Common use of Manufacturing and Supply Clause in Contracts

Manufacturing and Supply. (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

Manufacturing and Supply. 3.3.1 Subject to the terms and conditions of this Section 3.3, EPIZYME shall be responsible for the Manufacture and supply of Licensed Compounds and Licensed Products (aincluding the active pharmaceutical ingredients thereof) Depomed shall supply Product for use in conducting Depomed’s development activities for Product Development and Commercialization purposes by EPIZYME in the Field EPIZYME Territory and in the Territory (unless EISAI elects to undertake such Manufacture and supply as set forth in Exhibit D.Section 3.3.2) by EISAI in the EISAI Territory during the Term. (b) During 3.3.2 EISAI shall have the four-year period beginning on right, but not the Effective Date (the “Supply Period”)obligation, Depomed shall to elect to itself Manufacture and supply and package (or have Manufactured and supplied Licensed Compounds and packaged) Product pursuant Licensed Products for use for Japan-Specific Development Activities and Commercialization purposes by EISAI in the EISAI Territory during the Term upon written notice to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with EPIZYME of such election, provided that if such notice is provided after the date that is [**] prior to the projected date (as reasonably determined by EISAI) of the first filing of an NDA for a Licensed Product in the EISAI Territory, then: (i) unless otherwise agreed by the Parties, EISAI shall continue to purchase from EPIZYME its requirements of Licensed Compounds and Licensed Products for a period of [**] days after following such notice date (unless EPIZYME fails to supply such requirements of Licensed Compounds and Licensed Products as required under Section 3.3 and the Effective Date supply agreement(s) contemplated thereby); and (ii) EISAI shall reimburse EPIZYME for all EISAI Territory-specific costs and expenses incurred by EPIZYME attributable to the “Depomed Supply Agreement”) that will be freely assignable Manufacture and supply of Licensed Compounds and Licensed Products to Solvay or its AffiliatesEISAI and not recovered through transfer pricing amounts paid by EISAI to EPIZYME prior to such transition (such as, successors or assigns at by way of example, costs incurred in meeting any time. In additionregulatory requirements relating to the EISAI Territory and translation costs). 3.3.3 Upon written request by either Party, Depomed and Solvay will the Parties shall in good faith negotiate and enter into a Product clinical supply agreement pursuant to which EPIZYME would Manufacture and supply to EISAI such quantity of Licensed Compounds and Licensed Products as shall be reasonably requested by EISAI in writing in order to conduct Japan-Specific Development Activities. Such clinical supply agreement shall: (i) provide that EPIZYME shall Manufacture such Licensed Compounds and Licensed Products in accordance with business terms substantially similar cGMP and other Law in the EISAI Territory and the applicable specifications therefor, and shall deliver such Licensed Compounds and Licensed Products to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and EISAI FCA (Incoterms 2010) EPIZYME’s (or its contract manufacturer’s) manufacturing facility; (ii) provide that EISAI shall pay EPIZYME a purchase price equal to [***] for each such delivery of Licensed Compounds and Licensed Products; (iii) provide that EPIZYME shall invoice EISAI for the applicable purchase price promptly after delivery, and EISAI shall pay such invoice not later than forty-five (45) days after receipt thereof; and (iv) contain other reasonable and customary clinical supply terms, including provisions addressing forecasting and ordering, delivery, payment, acceptance and rejection procedures, regulatory assistance, warranties, indemnification, limitations of liability and quality assurance and control. 3.3.4 Subject to EISAI’s right to make the election set forth in Section 3.3.2, not later than one (1) year prior to the projected date (as reasonably determined by EISAI) of receipt of the Depomed Supply Agreement (first Regulatory Approval of a Licensed Product in the “Solvay Supply Agreement”, and, together with the Depomed Supply AgreementEISAI Territory, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable Parties shall in good faith negotiate and enter into a commercial supply agreement pursuant to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree which EPIZYME shall Manufacture and supply to supply Solvay with its requirements EISAI commercial quantities of finished, packaged Product during the Supply Period; (ii) All manufacturing Licensed Products for sale and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay distribution in the event Solvay wishes EISAI Territory. Such commercial supply agreement shall (a) provide that the purchase price for Licensed Product supplied thereunder shall be equal to qualify a backup Product manufacturer; (iv) Depomed shall [***]; ] percent (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% %) of DepomedEPIZYME’s out-of-pocket costs incurred in connection with such manufacture and supply Cost of Product to Solvay, Goods therefor and (Bb) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture contain other reasonable and customary commercial supply terms, including provisions addressing forecasting and ordering, delivery, payment, acceptance and rejection procedures, regulatory assistance, warranties, indemnification, limitations of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (liability and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);quality assurance and control.

Manufacturing and Supply. (a) Depomed During the Term, Transferee shall supply Product have the exclusive right within the Territory to Manufacture the Covered Products (and any corresponding Compound) solely for use in conducting Depomed’s development activities for Product in the Field Development and Commercialization of Covered Products in the Territory as set forth in Exhibit D.within the Field, itself or through one or more Affiliates or Permitted Transferees, or other Third Parties selected by Transferee. (b) During the four-year period beginning Company shall make its personnel that are knowledgeable on the Effective Date Manufacture of the Compounds (solely as such Manufacture relates to Covered Products in the Territory) and the Covered Product to Transferee for scientific and technical explanations, advice, and on-site support, that may reasonably be required by Transferee, relating to the manufacture of the Covered Product (“Supply PeriodManufacturing Support”). Transferee shall reimburse Company for Company’s Out-of-Pocket Expenses incurred in providing such Manufacturing Support, Depomed subject to the Company providing documented evidence of such Out-of-Pocket Expenses having been incurred and the time incurred by Company personnel in providing such support. (c) Until the First Commercial Sale of a Covered Product within the Territory, Transferee or its Affiliates or Permitted Transferees shall supply and package have the right to purchase such reasonable quantities of Compounds and/or Covered Product from Company (or have supplied purchase the right for delivery of clinical trials supplies so ordered from a Third Party contract manufacturer) as are reasonable and packagednecessary to conduct Clinical Trials of Covered Product in the Territory; provided that any such purchase does not reasonably interfere with Company having sufficient supplies of Compounds and/or Covered Products on hand for use in Development (including the conduct of Clinical Trials) Product pursuant to this Section 4.8or Commercialization outside of the Territory. Depomed Such purchases will use commercially reasonable efforts to enter into be made from Company on a long-term Product supply agreement with [***] basis. (d) Transferee and Permitted Transferees operating within the Territory shall have the sole and exclusive right during the Term to Import any and all Compounds and/or Covered Products into the Territory, and shall do so for solely for Development and Commercialization of Covered Products in the Territory. Promptly following receipt of written request from Transferee, Company, itself or through a Third Party contract manufacturer authorized by Company to manufacture and supply the Compound and Covered Products, shall within one hundred twenty (120) days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will of such request negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with Transferee to produce and supply needed quantities of Covered Product required solely for Commercialization of Covered Products in the execution Territory, on commercially fair and delivery by Depomed reasonable terms. Such Supply Agreement negotiations shall be in good faith and on an arm’s length basis, and shall provide for the commercial supply of Compound or Covered Products on a [***] of the Depomed basis. Any such Supply Agreement (shall not preclude Transferee from entering into other agreements with one or more other contract manufacturers for obtaining the “Solvay Supply Agreement”, and, together with Covered Product for Commercialization solely within the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained Territory in accordance with specificationsSection 3.5(a), cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);above.

Manufacturing and Supply. (a) Depomed During the Term and thereafter, Company shall supply Product for use in conducting Depomed’s development activities for Product have no right to Manufacture the Covered Products (or the Compound) in the Field and in the Territory as set forth in Exhibit D.Territory. (b) During Transferee shall have the four-year period beginning exclusive right within the Territory to Manufacture the Covered Products (and any corresponding Compound) solely for Development and Commercialization in the Territory within the Field, itself or through one or more Affiliates or Permitted Transferees, or other Third Parties located in the Territory selected by Transferee. (c) Until the First Commercial Sale of a Covered Product within the Territory, Transferee and any Permitted Transferee shall have the right to purchase supplies of Compound and/or Covered Product from Company as are reasonably available to Company and as are reasonable and necessary to conduct Clinical Trials of Covered Product in the Territory within the Field, provided that any such purchase does not reasonably interfere with Company having sufficient supplies of Compound and/or Covered Products on hand for use in Development (including the Effective Date (conduct of Clinical Trials) or Commercialization outside of the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8Territory. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that Such purchases will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into made on a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s outcost-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvayplus basis, not to exceed FTE Charges [XXXXXXXXX] above Company’s reasonable documented cost, to be negotiated in good faith by the Parties. The Parties shall enter into the Supply Agreement to supply Compound and/or Covered Product for Development in the Territory within sixty (60) calendar days from the Transferee’s request. Delivery terms specified in the Supply Agreement shall be construed in accordance with Incoterms 2010. (d) At least thirty six (36) months prior to the planned First Commercial Sale by the Transferee of a Covered Product in the Territory, the Parties shall negotiate in good faith a Supply Agreement pursuant to which Company, itself or through a Third Party contract manufacturer authorized by Company to manufacture and supply the Covered Products, shall supply needed quantities of Covered Product to Transferee and Permitted Transferees solely for Commercialization of Covered Products in the Field in the Territory, on commercially fair and reasonable terms. Such Supply Agreement negotiations shall be in good faith and on an aggregate arm’s length basis. Such purchases will be made on a cost-plus basis, not to exceed [XXXXXXXXX] above Company’s reasonable documented cost, to be negotiated in good faith by the Parties. In the event the Parties are unable to agree on pricing under the Supply Agreement, they shall engage an internationally recognized consulting firm reasonably acceptable to both Parties to perform an analysis to determine final pricing under the Supply Agreement, which decision shall be binding upon the Parties. Delivery terms specified in the Supply Agreement shall be construed in accordance with Incoterms 2010. (e) In the event that (i) the parties are unable to reach a reasonably acceptable Supply Agreement pursuant to Section 3.5(c) or 3.5(d) of this Agreement, or (ii) Company is unable to supply [***XXXXXXXXX] during any given REPRESENTS CONFIDENTIAL MATERIAL WHICH HAS BEEN REDACTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT IN ACCORDANCE WITH RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. A COMPLETE VERSION OF THIS SCHEDULE HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. the Compound or Covered Products to the Transferee under a Supply Agreement entered into pursuant to Section 3.5(c) or 3.5(d) of this Agreement for a period of at least sixty (60) calendar quarter days after the specified delivery date and Company thereafter fails to cure such failure within sixty (60) days after written notice from the Transferee, Company shall cooperate with the Transferee to identify a mutually acceptable alternative source of supply and Depomed shall provide the necessary consents to Solvay periodic reports detailing allow such alternative source of supply to provide the FTE Charges for which Solvay must pay Depomed hereunder);needed quantities of the Compound and/or the Covered Products to NovaMedica. The terms of the alternative source of supply would be negotiated directly by the Transferee with the supplier.

Manufacturing and Supply. (a) Depomed The LICENSEE shall supply Product for use in conducting Depomed’s development activities for Product purchase the PRODUCT(S) exclusively from KREUSSLER. b) By the end of every month following the REGISTRATION of the PRODUCT(S) in the Field TERRITORY, the LICENSEE will specify its demand for the coming twelve (12) months of each PRODUCT by mentioning quantities and desired delivery dates for the PRODUCT (“ROLLING FORECAST”). c) With each ROLLING FORECAST submitted to KREUSSLER, the LICENSEE shall submit monthly binding purchase orders to cover one hundred percent (100%) of the PRODUCT UNIT(S) included in such ROLLING FORECAST for the seventh month, the delivery period not being less than six (6) months from the date of the binding purchase order, unless otherwise agreed by KREUSSLER (Example: By the end of the month “zero” on December 31 the LICENSEE must place a binding order for the month July). With each ROLLING FORECAST, LICENSEE, at its discretion, may also place binding purchase orders for periods after the seventh month of the ROLLING FORECAST and the delivery period for those orders will be as specified by LICENSEE in the Territory purchase order (so long as set forth in Exhibit D.the delivery period is not less than six (6) months from the date of the purchase order unless otherwise agreed to by KREUSSLER). PRODUCT UNIT(S) forecast for the periods of the eight to twelfth month of the ROLLING FORECAST, for which no binding purchase order has been submitted according to the previous sentence, shall be non-binding. d) Each binding purchase order may (bonce per purchase order) During be increased by the four-year period beginning on LICENSEE by up to [****] prior written notice. KREUSSLER shall not be obligated to supply any such excess above the Effective Date (the “Supply Period”)[****], Depomed however, KREUSSLER shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use its commercially reasonable efforts to enter into a long-term Product supply agreement such excess. e) With the same purchase order according to Article VII (c), the LICENSEE shall confirm the exact delivery dates for this period mentioned in the ROLLING FORECAST and duly correct them, if necessary. The order becomes binding for KREUSSLER when accepted in writing. KREUSSLER shall only be obliged to supply PRODUCT(S) to the LICENSEE if full payment for all prior quantities of PRODUCT(S) supplied from KREUSSLER to the LICENSEE has been received by KREUSSLER in accordance with [this AGREEMENT. ***] days after * Certain information on this page has been omitted and filed separately with the Effective Date (Securities and Exchange Commission. Confidential treatment has been requested with respect to the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any timeomitted portions. In additioneach calendar year during the term of this AGREEMENT following Year 3, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar KREUSSLER shall not be obliged to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and produce more than [****] of the Depomed Supply Agreement (quantity of the total PRODUCT(S) produced by KREUSSLER in the preceding calendar year, provided, however, KREUSSLER will use best faith efforts to meet such increased demand. f) For the purposes of this AGREEMENT “Solvay Supply AgreementYears” are defined as calendar years following commercial launch of the PRODUCT(S). Should the commercial launch of a PRODUCT take place on or after July 1 of a calendar year, for reasons of practicability the remaining part of such calendar year shall be regarded as “Year 0”; until December 31 of this “Year 0”, andthe minimum annual purchase obligation shall be the pro rata temporis-amount calculated on the basis of the minimum annual purchase obligation from Year 1 as set forth in Annex II. Should the launch of a PRODUCT take place before July 1 of a calendar year, together such calendar year shall be regarded as “Year 1” and the minimum annual purchase obligations for this Year 1 as set forth in Annex II shall remain unchanged. g) The LICENSEE guarantees to purchase the minimum UNITS of the PRODUCT(S) in each Year as defined in Annex II. h) If the parties agree to a change in packaging of the PRODUCT(S) that effects the quantity of PRODUCT in a UNIT as of the EFFECTIVE DATE, the parties will agree on a mechanism to proportionally amend the minimum annual purchase amount defined in Annex II. i) KREUSSLER shall agree to the minimum UNITS for each Year after Year 4 with the Depomed Supply AgreementLICENSEE. The calculation after Year 4 shall be made ninety (90) days prior to the beginning of each consecutive Year and shall take into account the sales during the current and previous calendar year. If no agreement is reached as to the minimum quantity target within that ninety (90) day period, the “Supply Agreements”). The Supply Agreements will, together, contain LICENSEE shall increase the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall previous minimum annual purchase amount by [***]; *] for each consecutive Year. If the minimum annual purchase amount in a calendar year for a PRODUCT is not met, KREUSSLER may at its discretion either (vi) Solvay will pay Depomed terminate the following amounts in connection with all activities performed AGREEMENT for the respective PRODUCT by or on behalf of Depomed associated with Product manufacture and supply (other giving not less than activities specified on Exhibit D) (A) [***]% *] months written notice, unless LICENSEE has cured, or has initiated steps to cure, such breach within [****] months after the end of Depomed’s out-of-pocket costs incurred the previous calendar year, or (ii) ask the LICENSEE to pay to KREUSSLER within thirty (30) days after the end of each calendar year the difference between the purchase price of the quantities of PRODUCT actually purchased by the LICENSEE from KREUSSLER in connection with the preceding calendar year and the aggregated purchase price for the quantities of PRODUCT calculated on the basis of the minimum annual purchase volume for such manufacture and calendar year. j) The LICENSEE shall permanently keep a stock of an approximate [****] months supply of Product to Solvay, PRODUCT(S). **** Certain information on this page has been omitted and (B) a labor charge equal filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the FTE Charges for all Depomed employees allocated to the manufacture and omitted portions. k) KREUSSLER shall permanently keep a stock of an approximate [****] months supply of Product PRODUCT(S), of which up to Solvay, not [****] may be stored as semi-finished product (naked ampoules). KREUSSLER shall use commercially reasonable efforts to exceed FTE Charges for an aggregate maintain a minimum stock of [****] sufficient to produce [****] months of PRODUCT(S), calculated as [****] the latest ROLLING FORECAST. l) KREUSSLER will ensure the manufacture of the PRODUCT(S) in accordance with the then-current i) products specifications agreed to by the FDA as contained in Annex IV (the “PRODUCT SPECIFICATIONS”), ii) applicable regulations relating to current Good Manufacturing Practices (“cGMP”), quality system regulations of the FDA (“QSR”), including but not limited to master batch records, and iii) other pertinent rules and regulations of the REGULATORY AUTHORITY that has approved the sale of the PRODUCT(S) in the TERRITORY (in such case (iii) the LICENSEE will inform KREUSSLER in time of such rules and regulations). KREUSSLER shall include written evidence of compliance with the criteria set forth in the preceding sentence (Certificate of Analysis) in each order delivered to the LICENSEE. During the term of this AGREEMENT, KREUSSLER will maintain, or cause to be maintained at its contract manufacturer(s), the PRODUCT(S) manufacturing facility’s registration as a certified drug manufacturing facility with all applicable REGULATORY AUTHORITIES or cause such facility to be maintained such that the facility would pass an audit for compliance with cGMP and QSR. KREUSSLER shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this AGREEMENT, the LICENSEE’s standard requirements for approval as a vendor as described in the LICENSEE’s quality system review policy, and KREUSSLER’s standard quality assurance policies. For one year beyond the shelf life of each PRODUCT(S) UNIT delivered to the LICENSEE, or such longer period as may be required by cGMP and other applicable rules and regulations of any REGULATORY AUTHORITY in the TERRITORY upon prior information by the LICENSEE, KREUSSLER shall maintain traceability for each lot of PRODUCT(S) UNIT including the manufacturing date and lot number of each PRODUCT(S) UNIT and each component and material comprising each PRODUCT(S) UNIT and provide the LICENSEE a copy of such records upon the LICENSEE’s written request. m) The LICENSEE shall have the right to have its representatives present at the plant or plants at which PRODUCT(S) are manufactured during normal business hours to conduct an initial and periodic inspections of such facilities and manufacturing procedures for compliance with cGMP and QSR, the PRODUCT **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. SPECIFICATIONS and to inspect KREUSSLER’S inventory of PRODUCT(S), work-in-process, raw materials to be used for PRODUCT(S), production records, design history file, quality manuals, regulatory dossiers, and such other matters as may be pertinent to ensure proper quality assurance of PRODUCT(S) to be delivered hereunder; it being understood that the parties do not expect more than one inspection (up to 2 days) every second year, unless required by KREUSSLER’S or its AFFILIATE’S compliance status. The LICENSEE agrees to give KREUSSLER a minimum of twenty (20) business days’ prior notice of any given such inspection. KREUSSLER shall promptly use its best efforts to take such action as is required to correct any deficiencies identified by the LICENSEE and accepted by KREUSSLER relating to the production of PRODUCT(S). KREUSSLER further agrees to use its best efforts to provide such documentation or conduct such analyses as the LICENSEE may reasonably request in connection with any regulatory submission or audit. At the LICENSEE’S reasonable request, KREUSSLER will perform a quality system assessment of the vendors who provide KREUSSLER with raw components/materials, sub-assemblies or contract services in connection with the PRODUCT(S) and KREUSSLER shall promptly notify the LICENSEE of the results of such assessments. n) Without prejudice to the provisions set forth in Annex III, each party shall notify the other as soon as possible, but in no case later than fifteen (15) calendar quarter days by fax, with confirming notice via overnight delivery, as soon as it becomes aware of any critical or severe quality issue with PRODUCT(S) or their testing, manufacture, labeling, or packaging, occurring within the TERRITORY or, in so far as the PRODUCT(S) in the TERRITORY might be affected, outside of the TERRITORY, including any critical or severe quality issue relating to regulatory compliance, safety or efficacy of PRODUCT(S) . A quality issue shall be deemed to be “critical” or “severe” if it could reasonably be expected to affect the PRODUCT(S), in a way that it may potentially cause i) either severe health damage, such as: wrong product (declaration and Depomed content do not correspond, microbial contamination of sterile injectable product(s), chemical contamination with severe medical consequences, mix-ups of other products to significant extent, or ii) illness or mistreatment, such as false or missing product information, false or missing texts, insufficient closure with severe medical consequences. Without limiting the generality of the foregoing, each party will notify the other as soon as possible, but in no case later than fifteen (15) calendar days if it becomes aware of any regulatory inspections or other communications with REGULATORY AUTHORITIES related to the PRODUCT(S) that would materially impact the PRODUCT(S) or the party’s performance of its responsibilities hereunder. o) All PRODUCT(S) delivered by KREUSSLER hereunder shall provide be in full compliance with PRODUCT SPECIFICATIONS as described in Annex IV, shall have a minimum of [****] year shelf-life, shall be labeled specifically for the LICENSEE, and shall be ready for end-user sale, including all packaging, labeling, and instructions-for-use, as agreed between the parties always provided KREUSSLER has consented to Solvay periodic reports detailing such packaging, labeling, instructions-for-use and other characteristics in writing in advance, which consent shall not be unreasonably withheld, and further provided all such characteristics are in accordance with any applicable regulatory requirements. The LICENSEE will develop and implement packaging and labeling for PRODUCT(S), subject to applicable regulatory requirements and consent of KREUSSLER. Unless otherwise required by applicable regulatory requirements, changes to the FTE Charges packaging and labeling for which Solvay must pay Depomed hereundera particular PRODUCT may only be proposed from the LICENSEE to KREUSSLER in intervals greater than six (6) months. KREUSSLER shall ensure that all PRODUCT(S) shall be labeled in accordance with the procedures specified from time to time by the LICENSEE and the LICENSEE shall have final approval over the production (printing) of all secondary packaging and labeling material for PRODUCT(S);, except for the consent provided for in the immediately preceding sentence.

Manufacturing and Supply. (a) Depomed The LICENSOR shall supply continue to use Commercially Reasonable Efforts, at its own cost, to conduct the drug substance and drug product Development for the Existing Product for use the Initial Indications up to and until production scale in conducting Depomed’s development activities for Product in accordance with the Field and in the Territory as set forth in Exhibit D.Technical Development Plan. (b) During Subject to anything stated to the four-year period beginning on contrary, and subject to paragraph (a) in particular, the Manufacturing of Licensed Compound and Licensed Products for the exploitation of the License shall be the right and responsibility of LICENSEE at its own cost. (c) Promptly after the Effective Date Date, the Parties will start discussions and good faith negotiations to consider and contemplate the execution of a supply agreement regulating the details of Manufacturing of Licensed Compound and Licensed Products by LICENSOR or jointly by the Parties until the transfer of Manufacturing responsibility to either LICENSEE or CMOs under LICENSEE’s control (the “Supply Period”Agreement). The Parties shall execute such Supply Agreement if and to the extent the Manufacturing of Licensed Compound and Licensed Products by LICENSOR will best contribute to a technically and commercially successful exploitation of the License to the commercial benefit of both Parties. In such case, Depomed shall supply the Supply Agreement must be finally agreed and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with executed by no later than [****] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [****]) days prior to the first marketing authorization application for a Licensed Product in an Initial Indication submission in the USA or EU. (d) Notwithstanding the immediately foregoing, the Parties shall use Commercially Reasonable Efforts to agree, within [****] ([****]) days of the Depomed Supply Agreement Effective Date, on a Manufacturing strategy (the “Solvay Supply Agreement”including subsequent updates thereof) encompassing, and, together with the Depomed Supply Agreementwithout limitation, the “Supply Agreements”). The Supply Agreements willfollowing matters, together, contain such discussions and agreement to be conducted and achieved in the following provisions (among others mutually agreeable to the Parties):JTSC: (i) Under To assure that all CMC related work and contributions by LICENSOR are conducted and completed in time so as to permit Parties to apply for and obtain regulatory approvals for Licensed Products in the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply PeriodInitial Indications; (ii) All manufacturing To assure that the contributions of both Parties meet all quality and records will be performed safety related requirements for Licensed Products to obtain regulatory approvals and maintained reimbursement by local health insurance schemes in accordance with specifications, cGMP and Applicable Lawthe Licensed Territory; (iii) Depomed will provide reasonable assistance to Solvay To assure that the Manufacturing of Licensed Products meet the quantity and quality requirements in accordance with LICENSEE’s business plans for the event Solvay wishes to qualify a backup Product manufacturerexploitation of Licensed Products under the License; (iv) Depomed shall [***]To assure LICENSOR’s Manufacturing activities until the transfer of the Manufacturing responsibility to either LICENSEE or CMOs under LICENSEE’s control; (v) Solvay will pay Depomed To assure the following amounts transfer of LICENSOR’s documented Know-How within the LICENSOR Product Technology to LICENSEE or CMOs controlled by LICENSEE in connection with all activities performed case of a transfer of Manufacturing responsibilities to such recipients; (vi) To define the requirements for selection and contracting of CMOs; (vii) To assure the potential involvement of LICENSEE or its CMOs in the Manufacturing of the Licensed Product for sales by LICENSOR or on behalf its Affiliates or sub-licensees outside the Licensed Territory; and (viii) any other matter reasonably necessary or helpful to permit and facilitate best in class, professional and cost-effective Manufacturing of Depomed associated with Licensed Products in the Licensed Territory throughout the Term. (e) In each case, LICENSEE shall be given full and unlimited access to the LICENSOR Product manufacture Technology that is reasonably necessary or helpful to conduct or, as the case may be, supervise and supply (other than activities specified on Exhibit D) (A) direct the Manufacturing of Licensed Compound and Licensed Products. [****] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED]% of Depomed’s out-of-pocket costs incurred (f) In case either Party will supply products to the other, the supplies will be subject to either the Supply Agreement or, in connection with such manufacture case no Supply Agreement being executed, to customary and mutually agreed supply of Product agreement terms to Solvaybe agreed by the Parties, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of supplies shall be provided at [****] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);.

Manufacturing and Supply. 5.1 KNC agrees that during the QuickCat Manufacturing Period with respect to the QuickCat Products and during the SC/TC Manufacturing Period with respect to the SafeCross Products and the ThromCat Products, it will: (a) Depomed shall manufacture and supply Product Spectranetics with Spectranetics’ requirements for use the Products in conducting Depomed’s development activities for Product accordance with this Agreement, including manufacturing sufficient quantities of the Products in order to meet the Field Commitment and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term have Product units available for delivery to meet unanticipated spikes in demand for Products up to fifteen percent (15%) in excess of Commitment; (b) supply agreement Spectranetics with [Products that (i) are free from any material defect in manufacture when used under conditions of normal and proper use; (ii) conform to, and perform in all material respects in accordance with, the specifications provided on Schedule A hereto (the “Specifications”); (iii) are not adulterated or misbranded within the meaning of the U.S. Food, Drug and Cosmetic Act; (iv) comply with all applicable Laws, including the FDA Quality System Regulation, ISO 13485:2003 and any compliance updates to such Laws made during the ***] days **Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission. applicable Manufacturing Period; and (v) comply with all applicable industry standards (such as by way of example only, EN, ISO, IEC, AAMI, UL, etc.) that are used to maintain a compliant quality system and obtain regulatory approvals, including without limitation standards for labeling, packaging, biocompatibility, sterilization, manufacturing environment, mechanical attributes and electrical attributes, as such applicable standards may be revised over time. KNC agrees that the foregoing applies to all industry standards of jurisdictions where KNC is selling the Products as of the Effective Date, and the parties agree to consult in advance regarding the application of Laws and Standards to any new jurisdiction where Spectranetics may in future elect to sell the Products in order to assess the cost and feasibility of any such change order to ensure that the parties comply with all applicable Laws and standards for such jurisdiction. (c) provide packaged Product, including labeling and package inserts, in accordance with the prior written instructions or specifications of Spectranetics; (d) not sell or otherwise transfer the Product to any Person, other than as directed by Spectranetics; and (e) ship Product in accordance with Section 9 hereof, which shipment shall be made at Spectranetics’ expense and risk of loss. 5.2 Spectranetics agrees that during the QuickCat Manufacturing Period with respect to the QuickCat Products and during the SC/TC Manufacturing Period with respect to the SafeCross Products and the ThromCat Products, it will: (a) use its commercially reasonable efforts to sell the Products; (b) subject to Section 14.1(b)(4), exclusively purchase all of its requirements for the Products from KNC; (c) design and provide to KNC the appropriate instructions for use, together with all advertising, promoting and marketing aids, if any, to be packaged with Product; (d) be solely responsible for the cost of any Product redesign it requests and approves which impacts Product or materials already manufactured, or obsoleted thereby, after the Effective Date, (e.g., specifications, artwork, labeling, configurations, packaging). Spectranetics will provide at its expense, or reimburse KNC for, any inventory requirements of materials purchased for the purpose of fulfilling the next three (3) months of the existing Annual Forecast but made obsolete as a result of such changes as well as any longer lead time components that KNC had to purchase in *****Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission. advance to meet its Commitment supply obligations where use of such components has been rendered obsolete by the design change. Notwithstanding the foregoing provisions, the Product prices will not change as a result of the Product changes specified as of the Effective Date in the Development Agreement; (e) provide KNC with non-binding rolling twelve (12) month forecasts (“Annual Forecasts”) and ninety (90) day forecasts (“Quarterly Forecasts”) of Spectranetics’s requirements of Product (collectively, “Rolling Forecasts”). Such Rolling Forecasts shall be prepared in good faith and provided initially on the Effective Date of this Agreement and each month thereafter, no less than thirty (30) days prior to the beginning of the first month covered by the Rolling Forecast. The first three (3) months of the Rolling Forecast shall be consistent with firm blanket purchase orders (the “Depomed Supply AgreementCommitment”) that will to purchase Products, which blanket purchase order shall be freely assignable to Solvay or its Affiliatesin the form attached as Schedule B hereto (each, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply AgreementsBlanket Purchase Order”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (iif) All manufacturing issue, from time to time, as shipping order (in written or electronic form) against the Commitment, which shall be in the form attached as Schedule C hereto (each, a “Shipping Order”) or such other written or electronic form as may be agreed upon by the parties from time to time, and records will which shall (subject to Section 9 hereof) include the ship-to location, shipping date, Product and quantity to be performed and maintained in accordance with specifications, cGMP and Applicable Law;shipped; and (iiig) Depomed will provide reasonable assistance to Solvay except as otherwise provided in this Agreement, pay the event Solvay wishes to qualify a backup actual documented cost of shipping Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges be responsible for all Depomed employees allocated insurance, custom charges and taxes related to shipping and the manufacture and supply distribution of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);Product.

Manufacturing and Supply. 6.1 The parties shall use Commercially Reasonable Efforts to execute (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with within [***] days after the Effective Date Date, a separate written supply agreement for the supply by ANTHERA to ZENYAKU of clinical supplies of Compound and/or Product (the “Depomed Clinical Supply Agreement”), and (b) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and within [***] prior to the anticipated date of completion of enrollment in the Depomed Supply Agreement first Phase 3 Trial of Product that will be used to submit the first B.L.A. for Product, a separate written supply agreement for the supply by ANTHERA to ZENYAKU of commercial supplies of Compound and/or Product, which may at ZENYAKU’s option be supplied in bulk and/or filled and finished forms (the “Solvay Commercial Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Clinical Supply Agreements will, together, contain Agreement and the following provisions (among others mutually agreeable to Commercial Supply Agreement together are the Parties): (i) Under the Solvay “Product Supply Agreement, Depomed will agree .” The terms of the Product Supply Agreement shall be consistent with this Article 6 and shall provide for ANTHERA to supply Solvay with its ZENYAKU’s requirements of finishedCompound and Product on terms consistent with this Agreement, packaged including Article 6. 6.2 The Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed Agreement will provide reasonable assistance to Solvay that the supply price of Compound and Product supplied for use in clinical and registration activities in the event Solvay wishes to qualify a backup ZENYAKU Territory will equal ANTHERA’s Cost of Goods, and that the supply price of Compound and Product manufacturer; for commercial sale shall be the sum of (iva) Depomed shall ANTHERA’s Cost of Goods plus [***]; ] and (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (Ab) [***]% ] (together, “Commercial Transfer Price”). During the term of Depomedthe Product Supply Agreement, no more frequently than annually, the parties shall discuss whether to implement any changes to the supply price of Compound and Product as a result of any change in circumstances, including any reductions to NHI (National Health Insurance) price listing in Japan, net of the amount of Japanese consumption tax upon Product sale (net of such tax, the “NHI Pharmaceutical Product Price”), and including currency fluctuation, to the extent such reductions or fluctuations may adversely affect ZENYAKU’s out-of-pocket costs incurred margin on sales of Product in connection the ZENYAKU Territory. Without limiting the foregoing, the parties shall collaborate to identify alternative suppliers for the manufacture of Compounds and Product, including bulk and finished Product, with the purpose of reducing the supply price of such Compounds and Products. Notwithstanding anything express or implied: (a) The Product Supply Agreement shall include a right for ZENYAKU to practice its Manufacturing License granted under Section 2.1 to, or engage a Third Party to, (a) manufacture Compound or Product in the event ANTHERA fails to or will fail to timely supply ZENYAKU in accordance with the then current Joint Development Plan or otherwise fails to supply in accordance with the Product Supply Agreement, and (b) manufacture finished Product in the event that ANTHERA’s supply of Product under such Product Supply Agreement is in the form of Compound or bulk Product. The Product Supply Agreement shall contain other commercially reasonable terms and conditions to Solvaybe negotiated in good faith by the parties. If ANTHERA becomes aware that it is reasonably likely that ANTHERA will fail to timely supply ZENYAKU, ANTHERA shall promptly notify ZENYAKU in writing and the parties will reasonably cooperate regarding any reasonable measures that can be taken to avoid supply interruption to ZENYAKU; and (Bb) a labor charge equal to the FTE Charges The Clinical Supply Agreement and Commercial Supply Agreement shall each contain supply and ordering timelines and terms that are reasonable and customary for all Depomed employees allocated to the manufacture clinical supply and supply of Product to Solvaycommercial supply, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);respectively.

Manufacturing and Supply. 5.1 The Antidote supplied by TAb to Searxx xxxll be manufactured in compliance with (i) current Good Manufacturing Practices as promulgated by the FDA ("GMPs"), (ii) specifications developed by TAb and agreed to by Searxx (xxe "Specifications") to be attached hereto as Schedule 5.1 after review by applicable Regulatory Authorities, and (iii) the Regulatory Approvals. The Antidote will be manufactured, packaged, and labeled entirely by TAb and/or a third party designated by TAb, to which Searxx xxx no reasonable objection. 5.2 TAb shall have the exclusive supply rights to supply Searxx xxx all of its affiliates and marketing collaborators with any and all * Antibodies used by Searxx xx an antidote for the Material; provided, however, that if TAb is unable to fill an order made pursuant to Section 10.2 or Section 10.4 within six (6) months of the Agreed Delivery Date, Searxx xxxll have the right to terminate the exclusive supply rights by written notice unless TAb provides a commercially reasonable explanation for the delay and a proposal to resolve the shortfall in supply for Searxx'x xxxsent, which shall not be unreasonably withheld. 5.3 TAb shall provide Searxx xxxh regular updates with respect to production capacity for the Antidote so that the Parties may make good faith efforts to avoid or mitigate shortages in supply of Antidote and may encourage prompt or early delivery of the Antidote. Price adjustments for delivery of orders at times other than Agreed Delivery Dates shall be as follows: (a) Depomed In the event that TAb fails to fill an order made pursuant to Section 10.2 or Section 10.4 by the Agreed Delivery Date, then Searxx xxx give notice of such shortfall in supply to TAb. If TAb does not cover the shortfall in supply of the Antidote within thirty (30) days from the date of receipt of the notice (a "Notice of Supply Interruption"), then the Supply Price for the amount of the shortfall shall supply Product be reduced by * . The Supply Price for use in conducting Depomed’s development activities the amount of any respective shortfall for Product in the Field and in the Territory as set forth in Exhibit D.such order shall thereafter be reduced by an additional * per month, subject to a maximum price reduction of * after six (6) months. (b) During If, upon Searxx'x xxxuest, TAb fills an order for Antidote more than thirty (30) days and less than sixty (60) days before the four-year period beginning on the Effective Date delivery date agreed upon pursuant to Section 10.2 or Section 10.4 (the “Supply Period”"Agreed Delivery Date"), Depomed then the Supply Price for the amount of Antidote delivered early shall supply and package be increased by * . If, upon Searxx'x xxxuest, TAb fills an order sixty (60) or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] more days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar prior to the Depomed Agreed Delivery Date, then TAb may increase the Supply Agreement concurrently with Price for the execution and delivery by Depomed and [***] amount of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): Antidote delivered early at a rate of * for each month occurring between (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; actual delivery date and (ii) All the date that is sixty (60) days before the Agreed Delivery Date, subject to a maximum price increase of * for delivery more than six (6) months prior to the Agreed Delivery Date. * Confidential treatment requested. Omitted material filed separately. 5.4 In the event that TAb's exclusive supply rights are terminated pursuant to Section 5.2, Searxx xxx its designated third party supplier are hereby granted the right and license to manufacture the Antidote and use the Documentation, Proprietary Rights, Regulatory Approvals, Results, and Trade Secrets in connection therewith during the term hereof, subject to Sections 13.3, 15.1 and 18 of this Agreement; provided, that such right and license shall not be granted if: (a) TAb has delivered more than fifty percent (50%) of the amount of Antidote ordered in the partially unfilled Purchase Order and has provided reasonable assurance that the balance of the order will be delivered without undue delay; and (b) TAb has undertaken efforts to cure the shortage in supply which are reasonably satisfactory to Searxx. After Searxx xx a third party supplier has been granted a license to manufacture the Antidote, should TAb reasonably demonstrate to Searxx XXx's ability to discharge and fulfill its production and supply obligations hereunder, the license to manufacture and all rights granted in connection therewith shall revert to TAb. TAb and Searxx xxxll take any and all actions, and execute and deliver such documents and communications, as may be necessary to implement and effect the foregoing. In the event that Searxx xx a third party supplier exercise the right and license to manufacture the Antidote, (i) all of Searxx'x xxxigations hereunder, including, without limitation, payment obligations pursuant to Section 8.1 shall remain in full force and effect, and (ii) all of TAb's obligations set forth herein with respect to manufacturing the Antidote, including without limitation, compliance in manufacturing and records will be performed and maintained in accordance with specificationsrecordkeeping, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance shall apply to Solvay in Searxx xxx such third party suppliers instead of to TAb. Should the event Solvay wishes license to qualify a backup Product manufacturer; (iv) Depomed manufacture revert to TAb, TAb shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s credit direct out-of-pocket costs expenses incurred by Searxx (xxcluding such commitments to incur future direct out-of-pocket expenses as Searxx xxxsonably may incur) to develop an alternative source of supply for the Antidote towards Searxx'x xxxment obligations hereunder; provided that such expenses are reasonable and that Searxx xxxvides TAb prior written notice of the anticipated type and estimated amount of any such expense for which it shall seek credit. If TAb is in connection with Bankruptcy (as defined herein), Searxx xxx exercise the above manufacturing rights regardless of partial delivery or efforts to cure. 5.5 To the extent that the creation, development or manufacture of Antidote by TAb for Searxx xxxld otherwise infringe a claim of a patent issued to, owned or controlled by Searxx xx a Searxx xxxiliate now or during the term of this Agreement, Searxx xxxeby grants to TAb a personal, non-transferable, non-assignable, non-exclusive, royalty-free, license under such manufacture and supply claim in the Territory. Such license shall continue only for such period or periods in which TAb is manufacturing Antidote for Searxx xxx is not otherwise in breach of Product to Solvaythis Agreement, and (B) a labor charge equal shall be limited to the FTE Charges creation, development and manufacture of Antidote for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);Searxx.

Manufacturing and Supply. (a) Depomed Subject to (i) the terms and conditions of this Agreement and the Underlying GMP License and (ii) Licensor’s retained right to Manufacture Drug Product itself or through one or more Third Parties selected by Licensor on behalf of Licensee pursuant to this Section 3.3, Licensee shall supply Product for use in conducting Depomed’s development activities for Product in have the Field exclusive right to Manufacture the Compounds and in the Territory as set forth in Exhibit D.Licensed Products itself or through one or more Third Parties selected by Licensee. (b) During Subject to the four-year period beginning on the Effective Date Parties having entered a Manufacturing Quality Agreement, upon Licensee’s request (the “Supply PeriodRequest”), Depomed shall Licensor agrees to Manufacture and supply and package (or have supplied and packaged) Drug Product, Drug Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with assembled in [***] days after and/or placebo, as applicable, to Licensee for Clinical Trial supply in accordance with this Section 3.3(b). Licensor shall supply such Drug Product and placebo to [***] at Licensor’s Supply Costs, within [***] from the Effective Date (the “Depomed Supply Agreement”) that initiation of production, and Drug Product assembled in [***] and such placebo will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and delivered within [***] of the Depomed Supply Agreement (initiation of production of the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others Drug Product or at such other date mutually agreeable to agreed upon in writing by the Parties): (i) Under . Licensor shall initiate production of Drug Product, Drug Product assembled in [***] and/or placebo, as applicable, within [***] from Licensor’s receipt of a Supply Request; provided that the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed first production period shall begin no later than [***]; (v) Solvay will pay Depomed . Licensor shall provide an invoice to Licensee upon Licensor’s delivery of the following amounts Drug Product, Drug Product in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% ] and/or placebo, as applicable. (c) Licensor shall manufacture the Drug Product, Drug Product in [***] and/or placebo, as applicable, in accordance with this Section 3.3(c). The Parties acknowledge and agree that (i) the maximum quantity of Depomed’s out-of-pocket costs incurred in connection with such Drug Substance from which Licensor is obligated to manufacture and supply Drug Product hereunder is [***] of Product Drug Substance, which is expected to Solvayproduce between [***] to [***] syringes of Drug Product, depending on strength(s) targeted (as determined by Licensee) and (Bii) a labor charge equal to maximum of two manufacturing campaigns is foreseen (it being understood that any manufacturing campaign that results in Drug Product that does not comply with the FTE Charges for all Depomed employees allocated to Manufacturing Quality Agreement shall not count towards the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate foregoing maximum of [***] during manufacturing campaigns). A first slot, comprising up to [***] presentations (e.g., [***], [***] and [***]) but excluding assembly of [***] auto-injector devices, has been provisionally reserved for [***]. Licensor shall store the Drug Substance in a manner compliant with Applicable Laws and the Manufacturing Quality Agreement, and using at least the same standard of care consistent with Licensor’s past practices and shall not destroy, alter or otherwise dispose of any given calendar quarter Drug Substance without the prior written consent of Licensee. The Parties agree that the volumes set forth in this Section 3.3(c) with respect to Drug Product are estimates and are not binding. Licensor shall not be obliged to Manufacture Drug Product in excess of the amount of Drug Substance on stock with Licensor as of the Effective Date taking into account the respective yield and batch size. In the event that Drug Product Manufactured by Licensor is rejected pursuant to the Manufacturing Quality Agreement, Licensor shall replace such non-conforming Drug Product out of the Drug Substance inventory existing as of the Effective Date. Licensee shall have no claim for any loss of Drug Substance, nor shall Licensor be obligated to manufacture additional quantities of Drug Substance, and Licensee’s sole remedy in case of rejection of Drug Product shall be the repayment of any amounts paid by Licensee to Licensor for the manufacturing services provided hereunder. Upon the earlier to occur of (x) Licensee’s request or (y) the completion of the second manufacturing campaign hereunder, Licensor shall promptly transfer to Licensee at Licensee’s expense any and Depomed all remaining Drug Substance remaining in Licensor’s possession at such time. (d) Other than as provided in Section 3.3(b) and Section 3.3(c), Licensor shall provide have no further obligation to Solvay periodic reports detailing manufacture or supply Drug Product hereunder. Notwithstanding the FTE Charges foregoing, Licensor may consider in good faith to Manufacture further volumes of Drug Product upon timely request by Licensee and upon the supply of Drug Substance by Licensee, which final decision shall be under Licensor’s discretion. (e) As soon as reasonably practicable following the Effective Date (and, in any event, within [***] thereafter), the Parties shall agree upon and execute a Manufacturing Quality Agreement, which shall, at a minimum, contain the Product Specifications. The supply of Drug Product under this Section 3.3 by Licensor shall also be governed by the terms and conditions of the Manufacturing Quality Agreement. To the extent that there is any conflict between the terms and conditions of this Agreement and the Manufacturing Quality Agreement, the terms and conditions of this Agreement shall govern and control, except with respect to conflicts or contradictions for matters of quality or technical nature, in which Solvay must pay Depomed hereunder);case the Manufacturing Quality Agreement shall prevail.

Manufacturing and Supply. 9.1 Designation of Manufacturing Party. (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery Manufacture of Approved Products by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties):Organon. (i) Under Manufacture of Development Candidates and Approved Products for Development. Unless otherwise agreed by the Solvay Supply AgreementJoint Commercialization Committee, Depomed will agree Organon or its Affiliate(s) shall manufacture and supply all quantities of a Development Candidate or Approved Product necessary for development; provided that Organon may decline to manufacture and supply Solvay with its requirements such quantities of finished, packaged a Approved Product during for [...***...] by giving Cypress written notice to such effect no later than [...***...] after the Supply Period; (ii) All manufacturing and records will be performed and maintained Joint Development Committee’s selection designation of such Development Candidate in accordance with specificationsSection 4.3. Unless otherwise agreed by the Joint Development Committee, cGMP and Applicable Law; (iiiby December 31, 2005, the parties shall enter into a Clinical Supply Agreement under which Organon or its Affiliate(s) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges be responsible for all Depomed employees allocated to the manufacture and supply of all quantities of Development Candidates for use in development activities pursuant to this Agreement. (ii) Manufacture of Approved Products for Commercialization. Unless otherwise agreed by the Joint Commercialization Committee within 180 days after enrollment of the first patient in the first Phase III Clinical Trial with respect to any Development Candidate, the parties shall enter into a Manufacturing Agreement under which Organon or its Affiliate(s) shall be responsible for the manufacture and supply of all quantities of Approved Product necessary for commercialization; provided that Organon may decline to enter into such agreement for any reason by giving Cypress written notice to such effect no later than 60 days after the beginning of such 180-day period. In case Organon has exercised the Organon Option and has elected to manufacture for Cypress pursuant to Section 5.6, the price to be charged by Organon to Cypress will be subject to reasonable negotiation with Cypress and subject to the Manufacturing Agreement. (b) Manufacture of Approved Products by Third Parties. In the event that the Joint Development Committee or Joint Commercialization Committee determines that it is in the best interests of the parties for any one or more manufacturing activities with respect to an Approved Product to Solvay, be undertaken by an identified Third Party (whether as a result of a decision by Organon in accordance with Section 9.1(a) not to exceed FTE Charges undertake such manufacturing activities or otherwise), the negotiations with such Third Party relating to such manufacturing activities shall be led by Organon; provided that (A) Organon shall keep Cypress informed of the substance and status of such negotiations, and allow Cypress to participate in such negotiations, (B) Organon shall take into account in such negotiations the reasonable commercial interests of Cypress and the best interests of both parties, and (C) the final agreement with the Third Party shall be subject to mutual agreement of the parties. The parties each agree to grant such licenses or sublicenses under the Cypress Technology, Organon Technology, Joint Data and Joint Patents to any such Third Party as may be reasonably necessary for an aggregate of [***] during any given calendar quarter (and Depomed shall provide such Third Party to Solvay periodic reports detailing manufacture the FTE Charges for which Solvay must pay Depomed hereunder);Approved Product.