Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Exhibit 10.2
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
THIS COMMERCIAL SUPPLY AGREEMENT is made effective as of January 1, 2016 (the “Effective Date”), by and between Radius Health, Inc., a Delaware corporation with offices at 000 Xxxxxx Xxxxxx, 0xx Xxxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000, Xxxxxx Xxxxxx of America (“Radius”), and Xxxxxx Pharma International GmbH, a German corporation with an office at Xxxxxxxxxxxxxx 0, 00000 Xxxxxxxxxx, Xxxxxxx (“Vetter”), and Radius and Vetter are also individually referred to as a “Party” and collectively as the “Parties”,
WHEREAS, Radius is active in the pharmaceutical business and is the owner or licensee of rights to certain proprietary technical information, patents and/or patent applications relating to the Finished Product (as defined below);
WHEREAS, Xxxxxx provides services to its customers for supply with sterile finished dosage forms that it has converted from materials supplied by those customers and/or supplied by Xxxxxx and is the owner or licensee of rights to certain proprietary technical information, patents and/or patent applications relating to the Manufacture (as defined) of the Cartridges, the Pens and the Finished Products (as defined below);
WHEREAS, the Parties are parties to that certain Confidentiality Agreement dated May 1, 2007 (the “CDA”);
WHEREAS, the Parties are party to that certain Development and Manufacturing Services Agreement effective as of December 26, 2013 (the “DMSA”) under which Xxxxxx and its Affiliates performed development and manufacturing services on a scale appropriate for Radius’ abaloparatide clinical development program and under which any ongoing development work will continue to be performed;
WHEREAS, Radius desires to engage Xxxxxx to perform Services for the Manufacture (as defined below) of the Cartridges, the Pens and the Finished Products, in connection with the commercial use, marketing, sale, and/or distribution of the Finished Products by Radius and/or its Affiliates;
WHEREAS, Xxxxxx, directly or through its Affiliate Xxxxxx Pharma, possesses the requisite expertise, personnel, and Facilities (as defined below) for the Manufacture of the Cartridges, the Pens and the Finished Products, and is willing to provide Services and allocate and commit resources to Manufacture the Cartridges, the Pens and the Finished Products, on a contractual basis, for sale to Radius; and
WHEREAS, the Parties agree that the Parties’ respective rights and obligations to each other with respect to any Cartridges produced under the DMSA ([*]) shall be governed by the DMSA, and that the Parties’ respective rights and obligations to any third party, or to each other only pursuant to Article 12, with respect to such Cartridges shall be governed by this Agreement;
[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
NOW, THEREFORE, in consideration of the foregoing premises and the covenants of each of the Parties set forth in this Agreement, each of the Parties agrees as follows:
1.1
“Acceptance” and “Accept” means the acceptance by Radius of Release of a Product, to be given if the Manufacture of such Product has been performed in accordance with the Standard.
“Acceptance” and “Accept” means the acceptance by Radius of Release of a Product, to be given if the Manufacture of such Product has been performed in accordance with the Standard.
1.2
“Acquirer” means an acquirer or successor entity in connection with the sale of all (or substantially all) of Radius’ assets or the line of business, to which this Agreement relates, or a merger, consolidation or change of control.
“Acquirer” means an acquirer or successor entity in connection with the sale of all (or substantially all) of Radius’ assets or the line of business, to which this Agreement relates, or a merger, consolidation or change of control.
1.3
“Actual Yield” means the total actual yield of API resulting from the Manufacture of Cartridges in a given calendar year.
“Actual Yield” means the total actual yield of API resulting from the Manufacture of Cartridges in a given calendar year.
1.4
“Affiliate” means, with respect to Radius, any person, corporation, company, partnership, joint venture, entity and/or firm which is controlled by Radius, and with respect to Xxxxxx, any person, corporation, company, partnership, joint venture, entity and/or firm which is under common control of the trustees/executors of the estate of Xxxxxx Xxxxxx and, as used in this definition of the term Affiliate, “control” means (i) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors; (ii) in the case of non‑corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non‑corporate entity or the power to elect more than fifty percent (50%) of the members of the governing body of such non-corporate entity.
“Affiliate” means, with respect to Radius, any person, corporation, company, partnership, joint venture, entity and/or firm which is controlled by Radius, and with respect to Xxxxxx, any person, corporation, company, partnership, joint venture, entity and/or firm which is under common control of the trustees/executors of the estate of Xxxxxx Xxxxxx and, as used in this definition of the term Affiliate, “control” means (i) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors; (ii) in the case of non‑corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non‑corporate entity or the power to elect more than fifty percent (50%) of the members of the governing body of such non-corporate entity.
1.5
“Agreement” means this Commercial Supply Agreement, together with all Appendices attached hereto (specifically including the Quality Agreement), as amended from time to time by the Parties in accordance with Section 15.6.
“Agreement” means this Commercial Supply Agreement, together with all Appendices attached hereto (specifically including the Quality Agreement), as amended from time to time by the Parties in accordance with Section 15.6.
1.6
“Annual Cap” means an annual cap on Xxxxxx’x aggregate liability under Sections 4.8(d), 4.8(e), 6.6 and/or 13.3, in any given calendar year (January to December) during the term of this Agreement, equal to the smaller amount of (i) [*] percent ([*]%), in
“Annual Cap” means an annual cap on Xxxxxx’x aggregate liability under Sections 4.8(d), 4.8(e), 6.6 and/or 13.3, in any given calendar year (January to December) during the term of this Agreement, equal to the smaller amount of (i) [*] percent ([*]%), in
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Euros, of all of the net amounts paid by Radius to Xxxxxx during such given calendar year; and (ii) [*]Euros.
1.7
“Annual Price Adjustment” has the meaning set forth in Section 8.5.
“Annual Price Adjustment” has the meaning set forth in Section 8.5.
1.8
“API” means the active pharmaceutical ingredient known as abaloparatide, the same also known as BA058, a white powder that is a novel synthetic peptide analog of human parathyroid hormone-related protein, a naturally-occurring bone building hormone being developed by Radius for treatment of osteoporosis and for commercialization worldwide (excluding Japan).
“API” means the active pharmaceutical ingredient known as abaloparatide, the same also known as BA058, a white powder that is a novel synthetic peptide analog of human parathyroid hormone-related protein, a naturally-occurring bone building hormone being developed by Radius for treatment of osteoporosis and for commercialization worldwide (excluding Japan).
1.9
“API Value” means, in Euros, with respect to the amount of API contained in one (1) Batch, [*] of Xxxxxx’x price for such Batch, excluding taxes, customs, fees and other duties, if any.
“API Value” means, in Euros, with respect to the amount of API contained in one (1) Batch, [*] of Xxxxxx’x price for such Batch, excluding taxes, customs, fees and other duties, if any.
1.10
“Applicable Law” means all national, federal, state, or local statutes or laws applicable to Radius’ and its Affiliates’ respective business and shall be deemed also to refer to all rules and regulations promulgated thereunder by any Authorities, including, without limitation, those relating to Manufacture, use, marketing, sale, or distribution of pharmaceutical products, anti-corruption, and anti-bribery and, with respect to cGMPs, Applicable Law shall also include guidance documents formally promulgated by the governmental agency with jurisdiction over the Finished Product.
“Applicable Law” means all national, federal, state, or local statutes or laws applicable to Radius’ and its Affiliates’ respective business and shall be deemed also to refer to all rules and regulations promulgated thereunder by any Authorities, including, without limitation, those relating to Manufacture, use, marketing, sale, or distribution of pharmaceutical products, anti-corruption, and anti-bribery and, with respect to cGMPs, Applicable Law shall also include guidance documents formally promulgated by the governmental agency with jurisdiction over the Finished Product.
1.11
“Applicable Xxxxxx Law” means all applicable ordinances, rules, regulations, laws, guidelines, guidances, and requirements and court orders of any kind whatsoever, including non-Product-specific cGMP, of Germany, the European Union, the FDA, the EMA, and Swissmedic and, subject to the information requirements of Radius under Section 5.4(b), of Norway, Liechtenstein, Iceland and any Designated Country, all as amended from time to time.
“Applicable Xxxxxx Law” means all applicable ordinances, rules, regulations, laws, guidelines, guidances, and requirements and court orders of any kind whatsoever, including non-Product-specific cGMP, of Germany, the European Union, the FDA, the EMA, and Swissmedic and, subject to the information requirements of Radius under Section 5.4(b), of Norway, Liechtenstein, Iceland and any Designated Country, all as amended from time to time.
1.12
“Assignee” has the meaning set forth in Section 15.4(a).
“Assignee” has the meaning set forth in Section 15.4(a).
1.13
“Authority” means any government regulatory authority responsible for granting approvals for the performance of Services under this Agreement or for issuing regulations pertaining to the Manufacture and/or commercialization or use of the Finished Product in the intended country of use, including, without limitation, the FDA and the EMA.
“Authority” means any government regulatory authority responsible for granting approvals for the performance of Services under this Agreement or for issuing regulations pertaining to the Manufacture and/or commercialization or use of the Finished Product in the intended country of use, including, without limitation, the FDA and the EMA.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.14
“Batch” means, as described in the applicable Batch Record, a specific quantity of the Cartridge, the Pen or the Finished Product, that is intended to contain units of uniform character and quality, within specified limits, and is Manufactured during one cycle of Manufacture.
“Batch” means, as described in the applicable Batch Record, a specific quantity of the Cartridge, the Pen or the Finished Product, that is intended to contain units of uniform character and quality, within specified limits, and is Manufactured during one cycle of Manufacture.
1.15
“Batch Documentation” means the Certificate of Compliance, the Certificate of Analysis, the Specifications, and a complete and accurate copy of the executed Batch Records.
“Batch Documentation” means the Certificate of Compliance, the Certificate of Analysis, the Specifications, and a complete and accurate copy of the executed Batch Records.
1.16
“Batch Record” means the annotated production records that documents the Manufacturing actitivies in accordance with the Master Batch Records.
“Batch Record” means the annotated production records that documents the Manufacturing actitivies in accordance with the Master Batch Records.
1.17
“Cartridge” means a cartridge filled with API and excipients or placebo solution.
“Cartridge” means a cartridge filled with API and excipients or placebo solution.
1.18
“CDA” has the meaning set forth in the third whereas-clause.
“CDA” has the meaning set forth in the third whereas-clause.
1.19
“Certificate of Analysis” means a document signed by an authorized representative of Xxxxxx Pharma, describing Specifications for, and the testing methods applied to, the Cartridges, the Pens, or the Finished Product, and the results of testing.
“Certificate of Analysis” means a document signed by an authorized representative of Xxxxxx Pharma, describing Specifications for, and the testing methods applied to, the Cartridges, the Pens, or the Finished Product, and the results of testing.
1.20
“Certificate of Compliance” means a document, signed by an authorized representative of Xxxxxx Pharma, certifying that a particular Batch was Manufactured in accordance with the Standard.
“Certificate of Compliance” means a document, signed by an authorized representative of Xxxxxx Pharma, certifying that a particular Batch was Manufactured in accordance with the Standard.
1.21
“cGMP” means current good manufacturing practices and regulations applicable to the Manufacture that (i) are promulgated by the FDA, the EMA, Swissmedic, and/or agencies in Australia, Canada, Norway, Liechtenstein, Iceland and New Zealand and which, when specific to the Product, shall have been provided to Xxxxxx by Radius; or (ii) are specific to a Designated Country (and, for clarity, not included in the requirements of the agencies described above under subsection (i) hereof), all which shall have been provided to Xxxxxx by Radius, for clarity, including, but not limited to, when specific to the Product.
“cGMP” means current good manufacturing practices and regulations applicable to the Manufacture that (i) are promulgated by the FDA, the EMA, Swissmedic, and/or agencies in Australia, Canada, Norway, Liechtenstein, Iceland and New Zealand and which, when specific to the Product, shall have been provided to Xxxxxx by Radius; or (ii) are specific to a Designated Country (and, for clarity, not included in the requirements of the agencies described above under subsection (i) hereof), all which shall have been provided to Xxxxxx by Radius, for clarity, including, but not limited to, when specific to the Product.
1.22
“Change Order” means a document containing a description of required modifications and their effect on the scope, fees and timelines specified herein.
“Change Order” means a document containing a description of required modifications and their effect on the scope, fees and timelines specified herein.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.23
“Confidential Information” means any and all Information of a Party and/or its Affiliates, which Information is, during the term of this Agreement, or was, under any confidentiality or other agreement between Radius and Xxxxxx or Xxxxxx Pharma existing prior to the Effective Date (e.g., the CDA and the DMSA), or otherwise disclosed, including, but not limited to, Information which may have been disclosed, prior to the Effective Date, and may not be covered by any such confidentiality or other agreement, with the capitalized term “Information” being information relating to business, trade finances, affairs, operations, scientific and medical research, data, technical and technological information, processes, including manufacturing processes and procedures and processes as may be embodied or evidenced in formulae, manufacturing data, specifications and other related documents, patents and patented designs, trade secrets, copyrights, trademarks, industrial design, know-how, improvements, discoveries, inventions, formulas, ideas, devices, products, writings, any intellectual property and proprietary information relating to a product, as well as that directly derived or resulting from any of the foregoing, and any information or matter that a reasonable business person would or should deem confidential or proprietary.
“Confidential Information” means any and all Information of a Party and/or its Affiliates, which Information is, during the term of this Agreement, or was, under any confidentiality or other agreement between Radius and Xxxxxx or Xxxxxx Pharma existing prior to the Effective Date (e.g., the CDA and the DMSA), or otherwise disclosed, including, but not limited to, Information which may have been disclosed, prior to the Effective Date, and may not be covered by any such confidentiality or other agreement, with the capitalized term “Information” being information relating to business, trade finances, affairs, operations, scientific and medical research, data, technical and technological information, processes, including manufacturing processes and procedures and processes as may be embodied or evidenced in formulae, manufacturing data, specifications and other related documents, patents and patented designs, trade secrets, copyrights, trademarks, industrial design, know-how, improvements, discoveries, inventions, formulas, ideas, devices, products, writings, any intellectual property and proprietary information relating to a product, as well as that directly derived or resulting from any of the foregoing, and any information or matter that a reasonable business person would or should deem confidential or proprietary.
1.24
“Completion Date” means the effective date of expiration or termination of this Agreement.
“Completion Date” means the effective date of expiration or termination of this Agreement.
1.25
“Costs” means, collectively (except, for clarity, where “Costs” appears within another defined term or within a section heading), damages, liabilities, claims, suits, awards, judgments, costs and/or expenses, whether based on product liability or otherwise, including any court costs and/or reasonable attorneys’ fees.
“Costs” means, collectively (except, for clarity, where “Costs” appears within another defined term or within a section heading), damages, liabilities, claims, suits, awards, judgments, costs and/or expenses, whether based on product liability or otherwise, including any court costs and/or reasonable attorneys’ fees.
1.26
“Defective Product” has the meaning set forth in Section 6.6(a).
“Defective Product” has the meaning set forth in Section 6.6(a).
1.27
“Delivery Assistance” means assistance provided by Xxxxxx to Radius in connection with [*] by Radius of the Cartridge, Pen or Finished Product at the Facility, including, but not limited to, (i) addressing special shipping requirements; (ii) obtaining licenses, official authorizations, clearances, customs, any other documents and/or information, including security related information that Radius or its Affiliates may require for export, import or transport of the Finished Product to the final destination; (iii) making a contract for transport and/or insurance; (iv) loading the packed Finished Product in any container, collecting vehicle or other means of transport; (v) managing sample storage (using a centrally controlled and monitored access system) and shipment, data logging, shipment and storage under, and constant monitoring of, certain temperature conditions.
“Delivery Assistance” means assistance provided by Xxxxxx to Radius in connection with [*] by Radius of the Cartridge, Pen or Finished Product at the Facility, including, but not limited to, (i) addressing special shipping requirements; (ii) obtaining licenses, official authorizations, clearances, customs, any other documents and/or information, including security related information that Radius or its Affiliates may require for export, import or transport of the Finished Product to the final destination; (iii) making a contract for transport and/or insurance; (iv) loading the packed Finished Product in any container, collecting vehicle or other means of transport; (v) managing sample storage (using a centrally controlled and monitored access system) and shipment, data logging, shipment and storage under, and constant monitoring of, certain temperature conditions.
1.28
“Delivery Date” means the scheduled (as mutually agreed) date of delivery of Product, as more fully described in Section 7.2.
“Delivery Date” means the scheduled (as mutually agreed) date of delivery of Product, as more fully described in Section 7.2.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.29
“Demand” means Radius’ anticipated, to the best of its knowledge, demand for the Cartridges, the Pens and/or the Finished Products, in a given period, as communicated to Xxxxxx.
“Demand” means Radius’ anticipated, to the best of its knowledge, demand for the Cartridges, the Pens and/or the Finished Products, in a given period, as communicated to Xxxxxx.
1.30
“Designated Country” means any country (other than the United States of America, Canada, Australia, New Zealand, Switzerland, Norway, Liechtenstein, Iceland, and any member nation of the European Union) designated in writing by Radius to be a Designated Country, as set forth in and subject to Section 5.4(b).
“Designated Country” means any country (other than the United States of America, Canada, Australia, New Zealand, Switzerland, Norway, Liechtenstein, Iceland, and any member nation of the European Union) designated in writing by Radius to be a Designated Country, as set forth in and subject to Section 5.4(b).
1.31
“DMSA” has the meaning set forth in the fourth whereas-clause.
“DMSA” has the meaning set forth in the fourth whereas-clause.
1.32
“Effective Date” means the date first written above.
“Effective Date” means the date first written above.
1.33
“EMA” means the European Medicines Agency of the European Union, and any successor agency having substantially the same functions.
“EMA” means the European Medicines Agency of the European Union, and any successor agency having substantially the same functions.
1.34
“Equipment” means any equipment or machinery, including Radius Equipment, used by Xxxxxx Pharma in the Manufacturing.
“Equipment” means any equipment or machinery, including Radius Equipment, used by Xxxxxx Pharma in the Manufacturing.
1.35
“Equipment Letter” means that certain letter agreement between the Parties dated as of December 26, 2013, pursuant to which certain Radius Equipment was procured by Xxxxxx on behalf of Radius.
“Equipment Letter” means that certain letter agreement between the Parties dated as of December 26, 2013, pursuant to which certain Radius Equipment was procured by Xxxxxx on behalf of Radius.
1.36
“Facility” means the facility(ies) of Xxxxxx Pharma, approved by Radius for performance of the Services, and identified in the Quality Agreement.
“Facility” means the facility(ies) of Xxxxxx Pharma, approved by Radius for performance of the Services, and identified in the Quality Agreement.
1.37
“FDA” means the Food and Drug Administration of the United States of America, and any successor agency having substantially the same functions.
“FDA” means the Food and Drug Administration of the United States of America, and any successor agency having substantially the same functions.
1.38
“FDCA” means the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §321 et seq., as amended from time to time.
“FDCA” means the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §321 et seq., as amended from time to time.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.39
“Finished Product” means a Pen loaded with a Cartridge, in a labelled carton with all applicable country-specific labelling.
“Finished Product” means a Pen loaded with a Cartridge, in a labelled carton with all applicable country-specific labelling.
1.40
“Fixed Period” means the initial, earliest and binding period of each of both Forecasts, namely (i) [*] for the Cartridges and the Pens; and (ii) [*] for the Finished Products.
“Fixed Period” means the initial, earliest and binding period of each of both Forecasts, namely (i) [*] for the Cartridges and the Pens; and (ii) [*] for the Finished Products.
1.41
“Flexible Period” means such period, of each of both Forecasts, immediately following the Fixed Period, namely (i) [*] for the Cartridges and the Pens; and (ii) [*] for the Finished Products.
“Flexible Period” means such period, of each of both Forecasts, immediately following the Fixed Period, namely (i) [*] for the Cartridges and the Pens; and (ii) [*] for the Finished Products.
1.42
“Forecast” means written forecasts, showing Demand, both provided on a [*] rolling basis broken down by [*] increments, namely one for the Cartridges and the Pens, and one for the Finished Products, each covering each [*] of the then-immediately succeeding[*].
“Forecast” means written forecasts, showing Demand, both provided on a [*] rolling basis broken down by [*] increments, namely one for the Cartridges and the Pens, and one for the Finished Products, each covering each [*] of the then-immediately succeeding[*].
1.43
“Force Majeure” means a cause, an occurrence or an event that is unavoidable by or beyond the reasonable control of the affected Party or its Affiliate, including, without limitation, fire, flood, lightning, fog, storm, unusual weather conditions, explosion, accident, earthquake, volcanic ash, embargo, prohibition on import or export of the Xxxxxx Materials, the Radius Materials, the Cartridges, the Pens, the Finished Products and/or materials incorporated therein or parts thereof, shortage of energy or raw material or any inability to obtain any materials or shipping space, breakdown or delays of carriers or shippers, default or delay by any supplier or sub-contractor or other events due to internalization of operations and services typically and customarily provided by a third party, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorism, insurrections, riots, civil commotion, any public enemy, sabotage, invasion, strikes, stoppage of labor, lockout or any other labor trouble, acts of God or acts, governmental or administrative act or restraint or omissions, or delays in acting, by any governmental authority.
“Force Majeure” means a cause, an occurrence or an event that is unavoidable by or beyond the reasonable control of the affected Party or its Affiliate, including, without limitation, fire, flood, lightning, fog, storm, unusual weather conditions, explosion, accident, earthquake, volcanic ash, embargo, prohibition on import or export of the Xxxxxx Materials, the Radius Materials, the Cartridges, the Pens, the Finished Products and/or materials incorporated therein or parts thereof, shortage of energy or raw material or any inability to obtain any materials or shipping space, breakdown or delays of carriers or shippers, default or delay by any supplier or sub-contractor or other events due to internalization of operations and services typically and customarily provided by a third party, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorism, insurrections, riots, civil commotion, any public enemy, sabotage, invasion, strikes, stoppage of labor, lockout or any other labor trouble, acts of God or acts, governmental or administrative act or restraint or omissions, or delays in acting, by any governmental authority.
1.44
“ [*]” means[*].
“ [*]” means[*].
1.45
“Gross Negligence” means gross negligence, as applicable hereto, under and subject to Swiss law.
“Gross Negligence” means gross negligence, as applicable hereto, under and subject to Swiss law.
1.46
“Improvements” means any and all discoveries, inventions, developments (including, but not limited to, as part of the Services), modifications, innovations, updates, enhancements, or improvements under, or rights (whether or not protectable under patent,
“Improvements” means any and all discoveries, inventions, developments (including, but not limited to, as part of the Services), modifications, innovations, updates, enhancements, or improvements under, or rights (whether or not protectable under patent,
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
trademark, copyright or similar laws) to, Technology, that are conceived, discovered, invented, developed, created, made, generated or reduced to practice in connection with this Agreement.
1.47
“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce the Cartridge (by filling with the API (being part of the Radius Materials), formulated by Xxxxxx Pharma along with excipients or placebo solution), to assemble the Pen (by loading the pre-assembled pen components (being part of the Radius Materials), with the Cartridge, adding the dosing mechanism, cartridge holder, and pen caps) and/or to produce the Finished Product (by jointly secondary packaging both, the Cartridge and the Pen, and adding country-specific labelling), including, without limitation, manufacturing, processing, packaging, labeling, quality control testing, stability testing, and storing, respectively, the Cartridge, the Pen and/or the Finished Product, and Release hereunder to Radius.
“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce the Cartridge (by filling with the API (being part of the Radius Materials), formulated by Xxxxxx Pharma along with excipients or placebo solution), to assemble the Pen (by loading the pre-assembled pen components (being part of the Radius Materials), with the Cartridge, adding the dosing mechanism, cartridge holder, and pen caps) and/or to produce the Finished Product (by jointly secondary packaging both, the Cartridge and the Pen, and adding country-specific labelling), including, without limitation, manufacturing, processing, packaging, labeling, quality control testing, stability testing, and storing, respectively, the Cartridge, the Pen and/or the Finished Product, and Release hereunder to Radius.
1.48
“Manufacturing Improvements” means Improvements to the extent relating to any [*].
“Manufacturing Improvements” means Improvements to the extent relating to any [*].
1.49
“Manufacturing Process” means any and all processes and activities (or any step in any process or activity) used or planned to be used by Xxxxxx Pharma to Manufacture, as evidenced in the Batch Documentation or Master Batch Record.
“Manufacturing Process” means any and all processes and activities (or any step in any process or activity) used or planned to be used by Xxxxxx Pharma to Manufacture, as evidenced in the Batch Documentation or Master Batch Record.
1.50
“Market Launch Phase” means the period preceding and following market launch of the Product, which period shall commence upon receipt of the first marketing authorization for the Product granted by either the FDA or the EMA and expire [*] calendar months thereafter.
“Market Launch Phase” means the period preceding and following market launch of the Product, which period shall commence upon receipt of the first marketing authorization for the Product granted by either the FDA or the EMA and expire [*] calendar months thereafter.
1.51
“Master Batch Record” means the document, proposed by Xxxxxx and approved by Radius, which defines the Manufacturing methods, test methods and other procedures, directions and controls associated with the Manufacture and testing of the Cartridges, the Pens and the Finished Products.
“Master Batch Record” means the document, proposed by Xxxxxx and approved by Radius, which defines the Manufacturing methods, test methods and other procedures, directions and controls associated with the Manufacture and testing of the Cartridges, the Pens and the Finished Products.
1.52
“Negligence” means negligence (other than Gross Negligence), as applicable hereto, under and subject to Swiss law.
“Negligence” means negligence (other than Gross Negligence), as applicable hereto, under and subject to Swiss law.
1.53
“Pen” means pen device components, delivered in sets of components to the Facility by Radius, and further assembled by Xxxxxx Pharma (including loading by Xxxxxx Pharma with a Cartridge, and adding the dosing mechanism, cartridge holder, and pen caps).
“Pen” means pen device components, delivered in sets of components to the Facility by Radius, and further assembled by Xxxxxx Pharma (including loading by Xxxxxx Pharma with a Cartridge, and adding the dosing mechanism, cartridge holder, and pen caps).
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.54
“Pen Components Value” means, in Euros, [*] of Xxxxxx’x price for such Pen, excluding taxes, customs, fees and other duties, if any.
“Pen Components Value” means, in Euros, [*] of Xxxxxx’x price for such Pen, excluding taxes, customs, fees and other duties, if any.
1.55
“Planning Period” means the final and non-binding period, of each of both Forecasts (for planning purposes only) immediately following the Flexible Period, namely covering [*] for the Cartridges and the Pens, and [*] for the Finished Products.
“Planning Period” means the final and non-binding period, of each of both Forecasts (for planning purposes only) immediately following the Flexible Period, namely covering [*] for the Cartridges and the Pens, and [*] for the Finished Products.
1.56
“Product” means the Cartridge, the Pen, and/or the Finished Product, as the context requires.
“Product” means the Cartridge, the Pen, and/or the Finished Product, as the context requires.
1.57
“Product Costs” has the meaning set forth in Section 8.5.
“Product Costs” has the meaning set forth in Section 8.5.
1.58
“Purchase Order” means a document duly signed by or on behalf of Radius, which shall be binding and irrevocable and used only for ordering either the Cartridges and the Pens, or the Finished Products, whether or not consistent with the applicable Forecast, and/or for requesting an amendment of such quantities, subject to the provisions of this Agreement, and/or for requesting Delivery Dates; provided, however, no pre-printed or other term or condition thereon, or in any confirmation from Xxxxxx, shall have any force or effect, all of which terms and conditions shall be null and void unless otherwise specifically agreed in writing by and between the Parties and the provisions of this Agreement shall be deemed incorporated therein and, for clarity, Purchase Orders may be issued for filling the Cartridges and for assembling the Pens, separately from those issued for the Finished Products.
“Purchase Order” means a document duly signed by or on behalf of Radius, which shall be binding and irrevocable and used only for ordering either the Cartridges and the Pens, or the Finished Products, whether or not consistent with the applicable Forecast, and/or for requesting an amendment of such quantities, subject to the provisions of this Agreement, and/or for requesting Delivery Dates; provided, however, no pre-printed or other term or condition thereon, or in any confirmation from Xxxxxx, shall have any force or effect, all of which terms and conditions shall be null and void unless otherwise specifically agreed in writing by and between the Parties and the provisions of this Agreement shall be deemed incorporated therein and, for clarity, Purchase Orders may be issued for filling the Cartridges and for assembling the Pens, separately from those issued for the Finished Products.
1.59
“Quality Agreement” and “QA” means a quality agreement, with respect to the Manufacture and quality of the Cartridges, the Pens, and the Finished Product, which quality agreement Xxxxxx shall cause Xxxxxx Pharma to enter into with Radius, contained in a separate document but deemed an integral part of this Agreement and incorporated herein by reference.
“Quality Agreement” and “QA” means a quality agreement, with respect to the Manufacture and quality of the Cartridges, the Pens, and the Finished Product, which quality agreement Xxxxxx shall cause Xxxxxx Pharma to enter into with Radius, contained in a separate document but deemed an integral part of this Agreement and incorporated herein by reference.
1.60
“Radius Disclosed Manufacturing IP” has the meaning set forth in Section 9.1.
“Radius Disclosed Manufacturing IP” has the meaning set forth in Section 9.1.
1.61
“Radius Equipment” means the Equipment identified in Appendix A, being provided to the Facility by Radius or purchased or otherwise acquired by Xxxxxx or Xxxxxx Pharma at Radius’ costs and/or expenses.
“Radius Equipment” means the Equipment identified in Appendix A, being provided to the Facility by Radius or purchased or otherwise acquired by Xxxxxx or Xxxxxx Pharma at Radius’ costs and/or expenses.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.62
“Radius Improvements” means any and all Improvements that are[*].
“Radius Improvements” means any and all Improvements that are[*].
1.63
“Radius Indemnitees” has the meaning set forth in Section 12.1.
“Radius Indemnitees” has the meaning set forth in Section 12.1.
1.64
“Radius Materials” means the materials procured and provided by Radius for use by Xxxxxx Pharma to Manufacture the Cartridges, the Pens, and the Finished Product, namely the API, the pen device components sets, and certain labelling materials.
“Radius Materials” means the materials procured and provided by Radius for use by Xxxxxx Pharma to Manufacture the Cartridges, the Pens, and the Finished Product, namely the API, the pen device components sets, and certain labelling materials.
1.65
“Radius Technology” means (i) the Radius Materials and any intermediates, components, and/or derivatives of the Radius Materials; (ii) the Specifications, to the extent they (x) are specific to the API and/or to the Pens, and (y) do not contain any Xxxxxx Technology; and (iii) the Technology of Radius (x) existing prior to the Effective Date; (y) developed or obtained thereafter by or on behalf of Radius (from a source other than Xxxxxx Pharma) independent of this Agreement and without reliance upon any Confidential Information of Xxxxxx and/or any of its Affiliates; or (z) developed by or on behalf of Radius in connection with this Agreement that is not Xxxxxx Technology.
“Radius Technology” means (i) the Radius Materials and any intermediates, components, and/or derivatives of the Radius Materials; (ii) the Specifications, to the extent they (x) are specific to the API and/or to the Pens, and (y) do not contain any Xxxxxx Technology; and (iii) the Technology of Radius (x) existing prior to the Effective Date; (y) developed or obtained thereafter by or on behalf of Radius (from a source other than Xxxxxx Pharma) independent of this Agreement and without reliance upon any Confidential Information of Xxxxxx and/or any of its Affiliates; or (z) developed by or on behalf of Radius in connection with this Agreement that is not Xxxxxx Technology.
1.66
“Recall” means actions taken by Radius to remove Finished Product from the market.
“Recall” means actions taken by Radius to remove Finished Product from the market.
1.67
“Records” means records supporting the documentation required by Radius as detailed in the Quality Agreement and all other Services performed hereunder.
“Records” means records supporting the documentation required by Radius as detailed in the Quality Agreement and all other Services performed hereunder.
1.68
“Reduced Demand” means a reduction in such initial Demand, either for the Cartridges and the Pens, or for the Finished Products, for the Fixed Period and the Flexible Period combined, as set forth in the Forecast(s) applicable after (but, as provided, to be issued by Radius to Xxxxxx prior to) the end of the Market Launch Phase, and each calendar year thereafter, which is more than the greater of [*]or[*], compared to the Demand under (as measured by) the Purchase Orders, either for the Cartridges and the Pens, or for the Finished Products, actually placed during the [*]covered by such Fixed Period and Flexible Period combined, to be reconciled once [*] in which such [*] ends.
“Reduced Demand” means a reduction in such initial Demand, either for the Cartridges and the Pens, or for the Finished Products, for the Fixed Period and the Flexible Period combined, as set forth in the Forecast(s) applicable after (but, as provided, to be issued by Radius to Xxxxxx prior to) the end of the Market Launch Phase, and each calendar year thereafter, which is more than the greater of [*]or[*], compared to the Demand under (as measured by) the Purchase Orders, either for the Cartridges and the Pens, or for the Finished Products, actually placed during the [*]covered by such Fixed Period and Flexible Period combined, to be reconciled once [*] in which such [*] ends.
1.69
“Release” means, with respect to each Batch, the delivery by Xxxxxx Pharma to Radius, subject to Appendix 3 of the Quality Agreement, of the Certificate of Analysis, the Certificate of Compliance.
“Release” means, with respect to each Batch, the delivery by Xxxxxx Pharma to Radius, subject to Appendix 3 of the Quality Agreement, of the Certificate of Analysis, the Certificate of Compliance.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.70
“Representative” has the meaning set forth in Section 3.1.
“Representative” has the meaning set forth in Section 3.1.
1.71
“Reprocess” and “Reprocessing” means introducing a Cartridge,a Pen, or a Finished Product back into the Manufacturing Process, and repeating appropriate manipulation steps that are part of the established Manufacturing Process and, for clarity, a continuation of a process step after an in-process control test showing the process to be incomplete is not considered reprocessing.
“Reprocess” and “Reprocessing” means introducing a Cartridge,a Pen, or a Finished Product back into the Manufacturing Process, and repeating appropriate manipulation steps that are part of the established Manufacturing Process and, for clarity, a continuation of a process step after an in-process control test showing the process to be incomplete is not considered reprocessing.
1.72
“Rework” and “Reworking” means subjecting a Cartridge, a Pen, or a Finished Product to one or more Manufacturing Processing step(s) that is/are different from the established Manufacturing Process.
“Rework” and “Reworking” means subjecting a Cartridge, a Pen, or a Finished Product to one or more Manufacturing Processing step(s) that is/are different from the established Manufacturing Process.
1.73
“Services” means the Manufacturing and/or other services described herein and/or in the Quality Agreement.
“Services” means the Manufacturing and/or other services described herein and/or in the Quality Agreement.
1.74
“Shortfall” means a reduction in such initial Demand, either for the Cartridges and the Pens, or for the Finished Products, for the Fixed Period and the Flexible Period combined, as set forth in the Forecast(s) applicable after (but, as provided, to be issued by Radius to Xxxxxx prior to) the start of the Market Launch Phase for one (1) calendar year thereafter, which is more than the greater of [*] or [*], compared to the Demand under (as measured by) the Purchase Orders actually placed during the [*] covered by such Fixed Period and Flexible Period combined, to be reconciled [*] in which such [*] ends.
“Shortfall” means a reduction in such initial Demand, either for the Cartridges and the Pens, or for the Finished Products, for the Fixed Period and the Flexible Period combined, as set forth in the Forecast(s) applicable after (but, as provided, to be issued by Radius to Xxxxxx prior to) the start of the Market Launch Phase for one (1) calendar year thereafter, which is more than the greater of [*] or [*], compared to the Demand under (as measured by) the Purchase Orders actually placed during the [*] covered by such Fixed Period and Flexible Period combined, to be reconciled [*] in which such [*] ends.
1.75
“SOPs” means the standard operating procedures of Xxxxxx Pharma applicable to the Services.
“SOPs” means the standard operating procedures of Xxxxxx Pharma applicable to the Services.
1.76
“Specifications” means the agreed specifications, consisting of, but not limited to, a list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described to establish a set of criteria, label content, serialization where required, and aggregation when serialized, to which the Manufacture, at any stage, should conform to be considered acceptable that are provided by or approved by Radius, as such specifications are amended or supplemented from time to time by the Parties in writing, and mutually agreed by the Parties in accordance with Section 4(2) of the Quality Agreement and which, for clarity, shall include, as hereunder agreed, any regulatory requirements and cGMP specific to the Cartridge, the Pen, or the Finished Product.
“Specifications” means the agreed specifications, consisting of, but not limited to, a list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described to establish a set of criteria, label content, serialization where required, and aggregation when serialized, to which the Manufacture, at any stage, should conform to be considered acceptable that are provided by or approved by Radius, as such specifications are amended or supplemented from time to time by the Parties in writing, and mutually agreed by the Parties in accordance with Section 4(2) of the Quality Agreement and which, for clarity, shall include, as hereunder agreed, any regulatory requirements and cGMP specific to the Cartridge, the Pen, or the Finished Product.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.77
“Standard” means cGMP (if applicable), all other Applicable Xxxxxx Law, the Manufacturing Process, the Specifications and the terms of this Agreement applicable to the Manufacture of the Cartridges, the Pens, or the Finished Products, respectively.
“Standard” means cGMP (if applicable), all other Applicable Xxxxxx Law, the Manufacturing Process, the Specifications and the terms of this Agreement applicable to the Manufacture of the Cartridges, the Pens, or the Finished Products, respectively.
1.78
“Swissmedic” means the Swiss Agency for Therapeutic Products, and any successor agency having substantially the same functions.
“Swissmedic” means the Swiss Agency for Therapeutic Products, and any successor agency having substantially the same functions.
1.79
“Target Yield” has the meaning set forth in Section 4.8(d).
“Target Yield” has the meaning set forth in Section 4.8(d).
1.80
“Technology” means any and all Confidential Information, and any and all patents, patent applications, methods, techniques, trademarks, trade secrets, copyrights, industrial designs, know-how, data and other intellectual property of any kind (whether or not patentable, registered or otherwise protectable under patent, trademark, copyright or similar laws), and any Improvements thereto.
“Technology” means any and all Confidential Information, and any and all patents, patent applications, methods, techniques, trademarks, trade secrets, copyrights, industrial designs, know-how, data and other intellectual property of any kind (whether or not patentable, registered or otherwise protectable under patent, trademark, copyright or similar laws), and any Improvements thereto.
1.81
“Transition Compensation” means justifiable costs and/or expenses incurred by Xxxxxx and/or Xxxxxx Pharma in connection with the performance of any mutually agreed activities beyond the original scope of this Agreement that arise out of any assignment or transfer of this Agreement by Radius pursuant to Section 15.4, which costs and/or expenses and activities shall be negotiated in good faith and mutually agreed upon in advance by Xxxxxx on the one hand and Radius or such Assignee, Acquirer or Affiliate of Radius on the other hand and, for clarity, Xxxxxx shall have no obligation to undertake any such additional activities without Xxxxxx’x prior agreement, which shall not be unreasonably withheld, it being agreed and understood by Radius that Xxxxxx would be acting reasonably if Xxxxxx refused to undertake any such additional activities in the event not all requirements, as applicable, of Article 10 and/or Section 15.4 are satisfied, except if addressed by other means as agreed to by Xxxxxx in furtherance of such good faith discussions.
“Transition Compensation” means justifiable costs and/or expenses incurred by Xxxxxx and/or Xxxxxx Pharma in connection with the performance of any mutually agreed activities beyond the original scope of this Agreement that arise out of any assignment or transfer of this Agreement by Radius pursuant to Section 15.4, which costs and/or expenses and activities shall be negotiated in good faith and mutually agreed upon in advance by Xxxxxx on the one hand and Radius or such Assignee, Acquirer or Affiliate of Radius on the other hand and, for clarity, Xxxxxx shall have no obligation to undertake any such additional activities without Xxxxxx’x prior agreement, which shall not be unreasonably withheld, it being agreed and understood by Radius that Xxxxxx would be acting reasonably if Xxxxxx refused to undertake any such additional activities in the event not all requirements, as applicable, of Article 10 and/or Section 15.4 are satisfied, except if addressed by other means as agreed to by Xxxxxx in furtherance of such good faith discussions.
1.82
“Xxxxxx Indemnitees” has the meaning set forth in Section 12.2.
“Xxxxxx Indemnitees” has the meaning set forth in Section 12.2.
1.83
“Xxxxxx Materials” means any and all materials, supplies and other components (other than the Radius Materials), as listed in the Specifications and provided or procured by Xxxxxx to be used by Xxxxxx Pharma in the performance of Services.
“Xxxxxx Materials” means any and all materials, supplies and other components (other than the Radius Materials), as listed in the Specifications and provided or procured by Xxxxxx to be used by Xxxxxx Pharma in the performance of Services.
1.84
“Xxxxxx Pharma” means Xxxxxx Pharma-Fertigung GmbH & Co. KG, an Affiliate of Vetter duly organized and existing under the laws of Germany, having its principal place of business at Xxxxxxxxxxxxxx 00, 00000 Xxxxxxxxxx, Xxxxxxx.
“Xxxxxx Pharma” means Xxxxxx Pharma-Fertigung GmbH & Co. KG, an Affiliate of Vetter duly organized and existing under the laws of Germany, having its principal place of business at Xxxxxxxxxxxxxx 00, 00000 Xxxxxxxxxx, Xxxxxxx.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
1.85
“Xxxxxx Technology” means (i) the Specifications, to the extent they (x) are not specific to the API and/or to the Pens, and (y) contain Xxxxxx Technology; as well as (ii) the Technology of Xxxxxx (x) existing prior to the Effective Date; or (y) developed or obtained thereafter without use of, reference to, or reliance upon the Confidential Information of Radius, Radius Materials (except to the extent such mere use of the Radius Materials results in a Manufacturing Improvement), or Radius Technology.
“Xxxxxx Technology” means (i) the Specifications, to the extent they (x) are not specific to the API and/or to the Pens, and (y) contain Xxxxxx Technology; as well as (ii) the Technology of Xxxxxx (x) existing prior to the Effective Date; or (y) developed or obtained thereafter without use of, reference to, or reliance upon the Confidential Information of Radius, Radius Materials (except to the extent such mere use of the Radius Materials results in a Manufacturing Improvement), or Radius Technology.
1.86
“Willful Misconduct” means willful misconduct, as applicable hereto, under and subject to Swiss law.
“Willful Misconduct” means willful misconduct, as applicable hereto, under and subject to Swiss law.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Agreement shall restrict Radius from purchasing manufacturing services, cartridges, pens, or finished product from another source.
(a)
Except as expressly provided herein, Xxxxxx may not delegate any of its obligations to any third party, including, but not limited to, any Affiliate of Xxxxxx, to have performed any of its obligations under this Agreement, without the prior written consent of Radius to be set forth in a separate written amendment of this Agreement, to address, without limitation, responsibility and liability for performance or non-performance of such third party and audit and inspection of such third party; provided, however, that Xxxxxx may cause internal logistic and warehousing operations to be performed by[*], and that Xxxxxx is and shall be permitted to delegate to Xxxxxx Pharma as provided in Section 2.1. Neither [*] nor Xxxxxx Pharma shall be permitted to further delegate any obligations. Radius may not delegate any of its payment or other obligations to any third party, including, but not limited to, any Affiliate of Radius, to have performed any of its obligations under this Agreement, without the prior written consent of Xxxxxx; provided, however, that Xxxxxx shall not unreasonably withhold such consent and shall, upon request of Radius, negotiate in good faith appropriate amendment(s) to this Agreement to allow direct ordering and payment by any of the Radius Affiliates, instead of Radius, under this Agreement.
Except as expressly provided herein, Xxxxxx may not delegate any of its obligations to any third party, including, but not limited to, any Affiliate of Xxxxxx, to have performed any of its obligations under this Agreement, without the prior written consent of Radius to be set forth in a separate written amendment of this Agreement, to address, without limitation, responsibility and liability for performance or non-performance of such third party and audit and inspection of such third party; provided, however, that Xxxxxx may cause internal logistic and warehousing operations to be performed by[*], and that Xxxxxx is and shall be permitted to delegate to Xxxxxx Pharma as provided in Section 2.1. Neither [*] nor Xxxxxx Pharma shall be permitted to further delegate any obligations. Radius may not delegate any of its payment or other obligations to any third party, including, but not limited to, any Affiliate of Radius, to have performed any of its obligations under this Agreement, without the prior written consent of Xxxxxx; provided, however, that Xxxxxx shall not unreasonably withhold such consent and shall, upon request of Radius, negotiate in good faith appropriate amendment(s) to this Agreement to allow direct ordering and payment by any of the Radius Affiliates, instead of Radius, under this Agreement.
(b) Xxxxxx shall be, as herein provided, solely responsible for the performance or non-performance of Xxxxxx Pharma and/or[*], and for costs, expenses,
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
damages, and/or losses of any nature arising out of such performance or non-performance as if by Xxxxxx itself under this Agreement. Xxxxxx shall cause Xxxxxx Pharma and [*] to be bound by, and to comply with, the terms of this Agreement, as applicable, including, without limitation, all confidentiality, intellectual property, quality assurance, regulatory and other obligations and requirements of Xxxxxx set forth in this Agreement (including the Quality Agreement).
(c) Xxxxxx Pharma and [*] shall be subject to all of the audit and inspection provisions of Section 5.2 and Section 11.3(b); provided, however, Radius shall give as much advance notice as possible of any such audit and/or inspection. Xxxxxx agrees to cause Xxxxxx Pharma and [*] to satisfy all of the obligations set forth in this Agreement and Xxxxxx shall be responsible for actions and omissions of Xxxxxx Pharma and [*] as if Xxxxxx itself was performing or not performing, respectively, any such Services.
3.5 Regular Forecasts, Market Launch Phase, Post-Market Launch Phase, Purchase Orders, Purchase Order Cancellations/Postponements.
(a)
Regular Forecasts. Radius shall provide Xxxxxx with the Forecast in writing, beginning with[*], which shall thereafter, on a [*] rolling basis during the term of this Agreement [*], be updated. Each Forecast shall show the Demand, to be covered by Purchase Orders for the Fixed Period, and the Demand for the Flexible Period and Planning Period. Radius shall also give Xxxxxx, in January of each year during the term of this Agreement (but in 2016, in[*]), a forecast showing the anticipated Demand for the then-immediately succeeding [*] year period, which shall be non-binding and shall form the basis for mutual planning purposes only.
Regular Forecasts. Radius shall provide Xxxxxx with the Forecast in writing, beginning with[*], which shall thereafter, on a [*] rolling basis during the term of this Agreement [*], be updated. Each Forecast shall show the Demand, to be covered by Purchase Orders for the Fixed Period, and the Demand for the Flexible Period and Planning Period. Radius shall also give Xxxxxx, in January of each year during the term of this Agreement (but in 2016, in[*]), a forecast showing the anticipated Demand for the then-immediately succeeding [*] year period, which shall be non-binding and shall form the basis for mutual planning purposes only.
(b)
Market Launch Phase; Shortfall. Each Party understands that short-term demand may fluctuate significantly during the Market Launch Phase. Xxxxxx shall use commercially reasonable efforts to meet changing Demand, whether an incease or decrease, in accordance with the terms herein contained; provided, however, that, during the Market Launch Phase, in the event of a Shortfall, Radius shall pay to Xxxxxx, as compensation for unused Manufacturing capacity reserved (under Purchase Orders that have not been placed but that should have been placed, in accordance with the provisions hereof), due thirty (30) calendar days after the invoice date (receipt of readily available funds by Xxxxxx), an amount equal to [*] of the net revenue that Xxxxxx would have received from the sale of the Shortfall to Radius; provided, however, Xxxxxx shall use its commercially reasonable efforts to
Market Launch Phase; Shortfall. Each Party understands that short-term demand may fluctuate significantly during the Market Launch Phase. Xxxxxx shall use commercially reasonable efforts to meet changing Demand, whether an incease or decrease, in accordance with the terms herein contained; provided, however, that, during the Market Launch Phase, in the event of a Shortfall, Radius shall pay to Xxxxxx, as compensation for unused Manufacturing capacity reserved (under Purchase Orders that have not been placed but that should have been placed, in accordance with the provisions hereof), due thirty (30) calendar days after the invoice date (receipt of readily available funds by Xxxxxx), an amount equal to [*] of the net revenue that Xxxxxx would have received from the sale of the Shortfall to Radius; provided, however, Xxxxxx shall use its commercially reasonable efforts to
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
determine alternative use of the cGMP manufacturing space scheduled to be used for Radius but which becomes available due to any Shortfall, and if so successfully determined, and actually used by Xxxxxx Pharma, any payments due under this Section that are associated with such Shortfall shall be reduced by the amount of revenue generated by Xxxxxx from such alternative use (taking into account costs and/or expenses incurred by Xxxxxx, as prior thereto in good faith negotiated among the Parties, in connection with acquiring and/or transitioning to such alternative use); and, provided further, however, in no event shall any such reduction result in a refund or credit to Radius.
(c) Post-Market Launch Phase; Reduced Demand. After the Market Launch Phase, Xxxxxx shall use commercially reasonable efforts to meet changing Demand, whether an incease or decrease, in accordance with the terms herein contained; provided, however, that, in the event of a Reduced Demand, Radius shall pay to Xxxxxx, as compensation for unused Manufacturing capacity reserved (under Purchase Orders that have not been placed but that should have been placed, in accordance with the provisions hereof), due thirty (30) calendar days after the invoice date (receipt of readily available funds by Xxxxxx), an amount equal to [*] of the net revenue that Xxxxxx would have received from the sale to Radius of the Reduced Demand; provided, however, Xxxxxx shall use its commercially reasonable efforts to determine alternative use of the cGMP manufacturing space scheduled to be used for Radius but which becomes available due to any Reduced Demand, and if so successfully determined, and actually used by Xxxxxx Pharma, any payments due under this Section that are associated with such Reduced Demand shall be reduced by the amount of revenue generated by Xxxxxx from such alternative use (taking into account costs and/or expenses incurred by Xxxxxx, as prior thereto in good faith negotiated among the Parties, in connection with acquiring and/or transitioning to such alternative use); and, provided further, however, in no event shall any such reduction result in a refund or credit to Radius.
(d) Purchase Orders. On or before the fifth (5th) business day of each [*] during the term of this Agreement, Radius shall give and place with Xxxxxx, on a rolling [*] basis, Purchase Orders for at least [*], and, during the Market Launch Phase, for at least[*], of the Demand forecasted for the Flexible Period that has then-become the Fixed Period. For clarity, Purchase Orders for less than the amount described in the preceding sentence shall not result in any obligation of Radius to compensate Xxxxxx other than as set forth in Section 3.5(b) or Section 3.5(c), as applicable. Purchase Orders specifying the quantities of either the Cartridges and the Pens, or of the Finished Products, as applicable, and delivery date desired by Radius, shall be placed by Radius at least [*] prior thereto, for Cartridges and Pens, or [*] prior thereto for Finished Product, following approval of the Forecast. The Demand for the Fixed Period, if in accordance with Section 3.5, shall be deemed, subject to Section 3.5(e) below, to be ordered by a binding Purchase Order that does not need to be accepted by, and cannot be rejected by, Xxxxxx. Purchase Orders for Demand not in accordance with Section 3.5 shall be confirmed or rejected by Xxxxxx, in its sole discretion, by notice in writing to Radius within ten (10) business days of receipt of the respective Purchase Order. If a Purchase Order is provided by an authorized representative of Radius, Xxxxxx may fully rely thereon without independent investigation and such Purchase Order, if and as confirmed by Xxxxxx, shall be
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
valid for the purpose of confirming quantities and Delivery Dates of either the Cartridges and the Pens, or the Finished Products.
(e) Purchase Order Cancellations/Postponements. Should (i) Radius cancel any Purchase Order already placed with Xxxxxx by Radius, or postpone Manufacture that has been scheduled by Xxxxxx based on any Purchase Orders (or parts thereof), subject to the reduction allowance for Radius as set forth in Section 3.5, for any reason other than as set forth in Section 7.3, in Section 15.1 (Force Majeure) or Xxxxxx’x material breach of this Agreement as set forth in Section 14.3(ii); or (ii) the Radius Materials not be available for Manufacture at the Facility at least twelve (12) calendar days before the date set by Xxxxxx for certain Manufacture, then, in either of the foregoing cases, Xxxxxx shall cause its Affiliate Xxxxxx Pharma to use commercially reasonable efforts to, as the case may be, use such capacity, not used for Radius based on such cancellation of a Purchase Order, for another customer of Xxxxxx, or to reschedule, according to its capacity, in consideration of the Demand, such Manufacture postponed; provided, however, if Xxxxxx is not able to have such capacity used for another customer of Xxxxxx or to reschedule such postponed Manufacture, Xxxxxx shall invoice Radius, and Radius shall pay to Xxxxxx, due thirty (30) calendar days after the invoice date (receipt of readily available funds by Xxxxxx), compensation for unused Manufacturing capacity, according to the following chart:
Notification of cancellation or postponement occurring, prior to the scheduled Release date: | Compensation (in percent of Xxxxxx’x price per each[*], up to the [*]): |
[*] | [*] |
[*] | [*] |
[*] | [*] |
[*] | [*] |
Notification of cancellation or postponement occurring, prior to the scheduled packaging Release date: | Compensation (in percent of Xxxxxx’x price per each secondary packaging): |
[*] | [*] |
[*] | [*] |
[*] | [*] |
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
4. |
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use commercially reasonable efforts to procure and validate, especially if the Demand should be in excess of [*] Finished Products per the Fixed Period and the Flexible Period, a second (2nd) source of Xxxxxx Materials critical for the security of the supply chain (and if there should be more than one (1) supplier available for the procurement of Xxxxxx Materials, the Parties shall mutually agree on which of them to choose; provided, however, that if two (2) or more suppliers are considered equal, Xxxxxx may choose at its sole discretion). The Parties shall periodically review, and may decide on an adjustment of, the safety stock levels and storage period, at the costs and/or expenses of Radius. If Radius desires a safety stock of Xxxxxx Materials equal to a volume higher than the foregoing, Xxxxxx shall either cause third party suppliers to keep an additional rolling safety consignation stock, if feasible and available for free, or cause Xxxxxx Pharma to keep a higher volume, only against down payment by Radius which shall be refundable (or credited against amounts otherwise owed by Radius) as of winding down of such safety stock, all as separately agreed by and between the Parties in writing. Xxxxxx shall cause Xxxxxx Pharma to wind down such safety stock upon termination of this Agreement as mutually agreed with Radius. Radius shall reimburse Xxxxxx under this Section within thirty (30) calendar days of the date of Xxxxxx’x respective invoice.
4.3 Delayed Materials Supply. Radius and Xxxxxx shall each use commercially reasonable efforts to ensure that sufficient quantities of the Radius Materials (in the case of Radius) and the Xxxxxx Materials (in the case of Xxxxxx, by procuring the necessary amount, and replenishing the safety stock, under Section 4.1) are supplied to the Facility as are required to properly undertake the necessary preparations for the Services and to timely fulfill the tasks set forth herein.
(a) Delayed Radius Materials. If insufficient quantities of the Radius Materials are delivered or any insufficiency results due to the Radius Materials having been damaged or delayed in transit (or delayed due to any other circumstances prior to the delivery of same), Radius shall arrange for the timely supply of sufficient additional quantities of the relevant Radius Materials to enable Xxxxxx to meet the obligations herein. Radius shall not be in breach of this Agreement and, subject to the provisions regarding Force Majeure hereunder, a delay in meeting other relevant obligations under this Agreement shall be excused, to the extent Radius is, despite exercising commercially reasonable efforts, unable to timely procure sufficient and satisfactory supplies of the Radius Materials due to Force Majeure, and such Force Majeure has caused a failure to perform. Any delay in the Services arising from inadequate delivery of the Radius Materials (whether such delay is based on inadequacy of quality, quantity or otherwise) (herein, “delay”) shall postpone any Delivery Date requested by Radius and previously confirmed by Xxxxxx until such other date that Xxxxxx
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may reasonably determine in its sole reasonable discretion, after good faith consultation with Radius, taking into account such factors as Facility capacity and other production commitments. The Parties shall negotiate in good faith any additional charges which may arise due to rescheduling caused by a delay in delivery of Radius Materials.
(b) Delayed Xxxxxx Materials. If insufficient quantities of the Xxxxxx Materials are delivered or any insufficiency results due to the Xxxxxx Materials having been damaged or delayed in transit (or delayed due to any other circumstances prior to the delivery of same), Xxxxxx shall arrange for the timely supply of sufficient additional quantities of the relevant Xxxxxx Materials, to enable Xxxxxx to meet the obligations herein. Neither Xxxxxx nor Xxxxxx Pharma shall be in breach of this Agreement and, subject to the provisions regarding Force Majeure hereunder, a delay in meeting other relevant obligations under this Agreement shall be excused, to the extent Xxxxxx or Xxxxxx Pharma, as the case may be, is, despite exercising commercially reasonable efforts, unable to timely procure sufficient and satisfactory supplies of the Xxxxxx Materials due to Force Majeure, and such Force Majeure has caused a failure to perform. Any delay in the Services arising from inadequate delivery of the Xxxxxx Materials (whether such delay is based on inadequacy of quality, quantity or otherwise) (herein, “delay”) shall postpone any Delivery Date until such other date that Xxxxxx may reasonably determine in its sole reasonable discretion, after good faith consultation with Radius, taking into account (but, for clarity, not with respect to a delay caused by a breach of Xxxxxx under Section 4.1(a)), such factors as Facility capacity and other production commitments. The Parties shall negotiate in good faith any rescheduling caused by a delay in delivery of Xxxxxx Materials that is not caused by a breach of Xxxxxx under Section 4.1(a). The Parties shall mutually agree on any rescheduling caused by delay of Xxxxxx Materials, and Xxxxxx shall assist Radius in pursuing any rights existing against such third party supplier of the Xxxxxx Materials, as set forth in Section 4.9.
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(b) Surplus; Miscellaneous. Xxxxxx shall notify Radius in writing of any surplus of the Radius Materials and any such surplus shall, if not usable for the Manufacture, be disposed of, returned to Radius or otherwise handled, all as reasonably directed by and at the costs and/or expenses of Radius. Xxxxxx shall, and shall cause Xxxxxx Pharma to, keep the Radius Materials, the Finished Product, any intermediates and components of any Radius Materials or the Finished Product, and any work in progress, free and clear of any liens or encumbrances. Xxxxxx shall cause Xxxxxx Pharma to, at all times, take such reasonable measures as are required to protect the Radius Materials, the Finished Product, any intermediates and components of any Radius Materials or the Finished Product, the Radius Equipment, and any work in progress, from risk of loss or damage at all stages of the Manufacturing Process.
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respect to the first [*] initial Batches of Cartridges Manufactured hereunder, and any other costs and/or expenses incurred by Radius in respect thereof, and Xxxxxx shall be responsible to compensate Radius, at the API Value, for an Actual Yield less than[*], in the aggregate, in respect of such first [*] initial Batches of Cartridges Manufactured hereunder as mentioned above, and costs and/or expenses incurred in respect thereof. Once established, the Target Yield shall be reviewed and re-calculated[*], at the business review meetings of Radius and Xxxxxx, and an update thereof may be agreed by Parties from time to time through good faith negotiations, taking into account the previous year’s performance, process enhancements, improvements and changes, cGMP, SOPs and all other relevant circumstances; provided, however, that (i) the Target Yield shall never be less than[*], in the[*]; (ii) the Target Yield shall not be reviewed or re-calculated, as the case may be, but instead not apply at all, if the Manufacture of the Cartridges has been halted or interrupted for a period of [*] or more, or if, in any calendar year, less than one (1) commercial Batch has been Manufactured; (iii) Xxxxxx Pharma’s previous performance shall not be determinative and shall not by itself set any precedence for such review, good faith negotiations, and agreement. The Parties shall, after the end of each calendar year, mutually determine and agree on the total actual amount of API used in that calendar year and on the Actual Yield. To the extent that the Actual Yield is equal to, or greater than, the Target Yield, all use of API, and all costs and/or expenses incurred in respect thereof, shall be borne by Radius. If the Actual Yield should be less than the Target Yield, in the[*], Xxxxxx shall reimburse Radius for such excess use of API, multiplied by the API Value, subject to the Annual Cap. Any Defective Product that is subject to compensation according to Section 6.6 shall not be part of the yield calculation.
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4.9 Xxxxxx’x Liability for Radius Materials, Third Party Materials and/or Third Party Services. Except as otherwise expressly set forth herein and subject thereto, Xxxxxx, whether for itself and/or Xxxxxx Pharma, shall not be responsible or liable for any [*] (other than performed by Xxxxxx Pharma or[*], as referred to in Section 3.3, for which Xxxxxx shall be liable as in this Agreement provided), but Xxxxxx shall transfer, or cause to be transferred, to Radius, any warranties as received, if any, in respect of any of the foregoing, and Xxxxxx itself shall, if any such warranties should not be transferrable, enforce its agreements with such third parties, and shall otherwise assist Radius in Radius pursuing any such warranties or other remedies as may be available under such agreements between Xxxxxx and/or Xxxxxx Pharma and such third party.
(b)Maintenance. Xxxxxx shall cause Xxxxxx Pharma to, at all times, maintain the Radius Equipment, at Xxxxxx’x cost and/or expense, in accordance with all applicable cGMP, and German manufacturing guidelines, laws and regulations (and manufacturer or supplier instructions, except if in conflict with the foregoing), and Radius-approved cleaning validation processes, and consistent with German industry standards for equipment used in connection with the manufacture and supply of pharmaceutical products; provided, however, that Radius shall be responsible for (i) any individual maintenance costs and/or expenses greater than [*] Euros that is not incurred as a result of [*] of Xxxxxx or Xxxxxx Pharma, or Willful Misconduct of Xxxxxx or Xxxxxx Pharma; (ii) costs and/or expenses for replacement of the Radius Equipment (whether due to defect or at the end of its useful life following normal use, wear and tear); and (iii) any damage caused to the Radius Equipment, other than as a result of [*] of Xxxxxx or Xxxxxx Pharma, or Willful Misconduct of Xxxxxx or Xxxxxx Pharma.
(d)Ownership. Once Radius has fully paid for the Radius Equipment, Radius shall be the owner of the Radius Equipment and may (i) direct Xxxxxx to cause Xxxxxx Pharma to allow[*], as is and where is, and enable shipment of the Radius Equipment, at Radius’s costs and/or expenses, to another location or to be sent directly to Radius; and (ii) amortize the costs and/or expenses of the Radius Equipment on Radius’ books and records.
(e)Liens; Ownership; Notice. Xxxxxx shall, and shall cause Xxxxxx Pharma to, keep the Radius Equipment free and clear of any liens or encumbrances. To the extent
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Radius provides spare parts for the Radius Equipment, such spare parts shall remain the property of Radius and shall be used by Xxxxxx Pharma only for maintenance of the Radius Equipment. Xxxxxx shall without undue delay notify Radius if at any time Xxxxxx or Xxxxxx Pharma believes any Radius Equipment has been damaged, lost or stolen.
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5.2
Facility.
Facility.
(a) Performance of Services. Xxxxxx shall perform, or have performed, the Services in accordance with the terms of this Agreement, and Xxxxxx shall cause Xxxxxx Pharma to perform all Services at the Facility, provide all staff necessary to perform the Services in accordance with the terms of this Agreement, including the Quality Agreement, and hold at such Facility all Equipment, Radius Equipment, Radius Materials, Xxxxxx Materials, and other items used in the Services.
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(e)
Access to Facility. Xxxxxx shall cause Xxxxxx Pharma to permit Radius[*], and/or its duly authorized representatives to observe and consult with Xxxxxx Pharma during the performance of Services under this Agreement including, without limitation, the Manufacturing of any Batch. Such observation and consultation shall be at the costs and/or expenses of Radius, as prior thereto in good faith negotiated among the Parties, if observing ongoing Manufacturing that is not for cause and not associated with the development of the Product. Xxxxxx agrees, and shall cause Xxxxxx Pharma to agree, that Radius (and its duly authorized agents, subject to Section 10.1 and Section 10.2) shall have continuous access, during operational hours and during active Manufacturing, to inspect the Facility and Manufacturing Process to ascertain compliance by Xxxxxx Pharma with the relevant applicable terms of this Agreement and of the Quality Agreement, including, without limitation, inspection of (i) the Equipment and materials used in the performance of Services; (ii) the holding facilities for such materials and Equipment; and (iii) all Records relating to such Services and the Facility.
Access to Facility. Xxxxxx shall cause Xxxxxx Pharma to permit Radius[*], and/or its duly authorized representatives to observe and consult with Xxxxxx Pharma during the performance of Services under this Agreement including, without limitation, the Manufacturing of any Batch. Such observation and consultation shall be at the costs and/or expenses of Radius, as prior thereto in good faith negotiated among the Parties, if observing ongoing Manufacturing that is not for cause and not associated with the development of the Product. Xxxxxx agrees, and shall cause Xxxxxx Pharma to agree, that Radius (and its duly authorized agents, subject to Section 10.1 and Section 10.2) shall have continuous access, during operational hours and during active Manufacturing, to inspect the Facility and Manufacturing Process to ascertain compliance by Xxxxxx Pharma with the relevant applicable terms of this Agreement and of the Quality Agreement, including, without limitation, inspection of (i) the Equipment and materials used in the performance of Services; (ii) the holding facilities for such materials and Equipment; and (iii) all Records relating to such Services and the Facility.
(f)
Audits. Radius[*], and/or its duly authorized representatives shall, upon reasonable written notice and during normal business hours, have the right to regularly inspect (other
Audits. Radius[*], and/or its duly authorized representatives shall, upon reasonable written notice and during normal business hours, have the right to regularly inspect (other
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than for cause), [*], at no cost and/or expense to Radius, such areas of the Facility used for the Manufacture, which inspection shall not exceed the duration of [*] business days, except that such limits shall not apply in the event of any critical concern with respect of the quality of the Cartridges, the Pens or the Finished Products, or as necessary for cause. Xxxxxx agrees that Radius may include in its audit teams employees of an Affiliate of Radius, or of a[*]; provided, however, prior to any such audit with the participation of any such employee, a written agreement shall be in place protecting the confidentiality of such audit, and any such employees of an Affiliate of Radius and any [*] shall be deemed employees of Radius, including for purposes of confidentiality.
5.3
Changes to Scope of Services, Manufacturing Process and Specifications.
Changes to Scope of Services, Manufacturing Process and Specifications.
(a)
Changes to Scope of Services. If the scope of work of the Services changes, then this Agreement may be amended as provided in this Section 5.3(a). If a required modification to the scope of Services is identified by Radius or by Xxxxxx, the identifying Party shall notify the other Party in writing as soon as reasonably possible. Xxxxxx shall provide Radius with a Change Order, and shall use commercially reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order shall be effective unless and until it has been signed by authorized representatives of each of both Parties. If Radius does not approve such Change Order, then the Parties shall use commercially reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Xxxxxx and Xxxxxx Pharma shall continue to work under the existing scope of Services during any such negotiations, if such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but neither Xxxxxx nor Xxxxxx Pharma shall commence work in accordance with the Change Order until it is authorized in writing by Radius.
Changes to Scope of Services. If the scope of work of the Services changes, then this Agreement may be amended as provided in this Section 5.3(a). If a required modification to the scope of Services is identified by Radius or by Xxxxxx, the identifying Party shall notify the other Party in writing as soon as reasonably possible. Xxxxxx shall provide Radius with a Change Order, and shall use commercially reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order shall be effective unless and until it has been signed by authorized representatives of each of both Parties. If Radius does not approve such Change Order, then the Parties shall use commercially reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Xxxxxx and Xxxxxx Pharma shall continue to work under the existing scope of Services during any such negotiations, if such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but neither Xxxxxx nor Xxxxxx Pharma shall commence work in accordance with the Change Order until it is authorized in writing by Radius.
(b)
Process/Specifications Changes. Any change or modification to the Manufacturing Process or to the Specifications for the Manufacture of the Cartridges, the Pens, or the Finished Products, shall be approved in advance by Radius and shall be made in accordance with the change control provisions of the Quality Agreement.
Process/Specifications Changes. Any change or modification to the Manufacturing Process or to the Specifications for the Manufacture of the Cartridges, the Pens, or the Finished Products, shall be approved in advance by Radius and shall be made in accordance with the change control provisions of the Quality Agreement.
(c)
Applicable Law Violation. Notwithstanding anything to the contrary in this Agreement with respect to Change Orders, Xxxxxx and Xxxxxx Pharma shall not be required to continue the Services without implementation of a Change Order or to commence
Applicable Law Violation. Notwithstanding anything to the contrary in this Agreement with respect to Change Orders, Xxxxxx and Xxxxxx Pharma shall not be required to continue the Services without implementation of a Change Order or to commence
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implementation of a Change Order, either of which may be immediately discontinued without being deemed in breach of this Agreement following written notice of such intent to Radius, if Xxxxxx and Xxxxxx Pharma reasonably believe, and if Xxxxxx provides to Radius reasonable evidence, that implementation or non-implementation of such Change Order constitutes or will cause a violation of any Applicable Law.
(d)
Increased Risk Exposure. If Xxxxxx and Xxxxxx Pharma reasonably believe that implementation or non-implementation of a Change Order creates an increased risk that Xxxxxx and/or any of its Affiliates is or could be held responsible or liable for any third party claim with respect to the Product, (i) Xxxxxx shall notify Radius, and provide its reasonably detailed analysis to Radius; and (ii) Xxxxxx shall cause Xxxxxx Pharma to continue the Services as instructed by Radius; provided, however, in the event Xxxxxx Pharma proceeds, pursuant to Radius’ instruction, in the manner that creates such increased risk, Radius shall indemnify, defend and hold Xxxxxx and/or its Affiliates harmless from and against any and all Costs in connection with any actual action, suit, claim or demand brought or instituted against Xxxxxx and/or its Affiliates by a third party to the extent resulting from or arising out of such implementation or non-implementation at Radius’ instruction.
Increased Risk Exposure. If Xxxxxx and Xxxxxx Pharma reasonably believe that implementation or non-implementation of a Change Order creates an increased risk that Xxxxxx and/or any of its Affiliates is or could be held responsible or liable for any third party claim with respect to the Product, (i) Xxxxxx shall notify Radius, and provide its reasonably detailed analysis to Radius; and (ii) Xxxxxx shall cause Xxxxxx Pharma to continue the Services as instructed by Radius; provided, however, in the event Xxxxxx Pharma proceeds, pursuant to Radius’ instruction, in the manner that creates such increased risk, Radius shall indemnify, defend and hold Xxxxxx and/or its Affiliates harmless from and against any and all Costs in connection with any actual action, suit, claim or demand brought or instituted against Xxxxxx and/or its Affiliates by a third party to the extent resulting from or arising out of such implementation or non-implementation at Radius’ instruction.
(e)
Unsuccessful Discussions. In the event of such potential violation of any Applicable Law, if the Parties cannot reach mutual agreement within forty-five (45) calendar days of diligent, good faith negotiation, either Party shall have the right to terminate this Agreement, as provided in Section 14.3(iv).
Unsuccessful Discussions. In the event of such potential violation of any Applicable Law, if the Parties cannot reach mutual agreement within forty-five (45) calendar days of diligent, good faith negotiation, either Party shall have the right to terminate this Agreement, as provided in Section 14.3(iv).
(a)
Regulatory Approvals. Radius shall be responsible for obtaining, at its costs and/or expenses, all regulatory and governmental approvals and permits necessary for Radius’ commercialization, in the United States of America, Canada, Australia, New Zealand, any country of the European Union, Switzerland, Norway, Liechtenstein, Iceland and/or any Designated Country, of the Finished Product, including, without limitation, NDA submissions, and any required submissions to be filed by Radius with the appropriate Authority of a country other than the United States of America.
Regulatory Approvals. Radius shall be responsible for obtaining, at its costs and/or expenses, all regulatory and governmental approvals and permits necessary for Radius’ commercialization, in the United States of America, Canada, Australia, New Zealand, any country of the European Union, Switzerland, Norway, Liechtenstein, Iceland and/or any Designated Country, of the Finished Product, including, without limitation, NDA submissions, and any required submissions to be filed by Radius with the appropriate Authority of a country other than the United States of America.
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by Radius) necessary for any country to be a Designated Country; and (ii) Radius agrees to update Xxxxxx on any such requirements of Norway, Liechtenstein, and Iceland (for clarity, other than cGMP of Norway, Liechtenstein, and Iceland, to the extent not Product-specific). Once such working together has been completed and such necessary requirements have been mutually agreed upon, such requirements applicable to the Manufacture of the Cartridges, the Pens, or the Finished Products, intended for use by Radius in Norway, Liechtenstein, Iceland or such Designated Country, Xxxxxx shall cause Xxxxxx Pharma to Manufacture the Cartridges, the Pens, or the Finished Products in accordance with such requirements, which shall become part of the Standard, and Radius may thereafter sell, distribute or otherwise use, whether directly or indirectly, such Finished Product in Norway, Liechtenstein, Iceland or such Designated Country. Radius shall provide Xxxxxx Pharma with, included in any notice designating a country to be a Designated Country, the country specific legislation, rules and regulations and practices or requirements of the regulatory authorities and governmental bodies of such country which may affect the Manufacture and/or any Delivery Assistance, and shall inform Xxxxxx of the effect of any thereof. After good faith discussions on any of the foregoing contained in the previous sentences and mutual agreement in respect of any thereof, Xxxxxx shall thereafter comply with, and the definition of Applicable Xxxxxx Law shall thereafter be deemed to include, such requirements. For avoidance of doubt, Radius shall not be restricted from distributing Product for use in clinical trials in any country except as may be prohibited by Applicable Law.
(d)
Regulatory Inspections. Xxxxxx shall, and shall cause Xxxxxx Pharma to, permit Radius ( [*], subject to Section 10.1, Section 10.2) to the extent not prohibited by Applicable Law, to be present and participate in any inspection by any Authority of the Facility or the Manufacturing Process, to the extent any such inspection relates to the Cartridges, the Pens, or the Finished Products (and is not a general cGMP audit of the Facility, even if such general cGMP inspection also relates to the Cartridges, the Pens, or to the Finished Products); provided, however, such presence shall be limited to presence in the inspection room during the initial discussion, daily wrap-up discussions and the final discussions. Xxxxxx shall give as much advance notice as possible to Radius of any such inspection.
Regulatory Inspections. Xxxxxx shall, and shall cause Xxxxxx Pharma to, permit Radius ( [*], subject to Section 10.1, Section 10.2) to the extent not prohibited by Applicable Law, to be present and participate in any inspection by any Authority of the Facility or the Manufacturing Process, to the extent any such inspection relates to the Cartridges, the Pens, or the Finished Products (and is not a general cGMP audit of the Facility, even if such general cGMP inspection also relates to the Cartridges, the Pens, or to the Finished Products); provided, however, such presence shall be limited to presence in the inspection room during the initial discussion, daily wrap-up discussions and the final discussions. Xxxxxx shall give as much advance notice as possible to Radius of any such inspection.
(e)
Regulatory Communication. Xxxxxx shall cause Xxxxxx Pharma to provide Radius with a copy of any report or other written communication received from such Authority in connection with such inspection, and any written communication received from any Authority relating to the Product, the Facility or the Manufacturing Process (to the extent any such communication is not only generally related to cGMP, without impacting the quality of
Regulatory Communication. Xxxxxx shall cause Xxxxxx Pharma to provide Radius with a copy of any report or other written communication received from such Authority in connection with such inspection, and any written communication received from any Authority relating to the Product, the Facility or the Manufacturing Process (to the extent any such communication is not only generally related to cGMP, without impacting the quality of
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the Product), within [*] business days after receipt. The Parties shall consult each other in an effort to arrive at a mutually acceptable answer to any such communication, request or procedure for taking other appropriate action; provided, however, that nothing contained herein shall be construed as restricting the right of either Party to make a timely report of such matter to any Authority, or take other action, that it deems to be appropriate or required by any applicable law, regulation and/or the practices of any regulatory authority. Xxxxxx shall cause Xxxxxx Pharma to provide Radius with a copy of any final responses of Xxxxxx and/or Xxxxxx Pharma within [*] business days after submittal.
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respond without undue delay, but in any event within ten (10) calendar days, to any reasonable inquiry or request for a correction or change by the other Party with respect to such Batch Documentation. Radius has no obligation to Accept a Batch if such Batch was not Manufactured in accordance with the Standard; provided, however, that Xxxxxx and/or Xxxxxx Pharma shall be conclusively deemed [*] with respect to the relevant Manufacture if it can be shown, by way of the Batch Documentation, documents related to the Manufacture other than Batch documentation or samples of the Product, that the Product has been Manufactured in accordance with the Standard.
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testing laboratory or expert who will be involved in such testing/determination shall not have been employed by either Party for a period of ten (10) years prior to the Effective Date and shall have experience in the pharmaceutical industry, preferably in the field of contract manufacturing (sterile pre-filling) and the outsourcing thereof.
(b) Compensation for Radius Materials[*]. Such costs and/or expenses to be borne by Xxxxxx, as referred to under Section 6.6(a) above, shall specifically include the value of the Radius Materials used in the Manufacture of such Product, which shall only be reimbursed by Xxxxxx if such Product was not Manufactured in accordance with the Standard[*], subject to the Annual Cap.
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until such time as final disposition of rejected Batch(es) has been determined, and complete investigations have been finalized with root cause analysis and corrective actions to prevent further Batch rejections, which determinations shall be agreed to in writing by the Parties. Xxxxxx shall perform or have performed such investigations, root cause analysis and corrective actions diligently and expeditiously. Radius may request recommencement of Manufacture in writing, with and subject to assumption by Radius of all responsibility and liability for recommencement in the event of further Batch rejection for the same exact or similar reasons. For clarity, with respect to any delay or cessation of Manufacturing referred to hereunder, Radius shall be relieved of any of its obligations under Section 3.5 for the duration of any such discussion, evaluation, analysis, investigations, root cause analysis and corrective actions, under this Section 6.6(d).
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possible if unforeseen circumstances cause any such delay, in which event the Parties shall work together in good faith to address and separately agree in good faith on an alternative Delivery Date not to be delayed by more than thirty (30) calendar days, or such longer period as may be mutually agreed, to minimize such delay, such agreement not to be unreasonably withheld; provided, however, Xxxxxx may reasonably take into account such factors as Facility capacity, other production commitments and similar business factors. Upon any such inability not cured within such period of consecutive business days as set forth hereinabove or if the Parties do not reach agreement on an alternative Delivery Date, Radius may cancel, without penalty or liability under Section 3.5, all Purchase Orders accepted by Xxxxxx for any month of the Fixed Period affected by such inability, such cancellation being the sole remedy for any such delay or inability to deliver.
7.4
[*]. Finished Products and samples thereof shall be delivered [*] Facility ([*] Incoterms® 2010). Radius shall be responsible for arranging for shipment and in-time [*] of the Finished Products, using the Xxxxxx delivery management system which includes reserving [*] time slots provided by Xxxxxx. Xxxxxx shall cause Xxxxxx Pharma to store the Finished Products at the Facility, in the same way as set forth in Section 4.8(a), until the Delivery Date.
[*]. Finished Products and samples thereof shall be delivered [*] Facility ([*] Incoterms® 2010). Radius shall be responsible for arranging for shipment and in-time [*] of the Finished Products, using the Xxxxxx delivery management system which includes reserving [*] time slots provided by Xxxxxx. Xxxxxx shall cause Xxxxxx Pharma to store the Finished Products at the Facility, in the same way as set forth in Section 4.8(a), until the Delivery Date.
7.5
Product [*] Delay.
Product [*] Delay.
(a) Storage Continued. In the event of any delay in [*] following the Delivery Date established pursuant to Section 7.2, Xxxxxx shall cause Xxxxxx Pharma to warehouse such Finished Products, in accordance with the mutually agreed upon storage specifications for the Finished Product; provided, however, Xxxxxx and/or its Affiliates shall have no liability for the loss of any Finished Products stored at the Facility due to [*] delay by Radius, as long as it was stored in accordance with the mutually agreed upon storage specifications for the Finished Product set forth in Section 4.8(a), and the obligations of Xxxxxx and/or Xxxxxx Pharma under Section 4.8(e) shall not be applicable to the Finished Products stored due to any such [*] delay, except if in accordance with, and subject to, Section 7.5(c); provided, however, in the event of any such loss, Xxxxxx shall notify Radius thereof without undue delay.
(b) Storage Pricing Without Separate Agreement. If no separate agreement by the Parties should be in place with respect to storage of Finished Products at the Facility due to any such [*] delay, Radius may be invoiced by Xxxxxx for such storage within fourteen (14) calendar days of the Delivery Date, and Radius shall compensate Xxxxxx per each month of storage of the Finished Product (to be pro-rated as relevant) after such fourteen (14) calendar days’ grace period, in the amount of [*] per pallet per month; provided, however, for clarity, Xxxxxx shall not be liable for Product lost during such grace period, except in the event of Xxxxxx’x or Xxxxxx Pharma’s Willful Misconduct.
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(c) Storage Pricing Under Separate Agreement. If a separate agreement by the Parties should be in place with respect to storage of Finished Products at the Facility due to any such [*] delay, Radius shall be invoiced by Xxxxxx for such storage within fourteen (14) calendar days of the Delivery Date, and Radius shall compensate Xxxxxx per each month of storage of the Finished Products (to be pro-rated as relevant) after such fourteen (14) calendar days’ grace period, in the amount stipulated in the aforementioned separate agreement. In the event of loss of such Finished Product not timely [*] by Radius, Xxxxxx’x liability for such Product shall be as in Section 4.8(e) set forth.
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ownership of any Cartridges, Pens, and Finished Products upon Release, Acceptance, and payment therefor.
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contract manufacturing (sterile pre-filling and the outsourcing thereof); and (iv) shall decide within further thirty (30) calendar days. The Parties shall share the costs and/or expenses of the mediator, proportionally based on the outcome of the claim; provided, however, a fully unsuccessful Party (compared to its claim) shall carry the entirety of such costs and/or expenses.
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Manufacturing Improvements embodied in the Cartridges, the Pens, or the Finished Products Manufactured and supplied hereunder, all as herein contemplated and set forth.
9.3
Improvements.
Improvements.
(a) Xxxxxx Employee Inventions. Xxxxxx covenants that Xxxxxx and its Affiliates have complied, and will continue to comply, with the German Act on Employee Inventions (the “Act”). Xxxxxx shall take any and all actions to ensure that any Improvements made by employees of Xxxxxx or its Affiliates (“Xxxxxx employees”) are claimed by Xxxxxx in accordance with the Act, so that all rights to such Improvements are vested in Xxxxxx, and may be transferred or licensed to Radius (which may be transferred or sublicensed, by Radius, to its Affiliates and its sublicensees), if and as provided in and subject to this Agreement. Any costs and/or expenses associated with compliance with the provisions of the Act and any compensation that may be due to any Xxxxxx employees for such Improvements shall be paid by Xxxxxx.
(d) Manufacturing Improvements. Any Manufacturing Improvements shall be owned by Xxxxxx or any of its Affiliates, without any restrictions (subject only to the license granted to Radius in Section 9.2 above), including the right to assign, transfer and
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sublicense. Radius agrees (i) to disclose, without undue delay, to Xxxxxx any and all Manufacturing Improvements; and (ii) that any and all Manufacturing Improvements shall be the sole and exclusive property of Xxxxxx, and that any rights to such Manufacturing Improvements are hereby assigned to Xxxxxx; and (iii) that any such assignment to Xxxxxx shall be made without any compensation to Radius (for such assignment itself but, for clarity, whether Radius shall be compensated for making a Manufacturing Improvement shall be subject to good faith discussions among the Parties, in the light of such actual Manufacturing Improvement) or any Radius employee or representative thereof. Radius shall take such steps as Xxxxxx may reasonably request (at Xxxxxx’x costs and/or expenses) to vest in Xxxxxx ownership of the Manufacturing Improvements.
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(b)
Definition; Exceptions. Confidential Information of Xxxxxx includes, but is not limited to, Xxxxxx Technology and Manufacturing Improvements. Confidential Information of Radius includes, but is not limited to, Radius Technology and Radius Improvements. The obligations under this Section regarding Confidential Information shall not apply to any portion of the Confidential Information which (i) is known to the recipient at the time of disclosure (whether before or after the Effective Date) and is not subject to another confidentiality obligation to the discloser and/or any of its Affiliates at such time, as reasonably documented by recipient’s written records; (ii) after the time of disclosure becomes public knowledge through no fault of the recipient; (iii) is received from a third party having the lawful right to disclose it without obligation of confidentiality; and/or (iv) is independently developed by or on behalf of recipient without use of or reliance upon discloser’s Confidential Information.
Definition; Exceptions. Confidential Information of Xxxxxx includes, but is not limited to, Xxxxxx Technology and Manufacturing Improvements. Confidential Information of Radius includes, but is not limited to, Radius Technology and Radius Improvements. The obligations under this Section regarding Confidential Information shall not apply to any portion of the Confidential Information which (i) is known to the recipient at the time of disclosure (whether before or after the Effective Date) and is not subject to another confidentiality obligation to the discloser and/or any of its Affiliates at such time, as reasonably documented by recipient’s written records; (ii) after the time of disclosure becomes public knowledge through no fault of the recipient; (iii) is received from a third party having the lawful right to disclose it without obligation of confidentiality; and/or (iv) is independently developed by or on behalf of recipient without use of or reliance upon discloser’s Confidential Information.
(a) Limited Purpose. A Party may disclose Confidential Information of the other Party to (i) its Affiliates, and to its and their trustees/executors (if any), directors, employees, [*], in each case who have a specific need to know such Confidential Information and who are bound by obligations of confidentiality at least as restrictive as those set forth herein (it being agreed and understood that such Party shall be responsible and liable for any disclosure of such Confidential Information by any such person or entity herein mentioned); and (ii) the extent such disclosure is required to comply with any applicable law, regulation and/or the practices of any regulatory authority, order of a court of competent jurisdiction, the rules of any stock exchange or listing entity, or to defend or prosecute litigation; provided, however, the Party so intending to disclose hereunder (x) has provided prior written notice of such intended disclosure to the disclosing Party; and (y) reasonably cooperates with the disclosing Party, in its efforts to take reasonable and lawful actions to avoid or minimize the degree of such disclosure, including seeking confidential treatment of such Confidential Information; and (z) limits such disclosure to the maximum reasonable extent while in compliance with such legal requirement.
(b) [*].
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10.3
Return of Confidential Information. This Agreement does not constitute the conveyance of ownership with respect to or a license to any Confidential Information of the other Party, except as otherwise provided in this Agreement. Upon the expiration or termination of this Agreement for any reason, each Party agrees, except as otherwise provided in this Agreement, to return to the other Party all documentation or other tangible evidence or embodiment of Confidential Information belonging to the other Party and not to use such Confidential Information, unless otherwise agreed. Notwithstanding anything to the contrary contained in this Agreement with respect to the foregoing contained in this Section, one (1) archival copy may be maintained by the recipient and kept confidential in a secure location and the receiving Party will not be required to destroy any copies of such Confidential Information that are securely stored in automated electronic backups.
Return of Confidential Information. This Agreement does not constitute the conveyance of ownership with respect to or a license to any Confidential Information of the other Party, except as otherwise provided in this Agreement. Upon the expiration or termination of this Agreement for any reason, each Party agrees, except as otherwise provided in this Agreement, to return to the other Party all documentation or other tangible evidence or embodiment of Confidential Information belonging to the other Party and not to use such Confidential Information, unless otherwise agreed. Notwithstanding anything to the contrary contained in this Agreement with respect to the foregoing contained in this Section, one (1) archival copy may be maintained by the recipient and kept confidential in a secure location and the receiving Party will not be required to destroy any copies of such Confidential Information that are securely stored in automated electronic backups.
11.Covenants.
11.1
Xxxxxx’x Covenants.
Xxxxxx’x Covenants.
(a)
Xxxxxx covenants to Radius that:
Xxxxxx covenants to Radius that:
(i) it has the full power and right to enter into this Agreement, and that there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind held by other parties, private or public, that are inconsistent with the provisions of this Agreement;
(ii) the execution and delivery of this Agreement by Xxxxxx has been authorized by all requisite corporate action, and that this Agreement is and will remain a valid and binding obligation of Xxxxxx, enforceable in accordance with its terms, subject to German laws of general application relating to bankruptcy, insolvency and the relief of debtors;
(iii) the Services shall be performed with requisite care, skill and diligence, in accordance with Applicable Xxxxxx Law and the German pharmaceutical industry standards, and by individuals who are appropriately trained and qualified;
(iv) [*];
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(v) to its knowledge, the conduct and the provision of the Services will not violate any patent, trade secret or other proprietary or intellectual property rights of any third party, and that Xxxxxx shall, without undue delay, notify Radius in writing should Xxxxxx become aware of any claims asserting such violation;
(vi) Xxxxxx shall not knowingly use or incorporate any invention, discovery, technology, know-how and/or other intellectual property that is not owned by Xxxxxx or its Affiliates, or licensed by Xxxxxx or its Affiliates, for use in the performance of the Services as contemplated herein, without the prior written consent of Radius;
(vii) at the time of delivery to Radius, the Finished Product:
(x) shall have been Manufactured in accordance with the Standard;
(y) shall not be adulterated or misbranded under the FDCA or other Applicable Law;
(viii) Xxxxxx, its Affiliates, and each of their respective officers, employees and directors, as applicable, and that any person used by Xxxxxx or its Affiliates or[*], who perform Services under this Agreement:
(x) have not been debarred and are not subject to a pending debarment, and shall not use in any capacity in connection with the Services any person who has been debarred or is subject to a pending debarment pursuant to section 306 of the FDCA, 21 U.S.C. § 335a;
(y) are not disqualified by any government or regulatory agencies from performing specific services, and are not subject to a pending disqualification proceeding;
(z) have not been convicted of a criminal offense related to the provision of healthcare items or services and are not subject to any such pending action.
(b) Xxxxxx shall notify Radius without undue delay if Xxxxxx, its Affiliates, or[*], or any of their respective officers, employees or directors, as applicable, or any person used by Xxxxxx, its Affiliates, or [*]who performs Services under this Agreement, is subject to any of the foregoing set forth in Section 11.1(a)(viii), or if any action, suit, claim, investigation, or proceeding relating to the foregoing set forth in Section 11.1(a)(viii) is pending, or to the best of Xxxxxx’x knowledge, is threatened.
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11.2
Radius’ Covenants.
Radius’ Covenants.
(a)
Radius covenants to Xxxxxx that:
Radius covenants to Xxxxxx that:
(i) it has the full power and right to enter into this Agreement, and that there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind held by other parties, private or public, that are inconsistent with the provisions of this Agreement;
(ii) the execution and delivery of this Agreement by Radius has been authorized by all requisite corporate action, and that this Agreement is and will remain a valid and binding obligation of Radius, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors;
(iii) its obligations shall be performed with requisite care, skill and diligence, in accordance with Applicable Law and industry standards, and by individuals who are appropriately trained and qualified;
(iv) it has and shall continue to have written agreements with its Affiliates, [*] and third party contractors engaged by Radius to provide Radius Materials in connection with this Agreement, to effectuate the terms of this Agreement including, without limitation, Articles 9 and 10 hereof, as applicable, and that Radius shall enforce such agreements to provide Xxxxxx with the benefits thereof;
(v) to its knowledge, the conduct and the provision of its obligations will not violate any patent, trade secret or other proprietary or intellectual property rights of any third party, and that Radius shall, without undue delay, notify Xxxxxx in writing should Radius become aware of any claims asserting such violation;
(vi) Radius shall not knowingly use or incorporate any invention, discovery, technology, know-how and/or other intellectual property that is not owned by Radius or its Affiliates, or licensed by Radius or its Affiliates, for use in the performance of its obligations as contemplated herein without the prior written consent of Xxxxxx;
(vii) at the time of delivery to the Facility, the Radius Materials:
(x) shall have been manufactured in accordance with their specifications;
(y) shall not be adulterated or misbranded under the FDCA or other Applicable Law;
(viii) Radius, its Affiliates, and third party contractors engaged by Radius to provide Radius Materials in connection with this Agreement, and each of their
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respective officers, employees and directors, as applicable, and any person used by Radius, its Affiliates, and third party contractors engaged by Radius to provide Radius Materials in connection with this Agreement, or who perform obligations of Radius under this Agreement:
(x) have not been debarred and are not subject to a pending debarment, and shall not use in any capacity in connection with its obligations under this Agreement any person who has been debarred or is subject to a pending debarment pursuant to section 306 of the FDCA, 21 U.S.C. § 335a;
(y) are not disqualified by any government or regulatory agencies from performing specific services, and are not subject to a pending disqualification proceeding;
(z) have not been convicted of a criminal offense related to the provision of healthcare items or services and are not subject to any such pending action.
(b) Radius shall notify Xxxxxx without undue delay if Radius, its Affiliates, third party contractors engaged by Radius to provide Radius Materials in connection with this Agreement, or any of their respective officers, employees or directors, as applicable, or any person used by Radius, its Affiliates or third party contractors engaged by Radius to provide Radius Materials in connection with this Agreement, or who performs obligations of Radius under this Agreement, is subject to any of the foregoing set forth in Section 11.2(a)(viii), or if any action, suit, claim, investigation, or proceeding relating to the foregoing set forth in Section 11.2(a)(viii) is pending, or to the best of Radius’ knowledge, is threatened.
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(b)
Xxxxxx Compliance. Xxxxxx agrees to, and Xxxxxx shall cause its Affiliates and [*] to, conduct the business contemplated herein in a manner which does not violate applicable German anti-corruption and German anti-bribery laws and regulations, and good business ethics common in Germany. In performing the Services hereunder, Xxxxxx agrees that Xxxxxx will (and Xxxxxx shall cause its Affiliates and Xxxxxxxxxx and each of their respective officers, directors, and employees to) not offer to make, not make, not promise, not authorize and not accept any payment or give anything of value, including, without limitation, not make any bribes, or provide any gift, either directly or indirectly, to any public official or regulatory authority for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an advantage, or obtain or retain business, specifically in connection with this Agreement.
Xxxxxx Compliance. Xxxxxx agrees to, and Xxxxxx shall cause its Affiliates and [*] to, conduct the business contemplated herein in a manner which does not violate applicable German anti-corruption and German anti-bribery laws and regulations, and good business ethics common in Germany. In performing the Services hereunder, Xxxxxx agrees that Xxxxxx will (and Xxxxxx shall cause its Affiliates and Xxxxxxxxxx and each of their respective officers, directors, and employees to) not offer to make, not make, not promise, not authorize and not accept any payment or give anything of value, including, without limitation, not make any bribes, or provide any gift, either directly or indirectly, to any public official or regulatory authority for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an advantage, or obtain or retain business, specifically in connection with this Agreement.
11.4 Disclaimer of Representations and Warranties. NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL HAVE ANY LIABILITY FOR, AND NEITHER PARTY NOR ANY OF ITS AFFILIATES MAKES OR EXTENDS, ANY REPRESENTATIONS, AGREEMENTS (OR ANY COVENANTS EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT OR THE QUALITY AGREEMENT) OR ANY WARRANTIES OF ANY KIND, WHETHER EXPRESS, DIRECT OR IMPLIED, WRITTEN OR ORAL, DIRECT OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, QUALITY OR FITNESS FOR A PARTICULAR PURPOSE.
11.5 [*] Affiliates. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS AGREEMENT, IT IS EXPRESSLY AGREED BY AND BETWEEN THE PARTIES THAT [*] SHALL ASSUME ANY LIABILITY OR RESPONSIBILITY AND THAT [*] EXCLUSIVELY SHALL BE RESPONSIBLE AND LIABLE FOR THE PERFORMANCE OF ANY OF ITS AFFILIATES TO THE SAME EXTENT AS IF [*] PERFORMED OR FAILED TO PERFORM, ALL AS CONTEMPLATED OR REQUIRED HEREUNDER, AND ANY CLAIM MADE BY [*] (WHETHER ON BEHALF OF [*]ITSELF OR ITS AFFILIATES) SHALL BE MADE EXCLUSIVELY AGAINST [*] (INCLUDING IF UNDER THE QUALITY AGREEMENT AND WITH RESPECT TO ANY RIGHTS AND/OR OBLIGATIONS THEREUNDER, ALL OF WHICH SHALL BE SUBJECT TO THIS AGREEMENT, INCLUDING THOSE THAT SHALL SURVIVE THEREUNDER).
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the extent arising out of or resulting from (i) breach of this Agreement (including the Quality Agreement) by any of the Xxxxxx Indemnitees; (ii) any Xxxxxx Indemnitees’ [*] or Willful Misconduct in performing obligations under this Agreement or the Quality Agreement or in connection herewith or therewith; and/or (iii) infringement of any intellectual property of any third party under the patent or intellectual property laws of the United States of America and/or the European Union or any member state thereof by any manufacturing process owned and/or used hereunder by Xxxxxx and/or any of its Affiliates or by any Confidential Information of Xxxxxx, or by the use by Radius and/or any of its Affiliates of any thereof, in the course of performance of this Agreement; provided, however, Xxxxxx shall in good faith attempt to settle, at its costs and/or expenses, with such third party, any such infringement of any intellectual property of such third party, and prior to such settlement, Xxxxxx shall notify Radius of the conditions of such settlement by Xxxxxx with such third party, so that Radius may evaluate whether or not such settlement would in any way restrict Radius’ sale, distribution, or other use of the Product as contemplated herein, and, further provided, Xxxxxx shall only be responsible, under this sub-clause (iii), up to a maximum amount of [*] Euros, in the aggregate per each calendar year during the term of this Agreement.
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the other Party might be liable under Section 12.1 or Section 12.2, as the case may be. Subject to Section 12.4 and to the statutory rights of any insurer of either Party, the indemnifying Party shall have the sole right to defend, negotiate and/or settle such claims. The indemnified Party shall be entitled to participate in the defense of such matter and to employ counsel, at its costs and/or expenses, to assist in such defense; provided, however, that the indemnifying Party shall have final decision-making authority regarding all aspects of the defense of any claim, subject to the statutory rights of any insurer of either Party. The Party seeking indemnification shall provide the indemnifying Party with such information and assistance as the indemnifying Party may reasonably request, at the costs and/or expenses of the indemnifying Party. Each Party understands that no insurance deductible shall be credited against losses for which a Party is responsible under this Article 12.
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or any of its Affiliates whatsoever. Except as expressly set forth in this Agreement, neither Xxxxxx nor any of its Affiliates shall have any responsibility or liability vis-à-vis Radius and/or any of its Affiliates whatsoever; provided, however, the total annual aggregate liability of Xxxxxx [*], including for direct damages for product liability claims arising under or in connection with this Agreement in any given calendar year, shall be limited to five (5) million Euros, except to the extent such claims are a result of Xxxxxx’x or its Affiliates’ Willful Misconduct, fraud or a breach of the confidentiality and limited-use obligations contained herein, in any of which exception events such limitation of liability shall not apply. Neither Xxxxxx nor any of its Affiliates shall be liable to Radius or any third party for the performance or non-performance of the Pen, except for the Manufacture of the Pen by Xxxxxx Pharma in accordance with the Standard. Radius shall be responsible to include into the Specifications any instructions by Ypsomed AG for the Manufacture of the Pen.
13.1
Insurance. Following receipt by Radius of the marketing authorization for the Product, and prior to any use, including sale or distribution of the Product, Radius shall self-insure or maintain product liability insurance coverage with a reputable international insurance company, of at least forty (40) million United States Dollars per each calendar year in full force and effect throughout the term of this Agreement (and for at least five (5) years following the Completion Date for claims made coverage), which coverage shall exclude (namely not be reduced by) attorneys’ fees and/or court fees. Xxxxxx shall secure and maintain product liability insurance coverage (to the extent commercially reasonable and practicable and if otherwise, Xxxxxx shall remain responsible and liable for such following amount as set forth herein) in full force and effect, in the aggregate of [*] Euros per each calendar year throughout the term of this Agreement (and for at least five (5) years thereafter for claims made coverage), with a financially sound and reputable insurer, which coverage shall include (namely be reduced by) attorneys’ fees and/or court fees in the United States and/or Canada. Xxxxxx shall notify Radius in the event its coverage as set forth herein becomes more than fifty percent (50%) impaired as a result of claims in connection with services performed for other customers.
Insurance. Following receipt by Radius of the marketing authorization for the Product, and prior to any use, including sale or distribution of the Product, Radius shall self-insure or maintain product liability insurance coverage with a reputable international insurance company, of at least forty (40) million United States Dollars per each calendar year in full force and effect throughout the term of this Agreement (and for at least five (5) years following the Completion Date for claims made coverage), which coverage shall exclude (namely not be reduced by) attorneys’ fees and/or court fees. Xxxxxx shall secure and maintain product liability insurance coverage (to the extent commercially reasonable and practicable and if otherwise, Xxxxxx shall remain responsible and liable for such following amount as set forth herein) in full force and effect, in the aggregate of [*] Euros per each calendar year throughout the term of this Agreement (and for at least five (5) years thereafter for claims made coverage), with a financially sound and reputable insurer, which coverage shall include (namely be reduced by) attorneys’ fees and/or court fees in the United States and/or Canada. Xxxxxx shall notify Radius in the event its coverage as set forth herein becomes more than fifty percent (50%) impaired as a result of claims in connection with services performed for other customers.
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Manufacture in accordance with the Standard. In the event of any such [*] of Xxxxxx Pharma, Xxxxxx shall compensate Radius for any such costs and/or expenses, subject to the Annual Cap, up to an amount of fifty (50) thousand Euros per Recall, and in the event of any such Willful Misconduct, Xxxxxx shall compensate Radius for any such costs and/or expenses as actually incurred by Radius in connection with such Recall, and in either of such events, Section 6.6 shall apply to any recalled Finished Products.
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consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or becomes subject to involuntary proceedings under any bankruptcy or insolvency law applicable to the respective Party (which proceedings remain undismissed for ninety (90) calendar days); (ii) an allegedly breaching Party fails to start and diligently pursue the cure of a material breach of this Agreement within sixty (60) calendar days after receiving written notice from the other Party of such breach (within thirty (30) calendar days for breach of any payment obligation, as herein provided); (iii) a Force Majeure event continues to prevent performance (in whole or substantial part) of this Agreement for a period of at least ninety (90) calendar days; or (iv) the Parties fail to establish mutual agreement in accordance with Section 5.3(e).
14.5
Return of Materials/Confidential Information. Upon the Completion Date, each Party
Return of Materials/Confidential Information. Upon the Completion Date, each Party
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shall without undue delay return all Confidential Information of the other Party that it or any of its Affiliates has received as required by Section 10.3 and otherwise comply with the obligations set forth in Section 10.3. Xxxxxx shall also without undue delay cause Xxxxxx Pharma to make available for[*], as herein provided in respect of the Cartridges, the Pens, the Finished Products, all Radius Materials, Radius Equipment (as is and where is), retained samples, data, reports and other property, information and know-how in recorded form that was provided by Radius, or developed in the performance of the Services, that are owned by or licensed to Radius as herein provided.
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Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Section 15.1 and Sections 15.3 through 15.13 of this Agreement and the provisions of the Quality Agreement (to the extent set forth in the first sentence of this Section 14.8 immediately preceding this sentence) shall survive the Completion Date.
15.3
Legal Notices.
Legal Notices.
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Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Agreement below or in a subsequent notice as the recipient may specify in writing under this procedure. All notices must be given (i) by personal delivery, with receipt acknowledged; or (ii) by first class, prepaid certified or registered mail, return receipt requested; or (iii) by prepaid international express delivery service.
(b) Effective Date. Notices shall be effective upon receipt or at a later date stated in the notice.
(c) Vetter Addresses. All notices must be given, if to Xxxxxx, to:
Xxxxxx Pharma International GmbH
Xxxxxxxxxxxxxx 0
00000 Xxxxxxxxxx, Xxxxxxx
Attention: Managing Director
With copy to:
Xxxxxx Pharma-Fertigung GmbH & Co. KG
Xxxxxxxxxxxxxx 00
00000 Xxxxxxxxxx, Xxxxxxx
Attention: Head of Legal Department
(d) Radius Address. All notices must be given, if to Radius, to:
000 Xxxxxx Xxxxxx, 0xx Xxxxx
Xxxxxxx, Xxxxxxxxxxxxx 00000
Xxxxxx Xxxxxx of America
Attention: Senior Vice President & Chief Financial Officer
With a copy to: General Counsel
15.4
Assignment.
Assignment.
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Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
parties unrelated to this Agreement; (2) the Assignee or the Acquirer has the financial capacity to perform the obligations, responsibilities and liabilities of Radius existing or arising under this Agreement to be assumed by such Assignee or Acquirer under such assignment, such capacity as evidenced, where not available from publicly available sources, by Radius, or such Assignee or Acquirer in writing to Xxxxxx; and (3) the Assignee or the Acquirer agrees, in writing, to assume all of the rights, obligations, liabilities and responsibilities of Radius existing or arising under this Agreement; or (ii) to an Affiliate of Radius, subject to the following sentence. In the event of any assignment by Radius not requiring the prior written consent of Xxxxxx in accordance with and subject to the previous sentence, Xxxxxx shall continue to meet its obligations under this Agreement only if (i) Radius and any Affiliate of Radius to whom the Agreement is assigned, shall be jointly and severally liable for the performance of the obligations, liabilities and responsibilities of Radius existing or arising under this Agreement; and (ii) the Assignee, or the Acquirer, as the case may be, shall be responsible to fully compensate Xxxxxx for any Transition Compensation.
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Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
Pharma, solely with respect to the Quality Agreement). The Appendices of the Quality Agreement may be amended from time to time separately and independently of the Quality Agreement to the extent expressly provided therein.
15.12
Disputes.
Disputes.
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Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
enforcing any arbitration award by any court action, and within fifteen (15) calendar days after delivery of an initial notice of a dispute, the receiving Party shall submit to the other a written response. The notice and the response shall include a statement of that Party’s or its Affiliate’s position and a summary of arguments supporting that position, and the name and title of the executive who shall represent that Party or its Affiliate and of any other person who shall accompany the executive. Within a period not to exceed thirty (30) calendar days after delivery of the initial notice, such executives shall initially meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute. All reasonable requests for information made by a Party to the other Party shall be honored. All negotiations pursuant to this Section are confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence. If one Party fails to participate in the negotiation as agreed herein, the other Party may commence arbitration prior to the expiration of the time periods set forth above.
(b) Arbitration. If not settled as above provided, any and all disputes, whether based on tort or in contract, arising hereunder or in connection with this Agreement or the QA, including, without limitation, any dispute either concerning the validity of this Agreement, the QA, the Cartridges, the Pens, the Finished Products or the Manufacture, shall be exclusively and finally, except to the extent of a claim requesting a temporary restraining order, preliminary injunction, or permanent injunction to enforce intellectual property rights or confidentiality obligations, settled under the Rules of Conciliation and Arbitration of the International Chamber of Commerce (which shall be the sole and exclusive rules and procedures for the resolution of any such controversy, claim or dispute, and any and all applicable statutes of limitation shall be tolled while the procedures specified or referred to herein are pending) by three (3) arbitrators appointed in accordance with such Rules and who shall make their determination exclusively applying the laws of Switzerland, subject to the provisions set forth below in this Section. Two (2) arbitrators, one (1) of each of whom shall have been nominated by a Party within thirty (30) calendar days, shall have fifteen (15) calendar days to mutually appoint the third (3rd) arbitrator who shall be a lawyer of at least fifteen (15) years qualification and in good standing. If a Party should not appoint an arbitrator within thirty (30) calendar days of a written request to appoint, such Party shall be deemed having waived its right to appoint, and the International Chamber of Commerce shall appoint such arbitrator who shall agree with the arbitrator of the other Party on the third (3rd) arbitrator. If at the end of this period of fifteen (15) calendar days no decision has been made, the third (3rd) arbitrator shall be nominated according to said Rules.
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Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
of any such costs and/or expenses (including reasonable attorneys’ fees of the fully successful Party). All arbitration proceedings shall be conducted in English; provided, however, not to negate any portion of the provisions of this Section. The arbitrators shall decide the dispute in accordance with the laws of Switzerland governing this Agreement.
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Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2
IN WITNESS WHEREOF, each of the Parties caused this Agreement to be executed by its duly authorized representatives as of the Effective Date.
Waltham, Massachusetts, dated this 27th day of June (month), 2016
(signed) /s/ Xxxxxxx X. Xxxxxxxx
Name: Xxxxxxx X. Xxxxxxxx
Title: Chief Development Officer
XXXXXX PHARMA INTERNATIONAL GMBH
Ravensburg, Germany, dated this 28th day of June (month), 2016
(signed) /s/ Xxxxxxxxx Xxxxxx | (signed) /s/ Xxxxxxx X. Xxxxxxxxx |
Name: Xxxxxxxxx Xxxxxx | Name: Xxxxxxx X. Xxxxxxxxx |
Title: Direct Key Account | Title: Key Account Manager |
Management Europe
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APPENDIX A
RADIUS EQUIPMENT
The following Radius Equipment has been purchased by Xxxxxx or Xxxxxx Pharma at Radius’ costs and/or expenses:
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APPENDIX B
PRICES
Batch of [*] Cartridges | €[*]/unit |
Batch of [*] Pens | €[*]/unit |
Label and Pack of Pens [*] [*] [*] [*] [*] | €[*]/unit €[*]/unit €[*]/unit €[*]/unit €[*]/unit |
Label and Pack prices above are provided for reference only and based on representative materials, and not Radius Materials; pending completion of the process qualification runs, these prices shall be updated.
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[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.