Supply. i. For the Commercial Sales Stage, Acutus will provide forecasts covering four (4) quarters for amounts of Coating Materials and the immediate three (3) quarters will be binding on Acutus. ii. In the event Acutus does not purchase sufficient amounts of Coating Materials to meet its binding portion of the forecast for a given quarter, it shall have the option of satisfying its obligation by paying to Biotectix $[***] for such quarter. iii. Biotectix will fulfill purchase orders for Coating Materials for amounts of Coating Material up to [***]% of the amounts specified in the binding portion of the forecast and use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date shall not exceed thirty (30) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill the purchase orders that have been issued by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed accepted. iv. The Coating Materials shall conform with the specifications contained in (i) master files submitted by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material Specifications”). In the event of a Supply Failure by Biotectix and to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereof, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar to the terms in Biotectix’s agreements with its suppliers of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material as soon as possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License. v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents are available for purchase by Acutus at the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii) vi. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) [***] ([***]%) of the pricing for the preceding calendar year; and (b) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials in the Coating Material
Appears in 1 contract
Supply. i. 7.1 BDSI will be the exclusive supplier to Kunwha of the Product, and BDSI shall supply Product for commercial sale within the Territory exclusively to Kunwha, as described herein during the term of this Agreement.
7.2 Subject to the terms of this Agreement, BDSI shall supply to Kunwha Product for use, sale, or distribution in the Territory. BDSI shall be the sole and exclusive supplier of the Product to Kunwha during the term of this Agreement, and Kunwha shall purchase solely from BDSI all of its requirements for Product to be used, sold, or distributed in the Territory. Kunwha shall not manufacture or have manufactured on its behalf, nor obtain from any Affiliate of Kunwha or any Third Party, any Product. BDSI shall be entitled to engage Third Parties as necessary to fulfill BDSI’s obligations under this Agreement with respect to the supply of Product provided that BDSI shall continue to be responsible for such Third Party’s performance of BDSI’s obligations with respect to the supply of Product hereunder.
7.3 The manner and style of the labeling and trade dress of the Licensed Product shall be as mutually agreed upon by the Parties in writing consistent with this Agreement, and upon such mutual agreement shall be deemed part of the Product Specifications, subject to any future changes reasonably requested by Kunwha, agreed upon in writing by BDSI, and paid for by Kunwha. For the Commercial Sales Stageavoidance of doubt, Acutus will provide forecasts covering four (4) quarters Kunwha shall be solely responsible for amounts the contents of Coating Materials any product label and BDSI shall not be responsible in any manner, including but not limited to under any provision of this Agreement, for any error, mistake, violation of any Applicable Law or any other problem with the immediate three (3) quarters will content of the label unless BDSI does not follow label instructions provided by Kunwha in accordance with this Agreement. Any Kunwha-requested change or modification to a Product’s label or packaging shall be binding on Acutussubject to BDSI’s prior written approval of such change or modification. Kunwha shall reimburse BDSI for the reasonable total direct and indirect cost of any Product labels rendered obsolete by such change.
ii. In the event Acutus does not purchase sufficient amounts of Coating Materials 7.4 Kunwha may from time to meet its binding portion of the forecast for a given quartertime place, it shall have the option of satisfying its obligation by paying to Biotectix $[***] for such quarter.
iii. Biotectix and BDSI will fulfill accept, written purchase orders for Coating Materials batches of the Licensed Product and any other Products, as further described below and BDSI will use Commercially Reasonable Efforts to supply Products to Kunwha. However, Kunwha acknowledges both the inherent risk that one or more batches of bulk or finished Products may be lost in production or shipment and that any of its orders for Products could be delayed until demand (of both Kunwha and BDSI’s other licensees) of the Products and similar products is reasonably sufficient to justify BDSI’s production of any or all of the Products. All provisions of this Section 7 “Supply” regarding ordering and delivery of Products will be subject to the provisions contained in this Section 7.4 and Kunwha specifically acknowledges BDSI’s ability to delay production and delivery of Products, or upon Kunwha’s written request provide to Kunwha products on a mutually agreeable timeline and pricing schedule that will be negotiated outside of the terms of this Agreement.
7.5 To the extent Product Development requires Kunwha to conduct clinical trials in the Territory, Kunwha may from time to time place, and BDSI will accept, binding written purchase orders for batches of Products to be used for clinical studies conducted by Kunwha under the Development Program (“Clinical Supply Orders”). The Parties shall work together in good faith to establish the amounts of Coating Material up Products to [***]% of be used in any clinical trial(s) to be conducted under the amounts specified in Development Program and establish a delivery schedule for such Products, subject to the binding portion of the forecast Parties’ mutual written agreement with respect thereto, and BDSI shall use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time supply such Products to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment Kunwha in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date shall not exceed thirty such schedule (30) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill the purchase orders that have been issued by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed accepted.
iv. The Coating Materials shall conform with the specifications contained in (i) master files submitted by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material SpecificationsInitial Clinical Supply Order”). In Clinical Supply Orders for subsequent clinical trials (“Subsequent Clinical Orders”) shall be placed reasonably, but at least ***, in advance of the event requested date of a delivery subject to the terms of this Agreement. BDSI shall use Commercially Reasonable Efforts to deliver according to the delivery schedule contained in any Subsequent Clinical Supply Failure Order. Notwithstanding the foregoing, all delivery dates are targets only. No terms and conditions contained in any Clinical Supply Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by Biotectix and either Party shall be effective to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereofthey are inconsistent with, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products modify or Coated Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar add to the terms in Biotectix’s agreements with its suppliers of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material as soon as possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material Licenseconditions contained herein.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents are available for purchase by Acutus at the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii)
vi. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) [***] ([***]%) of the pricing for the preceding calendar year; and (b) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials in the Coating Material
Appears in 1 contract
Samples: License and Supply Agreement (Biodelivery Sciences International Inc)
Supply. i. 2.1 During the Term, NPM shall allocate capacity to and shall manufacture and sell to CTI no less than the amounts of Product ordered by CTI with the issuance of a Binding Forecast PO pursuant to Section 2.16. All batches of Product shall be produced utilizing the Process and in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreement.
2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement shall be null and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. **
2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. **
2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto.
2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. **
2.7 Subject to Sections 2.5 and 2.6, **
2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, the manufacture of the Product shall be in accordance with cGMP. For the Commercial Sales Stagepurpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, Acutus environmental and occupational health and safety laws and regulations, CTI shall have the right to audit and inspect per the Quality Agreement. **
2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **.
2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions.
2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”).
2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”).
2.13 During the Post-commercialization period **.
2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. **
2.15 NPM will ** provide forecasts covering four (4) quarters to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities.
2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph.
2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of Coating Materials e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO.
2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the immediate three (3) quarters will quantity of Product to be binding on Acutussupplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions.
ii. 2.19 In the event Acutus does NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows:
2.20 NPM shall not purchase sufficient amounts of Coating Materials manufacture or sell the Product to meet any party other than CTI, or its binding portion of the forecast for a given quarterdesignated affiliates or designated subsidiaries, it shall have the option of satisfying its obligation by paying to Biotectix $[***] for such quarterwithout CTI’s prior written consent.
iii. Biotectix will fulfill purchase orders for Coating Materials for amounts of Coating Material up to [***]% of the amounts specified in the binding portion of the forecast and use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date 2.21 NPM shall not exceed thirty use any materials (30including drug substance) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the purchase orders that have been issued by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed acceptedQuality Agreement.
iv. The Coating Materials shall conform with the specifications contained in (i) master files submitted by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material Specifications”). In the event of a Supply Failure by Biotectix and to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereof, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar to the terms in Biotectix’s agreements with its suppliers of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material as soon as possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents are available for purchase by Acutus at the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii)
vi. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) [***] ([***]%) of the pricing for the preceding calendar year; and (b) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials in the Coating Material
Appears in 1 contract
Samples: Drug Product Manufacturing Supply Agreement (Cell Therapeutics Inc)
Supply. i. 4.1 Subject to the terms of this Agreement, BDSI shall, beginning with the initial clinical trial to be conducted by Meda under the Development Program pursuant to the License Agreement, supply to Meda Products for use, sale, or distribution in the Territory. BDSI shall be the sole and exclusive supplier of the Products to Meda during the term of this Agreement, and Meda shall purchase solely from BDSI all of its requirements for Products to be used, sold, or distributed in the Territory unless a Back-Up Trigger occurs as set out in Section 4.11. Meda shall not manufacture or have manufactured on its behalf any Products except as may be permitted by Section 4.11. BDSI shall be entitled to engage Third Parties as necessary to fulfill BDSI’s obligations under this Agreement provided that BDSI shall continue to be responsible for such Third Party’s performance of BDSI’s obligations hereunder.
4.2 The manner and style of the labeling and trade dress of the Products shall be as described in the Packaging Specifications, subject to any further changes (i) reasonably requested by Meda or (ii) necessary to conform such Packaging Specifications to the regulatory requirements necessary to obtain and maintain Governmental Approvals with respect to the Products and to comply with all Applicable Laws, subject in each case to Sections 3.03 and 5.02 of the License Agreement. To the extent approved by relevant Competent Authorities and permitted by Applicable Law, and subject to (i) Meda’s compliance with Sections 3.03 and 5.02 of the License Agreement and (ii) BDSI’s approval of such change or modification pursuant to Section 5.02 of the License Agreement, BDSI shall use Meda’s specified labeling (and only such labeling) on the Products. For the Commercial Sales Stageavoidance of doubt, Acutus will provide forecasts covering four Meda shall be solely responsible for the contents of any product label and BDSI shall not be responsible in any manner, including but not limited to under any provision of this Agreement, for any error, mistake, violation of any Applicable Law or any other problem with the content of the label as specified by Meda unless BDSI does not follow label instructions provided by Meda. Any Meda-requested change or modification to a Product’s label shall, subject to (4i) quarters Meda’s compliance with Sections 3.03 and 5.02 of the License Agreement and (ii) BDSI’s approval of such change or modification pursuant to Section 5.02 of the License Agreement, be implemented by BDSI as soon as reasonably practicable. Meda shall reimburse BDSI for amounts the reasonable total direct and indirect cost of Coating Materials and the immediate three (3) quarters will be binding on Acutusany Product labels rendered obsolete by such change.
ii. In the event Acutus does not purchase sufficient amounts of Coating Materials 4.3 Meda may from time to meet its time place, and BDSI will accept, binding portion of the forecast for a given quarter, it shall have the option of satisfying its obligation by paying to Biotectix $[***] for such quarter.
iii. Biotectix will fulfill written purchase orders for Coating Materials batches of BEMA Fentanyl Products and all Placebos to be used for clinical studies conducted by Meda under the Development Program pursuant to the License Agreement (“Clinical Supply Orders”). The parties shall work together in good faith to establish the amounts of Coating Material up Products to [***]% of the amounts specified be used in the binding portion of initial clinical trial to be conducted under the forecast Development Program and establish a delivery schedule for such Products, subject to the Parties’ mutual agreement with respect thereto, and BDSI shall use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time supply such Products to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment Meda in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date shall not exceed thirty such schedule (30) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill the purchase orders that have been issued by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed accepted.
iv. The Coating Materials shall conform with the specifications contained in (i) master files submitted by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material SpecificationsInitial Clinical Supply Order”). In Clinical Supply Orders for subsequent clinical trials (“Subsequent Clinical Orders”) shall be placed reasonably, but at least ***, in advance of the event requested date of a Supply Failure by Biotectix and delivery subject to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereof, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated Products and to make such Coating Materials under the SurModics terms of this Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix BDSI shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using use commercially reasonable efforts to assist Acutus deliver according to the delivery schedule contained in securing supply any Subsequent Clinical Supply Order. Notwithstanding the foregoing, all delivery dates are targets only. The ESC will discuss delivery and scheduling issues as necessary. No terms for raw materials that and conditions contained in any Clinical Supply Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are similar inconsistent with, modify or add to the terms in Biotectix’s agreements with its suppliers of raw materials; and conditions contained herein.
4.4 Meda shall place an Order for Launch Stocks on a date not less than *** before the date on which it intends to commercially launch the BEMA Fentanyl Product (iii) transferring all materials, documentationthe “Date for Launch”), and equipment necessary shall use commercially reasonable efforts to manufacture avoid placing such Coating Material as soon as possible; Order more than *** before the Date For Launch (iv) reasonably cooperating with and assisting Acutus as notwithstanding that such date may not be reasonably necessary or desirable in order to enable Acutus to understand and implement capable of determination at the Biotectix Technology time for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing order). Upon receipt of such Coating Material Orders, BDSI shall use commercially reasonable efforts to answer Acutus’ questions related to such Coating Material; deliver the BEMA Fentanyl Product and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer Demonstration Samples in accordance therewith. However, for the manufacture avoidance of such Coating Materials that includes doubt, the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided Parties hereby confirm that (i) SurModics Reagents are available BDSI’s manufacturing obligations under this Section 4.4 shall only arise on receipt of Orders.
4.5 Within *** following Meda’s submission of the initial application for purchase Governmental Approval to a Competent Authority in the Territory with respect to the BEMA Fentanyl Product, Meda shall provide BDSI with a nonbinding Forecast of Meda’s requirements for the BEMA Fentanyl Product for the *** period following receipt of the anticipated Governmental Approval. The Forecast shall be updated *** until the date on which Meda places an Order for Launch Stocks. Except as otherwise provided herein, all Forecasts made hereunder shall, except as further described below, be nonbinding and made to assist BDSI in planning its production and Meda in planning marketing and sales.
4.6 All Orders for Products other than Clinical Supply Orders and Orders for Launch Stocks shall be governed by Acutus at the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clientsthis Section 4.6. Meda shall, which list SurModics or Biotectix will provide to Acutus no later not less than thirty (30) days after *** before the beginning of each calendar year thereafterquarter, give BDSI (i) its Order for the BEMA Fentanyl Products to be delivered to Meda during that calendar quarter and (ii)
vi. Acutus shall pay Biotectix for Coating Materials on ) a per unit basis as follows Forecast for the following ***. Notwithstanding the foregoing, Meda shall have no obligation to deliver Forecasts pursuant to this Section 4.6 until it places an Order for Launch Stocks. BDSI shall not be obligated to accept any Order for a calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution Aquarter that exceeds by more than 20% the amounts forecast for that quarter in the previous Forecast. However, 10 ml Solution B $ [BDSI shall make commercially reasonable efforts, but not be obligated, to also deliver such exceeding quantities. Meda may request amendment to an Order within *** ] 500 liter Solution Aafter such Order is given and BDSI shall use its commercially reasonably efforts to accept such amendment provided, 5 ml Solution B $ [however, BDSI shall not be obligated to accept such amendment if quantities specified in the Order are increased by more than ***% over the original Order, cause the Product scheduled for delivery in a quarter to exceed by more than ***% the amounts most recently Forecast for that quarter, or are decreased by more than ***% compared to the original Order. However, BDSI shall make commercially reasonable efforts, but not be obligated, to also deliver any quantities exceeding the aforementioned limitations. BDSI shall deliver according to the delivery schedule contained in any Order. The ESC will discuss delivery and scheduling issues as necessary. Each Forecast shall be deemed a binding commitment of Meda to purchase in the first calendar quarter thereof (i.e. the first quarter following the quarter covered by the accompanying Order) at least *** ] 100 liter Solution Aof the quantity of Products set forth with respect to such first calendar quarter. No terms and conditions contained in any Order, 1 ml Solution B $ [acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are inconsistent with, modify or add to the terms and conditions contained herein.
4.7 Meda shall be entitled at its option to reject such part of any delivery of the Products which does not comply with the Product Specifications, Packaging Specifications, or applicable regulatory requirements (including those contained in applicable Governmental Approvals and GMP), provided that Meda shall be deemed to have accepted any delivery of the Products unless it gives BDSI notice of its rejection within *** ] After 2015of delivery, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clientsor in case of a latent defect, which list Biotectix will provide to Acutus no later than thirty (30) days within *** after the beginning date Meda could have reasonably discovered such latent defect. BDSI shall, at BDSI’s option, promptly replace (without additional cost) or refund to Meda the amount actually paid by Meda to BDSI with respect to any such Products which do not comply with the Product Specifications, Packaging Specifications, or applicable regulatory requirements (including but not limited to those contained in applicable Governmental Approvals).
4.8 Meda shall return to BDSI, at BDSI’s cost, any Products rejected properly in accordance with this Section 4, in which case BDSI shall, consistent with Section 4.7 above, refund the amount actually paid by Meda to BDSI for such Products or promptly replace such Products at no additional charge, and pay to Meda the actual, reasonable, documented cost incurred by Meda in effecting the return of each calendar year thereafter; provided that such pricing shall be fixed Products.
4.9 If, with respect to any Products which have been replaced and/or for each calendar year which the amount actually paid by Meda therefore has been refunded is, following investigation, found by reasonable, independent, neutral, third party laboratory analysis pursuant to generally-accepted scientific methods, to have complied with the Product Specifications, Packaging Specifications, and shall all regulatory requirements (including but not exceed the greater of: limited to those described in applicable Governmental Approvals and GMP), Meda shall:
(a) [accept those Products as part of the next order and, if no Order will be placed before the termination of this Agreement, pay BDSI the applicable amount therefore pursuant to this Agreement, and
(b) refund any additional amount paid by BDSI to Meda with respect thereto.
4.10 If BDSI determines that it will not be able to supply Products to Meda in material satisfaction of the most recent Orders and/or Forecast, BDSI shall promptly notify Meda in writing of such determination, which notice shall provide Meda with the details on the extent of the expected shortfall of supply, the causes of such inability to supply, and BDSI’s proposed solution to the problem. Upon such notice of a supply problem, or in any event upon occurrence of a Back-Up Trigger (as defined below), (i) Meda and BDSI will immediately meet and work together, in good faith, to identify an appropriate resolution to the supply problem, provided that Section 4.11 shall remain applicable with respect to the occurrence of a Back-Up Trigger in the absence of any such resolution, and (ii) BDSI shall, during any such shortfall of supply, use commercially reasonable efforts to continue to supply to Meda an amount of Products proportionate to the quantity of Products ordered by Meda under this Agreement consistent with such Order and/or Forecast divided by the total demand during the same time period for Products by BDSI, its Affiliates, their sublicensees (including but not limited to Meda), and any other third parties to whom BDSI is obligated to supply Products. Any agreed resolution to the supply problem will be set forth in a writing executed by both parties.
4.11 In the event (i) BDSI cannot or does not properly supply on a timely basis in accordance with this Section 4 at least ***] % of the amount of Product specified in accepted Orders ([other than the Initial Supply Order) properly forecasted in any ***]%* or (ii) of the pricing occurrence of a breach of this Agreement by BDSI that, despite Meda’s compliance with Section 4.13 below, materially adversely affects Meda’s (or Meda’s Affiliates’) ability to develop and sell Products for a single consecutive period greater than *** (each of the foregoing, a “Back-Up Trigger”), Meda may, upon written notice to BDSI, terminate this Agreement or render it nonexclusive, enabling Meda to manufacture Products or have them manufactured on its behalf. Such notice by Meda shall describe the applicable Back-Up Trigger. Upon receipt of such notice, BDSI shall use commercially reasonable efforts to transfer to Meda, at Meda’s reasonable expense, copies of all information, including technical information, that is controlled by BDSI, that is useful or necessary in the manufacture of the Products and is reasonably necessary to enable Meda or any designated alternative supplier to manufacture such Products. Such transfer shall commence and be completed by BDSI as soon as reasonably practicable but in any event shall be completed prior to *** after BDSI’s receipt of notice from Meda. BDSI shall provide Meda reasonable assistance, at Meda’s request and expense, with respect to understanding such manufacturing information.
4.12 Contract Manufacturer(s). BDSI may, in its sole discretion, contract with Third Parties for the preceding calendar year; and (b) manufacture or supply of Products hereunder as it may determine necessary to enable it to satisfy its obligations hereunder. For purposes of clarification but not limitation, the price for Coating Material as adjusted for the increased actual cost performance of any of BDSI’s obligations hereunder by any such Third Parties shall be deemed to Biotectix for the raw materials in the Coating Materialsatisfy such obligations of BDSI.
Appears in 1 contract
Samples: Fentanyl Supply Agreement (Biodelivery Sciences International Inc)
Supply. i. For (a) Ardelyx shall be responsible for supplying such quantities of Licensed Compound and Licensed Product for use in the Commercial Sales Stage, Acutus will provide forecasts covering four Development and Commercialization of the Licensed Products under this Agreement as the Parties shall agree to and document in the MSA discussed below (4) quarters the “API Supply”). Ardelyx shall also be responsible for amounts supplying such quantities of Coating Materials Licensed Product and placebos for FOSUN’s Development activities hereunder as the immediate three Parties shall agree to and document in the MSA discussed below (3) quarters will the “Development Supply”). All API Supply and Development Supply delivered to FOSUN shall be binding on Acutuspaid for by FOSUN at the Transfer Price. Ardelyx shall deliver such quantities of API Supply to FOSUN for Development as the Parties shall agree.
ii. In (b) Ardelyx shall continue to supply sufficient Licensed Product to FOSUN for Commercialization, at the event Acutus does not purchase sufficient amounts of Coating Materials to meet its binding portion of the forecast for a given quarterTransfer Price, it shall have the option of satisfying its obligation by paying to Biotectix $[***] for such quarter.
iii. Biotectix will fulfill purchase orders for Coating Materials for amounts of Coating Material up to [***]% of the amounts specified in the binding portion of the forecast and use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment until FOSUN notify Ardelyx in accordance with reasonable delivery schedules the terms of the MSA to reduce or cease the supply due to the fact that (i) FOSUN is permitted under Applicable Law to Manufacture, or to have Manufactured, Licensed Product for Commercialization on its own, (ii) FOSUN has developed a commercial process for the Manufacture of the Licensed Product and lead times has scaled up that process to Manufacture the Licensed Product in such volumes as may be agreed upon from time reasonably take into account the anticipated demand for the Licensed Product throughout the Territory, and (iii) FOSUN has completed all the necessary regulatory procedures with CFDA to time by Acutus and Biotectix, provided that enable FOSUN to Manufacture commercial supplies of the maximum lead time from Acutus’ requested delivery date Licensed Product. FOSUN shall not exceed thirty (30) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill the purchase orders that have been issued by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed accepted.
iv. The Coating Materials shall conform with the specifications contained use Commercially Reasonable Efforts to complete all activities set forth in (i) master files submitted by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material Specifications”). In the event of a Supply Failure by Biotectix and to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereof, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar to the terms in Biotectix’s agreements with its suppliers of raw materials; through (iii) transferring all materials, documentation, above.
(c) The Parties agree and equipment necessary acknowledge that a separate manufacturing and supply agreement (“MSA”) is required to manufacture such Coating Material be entered into between the Parties to further govern the supply obligations undertaken by Ardelyx hereunder. The Parties shall also enter into a separate Quality Assurance Agreement (“QAA”) that shall define the manufacturing and supply quality responsibilities of the Parties for the Licensed Compound and the Licensed Product. The MSA and the QAA shall be negotiated in good faith between the Parties and be executed as promptly as possible following the Effective Date. The Parties’ objective is that the MSA and the QAA shall be entered into as soon as possible; (iv) reasonably cooperating with possible and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents are available for purchase by Acutus at the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii)
vi. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) within [***] ([***]%) days of the pricing for the preceding calendar year; and (b) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials in the Coating MaterialEffective Date.
Appears in 1 contract
Samples: License Agreement (Ardelyx, Inc.)
Supply. i. For 7.1 Subject to the Commercial Sales Stageterms of this Agreement, Acutus will provide forecasts covering four (4) quarters Aveva shall produce and supply to Arius Products for amounts of Coating Materials use, sale, or distribution in the Territory. Aveva shall be the sole and the immediate three (3) quarters will be binding on Acutus.
ii. In the event Acutus does not purchase sufficient amounts of Coating Materials to meet its binding portion exclusive supplier of the forecast Products to Arius in the Territory during the Original Term of this Agreement. During the Original Term of this Agreement Arius shall purchase from Aveva all of its requirements for Products to be used, sold, or distributed in the Territory unless a given quarterBack-Up Trigger occurs as set out in Section 7.14. Notwithstanding anything to the contrary herein, it Arius shall have be free to engage third parties to manufacture the option of satisfying its obligation by paying to Biotectix $[Products at any time for use, sale, or distribution outside the Territory. ***] CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for such quarterwhich confidential treatment are being requested are denoted with “*****”.
iii7.2 The manner and style of the labeling and trade dress of the Products shall be as described in the Packaging Specifications, subject to any further changes: (i) reasonably requested by Arius or (ii) necessary to conform such Packaging Specifications to the regulatory requirements necessary to obtain and maintain Product Approvals with respect to the Products in the reasonable discretion of Arius, including but not limited to the approval of alternative dosages, indications, or jurisdictions with respect to Products. Biotectix Aveva shall use Arius’ specified labeling (and only such labeling) on the Products, and shall not use such labeling on any other product. For the avoidance of doubt Arius shall be solely responsible for the contents of any product label and Aveva shall not be responsible under any provision of this Agreement for any error, mistake, violation of any Law or regulation or any other problem with the content of the label as specified by Arius unless Aveva does not follow label instructions provided by Arius. Any Arius-requested change or modification to a Product’s label shall be implemented by Aveva as soon as reasonably practicable following Aveva’s receipt of notification of such label changes from Arius. Arius shall reimburse Aveva for the reasonable documented direct cost of any Product labels rendered obsolete by such change.
7.3 Arius may from time to time place, and Aveva will fulfill accept, binding written purchase orders for Coating Materials batches of BEMA Fentanyl Products and all Placebos used for amounts of Coating Material up to [***]% laboratory, dose ranging, and clinical studies (“Clinical Supply Orders”). Clinical Supply Orders shall be placed reasonably, but at least 120 days, in advance of the amounts specified in requested date of delivery subject to the binding portion terms of the forecast and this Agreement. Aveva shall use commercially reasonable efforts to accept deliver according to the delivery schedule contained in any Clinical Supply Order and in any event within 10 days of such date. *****. Notwithstanding the foregoing, all delivery dates are targets only. The Joint Steering Committee will discuss delivery and scheduling issues as necessary. No terms and conditions contained in any Clinical Supply Order, acknowledgment, invoice, xxxx of lading, acceptance or other orders preprinted form issued by either party shall be effective to the extent they are inconsistent with, modify or add to the terms and conditions contained herein.
7.4 Arius shall place an Order for Coating MaterialsLaunch Stocks on a date not less than one hundred eighty (180) days before the date on which it intends to commercially launch the BEMA Fentanyl Product (the “Date for Launch”), and shall use commercially reasonable efforts to avoid placing such Order more than two hundred (200) days before the Date For Launch (notwithstanding that such date may not be capable of determination at the time for the order). Acutus Upon receipt of such Orders, Aveva shall issue orders use commercially reasonable efforts to deliver the BEMA Fentanyl Product in accordance therewith. However, for Coating Material from time the avoidance of doubt, the Parties hereby confirm that (i) Aveva’s manufacturing obligations under this Section 7.4 shall only arise on receipt of Orders, and (ii) all delivery dates are targets only and the Joint Steering Committee will discuss delivery and scheduling issues as necessary.
7.5 Within one hundred eighty (180) days following the submission of the NDA to time the FDA with respect to the BEMA Fentanyl Product, Arius shall provide Aveva with a nonbinding Forecast of Arius’ requirements for the BEMA Fentanyl Product for the twelve (12) month period following the anticipated FDA Approval. The Forecast shall be updated monthly until the date on which Arius places an Order for Launch Stocks. Except as otherwise provided herein, all Forecasts made hereunder shall, except as further described below, be nonbinding and made to assist Aveva in planning its production and Arius in planning marketing and sales. ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “*****”.
7.6 All Orders for BEMA Fentanyl Products other than Clinical Supply Orders and Orders for Launch Stocks shall be governed by this Section 7.6. Arius shall, not less than ninety (90) days before the beginning of each calendar quarter, give Aveva (i) its Order for the BEMA Fentanyl Products to be delivered to Arius during that calendar quarter and (ii) a Forecast for the Term following three (3) calendar quarters. Notwithstanding the foregoing, Arius shall have no obligation to deliver Forecasts pursuant to a written purchase order on its standard form and shall provide this Section 7.6 until it places an Order for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date Launch Stocks. Aveva shall not exceed be obligated to accept any Order for a calendar quarter that exceeds by more than 20% the amounts forecast for that quarter in the last Forecast. Arius may request amendment to an Order within thirty (30) days unless Acutus otherwise expressly agrees after such Order is given and Aveva shall use its commercially reasonably efforts to accept such amendment provided, however, Aveva shall not be obligated to accept such amendment if quantities specified in writingthe Order are increased by more than 20% over the original Order, cause the Product scheduled for delivery in a quarter to exceed by more than 20% the amounts most recently Forecast for that quarter or are decreased by more than 20% compared to the original Order. Biotectix Aveva shall accept use commercially reasonable efforts to deliver according to the delivery schedule contained in any Order, and fill the purchase orders that have been issued by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus any event within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase orderof the date specified in the applicable Order. In Notwithstanding the event Biotectix does not so notify Acutus within such ten (10) day periodforegoing, then such purchase order all delivery dates are targets only. The Joint Steering Committee will discuss delivery and scheduling issues as necessary. Each Forecast shall be deemed accepted.
iva binding commitment of Arius to purchase in the first calendar quarter thereof (the first quarter following the quarter covered by the accompanying Order) at least 75% of the quantity of Products set forth therein. The Coating Materials shall conform with the specifications No terms and conditions contained in (i) master files submitted any Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material Specifications”). In the event of a Supply Failure by Biotectix and either party shall be effective to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereofthey are inconsistent with, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products modify or Coated Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar add to the terms in Biotectix’s agreements with and conditions contained herein.
7.7 Arius shall be entitled at its suppliers option to reject such part of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material as soon as possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture any delivery of the Coating Material; Products which does not comply with the Product Specifications, Packaging Specifications, or applicable regulatory requirements (vincluding but not limited to those contained in Product Approvals). Aveva shall, at Arius’ option, immediately replace (without additional cost) making reasonably available Biotectix personnel or refund to Arius the Purchase Price of, any such Products which do not comply with expertise the Product Specifications, Packaging Specifications, or applicable regulatory requirements (including but not limited to those contained in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material LicenseProduct Approvals).
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants 7.8 Arius shall be deemed to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use have accepted any delivery of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents Products unless it gives Aveva notice of its rejection within fifteen (15) days of delivery unless any defect in the Coatings Materials; provided that (i) SurModics Reagents are available for purchase Products could not have been identified by Acutus at the same prices that SurModics ordinarily offers reasonable visual examination, in which event Arius shall not be deemed to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than have accepted such Products until thirty (30) days after the beginning date of each calendar year thereafterdelivery.
7.9 The Parties acknowledge that it is possible that Product delivered to Arius may not, at the time of delivery, be Conforming Product but the fact that it is not Conforming Product is at the time not discoverable upon reasonable physical inspection (iireferred to as “Latent Defect” or “Latent Defects”)
vi. Acutus shall pay Biotectix Notwithstanding Arius’ acceptance of such Product, Aveva is responsible for Coating Materials all Latent Defects that are attributable to the production of the Product by or on behalf of Aveva and cause such Product not to be Conforming Product. As soon as either Party discovers or becomes aware of a per unit basis as follows for Latent Defect in any Product produced and shipped by or on behalf of Aveva, such Party will promptly notify the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [other of the lot(s) involved and ***CONFIDENTIAL TREATMENT REQUESTED*** ] 500 liter Solution ANote: The portions hereof for which confidential treatment are being requested are denoted with “*****”. Aveva will refund the purchase price of such Product or replace such Product in the manner described in Section 7.10 below. Arius is responsible for any unsold or expired Product and all Product that ceases to be Conforming Product due to improper storage, 5 ml Solution B $ [handling and distribution of the Product by Arius or its Affiliates. In such cases, all related liabilities and the costs of the Product to be destroyed will be borne by Arius.
7.10 Arius shall return to Aveva, at Aveva’s cost, any Products rejected properly in accordance with this Section 7, in which case Aveva shall , consistent with Section 7.7 above, refund the Product Price of such Products or replace such Products at no additional charge, and pay to Arius the actual cost incurred by Arius in effecting the return of such Products.
7.11 If, with respect to any Products which have been replaced and/or for which the Purchase Price therefore has been refunded is, following investigation, found by reasonable, independent, neutral, third party analysis pursuant to generally-accepted scientific methods, to have complied with the Product Specifications, Packaging Specifications, and all regulatory requirements (including but not limited to those described in the Product Approvals), Arius shall:
(a) accept those Products as part of the next order and, if no Order will be placed before the termination of this Agreement, pay Aveva the applicable Product Price therefore, and
(b) refund any additional amount paid by Aveva to Arius with respect thereto.
7.12 Aveva shall use commercially reasonable efforts to ensure that it has sufficient capacity to enable it to supply ***** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty percent (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) [***] ([***]%) of the pricing quantity of Products specified in each Forecast, and if orders are placed for increased quantities Aveva will use commercially reasonable efforts to meet and fulfill such orders.
7.13 If Aveva determines that it will not be able to supply Products to Arius in material satisfaction of the most recent Orders and/or Forecast, Aveva shall, within ten (10) business days, notify Arius in writing of such determination, which notice shall provide Arius with the details on the extent of the expected shortfall of supply, the causes of such inability to supply, and Aveva’s proposed solution to the problem. Upon such notice of a supply problem, or in any event upon occurrence of a Back-Up Trigger (as defined below), Arius and Aveva will immediately meet and work together, in good faith, to identify an appropriate resolution to the supply problem, provided that Section 7.14 shall remain applicable with respect to any such problem in the absence of any such resolution. Any agreed resolution to the supply problem will be set forth in a writing executed by both parties.
7.14 In the event (i) Aveva cannot or does not properly supply on a timely basis in accordance with this Section 7 at least 75% of the amount of Product specified in accepted Orders properly forecasted in any two successive calendar quarters, (ii) Aveva fails to comply with Section 8.4, (iii) any facility owned or controlled by Aveva and involved in the manufacture or storage of Products hereunder is prohibited from, or materially adversely affected in its ability ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “*****”. to, produce, store, or otherwise be involved in the provision of Products to Arius under this Agreement by the appropriate regulatory authorities or due to such failure to comply, (iv) Aveva becomes insolvent, files for protection under bankruptcy laws, is the subject of such a filing by any creditors of, or interested parties in, Aveva, or enters into an assignment for the preceding calendar year; benefit of its creditors, or (v) of the occurrence of a breach of this Agreement by Aveva that materially adversely affects Arius’ ability (or Arius Affiliates’, sublicensees’, or other corporate partners’ ability) to develop and sell Products (b) each of the price foregoing, a “Back-Up Trigger”), Arius may, upon written notice to Aveva, cause the license granted in Section 3 to be immediately rendered nonexclusive and, upon such notice, Aveva shall be deemed to have licensed to Arius all Aveva Intellectual Property reasonably necessary to provide for Coating Material as adjusted for such manufacture (the increased actual cost “Back-Up License”), (which license will be nonexclusive worldwide, royalty free and transferable, and may be sublicensed to Biotectix for third parties engaged by Arius to manufacture the raw materials Products). Such notice by Arius shall describe the applicable Back-Up Trigger. Upon receipt of such notice, Aveva shall use commercially reasonable efforts to transfer to Arius, at Arius’ expense, which shall be commercially reasonable with estimates provided in advance, copies of all information, including technical information, that is controlled by Aveva, that is useful or necessary in the Coating Materialmanufacture of the Products and is reasonably necessary to enable Arius or any designated alternative supplier to manufacture such Products. Such transfer shall commence and be completed by Aveva as soon as reasonably practicable but in any event shall be completed prior to sixty (60) days after Aveva’s receipt of notice from Arius. Aveva shall provide Arius reasonable assistance, at Arius’ request and expense, with respect to understanding such manufacturing information and practicing the Back-Up License. In the event that any breach by Aveva of this Agreement is the cause of any Back-Up Trigger as described above and Aveva complies with its obligation to use commercially reasonable efforts to make such technology transfer under the preceding three (3) sentences of this Section 7.14, Arius’ right and option to issue notice and obtain a Back-Up License as described herein shall be Arius’ sole and exclusive remedy (other than termination pursuant to Section 18.2 hereof) as a result of such breach provided that the terms of this Agreement shall continue to apply with respect to any Product supplied by Aveva to Arius pursuant to this Agreement.
Appears in 1 contract
Samples: Supply Agreement (Biodelivery Sciences International Inc)
Supply. i. For 4.1 Subject to the Commercial Sales Stageterms of this Agreement, Acutus will provide forecasts covering four LTS shall employ its Commercially Reasonable Efforts to supply Products to BDSI for use or sale in the Territory. Except as permitted by, and subject to, Section 14, (4i) quarters LTS shall be the sole and exclusive supplier of the Products to BDSI for amounts sale in the Territory during the term of Coating Materials this Agreement and BDSI shall purchase solely from LTS all of BDSI’s requirements for Products to be sold in the immediate three Territory and (3ii) quarters will be binding BDSI shall not manufacture or have manufactured on Acutusits behalf any Products for sale in the Territory outside the scope of this Agreement.
ii. In the event Acutus does not purchase sufficient amounts of Coating Materials to meet its binding portion 4.2 The manner and style of the forecast for a given quarterlabeling, it packaging, and trade dress of the Products shall have be as described in the option of satisfying its obligation by paying to Biotectix $[Packaging Specifications. ***] . LTS shall use BDSI’s specified labeling (and only such labeling) on the Products. For the avoidance of doubt, BDSI shall be solely responsible for the contents of any product label and LTS shall not be responsible in any manner, including but not limited to any provision of this Agreement, for any error, mistake, violation of any applicable law, rule, regulation or guideline or any other problem with the content of the label as specified by BDSI unless LTS does not follow label instructions provided by BDSI. Any *** change or modification to a Product’s label or packaging shall be implemented by LTS as soon as reasonably practicable. BDSI shall reimburse LTS for the reasonable, documented total direct costs of any Product labels or packaging rendered obsolete by such quarterchange and for reasonable, documented costs for the change or modification to a Product’s label or packaging.
iii. Biotectix will fulfill purchase orders for Coating Materials for amounts of Coating Material up to [***]% of the amounts specified in the binding portion of the forecast and use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material 4.3 BDSI may from time to time during place binding written purchase orders for batches of BEMA Fentanyl Products, Demonstration Samples, and Placebos to be used for clinical studies (“Clinical Supply Orders”). BDSI may only place orders in multiples of the Term full batch sizes set forth on Exhibit F. Such purchase orders shall only be binding upon written confirmation by LTS within *** of receipt, provided that, notwithstanding foregoing, LTS’ obligation to deliver Product under this Agreement pursuant to a written purchase order on its standard form and shall provide for shipment orders placed in accordance with reasonable this Agreement shall remain unaffected. LTS shall confirm all such orders within *** of receipt. Clinical Supply Orders shall be placed reasonably, but at least *** in advance of the requested date of delivery schedules subject to the terms of this Agreement. LTS agrees to use Commercially Reasonable Efforts to deliver according to the delivery schedule contained in any Clinical Supply Order. No terms and lead times as conditions contained in any Clinical Supply Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are inconsistent with, modify or add to the terms and conditions contained herein.
4.4 As further depicted in Exhibit G, BDSI shall place Orders for Launch Stocks on a date not less than *** before the first and on a country-by-country basis each subsequent intended date of commercial launch of the BEMA Fentanyl Product in the Territory (the “Date for Launch”) (notwithstanding that such date may not be agreed capable of determination at the time for the order). BDSI may only place Orders in multiples of the full batch sizes set forth on Exhibit F. Such Orders shall only be binding upon from time to time written confirmation by Acutus and BiotectixLTS within *** of LTS’ receipt of such Order, provided that, notwithstanding foregoing, Confidential Treatment Requested by BioDelivery Sciences International, Inc. IRS Employer Identification No. 35-208985 Confidential treatment requested with respect to certain portions hereof denoted with “***” LTS’ obligation to deliver Product under this Agreement pursuant to orders placed in accordance with this Agreement shall remain unaffected. LTS shall confirm all such orders within *** of receipt. LTS shall use Commercially Reasonable Efforts to deliver the BEMA Fentanyl Product and Demonstration Samples in accordance with all Orders made in accordance with this Agreement.
4.5 Within *** following submission of the initial application for Governmental Approval in the Territory with respect to the BEMA Fentanyl Product, BDSI shall provide LTS with a non-binding Forecast of BDSI’s requirements for the BEMA Fentanyl Product for the *** period following receipt of the anticipated Governmental Approval. The Forecast shall be updated monthly until the date on which BDSI places an Order for Launch Stocks. Except as otherwise provided herein, all Forecasts made hereunder shall, except as further described below, be nonbinding and made to assist LTS in planning its production.
4.6 As further depicted in Exhibit G, all Orders for Products other than Clinical Supply Orders and Orders for Launch Stocks (“Commercial Supplies”) shall be governed by this Section 4.6:
(a) BDSI shall, not less than *** before the beginning of each calendar quarter, give LTS:
(i) Its Order for Commercial Supplies to be delivered to BDSI during that calendar quarter and,
(ii) a Forecast for the maximum lead time from Acutusfollowing *** calendar quarters.
(b) BDSI may only place Orders for Commercial Supplies in multiples of the full batch sizes set forth on Exhibit F. Such Orders shall only be binding upon written confirmation by LTS within *** of LTS’ receipt of such Order, provided that, notwithstanding foregoing, LTS’ obligation to deliver Product under this Agreement pursuant to orders placed in accordance with this Agreement shall remain unaffected. LTS shall confirm all such orders within *** of receipt. Notwithstanding the foregoing, BDSI shall have no obligation to deliver Forecasts pursuant to this Section 4.6 until it places an Order for Launch Stocks.
(c) LTS shall not be obligated to accept Orders for a calendar quarter to the extent, in the aggregate, they exceed by more than *** the amounts forecasted for that quarter in the previous Forecast. However, LTS shall make Commercially Reasonable Efforts, but not be obligated, to also deliver such exceeding quantities.
(d) LTS shall deliver according to the proposed delivery schedule contained in any Order. Confidential Treatment Requested by BioDelivery Sciences International, Inc. IRS Employer Identification No. 35-208985 Confidential treatment requested with respect to certain portions hereof denoted with “***”
(e) The Parties will discuss delivery and scheduling issues as necessary.
(f) Each Forecast shall be deemed a binding commitment of BDSI to purchase in the first calendar quarter thereof (i.e. the first quarter following the quarter covered by the accompanying Order) at least *** of the quantity of Products set forth with respect to such *** calendar quarter. The order quantities for Launch Stocks shall be deemed a binding commitment of BDSI to purchase *** percent *** of such quantities of Products.
(g) Shipment by LTS a quantity of the Product that is within plus or minus *** percent *** of the amount specified in BDSI’s Order, and a delivery date that is within plus or minus *** of such Order’s requested delivery date date, shall not exceed thirty constitute compliance with LTS’ delivery obligations hereunder. LTS shall only invoice BDSI for actually delivered amounts.
(30h) days unless Acutus otherwise expressly agrees No terms and conditions contained in writing. Biotectix shall accept and fill the purchase orders that have been any Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by Acutus in compliance with this Paragraph iii. Biotectix either Party shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. be effective to the extent they are inconsistent with, modify or add to the terms and conditions contained herein.
4.7 In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed accepted.
iv. The Coating Materials shall conform with the specifications contained in LTS (i) master files submitted by Biotectix has properly followed all procedures, processes, and protocols for the manufacture of Product, including those provided in the Product Specifications or SurModics any regulatory approvals or legal requirements, (ii) has used Commercially Reasonable Efforts to manufacture Products that will conform to the FDA Product Specifications, and maintained (iii) reasonably determines that a batch of Product does not conform to the Product Specifications (“OOS Batch”) and would, if shipped, constitute Defective Product the Parties agree to the following:
(a) BDSI shall bear the total reasonable, documented *** costs for the first OOS Batch of each *** consecutive batches of Product manufactured under this Agreement (regardless of size or country destination);
(b) LTS shall bear such total *** costs for all other OOS Batches in any *** consecutive batch series of batches of Product manufactured under this Agreement; and
(c) If LTS incurs *** costs for *** or more OOS Batches *** within any *** consecutive batch series of batches of Product in accordance with subsection (b) above (i.e. before BDSI is obliged to cover again any *** costs under subsection (a)), in accordance with this Section 4.7, then, upon written notice from either Party to the other Party, the Parties shall enter into good faith discussions about the continuation of the manufacture of the Product at LTS. Should the Parties not reach a definitive agreement on all terms and all conditions reasonably necessary for the continuation the manufacture of Product at LTS in light of the frequency of OOS Batches or changes to Product Specifications or manufacturing processes Confidential Treatment Requested by Biotectix BioDelivery Sciences International, Inc. IRS Employer Identification No. 35-208985 Confidential treatment requested with respect to certain portions hereof denoted with “***” required to sufficiently reduce such frequency of OOS Batches, then either Party shall have the right to terminate the Agreement on *** days written notice to the other Party. Notwithstanding anything to the contrary, the Parties agree that (i) each *** consecutive batch series of batches of Product including one (or SurModics more) OOS Batch(e)s referenced in the preceding sentence shall not include any batches of Product included in any prior or subsequent *** consecutive batch series of Product including any OOS Batch(es) (i.e. no “*** consecutive batch series of batches of Product” may overlap by including the same batch of Product in *** such series for purposes of premarket approval of medical devices and this Section 4.7), (ii) Biotectix product specification files the first “*** consecutive batch series of batches of Product” under this Section 4.7 shall begin with the first OOS Batch, and (collectivelyiii) each subsequent “*** consecutive batch series of batches of Product” shall begin with the first OOS Batch occurring following the tenth batch of the previous “*** consecutive batch series of batches of Product. For purposes of clarification, but not limitation, the “Coating Material Specifications”). In rights and obligations of the Parties under this Section 4.7 shall be in addition to, and without limitation of, any rights or obligations either Party may have in the event of a Supply Failure by Biotectix and Back-up Trigger or with respect to any Back-up Supplier.
4.8 Within *** of the extent the Coating Materials contain date of delivery of a SurModics Reagent and Biotectix has provided written notice thereofDefective Product, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated LTS will replace such Defective Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only deliver them at Acutus’ advance written request, grant such sublicense and provide technology transfer no additional costs for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar to the terms in Biotectix’s agreements with its suppliers of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material BDSI as soon as reasonably possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents BDSI supplies the necessary quantities of Active Principle to LTS according to Section 5 and (ii) if LTS is not able to replace such Defective Products with Products that are available for purchase not Defective Products within a reasonable period of time following notification of such Defective Product (and despite reasonably adequate quantities of Active Principle), LTS shall, upon BDSI’s request and instead of the replacement referenced above, promptly refund any amounts actually paid by Acutus BDSI with respect to such Defective Product. “Defective” shall mean any Product not manufactured in accordance with, or otherwise not complying with, the Product Specifications, Packaging Specifications or GMP, subject to BDSI having had appropriate and correct storage at all times according to the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clientsstorage specifications, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii)
vi. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced Product has been delivered by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) [***] ([***]%) of the pricing for the preceding calendar year; and (b) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials in the Coating MaterialLTS.
Appears in 1 contract
Supply. i. For Fennec shall supply or have supplied the Commercial Sales StageProduct in conformity with the Specifications and Good Manufacturing Practices, Acutus will provide forecasts covering four (4) quarters together with such documentation as required under the Quality Agreement. Fennec shall not be responsible for amounts of Coating Materials and any damages or losses suffered by Licensee resulting from the immediate three (3) quarters will be binding on Acutus.
ii. In the event Acutus does not purchase sufficient amounts of Coating Materials to meet its binding portion storage, testing, use or sale of the forecast for a given quarter, it Product by Licensee after delivery. Licensee shall inform Fxxxxx of any claim relating to quantitative deficiencies in any delivery of Product which Licensee considers to have the option of satisfying its obligation by paying been caused prior to Biotectix $delivery within [***] Working Days following actual receipt of any such delivery. Any claim for a quantitative deficiency which is not made within such quarter.
iii. Biotectix will fulfill purchase orders for Coating Materials for amounts of Coating Material up period shall be deemed to [***]% of the amounts specified in the binding portion of the forecast and use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date shall not exceed thirty (30) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill the purchase orders that have been issued waived by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase orderLicensee. In the event Biotectix does not so notify Acutus within Fennec determines there is a quantitative deficiency from the applicable order, the Parties shall investigate such ten deficiency and, if such deficiency occurred prior to delivery to Licensee, Licensee shall only be obligated to pay for actual quantities delivered; provided, however, that Fennec shall have the option, subject to prior agreement of Licensee, of rectifying any such deficiency that occurred prior to delivery by promptly delivering the appropriate quantities (10with no additional shipment costs for Licensee) day periodof Product to Licensee, then such purchase order in which case Licensee shall be deemed accepted.
iv. The Coating Materials shall conform with the specifications contained in (i) master files submitted by Biotectix or SurModics obligated to the FDA and maintained by Biotectix or SurModics pay for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material Specifications”). In the event of a Supply Failure by Biotectix and to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereof, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated Products and to make any such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar quantities pursuant to the terms in Biotectix’s agreements with its suppliers and conditions of raw materials; this Agreement. Any such quantitative deficiencies (iiiwhether or not subsequently delivered by Fennec) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material as soon as possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for deducted from the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents are available for purchase applicable Minimum Purchase Quantity required to be purchased by Acutus Licensee under Section 4.5. Fennec shall, at the same prices that SurModics ordinarily offers all times, maintain, at its own cost, inventory equivalent to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii)
vi. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) [***] supply of Product based on the Rolling Forecast, at its European releasing site ([***]%Almac Pharma Services Limited, Finnabair Industrial Estate, Dundalk, Co. Louth, Ireland A00 X0XX) of the pricing for the preceding calendar year; and shall manage such inventory on a FEFO (bfirst expiry, first out) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials in the Coating Materialbasis.
Appears in 1 contract
Samples: License and Supply Agreement (Fennec Pharmaceuticals Inc.)
Supply. i. For 4.1 Subject to the Commercial Sales Stageterms of this Agreement, Acutus will provide forecasts covering four LTS shall employ its Commercially Reasonable Efforts to supply Products to BDSI for use or sale in the Territory. Except as permitted by, and subject to, Section 14, (4i) quarters LTS shall be the sole and exclusive supplier of the Products to BDSI for amounts sale in the Territory during the term of Coating Materials this Agreement and BDSI shall purchase solely from LTS all of BDSI’s requirements for Products to be sold in the immediate three Territory and (3ii) quarters will be binding BDSI shall not manufacture or have manufactured on Acutusits behalf any Products for sale in the Territory outside the scope of this Agreement.
ii. In the event Acutus does not purchase sufficient amounts of Coating Materials to meet its binding portion 4.2 The manner and style of the forecast for a given quarterlabeling, it packaging, and trade dress of the Products shall have be as described in the option of satisfying its obligation by paying to Biotectix $[Packaging Specifications. ***] . LTS shall use BDSI’s specified labeling (and only such labeling) on the Products. For the avoidance of doubt, BDSI shall be solely responsible for the contents of any product label and LTS shall not be responsible in any manner, including but not limited to any provision of this Agreement, for any error, mistake, violation of any applicable law, rule, regulation or guideline or any other problem with the content of the label as specified by BDSI unless LTS does not follow label instructions provided by BDSI. Any *** change or modification to a Product’s label or packaging shall be implemented by LTS as soon as reasonably practicable. BDSI shall reimburse LTS for the reasonable, documented total direct costs of any Product labels or packaging rendered obsolete by such quarterchange and for reasonable, documented costs for the change or modification to a Product’s label or packaging.
iii. Biotectix will fulfill purchase orders for Coating Materials for amounts of Coating Material up to [***]% of the amounts specified in the binding portion of the forecast and use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material 4.3 BDSI may from time to time during place binding written purchase orders for batches of BEMA Fentanyl Products, Demonstration Samples, and Placebos to be used for clinical studies (“Clinical Supply Orders”). BDSI may only place orders in multiples of the Term full batch sizes set forth on Exhibit F. Such purchase orders shall only be binding upon written confirmation by LTS within *** of receipt, provided that, notwithstanding foregoing, LTS’ obligation to deliver Product under this Agreement pursuant to a written purchase order on its standard form and shall provide for shipment orders placed in accordance with reasonable this Agreement shall remain unaffected. LTS shall confirm all such orders within *** of receipt. Clinical Supply Orders shall be placed reasonably, but at least *** in advance of the requested date of delivery schedules subject to the terms of this Agreement. LTS agrees to use Commercially Reasonable Efforts to deliver according to the delivery schedule contained in any Clinical Supply Order. No terms and lead times as conditions contained in any Clinical Supply Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are inconsistent with, modify or add to the terms and conditions contained herein.
4.4 As further depicted in Exhibit G, BDSI shall place Orders for Launch Stocks on a date not less than *** before the first and on a country-by-country basis each subsequent intended date of commercial launch of the BEMA Fentanyl Product in the Territory (the “Date for Launch”) (notwithstanding that such date may not be agreed capable of determination at the time for the order). BDSI may only place Orders in multiples of the full batch sizes set forth on Exhibit F. Such Orders shall only be binding upon from time to time written confirmation by Acutus and BiotectixLTS within *** of LTS’ receipt of such Order, provided that, notwithstanding foregoing, LTS’ obligation to deliver Product under this Agreement pursuant to orders placed in accordance with this Agreement shall remain unaffected. LTS shall confirm all such orders within *** of receipt. LTS shall use Commercially Reasonable Efforts to deliver the BEMA Fentanyl Product and Demonstration Samples in accordance with all Orders made in accordance with this Agreement.
4.5 Within *** following submission of the initial application for Governmental Approval in the Territory with respect to the BEMA Fentanyl Product, BDSI shall provide LTS with a non-binding Forecast of BDSI’s requirements for the BEMA Fentanyl Product for the *** period following receipt of the anticipated Governmental Approval. The Forecast shall be updated monthly until the date on which BDSI places an Order for Launch Stocks. Except as otherwise provided herein, all Forecasts made hereunder shall, except as further described below, be nonbinding and made to assist LTS in planning its production.
4.6 As further depicted in Exhibit G, all Orders for Products other than Clinical Supply Orders and Orders for Launch Stocks (“Commercial Supplies”) shall be governed by this Section 4.6:
(a) BDSI shall, not less than *** before the beginning of each calendar quarter, give LTS:
(i) Its Order for Commercial Supplies to be delivered to BDSI during that calendar quarter and,
(ii) a Forecast for the maximum lead time from Acutusfollowing *** calendar quarters.
(b) BDSI may only place Orders for Commercial Supplies in multiples of the full batch sizes set forth on Exhibit F. Such Orders shall only be binding upon written confirmation by LTS within *** of LTS’ receipt of such Order, provided that, notwithstanding foregoing, LTS’ obligation to deliver Product under this Agreement pursuant to orders placed in accordance with this Agreement shall remain unaffected. LTS shall confirm all such orders within *** of receipt. Notwithstanding the foregoing, BDSI shall have no obligation to deliver Forecasts pursuant to this Section 4.6 until it places an Order for Launch Stocks.
(c) LTS shall not be obligated to accept Orders for a calendar quarter to the extent, in the aggregate, they exceed by more than *** the amounts forecasted for that quarter in the previous Forecast. However, LTS shall make Commercially Reasonable Efforts, but not be obligated, to also deliver such exceeding quantities.
(d) LTS shall deliver according to the proposed delivery schedule contained in any Order.
(e) The Parties will discuss delivery and scheduling issues as necessary.
(f) Each Forecast shall be deemed a binding commitment of BDSI to purchase in the first calendar quarter thereof (i.e. the first quarter following the quarter covered by the accompanying Order) at least *** of the quantity of Products set forth with respect to such *** calendar quarter. The order quantities for Launch Stocks shall be deemed a binding commitment of BDSI to purchase *** percent *** of such quantities of Products.
(g) Shipment by LTS a quantity of the Product that is within plus or minus *** percent *** of the amount specified in BDSI’s Order, and a delivery date that is within plus or minus *** of such Order’s requested delivery date date, shall not exceed thirty constitute compliance with LTS’ delivery obligations hereunder. LTS shall only invoice BDSI for actually delivered amounts.
(30h) days unless Acutus otherwise expressly agrees No terms and conditions contained in writing. Biotectix shall accept and fill the purchase orders that have been any Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by Acutus in compliance with this Paragraph iii. Biotectix either Party shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. be effective to the extent they are inconsistent with, modify or add to the terms and conditions contained herein.
4.7 In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed accepted.
iv. The Coating Materials shall conform with the specifications contained in LTS (i) master files submitted by Biotectix has properly followed all procedures, processes, and protocols for the manufacture of Product, including those provided in the Product Specifications or SurModics any regulatory approvals or legal requirements, (ii) has used Commercially Reasonable Efforts to manufacture Products that will conform to the FDA Product Specifications, and maintained (iii) reasonably determines that a batch of Product does not conform to the Product Specifications (“OOS Batch”) and would, if shipped, constitute Defective Product the Parties agree to the following:
(a) BDSI shall bear the total reasonable, documented *** costs for the first OOS Batch of each *** consecutive batches of Product manufactured under this Agreement (regardless of size or country destination);
(b) LTS shall bear such total *** costs for all other OOS Batches in any *** consecutive batch series of batches of Product manufactured under this Agreement; and
(c) If LTS incurs *** costs for *** or more OOS Batches *** within any *** consecutive batch series of batches of Product in accordance with subsection (b) above (i.e. before BDSI is obliged to cover again any *** costs under subsection (a)), in accordance with this Section 4.7, then, upon written notice from either Party to the other Party, the Parties shall enter into good faith discussions about the continuation of the manufacture of the Product at LTS. Should the Parties not reach a definitive agreement on all terms and all conditions reasonably necessary for the continuation the manufacture of Product at LTS in light of the frequency of OOS Batches or changes to Product Specifications or manufacturing processes required to sufficiently reduce such frequency of OOS Batches, then either Party shall have the right to terminate the Agreement on *** days written notice to the other Party. Notwithstanding anything to the contrary, the Parties agree that (i) each *** consecutive batch series of batches of Product including one (or more) OOS Batch(e)s referenced in the preceding sentence shall not include any batches of Product included in any prior or subsequent *** consecutive batch series of Product including any OOS Batch(es) (i.e. no “*** consecutive batch series of batches of Product” may overlap by Biotectix or SurModics including the same batch of Product in *** such series for purposes of premarket approval of medical devices and this Section 4.7), (ii) Biotectix product specification files the first “*** consecutive batch series of batches of Product” under this Section 4.7 shall begin with the first OOS Batch, and (collectivelyiii) each subsequent “*** consecutive batch series of batches of Product” shall begin with the first OOS Batch occurring following the tenth batch of the previous “*** consecutive batch series of batches of Product. For purposes of clarification, but not limitation, the “Coating Material Specifications”). In rights and obligations of the Parties under this Section 4.7 shall be in addition to, and without limitation of, any rights or obligations either Party may have in the event of a Supply Failure by Biotectix and Back-up Trigger or with respect to any Back-up Supplier.
4.8 Within *** of the extent the Coating Materials contain date of delivery of a SurModics Reagent and Biotectix has provided written notice thereofDefective Product, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products or Coated LTS will replace such Defective Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only deliver them at Acutus’ advance written request, grant such sublicense and provide technology transfer no additional costs for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar to the terms in Biotectix’s agreements with its suppliers of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material BDSI as soon as reasonably possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material License.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents BDSI supplies the necessary quantities of Active Principle to LTS according to Section 5 and (ii) if LTS is not able to replace such Defective Products with Products that are available for purchase not Defective Products within a reasonable period of time following notification of such Defective Product (and despite reasonably adequate quantities of Active Principle), LTS shall, upon BDSI’s request and instead of the replacement referenced above, promptly refund any amounts actually paid by Acutus BDSI with respect to such Defective Product. “Defective” shall mean any Product not manufactured in accordance with, or otherwise not complying with, the Product Specifications, Packaging Specifications or GMP, subject to BDSI having had appropriate and correct storage at all times according to the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clientsstorage specifications, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii)
vi. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [*** ] 500 liter Solution A, 5 ml Solution B $ [*** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced Product has been delivered by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter; provided that such pricing shall be fixed for each calendar year and shall not exceed the greater of: (a) [***] ([***]%) of the pricing for the preceding calendar year; and (b) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials in the Coating MaterialLTS.
Appears in 1 contract
Samples: Manufacturing, Supply, and License Agreement (Biodelivery Sciences International Inc)
Supply. i. For the Commercial Sales Stage, Acutus will provide forecasts covering four (4) quarters for amounts of Coating Materials and the immediate three (3) quarters 7.1. BDSI will be binding on Acutusthe exclusive supplier to TTY of the Product, and BDSI shall supply Product for commercial sale within the Territory exclusively to TTY, as described herein during the term of this Agreement.
ii7.2. In Subject to the event Acutus does not purchase sufficient amounts terms of Coating Materials this Agreement, BDSI shall supply to meet its binding portion TTY Product for use, sale, or distribution in the Territory. BDSI shall be the sole and exclusive supplier of the forecast for a given quarter, it shall have the option of satisfying its obligation by paying to Biotectix $[Product CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***] ” to TTY during the term of this Agreement, and TTY shall purchase solely from BDSI all of its requirements for Product to be used, sold, or distributed in the Territory. TTY shall not manufacture or have manufactured on its behalf, nor obtain from any Affiliate of TTY or any Third Party, any Product. BDSI shall be entitled to engage Third Parties as necessary to fulfill BDSI’s obligations under this Agreement with respect to the supply of Product provided that BDSI shall continue to be responsible for such quarterThird Party’s performance of BDSI’s obligations with respect to the supply of Product hereunder.
iii7.3. Biotectix The manner and style of the labeling and trade dress of the Licensed Product shall be as mutually agreed upon by the Parties in writing consistent with this Agreement, and upon such mutual agreement shall be deemed part of the Product Specifications, subject to any future changes reasonably requested by TTY, agreed upon in writing by BDSI, and paid for by TTY. For the avoidance of doubt, TTY shall be solely responsible for the contents of any product label and BDSI shall not be responsible in any manner, including but not limited to under any provision of this Agreement, for any error, mistake, violation of any Applicable Law or any other problem with the content of the label unless BDSI does not follow label instructions provided by TTY in accordance with this Agreement. Any TTY-requested change or modification to a Product’s label or packaging shall be subject to BDSI’s prior written approval of such change or modification. TTY shall reimburse BDSI for the reasonable total direct and indirect cost of any Product labels rendered obsolete by such change.
7.4. TTY may from time to time place, and BDSI will fulfill accept, written purchase orders for Coating Materials batches of the Licensed Product and any other Products, as further described below and BDSI will use Commercially Reasonable Efforts to supply Products to TTY. However, TTY acknowledges both the inherent risk that one or more batches of bulk or finished Products may be lost in production or shipment and that any of its orders for amounts Products could be delayed until demand (of Coating Material up both TTY and BDSI’s other licensees) of the Products and similar products is reasonably sufficient to [justify BDSI’s production of any or all of the Products. All provisions of this Section 7 regarding ordering and delivery of Products will be subject to the provisions contained in this Section 7.4. Unless otherwise stipulated in this Agreement, TTY specifically acknowledges BDSI’s ability to delay production and delivery of Products, or upon TTY’s written request provide to TTY Products on a mutually agreeable timeline and pricing schedule that will be negotiated outside of the terms of this Agreement. BDSI understands that TTY must provide specific and timely dates of Licensed Product delivery and will work with TTY such that dates of delivery are provided (within *** of the delivery date) to comply with the Taiwan government agent National Bureau of Controlled Drug requirements. Should BDSI fail to provide product to TTY in compliance with delivery date as required by the Taiwan government agent, National Bureau of Controlled Drug Requirements and TTY is fined for any such late delivery; BDSI will reimburse TTY for any fine levied on TTY by the Taiwan government agent, National Bureau of Controlled Drug Requirements. TTY estimates that it will place Orders for delivery by BDSI approximately ***]% . BDSI will work with TTY in good faith to fulfill other Orders requested by TTY when and as requested.
7.5. To the extent Product Development requires TTY to conduct clinical trials in the Territory, TTY may from time to time place, and BDSI will accept, binding written purchase CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***” orders for batches of Products to be used for clinical studies conducted by TTY under the Development Program (“Clinical Supply Orders”). The Parties shall work together in good faith to establish the amounts specified of Products to be used in any clinical trial(s) to be conducted under the binding portion of Development Program and establish a delivery schedule for such Products, subject to the forecast Parties’ mutual written agreement with respect thereto, and BDSI shall use commercially reasonable efforts to accept all other orders for Coating Materials. Acutus shall issue orders for Coating Material from time supply such Products to time during the Term pursuant to a written purchase order on its standard form and shall provide for shipment TTY in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Acutus and Biotectix, provided that the maximum lead time from Acutus’ requested delivery date shall not exceed thirty such schedule (30) days unless Acutus otherwise expressly agrees in writing. Biotectix shall accept and fill the purchase orders that have been issued by Acutus in compliance with this Paragraph iii. Biotectix shall notify Acutus within ten (10) days after receiving a purchase order if there is any reason why it cannot accept such purchase order. In the event Biotectix does not so notify Acutus within such ten (10) day period, then such purchase order shall be deemed accepted.
iv. The Coating Materials shall conform with the specifications contained in (i) master files submitted by Biotectix or SurModics to the FDA and maintained by Biotectix or SurModics for purposes of premarket approval of medical devices and (ii) Biotectix product specification files (collectively, the “Coating Material SpecificationsInitial Clinical Supply Order”). In Clinical Supply Orders for subsequent clinical trials (“Subsequent Clinical Orders”) shall be placed reasonably, but at least ***, in advance of the event requested date of a delivery subject to the terms of this Agreement. BDSI shall use Commercially Reasonable Efforts to deliver according to the delivery schedule contained in any Subsequent Clinical Supply Failure Order. Except as otherwise agreed by Biotectix both parties hereto, all delivery dates are targets only. No terms and conditions contained in any Clinical Supply Order, acknowledgment, invoice, xxxx of landing, acceptance or other preprinted form issued by either Party shall be effective to the extent the Coating Materials contain a SurModics Reagent and Biotectix has provided written notice thereofthey are inconsistent with, Biotectix shall request from SurModics the right to grant a sublicense to Acutus which includes the right for Acutus to “have made” Licensed Products modify or Coated Products and to make such Coating Materials under the SurModics Agreement. If SurModics consents to the grant of such sublicense, Biotectix shall, only at Acutus’ advance written request, grant such sublicense and provide technology transfer for manufacture of the Coating Materials using the SurModics Reagent as provided in this paragraph. In the event of a Supply Failure by Biotectix and to the extent the Coating Materials do not contain a SurModics Reagent, Biotectix shall grant to Acutus a right to make the Coating Materials and provide technology transfer for manufacture of the Coating Materials as provided in this paragraph. Technology transfer for manufacture of the Coating Materials includes (i) identifying qualified manufacturers of products and relevant components; (ii) using commercially reasonable efforts to assist Acutus in securing supply terms for raw materials that are similar add to the terms in Biotectix’s agreements with its suppliers of raw materials; (iii) transferring all materials, documentation, and equipment necessary to manufacture such Coating Material as soon as possible; (iv) reasonably cooperating with and assisting Acutus as may be reasonably necessary or desirable in order to enable Acutus to understand and implement the Biotectix Technology for manufacture of the Coating Material; (v) making reasonably available Biotectix personnel with expertise in manufacturing of such Coating Material to answer Acutus’ questions related to such Coating Material; and (vi) otherwise diligently cooperating with Acutus without charge as reasonably necessary to enable Acutus to exercise its rights under the Coating Material Licenseconditions contained herein.
v. In the event of (i) such a Supply Failure of Coating Materials that contain a SurModics Reagent by Biotectix during the Commercial Sales Stage and (ii) Biotectix grants to Acutus the sublicense right to make Coating Materials containing a SurModics Reagent and (iii) Acutus requests technology transfer for the manufacture of such Coating Materials that includes the use of the SurModics Reagent, Acutus agrees that SurModics shall be Acutus’ sole source for the SurModics Reagents in the Coatings Materials; provided that (i) SurModics Reagents are available for purchase by Acutus at the same prices that SurModics ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which SurModics provides to its clients, which list SurModics or Biotectix will provide to Acutus no later than thirty (30) days after the beginning of each calendar year thereafter, (ii)
vi7.6. Acutus shall pay Biotectix for Coating Materials on a per unit basis as follows for the calendar year 2015: Coating Material Description Price per Xxxx 0 liter Solution A, 10 ml Solution B $ [Within *** ] 500 liter Solution Afollowing TTY’s submission of the initial application for Governmental Approval to a Competent Authority in the Territory with respect to the Licensed Product, 5 ml Solution B $ [TTY shall provide BDSI with a Forecast of TTY’s requirements for Products for the *** ] 100 liter Solution A, 1 ml Solution B $ [*** ] After 2015, Acutus shall pay Biotectix for Coating Materials at period following receipt of the same prices that Biotectix ordinarily offers to its other clients for equivalent volume consumption as evidenced by the most current annual price list which Biotectix provides to its clients, which list Biotectix will provide to Acutus no later than thirty anticipated Marketing Authorization (30) days after the beginning of each calendar year thereafter; provided that such pricing including any required Pricing and Reimbursement Approvals). The Forecast shall be fixed for each calendar year updated regularly, and on no less than a monthly basis, until the date on which TTY places its first Order other than a Clinical Supply Order, at which time Forecasts shall not exceed the greater of: (a) [***] ([***]%) of the pricing for the preceding calendar year; and (b) the price for Coating Material as adjusted for the increased actual cost to Biotectix for the raw materials be provided in the Coating Materialaccordance with Section 7.
Appears in 1 contract
Samples: License and Supply Agreement