Common use of Packaging and Labeling Clause in Contracts

Packaging and Labeling. The 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 logo and the layout required to Label the CCP-08 Product in accordance with Applicable Laws and Section 4.10(a). TRIS shall be responsible, at its sole cost and expense, for securing any approvals required by Agencies in the Territory or other applicable Regulatory Approvals for the initial Label for the CCP-08 Product, and shall use Commercially Reasonable Efforts, at its own cost and expense (including stability testing) to develop a bottle size smaller than [**] 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.

Packaging and Labeling. The Parties (a) Immediately following execution of this Agreement Licensor shall reasonably cooperate to change provide Licensee with a copy of the Label of Tuzistra XR so that such label for the Licensed Product may be Launched as soon as reasonably practicable after the Effective Date (the “Tuzistra XR Initial Label Changes”"Licensed Product Labeling"). Within three Licensor is responsible for ensuring that the Licensed Product Labeling is accurate, current and complete (3) months consistent with the Product [***]), and complies with applicable requirements of the Effective DateFDA (and applicable Governmental Entities), AYTU the REMS Program and applicable Governmental Rules. Licensee will be responsible for modifying the Licensed Product Labeling in order to generate the content of the label for the 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 supply to TRISinclude the appropriate Licensee Trademarks and any other prescribing information for the Licensed Product that is required by the FDA (and applicable Governmental Entities) and the REMS Program, in the manner and to the extent specified in the Specifications (collectively, the "Product Labeling", with the content of the 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 Product Labeling) being referred to as the "Modified Product Labeling"); provided that, Licensor shall have a timely fashionreasonable opportunity to review and provide comments on the proposed Product Labeling. Licensee shall not include any information on the Modified Product Labeling that is not approved by the FDA or, its logo 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 layout required to Label the CCP-08 Product REMS Program. Such packaging and labels will be in accordance with Applicable Laws the Specifications. Licensor shall promptly inform Licensee of any changes to the Licensed Product Labeling. Upon written notification from Licensor, the Licensee will make any changes to the Product Labeling to conform to the License Product Labeling (as applicable) or as otherwise required by applicable Law, the REMS Program or the FDA, and Section 4.10(a). TRIS shall be responsiblewill consider in good faith making any other changes requested by the Licensor, at its the Licensee's sole cost and expense, within a reasonable timeframe to be agreed upon in writing by both Parties. The Licensee will be responsible for securing any approvals required by Agencies in preparing (but shall not submit) all regulatory or governmental submissions relating to the Territory or other applicable Regulatory Approvals Product Labeling (whether for the initial Label 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 CCP-08 Product, and shall use Commercially Reasonable Efforts, at Licensor unless otherwise agreed to in writing. At such time that Licensor has established its own cost internal capabilities to secondary package and expense (including stability testing) to develop a bottle size smaller than 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 larger than 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 "[**], which *] Finished Product") and (iii) the Parties currently expect will be a [***] bottle size Finished Product will be delivered CIP US Port (Incoterms 2010)). Additionally, as part of the “Medium Bottle Size”) with entry into such amendment, the exact size determined Parties shall negotiate in TRIS’ sole discretion after consultation with AYTU for good faith the Products; provided however, that costs and expenses remaining shelf life of Labeling design (except for the Tuzistra XR Initial Label Changes) and filings and interactions with Regulatory Authorities shall be [***] Finished Product at the sole cost and expense time of AYTU delivery to Licensee (which 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 Authoritiesclarity, shall be at TRIS’ sole cost and expenseno 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 Product Labeling, including color changes or updates to packaging or Licensee Trademarks, etc., in each case, that would require a submission to any Governmental Entity or to the REMS Program (each an "Additional Change"), Licensee shall first discuss such proposed Additional Change with the Licensor. In the event that AYTU wishes Licensor agrees to modify permit any such Additional Change (such permission not to be 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 any Additional Change. For clarity, the Licensor may reject in its sole discretion any Additional Change or other 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 Product 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 is requested by AYTUthe Licensee.

Packaging and Labeling. The Parties (a) Immediately following execution of this Agreement Licensor shall reasonably cooperate to change provide Licensee with a copy of the Label of Tuzistra XR so that such label for the Licensed Product may be Launched as soon as reasonably practicable after the Effective Date (the “Tuzistra XR Initial Label Changes”"Licensed Product Labeling"). Within three Licensor is responsible for ensuring that the Licensed Product Labeling is accurate, current and complete (3) months consistent with the Product [***]), and complies with applicable requirements of the Effective DateFDA (and applicable Governmental Entities), AYTU the REMS Program and applicable Governmental Rules. Licensee will be responsible for modifying the Licensed Product Labeling in order to generate the content of the label for the 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 supply to TRISinclude the appropriate Licensee Trademarks and any other prescribing information for the Licensed Product that is required by the FDA (and applicable Governmental Entities) and the REMS Program, in the manner and to the extent specified in the Specifications (collectively, the "Product Labeling", with the content of the 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 Product Labeling) being referred to as the "Modified Product Labeling"); provided that, Licensor shall have a timely fashionreasonable opportunity to review and provide comments on the proposed Product Labeling. Licensee shall not include any information on the Modified Product Labeling that is not approved by the FDA or, its logo 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 layout required to Label the CCP-08 Product REMS Program. Such packaging and labels will be in accordance with Applicable Laws the Specifications. Licensor shall promptly inform Licensee of any changes to the Licensed Product Labeling. Upon written notification from Licensor, the Licensee will make any changes to the Product Labeling to conform to the License Product Labeling (as applicable) or as otherwise required by applicable Law, the REMS Program or the FDA, and Section 4.10(a). TRIS shall be responsiblewill consider in good faith making any other changes requested by the Licensor, at its the Licensee's sole cost and expense, within a reasonable timeframe to be agreed upon in writing by both Parties. The Licensee will be responsible for securing any approvals required by Agencies in preparing (but shall not submit) all regulatory or governmental submissions relating to the Territory or other applicable Regulatory Approvals Product Labeling (whether for the initial Label 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 CCP-08 Product, and shall use Commercially Reasonable Efforts, at Licensor unless otherwise agreed to in writing. At such time that Licensor has established its own cost internal capabilities to secondary package and expense (including stability testing) to develop a bottle size smaller than label products, if ever, in [***] and larger than [**](the "Licensor Facility"), which the Parties currently expect 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 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 provide at the sole cost Licensor Facility any secondary packaging, labeling 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 related services with respect to filings 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 interactions with Regulatory Authoritiespackaged product that is ready for shipment (the "DRL Finished Product") and (iii) the DRL Finished Product will be delivered CIP US Port (Incoterms 2010)). Additionally, as part of the entry into such amendment, the Parties shall negotiate in good faith the remaining shelf life of the DRL Finished Product at the time of delivery to Licensee (which for clarity, shall be at TRIS’ sole cost and expenseno 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 Product Labeling, including color changes or updates to packaging or Licensee Trademarks, etc., in each case, that would require a submission to any Governmental Entity or to the REMS Program (each an "Additional Change"), Licensee shall first discuss such proposed Additional Change with the Licensor. In the event that AYTU wishes Licensor agrees to modify permit any such Additional Change (such permission not to be 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 any Additional Change. For clarity, the Licensor may reject in its sole discretion any Additional Change or other 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 Product 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 is requested by AYTUthe Licensee.

Packaging and Labeling. The Parties shall reasonably cooperate Notwithstanding anything 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 Datecontrary contained herein, AYTU shall supply to TRIS, in a timely fashion, its logo and the layout required to Label the CCP-08 Product in accordance with Applicable Laws the procedures set forth in the Quality Agreement and Section 4.10(a). TRIS 7.6.3, Auxilium or its designated Third Party shall be responsible, responsible (at its sole cost and expense) for all final product labeling and packaging (whether in commercial or clinical packaging presentation), for securing including insertion of materials such as applicators, transfer needles, syringes, patient inserts, patient medication guides, professional inserts and any approvals required by Agencies in other written, printed or graphic materials accompanying the Territory Bulk Product, considered to be part of the Finished Product (collectively, “Packaging and Labeling”). To the extent that Auxilium uses a Third Party to assist with Packaging and Labeling, Auxilium shall be wholly responsible for, and bear all of the costs related to, qualifying such Third Party to perform such activities. Auxilium or other applicable its designated Third Party shall ensure that all such Packaging and Labeling shall comply with Laws, GMPs and the Regulatory Approvals for the initial Label Finished Product in the Territory, including the Product Specifications. Notwithstanding the foregoing, Sobi shall be responsible for reimbursing Auxilium for the CCP-08 Product, and shall use Commercially Reasonable Effortscost of preparing any new artwork or labeling not listed on Schedule 7.5.1 or any changes to the artwork or labeling listed on Schedule 7.5.1, at its own Auxilium’s cost and expense (including stability testing) to develop a bottle size smaller than plus [**] and larger than [**], which . Sobi shall review any new or modified artwork to ensure regulatory compliance in the Parties currently expect will Territory. Such review shall be a [**] bottle size made in ten (the “Medium Bottle Size”10) with the exact size determined in TRIS’ sole discretion after consultation with AYTU business days. Sobi shall be permitted to apply Xxxxxxx stickers or other similar relabeling for the Products; provided however, that costs and expenses of Labeling design (except Product for use in different countries in the Tuzistra XR Initial Label Changes) and filings and interactions with Regulatory Authorities shall be Territory 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 AYTUSobi’s sole cost expense and expense. Any changes risk, provided that Sobi does so in compliance with all applicable Laws and further provided that Sobi indemnifies and holds harmless Auxilium from any liabilities 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 obligations arising out of such desired change relabeling by Sobi. For the avoidance of doubt, Sobi shall not be permitted to TRIS and forward such modifications or changes to TRIS for incorporation into re-package 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 AYTUProduct.

Packaging and Labeling. The Parties (a) Unless otherwise agreed by the Parties, CODMAN shall reasonably cooperate to change be responsible for packaging the Label of Tuzistra XR so that such Product may be Launched as soon as reasonably practicable after Existing Products, other than the Effective Date (the “Tuzistra XR Initial Label Changes”). Within three (3) months of the Effective Date, AYTU shall supply to TRISXxxxxxxx-Xxxxx® Forceps, in a timely fashion, its logo and finished package form. Synergetics shall be responsible for packaging the layout required to Label the CCP-08 Product Xxxxxxxx-Xxxxx Forceps in finished package form in accordance with Applicable Laws and Section 4.10(a). TRIS the packaging specifications set forth in Schedule D. (b) For all Existing Products, Synergetics shall be responsible, at its sole cost and expense, for securing any approvals required by Agencies in the Territory or other applicable Regulatory Approvals responsible for the initial Label for text, content and regulatory compliance of the CCP-08 Productlabels on the package and the product, the labeling and product package inserts. For purposes of this Agreement the terms “label” and “labeling” shall use Commercially Reasonable Efforts, at its own cost and expense (including stability testing) to develop a bottle size smaller than [**] and larger than [**], which have the Parties currently expect will be a [**] bottle size (the “Medium Bottle Size”) with the exact size determined meanings set forth 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 ChangesSections 201(k) 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 201(m) respectively of the NDA for a Product to AYTU shall be at AYTU’s sole cost U.S. Federal Food, Drug 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 expenseCosmetics Act. 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 Synergetics shall provide at least sixty the English version of all Existing Product labels to CODMAN. Exhibit 10.30 (60c) daysSynergetics shall have the right to apply reasonable patent marking on the Existing Products indicating Synergetics’ advance notice of such desired change to TRIS and forward such modifications or changes to TRIS for incorporation into Patents covering the Packaging and Labeling of such Existing 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 reasonable marking (i) on those products that Synergetics manufactures indicating such manufacture by Synergetics and other costs (including TRIS’ reasonable ii) that the Xxxxx trademark (and documented outin the case of the Xxxxxxxx-of-pocket costs Xxxxx Forceps, the Spetzler™ trademark) is used under license from Synergetics; provided, however that it is understood and expensesagreed that this clause (c) relating to Labels or Packaging that are no longer usable, shall be paid by AYTU 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 TRIS within thirty repackage any Existing Products solely to comply with this clause (30c). (d) days of invoice to AYTU For all Existing Products other than the Xxxxxxxx-Xxxxx® 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 Xxxxxxxx-Xxxxx® Forceps, Synergetics shall be responsible for examplecopy format, expenses 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 Labels 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 XX-Xxxx (or Packaging materials that are no longer useable by TRIS any other required EU-wide Governmental Registration) for all Existing Products during the Term in the Packaging European Union and CODMAN shall apply for and maintain in its name and at its cost any other (i.e., national or Labeling local) Governmental Registrations in EU member states for CODMAN and/or its relevant affiliates to market all Existing Products during the Term in the European Union. (ii) If the Parties agree that CODMAN will be identified as the legal manufacturer on product label and labeling of an Existing Product in the 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 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 Synergetics’ documents required to complete all Governmental Registrations for the 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 non-confidential regulatory submissions for the Existing Products.” 5. Section 3.06(c) (EU Authorized Representative) of the Products because of (a) TRIS’ reliance on the Forecasts provided pursuant to Section 5.1 hereof, or (b) changes requested by AYTU.Distribution Agreement is hereby deleted in its entirety. Exhibit 10.30

Packaging and Labeling. The 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 logo and the layout required to Label the CCP-08 Product in accordance with Applicable Laws and Section 4.10(a). TRIS shall be responsible, at its sole cost and expense, for securing any approvals required by Agencies in the Territory or other applicable Regulatory Approvals for the initial Label for the CCP-08 Product, and shall use Commercially Reasonable Efforts, at its own cost and expense (including stability testing) to develop a bottle size smaller than [**] 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: [**] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.