipment, and Takeda shall pay such invoices within thirty (30) days of its receipt of such invoice. The price cost for supplies from Affymax to Takeda Rhizen of Finished Product or Bulk API for (non-clinical and clinical) Development of the Product shall be [*] equal to the actual external costs for such Bulk API. The price of Finished Product or Bulk API used for the U.S. Development as well as plus the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda Rhizen or TGTX with regard to such Bulk API or Finished Product shall be included in the Development Expenses; provided, however, that following the exercise of either of the License Options, such amounts shall be invoiced and paid for by TGTX. * Confidential material redacted and filed separately with the Commission. (d) All Finished Product or Bulk API supplied by Affymax Rhizen to Takeda TGTX shall, when delivered, have been manufactured, handled and stored by Affymax Rhizen or its Third Party contract manufacturer(s) in compliance with all agreed-upon specifications and applicable Laws, including without limitation then-current GMP requirements. (e) Subject to the following Section 7.2(f), the terms described in Sections 7.2(a), (b) and (d) above shall apply, mutatis mutandis, to Takeda's provision of Finished Product to Affymax, it being understood that Affymax shall provide Finished Product to both Parties during such time as Takeda is establishing a source of Finished Product, not to exceed twelve (12) months after the Effective Date, unless mutually agreed upon otherwise by the Parties, and the terms described in Section 7.2(c) above shall apply, mutatis mutandis, to Affymax's provision of Finished Product to Takeda. (f) With regard to the Finished Product manufactured by or on behalf of Takeda and provided to Affymax, Takeda shall not invoice Affymax. The Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus provided to Affymax or used by Takeda for the U.S. Development, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product supplied to Affymax or used by Takeda, shall be included in the Development Expenses. Likewise, the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Affymax with regard to such Finished Product supplied to Affymax by Takeda, shall be included in the Development Expenses. (g) Within ninety (90) days after the Effective Date, the Parties shall discuss and agree upon the terms pursuant to which Affymax shall provide to Takeda reasonable quantities of: (i) reference standard compounds to the extent same are required to exercise methods in Product specifications; and (ii) related substances, both (i) and (ii) to the extent reasonably necessary for Takeda to Develop the Product. Provision of other non-Product synthetic peptides (i.e., placebo) by Affymax to Takeda for Product development purposes shall be discussed by the JSC and Affymax shall supply these at [*] cost of preparation to Takeda as soon as reasonably practicable after approval by the JSC. For the purpose of this Section 7.2, both Parties shall abide by the above-mentioned (a) to (gd) prior to the conclusion of a clinical supply agreement.

Preclinical and Clinical Supply. Affymax shall, by itself or through its Third Party contract manufacturers, supply to Takeda all quantities of Bulk API reasonably required by Takeda to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW Development. Takeda shall, by itself or through its Third Party contract manufacturers and by using the Bulk API thus supplied by Affymax, supply to both Parties all quantities of Finished Product reasonably required to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW Development. Such quantities of Bulk API and Finished Product, and the schedule for such supply, shall be confirmed and if necessary updated by the JSC in a manner consistent with the U.S. Development Plan and a plan for the ROW Development. Such supply shall be governed by clinical supply and Bulk API manufacturing agreements that the Parties shall negotiate in good faith promptly within ninety (90) days following the Effective Date. The clinical supply agreement shall, in addition to other terms and conditions agreed upon by the Parties, provide for the following: (a) Affymax shall, before entering into negotiation for an agreement with a Third Party contract manufacturer of Bulk API for supply to Takeda hereunder, notify Takeda of the fact. Thereafter, Takeda shall have the right to provide input regarding the terms of such agreement (as well as any amendments thereof), review and comment on agreement drafts and forms, consult with Affymax regarding the negotiation of such agreement, and participate in person in the negotiation of such agreement, as the Parties may agree, it being understood that Affymax shall retain the final authority over the terms and conditions of any such agreement with such Third Party contractor. The Parties agree that [*] should be qualified to manufacture Bulk API. (b) From time to time, Takeda shall submit to Affymax purchase orders for quantities of Bulk API for such use consistent, as far as reasonably practicable, with such confirmed, or, if applicable, updated quantity and schedule which confirmation or update shall be consistent, as much as reasonably possible, with the then-current U.S. Development Plan and a plan for the ROW Development, and Affymax shall supply or have supplied to Takeda such quantities of Bulk API. All shipments to Takeda of Bulk API shall be made [*]. (c) Affymax shall invoice Takeda for such Bulk API with each shipment, and Takeda shall pay such invoices within thirty (30) days of its receipt of such invoice. The price for supplies from Affymax to Takeda of Bulk API for (non-clinical and clinical) Development of the Product shall be [*] for such Bulk API. The price of Bulk API used for the U.S. Development as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Bulk API shall be included in the Development Expenses. (d) All Bulk API supplied by Affymax to Takeda shall, when delivered, have been manufactured, handled and stored by Affymax or its Third Party contract manufacturer(s) in compliance with all agreed-upon specifications and applicable Laws, including without limitation then-current GMP requirements. (e) Subject to the following Section 7.2(f), the terms described in Sections 7.2(a), (b) and (d) above shall apply, mutatis mutandis, to Takeda's provision of Finished Product to Affymax, it being understood that Affymax shall provide Finished Product to both Parties during such time as Takeda is establishing a source of Finished Product, not to exceed twelve (12) months [*] after the Effective Date, unless mutually agreed upon otherwise by the Parties, and the terms described in Section 7.2(c) above shall apply, mutatis mutandis, to Affymax's provision of Finished Product to Takeda. (f) With regard to the Finished Product manufactured by or on behalf of Takeda and provided to Affymax, Takeda shall not invoice Affymax. The Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus provided to Affymax or used by Takeda for the U.S. Development, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product supplied to Affymax or used by Takeda, shall be included in the Development Expenses. Likewise, the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Affymax with regard to such Finished Product supplied to Affymax by Takeda, shall be included in the Development Expenses. (g) Within ninety (90) days [*] after the Effective Date, the Parties shall discuss and agree upon the terms pursuant to which Affymax shall provide to Takeda reasonable quantities of: (i) reference standard compounds to the extent same are required to exercise methods in Product specifications; and (ii) related substances, both (i) and (ii) to the extent reasonably necessary for Takeda to Develop the Product. Provision of other non-Product synthetic peptides (i.e., placebo) by Affymax to Takeda for Product development purposes shall be discussed by the JSC and Affymax shall supply these at [*] cost of preparation to Takeda as soon as reasonably practicable after approval by the JSC. For the purpose of this Section 7.2, both Parties shall abide by the above-mentioned (a) to (g) prior to the conclusion of a clinical supply agreement.

Preclinical and Clinical Supply. Affymax shall, by itself or through its Third Party contract manufacturers, supply to Takeda all quantities of Bulk API reasonably required by Takeda to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW Development. Takeda shall, by itself or through its Third Party contract manufacturers and by using the Bulk API thus supplied by Affymax, supply to both Parties all quantities of Finished Product reasonably required to Develop the Product in the Licensed Territory pursuant to the U.S. Development Plan and a plan for the ROW Development. Such quantities of Bulk API and Finished Product, and the schedule for such supply, shall be confirmed and if necessary updated by the JSC in a manner consistent with the U.S. Development Plan and a plan for the ROW Development. Such supply shall be governed by clinical supply and Bulk API manufacturing agreements that the Parties shall negotiate in good faith promptly within ninety (90) days following the Effective Date. The clinical supply agreement shall, in addition to other terms and conditions agreed upon by the Parties, provide for the following: (a) Affymax shall, before entering into negotiation for an agreement with a Third Party contract manufacturer of Bulk API for supply to Takeda hereunder, notify Takeda of the fact. Thereafter, Takeda shall have the right to provide input regarding the terms of such agreement (as well as any amendments thereof), review and comment on agreement drafts and forms, consult with Affymax regarding the negotiation of such agreement, and participate in person in the negotiation of such agreement, as the Parties may agree, it being understood that Affymax shall retain the final authority over the terms and conditions of any such agreement with such Third Party contractor. The Parties agree that [*[ * ] should be qualified to manufacture Bulk API. (b) From time to time, Takeda shall submit to Affymax purchase orders for quantities of Bulk API for such use consistent, as far as reasonably practicable, with such confirmed, or, if applicable, updated quantity and schedule which confirmation or update shall be consistent, as much as reasonably possible, with the then-current U.S. Development Plan and a plan for the ROW Development, and Affymax shall supply or have supplied to Takeda such quantities of Bulk API. All shipments to Takeda of Bulk API shall be made [*[ * ]. (c) Affymax shall invoice Takeda for such Bulk API with each shipment, and Takeda shall pay such invoices within thirty (30) days of its receipt of such invoice. The price for supplies from Affymax to Takeda of Bulk API for (non-clinical and clinical) Development of [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. the Product shall be [*[ * ] for such Bulk API. The price of Bulk API used for the U.S. Development as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Bulk API shall be included in the Development Expenses. (d) All Bulk API supplied by Affymax to Takeda shall, when delivered, have been manufactured, handled and stored by Affymax or its Third Party contract manufacturer(s) in compliance with all agreed-upon specifications and applicable Laws, including without limitation then-current GMP requirements. (e) Subject to the following Section 7.2(f), the terms described in Sections 7.2(a), (b) and (d) above shall apply, mutatis mutandis, to Takeda's ’s provision of Finished Product to Affymax, it being understood that Affymax shall provide Finished Product to both Parties during such time as Takeda is establishing a source of Finished Product, not to exceed twelve (12) months after the Effective Date, unless mutually agreed upon otherwise by the Parties, and the terms described in Section 7.2(c) above shall apply, mutatis mutandis, to Affymax's ’s provision of Finished Product to Takeda. (f) With regard to the Finished Product manufactured by or on behalf of Takeda and provided to Affymax, Takeda shall not invoice Affymax. The Manufacturing Cost incurred by Takeda for the Finished Manufacture of the Finished Product thus provided to Affymax or used by Takeda for the U.S. Development, as well as the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Takeda with regard to such Finished Product supplied to Affymax or used by Takeda, shall be included in the Development Expenses. Likewise, the freight, postage, shipping, transportation, insurance, warehousing and handling charges actually allowed or paid by Affymax with regard to such Finished Product supplied to Affymax by Takeda, shall be included in the Development Expenses. (g) Within ninety (90) days after the Effective Date, the Parties shall discuss and agree upon the terms pursuant to which Affymax shall provide to Takeda reasonable quantities of: (i) reference standard compounds to the extent same are required to exercise methods in Product specifications; and (ii) related substances, both (i) and (ii) to the extent reasonably necessary for Takeda to Develop the Product. Provision of other non-Product synthetic peptides (i.e., placebo) by Affymax to Takeda for Product development purposes shall be discussed by the JSC and Affymax shall supply these at [*[ * ] cost of preparation to Takeda as soon as reasonably practicable after approval by the JSC. For the purpose of this Section 7.2, both Parties shall abide by the above-mentioned (a) to (g) prior to the conclusion of a clinical supply agreement.