EXCLUSIVE LICENSE AGREEMENT
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Exhibit 10.4
Execution Copy
Confidential
This Exclusive License Agreement (this “Agreement”), dated as of April 14, 2021 (“Effective Date”), is by and between Alimera Sciences, Inc., a company organized and existing under the laws of the State of Delaware, United States of America (“Alimera”), and Ocumension (Hong Kong) Limited, a company organized and existing under the laws of Hong Kong (“Ocumension”). Alimera and Ocumension are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Alimera is a pharmaceutical company specializing in the commercialization and development of prescription ophthalmology treatment for the management of retinal diseases;
WHEREAS, Alimera has developed the Product (as defined below), and commercializes the Product under the Iluvien® trademark under a Second Amended and Restated Collaboration Agreement dated as of 10 July, 2017 by and between Alimera and pSivida US Inc. (n/k/a EyePoint Pharmaceuticals, Inc. (“EyePoint”), with the right of Alimera to sub-license under the terms and conditions set forth therein (“Master License”);
WHEREAS, the Product has received regulatory approval for marketing and sale for specific usage indications in various countries, including the United States of America, 17 countries of the European Economic Area, and Australia, Canada, Israel, UAE, Kuwait and Lebanon;
WHEREAS, Ocumension desires to obtain from Alimera the exclusive right and license to register, seek reimbursement for, import, export, market, promote, distribute, and sell Product in the Field (as defined below) in the Territory (as defined below), and Alimera desires to grant such right and license, all under the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
Section 1.1 Definitions. When used in this Agreement, each of the following terms, whether used in the singular or plural, shall have the meanings set forth in this Section 1.1. |
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“Affiliate” means, with respect to a Party, any Person directly or indirectly, through one or more intermediaries, controlling, controlled by, or under common control with such Party. For this purpose, “control” (including the terms controlling, controlled by and under common control with) means the power whether or not normally exercised, to direct the management and affairs of another Person, directly or indirectly, whether through the ownership of voting securities, by contract, or otherwise. In case of a corporation, the direct or indirect ownership of fifty percent (50%) or more of its outstanding voting securities shall in any case be deemed to confer “control.” Notwithstanding a potential share purchase by Ocumension, for the purposes of this Agreement, Alimera shall not be regarded as an Affiliate of Ocumension.
“Ancillary Agreements” means the Pharmacovigilance Agreement, the Supply Agreement and the Quality Agreement.
“Applicable Laws” mean any and all laws, rules, regulations, directives, treaties, statutes, ordinances, codes, administrative circulars, guidelines and guidances (including cGCP, cGLP and cGMP) of any governmental authority within the applicable country or jurisdiction, as amended from time-to-time, pertaining to any and all activities under this Agreement.
“Approved Labels” means the following labels: “The treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids,” “treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies,” and/or any other label approved in writing by Alimera (such approval not to be unreasonably withheld, conditioned or delayed) in the Field to the extent permissible under the Applicable Laws in any country or jurisdiction in the Territory.
“Business Day” means any day on which commercial banks are open for business in, for Alimera, Atlanta, Georgia, United States, and for Ocumension, Beijing, China.
“Calendar Quarter” means a period of three (3) consecutive months ending on the last day of March, June, September or December, respectively.
“Calendar Year” means a period of twelve (12) consecutive months beginning on January 1 and ending on December 31.
“cGCP” means the current good clinical practices officially published and interpreted or required by (i) the FDA, as set forth in FDA regulations in 21 C.F.R. Parts 11, 50, 54, 56, and 312 (and any successor statutes and/or regulations) and related FDA guidance documents, (ii) the NMPA, or (iii) the ICH, in each case, to the extent applicable to activities under this Agreement and required by Applicable Laws in the Territory.
“cGLP” means the current good laboratory practices and procedures officially promulgated or endorsed by (i) the FDA, as set forth in 21 C.F.R. Part 58 (and any successor statutes and/or regulations), and related FDA guidance documents and comparable regulatory standards, (ii) the NMPA, or (iii) other Regulatory Authorities, in each case, to the extent applicable to activities under this Agreement and required by Applicable Laws in the Territory, as they may be updated from time to time, including applicable guidelines promulgated under the ICH.
“cGMP” means the current good manufacturing practices officially promulgated or
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enforced by (i) the FDA, as codified in the U.S. Code of Federal Regulations, (ii) the NMPA, or (iii) other Regulatory Authorities, in each case, to the extent applicable to activities under this Agreement and required by Applicable Laws in the Territory, all as amended from time to time.
“Change of Control” means, with respect to either Party, (i) a merger, acquisition or consolidation with a Third Party which results in the voting securities of that Party outstanding immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, acquisition or consolidation, (ii) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of the Party, (iii) the sale or other transfer to a Third Party of all or substantially all of the Party’s assets or business to which the subject matter of this Agreement relates, (iv) the stockholders or equity holders of the Party shall approve a plan of complete liquidation of the Party or an agreement for the sale or disposition by the Party of all or a substantial portion of the Party’s assets, other than pursuant to the transaction as described above or to an Affiliate, or (v) a change in the composition of the Party’s board of directors (the “Board”) over a period of twelve (12) consecutive months or less such that a majority of the Board members cease by reason of one or more contested elections for Board membership to be comprised of individuals whose election is endorsed by a majority of the members of the Board immediately before the date of election.
“Clinical Trials” means a clinical trial of a pharmaceutical product or compound in human patients, including Xxxxx 0, Xxxxx 2 or Phase 3 clinical trials, as defined in 21 C.F.R. 312.21, as amended from time to time, or the corresponding foreign regulations, as well as other clinical trials that may be conducted in connection with or in order to obtain or maintain a Regulatory Approval.
“Commercialize” or “Commercialization” means all activities directed to the use, marketing, promotion, sale, offering for sale, distribution, and/or importation and exportation of the Product, including planning, market research, advertising, educating, marketing, promoting, importing, exporting, distributing and post-marketing safety surveillance and reporting.
“Commercially Reasonable Efforts” means, with respect to a Party’s obligations or activities under this Agreement, the carrying out of such obligations or activities with a level of effort and resources consistent with the commercially reasonable practices normally devoted by a similarly situated company within the pharmaceutical industry, as part of an active and continuing program of Development and Commercialization of a pharmaceutical product of similar market potential, at a similar stage of its product life, taking into account the competitiveness of the marketplace and the proprietary position, regulatory status, and relative safety and efficacy of such product.
“Control” or “Controlled” means, with respect to any compound, product, material, information, data, Patent, Trademark or other Intellectual Property right, that a Party owns or has a license to such compound, product, material, information, Patent, Trademark or other Intellectual Property right and has the ability to grant to the other Party access, a license or a sublicense (as applicable) to such compound, product, material, information, Patent, Trademark or other Intellectual Property right as provided for herein, unless, to the extent the consent of a Third Party is required for such access, license or sublicense, such Party is unable to obtain such consent after using Commercially Reasonable Efforts to obtain such consent.
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“Develop” or “Development” means all activities directed to the development of the Product, including conducting any Clinical Trials and other activities directed to obtaining and maintaining any Regulatory Approval in the Field, including any marketing, pricing or reimbursement approval. For the sake of clarity, Development shall not include Commercialization.
“Dollars” means the legal tender of the United States.
“EyePoint IP” means all compounds, products, materials, information, data, Patents, Inventions and other Intellectual Property covered by the Master License.
“FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78dd-1, et seq.) as amended.
“FDA” means the United States Food and Drug Administration, or any successor agency or authority thereto.
“Field” means treatment and prevention of eye diseases in humans and excludes treatment and prevention of uveitis.
“First Commercial Sale” means the first invoiced sale of the Product in the relevant country or jurisdiction in the Territory by or on behalf of Ocumension, its Affiliates or Sublicensees to a Third Party after receipt of Regulatory Approval (other than pricing and reimbursement approval) for such Product in such country or jurisdiction or, if no such Regulatory Approval or similar marketing approval is required, the date upon which the Product is first commercially launched in such country or jurisdiction. In furtherance, and not in limitation of the foregoing, First Commercial Sale shall exclude transfers or dispositions of the Product as follows: (i) in connection with patient assistance programs; (ii) for charitable or promotional purposes; (iii) for preclinical, clinical, regulatory or governmental purposes or under so-called “named patient”, “compassionate use” or other limited access programs; or (iv) for use in any tests or studies reasonably necessary to comply with Applicable Laws or a request by a Regulatory Authority.
“ICH” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use of the World Health Organization, or any successor conference, council or organization.
“IFRS” means international financial reporting standards as consistently applied.
“IND” means the equivalent application of an Investigational New Drug application to the FDA, such as a clinical trial application or a clinical trial exemption, the filing of which is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in a particular country or jurisdiction.
“Initial Regulatory Materials” shall mean specifically the IND and NDA for the Product as filed with the FDA, as well as all reasonably accessible and material FDA correspondence related to the submission and approval of both the IND and the NDA for the Product. For clarity, Initial Regulatory Materials transferred to Ocumension will not include the drug master files held by suppliers or contract manufacturers for the Product.
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“Intellectual Property” shall mean: (i) rights associated with works of authorship, including copyrights, copyrights restrictions, mask work rights, moral rights, and registrations and applications for registration of any of the foregoing, (ii) Patents, (iii) Inventions, (iv) Trademarks, (v) all rights related to trade secrets and know-how, including technical information and data, and (vi) rights analogous to those set forth herein, and any and all other intellectual property and proprietary rights, whether or not registrable or patentable.
“Invention” means any invention, discovery or development, whether or not patentable, made, conceived or reduced to practice in relation to the Product, whether made, conceived or reduced to practice solely by, or on behalf of, Ocumension, Alimera, the Parties jointly, or any Affiliate, Sublicensee, or other agent of the same.
“Manufacturing Costs” means, with respect to a Product, the costs of manufacturing such Product, calculated in accordance with Alimera’s internal accounting policies and principles, which are in accordance with GAAP and applied consistently to other products that Alimera produces.
“NDA” or “New Drug Application” means (i) the single application or set of applications for Regulatory Approval to Commercialize in the Territory a pharmaceutical product filed with a Regulatory Authority, and any related registrations with or notifications to such Regulatory Authority, and (ii) all supplements and amendments that may be filed with respect to any of the foregoing.
“Net Sales” means with respect to the Product for any period, the gross invoiced sales price of the Product sold during such period by or on behalf of Ocumension or its Affiliates or Sublicensees in the Territory in finished product form, (re-)packaged and labeled for sale to Third Parties (including wholesalers or distributors), further less the following deductions:
(i)trade, cash and quantity discounts (including for timely payment);
(ii)price reductions or rebates, retroactive or otherwise;
(iii)taxes on sales (such as sales, value added, or use taxes);
(iv)amounts repaid or credited (such as by reason of rejections or defects);
(v)any invoiced amounts from any prior period which are not collected and are written off in good faith by Ocumension or its Affiliate or Sublicensee, including bad debts specifically in relation to the sale of Product; provided, that if any written off or written down amounts are recovered, then such amounts would constitute part of Net Sales for the period in which such amounts are recovered;
(vi)freight, insurance and other transportation charges relating to the sale of Product;
(vii)costs associated with administering any contractual and governmental rebates or co-pay assistance program; and
(viii)any other similar or customary deductions in accordance with IFRS.
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The foregoing notwithstanding:
(A) the foregoing items (iii) and (viii) may be deducted only to the extent included in the gross invoiced sales price; |
(B) when calculating Net Sales, Ocumension and its Affiliates and Sublicensees shall not be permitted to make any deductions from gross amounts invoiced that they would not deduct from revenue in producing their financial statements in accordance with IFRS; |
(C) where a sale or supply of a Product is in a transaction that is not at arm’s length, the Net Sales for such transaction shall be the price that would have been so invoiced if it had been at arm’s length; and |
(D) where the sale or supply of Product is in a transaction that is not exclusively for money, the Net Sales for such transaction shall be the price that would have been so invoiced if it had been at arm’s length and exclusively for money. |
Net Sales shall not include (1) any transfers between Ocumension and its Affiliates and (2) transfers or dispositions of the Product for charitable, compassionate use, named patient use, promotional, preclinical, clinical trial or development, or regulatory purposes. Net Sales shall not include sales between or among Ocumension, its Affiliates or Sublicensees except where such Affiliates or Sublicensees are end users. Subject to the above, Net Sales shall be calculated in accordance with IFRS, consistently applied.
In the event that a Product is sold as part of a combination (“Combination Product”) with a second product in addition to the Product (a “Second Product”), then Net Sales for the Product shall be determined by multiplying actual Net Sales of the Combination Product by the fraction A/(A+B) where (1) A is the mean selling price in the relevant region of the countries in the Territory of the Product sold separately in the same formulation and dosage as in the Combination Product and (2) B is the mean selling price in such region of the countries of the Territory of the Second Product (excluding any other products in combination with which the Second Product has been granted Regulatory Approval) when sold separately in the same formulation and dosage, in each case during the applicable financial year.
If either the Licensed Product or the Second Product are not sold separately in the same formulation and dosage as in the Combination Product in such region of the Territory, or the relevant mean selling price cannot be determined, the Parties shall seek to agree the fair market value of each of the Product and Second Product and the same calculation shall apply.
Ocumension may not sell the Product in combination with a Second Product without Alimera’s prior written consent, which shall not be unreasonably withheld, delayed or conditioned.
“NMPA” means the National Medical Product Administration, formerly known as the China Food and Drug Administration, and local or provincial counterparts thereto, and/or any successor agency or authority thereto having substantially the same function.
“Patents” means any patents and patent applications and all substitutions, divisionals, continuations, continuation-in-parts, any patent issued with respect to any such patent applications,
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any reissue, reexamination, utility models or design patents, renewal or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof in any country.
“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.
“Product” means Alimera’s 190 microgram fluocinolone acetonide intravitreal implant in applicator, for which Regulatory Approval was granted in the United States.
“Product Improvement” means collectively any right, title and interest in any improvements and modifications (other than Trademarks) that are developed by or on behalf of a Party or its Affiliates under this Agreement and covered by or derived from practice of Product IP (other than Joint Inventions and Joint Patents), whether or not protectable under patent, trademark, copyright or similar law.
“Product IP” means (a) the Patents as set forth in Exhibit 1 hereto, and (b) any other Intellectual Property (other than Trademarks) (i) necessary or reasonably useful for, or related to, the Development or Commercialization of the Product in the Field in the Territory and (ii) Controlled by Alimera or its Affiliates as of the Effective Date or at any time during the Term of this Agreement.
“Product Trademarks” means Trademarks Controlled by Ocumension that are selected by Ocumension (with reasonable consultation with Alimera) for the purpose of implementation of this Agreement, to be specific to the Product in the Territory.
“Regulatory Approval” means shall mean any approvals, registrations or authorizations by a Regulatory Authority, necessary for the import, export, use and Commercialization of the Product in a particular country or jurisdiction, including an NDA and any analogous approval, license, registration or authorization of any Regulatory Authority in a particular country or jurisdiction and any supplements and amendments thereto.
“Regulatory Authority” shall mean any national, regional, state or local regulatory agency, authority, department, bureau, commission, council or other governmental entity, including the NMPA, having jurisdiction over this Agreement or any of the Parties or Affiliates or Sublicensees or over development, manufacture, sale or use of Product, including the granting of Regulatory Approval for the Product.
“Regulatory Materials” means documents and other materials developed or compiled in preparation for, or relating to, Regulatory Authority meetings, or regulatory applications or approvals, including INDs, NDAs, DMFs of drug substance, excipients, packaging materials, and medical devices, correspondences, meeting background materials, meeting minutes with Regulatory Authorities, letters, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority with respect to the Product in a particular country or jurisdiction.
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“Term” means the term of this Agreement as set forth in Section 10.1.
“Territory” means the Peoples Republic of China, including Hong Kong SAR and Xxxxx XXX, xxxxxx xx Xxxxxx, Xxxxx Xxxxx, Xxxxxx, Xxxxxxxx, East Timor, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
“Third Party” means an individual, corporation, partnership, joint venture, limited liability entity, governmental authority, unincorporated organization, trust, association or other entity that is not related to (directly or indirectly), or an Affiliate of, a Party hereto.
“Trademarks” means trademarks, service marks, logos, slogans, trade names, Internet domain names and any other indicator of the source of origin of goods or services, together with goodwill associated therewith.
Section |
|
Agreement |
Preamble |
Alimera |
Preamble |
Alimera Assistance |
Section 3.2(b) |
Alimera Expenses |
Section 3.3 |
Alimera Patents |
Section 11.7(a) |
Breaching Party |
Section 10.3 |
Combination Product |
Section 1.1 |
Confidential Information |
Section 12.1 |
Cure Period |
Section 10.3 |
Disclosing Party |
Section 12.1 |
Effective Date |
Preamble |
EyePoint |
Recital |
Indemnification Claim Notice |
Section 9.3(a) |
Indemnified Party |
Section 9.3(a) |
Indemnifying Party |
Section 9.3(a) |
Initial Regulatory Materials |
Section 3.2(a) |
Joint Inventions |
Section 11.6(b) |
Joint Patents |
Section 11.7(c) |
JSC |
Section 4.1 |
JSC Member |
Section 4.2 |
Ocumension |
Preamble |
Ocumension Patents |
Section 11.7(b) |
Party and Parties |
Preamble |
Quality Agreement |
Section 6.2 |
Receiving Party |
Section 12.1 |
Sales Milestone Event |
Section 5.2 |
Sales Milestone Payments |
Section 5.2 |
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Second Product |
Section 1.1 |
Sole Inventions |
Section 11.6(a) |
Sublicensee |
Section 2.3 |
Supply Agreement |
Section 6.2 |
Terminating Party |
Section 10.3 |
Territory Filings and Approvals |
Section 3.10 |
Transfer Price |
Section 6.3 |
(c) exercise its rights and perform its obligations under this Agreement and the Ancillary Agreements. |
Ocumension shall remain liable for its Affiliates’, Sublicensees’, and subcontractors’ compliance with the applicable terms of this Agreement and shall be solely and severally liable for any breach of applicable obligations hereunder by any Affiliate, Sublicensee or subcontractor of Ocumension, notwithstanding any degree of Ocumension’s own fault. Alimera may bring at any time any claim against Ocumension directly for breach of applicable obligations of this Agreement by any Affiliate or Sublicensee or subcontractor of Ocumension.
Section 2.4 Delivery. Within sixty (60) days after the Effective Date (with respect to Product IP existing as of the Effective Date), and within sixty (60) days after the creation or development of any other Product IP (with respect to any Product IP created or developed during the Term), Alimera shall deliver to Ocumension all information, documents, materials and other embodiments of the Product IP (including relating to Patents, trade secrets and know-how) reasonably necessary to enable and assist Ocumension to exercise its rights and conduct the activities contemplated by this Agreement. |
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Section 2.5 Product Trademarks. Ocumension may (i) Develop and Commercialize the Product under any Product Trademarks and (ii) use the Product Trademarks in connection with the Product. The Product Trademarks shall be distinct from any Trademark used by Ocumension for any other product marketed by Ocumension in the Territory, including the product licensed by Ocumension from EyePoint for treatment of uveitis. The Product Trademarks shall not be filed, registered or used by Ocumension outside the Territory. Nothing in this Agreement grants Ocumension any right to Control or use any Trademark owned by Alimera, including ILUVIEN®, its transliterations, or confusingly similar Trademarks in or outside the Territory, without Alimera’s prior written consent. |
Section 2.6 Approved Labels. Except as permitted by Applicable Laws, Ocumension will Commercialize the Product under only Approved Labels. If Ocumension or its Affiliates or Sublicensees through independent research and development under this Agreement identifies new indications for use of Product, Ocumension shall prior to any application or use of such findings share related data, studies, clinical protocols, clinical data, reports, chemistry, manufacturing and control data and information (in each case, in Ocumension’s possession and control) with Alimera. Alimera shall consider and agree in good faith to adjust the Approved Labels to reflect such new indications. |
Section 2.7 Master License. Each Party hereby acknowledges and agrees that: |
(a) Ocumension is not and will not become an Affiliate of Alimera for the purposes of this Agreement; |
(b) this Agreement is and will remain an arm’s length transaction; |
(c) this Agreement is intended to (i) be consistent with the terms and conditions of the Master License and (ii) have included such terms and conditions as are necessary to permit Alimera to fulfill its obligations under the Master License, and the Parties in case of conflict between this Agreement and the Master License shall agree and modify this Agreement to this end, if applicable; provided that Alimera shall indemnify and hold harmless Ocumension and its Affiliates from and against any and all Losses arising in connection with such any amendment; |
(d) nothing in this Agreement will expand any rights granted by licensor under Master License to Alimera; and |
(e) nothing in this Agreement may be construed as (i) a waiver of respective rights under the Master License, which remain reserved, or (ii) an interpretation, clarification, amendment or expansion of, or evidence of any course of dealings with respect to any provisions of the Master License. |
Section 3.1 Development and Commercialization Efforts. Ocumension shall use
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Commercially Reasonable Efforts to Develop, obtain Regulatory Approval for and Commercialize the Product in the Field in the Territory. For clarity, the Parties confirm their understanding that Commercially Reasonable Efforts for Development and Commercialization do not require or include local manufacturing by Ocumension or its Affiliate, Sublicensee, or subcontractor in the Territory. |
Section 1.7 Alimera’s Support for Development and Commercialization. |
Alimera has provided, and Ocumension has had access to and has reviewed, a portion of the Initial Regulatory Materials in an electronic data room. Ocumension will provide, within fourteen (14) days from the Effective Date, a complete list (in English) of any additional Initial Regulatory Materials reasonably necessary to perform Ocumension’s Product Development responsibilities under this Agreement, and Alimera shall initiate transfer of all information and documentation on the list and under Alimera’s Control within sixty (60) days of the Effective Date and complete such transfer within ninety (90) days of the Effective Date in a manner and form as agreed by Alimera and Ocumension; Ocumension shall confirm receipt in writing and be responsible for any translations at its own cost and Alimera will use Commercially Reasonable Efforts to cause drug substance vendors, excipients vendors and medical devices vendors to file drug master files to the NMPA, and other Regulatory Authority in the countries and jurisdictions of the Territory, if and as required and applicable. Upon Ocumension’s request, Alimera will use Commercially Reasonable Efforts to cause suppliers of packing components and items which make up the Product’s administration kit to make medical device-related filings to NMPA, and other Regulatory Authority in the countries and jurisdictions of the Territory, if and as required and applicable. The list of Initial Regulatory Materials shall include a letter of authorization allowing Ocumension to file the Product data and reports to the Regulatory Authorities in the Territory, the complete Product IND dossier with FDA correspondence, the complete Product NDA dossier with FDA correspondence and the latest version of the NDA dossiers updated post-FDA approval. Alimera will provide Ocumension with subsequent NDA submissions and other Regulatory Materials in relation to the Product, including annual reports, approval supplements, changes being effected, and FDA correspondences, within ten (10) Business Days after the submission or receipt thereof. In addition, Alimera will file a Certificate of a Pharmaceutical Product with the FDA and EMA no later than thirty (30) days after execution of this Agreement. Without limiting the generality of the foregoing, Alimera shall, and shall cause its Affiliates to, upon being contacted
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by the FDA or another Regulatory Authority, regarding any material regulatory purpose pertaining to this Agreement or to the Product, including for risk management communications, dear doctor letters, urgent safety restrictions or labeling changes, communicate with and timely inform Ocumension. If Alimera intends to make, or becomes aware of, any actual or potential material changes relating to the Product, including relating to safety, specifications, manufacturing, Regulatory Approvals or other aspects of the Product, whether in or outside of the Territory, Alimera shall promptly inform Ocumension of such changes in writing, in any event prior to seeking Regulatory Approvals for such changes with the FDA or another Regulatory Authority. Alimera shall provide Ocumension with copies of all material correspondence by it or any of its Affiliates or licensees or sublicensees (to which Alimera has access) with any FDA or another Regulatory Authority with respect to the Product, as well as a roadmap of such correspondence, within ten (10) days after receipt or submission of such correspondence, and Alimera acknowledges and agrees that Ocumension may share such information (excluding any information which is marked or reasonably understood to be trade secrets or confidential information) with its contractual partners, Sublicensees and/or subcontractors with any rights to Develop and Commercialize Product in the Territory (for use in connection with any such rights).
(i) Alimera will make Commercially Reasonable Efforts to provide support to Ocumension reasonably requested by Ocumension (taking into account any applicable legal restrictions) (including by in-country presence of Alimera’s personnel, taking into consideration of any negative impact on taxation of Alimera by such country and subject to reasonable security concerns) in preparing materials for submission in obtaining Marketing Authorization and reimbursement pricing, including providing access to data and documentation in Alimera’s control, granting the right of reference to approved regulatory dossiers, and helping to create and develop value arguments. |
(ii) Alimera will provide Ocumension with approved promotional, scientific and training material related to the Product, and Alimera will reasonably assist Ocumension in the initial training of Ocumension. The Parties will promptly agree on details of such training assistance in good faith. |
(iii) Alimera will provide Ocumension with Alimera-approved, English language promotional materials for translation and use locally under the Product Trademarks, pending the obtaining of an Approved Label in the applicable country or jurisdiction of the Territory. Ocumension shall bear all responsibility (including compliance with Applicable Laws in the Territory) for development of promotional materials for the Territory and shall indemnify
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Alimera and its Affiliates accordingly pursuant to Section 9.1. Alimera in addition shall have the right to review Product promotional materials for compliance with this Agreement. |
Section 1.11 Pricing and Marketing. Ocumension shall, in its sole discretion and subject
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to Applicable Laws, determine and control Product pricing, marketing and promotion in the Territory. |
(b) Timely information. Ocumension and its Affiliates shall, and Ocumension shall contractually require its Sublicensees to, upon being contacted by the FDA or another Regulatory Authority, regarding any material regulatory purpose pertaining to this Agreement or to the Product, including for risk management communications, dear doctor letters, urgent safety restrictions or labeling changes, communicate with and timely inform Alimera. For clarity, Ocumension shall keep Alimera reasonably informed of material developments and results of applications for Regulatory Approval of the Product in the Territory under this Agreement. Ocumension shall provide Alimera with copies of all material correspondence (in original language) by it or any of its Affiliates or Sublicensees (to which Ocumension has access) with any such Regulatory Authority with respect to Product, as well as English translation of a roadmap of such correspondence, within ten (10) Business Days after its receipt or submission of such correspondence, and Ocumension acknowledges and agrees that Alimera may share such
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information (excluding any information which is marked or reasonably understood to be trade secrets or confidential information) with its contractual partner under the Master License and other distributors and/or licensees with any rights to promote, market, distribute and/or sell Product outside the Territory (for use in connection with any such rights). |
(d) it will use Commercially Reasonable Efforts to pursue Regulatory Approval and reimbursement for the Product in the Field and Territory consistent with the Approved Labels. |
Section 3.2 No Violation of Applicable Laws. Notwithstanding anything that may be to the contrary, neither Party shall be required to perform any obligations under this Agreement if the performance of such obligations would, or would reasonably be expected to, result in a violation of Applicable Laws, which could not be promptly remedied by Commercially Reasonable Efforts. Each Party will promptly notify the other Party and keep the other Party reasonably informed of any such affected obligations and use Commercially Reasonable Efforts to cooperate with the other Party and arrange a substitute means of performing substantially similar obligations reasonably acceptable to the other Party. |
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JOINT STEERING COMMITTEE
Section 1.17 Responsibilities of the JSC. The JSC shall have, inter alia, the following responsibilities: |
(e) coordinating the activities of the Parties under this Agreement and providing a forum to facilitate communications between the Parties under this Agreement; |
(f) reviewing and discussing the Development and Commercialization of the Product in the Field in the Territory; |
The JSC shall not have any authority to amend, modify or waive compliance with this Agreement.
Sales Milestone Event (in Dollars) |
Sales Milestone Payment (in Dollars) |
[***] |
[***] |
[***] |
[***] |
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[***] |
[***] |
In the event that more than one Sales Milestone Event is first achieved in the same Calendar Year, then Ocumension shall pay to Alimera each of the corresponding Sales Milestone Payments for each such Sales Milestone Event that has been achieved in that Calendar Year. Ocumension shall notify Alimera in writing within thirty (30) days following the achievement of a Sales Milestone Event for which a Sales Milestone Payment is payable. Ocumension shall pay to Alimera the applicable Sales Milestone Payment within fifteen (15) days following the date of the written notice provided by Ocumension of the achievement of the relevant Sales Milestone Event. For clarity, each Sales Milestone Payment is only payable once, upon the first achievement of the applicable Sales Milestone Event, and in no event shall the total amount of Sales Milestone Payments exceed Eighty-Nine Million Dollars ($89,000,000).
Section 1.24 Net Sales Report. Not later than forty-five (45) days following the end of each Calendar Quarter following the First Commercial Sale of the Product in a given country of the Territory (including the Calendar Quarter in which the expiry or termination of this Agreement takes effect), Ocumension shall submit to Alimera a written report detailing, in respect of each country and jurisdiction of the Territory in which the Product is sold by Ocumension or its Affiliates or Sublicensees during such Calendar Quarter: |
(a) the quantity of Product invoiced; |
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(b) the gross amounts invoiced and from which Net Sales were calculated; |
(c) the total Net Sales of Product during the relevant Calendar Quarter, in Dollars and the currency in which the Net Sales were recorded, showing the conversion rates used; and |
(d) the amount of any Sales Milestone Payment due in relation to such Net Sales pursuant to this Section, if any. |
Ocumension shall pay to Alimera any Sales Milestone Payment due in respect of the Net Sales as stipulated in Section 5.2 herein.
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Section 1.27 Terms of Supply. Demand forecasts will be set forth in the Supply Agreement, including minimum order quantities for the term of the Supply Agreement. The Supply Agreement shall also include the following terms: |
(a) Alimera will manufacture the FD Product to meet the quantities set out in purchase orders from Ocumension, subject to Alimera’s reasonable acceptance of such orders. |
(b) Ocumension will provide a monthly twelve (12)-month rolling forecast, the first four (4) months of which will be binding. |
(c) Alimera will meet Ocumension’s requirements and assign shipping dates as close as practicable to the dates requested by Ocumension, provided that the requested date is not sooner than one hundred and eighty (180) days from the order date. |
(d) Prior to any shipment of FD Product, Alimera will notify Ocumension of the shipment, including estimated date and time of arrival. |
(e) Unless otherwise agreed with Ocumension, Alimera will supply FD Product made to order, with a minimum of seventy-five (75%) of shelf life on date of shipment to Ocumension. |
(f) Delivery terms shall be FCA Supplier Facility (Incoterms 2020). |
(g) Payment for FD Product must be made within thirty (30) days after receipt of invoice issued upon shipment of the FD Products. |
(h) Ocumension will have the right to conduct quality assurance audits and inspections of (i) Alimera’s books and records to the extent reasonably necessary to verify compliance with the Supply Agreement and the Quality Agreement and any regulatory requirements and Applicable Laws to which Ocumension is subject and which are applicable to the manufacture, importation and marketing of the Product, and (ii) to the extent requested by Regulatory Authorities or otherwise necessary for purposes of compliance with Applicable Laws, the facilities (including any third party facilities) where the Product is manufactured, tested or stored. |
Section 1.32 Cost of Audit by Ocumension. The cost of the audit set forth in Section 7.4 will be borne by Ocumension, unless the audit reveals an overpayment of the Transfer Price by Ocumension, in which case, Alimera shall reimburse Ocumension for the reasonable costs of such audit. |
Section 1.33 Representations, Warranties and Covenants of Alimera. Alimera represents, warrants and covenants that as of the Effective Date, and during the Term: |
(a) it has the corporate authority to enter into this Agreement and to perform its obligations hereunder; |
(b) entering into this Agreement and performing the obligations hereunder will not conflict with (i) its organizational documents, (ii) its material contracts, or (iii) Applicable Laws; |
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(d) at the Effective Date (but, for the avoidance of doubt, without limiting any of the other representations, warranties or covenants herein), the Master License is valid, enforceable and in full force and effect; |
(f) Alimera will (i) not enter into any amendment to the Master License that would reasonably be expected to limit the scope of the licenses or rights granted thereunder, or conflict with this Agreement, and (ii) subject to and without limiting Section 10.2, not terminate the Master License without valid legal reason under the Master License; |
(g) Alimera is and will be in compliance with the Master License, except for any non-compliance that does not, and would not reasonably be expected to, have a material adverse impact on the licenses, rights or obligations hereunder; |
(h) Alimera has provided Ocumension with an accurate and complete copy of the terms and conditions of the Master Agreement; |
(c) to its knowledge, all of the Product IP is valid and enforceable; and |
(d) it shall perform its obligations under this Agreement in compliance with all Applicable Laws in all material respects. |
Section 8.2 Representations, Warranties and Covenants of Ocumension. Ocumension represents, warrants and covenants that as of the Effective Date and during the Term: |
(a) it has the corporate authority to enter into this Agreement and to perform its obligations hereunder; |
(e) entering into this Agreement and performing the obligations hereunder will
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not conflict with (i) its organizational documents, (ii) its material contracts, including license agreements for “Yutiq” or otherwise with EyePoint, or (iii) Applicable Laws; |
(g) it has the pharmaceutical distribution permits or other permits necessary to meet its obligations under this Agreement to Develop and Commercialize the Product in the Field in the Territory; |
(h) it shall not manufacture or have manufactured the Product (other than (i) manufacturing by Alimera or its Affiliates or subcontractors or (ii) finishing any part-finished Product supplied by Alimera or its Affiliates or subcontractors or labeling or packaging any Product supplied by Alimera or its Affiliates or subcontractors) during the Term; and |
(i) it shall perform its obligations under this Agreement in compliance with all Applicable Laws in all material respects. |
Section 1.2 Anti-Corruption Compliance. Each Party represents, warranties and covenants that as of the Effective Date and during the Term: |
(b) No Foreign Official Agents. No director, officer, employee, agent, consultant or other representative of either Party is a “foreign official” (as defined in the FCPA). |
(c) Cooperation with Investigations. Each Party will fully cooperate with any ethics or compliance investigations into possible FCPA violations of the FCPA or the anti-bribery laws and regulations of the Territory or other countries that arise in connection with this Agreement. |
(d) Complete and Accurate Books and Records. Each Party will keep accurate financial books and records in connection with its performance under this Agreement. |
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notice except to the extent that such delay actually prejudices the defense of such proceeding. Each Indemnification Claim Notice shall contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss are known at such time). Together with the Indemnification Claim Notice, the Indemnified Party will furnish promptly to the Indemnifying Party copies of all notices and documents (including court papers) received by any Indemnified Party in connection with the Third Party Claim. |
(c) Right to Participate in Defense. Without limiting the foregoing, any Indemnified Party will be entitled to participate in the defense of a Third Party Claim for which it has sought indemnification hereunder and to employ counsel of its choice for such purpose; provided, however, that such employment will be at the Indemnified Party’s own expense unless (i) the employment thereof has been specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party has failed to assume the defense (or continue to defend such Third Party Claim in good faith) and employ counsel in accordance with this Section 9.3, in which case the Indemnified Party will be allowed to control the defense at the Indemnifying Party’s expense. |
(d) Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that will not result in the Indemnified Party (i) becoming subject to injunctive or other relief, or (ii) admitting any breach or violation of contract or law, the Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its reasonable discretion, will deem appropriate (provided, however, that such terms shall include a complete and unconditional release of the Indemnified Party from all liability with respect thereto). With respect to all other Losses in connection with Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 9.3(b), the Indemnifying Party will have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss; provided, it obtains the prior written consent of the Indemnified Party (which consent will be not be unreasonably withheld, conditioned or delayed). The Indemnifying Party that has assumed the defense of (and continues to defend) the Third Party Claim in accordance with Section 9.3(b) will not be liable for any settlement or other disposition of a Loss by an Indemnified Party that is reached without the written consent of such Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, no Indemnified Party will admit any liability
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with respect to, or settle, compromise or discharge, any Third Party Claim without first offering to the Indemnifying Party the opportunity to assume the defense of the Third Party Claim in accordance with Section 9.3(b). |
(e) Cooperation. If the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party will, and will cause each other Indemnified Party to, cooperate in the defense or prosecution thereof and will furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection with such Third Party Claim. Such cooperation will include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making Indemnified Parties and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation. |
Section 9.5 Insurance. During the Term, each Party shall procure, provide a certificate of insurance of, and maintain insurance, including general liability insurance and product liability insurance, adequate to cover its obligations hereunder and which is consistent with normal business practices of prudent companies similarly situated at least thirty (30) days prior to when Product is being clinically tested in human subjects (in the case of clinical trial insurance) or commercially distributed or sold (in the case of product liability insurance) by such Party pursuant to this Agreement. The policies of insurance obtained by the Parties hereunder must state that the insurer shall notify the other Party at least thirty (30) days prior to termination, cancellation of, or any material change in, the coverage provided. |
(a) Subject to this Section 10.2, this Agreement shall terminate in its entirety in the event that the Master License terminates; provided that (i) Alimera shall use Commercially Reasonable Efforts to inform Ocumension promptly in writing of any actual, anticipated, likely or imminent termination notice relating to the Master License, and (ii) if Ocumension obtains or can demonstrate that it reasonably expects to promptly obtain a license from EyePoint or its Affiliates, (A) this Agreement shall continue in full force and effect and shall not be terminated except solely with respect to the sublicense granted by Alimera to Ocumension under the EyePoint IP under the Product License, and (B) Alimera shall be responsible for Ocumension’s reasonable Third Party costs for obtaining a license from EyePoint or its Affiliates (including reasonable amounts payable to EyePoint or its Affiliates in connection with or under a license to EyePoint IP), and (C) Alimera and Ocumension will discuss and agree on in good faith any other amendment appropriate to reflect such partial termination of this Agreement. |
(c) In the event that the Master License is terminated or is expected to be terminated (other than solely caused by Ocumension’s breach of this Agreement), Alimera shall, at its sole cost, use Commercially Reasonable Efforts to, as soon as practicable: (a) assist Ocumension in obtaining a direct license under EyePoint IP from EyePoint to Ocumension on commercially reasonable terms and conditions; (b) either (i) continue to perform Alimera’s obligations under the Supply Agreement according to its terms and conditions, or (ii) assist Ocumension in obtaining direct licenses and direct supply and manufacturing agreements on commercially reasonable terms from Alimera’s suppliers and manufacturers of the Product or any components of the Product; (c) reasonably cooperate with Ocumension (and its designees) in Ocumension’s efforts to assume, directly or indirectly through a designee, performance of the activities relating to this Agreement; and (d) provide Ocumension with reasonable transition
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For the purposes of this Section 10.3, the following are deemed to be a “material breach” of this Agreement (which, for the avoidance of doubt, shall be subject to the Cure Period and the procedures and requirements set forth in this Section 10.3): (a) with respect to Alimera as the Breaching Party, breach of Section 2.5; and (b) with respect to Ocumension as the Breaching Party, (i) breach of Section 2.6, (ii) breach of Section 3.11(d), filing patent applications by Ocumension or its Affiliates for inventions incorporating trade secrets or other confidential information of Alimera disclosed by Alimera to Ocumension as Product IP under this Agreement, or (iii) failure to make the payment described in Section 5.1 or the payments (that are not disputed in good faith) described in Section 5.2.
Any termination of this Agreement pursuant to this Section 10.3 shall become effective upon written notice from the Terminating Party delivered no earlier than at the end of the Cure Period, unless the Breaching Party has cured any such material breach prior to the expiration of such Cure Period; provided, however, in the event that the Breaching Party disputes in good faith the breach alleged by the Terminating Party, this Agreement shall continue in full force and effect and each Party may continue to exercise its rights under this Agreement during any dispute resolution process set forth in Section 13.9 relating to such alleged breach, except that the Terminating Party may suspend the performance of its obligations under this Agreement until the conclusion of such dispute resolution process; provided further, however, that in the event that the arbitrators decide that the alleged breach does not constitute a breach or the termination is not effective, then the Terminating Party shall compensate the alleged Breaching Party and its Affiliates for any and all Losses arising in connection with any inability to exercise any rights or suspension of performance under this Agreement.
Section 10.4 Termination due to Bankruptcy. Either Party may terminate upon thirty (30) days’ written notice if the other Party (i) becomes subject to a voluntary petition in
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(b) all payment obligations hereunder shall terminate, other than those that are accrued and unpaid as of the effective date of such termination; |
(a) in the event of termination of this Agreement as a result of Ocumension’s material breach under Section 10.3 or Ocumension’s bankruptcy under Section 10.4, Ocumension shall promptly deliver to Alimera or destroy upon request from Alimera any document authorising Ocumension or its Affiliates or agents or Sublicensees to obtain or hold or use any import authorisation or other Regulatory Approval in respect of the Product. In such event, such
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authorisation shall be deemed to be terminated and revoked immediately upon the effective date of termination; |
(b) in the event of termination of this Agreement as a result of Ocumension’s material breach under Section 10.3 or Ocumension’s bankruptcy under Section 10.4, Ocumension shall cease use of the Product Trademarks on products in the Field in the Territory after termination to the extent that such use of the Product Trademarks result in consumer confusion in relation to the source of the Product; |
(c) Ocumension shall terminate all sublicense and subcontracting agreements with its Sublicensees hereunder and indemnify and hold Alimera harmless from and against all losses caused by any claims asserted by Ocumension’s Affiliates or Sublicensees or Third Parties against Alimera and its Affiliates based on the continuance of such sublicense agreements after the termination of this Agreement; |
(e) Ocumension may sell off consistent with Applicable Laws any and all inventory of the Product on hand at the time of such termination. |
Section 11.2 No Implied Rights. The Parties acknowledge and agree that, except as expressly provided in this Agreement, neither Party or its Affiliates shall be deemed by estoppel, implication or otherwise to have granted any license, assignment or other right with respect to any
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Intellectual Property or Confidential Information of such Party or its Affiliates to the other Party or its Affiliates. The Parties acknowledge and agree that nothing in this Agreement is intended to be or will be interpreted to be an assignment of any Intellectual Property, Product IP or rights in Confidential Information from either Party to the other Party or its Affiliates or Sublicensees. |
Section 11.3 Filing for Product IP. Except as permitted by Section 11.7, Ocumension shall not, and shall cause its Affiliates and contractually require its Sublicensees not to, file or register, or directly assist any Third Party to file or register, anywhere in the world any Product IP (other than Joint Inventions and Joint Patents) without the prior written consent of Alimera. In case of such breach, notwithstanding any further claims under this Agreement or the Applicable Laws, Ocumension, upon Alimera’s request, shall take all actions required and assign, and shall cause its Affiliates and contractually require its Sublicensees, if applicable, to assign, free of charge any such filing or registration obtained by Ocumension and Affiliates free of encumbrance to Alimera or any entity designated by it. If such assignment for whatever reason is not possible, Ocumension shall grant, and shall cause its Affiliates and contractually require its Sublicensees, if applicable to grant, Alimera an exclusive (even in relation to Ocumension, its Affiliates and Sublicensees, if applicable), worldwide, unrestricted, perpetual, irrevocable, fully assignable and sublicensable (by multiple tiers) royalty-free license to any such filing or registration. This obligation shall survive termination of this Agreement. |
Section 11.4 Registration and Right to be Informed. If requested by a Party, the other Party shall execute such formal licenses and assignments as may be necessary for registration with patent offices and other relevant authorities of the rights granted under this Agreement. In the event that this Agreement requires registration and/or approval with any governmental authority under Applicable Laws in the Territory, such as for technology import or export, Ocumension will be responsible for obtaining such registration or approval for this Agreement with the competent governmental authority in the Territory at its own expense. Upon Alimera’s written request, Ocumension will provide Alimera with a copy of proof of such registrations and approvals, as applicable. |
Section 11.5 Publications. The Parties shall discuss and agree on the strategy for publications relating to the Product. Neither Party shall make any non-confidential presentation or publication of any data developed or generated by or on behalf of such Party or its Affiliates relating to a Product unless such Party has provided to the other Party a copy of such proposed presentation or publication at least thirty (30) days prior to the intended date of disclosure and, upon request of the other Party, (i) complied with any request to delay such disclosure for the purposes of filing a patent application; (ii) complied with any request by the other Party to remove the other Party's Confidential Information from such proposed presentation or publication; and (iii) considered in good faith any request from the other Party for amendments or delay of such proposed presentation or publication. |
Section 11.6 Ownership of Inventions. |
Section 11.7 Prosecution of Patents. |
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Section 11.9 Scope of binding effect. Each Party shall ensure and cause its Affiliates and Sublicensees and licensees and sublicensees, to agree to and be bound by this ARTICLE 11 and ARTICLE 12. |
(a) were already known to the Receiving Party (other than under an obligation of confidentiality), at the time of disclosure by the Disclosing Party, to the extent such Receiving Party has documentary evidence to that effect; |
(b) were generally available to the public or otherwise part of the public domain at the time of disclosure thereof to the Receiving Party; |
(c) became generally available to the public or otherwise part of the public domain after disclosure or development thereof, as the case may be, and other than through any act or omission of a Party in breach of such Party’s confidentiality obligations under this Agreement; |
(d) were disclosed to a Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or |
(e) were independently discovered or developed by or on behalf of the Receiving Party without the use of the Confidential Information belonging to the other Party, to the extent such Receiving Party has documentary evidence to that effect. |
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Neither Party shall use such Confidential Information for any purpose other than as permitted by, or in connection with, the exercise of rights or performance of obligations under this Agreement or disclose the same to any other person other than to such of its and its Affiliates’ directors, officers, managers, employees, independent contractors (e.g., contract research organization (CRO), site management organization (SMO), and investigational sites), agents, consultants or, solely with respect to Ocumension, its Sublicensees and subcontractors, who have a need to know such Confidential Information to implement the terms of this Agreement or in connection with the exercise of rights or performance of obligations under this Agreement; provided, however, that a Receiving Party shall advise any of its and its Affiliates’ directors, officers, managers, employees, independent contractors (e.g., CRO, SMO, and investigational sites), agents, consultants or, solely with respect to Ocumension, its Sublicensees and subcontractors, who receive such Confidential Information of the confidential nature thereof and of the obligations contained in this Agreement relating thereto, and the Receiving Party shall ensure (including, in the case of a Third Party, by means of a written agreement with such Third Party having terms at least as protective as those contained in this ARTICLE 12) that all such directors, officers, managers, employees, independent contractors (e.g., CRO, SMO, and investigational sites), agents, consultants or, solely with respect to Ocumension its Sublicensees and subcontractors, comply with such obligations. Receiving Party shall inform the Disclosing Party immediately if it becomes aware of the unauthorized disclosure or use of any of the Confidential Information of the Disclosing Party to an unauthorised person, and shall provide any assistance in relation to any such unauthorised disclosure that the Disclosing Party may require.
Upon termination of this Agreement, the Receiving Party shall return or destroy all documents, tapes or other media (including cloud-based storage systems) containing Confidential Information of the Disclosing Party that remain in the possession of the Receiving Party or its directors, officers, managers, employees, independent contractors (e.g., CRO, SMO, and investigational sites), agents, consultants or, solely with respect to Ocumension, its Sublicensees, except that the Receiving Party may keep one copy of the Confidential Information in the legal department files of the Receiving Party, solely for archival purposes. Such archival copy shall be deemed to be the property of the Disclosing Party and shall continue to be subject to the provisions of this ARTICLE 12.
It is understood that receipt of Confidential Information under this Agreement will not limit the Receiving Party from assigning its employees to any particular job or task in any way it may choose, so long as such recipient shall have agreed in writing to maintain the confidentiality of Confidential Information in accordance with the terms of this Agreement. The Receiving Party shall remain responsible for any failure by any such Person to treat such Confidential Information as required by this Agreement.
If the Receiving Party is required to disclose Confidential Information in response to a court order or subpoena or to comply with Applicable Law or the rules or regulations of a regulatory agency, governmental agency or securities listing organization in any country, the Receiving Party shall
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provide prior notice of such intended disclosure to the Disclosing Party in sufficient time to enable the Disclosing Party to reasonably object or seek a limitation as to the scope of the disclosure.
Either Party may provide a copy of this Agreement or otherwise disclose its terms in connection with (i) any financing transaction or due diligence inquiry, including any Third Parties that may assist such Party in its due diligence inquires or ongoing requirements hereunder, such as foreign corrupt practices compliance and (ii) obtaining any necessary consents from any Third Party to perform its obligations hereunder, provided that the person or entity to whom a copy of this Agreement is provided or to whom the terms of this Agreement are disclosed is bound by reasonable confidentiality obligations, and provided further that such Party is responsible for breaches of confidentiality hereunder by such person or entity to whom a copy of this Agreement is provided or to whom the terms of this Agreement are disclosed; for clarity, Alimera may provide a copy of this Agreement to Eyepoint and its legal successor in title, if any. Notwithstanding the foregoing, the Parties shall agree upon and issue a press release announcing the execution of this Agreement and describing the relationship of the Parties under the Agreement. In addition, each Party may disclose to Third Parties the information disclosed in such press release without the need for further approval by the other Party, and Alimera may disclose to Third Parties (via press releases or otherwise) the achievement of any material milestones in connection with this Agreement without prior approval by Ocumension, including by way of example only, receiving an appropriate price from the relevant Regulatory Authorities and the first sale by the Ocumension in the Territory.
Section 12.4 Notification. The Receiving Party shall notify the Disclosing Party promptly upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information and will cooperate with the Disclosing Party in any reasonably requested fashion to assist the Disclosing Party to regain possession of such Confidential Information and to prevent its further unauthorized use or disclosure. |
Section 13.1 Taxes. Any taxes, duties, VAT or other assessments, including as
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Section 13.6 Severability. If any provision of this Agreement is held invalid, illegal or unenforceable, the remaining provisions of this Agreement remain in full force and effect, if the essential terms and conditions of this Agreement for each party remain valid, binding and enforceable. |
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(v) In any arbitration proceedings, any legal proceedings to enforce any arbitration award and in any other legal proceedings between the Parties pursuant to or relating to this Agreement, each Party expressly waives the defence of sovereign immunity and any other defence based on the fact or allegation that it is an agency or instrumentality of a sovereign state or is otherwise entitled to immunity; |
(vi) After submittal of the dispute to arbitration, the Parties shall continue to exercise any other rights and perform any other obligations hereunder, unless such obligations are directly related to the matter under dispute. |
Section 13.9 Governing Law. Governing law shall be the law of the State of New York, without regard to conflict of laws provisions that would require the application of the laws of any other jurisdiction, and the application of United Nations Convention on Contracts for the International Sale of Goods is expressly excluded. |
remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege. |
Section 13.12 Third Party Beneficiaries. This Agreement is entered into for the sole protection and benefit of the Parties, and their respective permitted successors and assigns. No other person shall have any rights or causes of action under this Agreement. |
If to Alimera:
Alimera Sciences, Inc.
0000 Xxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000, XXX
Attention: Xxxxxxx X. Xxxxxxxx, Xx.
Email: xxxx.xxxxxxxx@xxxxxxxxxxxxxxx.xxx
with a copy (which shall not constitute notice) to:
Alimera Sciences, Inc.
0000 Xxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000, XXX
Attention: Xxxxxxxxxxx X. Xxxxxx
Email: xxxxx.xxxxxx@xxxxxxxxxxxxxxx.xxx
If to Ocumension:
Ocumension (Hong Kong) Ltd.
Room 502-1, Want Want Plaza
No. 211 Xxxxxx Xx Road
Jing’an District, Shanghai 200041, PRC
Attention: Xxxxxx Xxx
Email: xx.xxx@xxxxxxxxxx.xxx
with a copy (which shall not constitute notice) to:
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Xxxxxxxx & Xxxxx LLP
000 Xxxxx XxXxxxx
Xxxxxxx, XX 00000, XXX
Attention: Xxx Xxxx
Email: xxx.xxxx@xxxxxxxx.xxx
Section 13.14 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Alimera to Ocumension are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that Ocumension, as licensee of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction. |
Section 13.15 Construction. The headings contained in this Agreement are inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement. Unless otherwise indicated to the contrary herein by the context or use thereof: (i) the words, “herein,” “hereto,” “hereof” and words of similar import refer to this Agreement as a whole, including the Appendixes, and not to any particular section, subsection, paragraph, subparagraph or clause contained in this Agreement; (ii) masculine gender shall also include the feminine and neutral genders, and vice versa; (iii) words importing the singular shall also include the plural, and vice versa; (iv) the words “include,” “includes” or “including” shall be deemed to be followed by the words “without limitation”; (v) the word “or” shall not be exclusive and shall have the same meaning as the words “and/or”; and (vi) the word “will” shall be construed to have the same meaning and effect as the word “shall,” and vice versa. The Parties have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement. |
Section 13.16 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by .pdf or other electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were the original signatures. |
[Signature page follows]
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In Witness Whereof, the Parties have executed this Agreement by their duly authorized representatives as of the Effective Date.
ALIMERA SCIENCES, INC.
By:/s/ Xxxxxxx X. Xxxxxxxx, Xx.
Name: Xxxxxxx X. Xxxxxxxx, Xx.
Title: President & Chief Executive Officer
OCUMENSION (HONG KONG) LTD.
By:/s/ Ye Liu
Name: Ye Liu
Title: CEO
Signature page to Exclusive License Agreement
Exhibit 1: Schedule of Patents
[Exhibit omitted pursuant to Item 601(a)(5) of Regulation S-K]