Common use of Packaging and Labeling Clause in Contracts

Packaging and Labeling. Kissei, in its capacity as manufacturer and MAA holder, will be responsible for the elaboration and filing of packaging artworks and mock-ups, and for the routine maintenance and production of Packaging and Labeling components for the Licensed Products for the Territory in or outside the Territory. Kissei must consult with Viridian during the development of the Approved Labeling for the Licensed Products in the Territory, and provide Viridian with the opportunity to review and provide comments on, all Licensed Product look and feel of Packaging and Labeling (including providing Viridian the right to review all mockups thereof prior to submission thereof to the Regulatory Authorities in the Territory). [***]. The Parties will discuss and agree in writing on the implementation of any label changes to the Approved Labeling based on then-current Licensed Product inventory labels prior to making any submission to any Regulatory Authority in the Territory regarding such label changes. Kissei will be solely responsible for all costs and expenses associated with Packaging and Labeling the Licensed Products received from Viridian as necessary to Commercialize the Licensed Products in the Territory, including any costs or expenses associated with any label changes or remanufacturing of any Licensed Product due to changes requested or required by any Regulatory Authority in the Territory. Kissei will provide to Viridian the most up-to-date version of prescribing information, labels, inserts, and other materials to be included in the Approved Labeling of such Licensed Product in the Territory in the form of image files for Viridian’s reference purposes (a) [***] prior to [***] and (b) [***]. Kissei will provide such prescribing information, labels, inserts, and other materials in their original language and, if not in English, translated versions of such prescribing information, labels, inserts, and other materials in English in accordance with Section 15.16 (Language; Translations).

Packaging and Labeling. KisseiNotwithstanding anything to the contrary contained herein, in accordance with the procedures set forth in the Quality Agreement and Section 7.6.3, Auxilium or its capacity as manufacturer and MAA holder, will designated Third Party shall be responsible (at its sole cost and expense) for all final product labeling and packaging (whether in commercial or clinical packaging presentation), including insertion of materials such as applicators, transfer needles, syringes, patient inserts, patient medication guides, professional inserts and any other written, printed or graphic materials accompanying the elaboration Bulk Product, considered to be part of the Finished Product (collectively, “Packaging and filing of packaging artworks Labeling”). To the extent that Auxilium uses a Third Party to assist with Packaging and mock-upsLabeling, Auxilium shall be wholly responsible for, and for bear all of the routine maintenance and production of costs related to, qualifying such Third Party to perform such activities. Auxilium or its designated Third Party shall ensure that all such Packaging and Labeling components shall comply with Laws, GMPs and the Regulatory Approvals for the Licensed Products for the Territory in or outside the Territory. Kissei must consult with Viridian during the development of the Approved Labeling for the Licensed Products Finished Product in the Territory, and provide Viridian with including the opportunity to review and provide comments onProduct Specifications. Notwithstanding the foregoing, all Licensed Product look and feel Sobi shall be responsible for reimbursing Auxilium for the cost of Packaging and Labeling (including providing Viridian the right to review all mockups thereof prior to submission thereof preparing any new artwork or labeling not listed on Schedule 7.5.1 or any changes to the Regulatory Authorities in the Territory). artwork or labeling listed on Schedule 7.5.1, at Auxilium’s cost plus [***]. The Parties will discuss and agree in writing on the implementation of Sobi shall review any label changes new or modified artwork to the Approved Labeling based on then-current Licensed Product inventory labels prior to making any submission to any Regulatory Authority in the Territory regarding such label changes. Kissei will be solely responsible for all costs and expenses associated with Packaging and Labeling the Licensed Products received from Viridian as necessary to Commercialize the Licensed Products in the Territory, including any costs or expenses associated with any label changes or remanufacturing of any Licensed Product due to changes requested or required by any Regulatory Authority ensure regulatory compliance in the Territory. Kissei will provide Such review shall be made in ten (10) business days. Sobi shall be permitted to Viridian apply ▇▇▇▇▇▇▇ stickers or other similar relabeling for the most up-to-date version of prescribing information, labels, inserts, and other materials to be included Product for use in the Approved Labeling of such Licensed Product different countries in the Territory at Sobi’s sole expense and risk, provided that Sobi does so in the form of image files for Viridian’s reference purposes (a) [***] prior to [***] compliance with all applicable Laws and (b) [***]. Kissei will provide such prescribing information, labels, inserts, further provided that Sobi indemnifies and other materials in their original language and, if not in English, translated versions holds harmless Auxilium from any liabilities or obligations arising out of such prescribing informationrelabeling by Sobi. For the avoidance of doubt, labels, inserts, and other materials in English in accordance with Section 15.16 (Language; Translations)Sobi shall not be permitted to re-package the Product.

Packaging and Labeling. KisseiThe Parties shall reasonably cooperate to change the Label of Tuzistra XR so that such Product may be Launched as soon as reasonably practicable after the Effective Date (the “Tuzistra XR Initial Label Changes”). Within three (3) months of the Effective Date, AYTU shall supply to TRIS, in a timely fashion, its capacity as manufacturer logo and MAA holder, will be responsible for the elaboration layout required to Label the CCP-08 Product in accordance with Applicable Laws and filing of packaging artworks and mock-ups, and for the routine maintenance and production of Packaging and Labeling components for the Licensed Products for the Territory in or outside the Territory. Kissei must consult with Viridian during the development of the Approved Labeling for the Licensed Products in the Territory, and provide Viridian with the opportunity to review and provide comments on, all Licensed Product look and feel of Packaging and Labeling (including providing Viridian the right to review all mockups thereof prior to submission thereof to the Regulatory Authorities in the TerritorySection 4.10(a). [***]. The Parties will discuss TRIS shall be responsible, at its sole cost and agree in writing on the implementation of expense, for securing any label changes to the Approved Labeling based on then-current Licensed Product inventory labels prior to making any submission to any Regulatory Authority approvals required by Agencies in the Territory regarding such label changes. Kissei will be solely responsible or other applicable Regulatory Approvals for all costs and expenses associated with Packaging and Labeling the Licensed Products received from Viridian as necessary to Commercialize initial Label for the Licensed Products in the Territory, including any costs or expenses associated with any label changes or remanufacturing of any Licensed Product due to changes requested or required by any Regulatory Authority in the Territory. Kissei will provide to Viridian the most up-to-date version of prescribing information, labels, insertsCCP-08 Product, and other materials shall use Commercially Reasonable Efforts, at its own cost and expense (including stability testing) to be included in the Approved Labeling of such Licensed Product in the Territory in the form of image files for Viridian’s reference purposes (a) develop a bottle size smaller than [***] prior to [***] and larger than [**], which the Parties currently expect will be a [**] bottle size (the “Medium Bottle Size”) with the exact size determined in TRIS’ sole discretion after consultation with AYTU for the Products; provided however, that costs and expenses of Labeling design (except for the Tuzistra XR Initial Label Changes) and filings and interactions with Regulatory Authorities shall be at the sole cost and expense of AYTU for any post-NDA Approval Regulatory Approval. All changes to Labels or Packaging prior to Regulatory Approval shall be at AYTU’s sole cost and expense. Any changes or supplements to the Labeling for any Product following the transfer of the NDA for a Product to AYTU shall be at AYTU’s sole cost and expense; provided, however, that the costs and expenses of the Tuzistra XR Initial Label Changes, other than incurred with respect to filings and interactions with Regulatory Authorities, shall be at TRIS’ sole cost and expense. In the event that AYTU wishes to modify or change the Label for a Product, other than such changes to the Label as of the Effective Date on Tuzistra XR to effectuate the Tuzistra XR Initial Label Changes, AYTU shall provide at least sixty (60) days’ advance notice of such desired change to TRIS and forward such modifications or changes to TRIS for incorporation into the Packaging and Labeling of such Products. All reasonable costs relating to changes in the Labels or Packaging, other than changes with respect to the Label of Tuzistra XR existing as of the Effective Date which are necessary to effectuate the Tuzistra XR Initial Label Changes, including artwork, as well as destruction and other costs (including TRIS’ reasonable and documented out-of-pocket costs and expenses) relating to Labels or Packaging that are no longer usable, shall be paid by AYTU to TRIS within thirty (30) days of invoice to AYTU including, for example, expenses of Labels or Packaging materials that are no longer useable by TRIS in the Packaging or Labeling of the Products because of (a) TRIS’ reliance on the Forecasts provided pursuant to Section 5.1 hereof, or (b) [***]. Kissei will provide such prescribing information, labels, inserts, and other materials in their original language and, if not in English, translated versions of such prescribing information, labels, inserts, and other materials in English in accordance with Section 15.16 (Language; Translations)changes requested by AYTU.

Packaging and Labeling. Kissei(a) Immediately following execution of this Agreement Licensor shall provide Licensee with a copy of the label for the Licensed Product (the "Licensed Product Labeling"). Licensor is responsible for ensuring that the Licensed Product Labeling is accurate, in its capacity as manufacturer current and MAA holdercomplete (consistent with the Product [***]), and complies with applicable requirements of the FDA (and applicable Governmental Entities), the REMS Program and applicable Governmental Rules. Licensee will be responsible for modifying the elaboration and filing Licensed Product Labeling in order to generate the content of packaging artworks and mock-ups, and the label for the routine maintenance Product, together with any other written or graphic matter contained upon any wrapper, packaging, package insert or outset utilized for the Product (which for clarity, shall include the appropriate Licensee Trademarks and production of Packaging and Labeling components any other prescribing information for the Licensed Products for Product that is required by the Territory FDA (and applicable Governmental Entities) and the REMS Program, in or outside the Territory. Kissei must consult manner and to the extent specified in the Specifications (collectively, the "Product Labeling", with Viridian during the development content of the Approved Product Labeling that is added and/or modified in any way (including relating to formatting and placement) by Licensee (excluding, for clarity, the unmodified Licensed Products in Product Labeling) being referred to as the Territory"Modified Product Labeling"); provided that, and provide Viridian with the Licensor shall have a reasonable opportunity to review and provide comments onon the proposed Product Labeling. Licensee shall not include any information on the Modified Product Labeling that is not approved by the FDA or, solely with respect to Additional Changes, Licensor. The Licensee will be responsible for ensuring the accuracy of all information contained on the Product Labeling and for the compliance of all such labels with applicable Governmental Rules and the REMS Program. Such packaging and labels will be in accordance with the Specifications. Licensor shall promptly inform Licensee of any changes to the Licensed Product look and feel of Packaging and Labeling. Upon written notification from Licensor, the Licensee will make any changes to the Product Labeling to conform to the License Product Labeling (including providing Viridian as applicable) or as otherwise required by applicable Law, the right REMS Program or the FDA, and will consider in good faith making any other changes requested by the Licensor, at the Licensee's sole cost and expense, within a reasonable timeframe to review be agreed upon in writing by both Parties. The Licensee will be responsible for preparing (but shall not submit) all mockups thereof prior to submission thereof regulatory or governmental submissions relating to the Regulatory Authorities Product Labeling (whether for the initial submissions to the Product Labeling or subsequent submissions relating to changes required by Governmental Rules, or by any Governmental Entity or the REMS Program) and the parties will work together to submit any such changes to all applicable Governmental Entities for approval, if required, which filings shall be completed by the Licensor unless otherwise agreed to in the Territory)writing. At such time that Licensor has established its own internal capabilities to secondary package and label products, if ever, in [***]] (the "Licensor Facility"), the Parties shall negotiate in good faith an amendment to this Agreement to take into account such capabilities (which amendment, for clarity, shall contain the following terms: (i) Licensor will provide at the Licensor Facility any secondary packaging, labeling and related services with respect to the Product, with the Supply Price to be negotiated at the time of such amendment, (ii) the Product will be delivered to Licensee as a fully labeled and packaged product that is ready for shipment (the "DRL Finished Product") and (iii) the DRL Finished Product will be delivered CIP US Port (Incoterms 2010)). The Additionally, as part of the entry into such amendment, the Parties will discuss and agree shall negotiate in writing good faith the remaining shelf life of the DRL Finished Product at the time of delivery to Licensee (which for clarity, shall be no less than eighteen (18) months' as of the date of delivery of such DRL Finished Product to Licensee). (b) In the event that Licensee wishes to make any change to the artwork on the implementation of any label Product Labeling, including color changes or updates to the Approved Labeling based on then-current Licensed Product inventory labels prior to making any packaging or Licensee Trademarks, etc., in each case, that would require a submission to any Regulatory Authority in Governmental Entity or to the Territory regarding REMS Program (each an "Additional Change"), Licensee shall first discuss such label changesproposed Additional Change with the Licensor. Kissei will In the event that Licensor agrees to permit any such Additional Change (such permission not to be solely responsible for unreasonably withheld, conditioned or delayed), Licensee shall prepare all submissions and Licensor shall cooperate with Licensee to make any applicable submissions to Governmental Entities and/or REMS Program, provided, that Licensee shall bear all costs and expenses associated with Packaging and Labeling any Additional Change. For clarity, the Licensed Products received from Viridian as necessary Licensor may reject in its sole discretion any Additional Change or other change to Commercialize the Licensed Products in Product that is requested by the Territory, including any costs or expenses associated with any label changes or remanufacturing of any Licensed Product due to changes requested or required by any Regulatory Authority in the Territory. Kissei will provide to Viridian the most up-to-date version of prescribing information, labels, inserts, and other materials to be included in the Approved Labeling of such Licensed Product in the Territory in the form of image files for Viridian’s reference purposes (a) [***] prior to [***] and (b) [***]. Kissei will provide such prescribing information, labels, inserts, and other materials in their original language and, if not in English, translated versions of such prescribing information, labels, inserts, and other materials in English in accordance with Section 15.16 (Language; Translations)Licensee.

Packaging and Labeling. Kissei(a) Immediately following execution of this Agreement Licensor shall provide Licensee with a copy of the label for the Licensed Product (the "Licensed Product Labeling"). Licensor is responsible for ensuring that the Licensed Product Labeling is accurate, in its capacity as manufacturer current and MAA holdercomplete (consistent with the Product [***]), and complies with applicable requirements of the FDA (and applicable Governmental Entities), the REMS Program and applicable Governmental Rules. Licensee will be responsible for modifying the elaboration and filing Licensed Product Labeling in order to generate the content of packaging artworks and mock-ups, and the label for the routine maintenance Product, together with any other written or graphic matter contained upon any wrapper, packaging, package insert or outset utilized for the Product (which for clarity, shall include the appropriate Licensee Trademarks and production of Packaging and Labeling components any other prescribing information for the Licensed Products for Product that is required by the Territory FDA (and applicable Governmental Entities) and the REMS Program, in or outside the Territory. Kissei must consult manner and to the extent specified in the Specifications (collectively, the "Product Labeling", with Viridian during the development content of the Approved Product Labeling that is added and/or modified in any way (including relating to formatting and placement) by Licensee (excluding, for clarity, the unmodified Licensed Products in Product Labeling) being referred to as the Territory"Modified Product Labeling"); provided that, and provide Viridian with the Licensor shall have a reasonable opportunity to review and provide comments onon the proposed Product Labeling. Licensee shall not include any information on the Modified Product Labeling that is not approved by the FDA or, solely with respect to Additional Changes, Licensor. The Licensee will be responsible for ensuring the accuracy of all information contained on the Product Labeling and for the compliance of all such labels with applicable Governmental Rules and the REMS Program. Such packaging and labels will be in accordance with the Specifications. Licensor shall promptly inform Licensee of any changes to the Licensed Product look and feel of Packaging and Labeling. Upon written notification from Licensor, the Licensee will make any changes to the Product Labeling to conform to the License Product Labeling (including providing Viridian as applicable) or as otherwise required by applicable Law, the right REMS Program or the FDA, and will consider in good faith making any other changes requested by the Licensor, at the Licensee's sole cost and expense, within a reasonable timeframe to review be agreed upon in writing by both Parties. The Licensee will be responsible for preparing (but shall not submit) all mockups thereof prior to submission thereof regulatory or governmental submissions relating to the Regulatory Authorities Product Labeling (whether for the initial submissions to the Product Labeling or subsequent submissions relating to changes required by Governmental Rules, or by any Governmental Entity or the REMS Program) and the parties will work together to submit any such changes to all applicable Governmental Entities for approval, if required, which filings shall be completed by the Licensor unless otherwise agreed to in the Territory)writing. At such time that Licensor has established its own internal capabilities to secondary package and label products, if ever, in [***]] (the "Licensor Facility"), the Parties shall negotiate in good faith an amendment to this Agreement to take into account such capabilities (which amendment, for clarity, shall contain the following terms: (i) Licensor will provide at the Licensor Facility any secondary packaging, labeling and related services with respect to the Product, with the Supply Price to be negotiated at the time of such amendment, (ii) the Product will be delivered to Licensee as a fully labeled and packaged product that is ready for shipment (the "[***] Finished Product") and (iii) the [***] Finished Product will be delivered CIP US Port (Incoterms 2010)). The Additionally, as part of the entry into such amendment, the Parties will discuss and agree shall negotiate in writing good faith the remaining shelf life of the [***] Finished Product at the time of delivery to Licensee (which for clarity, shall be no less than eighteen (18) months' as of the date of delivery of such [***] Finished Product to Licensee). (b) In the event that Licensee wishes to make any change to the artwork on the implementation of any label Product Labeling, including color changes or updates to the Approved Labeling based on then-current Licensed Product inventory labels prior to making any packaging or Licensee Trademarks, etc., in each case, that would require a submission to any Regulatory Authority in Governmental Entity or to the Territory regarding REMS Program (each an "Additional Change"), Licensee shall first discuss such label changesproposed Additional Change with the Licensor. Kissei will In the event that Licensor agrees to permit any such Additional Change (such permission not to be solely responsible for unreasonably withheld, conditioned or delayed), Licensee shall prepare all submissions and Licensor shall cooperate with Licensee to make any applicable submissions to Governmental Entities and/or REMS Program, provided, that Licensee shall bear all costs and expenses associated with Packaging and Labeling any Additional Change. For clarity, the Licensed Products received from Viridian as necessary Licensor may reject in its sole discretion any Additional Change or other change to Commercialize the Licensed Products in Product that is requested by the Territory, including any costs or expenses associated with any label changes or remanufacturing of any Licensed Product due to changes requested or required by any Regulatory Authority in the Territory. Kissei will provide to Viridian the most up-to-date version of prescribing information, labels, inserts, and other materials to be included in the Approved Labeling of such Licensed Product in the Territory in the form of image files for Viridian’s reference purposes (a) [***] prior to [***] and (b) [***]. Kissei will provide such prescribing information, labels, inserts, and other materials in their original language and, if not in English, translated versions of such prescribing information, labels, inserts, and other materials in English in accordance with Section 15.16 (Language; Translations)Licensee.

Packaging and Labeling. KisseiThe Parties shall reasonably cooperate to change the Label of Tuzistra XR so that such Product may be Launched as soon as reasonably practicable after the Effective Date (the “Tuzistra XR Initial Label Changes”). Within three (3) months of the Effective Date, AYTU shall supply to TRIS, in a timely fashion, its capacity as manufacturer logo and MAA holder, will be responsible for the elaboration layout required to Label the CCP-08 Product in accordance with Applicable Laws and filing of packaging artworks and mock-ups, and for the routine maintenance and production of Packaging and Labeling components for the Licensed Products for the Territory in or outside the Territory. Kissei must consult with Viridian during the development of the Approved Labeling for the Licensed Products in the Territory, and provide Viridian with the opportunity to review and provide comments on, all Licensed Product look and feel of Packaging and Labeling (including providing Viridian the right to review all mockups thereof prior to submission thereof to the Regulatory Authorities in the TerritorySection 4.10(a). [***]. The Parties will discuss TRIS shall be responsible, at its sole cost and agree in writing on the implementation of expense, for securing any label changes to the Approved Labeling based on then-current Licensed Product inventory labels prior to making any submission to any Regulatory Authority approvals required by Agencies in the Territory regarding such label changes. Kissei will be solely responsible or other applicable Regulatory Approvals for all costs and expenses associated with Packaging and Labeling the Licensed Products received from Viridian as necessary to Commercialize initial Label for the Licensed Products in the Territory, including any costs or expenses associated with any label changes or remanufacturing of any Licensed Product due to changes requested or required by any Regulatory Authority in the Territory. Kissei will provide to Viridian the most up-to-date version of prescribing information, labels, insertsCCP-08 Product, and other materials shall use Commercially Reasonable Efforts, at its own cost and expense (including stability testing) to be included in the Approved Labeling of such Licensed Product in the Territory in the form of image files for Viridian’s reference purposes (a) develop a bottle size smaller than [***] prior to [***] and larger than [**], which the Parties currently expect will be a [**] bottle size (the “Medium Bottle Size”) with the exact size determined in TRIS’ sole discretion after consultation with AYTU for the Products; provided however, that costs and expenses of Labeling design (except for the Tuzistra XR Initial Label Changes) and filings and interactions with Regulatory Authorities shall be at the sole cost and expense of AYTU for any post-NDA Approval Regulatory Approval. All changes to Labels or Packaging prior to Regulatory Approval shall be at AYTU’s sole cost and expense. Any changes or supplements to the Labeling for any Product following the transfer of the NDA for a Product to AYTU shall be at AYTU’s sole cost and expense; provided, however, that the costs and expenses of the Tuzistra XR Initial Label Changes, other than incurred with respect to filings and interactions with Regulatory Authorities, shall be at TRIS’ sole cost and expense. In the event that AYTU wishes to modify or change the Label for a Product, other than such changes to the Label as of the Effective Date on Tuzistra XR to effectuate the Tuzistra XR Initial Label Changes, AYTU shall provide at least sixty (60) days’ advance notice of such desired change to TRIS and forward such modifications or changes to TRIS for incorporation into the Packaging and Labeling of such Products. All reasonable costs relating to changes in the Labels or Packaging, other than changes with respect to the Label of Tuzistra XR existing as of the Effective Date which are necessary to effectuate the Tuzistra XR Initial Label Changes, including artwork, as well as destruction and other costs (including TRIS’ reasonable and documented out-of-pocket costs and expenses) relating to Labels or Packaging that are no longer usable, shall be paid by AYTU to TRIS within thirty (30) days of invoice to AYTU including, for example, expenses of Labels or Packaging materials that are no longer useable by TRIS in the Packaging or Labeling of the Products because of (a) TRIS’ reliance on the Forecasts provided pursuant to Section 5.1 hereof, or (b) changes requested by AYTU. EXPLANATORY NOTE: [***]. Kissei will provide such prescribing information, labels, inserts, and other materials in their original language and, if not in English, translated versions of such prescribing information, labels, inserts, and other materials in English in accordance with Section 15.16 ] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (Language; Translations)I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.

Packaging and Labeling. Kissei(a) Unless otherwise agreed by the Parties, CODMAN shall be responsible for packaging the Existing Products, other than the ▇▇▇▇▇▇▇▇-▇▇▇▇▇® Forceps, in its capacity as manufacturer and MAA holderfinished package form. Synergetics shall be responsible for packaging the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Forceps in finished package form in accordance with the packaging specifications set forth in Schedule D. (b) For all Existing Products, will Synergetics shall be responsible for the elaboration text, content and filing of packaging artworks and mock-ups, and for the routine maintenance and production of Packaging and Labeling components for the Licensed Products for the Territory in or outside the Territory. Kissei must consult with Viridian during the development regulatory compliance of the Approved Labeling for labels on the Licensed Products package and the product, the labeling and product package inserts. For purposes of this Agreement the terms “label” and “labeling” shall have the meanings set forth in Sections 201(k) and 201(m) respectively of the TerritoryU.S. Federal Food, Drug and Cosmetics Act. Synergetics shall provide Viridian with the opportunity English version of all Existing Product labels to review and provide comments on, all Licensed Product look and feel of Packaging and Labeling CODMAN. Exhibit 10.30 (including providing Viridian c) Synergetics shall have the right to review apply reasonable patent marking on the Existing Products indicating Synergetics’ Patents covering the Existing Products, as well as reasonable marking (i) on those products that Synergetics manufactures indicating such manufacture by Synergetics and (ii) that the ▇▇▇▇▇ trademark (and in the case of the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Forceps, the Spetzler™ trademark) is used under license from Synergetics; provided, however that it is understood and agreed that this clause (c) shall be applied prospectively as new labeling is developed and existing Existing Product packaging inventories are drawn down. For the avoidance of doubt, the parties agree that CODMAN is not required to repackage any Existing Products solely to comply with this clause (c). (d) For all mockups thereof prior to submission thereof Existing Products other than the ▇▇▇▇▇▇▇▇-▇▇▇▇▇® Forceps, CODMAN shall be responsible for copy format, artwork preparation, translations and production and all related costs for the labeling, including, but not limited to, translations and production shall be the responsibility of CODMAN. With respect to the Regulatory Authorities ▇▇▇▇▇▇▇▇-▇▇▇▇▇® Forceps, Synergetics shall be responsible for copy format, artwork preparation, translations and production and all related costs for the labeling, including, but not limited to, translations and production, all in accordance with labeling specifications agreed between the Parties.” 4. Section 3.06(b) (Government Registrations) of the Distribution Agreement is hereby replaced with the following new Section 3.06(b): (i) Synergetics shall apply for and maintain, in its name and at its cost, a ▇▇-▇▇▇▇ (or any other required EU-wide Governmental Registration) for all Existing Products during the Term in the Territory). [***]. The Parties will discuss European Union and agree CODMAN shall apply for and maintain in writing on its name and at its cost any other (i.e., national or local) Governmental Registrations in EU member states for CODMAN and/or its relevant affiliates to market all Existing Products during the implementation of any label changes to the Approved Labeling based on then-current Licensed Product inventory labels prior to making any submission to any Regulatory Authority Term in the Territory regarding such label changes. Kissei European Union. (ii) If the Parties agree that CODMAN will be solely responsible for all costs identified as the legal manufacturer on product label and expenses associated with Packaging and Labeling the Licensed Products received from Viridian as necessary to Commercialize the Licensed Products in the Territory, including any costs or expenses associated with any label changes or remanufacturing labeling of any Licensed Product due to changes requested or required by any Regulatory Authority in the Territory. Kissei will provide to Viridian the most up-to-date version of prescribing information, labels, inserts, and other materials to be included in the Approved Labeling of such Licensed an Existing Product in the Territory European Union, CODMAN shall apply for and maintain, in its name and at its cost, an Own-Brand Label Government Registration required to market that Existing Product during the term in the form European Union under the CODMAN name. (iii) Synergetics shall apply for and maintain, in its name and at its cost all Governmental Registrations required for CODMAN to market all Existing Products during the Term in the United States. (iv) CODMAN and/or its relevant affiliates shall apply for and maintain, in its name and at its cost, all Governmental Registrations required for CODMAN and/or its relevant affiliates to market all Existing Products during the Term in countries other than the United States or the European Union. (v) Synergetics shall reasonably cooperate with CODMAN in its efforts to obtain any Governmental Registrations under clauses (ii) or (iv), above. (vi) Synergetics agrees that CODMAN shall have access, upon ten (10) days’ prior written notice, to all of image files Synergetics’ documents required to complete all Governmental Registrations for Viridianthe Existing Products to the extent necessary to enable CODMAN to exercise its rights or fulfill its obligations hereunder. Likewise, CODMAN agrees that Synergetics shall have access, upon ten (10) days’ prior written notice, to all of CODMAN’s reference purposes non-confidential regulatory submissions for the Existing Products.” 5. Section 3.06(c) (aEU Authorized Representative) [***] prior to [***] and (b) [***]of the Distribution Agreement is hereby deleted in its entirety. Kissei will provide such prescribing information, labels, inserts, and other materials in their original language and, if not in English, translated versions of such prescribing information, labels, inserts, and other materials in English in accordance with Section 15.16 (Language; Translations).Exhibit 10.30