pnt-2002licenseandcollab






  Exhibit 10.1    Execution Version  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND  REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED  FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) THE TYPE THAT  THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.    LICENSE AND COLLABORATION AGREEMENT    BETWEEN    POINT BIOPHARMA, INC.,    LANTHEUS TWO, LLC    AND, FOR PURPOSES OF SECTION 17.16 ONLY,    LANTHEUS MEDICAL IMAGING, INC.  NOVEMBER 11, 2022      





 






   1  [***] = Indicates confidential information omitted from the exhibit.  LICENSE AND COLLABORATION AGREEMENT  (PNT-2002)  This LICENSE AND COLLABORATION AGREEMENT (the “Agreement”) is entered into as of  November 11, 2022 (the “Execution Date”) by and between POINT BIOPHARMA, INC., a  Delaware corporation whose registered address is 4850 West 78th Street, Indianapolis, IN 46268  (“POINT”), LANTHEUS TWO, LLC, a Delaware limited liability company with its principal office  at 331 Treble Cove Road, North Billerica, MA 01949 (“LANTHEUS”), and, for purposes of  Section 17.16 only, LANTHEUS MEDICAL IMAGING, INC., a Delaware corporation with its  principal office at 331 Treble Cove Road, North Billerica, MA 01949 (“LANTHEUS  GUARANTOR”).  Capitalized terms used in this Agreement are defined in Article 1 below unless  defined elsewhere herein.  RECITALS:  WHEREAS, POINT is developing PNT-2002 for the treatment of metastatic castrate- resistant prostate cancer and has experience and expertise in the manufacturing of  radiopharmaceutical products;   WHEREAS, LANTHEUS has experience and expertise in the development and  commercialization of radiopharmaceutical products;   WHEREAS, POINT wishes to grant to LANTHEUS, and LANTHEUS wishes to obtain, an  exclusive license to Exploit the Licensed Product in the Field in the Territory, all on the terms and  subject to the conditions set forth in this Agreement;  WHEREAS, the Parties intend for POINT to generate all clinical and nonclinical data,  analysis and other information (including relating to chemistry, Manufacturing and controls)  necessary to obtain Regulatory Approval of the Licensed Product NDA in a timely manner; and  WHEREAS, the Parties intend for LANTHEUS, with POINT’s cooperation and assistance,  to prepare and submit the Licensed Product NDA in a timely manner after POINT’s completion  of all necessary Clinical Trials and related data collection and analysis.  NOW, THEREFORE, in consideration of this Agreement and the premises and the mutual  covenants and agreements set forth herein, and other good and valuable consideration, the receipt  and sufficiency of which are hereby acknowledged, the Parties agree as follows:  ARTICLE 1    DEFINITIONS  1.1. Defined Terms.  When used in this Agreement, each of the following terms will  have the meanings set forth in this Article 1:  1.1.1. “Affiliate” means, with respect to any Party, any entity that, directly or  indirectly, controls, is controlled by, or is under common control with such Party, but only for so  long as such control continues.  For these purposes, “control” will refer to: (i) the possession,  





 






   2  [***] = Indicates confidential information omitted from the exhibit.  directly or indirectly, of the power to direct the management or policies of an entity, whether  through ownership of voting securities, by contract or otherwise or (ii) the ownership, directly or  indirectly, of at least fifty percent (50%) of the equity securities of the entity entitled to vote in the  election of directors (or, in the case of an entity that is not a corporation, at least fifty percent (50%)  of the equity securities of the entity entitled to vote in the election of the corresponding managing  authority or entitled to direct the management and policies of such entity).  1.1.2. “Alternate License Proposal” means any transaction or series of related  transactions under which any Person(s) (other than LANTHEUS), directly or indirectly, acquires,  licenses or otherwise secures rights in or under the Licensed Product Business (other than for  academic research purposes under customary written agreements that will be assigned to  LANTHEUS on or after the Effective Date).  1.1.3. “Applicable Law” means all applicable laws, statutes, rules, regulations,  court orders, legislation, principles of common law, codes, treaties, ordinances and other  pronouncements and requirements having the binding effect of law of any applicable  Governmental Authority, including any rules, regulations, guidelines or other requirements of the  Regulatory Authorities (including applicable regulations and guidance of the FDA and EMA (and  national implementations thereof) that constitute good laboratory practices, good manufacturing  practices, and good clinical practices and, if and as appropriate and applicable under the  circumstances, ICH guidance or other comparable regulations and guidance of any applicable  Governmental Authority), that may be in effect and legally binding on a Party or a Party’s  Affiliates from time to time in the Territory.  1.1.4. “Approval Failure” means a complete and final response letter from the  FDA failing to grant Regulatory Approval of the Licensed Product NDA.  1.1.5. “Approved PSMA Radioligand Therapies” means any 177Lu-radiolabelled  PSMA-targeting therapeutic drug that has received Regulatory Approval of its NDA for the Initial  Indication in the U.S.   1.1.6. “ASP Percentage Decrease” means, with respect to any full Calendar Year  following Generic Entry in a country in the Territory, that percentage decrease in the average  annual sales price of the Licensed Product in such country in that full Calendar Year, as compared  to the average annual sales price of the Licensed Product in such country in the full Calendar Year  prior to Generic Entry.  1.1.7. “Bankruptcy Code” means Title 11, U.S. Code, or analogous provisions of  Applicable Law outside the U.S.  1.1.8. “Business Day” means a day on which banking institutions in Boston,  Massachusetts are open for business.  1.1.9. “Calendar Quarter” means each three (3)-month period of January through  March, April through June, July through September and October through December.  1.1.10. “Calendar Year” means each annual twelve (12)-month period starting on  January 1 and ending on December 31.  





 






   3  [***] = Indicates confidential information omitted from the exhibit.  1.1.11. “Change of Control” means, with respect to a Party, (i) an acquisition,  reorganization, merger or consolidation of such Party with a Third Party (together with its  Affiliates and any other person with whom it is acting in concert or as a “group” (as defined under  Section 13 of the Securities Exchange Act of 1934, as amended)), in which the holders of the  voting securities of such Party outstanding immediately prior thereto cease to beneficially own at  least fifty percent (50%) of the combined voting power of the surviving entity, directly or  indirectly, immediately after such acquisition, reorganization, merger or consolidation, (ii) a  transaction or series of related transactions in which a Third Party (together with its Affiliates and  any other person with whom it is acting in concert or as a “group” (as defined under Section 13 of  the Securities Exchange Act of 1934, as amended)) becomes the beneficial owner of fifty percent  (50%) or more of the combined voting power of the outstanding securities of such Party, or (iii)  the sale or other transfer to a Third Party (together with its Affiliates and any other person with  whom it is acting in concert or as a “group” (as defined under Section 13 of the Securities Exchange  Act of 1934, as amended)), of all or substantially all of such Party’s assets.  1.1.12. “Clinical Supplies” means supplies of a Licensed Product to be used for the  conduct of pre-clinical studies, Post-Marketing Commitments or Clinical Trials of a Licensed  Product in the Field in the Territory pursuant to this Agreement.  1.1.13. “Clinical Trials” means human studies designed to measure the safety or  efficacy of a Licensed Product that is conducted for the purpose of obtaining, supporting, or  maintaining Regulatory Approval.  1.1.14.   “Collaboration Know-How” means any Know-How invented by a Party’s  or its Affiliates’ employees, agents or independent contractors, either alone or jointly with the  other Party’s or its Affiliates’ employees, agents or independent contractors, in the Development  of the Licensed Product (including the performance of activities under the Manufacturing,  Development and Regulatory Plan, Post-Marketing Commitments, and Post-Marketing Clinical  Trials) following the Effective Date and thereafter for the duration of the Term.  1.1.15. “Collaboration Patents” means any Patent Rights invented by a Party’s or  its Affiliates’ employees, agents or independent contractors, either alone or jointly with the other  Party’s or its Affiliates’ employees, agents or independent contractors, in the performance of  activities under the Manufacturing, Development and Regulatory Plan following the Effective  Date and thereafter for the duration of the Term that Cover any Collaboration Know-How.  1.1.16. “Collaboration Technology” means the Collaboration Know-How and the  Collaboration Patents.  1.1.17. “Combination Product” means (a) any single product in finished form  containing as pharmacologically active ingredients both (i) the Licensed Product and (ii) one or  more other pharmaceutically active compounds or substances that are not Licensed Products,  whether co-formulated or co-packaged (i.e., within a single box or sales unit); (b) any Licensed  Product sold in combination with one or more other products (such as devices or diagnostics) or  services that are not Licensed Products for a single invoice price; or (c) any Licensed Product sold  where the sale of the Licensed Product is only available from the seller with the purchase of other  products or services that are not Licensed Products (such other pharmaceutically active compounds  





 






   4  [***] = Indicates confidential information omitted from the exhibit.  or substances, or such other products or services referred to in clauses (a) through (c) hereof, the  “Other Components”).  1.1.18. “Commercial Supplies” or “Commercial Supply” means supplies of a  Licensed Product for commercial sale or as promotional samples or evaluation product, or for use  in Post-Marketing Clinical Trials.  1.1.19. “Commercialization” means the performance, whether directly or  indirectly through an Affiliate or Third Party, of any and all activities directed to promoting,  marketing, importing, exporting, distributing, selling or offering to sell the Licensed Product  following or in expectation of receipt of Regulatory Approval (but excluding Development and  Manufacture).  When used as a verb, “Commercialize” means to engage in Commercialization.  1.1.20. “Commercially Reasonable Efforts” means, with respect to the  Development or Commercialization of the Licensed Product in or for a particular country, that  level of effort and resources that would normally be used by similarly situated radiopharmaceutical  companies with respect to Development or Commercialization, as the case may be, of a  radiopharmaceutical product owned by it or to which it has rights, which is of similar market  potential at a similar stage in development or product life as the Licensed Product, and taking into  account, without limitation: issues of safety and efficacy; product profile; proprietary position  (including patent and license coverage and regulatory exclusivity); the then-current competitive  market environment; likely timing of the radiopharmaceutical’s entry into the market; the then- current market penetration; market potential (including market size, patient population, pricing  and reimbursement); potential profitability (including Third Party costs and expenses) of each  product; regulatory environment; and other relevant legal, regulatory, scientific, technical and  commercial factors; in each case, measured by the facts and circumstances at the time such efforts  are due.  1.1.21. “Confidentiality Agreement” means the Mutual Nondisclosure  Agreement by and between POINT and LANTHEUS Guarantor, dated as of 11 February 2022.  1.1.22. “Controlled” means, with respect to Patent Rights or Know-How,  that the applicable Party, in whole or in part, owns or has a license to such Patent Rights or Know- How (but without taking into account any rights granted by one Party to the other Party pursuant  to this Agreement) and has the ability to grant a license or a sublicense, as applicable, or to  otherwise disclose proprietary or trade secret information, to such other Party, without  misappropriating the proprietary or trade secret information of a Third Party or violating the terms  of any agreement or other arrangement with any Third Party existing and in effect at the time such  Party would be required hereunder to grant the other Party such license or sublicensee; provided,  however, that if a Party is acquired pursuant to a Change of Control, the acquired Party will not be  deemed to Control any Know-How, Patent Rights or other intellectual property rights owned or  controlled prior to such Change of Control by any entities that (a) were not Affiliates of the  acquired Party prior to such Change of Control and (b) become Affiliates of the acquired Party in  connection with such Change of Control merely by reason of such Change of Control, in each case,  unless and until the acquired Party actually owns, has such a license or ability to grant a license or  a sublicense, or otherwise disclose such proprietary or trade secret information.  





 






   5  [***] = Indicates confidential information omitted from the exhibit.  1.1.23. “Cost of Goods Sold” means, for any period, the price actually paid  for Licensed Products.  For a Licensed Product provided under the Manufacture and Supply  Agreement applicable to Manufacture by POINT in the U.S., the Cost of Goods Sold is the Dose  Price set forth in Exhibit C and, for Licensed Product provided under any other Manufacture and  Supply Agreement, the Cost of Goods Sold is the purchase price set forth in that Manufacture and  Supply Agreement.  Cost of Goods Sold shall not include any expenses reimbursed under the  applicable Manufacture and Supply Agreement(s).    1.1.24. “Cover” means, as to a particular subject matter at issue and a claim  of a relevant Patent Right, that, in the absence of a license granted under, or ownership of, such  Patent Right, the making, using, selling, offering for sale or importation of such subject matter  would infringe such Patent Right or, as to a pending claim included in such Patent Right, the  making, using, selling, offering for sale or importation of such subject matter would infringe such  pending claim if such claim were to issue in an issued patent without modification.  1.1.25. “Development” means the performance, whether directly or  indirectly through an Affiliate or Third Party, of any and all activities relating to the development  of the Licensed Product in preparation for Regulatory Approval of the Licensed Product in the  Field in the Territory, including pre-clinical studies, pharmacokinetic studies, toxicology studies,  formulation, test method development, assay development and stability testing, manufacturing  process development, chemistry, manufacturing and control (CMC) management, manufacturing  technical support, biomarker development, validation and scale-up (including bulk compound  production), Manufacturing of Clinical Supplies and activities relating to developing the ability to  Manufacture and to continue to Manufacture the Licensed Product, quality assurance and quality  control for formulations of the Licensed Product, design and conduct of Clinical Trials or studies  (including all Post-Marketing Commitments), report writing, statistical analysis and regulatory  affairs including regulatory legal services. When used as a verb, “Develop” means to engage in  Development.  1.1.26. “Development Costs” means all actual, out-of-pocket costs  (including FTEs) incurred (i.e., paid or accrued) by either Party, in each case, in accordance with  GAAP, to the extent attributable to Development of the Licensed Product in the Initial Indication  for the purpose of obtaining Regulatory Approval of the Licensed Product in the U.S. for the Initial  Indication (including the performance of all Post-Marketing Commitments) or fulfilling such  Party’s responsibilities under the Manufacturing, Development and Regulatory Plan in accordance  therewith and with this Agreement.  Such costs will include:  (i) costs of studies on the toxicological, pharmacokinetic, metabolic or  clinical aspects of the Licensed Product in the Initial Indication conducted internally or by  individual investigators or consultants, necessary or desirable for the purpose of obtaining,  supporting or maintaining Regulatory Approval of the Licensed Product in the Initial Indication in  the U.S. and for conducting Post-Marketing Commitments to support or maintain such Regulatory  Approval, including the costs of personnel engaged in the foregoing activities at the applicable  Development FTE Rate;   (ii) costs of Manufacturing process development, validations, scale-up,  quality assurance and quality control for the Licensed Product pursued by the Parties under the  





 






   6  [***] = Indicates confidential information omitted from the exhibit.  Initial Manufacturing, Development and Regulatory Plan, to the extent not included in the Fully  Burdened Manufacturing Costs of Clinical Supplies;  (iii) costs of preparing and reviewing data or information for the purpose  of submitting the Licensed Product NDA to the FDA;  (iv) costs of communications and meetings with the FDA, and exchange  of information and assistance related thereto, in each case, until the earlier of (a) Regulatory  Approval of the Licensed Product NDA and completion of all associated Post-Marketing  Commitments or (b) the date of Approval Failure; and  (v) costs incurred in connection with receiving, investigating,  recording, reviewing, communicating and exchanging adverse events and other reportable  information, in each case, as provided in any safety data exchange agreement entered into between  the Parties to the extent relating to the Development of the Licensed Product in the Initial  Indication in the U.S.  1.1.27. “Development FTE Rate” means initially an amount equal to  $[***] per FTE per year; on January 1, 2024, and annually thereafter, such amount will be adjusted  to reflect any increase, since the prior adjustment (or the initial rate, as applicable), based on the  most recent monthly index available as of the adjustment date set forth in the Bureau of Labor  Statistics Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W), all items  less food and energy, which, for clarity, was $[***] in June 2022.   1.1.28. “Distributor” means, with respect to a country, any Third Party that  purchases its requirements for the Licensed Product in such country from or on behalf of  LANTHEUS or its Affiliates or LANTHEUS Sublicensees and is appointed by LANTHEUS or  its Affiliates or LANTHEUS Sublicensees as a distributor to distribute, market and resell the  Licensed Product in such country, even if such Third Party is granted ancillary rights to develop,  package or obtain Regulatory Approval of the Licensed Product in order to distribute, market or  sell the Licensed Product in such country.  1.1.29. “Eligible Net Sales” means, for any period, (i) Excess Gross Profit  (if any) for that period, divided by (ii) the Gross Profit Margin Percentage for that period.  1.1.30. “EMA” means the European Medicines Agency or any successor  agency.  1.1.31. “Excess Gross Profit” means, for any period, the amount (if any)  by which Gross Profit for such period exceeds the Gross Profit Hurdle applicable for such period.   1.1.32. “Excluded Territory” means China (inclusive of Taiwan, Hong  Kong and Macau), Japan, South Korea, Indonesia and Singapore.  1.1.33. “Exploit” means to perform Medical Activities or Regulatory  Activities, Develop, Manufacture (solely to the extent expressly permitted hereunder), and  Commercialize, including, solely to the extent expressly permitted by this Agreement, to make,  have made, use, sell, offer for sale, import and export.   





 






   7  [***] = Indicates confidential information omitted from the exhibit.  1.1.34. “FDA” means the U.S. Food and Drug Administration or any  successor agency.  1.1.35. “Field” means all fields of use, including the treatment, prevention  or diagnosis of any disease, disorder or condition.  1.1.36. “First Commercial Sale” means, with respect to a country in the  Territory, the first sale for use or consumption by the general public of the Licensed Product by  LANTHEUS or an Affiliate or LANTHEUS Sublicensee to a Third Party (including a Distributor)  in such country after the Licensed Product has been granted Regulatory Approval by the  appropriate Regulatory Authority(ies) in such country. Any transfer of the Licensed Product as  part of an expanded access program, compassionate sales or use program, an indigent program, as  bona fide samples, as donations, for the performance of Clinical Trials or other studies or for  similar bona fide business purposes in accordance with Applicable Law will not constitute a “First  Commercial Sale” hereunder.  1.1.37. “First FDA Approval” means the FDA’s approval of an NDA for  the Licensed Product for the Initial Indication in the U.S.  1.1.38. “FTE” means the equivalent of one (1) person who is employed by  a Party or its Affiliates, or (solely with respect to technical personnel) hired as an independent  contractor by a Party or its Affiliates in lieu of such Party’s own employees, who is qualified to  perform the tasks assigned to such person.  For FTEs performing Development activities pursuant  to the Initial Manufacturing, Development and Regulatory Plan, one (1) FTE will perform a total  of one thousand eight hundred eighty (1,880) hours of work per Calendar Year.  Any FTE who  devotes less or more than and one thousand eight hundred eighty (1,880) hours of work per  Calendar Year to such work will be treated as an FTE on a pro-rata basis calculated by dividing  the actual number of hours spent on such work during such Calendar Year by and one thousand  eight hundred eighty (1,880).  Such FTEs will be charged at an hourly rate hereunder by the Parties.    1.1.39. “Fully Burdened Manufacturing Cost” means the costs incurred  (i.e., paid or accrued) by POINT or its Affiliates or agents in the Manufacture of a Licensed  Product, which shall be the sum of direct labor, direct material and allocable overhead incurred in  the Manufacture of such Licensed Product, as reflected in the auditor-reviewed or -audited  financial statements of it or its parent company and as determined in accordance with GAAP.   Notwithstanding the foregoing, Fully Burdened Manufacturing Costs exclude (i) all payments  (including upfront fees, milestones and royalties) to any Third Party to obtain rights (whether by  acquisition, license or otherwise) to any Intellectual Property that is necessary or useful to  Manufacture Clinical Supplies or Commercial Supplies in any country and (ii) any and all costs  and expenses incurred in connection with the acquisition of any such intellectual property rights.  1.1.40. “GAAP” means, with respect to any Party or its Affiliates, U.S.  Generally Accepted Accounting Principles, consistently applied by such Party or its Affiliates.  1.1.41. “Governmental Authority” means any government, court, tribunal,  agency, authority, ministry, department, legislative body, bureau, commission or other  





 






   8  [***] = Indicates confidential information omitted from the exhibit.  instrumentality of any supranational, national, regional, state, county, city, local or other political  subdivision in the Territory.   1.1.42. “Gross Margin” means, with respect to any Calendar Year  following Generic Entry in a country in the Territory, (A) the aggregate Net Sales of Licensed  Product, minus (B) the aggregate Cost of Goods Sold for Licensed Product, minus (C) the  aggregate royalties owed under Section 9.3.1, in each case, in that Calendar Year in that country.  1.1.43. “Gross Profit” means, for any period, (i) Net Sales for that period,  minus (ii) Cost of Goods Sold for that period.     1.1.44. “Gross Profit Hurdle” means (i) up to One Hundred Million U.S.  Dollars (US$100,000,000) for each Calendar Year prior to and including the Trigger Year; (ii)  One Hundred Twenty Million U.S. Dollars (US$120,000,000) for each of the three (3) Calendar  Years following the Trigger Year; and (iii) One Hundred Ten Million U.S. Dollars  (US$110,000,000) for the fourth Calendar Year following the Trigger Year.  1.1.45. “Gross Profit Margin Percentage” means, for any period, (i) Gross  Profit for that period, divided by (ii) Net Sales for that period, expressed as a percentage.  1.1.46. “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements  Act of 1976 and the rules and regulations thereunder, each as amended.  1.1.47. “IND” means an Investigational New Drug Application, as defined  in the Federal Food, Drug, and Cosmetic Act, as amended or similar application or submission that  is required to be filed with any Regulatory Authority before beginning Clinical Trials of a  pharmaceutical product.   1.1.48. “Initial Indication” means the treatment of metastatic castrate- resistant prostate cancer (mCRPC).   1.1.49. “Know-How” means, to the extent specifically relating to the  Licensed Products, all non-public, proprietary data and results, technical information, know-how,  inventions, discoveries, trade secrets, processes, procedures, techniques, new developments,  compositions, products, compounds, material, methods, formulas, formulation, improvements,  protocol, result of experimentation or testing, technology, ideas or other proprietary information  and documentation thereof (including related papers, invention disclosures, blueprints, drawings,  flowcharts, diagrams, diaries, notebooks, specifications, (subject to Section 6.1.3) methods of  Manufacture, methods of service, data processing techniques, compilations of information,  customer and supplier lists, pricing and cost information, and business and marketing plans and  proposals), design or other know-how, whether or not patentable or copyrightable.  Know-How  will not include any Patent Rights with respect thereto.    1.1.50. “Knowledge” means the actual knowledge of its senior  management (with a title of vice president or higher) and patent counsel based on such individuals’  good faith understanding of the facts and information in their possession or control following  reasonable inquiry and investigation of personnel and patent counsel, in each case, with relevant  functional responsibilities with respect to such facts and information but without conducting  





 






   9  [***] = Indicates confidential information omitted from the exhibit.  additional searches of any publicly available records or other materials outside of the possession  or control of such Persons.  1.1.51. “LANTHEUS Patent Rights” means any Patent Rights Controlled  by LANTHEUS or its Affiliates necessary for POINT to perform its obligations under this  Agreement or any Manufacture and Supply Agreement.  1.1.52. “LANTHEUS Sublicense Agreement” means a written, definitive  agreement for a sublicense between LANTHEUS and a LANTHEUS Sublicensee.  1.1.53. “LANTHEUS Sublicensee” means any Third Party, other than a  Distributor, to whom rights are granted pursuant to a LANTHEUS Sublicense Agreement under  any of the rights licensed to LANTHEUS by POINT under Section 6.1 with respect to any  Licensed Product, including through any license, sublicense, co-development, co-discovery, co- promotion, distribution, joint venture, Development and Commercialization collaboration or  similar transaction between LANTHEUS (or an Affiliate of LANTHEUS) and such Third Party.    1.1.54. “Licensed Know-How” means (i) any Know-How Controlled by  POINT or its Affiliates on the Effective Date, or thereafter during the Term that is necessary to  Exploit the Licensed Products in the Field in the Territory, including but not limited to the  Manufacture of Licensed Products pursuant to Section 6.1.3 (collectively the “POINT Know- How”); and (ii) POINT’s interest in the Collaboration Know-How in the Territory. Unless  otherwise added under Section 6.1.3, and for the avoidance of doubt, Licensed Know-How  specifically excludes methods of Manufacturing of the Licensed Product beyond what is strictly  necessary to disclose to the FDA as part of the Licensed Product NDA or to other Regulatory  Authorities in the Territory as part of obtaining Regulatory Approval in the applicable country or  jurisdiction. Further, any and all Know-How related to the development or manufacture of any  therapeutic ingredients or related inputs and services, including 177Lu, shall be excluded from the  Licensed Know-How. With respect to POINT Know-How, upon a Change of Control of POINT,  any Know-How arising or acquired thereafter or previously the Know-How of acquiror which is  not Collaboration Know-How and not otherwise necessary for the performance of POINT’s  obligations under this Agreement, shall be excluded from this definition of Licensed Know-How.  1.1.55. “Licensed Patents” means: (i) the Patent Rights set forth on Exhibit  B, and any Patent Rights Controlled by POINT or its Affiliates issuing from or claiming priority  to Patent Rights listed on Exhibit B; (ii) POINT’s interest in the Collaboration Patents; and (iii)  any other Patent Rights owned or Controlled (and sublicensable) by POINT or any of its Affiliates  at or after the Effective Date (other than Collaboration Patents) which are reasonably necessary  for LANTHEUS to formulate, use, sell, or otherwise Commercialize Licensed Products in the  Field; provided that, upon a Change of Control of POINT, any Patent Rights of the acquiror or its  Affiliates or arising or acquired thereafter or previously, and not otherwise used in the course of  performance of POINT’s obligations under this Agreement, shall be excluded from this definition  of Licensed Patents.  For the avoidance of doubt, Patent Rights under subsection (iii) shall not  include rights directed to other proprietary agents or proprietary combinations of other agents with  the Licensed Product where the other agent is, to illustrate, a pharmacologically active agent, an  agent for sensitizing target tissues to radioligand therapy killing, or agents for protecting non-target  tissues from radioligand therapy toxicity.  The Licensed Patents as of the Effective Date are listed  





 






   10  [***] = Indicates confidential information omitted from the exhibit.  on Exhibit B, provided that any Patent Right that is not listed therein but is otherwise described in  this definition, will still be considered a Licensed Patent hereunder.    1.1.56. “Licensed Product” means a product containing PNT-2002.  1.1.57. “Licensed Product NDA” means the first NDA filed for the  Licensed Product in the Initial Indication to the FDA in the U.S. pursuant to the NDA regulatory  pathway, as set forth in the Manufacturing, Development and Regulatory Plan.  1.1.58. “Major Competitors” means, at any given time, the top [***]  ([***]) largest radiopharmaceutical or contrast agent companies in the Territory, measured by the  estimated annual radiopharmaceutical and contrast agent revenue of those companies in the  Territory.  1.1.59.   “Manufacturing” means the performance, whether directly or indirectly  through an Affiliate or Third Party, of any or all activities directed to producing, manufacturing,  labeling, validating, scaling up, processing, filling, finishing, packaging, quality assurance, quality  control, testing and release, test development, storing, shipping and warehousing of the Licensed  Product. When used as a verb, “Manufacture” means to engage in Manufacturing.  1.1.60. “Manufacture and Supply Agreement” means any agreement  between the Parties for the Manufacture and supply by POINT of Clinical Supply or Commercial  Supply of the Licensed Product (including a Technical and Quality Agreement relating thereto),  as such agreement may be amended, modified, supplemented, renewed and/or superseded from  time to time in accordance with its terms.  1.1.61. “Manufacturing Interruptions” occur when, for any reason  (including breach of this Agreement or any Manufacture and Supply Agreements, Force Majeure  Delay or as a result of violations of Applicable Law, warning letters issued by Regulatory  Authorities or similar events or circumstances), POINT either fails, or notifies Lantheus that it will  fail, or is otherwise reasonably expected to fail, to Manufacture, supply and deliver all Firm Orders  (as defined in the applicable Manufacture and Supply Agreement(s)) for patient doses of Licensed  Product on time in full in accordance with the requirements under the applicable Manufacture and  Supply Agreement(s).   1.1.62. “Manufacturing Underperformance” occurs when, for any reason  (including breach of this Agreement or any Manufacture and Supply Agreements, Force Majeure  Delay or as a result of violations of Applicable Law, warning letters issued by Regulatory  Authorities or similar events or circumstances): (i) POINT fails to Manufacture, supply and deliver  at least eighty five percent (85%) of all Firm Orders (as defined in the applicable Manufacture and  Supply Agreement(s)) for patient doses of Licensed Product on time in full on average in any  rolling twelve (12) month period in accordance with the requirements under the applicable  Manufacture and Supply Agreement(s) or (ii) POINT experiences any serious and repeated  failures, shutdowns or delays in Manufacturing, supplying and/or delivering patient doses of  Licensed Product for a period of six (6) months or more in any twelve (12)-rolling month period.   1.1.63. “Medical Activities” means any and all activities directed to the  formulation and performance of (i) Post-Marketing Clinical Trials; (ii) market and key opinion  





 






   11  [***] = Indicates confidential information omitted from the exhibit.  leader plans for the Development of the Licensed Products, including plans to support continuing  medical education; (iii) publication plans for the Licensed Products; (iv) plans to ensure  appropriate medical information responses with respect to the Licensed Products; (v) safety  monitoring plans for the Licensed Products; (vi) plans and expected activities for field based  medical affairs personnel for the Licensed Products; and (vii) other comparable medical affairs  activities.  1.1.64. “NDA” means a New Drug Application filed with the FDA as  described in 21 C.F.R. § 314, or any equivalent or corresponding application for Regulatory  Approval (including pricing and reimbursement approval required by Applicable Law prior to sale  of a pharmaceutical product) in any country or regulatory jurisdiction other than the U.S.  1.1.65. “Net Sales” means the amount billed by LANTHEUS and its  Affiliates for sales of Licensed Product in the Territory to a Third Party (excluding transactions  with any Affiliates of LANTHEUS), as well as the amount billed by LANTHEUS Sublicensees  for sales of Licensed Product to a Third Party in the United States, less the sum of the following  (to the extent not reimbursed by any Third Party):   (i) trade discounts actually allowed or given (including cash discounts and quantity  discounts), cash and non-cash coupons, retroactive price reductions, charge back  payments, fees and rebates paid, granted or accrued to: managed care organizations;  federal, state and local governments or their agencies; purchasers, group purchasing  organizations or integrated delivery networks; payors or reimbursers; or customers  or patients, including co-pay assistance;  (ii) credits or allowances actually paid, granted or accrued upon claims, damaged  goods, rejections or returns of such Licensed Product, including Licensed Product  returned in connection with recalls or withdrawals;  (iii) taxes or duties levied on, absorbed or otherwise imposed on sale of the  Licensed Product, including value added taxes, healthcare taxes, pharmaceutical  excise taxes (such as those imposed by the United States Patient Protection and  Affordable Care Act of 2010 and other comparable laws) or other governmental  charges otherwise imposed upon the billed amount (to the extent not paid by the  Third Party), as adjusted for rebates and refunds;   (iv) charges and expense for freight, customs and insurance directly related to the  distribution of the Licensed Product and wholesaler and distributor administration  fees; and  (v) other future similar deductions, taken in the ordinary course of business in  accordance with the recording of Net Sales under GAAP and LANTHEUS’s  standard practices.   Such amounts shall be determined consistent with LANTHEUS’ standard practices  and in accordance with GAAP.  It is understood that any accruals for individual items reflected in  Net Sales are periodically (at least quarterly) trued up and adjusted by LANTHEUS consistent  with its standard practices and in accordance with GAAP.  





 






   12  [***] = Indicates confidential information omitted from the exhibit.  Notwithstanding anything to the contrary, Licensed Products transferred to Third  Parties as part of an expanded access program, compassionate sales or use program, an indigent  program, as bona fide samples or evaluation product, as donations, for the performance of Clinical  Trials or other studies, or for similar bona fide business purposes in accordance with Applicable  Laws, shall not constitute “Net Sales” under this Agreement.  The sale or transfer of Licensed Products between or among Related Parties shall  not result in any Net Sales, with Net Sales to be based only on any subsequent sales or dispositions  to a non-Affiliate.  To the extent that Related Parties receives consideration other than or in  addition to cash upon the sale or disposition of a Licensed Product to a non-Related Party, Net  Sales shall be calculated based on the average price charged for such Licensed Product, as  applicable, during the preceding royalty period, or in the absence of such sales, based on the fair  market value of the Licensed Products, as determined by the JCSC in good faith.  For clarity, (a)  Net Sales shall not include amounts or other consideration that constitutes Net Sublicense  Proceeds, provided that such consideration is not in lieu of all or a portion of the transfer price of  the Licensed Product, (b) sales to a Distributor, wholesaler, group purchasing organization,  pharmacy benefit manager, or retail chain customer shall be considered sales to a non-Related  Party and not to a LANTHEUS Sublicensee, and (c) Net Sales by a Related Party to a non-Related  Party consignee are not recognized as Net Sales by such Related Party until the non-Related Party  consignee sells the Licensed Product.  In no event will any particular amount identified above be  deducted more than once in calculating Net Sales.   In the case of any Combination Product sold in a given country in the Territory,  Net Sales for such Combination Product in such country shall be calculated by multiplying actual  Net Sales of such Combination Product by the fraction A/(A+B), where A is the invoice price of  the Licensed Product if sold separately in the same indication in such country, and B is the total  invoice price of the Other Components in the Combination Product, if sold separately in the same  indication in such country.  If, on a country-by-country basis, the Other Components in the  Combination Product are not sold separately in the same indication in such country, Net Sales for  the purpose of determining royalties of the Combination Product for such country shall be  calculated by multiplying actual Net Sales of the Combination Product by the fraction C/D, where  C is the invoice price of the Licensed Product if sold separately in the same indication in such  country, and D is the invoice price of the Combination Product in such country.  If neither the  Licensed Product nor the Other Components are sold separately in the same indication in a given  country, then Net Sales shall be calculated based on the JCSC’s good faith estimate of the fair  market value of the Licensed Product and each of the Other Components included in such  Combination Product.  1.1.66. “Net Sublicense Proceeds” means, with respect to Lantheus or its  Affiliates under Section 6.1.5 and with respect to POINT and its Affiliates under Section 6.1.6,  any payment and the value of any non-monetary consideration actually received by such Party or  its respective Affiliates in consideration for granting to any Third Party a sublicense to  Commercialize Licensed Products outside of the United States (in each case, except as provided  below), and including the following to the extent received by such Party or its Affiliates in  consideration for such a sublicense with respect to the Licensed Products:  





 






   13  [***] = Indicates confidential information omitted from the exhibit.  (i) up-front, milestone, success, bonus, maintenance and periodic payments in  respect of Licensed Products;  (ii) royalty payments or other payment received from the sublicensee in respect  of the sale of a Licensed Product;   (iii) payments in respect of the funding of research, Development or  Manufacturing activities related to any Licensed Product, but only to the  extent that such payments are not actually expended on such activities;  (iv) where any sublicense is to be granted by such Party or its Affiliates under  cross-licensing arrangements not related to the Licensed Product, the fair  market value of the Third Party license obtained under such arrangements;  (v) any premium paid over the fair market value of shares, options or other  securities in respect of any of the capital stock of such Party or its Affiliates  (other than in connection with a Change of Control or similar transaction);  and  (vi) the fair market value of any shares, options, or other securities obtained  from a Third Party.   Notwithstanding the foregoing, Net Sublicense Proceeds shall not include any payment received  by such Party or its Affiliates or the value of any non-monetary consideration obtained such Party  or its Affiliates in respect of:  (A) value added tax or other taxes paid to such Party or its Affiliates;   (B) equity investments by any sublicensee in such Party or its Affiliates  at fair market value;   (C) loans from any sublicensee as part of a debt financing; or  (D) the funding by a sublicensee of bona fide research, Development or  Manufacturing activities related to Licensed Products, to the extent  actually expended on such research, Development, Manufacturing  or Commercialization.  Notwithstanding anything to the contrary, up to Twelve Million Five Hundred Thousand Dollars  ($12,500,000) of the actual out-of-pocket costs and expenses (including attorneys’ and  accountant’s fees) made or required to be made by the Party granting the sublicense under Section  6.1.5 or 6.16, as appliance, or its respective Affiliates pursuant to the terms of, or for purposes of  entering into or effectuating the activities under, such sublicense transaction (including  establishing Manufacturing in the sublicensed portion of the Territory), shall be deducted from the  Net Sublicense Proceeds.  1.1.67. “Party” means LANTHEUS or POINT and, when used in the  plural, will mean both LANTHEUS and POINT.  





 






   14  [***] = Indicates confidential information omitted from the exhibit.  1.1.68. “Patent Rights” means any and all of the following: (i) patent  applications (including provisional patent applications) and patents (including inventor’s  certificates); (ii) any substitution, extension (including patent term extensions, patent term  adjustments, supplementary protection certificates and pediatric exclusivity periods), registration,  confirmation, reissue, continuation, divisional, continuation-in-part, reexamination, renewal,  patent of addition or the like thereof or thereto; (iii) applications and patents claiming the right of  priority to any of the foregoing; and (iv) all foreign counterparts of any of the foregoing, including  Patent Cooperation Treaty applications.  1.1.69. “Person” means any individual, firm, corporation, partnership,  trust, business trust, joint venture, limited liability company, Governmental Authority, association  or other entity.  1.1.70. “PNT-2002” means the compound having the structure set forth in  Exhibit A, complexes, salts, and precursors thereof, including radiolabeled compounds of any of  the foregoing including but not limited to compounds complexed with 177Lu, including the PNT- 2002 Product in Development by POINT as of the Execution Date.  1.1.71. “PNT-2002 Clinical Trial” means the Clinical Trial sponsored by  POINT with ClinicalTrials.gov identifier NCT04647526.  1.1.72. “Post-Marketing Clinical Trial” means a Clinical Trial that is  conducted for a purpose other than to obtain, support or maintain Regulatory Approval.  For the  avoidance of doubt, a Clinical Trial that is a Post-Marketing Commitment does not constitute a  Post-Marketing Clinical Trial.  1.1.73. “Post-Marketing Commitments” means any and all items, tasks,  activities, studies, trials or other commitments the completion of which is recommended or  required by the FDA in connection with the initial grant of Regulatory Approval for the Licensed  Product in the Initial Indication in the U.S. or required by the FDA to maintain such Regulatory  Approval.    1.1.74. “Regulatory Activities” means (i) the preparation and submission  of the Licensed Product NDA, (ii) leading interactions with the FDA, including with respect to  any pre-NDA filing meeting and FDA’s review of the Licensed Product NDA, (iii) being  designated as the holder of the Regulatory Approvals for the Licensed Product, (iv) maintaining,  supporting and expanding such Regulatory Approvals, including through managing the Post- Marketing Commitment and pharmacovigilance and through life cycle management, (v) any other  activities expressly required to be performed by LANTHEUS under the Manufacturing,  Development and Regulatory Plan, and (vi) any activities equivalent to the foregoing in the  Territory outside of the U.S.   1.1.75. “Regulatory Approval” means, with respect to a country or other  jurisdiction in the Territory, all approvals necessary for the Commercialization of a pharmaceutical  product for one or more indications in such country or jurisdiction, which may include satisfaction  of applicable regulatory and notification requirements and, where required by Applicable Law,  separate pricing and reimbursement approvals prior to sale of a pharmaceutical product.  





 






   15  [***] = Indicates confidential information omitted from the exhibit.  1.1.76. “Regulatory Authority” means any applicable Governmental  Authority involved in regulating Development of, and granting Regulatory Approval for, a  pharmaceutical product in a regulatory jurisdiction within the Territory, including the FDA and  the EMA.  1.1.77. “Regulatory Costs” means all costs incurred (i.e., paid or accrued)  by either Party, in each case, in accordance with GAAP, to the extent attributable to the  performance of Regulatory Activities.    1.1.78. “Related Party” means LANTHEUS, any of its Affiliates or any  U.S. LANTHEUS Sublicensees that is granted rights under a LANTHEUS Sublicense Agreement  to Commercialize the Licensed Product in the U.S.  1.1.79. “Return Hurdle” means (i) the cumulative amount of Gross Profit  earned from and after the First Commercial Sale of the Licensed Product in the Territory, minus  (ii) the cumulative amount of royalty payments paid to POINT.  1.1.80. “Target NDA Approval Date” means June 30, 2025.   1.1.81. “Territory” means all countries of the world but excluding the  Excluded Territory.  1.1.82. “Third Party” means any Person other than the Parties or their  respective Affiliates.  1.1.83. “Trigger Year” means the first Calendar Year in which Gross Profit  meets or exceeds One Hundred Million U.S. Dollars (US$100,000,000).  1.1.84. “U.S.” means the United States of America.  1.1.85. “U.S. Dollars,” “US$” or “$” means United States Dollars.  1.1.86. “Valid Claim” means a claim of an issued and unexpired Patent  Right (including, as applicable, any Licensed Patents or Collaboration Patents) or pending claim  of a patent application, which claim or pending claim has not been revoked or held unenforceable,  unallowable, unpatentable or invalid by a decision of a court or other Governmental Authority of  competent jurisdiction, which claim or pending claim is not appealable or has not been appealed  within the time allowed for appeal, and which claim or pending claim has not been cancelled,  withdrawn from consideration, abandoned, disclaimed, denied or admitted to be invalid or  unenforceable through reissue, re-examination, inter partes review, post-grant review or  disclaimer, opposition procedure, nullity suit, or otherwise; provided, however, that if the holding  of such court or Governmental Authority is later reversed by a court or Governmental Authority  with overriding authority, the claim will be reinstated as a Valid Claim with respect to Net Sales  made after the date of such reversal; and provided, further, that a claim of a patent application  pending for more than seven (7) years from the earliest date from which such patent application  claims priority will not be considered to be a Valid Claim for purposes of this Agreement unless  and until a patent with respect to such application issues with such claim, in which case such claim  





 






   16  [***] = Indicates confidential information omitted from the exhibit.  will be reinstated and be deemed to be a Valid Claim, but only as of the date of issuance of such  patent.  1.1.87. “Working Plans” means the Commercialization Plan, the  Manufacturing, Development and Regulatory Plan, and the Transition Plan.  1.2. Additional Definitions.  The following terms have the meanings set forth in the  corresponding Sections of this Agreement:  TERMS SECTION  AAA Rules 14.1.3  Agreement Preamble  Alliance Managers 2.1  Auditing Party 9.5.2  Claim 13.2  Closing 12.1  Complaining Party 14.1.2  Confidential Information 8.1  control 1.1.1  CRPC 6.4.1  Manufacturing, Development and Regulatory Plan 3.1.2  Dispute 14.1.1(i)  Dispute Notice 14.1.2  Dose Price 5.4.3  Executive Steering Committee (ESC) 2.2.1  Effective Date 12.1  Escalation Procedure 2.2.4  Execution Date Preamble  Extension Fee 16.1.4  First Pre-NDA Filing Meeting 16.2.2(i)  Force Majeure Delay 17.10  Generic Entry 9.3.6  Hatch-Waxman Act 7.5.1  Indemnitee 13.4  Infringement 7.5.1  Infringement Claim 7.6.1  Commercialization Plan 4.1.2(i)  Manufacturing, Development and Regulatory Plan 3.1.2  Insolvency Event 16.2.4  IP 16.3.4(i)  JCSC Leader 4.1.1  JDRSC Leader 3.1.1  JMSC Leader 5.1.1  Joint Commercialization Steering Committee (JCSC) 4.1.1  Joint Development Steering Committee (JDRSC) 3.1.1  





 






   17  [***] = Indicates confidential information omitted from the exhibit.  TERMS SECTION  Joint Manufacturing Steering Committee (JMSC) 5.1.1  Joint Steering Committee (JSC) 2.2.2(ii)  LANTHEUS Preamble  LANTHEUS Indemnified Party 13.3  LANTHEUS Senior Management 14.1.2  Licensed Product Business 11.1.1  Losses 13.2  Non-CRPC Indications 6.4.2  Other Component 1.1.17  Patent Action 6.3  Patent Committee 7.3  POINT Preamble  POINT Indemnified Party 13.2  POINT Know-How 1.1.54  POINT Manufacturing Know-How 5.6.4(i)  POINT Senior Management 14.1.2  Product Trademarks 7.1.1  Prosecution 7.4.1(i)  Protection 7.4.1(iii)  Recording Party 9.5.1  Regulatory Filings 3.4.1  Regulatory Milestone Catch-Up Amount 9.2.1(ii)  Regulatory Milestone Payment 9.2.1  Related Party 1.1.65  Representatives 11.3  Requirements Commitment 5.6.5  Responding Party  14.1.2  Response 14.1.2  Royalty Term 9.3.3  Senior Management 14.1.2  Specified Product Candidate 6.4.2  Sublicense Diligence Period 6.1.5(iii)  Sued Party 7.6.1  Surviving Sublicensee 16.3.3(iv)  Technical and Quality Agreement 5.4.1  Term 15.1  Termination Date 16.1.4  Transfer Completion Date 3.4.1  Transition Plan 3.3.4  Up-Front Payment 9.1    1.3. Interpretation.  Except where the context expressly requires otherwise in this  Agreement, (a) the use of any gender herein will be deemed to encompass references to either or  





 






   18  [***] = Indicates confidential information omitted from the exhibit.  both genders, and the use of the singular will be deemed to include the plural (and vice versa); (b)  the words “include,” “includes,” and “including” will be deemed to be followed by the phrase  “without limitation” and will not be interpreted to limit the provision to which it relates; (c) the  word “will” will be construed to have the same meaning and effect as the word “shall”; (d) any  definition of or reference to any agreement, instrument or other document herein will be construed  as referring to such agreement, instrument or other document as from time to time amended,  supplemented or otherwise modified (subject to any restrictions on such amendments, supplements  or modifications set forth herein); (e) any reference herein to any Person will be construed to  include the Person’s successors and assigns to the extent not prohibited by this Agreement; (f) the  words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer  to this Agreement in its entirety, as the context requires, and not to any particular provision hereof;  (g) all references herein to Sections, Articles, Exhibits or Schedules will be construed to refer to  Sections, Articles, Exhibits, or Schedules of this Agreement, and references to this Agreement  include all Schedules and Exhibits hereto; (h) the word “notice” means notice in writing (whether  or not specifically stated) (email in accordance with Section 17.2 is sufficient) and will include  notices, consents, approvals and other written communications contemplated under this  Agreement; (i) provisions that require that a Party, the Parties or any committee hereunder “agree,”  “consent,” or “approve” or the like will require that such agreement, consent or approval be  specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but  excluding e-mail and instant messaging); (j) references to any specific law, rule or regulation, or  article, Section or other division thereof, will be deemed to include the then-current amendments  thereto or any replacement or successor law, rule or regulation thereof; (k) references to a particular  statute or regulation include all rules and regulations thereunder and any predecessor or successor  statute, rules or regulations, in each case, as amended or otherwise modified from time to time; (l)  unless the context otherwise requires, the term “or” will be interpreted in the inclusive sense  commonly associated with the term “and/or”; (m) whenever this Agreement refers to a number of  days, such number will refer to calendar days unless Business Days are specified; and, (n) except  as otherwise provided herein, this Agreement shall take precedence over any contrary terms in any  Manufacture and Supply Agreement and any Working Plan, unless any such Manufacture and  Supply Agreement or Working Plan expressly states that it is intended to take precedence over a  contrary provision in this Agreement, in which case such conflicting provision will be superseded  only with respect to the Manufacture and Supply Agreement or Working Plan that is expressly  stated to supersede it and references this Interpretation clause (n).  ARTICLE 2    MANAGEMENT OF THE COLLABORATION  2.1. Alliance Managers.  On the Effective Date, each Party will appoint, and identify  to the other Party in writing (email is sufficient), an appropriately qualified individual to serve as  an alliance manager under this Agreement (the “Alliance Managers”), who may serve as the  primary point of contact for any matters arising under this Agreement and who will endeavor to  assure clear and responsive communication between the Parties and the effective exchange of  information.  The Alliance Managers will ensure each Party’s awareness and compliance of the  governance procedures and rules under this Agreement.  The Alliance Managers may attend  meetings of all JSCs and the ESC under this Agreement and may raise issues for the applicable  





 






   19  [***] = Indicates confidential information omitted from the exhibit.  JSC and ESC for discussion.  The Alliance Managers will have decision-making authority limited  to the administration of the alliance management activities under this Agreement.  2.2. Executive Steering Committee.  2.2.1. On the Effective Date, the Parties will establish the Executive Steering  Committee (the “ESC”), which will have overall responsibility for overseeing the collaboration  between the Parties with respect to the Development, Manufacturing and Commercialization of  the Licensed Product as contemplated by this Agreement.  The ESC will comprise three (3)  representatives by each Party upon notice to the other Party in accordance with this Agreement.   Such representatives will include individuals of each Party with decision-making authority with  respect to the matters within the authority of the ESC.  2.2.2. ESC Responsibilities.  The ESC will perform the following functions:  (i) for the Licensed Product for the Initial Indication in the U.S., review  and, in its discretion, approve amendments, modifications and supplements to the Working Plans;   (ii) review reports received from each Joint Steering Committee  established by this Agreement or created during the Term (each, a “JSC”) and provide direction  to each JSC regarding the performance of its responsibilities;  (iii) serve as the first forum for any Escalation Procedure or the  settlement of disputes or disagreements between the Parties arising in each JSC; and  (iv) perform such other functions as appropriate to further the purposes  of this Agreement as determined by mutual agreement of the Parties.  2.2.3. ESC Meetings. To conduct the activities described, the ESC will meet at  least once each Calendar Quarter until disbandment of the ESC pursuant to Section 2.3, or more  frequently if agreed by the ESC or as needed in the event of invocation of the Escalation Procedure  or other dispute resolution. Meetings may be held in-person, telephonically or by videoconference,  as agreed upon by the Parties.  Either Party may request that specific items be included in the  agenda.  A quorum of at least one (1) ESC representative appointed by each Party will be present  at or will otherwise participate in each ESC meeting.  If mutually agreed by the Parties on a case- by-case basis, the ESC may invite other non-members to participate in the discussions and  meetings, provided that the presence of such participants will not be considered in determining  whether there is a quorum of the ESC.   One (1) person (who need not be a member of the ESC)  will attend each meeting and record the minutes of such meeting in writing.  Such minutes will be  circulated to the Parties promptly following each meeting for review, comment and approval.  If  no comments are received from a Party within ten (10) Business Days after receipt of the minutes  by such Party, then such minutes will be deemed to be approved by such Party.  2.2.4. ESC Decision Making.  As a general principle, the ESC will operate by  consensus, with the representatives of each Party collectively having one (1) vote, respectively.  In  the event that the ESC committee members do not reach consensus with respect to a matter that is  within the ESC committee’s decision-making authority within fifteen (15) Business Days after  they have met and attempted to reach such consensus, such matter may be escalated to resolution  





 






   20  [***] = Indicates confidential information omitted from the exhibit.  by each Party’s Chief Executive Officers by the written request of either Party (“Escalation  Procedure”).  If the Chief Executive Officers are unable to resolve such matter within ten (10)  days of the date of such written Escalation Procedure request, then:  (i) POINT will have the final decision-making authority if such matter  relates to the day-to-day activities related to the PNT-2002 Clinical Trial or Manufacture of the  Licensed Product, subject the terms of the applicable Manufacture and Supply Agreement(s), in  each case, in accordance with the respective Working Plans; and   (ii) LANTHEUS will have the final decision-making authority with  respect to any other matter, including any amendments, modifications and supplements to Working  Plans and any material decisions, including those that affect project timelines, approvability,  product profile and probabilities of success; provided that such amendments, modifications and  supplements shall not, in and of themselves, increase the aggregate, reasonably documented, out- of-pocket costs (excluding FTEs) that POINT, from and after the Effective Date, has incurred and  will be required to incur to fulfill all of its obligations under the Working Plans in excess of one  hundred sixty two million five hundred thousand dollars (US$162.5M), it being the understanding  of the Parties that POINT will have invested at least an aggregate $250M in the Licensed Product  program, inclusive of its investments made prior to the Effective Date.  Notwithstanding anything to the contrary, to the extent any matters are required by Applicable  Law or due to safety concerns with respect to a Licensed Product to be resolved within a shorter  period of time than the periods set forth in this Article 2, the periods set forth will be shortened as  appropriate to permit the resolution of such matters within the required period.  2.3. Disbandment of the ESC.  The ESC will automatically disband on the earlier of  (i) the mutual written agreement of the Parties, (ii) the occurrence of an event contemplated by  Section 17.5(iii), or (iii) the termination or expiration of this Agreement.  Thereafter, LANTHEUS  will have the sole decision-making authority over all matters that were within the authority of the  ESC prior to such disbandment.  2.4. Restrictions on Authority.  The ESC and each JSC will have solely the powers  expressly assigned to it in this Agreement.  Neither the ESC nor any JSC will have any power to  amend, modify, or waive compliance with this Agreement.     2.5. Compliance with Working Plans. Each Party shall comply with and perform its  duties and obligations under the Working Plans.  ARTICLE 3    DEVELOPMENT  3.1. Joint Development and Regulatory Steering Committee.    3.1.1. Establishment of the Joint Development and Regulatory Steering  Committee.  On the Effective Date, the Parties will establish the Joint Development and  Regulatory Steering Committee (the “JDRSC”) to coordinate and implement all activities for the  Development of the Licensed Products in the United States in accordance with the Manufacturing,  





 






   21  [***] = Indicates confidential information omitted from the exhibit.  Development and Regulatory Plan.  One (1) representative from each Party will be designated as  that Party’s “JDRSC Leader” to act as the primary JDRSC contact for that Party.  Unless otherwise  agreed by the Parties in writing (email is sufficient), the JDRSC will comprise an equal number of  representatives of each Party as is reasonably necessary to accomplish the goals of the JDRSC  hereunder.  Such representatives will include individuals with expertise and responsibilities in the  areas of clinical development and regulatory affairs.  Either Party may replace any or all of its  JDRSC representatives, including its JDRSC Leader, at any time upon notice to the other Party in  accordance with this Agreement.  3.1.2. JDRSC Responsibilities.  The JDRSC will perform the following  functions:   (i) for the Licensed Product for its Initial Indication in the U.S., oversee  execution of (formulate amendments, modifications and supplements to) the Manufacturing,  Development and Regulatory Plan, including monitoring the execution of the PNT-2002 Clinical  Trial, deciding and managing any Investigator Sponsored Study or Investigator Sponsored Trial,  overseeing NDA strategy, data compilation and interactions with FDA, in each case, as set forth  therein;  (ii) reviewing and overseeing the potential execution of any  requirements for the amendment of the PNT-2002 Clinical Trial required by Regulatory  Authorities, investigators or either Party;  (iii) determining and implementing regulatory strategy and  communications with FDA and other Governmental Authorities;  (iv) reviewing requirements related to the NDA and collectively  addressing FDA questions and requirements;  (v) overseeing the Patent Committee with respect to intellectual  property strategy and execution for the Licensed Product;   (vi) coordinating implementation of all Development activities for the  Licensed Product for its Initial Indication in the U.S. pursuant to the Manufacturing, Development  and Regulatory Plan;  (vii) exchanging information and facilitating cooperation and  coordination between the Parties as they exercise their respective rights and meet their respective  obligations under the Manufacturing, Development and Regulatory Plan;  (viii) providing status updates to the ESC regarding Development  activities for the Licensed Product for the Initial Indication in the U.S. pursuant to the  Manufacturing, Development and Regulatory Plan, including progress towards achieving key  milestone events; and  (ix) performing such other functions as appropriate to further the  purposes of this Agreement as determined by mutual agreement of the Parties.  





 






   22  [***] = Indicates confidential information omitted from the exhibit.  In addition, the JDRSC may designate sub-teams as appropriate to facilitate coordination and  cooperation in key areas.  The Parties, as of the Execution Date, have agreed upon a high level  summary of the initial Manufacturing, Development and Regulatory plan covering, among other  things, Development activities for the Licensed Product for the Initial Indication in the U.S.  through the filing of the Licensed Product NDA (including the regulatory strategy for obtaining,  supporting or maintaining First FDA Approval), and such plan may be amended, modified and/or  supplemented from and after the Execution Date in accordance with this Agreement to include all  Development activities for the Licensed Product for the Initial Indication in the U.S., including  Post-Marketing Commitments in accordance with Section 3.2.1(ii) (as so amended, modified or  supplemented from time to time, the “Manufacturing, Development and Regulatory Plan”).   Notwithstanding anything to the contrary set forth under this Agreement, the Manufacturing,  Development and Regulatory Plan will not include (unless POINT consents in writing) any Post- Marketing Clinical Trials for the Licensed Product.  The JDRSC may formulate amendments,  modifications and supplements to the Manufacturing, Development and Regulatory Plan at any  time and submit such amendments, modifications and supplements to the ESC for review and  approval in accordance with Section 2.2.2(i).    3.1.3. JDRSC Meetings.  The JDRSC will meet at least once each month or as  agreed by the JDRSC, until the disbandment of the JDRSC pursuant to Section 3.1.5.  Either Party  may request that specific items be included in the agenda.  Meetings may be held in-person,  telephonically or by videoconference, as agreed upon by the Parties.  A quorum of at least two (2)  JDRSC members appointed by each Party will be present at or will otherwise participate in each  JDRSC meeting.  If mutually agreed by the Parties on a case-by-case basis, the JDRSC may invite  other non-members to participate in the discussions and meetings of the JDRSC, provided that the  presence of such participants will not be considered in determining whether there is a quorum at  the JDRSC.  One (1) person (who need not be a member of the JDRSC) will attend each meeting  and record the minutes of such meeting in writing.  Such minutes will be circulated to the Parties  promptly following the meeting for review, comment and approval.  If no comments are received  from a Party within ten (10) Business Days after receipt of the minutes by such Party, such minutes  will be deemed to be approved by such Party.  3.1.4. JDRSC Decision Making.  As a general principle, the JDRSC will operate  by consensus, with the JDRSC representatives of each Party collectively having one (1) vote,  respectively.  In the event that the JDRSC members do not reach consensus with respect to a matter  that is within the purview of the JDRSC within ten (10) Business Days after they have met and  attempted to reach such consensus, such matter will be presented to the ESC for resolution in  accordance with Section 2.2.2(iii).   3.1.5. Disbandment of the JDRSC.  The JDRSC will automatically disband on  the earlier of (i) the mutual written agreement of the Parties, (ii) the occurrence of an event  contemplated by Section 17.5 or (iii) the termination or expiration of this Agreement.  Thereafter,  LANTHEUS will have the sole decision-making authority over all matters that were within the  authority of the JDRSC prior to such disbandment.  3.2. Licensed Product Development and Regulatory Responsibilities and Rights.    3.2.1. Licensed Product Development Rights and Responsibilities of POINT.    





 






   23  [***] = Indicates confidential information omitted from the exhibit.  (i) POINT will perform all activities expressly required under, or  reasonably inferable from, the Manufacturing, Development and Regulatory Plan (which may be  updated from time to time as set forth herein), including all Development activity required for First  FDA Approval.  Not in limitation of the foregoing, POINT will generate in a timely manner all  clinical and nonclinical data, analysis and other information (including relating to chemistry,  Manufacturing and controls) necessary to obtain Regulatory Approval of the Licensed Product  NDA, including, but not limited to:   (A) with respect to PNT-2002 Clinical Trial, Clinical Overview  of Safety, Integrated Summary of Safety, Clinical Overview of Efficacy,  Integrated Summary of Efficacy, PNT-2002 Clinical Trial Study Report  including all appendices, Narratives (as applicable), STDM data package,  ADaM data package, QTc validation plan, annotated CRF, Trial Master  File; and   (B) with respect to CMC/Manufacturing, all deliverables  associated with M2 & M3 for the Licensed Product NDA (includes critical  raw materials, drug substance, drug product), Validation Master Plan,  Master Batch Records, Development Reports, Validation Protocols and  Reports, Standard Test Methods, and Specifications.    POINT shall bear the cost of completing the PNT-2002 Clinical Trial, including the activities  related thereto as agreed in the Manufacturing, Development and Regulatory Plan, and generating  the data, analysis and other information described above, with any other expenses (including  POINT’s FTE costs) associated with additional activities conducted by POINT intended to address  the FDA’s requirements (including suggestions from FDA that Lantheus could reasonably infer as  being necessary for FDA approval) for First FDA Approval arising out of pre-NDA filing  meeting(s) with FDA being borne by LANTHEUS and POINT equally.   (ii) Following receipt of First FDA Approval for the Licensed Product  NDA, POINT will conduct any applicable Post-Marketing Commitments for the Licensed Product  in the Initial Indication in the U.S. required in connection with such Regulatory Approval, with  expenses (including POINT’s and LANTHEUS’ FTE costs) associated with POINT’s and  LANTHEUS’ performance under this subsection 3.2.1(ii) being borne by LANTHEUS and  POINT equally.  (iii) If POINT desires to perform any tasks, obligations or support that  POINT is required to perform or provide hereunder through any of its qualified Affiliates,  contractors or agents, then POINT may engage such Affiliates, contractors or agents to perform  such tasks, obligations or support, but POINT will remain responsible for performance of its  obligations hereunder.   (iv) POINT will use the proceeds from the Up-Front Payment to fund all  activities necessary for it to complete its responsibilities under the Working Plans and fulfill all of  its obligations under, and in accordance with, this Section 3.2.1, and POINT will prioritize use of  such proceeds for these purposes over all other purposes or projects.  In the event that, prior to  First Commercial Sale, the amount of cash and cash equivalents reflected on POINT’s balance  





 






   24  [***] = Indicates confidential information omitted from the exhibit.  sheet included in Form 10-K or Form 10-Q filed with the Securities and Exchange Commission is  less than two (2) times the amount required to complete its obligations under the Working Plans,  then upon LANTHEUS’ request within five (5) Business Days of POINT publicly disclosing its  quarterly financial results by way of filing its Form 10-K or Form 10-Q with the Securities and  Exchange Commission, POINT’s Chief Financial Officer will organize a timely meeting with  representatives from LANTHEUS to discuss and demonstrate POINT’s ability to fund and fulfill  its obligations under this Section 3.2.1 with its cash then-on hand and its then-committed-and- available financial resources.    3.2.2. Licensed Product Development Rights and Responsibilities of  LANTHEUS.  (i) Following the Effective Date, LANTHEUS will use Commercially  Reasonable Efforts to reasonably cooperate with POINT to facilitate the Development of the  Licensed Product in accordance with the Manufacturing, Development and Regulatory Plan and  will diligently respond with knowledgeable personnel to any reasonable requests of POINT.   (ii) Following the First FDA Approval, LANTHEUS will have the sole  discretion and unilateral right, itself or through its Affiliates, LANTHEUS Sublicensees,  subcontractors or Distributors, to conduct any further Development (excluding Manufacture,  which is covered in Article 5 and Section 6.1.3) of the Licensed Product at its own cost and  expense; provided that, (A) POINT agrees to provide support in such further Development, at its  own FTE cost, to the extent relating to collating, analyzing and/or reporting the data and other  information it generated in support of the First FDA Approval or the PNT2002 Clinical Trial and,  (B) if POINT agrees to participate in any other Development activities, then LANTHEUS agrees  to reimburse POINT for all documented, out-of-pocket expenses and FTE costs.  (iii) LANTHEUS will be responsible for any and all interactions with  the FDA in relation to the Licensed Product NDA, including but not limited to preparing and  seeking Regulatory Approval and Post-Marketing Commitments.   (iv) LANTHEUS will perform all activities expressly required under, or  reasonably inferable from, the Manufacturing, Development and Regulatory Plan (which may be  updated from time to time).    3.3. Transfer of Licensed Know-How to Support the NDA.    3.3.1. As of the Effective Date.  Promptly following the Effective Date (but in  any event no later than ninety (90) days thereafter, unless an earlier or later deadline is set forth in  the applicable Working Plan), subject to the limitations set forth herein with respect to POINT  Manufacturing Know-How, POINT will transfer a true and complete copy of or provide access to  (whichever is feasible) to LANTHEUS, at POINT’s sole cost and expense, all (a) data and results  generated from any Development activities conducted by or on behalf of POINT with respect to  any Licensed Product prior to the Effective Date (as evidenced by all pre-clinical study reports and  clinical study reports for completed Clinical Trials of the Licensed Products), (b) Trial Master  Files (including any Trial Master File plans, tables of contents or indices and any evidence or  certification of related quality checks) or equivalents thereof, for all completed or ongoing Clinical  





 






   25  [***] = Indicates confidential information omitted from the exhibit.  Trials of any Licensed Product conducted by or on behalf of POINT and (c) other tangible  embodiments of the Licensed Know-How; provided, however, that POINT will not be obligated  (except as otherwise provided herein) to disclose directly to LANTHEUS any POINT  Manufacturing Know-How beyond that which is necessary to disclose to Regulatory Authorities  in any country in the Territory as part of obtaining and maintaining Regulatory Approval in such  country.    3.3.2. During the Term.  After the Effective Date, and thereafter for the duration  of the Term, on a quarterly basis until POINT’s successful completion of all of its activities under  the Manufacturing, Development and Regulatory Plan, or more frequently as (a) new data and  results with respect to the Licensed Products (subject to Section 6.1.7(i)), (b) new or updated Trial  Master Files or (c) new tangible embodiments of the Licensed Know-How, in each of clauses (a)  through (c), come into POINT’s possession or Control, POINT will transfer a true and complete  copy of or provide access to (whichever is feasible) to LANTHEUS, at POINT’s sole cost and  expense, any such new data and results generated from any Development activities  conducted by  or on behalf of POINT with respect to any Licensed Product for all ongoing Clinical Trials  conducted by or on behalf of POINT, as evidenced by all pre-clinical study reports and clinical  study reports for other Clinical Trials of the Licensed Product for its Initial Indication, or new or  updated Trial Master Files or new tangible embodiments of the Licensed Know-How. Without  limiting the foregoing, subject to the limitations set forth herein with respect to POINT  Manufacturing Know-How, POINT will, prior to the Transfer Completion Date, transfer or have  transferred to LANTHEUS true and complete copies of (a) all data and results generated from any  Development activities  conducted by or on behalf of POINT with respect to the Licensed Products  for all ongoing Clinical Trials conducted by or on behalf of POINT (including all pre-clinical  studies and Clinical Trials of the Licensed Product for the Initial Indication), (b) all Trial Master  Files (including any Trial Master File plans, tables of contents or indices and any evidence or  certification of related quality checks) or equivalents thereof, for all Clinical Trials of the Licensed  Products conducted by or on behalf of POINT and (c) all other tangible embodiments of the  Licensed Know-How in POINT’s possession or Control as of the Transfer Completion Date.    3.3.3. Format.  For the avoidance of doubt, any of the files, data, information or  materials provided under this Section 3.3 is part of the Licensed Know and subject to the license  grants set forth in Section 6.1.2(ii). Any transfer under this Section 3.3 will be in such format  mutually agreed upon by the Parties or as set forth in the Transition Plan (including by download  of digital files to a secure website or e-room designated and controlled by LANTHEUS, to which  POINT may be given access).    3.3.4. Transition Plan. Following First FDA Approval, the Parties will cooperate  with each other to ensure a smooth and orderly transition to LANTHEUS or LANTHEUS’s  designee of ongoing Development activities (excluding Manufacture, which is covered in Article  5 and Section 6.1.3) related to the Licensed Product, including taking the actions specified in the  Transition Plan.  Within ninety (90) days after the Effective Date, the Parties, each acting  reasonably and in good faith, will develop a transition plan covering matters not contemplated in  the Working Plans that are necessary to the accomplishment of the fundamental purposes of this  Agreement (as such plan may be amended, modified and/or supplemented in accordance with this  Agreement from time to time, the “Transition Plan”).  If there is any inconsistency between the  Transition Plan and this Agreement, the terms of this Agreement will prevail.  The Transition Plan  





 






   26  [***] = Indicates confidential information omitted from the exhibit.  shall also include plans for the Parties to manage, and to the extent permissible transitioning to  LANTHEUS the roles, rights and responsibilities under currently ongoing active Investigator- Initiated Research studies involving the Licensed Product listed on Exhibit E.   3.4. Regulatory Filings.    3.4.1. Licensed Product in the Initial Indication in the U.S.  Subject to  POINT’s performance of its obligations in Section 3.2.1 and LANTHEUS’ right to terminate under  Section 16.2.2, LANTHEUS will be responsible for preparing and submitting all regulatory filings  with the FDA in respect of the Licensed Product, including the Licensed Product NDA.   LANTHEUS will, using Commercially Reasonable Efforts, submit all such regulatory filings in  accordance with the Manufacturing, Development and Regulatory Plan.  At LANTHEUS’ request,  POINT will (at its own cost) provide all reasonable cooperation and assistance in preparing the  Licensed Product NDA and seeking Regulatory Approval thereof.  All such filings and Regulatory  Approval (if granted) for the Licensed Product NDAs will be held by and in the name of  LANTHEUS, except as set forth in Section 3.4.2 upon termination of this Agreement by POINT.   At a time determined by the JDRSC (but no later than the date of the First Pre-NDA Filing  Meeting), POINT will assign to LANTHEUS its entire right, title and interest in and to all  regulatory filings related to the Licensed Product in the Initial Indication, including the Licensed  Product INDs, and will promptly transfer to LANTHEUS complete and correct copies of all such  regulatory filings and any and all related regulatory documentation (such filing documentation and  material the “Regulatory Filings”).  The date on which such assignment and transfer of Regulatory  Filings are complete will be deemed the “Transfer Completion Date.”  Promptly following the  Transfer Completion Date, POINT will notify the FDA of, and take all actions reasonably  necessary to effect or evidence, the assignment and transfer of Regulatory Filings to LANTHEUS.   3.4.2. Return of Regulatory Filings upon Termination. Upon termination of  this Agreement by POINT with respect to any country, any and all Regulatory Filings and related  Regulatory Approvals for that country will be held by and in the name of POINT, and upon such  termination LANTHEUS hereby assigns to POINT its rights, title, and interests in and to such  filings and Regulatory Approvals.  Further, upon termination of this Agreement by POINT with  respect to any country, LANTHEUS shall as promptly as reasonably practicable provide to POINT  all documents, information, data, historical files, minutes, reports, and any other materials related  to Regulatory Filings and, within ten (10) Business Days (with respect to the U.S.) or ninety (90)  days (with respect to any other country in the Territory) following any such termination of this  Agreement, shall, to the extent required under the rules of the applicable Regulatory Authority,  notify the applicable Regulatory Authority of, and take all actions reasonably necessary to effect  or evidence, the assignment and transfer of such Regulatory Filings to POINT.  3.4.3. Other Products.  LANTHEUS will have the unilateral right, in its sole  discretion and at its own cost and expense, to submit any regulatory filings, including INDs and  NDAs for, and seek Regulatory Approval of, any Licensed Products in the Field in the Territory,  in its sole discretion.   3.5. Regulatory Meetings and Communications.    





 






   27  [***] = Indicates confidential information omitted from the exhibit.  3.5.1. Responsibilities for the Licensed Product in the Initial Indication in the  U.S.  LANTHEUS will be responsible for conducting meetings and discussions with the FDA  related to the Licensed Product.  At LANTHEUS’ request, POINT will (at its own expense)  consult, participate and/or otherwise reasonably cooperate with LANTHEUS with respect to such  meetings and discussions. LANTHEUS will keep the JDRSC reasonably and regularly informed  as to the status of all material Regulatory Filings and Regulatory Approvals with respect to the  Licensed Products in the Field in the Territory.  3.5.2. Regulatory Authority Communications by LANTHEUS.    (i) LANTHEUS will give POINT reasonable advance notice of  meetings and discussions, including meetings or discussions that take place in-person or via  teleconference or videoconference, with any Regulatory Authority related to the Licensed Product,  and POINT will have the right to send representatives of its regulatory department with expertise  in matters related to interactions with Regulatory Authorities to prepare for and participate in  person at all such meetings and discussions. LANTHEUS shall promptly provide to POINT, upon  POINT’s request, access to and/or copies of any and all substantive minutes, submissions,  correspondence, and any other substantive materials or information prepared or received by  LANTHEUS in connection with any interaction with a Regulator Authority regarding the Licensed  Product.     (ii) If either Party receives any material communications with the FDA  relating to the Licensed Products, then the Party will notify the other Party and, (a) as soon as  practicable, but in no case later than twenty-four (24) hours following receipt of such  communication, and provide an advance copy to the other Party of any such written  communication directed to the FDA or notes if such was orally communicated.  The Parties will  cooperate and will consider in good faith any comments any planned written communication to  the FDA consistent herewith.    (iii) In the event that, at any time during the Term following the  Execution Date, POINT receives any communication from any Regulatory Authority relating to  any Licensed Product, POINT will notify LANTHEUS and provide a copy to LANTHEUS of any  such written communication promptly following receipt of such communication.  On  LANTHEUS’s written request promptly following receipt of such notice, POINT will not respond  to any such communication and instead will permit LANTHEUS to respond on POINT’s behalf;  provided, however, that during any period in which POINT is responsible for Manufacturing any  Licensed Product, POINT will have the right (after informing and conferring with LANTHEUS)  to respond to communications from the FDA or other Regulatory Authority to the extent solely  related to the Manufacture of a Licensed Product by or on behalf of POINT or its Affiliate or  subcontractors and reasonably required to comply with Applicable Laws.   3.6. Debarment Limitations.  In the course of Development of the Licensed Product  in the Territory by or on behalf of a Party, each Party will not knowingly use any employee or  consultant who is or has been debarred by the FDA or any other Regulatory Authority, or, to the  best of such Party’s Knowledge, who is or has been the subject of debarment proceedings by the  FDA or any such Regulatory Authority.  Each Party will promptly notify the other Party of, and  provide the other Party with a copy of, any correspondence or other reports that such Party receives  





 






   28  [***] = Indicates confidential information omitted from the exhibit.  from any Third Party with respect to any use of a debarred employee or consultant in connection  with such Party’s performance of its obligations under this Agreement.  3.7. Compliance.  Each Party will conduct its Development activities under this  Agreement in compliance with all Applicable Laws and the terms and conditions set forth in this  Agreement.  3.8. Safety Reporting.  Within sixty (60) days after the Effective Date, the Parties will  enter into a mutually acceptable safety data exchange agreement, setting forth guidelines and  procedures for the receipt, investigation, recordation, review, communication, and exchange (as  between the Parties) of adverse event reports, pregnancy reports, technical complaints and any  other information concerning the safety of the Licensed Products, as well as safety governance and  decision-making roles.  Such guidelines and procedures will be in accordance with, and enable the  Parties and their Affiliates to fulfill, reporting obligations to the FDA or any other Regulatory  Authority.  Furthermore, such guidelines and procedures will be consistent with relevant  International Council on Harmonization (ICH) guidelines, except where said guidelines may  conflict with reporting requirements of local Regulatory Authorities, in which case local reporting  requirements will prevail.  The Parties’ costs incurred in connection with receiving, investigating,  recording, reviewing, communicating and exchanging adverse events and other reportable  information as provided in such safety data exchange agreement will be included as an element of  Development Costs (to the extent relating to the Development of a Licensed Product).  ARTICLE 4    COMMERCIALIZATION  4.1. Joint Commercialization Steering Committee.    4.1.1. Establishment of the Joint Commercialization Steering Committee.  On  the Effective Date, the Parties will establish the Joint Commercialization Steering Committee (the  “JCSC”) to coordinate and implement all activities for the Commercialization of the Licensed  Products in the U.S.  One (1) representative from each Party will be designated as that Party’s  “JCSC Leader” to act as the primary JCSC contact for that Party.  Unless otherwise agreed by the  Parties in writing (email is sufficient), the JCSC will comprise an equal number of representatives  of each Party as is reasonably necessary to accomplish the goals of the JCSC hereunder.  Such  representatives will include individuals with expertise and responsibilities in the areas of sales,  marketing and market access.  Either Party may replace any or all of its JCSC representatives,  including its JCSC Leader, at any time upon notice to the other Party in accordance with this  Agreement.  4.1.2. JCSC Responsibilities.  The JCSC will perform the following functions:   (i) for the Licensed Product for its Initial Indication in the U.S.,  formulate the initial commercialization plan, which shall include reasonable detail regarding the  plans for pre-launch, launch, and subsequent Medical Affairs and Commercialization activities of  the Licensed Product in the Territory (as such plan may be amended, modified and/or  supplemented in accordance with this Agreement from time to time, “Commercialization Plan”)  





 






   29  [***] = Indicates confidential information omitted from the exhibit.  and shall be prepared and submitted for review by the ESC as soon as reasonably practicable and,  in any event no later than sixty (60) days after the First Pre-NDA Filing Meeting.  Following such  review by the ESC, the Commercialization Plan will become effective, though the Parties agree  that it may be updated from time-to-time thereafter upon agreement of the ESC.   (ii) generate forecasts of supply requirements for the Licensed Products  pursuant to the Commercialization Plan and delivering such forecasts to the JMSC;  (iii) provide status updates to the ESC regarding Commercialization  activities for the Licensed Product for the Initial Indication in the U.S. pursuant to the  Commercialization Plan, including progress towards achieving key milestone events and  Commercialization cost expenditures, Post-Marketing Commitments, and Post-Marketing Clinical  Trials;   (iv) oversee efforts to enter into sublicenses pursuant to Section 6.1.4;  (v) perform such other functions as appropriate to further the purposes  of this Agreement as determined by mutual agreement of the Parties.  (vi) formulate amendments, modifications and/or supplements to the  Commercialization Plan at any time and submit such amendments, modifications and/or  supplements to the ESC for review and approval.    4.1.3. JCSC Meetings.  The JCSC will meet at least once each quarter or as  agreed by the JCSC, until the disbandment of the JCSC pursuant to Section 4.1.5.  Either Party  may request that specific items be included in the agenda. Meetings may be held in-person,  telephonically or by videoconference, as agreed upon by the Parties.  A quorum of at least two (2)  JCSC members appointed by each Party will be present at or will otherwise participate in each  JCSC meeting.  If mutually agreed by the Parties on a case-by-case basis, the JCSC may invite  other non-members to participate in the discussions and meetings of the JCSC, provided that the  presence of such participants will not be considered in determining whether there is a quorum at  the JCSC.  One (1) person (who need not be a member of the JCSC) will attend each meeting and  record the minutes of such meeting in writing.  Such minutes will be circulated to the Parties  promptly following the meeting for review, comment and approval.  If no comments are received  from a Party within ten (10) Business Days after receipt of the minutes by such Party, such minutes  will be deemed to be approved by such Party.  4.1.4. JCSC Decision Making.  As a general principle, the JCSC will operate by  consensus, with the JDRSC representatives of each Party collectively having one (1) vote,  respectively.  In the event that the JCSC members do not reach consensus with respect to a matter  that is within the purview of the JCSC within ten (10) Business Days after they have met and  attempted to reach such consensus, such matter will be presented to the ESC for resolution in  accordance with Section 2.2.2(iii).   4.1.5. Disbandment of the JCSC.  The JCSC will automatically disband on the  earlier of (i) the mutual written agreement of the Parties, (ii) the occurrence of an event  contemplated by Section 17.5 and (iii) expiration or termination of this Agreement.  Thereafter,  





 






   30  [***] = Indicates confidential information omitted from the exhibit.  LANTHEUS will have the sole decision-making authority over all matters that were within the  authority of the JCSC prior to such disbandment.  4.2. Commercialization Rights.  Subject to Article 6.1.2, during the Term,  LANTHEUS will have the unilateral right, itself or through its Affiliates, LANTHEUS  Sublicensees, subcontractors or Distributors, to Commercialize the Licensed Products in the Field  in the Territory upon advice and consultation with the JSCS.    4.3. Commercialization Efforts.  Subject to Article 3, following (i) receipt of  Regulatory Approval for the Licensed Product in the Initial Indication in the U.S. and  LANTHEUS’ completion of all Post-Marketing Commitments and (ii) the Transfer Completion  Date, LANTHEUS will use Commercially Reasonable Efforts to Commercialize the Licensed  Product in the Initial Indication in the U.S.   4.4. Commercialization Costs.  LANTHEUS will be responsible for all costs of  conducting Commercialization of Licensed Products.    4.5. Compliance.  LANTHEUS will Commercialize the Licensed Products in the Field  in the Territory in compliance with all Applicable Laws and the terms and conditions set forth in  this Agreement.  ARTICLE 5    MANUFACTURE AND SUPPLY  5.1. Joint Manufacturing Steering Committee.    5.1.1. Establishment of the Joint Manufacturing Steering Committee.  On the  Effective Date, the Parties will establish the Joint Manufacturing Steering Committee (the  “JMSC”) to coordinate all activities for the Manufacture and supply of the Licensed Products in  the Territory in accordance with one or more Manufacture and Supply Agreements.  One (1)  representative from each Party will be designated as that Party’s “JMSC Leader” to act as the  primary JMSC contact for that Party.  Unless otherwise agreed by the Parties in writing (email is  sufficient), the JMSC will comprise an equal number of representatives of each Party as is  reasonably necessary to accomplish the goals of the JMSC hereunder.  Such representatives will  include individuals with expertise and responsibilities in the areas of manufacturing, supply chain,  logistics, process sciences, quality control, quality assurance, regulatory affairs and/or process  development.  Either Party may replace any or all of its JMSC representatives, including its JMSC  Leader, at any time upon notice to the other Party in accordance with this Agreement.  5.1.2. JMSC Responsibilities.  The JMSC will perform the following functions:   (i) participate in drafting and updating the Manufacturing,  Development and Regulatory Plan to include integrated Manufacturing-related procurement,  buildout, validation, qualification, compliance, Regulatory Approval-related inspection and  commercial scale operation timelines, activities and roles and responsibilities required to  Manufacture the Licensed Product;  





 






   31  [***] = Indicates confidential information omitted from the exhibit.  (ii) review and provide status updates to the ESC regarding demand  forecasts and Manufacture and supply activities for the Licensed Product; and  (iii) monitor the performance of POINT’s obligations and activities  under the applicable Manufacture and Supply Agreement(s) for Clinical Supply and Commercial  Supply and perform such other functions as appropriate to further the purposes of this Agreement  as determined by mutual agreement of the Parties.  5.1.3. JMSC Meetings.  The JMSC will meet at least once each quarter or as  agreed by the JMSC, until the disbandment of the JMSC pursuant to Section 5.2.  Either Party may  request that specific items be included in the agenda. Meetings may be held in-person,  telephonically or by videoconference, as agreed upon by the Parties.  A quorum of at least two (2)  JMSC members appointed by each Party will be present at or will otherwise participate in each  JMSC meeting.  If mutually agreed by the Parties on a case-by-case basis, the JMSC may invite  other non-members to participate in the discussions and meetings of the JMSC, provided that the  presence of such participants will not be considered in determining whether there is a quorum at  the JMSC.  One (1) person (who need not be a member of the JMSC) will attend each meeting and  record the minutes of such meeting in writing.  Such minutes will be circulated to the Parties  promptly following the meeting for review, comment and approval.  If no comments are received  from a Party within ten (10) Business Days after receipt of the minutes by such Party, such minutes  will be deemed to be approved by such Party.  5.1.4. JMSC Decision Making.  As a general principle, the JMSC will operate by  consensus, with the JMSC representatives of each Party collectively having one (1) vote,  respectively.  In the event that the JMSC members do not reach consensus with respect to a matter  that is within the purview of the JMSC within ten (10) Business Days after they have met and  attempted to reach such consensus, such matter will be presented to the ESC for resolution in  accordance with Section 2.2.2(iii). POINT will have the final decision-making authority if such  matter relates to the day-to-day activities related to the PNT-2002 Clinical Trial and Manufacture  of the Licensed Product, subject the terms of the applicable Manufacture and Supply  Agreement(s), in each case, in accordance with the respective Working Plans.  5.2. Disbandment of the JMSC.  The JMSC will automatically disband on the earlier  of (i) the mutual written agreement of the Parties, (ii) the occurrence of an event contemplated by  Section 17.5, or (iii) expiration or termination of the later of this Agreement or all Manufacture  and Supply Agreements.  Thereafter, except as set forth herein, LANTHEUS will have the sole  decision-making authority over all matters that were within the authority of the JMSC prior to such  disbandment.  5.3. Manufacturing Rights.  Except as expressly set forth herein, including in Sections  5.6.2 and 6.1.3, or in a Manufacture and Supply Agreement, POINT will have the sole right to  Manufacture and supply the Licensed Product in the Territory, and neither LANTHEUS nor any  Affiliate of LANTHEUS (nor any others on behalf of or under license or sublicense from  LANTHEUS or any of its Affiliates) will Manufacture any Licensed Product.  LANTHEUS shall,  promptly upon POINT’s written request, provide to POINT access to all materials in its possession  or control required for its performance under the Manufacture and Supply Agreements.  





 






   32  [***] = Indicates confidential information omitted from the exhibit.  5.4. Manufacture and Supply Agreement.    5.4.1. The Parties, each acting reasonably and in good faith, will negotiate  and will endeavor within sixty (60) days after the date of the First Pre-NDA Filing Meeting  to finalize and execute a Manufacture and Supply Agreement on terms and conditions  consistent with those set forth in Exhibit C (or as otherwise mutually agreed), pursuant to  which POINT will Manufacture or have Manufactured, and LANTHEUS and its Affiliates  and, as applicable, LANTHEUS Sublicensees in the U.S. will purchase from POINT,  Supplies of Licensed Product in the United States.  The Parties, each acting reasonably and  in good faith, will negotiate and will endeavor within ninety (90) days after the date of the  First Pre-NDA Filing Meeting to finalize and execute a Technical and Quality Agreement,  which will be appended to, and incorporated by reference into, the Manufacture and Supply  Agreement and which will specify certain quality assurance and quality control  requirements relating to the Manufacture of Licensed Product (as such agreement may be  amended, modified, supplemented, renewed and/or superseded from time to time in  accordance with its terms, the “Technical and Quality Agreement”).  5.4.2. The Parties, each acting reasonably and in good faith, agree to  consider amending, modifying and/or supplementing such Manufacture and Supply  Agreement and Technical and Quality Agreement, as may be recommended by the Parties  or the JMSC from time to time, including updates necessary to account for changes in the  approved NDA and finalization of the Licensed Product distribution model.  For other  countries in the Territory other than the United States, the Parties agree to use reasonable,  good faith efforts to either amend the Manufacture and Supply Agreement and Technical  and Quality Agreement to include such other countries, or to enter into additional  Manufacture and Supply Agreement(s) and Technical and Quality Agreement(s) on  mutually agreed terms.     5.4.3. The initial purchase price per patient-ready dose of Licensed Product  under the Manufacture and Supply Agreement is set forth in Exhibit C (the “Dose Price”);  provided that, at the end of the first full Calendar Year after the First Commercial Sale of  Licensed Product and at the end of each subsequent Calendar Year, POINT shall in good  faith examine the average Fully Burdened Manufacturing Cost per dose of Licensed Product  during that Calendar Year, relative to the average Fully Burdened Manufacturing Cost per  dose of Licensed Product at the effective date of such Manufacture and Supply Agreement  (or for the previous Calendar Year, as case may be), and will (i) decrease the Dose Price for  orders in the subsequent Calendar Year by an amount equal to [***] percent ([***]%) of  any reduction in the average Fully Burdened Manufacturing Cost or, (ii) in the event of any  increase in the average Fully Burdened Manufacturing Cost above [***] percent ([***]%),  increase the Dose Price for orders in the subsequent Calendar Year by an amount that is  equal to the total amount of the increase to POINT in the average Fully Burdened  Manufacturing Cost from the prior Calendar Year that exceeds [***] percent ([***]%).  Notwithstanding clause (i) of the foregoing sentence, in no event will the Dose Price for any  order under any Manufacture and Supply Agreement be an amount less than [***] percent  ([***]%) of the average Fully Burdened Manufacturing Cost per dose of Licensed Product  for the prior Calendar Year; provided that any subsequent decrease under subsection (i)  





 






   33  [***] = Indicates confidential information omitted from the exhibit.  following any increase under this sentence or under subsection (ii) shall reduce the Dose  Price [***] rather than by only [***] percent ([***]%).  5.4.4. LANTHEUS shall purchase from POINT, and POINT shall supply,  under the Manufacture and Supply Agreement at least [***] ([***]) patient doses of the  Licensed Products in the first full Calendar Year after the First Commercial Sale.  5.5. Manufacturing Intellectual Property.  POINT will be responsible for (i)  obtaining rights to any intellectual property of any Third Party that is necessary for POINT to  Manufacture Clinical Supplies or Commercial Supplies in the Territory and (ii) all payments  (including upfront fees, milestones and royalties) due to any such Third Party in consideration for  any such grant of rights.  POINT will keep LANTHEUS informed of any such activities.  5.6. Additional Manufacturing and Supply Sources.    5.6.1. POINT acknowledges and agrees that, in consideration for LANTHEUS  agreeing to the initial limitations on its ability to Manufacture the Licensed Product and the initial  limitations on its access to POINT Manufacturing Know-How under this Agreement, POINT’s  establishment, maintenance and assurances of a robust, reliable, uninterrupted, redundant, diverse  and secure Manufacturing and supply chain for the Licensed Product in the Territory that complies  with Applicable Laws is an essential purpose of this Agreement.  POINT will maintain and utilize  (and not deprioritize for other customers, programs, projects or products) the experience,  capabilities, resources, personnel, facilities and manufacturing capacity necessary to Manufacture,  supply and deliver patient doses of Licensed Product on time in full in compliance with the  requirements of this Agreement and the Manufacture and Supply Agreement and all Applicable  Laws.    5.6.2. Upon the occurrence of any of the following events:   (i) the commencement of the Development of the Licensed Product by  LANTHEUS or one of its Affiliates directly in any country in the Territory outside of North  America or LANTHEUS entering into a LANTHEUS Sublicense Agreement with a LANTHEUS  Sublicensee in any country in the Territory outside of North America;  (ii) LANTHEUS achieving either (i) US$[***] of annual Net Sales of  Licensed Product in North America by the [***] ([***]) full Calendar Year anniversary of First  Commercial Sale and Net Sales growing by at least [***] percent ([***]%) over the previous  Calendar Year or (ii) US$[***] of annual Net Sales of Licensed Product in the Territory at any  time;  (iii) POINT’s Manufacturing Underperformance;   (iv) POINT undergoes an Insolvency Event; or  (v) POINT undergoes a Change of Control transaction involving a  Major Competitor, or POINT assigns its rights under this Agreement (or its rights to the Licensed  Patents), whether in whole or in part, to a Major Competitor;     





 






   34  [***] = Indicates confidential information omitted from the exhibit.  at LANTHEUS’s written request, POINT will (at POINT’s election) either (A) establish, qualify  and obtain Government Authority approvals for its own new site of Manufacture of the Licensed  Product in the relevant portion of the Territory identified by LANTHEUS or (B) facilitate and  effect a technology transfer (as described and subject to the limitations herein) to, and qualification  of, a new LANTHEUS-owned and operated or Third Party-owned and operated site of  Manufacture of the Licensed Product in the relevant portion of the Territory identified by  LANTHEUS; provided that, if POINT undergoes an Insolvency Event, POINT undergoes a  Change of Control transaction involving a Major Competitor, or POINT assigns its rights under  this Agreement (or its rights to the Licensed Patents), whether in whole or in part, to a Major  Competitor, then the foregoing clause (A) will not apply (unless LANTHEUS consents in advance  in writing).    5.6.3. In the event of a technology transfer contemplated by Section  5.6.2(A) above, POINT will establish and qualify such site with sufficient human, technical and  other resources, expertise and efforts to complete the establishment of such site in a reasonably  prompt manner (in no event will such resources, expertise and efforts be less than the levels used  to establish and qualify its first Manufacturing site in Indiana),and LANTHEUS will be  responsible for reimbursing (on a quarterly basis) POINT for its reasonable external, documented,  out-of-pocket costs for work, equipment and capabilities dedicated to transfer of the Manufacture  of the Licensed Product, at an aggregate cost no greater than the average of three Third Party bids  (or a fewer such number of Third Party bids as are reasonably available under the circumstances),  and the Parties will negotiate in good faith the purchase price for patient doses of Licensed Product  produced at such new Manufacturing site and any other mutually agreed economic terms; provided  that, if the Parties fail to agree after good faith negotiations on the terms thereof within three (3)  months after LANTHEUS’ written request, then LANTHEUS will be entitled to progress to a  technology transfer to a LANTHEUS-owned and operated facility or a Third Party-owned and  operated Manufacturing facility pursuant to Section 5.6.2(B) above.  5.6.4. In the event of a technology transfer contemplated by Clause (B)  of Section 5.6.2 above:  (i) POINT will perform technical services reasonably requested by  LANTHEUS to facilitate the technology transfer described in this Section 5.6 (at LANTHEUS’s  cost) and with sufficient human, technical and other resources, expertise and efforts to complete  such services in a reasonably prompt manner (in no event will such resources, expertise and efforts  be less than the levels used to establish and qualify its own Manufacturing site in Indiana),  including by making available to LANTHEUS or such Third Party, as applicable, all Licensed  Know-How (including all historical process or analytical information (i.e., all experimentally or  literature-derived data used to Manufacture any Licensed Product)) that is necessary to enable the  Manufacture of all Licensed Products by or on behalf of LANTHEUS or such Third Party (the  “POINT Manufacturing Know-How”), by providing copies or samples of relevant  documentation, materials and other embodiments of POINT Manufacturing Know-How, including  data within reports, notebooks and electronic files;   (ii) in the case of a technology transfer to a Third Party for  Manufacturing on behalf of LANTHEUS under Section 5.6.2(i), (ii), (iii) or (v) but not (iv) (where  POINT undergoes an Insolvency Event), POINT will be a direct party to LANTHEUS’  





 






   35  [***] = Indicates confidential information omitted from the exhibit.  manufacture and supply agreement with such Third Party, which shall obligate such Third Party  to maintain any POINT Manufacturing Know-How provided to such Third Party in strict  confidence and not to disclose POINT Manufacturing Know-How to any other Person, for  purposes of having direct enforcement rights against such Third Party in relation to the POINT  Manufacturing Know-How; and  5.6.5. Unless POINT otherwise consents, LANTHEUS will source from POINT  no less than [***] percent ([***]%) of its annual requirements for Licensed Product in North  America (the “Requirements Commitment”); provided that, notwithstanding the foregoing:  (i) during any period of Manufacturing Interruptions or Manufacturing  Underperformance: (A) POINT will reasonably and in good faith use its best reasonable efforts to  return to a state of uninterrupted supply of Licensed Product to LANTHEUS as promptly as  practicable and reasonably cooperate with LANTHEUS (including by coordinating with, or  routing orders through, its other Manufacturing sites or LANTHEUS or Third Party Manufacturing  sites); (B) LANTHEUS may source Licensed Product from any LANTHEUS or Third Party  Manufacturing sites only for as long as such events or circumstances continue and for a reasonable  time thereafter (for instance, to take into account binding orders, lead-times and the key raw  material supply chain commitments of the LANTHEUS or Third Party Manufacturing site); and,  (C) the purchases made under Clause (B) of this Section 5.6.5(i) will be deemed to have been made  from POINT for purposes of determining whether LANTHEUS has satisfied its Requirements  Commitment; and  (ii) in the event that LANTHEUS or a Third Party establishes a  Manufacturing site as contemplated by Clause (B) of Section 5.6.2, the Requirements Commitment  will be [***] percent ([***]%) solely to the extent necessary for a Regulatory Authority to grant  Regulatory Approval and only until such site is granted Regulatory Approval to manufacture and  supply Licensed Product through the [***] ([***]) full Calendar Year thereafter.  ARTICLE 6    LICENSE GRANTS  6.1. Patent and Know-How License Grant.    6.1.1. Grant to POINT under LANTHEUS Patent Rights. Subject to the terms  and conditions of this Agreement, as of the Effective Date and through the Term, LANTHEUS  hereby grants to POINT a non-exclusive, non-transferrable license, without the right to sublicense,  under the LANTHEUS Patent Rights solely to perform its obligations set forth under the  Manufacturing, Development and Regulatory Plan and under the Manufacture and Supply  Agreement(s) with respect to the Licensed Product in the Field in the U.S., which for clarity, does  not include any rights to Commercialize any Licensed Product.   6.1.2. Grant to LANTHEUS.  Subject to the terms and conditions of this  Agreement, including the rights reserved to POINT in Section 6.1.7, as of the Effective Date and  through the Term, POINT hereby grants to LANTHEUS an exclusive (even as to POINT and its  Affiliates), royalty-bearing, non-transferable (except as set forth in Section 6.1.5) license under  





 






   36  [***] = Indicates confidential information omitted from the exhibit.  the Licensed Patents and the Licensed Know-How to Exploit (but subject to Section 6.1.3 with  respect to Manufacturing) Licensed Products in the Field in the Territory.   6.1.3. Manufacturing License Grant.  Notwithstanding Section 6.1.2,  LANTHEUS’s right to Manufacture is subject to Section 5.6.2.   6.1.4. Grant to POINT under Collaboration Patents and Collaboration  Know-How.  As of the Effective Date, LANTHEUS hereby grants to POINT an exclusive (even  as to LANTHEUS), royalty-free, transferable license, with the right to sublicense, under  LANTHEUS’ interest in the Collaboration Patent Rights and Collaboration Know-How solely  invented by employees of POINT to Exploit Licensed Products in the Excluded Territory.    6.1.5. Sublicenses.    (i) Subject to the terms and conditions of this Agreement, as of the  Effective Date, LANTHEUS will have the right to grant sublicenses through multiple tiers to  LANTHEUS Sublicensees of the rights granted to LANTHEUS under this Agreement in  accordance with the terms and conditions of this Section 6.1.5. The grant of any such sublicense  will not relieve LANTHEUS of its obligations under this Agreement (including its financial  obligations), and LANTHEUS shall be responsible for any and all obligations, acts, and omissions  of each LANTHEUS Sublicensee as if LANTHEUS Sublicensee were LANTHEUS under this  Agreement. As a condition precedent to and requirements of granting any such sublicense or any  amendment or modification (including to any Distributor), each LANTHEUS Sublicensee will  agree in writing to be bound by substantially identical obligations as LANTHEUS hereunder with  respect to the activities of such LANTHEUS Sublicensee. In addition, POINT shall (subject to  Section 5.6.1 through 5.6.4, as well as POINT’s demonstrated ability to reliably Manufacture and  supply Licensed Product to LANTHEUS and all LANTHEUS Sublicensees) have the right, but  not the obligation, to require that, prior to the execution of such LANTHEUS Sublicense  Agreement, the applicable LANTHEUS Sublicensee(s) agree in writing to purchase Licensed  Product, including Clinical and Commercial Supplies thereof, from POINT.  Each LANTHEUS  Sublicense Agreement will be consistent in all respects with all applicable terms and conditions of  this Agreement.  LANTHEUS will provide POINT with a copy of such LANTHEUS Sublicense  Agreement, and any modification or termination thereof, promptly after execution of such  LANTHEUS Sublicense Agreement, modification or termination (and in any event within thirty  (30) days after such LANTHEUS Sublicense Agreement has been fully executed or modified or  termination of such LANTHEUS Sublicense Agreement has occurred); provided that any such  copy may be redacted to remove any commercially sensitive information of LANTHEUS or the  LANTHEUS Sublicensee, so long as not necessary for POINT to assess LANTHEUS’s and  LANTHEUS Sublicensee’s compliance with the terms of this Agreement.  LANTHEUS shall use  all Commercially Reasonable Efforts to collect amounts due, and as appropriate to exercise any  applicable rights under any LANTHEUS Sublicense Agreement with a LANTHEUS Sublicensee,  including if applicable to terminate the LANTHEUS Sublicense Agreement with a LANTHEUS  Sublicensee, to the extent such LANTHEUS Sublicensee fails to meet its payment obligations  therein.  With respect to any sublicense agreement entered into by POINT within the Territory  pursuant to Section 6.1.1, POINT shall use all Commercially Reasonable Efforts to collect  amounts due, and as appropriate to exercise any applicable rights under such sublicense agreement  





 






   37  [***] = Indicates confidential information omitted from the exhibit.  with its sublicensee, including if applicable to terminate such sublicense agreement with its  sublicensee to the extent such sublicensee fails to meet its payment obligations therein.  (ii) Net Sublicense Proceeds actually paid to a Party (which may include  proceeds received by such Party as a result of enforcing the payment obligations against such  sublicensee thereunder, including without limitation any amounts received by such Party in  connection with the enforcement or resolution of a payment dispute) by a sublicensee will be split:  (A) for any LANTHEUS Sublicense Agreement entered into  for the applicable region of the Territory during the applicable  Sublicensing Diligence Period: sixty percent (60%) in favor of  LANTHEUS, and forty percent (40%) in favor of POINT; and  (B) for any sublicense agreement entered into by POINT or its  Affiliates for the applicable region of the Territory after the applicable  Sublicensing Diligence Period: forty percent (40%) in favor of  LANTHEUS, and sixty percent (60%) in favor of POINT.   (iii) In the event that LANTHEUS determines not to Develop and  Commercialize the Licensed Product in any region of the Territory set forth below as determined  in consultation with the JCSC, LANTHEUS will use Commercially Reasonable Efforts to  sublicense the Development and Commercialization of the Licensed Product in the region of the  Territory within the applicable period specified below (the “Sublicense Diligence Period”).  Region of the Territory Sublicense Diligence Period Ends on  European Union   (provided that a sublicense covering Germany  and France will satisfy LANTHEUS’  obligations to sublicense with respect to all of  the European Union)  Within 48 months after First FDA Approval  Middle East Within 60 months after First FDA Approval  Africa Within 60 months after First FDA Approval  Latin America Within 60 months after First FDA Approval    LANTHEUS shall provide the JCSC regular updates with respect to the status of its sublicensing  activities. Notwithstanding the foregoing, the applicable Sublicense Diligence Period above will  be extended by one day for each day during which any Manufacture and Supply Agreement or  Manufacturing technology transfer arrangements with LANTHEUS or a proposed LANTHEUS  Sublicensee are being negotiated with POINT in good faith.  





 






   38  [***] = Indicates confidential information omitted from the exhibit.  6.1.6. POINT Leading Sublicensing Activities.  Notwithstanding Section 6.1.5,  if (i) the Licensed Product is not sublicensed by LANTHEUS or its Affiliates within an applicable  region of the Territory within its respective Sublicense Diligence Period or, (ii) in the event that  the Licensed Product has not been sublicensed within an applicable region of the Territory, and  LANTHEUS has not commenced and diligently pursued (or has abandoned) Clinical Trials for the  Licensed Product in support of Regulatory Approval in an applicable region of the Territory within  its respective Sublicense Diligence Period , then in either case, following the expiration of such  Sublicense Diligence Period, POINT will (upon thirty (30) days’ prior written notice to  LANTHEUS) have the right to grant sublicenses in the Territory its sole discretion.    6.1.7. No Implied Licenses; Negative Covenant.  Except as expressly granted  herein, neither Party grants to the other Party any right or license under any intellectual property  rights Controlled by such first Party.   (i) POINT Reservation of Rights.    (A) Reservation of IP Rights. Except for the limited licenses  set forth in Section 6.1.2 (Grant to LANTHEUS), and Section 6.1.3  (Manufacturing License Grant), POINT is not granting LANTHEUS any  license, express or implied, under any intellectual property rights Controlled  by POINT, including as licensed to POINT by a Third Party. For clarity, the  license or rights granted pursuant to Section 6.1.2 (Grant to LANTHEUS),  and Section 6.1.3 (Manufacturing License Grant) shall not include the  license or right under the Licensed Patents and the Licensed Know-How to  Exploit any product or other active therapeutic ingredient(s) that are not the  Licensed Product, and all ownership rights therein are expressly reserved  by POINT, subject to Section 7.1.2(i).    (B) Manufacturing Reservation. The license granted in  Sections 6.1.2 is subject to a reserved non-exclusive, non-transferable, and,  except as necessary for POINT to Manufacture Clinical Supplies and  Commercial Supplies in accordance with this Agreement and the applicable  Manufacture and Supply Agreement(s), non-sublicensable right of POINT  under the Licensed Patents and Licensed Know-How solely to exercise its  rights and perform its obligations under this Agreement and the  Manufacture and Supply Agreement.  6.2. Patent Update.  To the extent not already available to LANTHEUS through its  own control of Prosecution, upon LANTHEUS’s written request, at least once annually, POINT  will provide to LANTHEUS an update to the list of Licensed Patents set forth on Exhibit B, which  will automatically be modified to include such updates.    6.3. POINT Termination of License to Contested Patent Rights. If LANTHEUS or  any of its Affiliates or LANTHEUS Sublicensees (i) initiates or (ii) knowingly provides financial  support (other than equity funding) or proprietary information regarding patent strategy,  prosecution or maintenance to a Third Party in order to enable such Third Party to initiate, any  action or proceeding in any forum of competent jurisdiction in the Territory (including a court, a  





 






   39  [***] = Indicates confidential information omitted from the exhibit.  patent office or an arbitral tribunal, and whether in the form of petitions for declaratory relief,  claims, counterclaims, defenses, interferences, petitions for reexamination, inter partes review,  post-grant review, or otherwise, but excluding any action that may be necessary or reasonably  required in response to a subpoena or court or administrative law request or order) that any Patent  Right (or any claim thereof) within the Licensed Patents is unpatentable, invalid or unenforceable  (any such action or proceeding, a “Patent Action”) and a final, non-appealable order is made in  any such forum that such Patent Right or claim thereof is patentable, valid or enforceable, as  applicable, then POINT, as the licensor of the Licensed Patents under this Agreement, may at its  discretion, (a) invoice LANTHEUS for all expenses incurred by POINT in such Patent Action,  including reasonable attorneys’ fees, experts’ fees and other costs of investigation or defense, court  costs and other litigation expenses, and LANTHEUS shall pay all amounts set forth in such invoice  within sixty (60) days after receipt of such invoice and/or (b) terminate its license to LANTHEUS  pursuant to this Article 6 to such Patent Right, whereupon such Patent Right will no longer be  deemed to be within the Licensed Patents.  Notwithstanding the foregoing, (1) if any Affiliate of  LANTHEUS that becomes an Affiliate of LANTHEUS through a Change of Control of  LANTHEUS is engaged in a Patent Action at the time of such Change of Control, the provisions  of this Section 6.3 shall not be deemed to apply as a result of such Patent Action by such Affiliate  of LANTHEUS, (2) LANTHEUS shall have the right to defend itself against any action or  proceeding in any forum of competent jurisdiction in the Territory brought by POINT or any of its  Affiliates or sublicensees alleging infringement of any Patent Right and (3) in the case of a Patent  Action by a sublicensee, POINT shall not have the right to take the actions described in the  preceding sentence unless LANTHEUS fails to either terminate the applicable sublicense or cause  the Sublicensee to cease pursuing such Patent Action within one hundred twenty (120) days of the  date that LANTHEUS becomes aware of such Patent Action.    6.4. Exclusivity.    6.4.1. From the Effective Date and for a period of three (3) years after the  Term, POINT and its Affiliates shall not directly or indirectly Develop, Manufacture,  Commercialize or otherwise Exploit any 177Lu-radiolabelled PSMA-targeting therapeutic  drug in castration resistant prostate cancer (“CRPC”) anywhere in the Territory, unless in  collaboration with LANTHEUS or its Affiliates; provided that the foregoing shall not  extend or apply to any product or intellectual property Controlled by any Third Party with  which POINT undergoes a Change of Control, or any such product or intellectual property  of an Affiliate of such Third-Party acquiror, in any case, which is in production or existence  at the time of the Change of Control, in any case, provided neither POINT or any of its  controlled Affiliates directly becomes involved or otherwise participates in the  development, manufacture, commercialization or other exploitation thereof during the Term  and for a period of three (3) years thereafter.  6.4.2. Notwithstanding the foregoing, in order to provide LANTHEUS with  the option of expanding the indications into which Licensed Products can be  Commercialized, POINT will forgo Developing a 177Lu-radiolabelled PSMA-targeting  therapeutic drug (a “Specified Product Candidate”) for any therapeutic use in prostate  cancer which is for castration-sensitive prostate cancer (i.e., “CSPC Indications”) until the  earlier to occur of (i) the fifth (5th) anniversary of the First FDA Approval or (ii) the date  on which LANTHEUS commences development of any agent which is not a Licensed  





 






   40  [***] = Indicates confidential information omitted from the exhibit.  Product for CSPC Indications.  The generality of the above notwithstanding, POINT shall  continue to forgo developing a Specified Product Candidate for CSPC Indications so long  as LANTHEUS, its Affiliates or LANTHEUS Sublicensees anywhere in the Territory have  initiated and are diligently pursuing Development, Clinical Trials and/or Commercialization  of a Licensed Product in a CSPC Indication, or the Licensed Product is referred to for use  in CSPC under NCCN or similar guidelines.  For the avoidance of doubt, the foregoing shall  not extend or apply to any product or intellectual property Controlled by any Third Party  with which POINT undergoes a Change of Control, or any such product or intellectual  property of an Affiliate of such Third-Party acquiror, in any case, which is in production or  existence at the time of the Change of Control, in any case, provided neither POINT or any  of its controlled Affiliates becomes involved or otherwise participates in the development,  manufacture, commercialization or other exploitation thereof during the Term and for a  period of three (3) years thereafter.  As requested by POINT, LANTHEUS shall provide to  POINT reasonable documentation and information to verify LANTHEUS’s Development  and Clinical Trial activities for the CSPC Indications as necessary for POINT to determine  its rights under this Section 6.4.2.  Any dispute between the Parties with respect to  LANTHEUS’s commencement of Development of Clinical Trial activities for a Non-CRPC  Indication shall be resolved in accordance with Article 14.  6.4.3. If POINT or its sublicensees Commercialize or otherwise Exploit a  Specified Product Candidate, then POINT will, and will cause its Affiliates and licensees  to, (i) avoid sales of the Specified Product Candidate outside of the CSPC Indication and  (ii) adopt measures designed to allow each Party to track and audit sales of POINT.  If  LANTHEUS has evidence that there have been sales of the Specified Product Candidate  outside of the CSPC Indication, then the Parties will determine a fair amount of  compensation that POINT will pay to LANTHEUS to compensate it for its lost profit from  the sale of the Specified Product Candidate outside of the CSPC Indication.  If the Parties  are unable to unanimously determine whether or not there have been sales of Specified  Product Candidate outside of the CSPC Indication or that there have been such sales, but  the Parties cannot determine the proper amount that POINT should pay to LANTHEUS to  compensate it for such sales, then either Party may refer the dispute to arbitration in  accordance with Section 14.1.4.    ARTICLE 7    INTELLECTUAL PROPERTY RIGHTS  7.1. Ownership of Intellectual Property.    7.1.1. Product Trademarks.  LANTHEUS may, in its sole discretion, select any  trademarks, trade dress, designs, logos or slogans to be used in connection with the Exploitation  of the Licensed Products in the Field in the Territory (collectively, the “Product Trademarks”)  and will own all such Product Trademarks.  Neither POINT nor its Affiliates will, without  LANTHEUS’ prior written consent, use or seek to register, anywhere in the world, any trademarks  that are confusingly similar to any Product Trademark during the Term. Upon termination (but not  expiration) of this Agreement, POINT shall have the right to use the Product Trademarks as set  forth in Section 16.3.3 in the terminated countries of the Territory.  





 






   41  [***] = Indicates confidential information omitted from the exhibit.  7.1.2. Collaboration Technology.  (i) Ownership.  Subject to POINT’s rights, title, and interest in  Collaboration Technology in the event of termination pursuant to Section 16.2.2, the Parties will  jointly own all Collaboration Know-How and Collaboration Patents in the Territory. Subject to the  terms and conditions of this Agreement, each Party will be free to exploit, either itself or through  the grant of licenses to Third Parties (which Third Party licenses may be further sublicensable), its  rights, title and interest in and to the Collaboration Technology in the Territory, without the need  to obtain further consent from the other Party, and without any duty to account or payment of any  compensation to the other Party; provided, however, that if either Party expressly disclaims in  writing with reference to this Section 7.1.2(i) its ownership interest in any Collaboration  Technology, then such Collaboration Technology will become solely owned by the other Party  and such disclaiming Party will and hereby does assign to the other Party all of its rights, title and  interests in and to such disclaimed Collaboration Technology.  Inventorship of any Collaboration  Technology will be determined in accordance with United States patent laws.  For the avoidance  of doubt, any Know-How invented solely by POINT or its Affiliates’ employees, agents or  independent contractors during the Term and any Patent Rights Covering such Know-How shall,  in the Excluded Territory, be solely and exclusively owned by POINT, and LANTHEUS shall  have no right, title, or interest in or to, or any license to exploit, such Know-How and Patent Rights  in the Excluded Territory.  (ii) Assignment of Inventions.  Each employee, agent or independent  contractor (including all subcontractors) of a Party or its respective Affiliates performing work  under this Agreement will, prior to commencing such work, be bound by invention assignment  obligations as set forth in a written agreement, including: (a) promptly reporting any invention,  discovery, process or other intellectual property right; (b) presently assigning to the applicable  Party or Affiliate all of his or her right, title and interest in and to any invention, discovery, process  or other intellectual property; (c) cooperating in the preparation, filing, prosecution, maintenance  and enforcement of any patent or patent application; and (d) performing all acts and signing,  executing, acknowledging and delivering any and all documents required for effecting the  obligations and purposes of this Agreement.  It is understood and agreed that such invention  assignment agreement need not reference or be specific to this Agreement.  7.2. Disclosure of Inventions.  During the Term, each Party will promptly (but no later  than sixty (60) days following such Party’s receipt of an invention disclosure) provide to the other  Party any invention disclosure submitted to such Party that discloses any Collaboration  Technology.  7.3. Patent Committee.  Each Party will appoint one (1) representative with patent and  intellectual property expertise on the Effective Date.  Such representatives (the “Patent  Committee”) will meet (in-person, by telephone or videoconference) upon request by either Party  during the Term to coordinate, discuss, and review strategies with respect to preparing, filing,  prosecuting, maintaining, and enforcing the Licensed Patents and the Collaboration Patents.  The  Patent Committee will report to the JDRSC.  The Patent Committee will automatically disband on  the earlier of (i) the mutual written agreement of the Parties, (ii) the occurrence of an event  contemplated by Section 17.5(iii) and (iii) the expiration or termination of this Agreement.   





 






   42  [***] = Indicates confidential information omitted from the exhibit.  Thereafter, LANTHEUS will have the sole decision-making authority over all matters that were  within the authority of the Patent Committee prior to such disbandment.  7.4. Patent Filings.    7.4.1. Prosecution.    (i) LANTHEUS will lead prosecution of the Licensed Patents and  Collaboration Patents in the Territory, at its own cost and expense, using patent counsel to which  the Parties have mutually agreed, and shall prepare, file, prosecute and maintain these Patent  Rights in the Territory, including any appeal proceeding made at the applicable patent office  following such patent office’s failure to issue any such patent (collectively, “Prosecution”).   LANTHEUS will provide POINT with copies of all material documents and correspondence  relating to the Prosecution of the Licensed Patents and the Collaboration Patents (a) promptly after  receipt, with respect to communications from applicable patent authorities and (b) a reasonable  time in advance of filing, for documents to be filed by LANTHEUS, in each case (a) and (b), to  allow POINT reasonable time to review such materials and comment thereon.  LANTHEUS will  implement POINT’s reasonable comments on the documents filed.  POINT will provide  LANTHEUS all reasonable assistance in the Prosecution of such Licensed Patents and  Collaboration Patents in the Territory, including by making its employees, agents and consultants  reasonably available to LANTHEUS (or LANTHEUS’s authorized attorneys, agents or  representatives), to the extent reasonably necessary to enable LANTHEUS to undertake  Prosecution as contemplated by this Agreement.   (ii) POINT will lead Prosecution of the Licensed Patents in the  Excluded Territory, at its own cost and expense, using patent counsel to which the Parties have  mutually agreed.  POINT will provide LANTHEUS with copies of all material documents and  correspondence relating to the Prosecution of such Licensed Patents (a) promptly after receipt,  with respect to communications from applicable patent authorities and (b) a reasonable time in  advance of filing, for documents to be filed by POINT, in each case (a) and (b), to allow  LANTHEUS reasonable time to review such materials and comment thereon.  POINT will  implement LANTHEUS’s reasonable comments on the documents filed.    (iii) In addition, and notwithstanding anything to the contrary set forth  in this Agreement, LANTHEUS will have the sole right, using patent counsel of its choosing, to  direct and control any patent interferences, reexaminations, inter partes reviews, reissuances,  revocations, oppositions and appeals from any such proceedings of the Licensed Patents and the  Collaboration Patents in the Territory (collectively, “Protection”). POINT will provide  LANTHEUS reasonable assistance in the Prosecution and Protection of such Licensed Patents or  Collaboration Patents in the Territory, including by making its employees, agents and consultants  reasonably available to LANTHEUS (or LANTHEUS’s authorized attorneys, agents or  representatives), to the extent reasonably necessary to enable LANTHEUS to undertake  Prosecution as contemplated by this Agreement.    (iv) Except as expressly provided in this Section 7.4.1, each Party will  have the sole right, in its sole discretion, to conduct Prosecution of any Patent Rights owned by  such Party.  





 






   43  [***] = Indicates confidential information omitted from the exhibit.  7.4.2. Common Interest.  All information exchanged between the Parties or  between the Parties’ outside patent counsel regarding Prosecution of the Licensed Patents and the  Collaboration Patents will be deemed Confidential Information subject to Article 8.  In addition,  the Parties acknowledge and agree that, with regard to Prosecution of the Licensed Patents and the  Collaboration Patents, the interests of the Parties as licensor and licensee are aligned and are legal  in nature.  The Parties agree and acknowledge that they have not waived, and nothing in this  Agreement constitutes a waiver of, any legal privilege concerning the Licensed Patents or the  Collaboration Patents, including privilege under the common interest doctrine and similar or  related doctrines.  7.4.3. Patent Term Extensions.  The Parties will use reasonable efforts and  cooperate with one another to obtain all available supplementary protection certificates, patent  term restorations and other patent extensions with respect to the Licensed Products in the Territory,  and to make any filings with respect thereto. POINT will cooperate with LANTHEUS’s reasonable  written request with respect to any such filings, including by executing such authorizations and  other documents and taking such other actions as may be reasonably requested by LANTHEUS to  obtain such extensions.  In the event the Parties disagree as to how to effectuate or whether to  obtain any supplementary protection certificates, patent term restorations or other patent term  extensions, the matter will be referred to the ESC, which will have final decision-making authority.  7.5. Enforcement Rights.    7.5.1. Notification of Infringement. If either Party learns of any actual or  threatened infringement by a Third Party of a LANTHEUS Patent Right, Licensed Patent or  Collaboration Patent in the Territory or any attack by a Third Party on the validity or enforceability  of a LANTHEUS Patent Right, Licensed Patent or Collaboration Patent in the Territory, including  any certification received by such Party under the U.S. Drug Price Competition and Patent Term  Restoration Act of 1984 (Public Law 98-417, as amended, the “Hatch-Waxman Act”), with  respect to a LANTHEUS Patent Right, Licensed Patent or Collaboration Patent or a Licensed  Product in the Field (each, an “Infringement”), such Party will promptly, and in any event within  five (5) days, notify the other Party and will provide the other Party with available evidence of  such events.  7.5.2. Enforcement of Licensed Patents and Collaboration Patents.   LANTHEUS will have the first right, but not the obligation, at its own cost and expense and using  counsel of its choosing, to institute any action, suit or proceeding against any Infringement of a  Licensed Patent or Collaboration Patent in the Territory.  LANTHEUS will have the right to cause  POINT to join LANTHEUS as a party plaintiff to any such action, suit or proceeding in the  Territory, at LANTHEUS’s sole expense.  LANTHEUS will keep POINT reasonably informed  regarding such action, suit or proceeding and will reasonably consider POINT’s input regarding  such action, suit or proceeding.  In connection with such action, suit or proceeding, the Parties will  cooperate with and assist each other in all reasonable respects. If, after ninety (90) days after the  date of notice given pursuant to Section 7.5.1, LANTHEUS has not instituted any action, suit or  proceeding against the applicable Infringement or provided POINT with information and  arguments demonstrating that there is insufficient basis for the allegation of such Infringement,  then POINT will have the right, but not the obligation, at its own cost and expense and using  counsel of its choosing, to institute any action, suit or proceeding against such Infringement;  





 






   44  [***] = Indicates confidential information omitted from the exhibit.  provided that, if LANTHEUS provides notice to POINT that LANTHEUS has determined for  strategic reasons not to initiate an action, suit or proceeding against such Infringement, POINT  will not have the right to institute an action, suit or proceeding against such Infringement.  7.5.3. Recoveries.  In the event that either Party exercises the rights conferred in  Section 7.5.2 and recovers any damages or other sums in such action, suit or proceeding or in  settlement thereof, such damages or other sums recovered will first be applied to all reasonable  out-of-pocket costs and expenses incurred by the Parties in connection therewith, including  attorneys’ fees.  If such recovery is insufficient to cover all such costs and expenses of both Parties,  it will be shared pro rata in proportion to the total of such costs and expenses incurred by each  Party based on a reasonable and good faith accounting provided by each Party.  If, after such  reimbursement, any funds will remain from such damages or other sums recovered, the recovering  Party will be entitled to eighty percent (80%) of such net recovery, and the other Party will be  entitled to twenty percent (20%) of such net recovery.   7.5.4. Other Patent Rights.  Except as expressly provided in Section 7.5.2, each  Party will have the sole right, in its sole discretion, to institute any action, suit or proceeding against  any Infringement of any Patent Right owned by such Party, including but not limited to the  LANTHEUS Patent Right.  7.6. Infringement Defense.    7.6.1. Notice.  In the event that a Third Party at any time provides written notice  of a claim to, or brings an action, suit or proceeding against, either Party, or any of their respective  Affiliates or sublicensees (each person so sued being referred to herein as a “Sued Party”),  claiming infringement of such Third Party’s Patent Rights or unauthorized use or misappropriation  of its Know-How based upon an assertion or claim arising out of the Exploitation of a Licensed  Product in the Field in the Territory (“Infringement Claim”), such Party will promptly notify the  other Party of the Infringement Claim or the commencement of such action, suit or proceeding,  enclosing a copy of the Infringement Claim and all papers served.    7.6.2. Right to Defend.  If the Sued Party with respect to any Infringement Claim  is entitled to indemnification under Article 13 with respect to such Infringement Claim, then the  terms and conditions of Article 13 and not this Section 7.6.2 will apply to such Infringement Claim.  In all other cases, LANTHEUS will have the right, but not the obligation, at its own cost and  expense and using counsel of its choosing, to defend against any Infringement Claim brought  against LANTHEUS or its Affiliates or LANTHEUS Sublicensees, and POINT will have the right,  but not the obligation, at its own cost and expense and using counsel of its choosing, to defend  against any Infringement Claim brought against POINT or its Affiliates or sublicensees.  The Sued  Party will keep the other Party reasonably informed of all material developments in connection  with any such suit and will not, without the other Party’s prior written consent, enter into any  settlement or consent decree that requires any payment by or admits or imparts any other liability  to the other Party.  The other Party will make available to the Sued Party its advice and counsel  regarding any Infringement Claim and will offer reasonable assistance in connection with any  Infringement Claim to the Sued Party, at the Sued Party’s cost and expense.  





 






   45  [***] = Indicates confidential information omitted from the exhibit.  7.7. Patent Marking.  LANTHEUS agrees to mark, and to require any of its Affiliates  or LANTHEUS Sublicensees to mark, any Licensed Products (or their containers or labels) made,  sold, or otherwise distributed by it or them with any notice of Patent Rights required under  Applicable Law to enable such Patent Rights to be enforced to their full extent in any country  where Licensed Products are made, used, sold, or offered for sale.  7.8. Orange Book Listings.  With respect to patent listings in the FDA Orange Book  for issued patents for the Licensed Product, LANTHEUS will determine in consultation with  POINT which patents to list in the FDA Orange Book (a) prior to the submission of the Licensed  Product NDA submitted to the FDA and (b) within twenty (20) days after the receipt of First FDA  Approval.    7.9. Trademark Infringement.    7.9.1. Notification of Infringement.  If POINT learns that a Third Party is  infringing any Product Trademark in the Territory, POINT will promptly notify LANTHEUS.  7.9.2. Infringement Action.  LANTHEUS will have the sole right, at its own cost  and expense and in its sole discretion, to take any action with respect to any infringement of a  Product Trademark in the Territory, with counsel of its own choice.  Any recovery from any  settlement or judgment from such action will be retained by LANTHEUS.   ARTICLE 8    CONFIDENTIALITY; PUBLICITY  8.1. Confidentiality.  Except to the extent authorized by this Agreement or otherwise  agreed upon in writing, the Parties agree that the receiving Party will keep confidential and will  not publish or otherwise disclose or use for any purpose, any proprietary and confidential  information and materials furnished to it by the disclosing Party pursuant to this Agreement  (collectively, “Confidential Information”), except to the extent that it can be established by the  receiving Party that such Confidential Information:  8.1.1. was already known to the receiving Party or its Affiliates, as demonstrated  by competent written records at the time of disclosure by the disclosing Party;  8.1.2. was generally available to the public or otherwise part of the public domain  at the time of its disclosure by the disclosing Party;  8.1.3. became generally available to the public or otherwise part of the public  domain after its disclosure by the disclosing Party and other than through any act or omission of  the receiving Party or its Affiliates in breach of this Agreement;   8.1.4. was disclosed to the receiving Party or its Affiliates, 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  





 






   46  [***] = Indicates confidential information omitted from the exhibit.  8.1.5. was subsequently developed by the receiving Party or its Affiliates without  use of or reference to the Confidential Information of the disclosing Party as demonstrated by  competent written records.  Licensed Know-How and unpublished Licensed Patents will be considered Confidential  Information of POINT, provided that LANTHEUS may use or disclose such Licensed Know-How  and Licensed Patents solely in exercising its rights under the Licensed Patents and Licensed Know- How granted under Section 6.1.2. Notwithstanding anything to the contrary set forth in this  Agreement, after the Effective Date, for the duration of the remainder of the Term, the Parties will  each use at least the same degree of care to protect the secrecy of such Licensed Know-How and  unpublished Licensed Patents that it uses to prevent the disclosure of its own other confidential  information of similar importance and in any event a reasonable duty of care.    8.2. Authorized Use and Disclosure.  Each Party will maintain the Confidential  Information of the other Party in confidence and may use the Confidential Information of the other  Party only in performance of its obligations under this Agreement and the Manufacture and Supply  Agreement(s).  Each Party may disclose such Confidential Information to its employees, Affiliates,  sublicensees, agents, consultants or other Third Parties who need to know such Confidential  Information in connection with the performance of such Party’s obligations under this Agreement  or the Manufacture and Supply Agreement(s) and who are bound by obligations of confidentiality  and non-use at least as protective as the obligations of this Article 8.  Each Party will be liable for  any unauthorized use or disclosure of Confidential Information by its employees, Affiliates,  sublicensees, agents, consultants or other Third Parties to which it has disclosed or transferred such  Confidential Information.  Without limiting the generality of the foregoing paragraph but subject to the terms thereof,  a Party may disclose Confidential Information of the other Party to the extent that such disclosure  is reasonably necessary in connection with:  8.2.1. filing or prosecuting patent or trademark applications relating to the  Licensed Products;  8.2.2. prosecuting or defending litigation relating to the Licensed Products;  8.2.3. Exploiting the Licensed Products;  8.2.4. seeking Regulatory Approval of the Licensed Product, including  Regulatory Approval of a Manufacturing facility for the Licensed Product;  8.2.5. seeking reimbursement or pricing approvals for the Licensed Product from  Governmental Authorities;  8.2.6. complying with Applicable Laws, including securities laws and the rules of  any securities exchange or market on which a Party’s or its Affiliates’ securities are listed or traded,  all as determined in the reasonable discretion the Party or Affiliate bound by such Applicable  Laws; or  





 






   47  [***] = Indicates confidential information omitted from the exhibit.  8.2.7. complying with subpoenas or requests for information from Governmental  Authorities.  In making any disclosures set forth in Section 8.2.1 through Section 8.2.7 above, the disclosing  Party will, except where legally prohibited or impracticable for necessary disclosures (as in the  event of medical emergency), give such advance notice to the other Party of such disclosure  requirement as is reasonable under the circumstances and, except to the extent inappropriate (as in  the case of patent applications), use its reasonable efforts to cooperate with the other Party in order  to secure confidential treatment of such Confidential Information required to be disclosed, except  to the extent that the disclosing Party receives advice from its legal counsel or independent  registered public accounting firm that such information is required to be disclosed under  Applicable Laws, including securities laws and the rules of any securities exchange or market on  which a Party’s or its Affiliates’ securities are listed or traded.  8.3. Disclosure to Potential Business Partners. The Parties acknowledge that each  Party may, from time to time, engage or have engaged in mergers, acquisitions and similar  transactions and equity or debt fundraising. The Parties may disclose a copy of this Agreement,  under terms of confidentiality no less strict than those contained in this Agreement, to their  respective actual or bona fide potential transaction counterparties, investors or debt financing  sources (and to their respective bankers, lawyers, accountants and agents) as may be necessary in  connection with their evaluation of such potential or actual transaction or investment subject to  compliance with Applicable Laws, including U.S. securities laws. Notwithstanding anything to the  contrary, neither Party shall be prevented from complying with any duty of disclosure it may have  pursuant to Applicable Law, including securities laws applicable to a public company.    8.4. Residual Knowledge.  At any time following the Effective Date, a Party or any  Affiliate of such Party may use for its internal research purposes all information in non-tangible  form resulting from access to or work with the Licensed Products or under this Agreement prior  to the effective date of termination of this Agreement, including ideas, concepts, Know-How or  techniques contained therein, in each case, that may be retained in the unaided memories of persons  who have had access thereto prior to the effective date of termination of this Agreement; provided  that such use does not result in a breach of confidentiality under this Agreement or use or  misappropriate the other Party’s intellectual property.  8.5. Survival.  This Article 8 will survive the termination or expiration of this  Agreement for a period of ten (10) years, except that, with respect to each Party’s Confidential  Information that is a trade secret, this Article 8 will survive so long as such Confidential  Information constitute trade secrets under Applicable Law.  8.6. Publications or Presentations.    8.6.1. General.  Except as set forth herein, LANTHEUS will have the sole right,  in its sole discretion, to present at symposia, national or regional professional meetings and to  publish in journals regarding LANTHEUS’s use of the Licensed Products as part of its Medical  Activities, provided that any such presentation or publication will not include any Confidential  Information of POINT.  With respect to its contributions to the PNT-2002 Clinical Trial and other  Development activities, POINT shall be entitled to jointly author, present and publish materials  





 






   48  [***] = Indicates confidential information omitted from the exhibit.  under this Section with LANTHEUS (and have POINT’s employees be named as co-authors to  the extent consistent with generally accepted rules for authorship in scientific publications and  communications).  The Parties will cooperate in good faith in the preparation, presentation, and  publication of any such joint materials and shall mutually agree in writing upon a schedule for and  any other terms applicable to the preparation, presentation, and publication of such materials.    8.6.2. Ex-Territory Development and Publications.  POINT agrees to  implement and maintain reasonable governance requirements with Third Parties involved in the  Exploitation of the Licensed Product outside of the Territory to ensure that LANTHEUS and  LANTHEUS Sublicensees in the Territory, on the one hand, and POINT and its sublicensees  outside of the Territory, on the other hand, reasonably confer on Development and intellectual  property matters and scientific publications relating to, or otherwise affecting, the Licensed  Product (and its equivalents outside of the Territory), including by allowing such parties sufficient  time and opportunity to review, discuss and/or provide feedback on: Phase 3 and 4 Clinical Trial  designs and protocols; material intellectual property prosecution, maintenance, enforcement and  defense; and publications in scientific journals; provided that no party will need to be legally bound  to implement any other party’s feedback (unless expressly agreed otherwise).  8.6.3. Publicity.  Within one (1) Business Day after the Execution Date, the  Parties will issue a mutually agreed joint press release and other public communications  announcing this Agreement. Subject to the limitations set forth herein, each Party retains the right  to make publications about its activities under the Agreement up until the first Regulatory  Approval for the Licensed Product, with the consent of the other Party, which consent will not be  unreasonably withheld or delayed.  Notwithstanding the foregoing, neither Party will be required  to seek the permission of the other Party to repeat any information, including making any  statement, regarding the terms of this Agreement or the arrangements hereunder to the extent the  same has already been publicly disclosed by such Party or by the other Party; provided that such  information remains true, correct and consistent with the most recent information related thereto  that has been publicly disclosed. Routine references to this Agreement and the arrangements  hereunder in accordance herewith and in the context of disclosures or publications regarding a  Party’s business in general will be allowed in the usual course of a Party’s business, including the  use of other Party’s name.  Each Party may use the other Party’s corporate logo(s) or Product  Trademarks in accordance with the other Party’s internal policies.   8.7. Confidentiality Agreement.  For the avoidance of doubt, the Parties agree that the  Confidential Information disclosed under or in connection with the Confidentiality Agreement  shall be treated as Confidential Information under this Agreement. The confidentiality obligations  and other provisions set forth in this Article 8 shall supersede the Confidentiality Agreement (and  other provisions set forth therein) and apply to the confidential information disclosed under or in  connection with the Confidentiality Agreement.  ARTICLE 9    PAYMENTS  9.1. Up-Front Payment.  Within five (5) Business Days after the Effective Date, as an  upfront, one-time, nonrefundable and non-creditable fee in consideration of the grant of the  





 






   49  [***] = Indicates confidential information omitted from the exhibit.  licenses set forth in Section 6.1 and the performance of POINT’s other obligations hereunder,  LANTHEUS will pay to POINT the amount of Two Hundred Fifty Million U.S. Dollars  (US$250,000,000) (the “Up-Front Payment”); provided that if LANTHEUS has paid the  Extension Fee pursuant to Section 16.1.4, then the amount paid with respect to the Extension Fee  will be subtracted from the Up-Front Payment.  9.2. Regulatory Milestones.   9.2.1. As further consideration of the grant of the licenses set forth in Section 6.1  and the performance of POINT’s other obligations hereunder, LANTHEUS will pay to POINT the  following regulatory milestone payments (each, a “Regulatory Milestone Payment”) for such  milestones that LANTHEUS, its Affiliates, or (in the case of Regulatory Milestone Payments  arising from Regulatory Approval in the United States) any LANTHEUS Sublicensee or Affiliate  thereof, achieves:  (i) The applicable amount set forth in the table below, upon  LANTHEUS’ receipt of approval of the first Regulatory Approval of a Licensed Product in the  Initial Indication in the U.S.:  Time at which the  Regulatory Approval for  the Licensed Product in the  Initial Indication is  approved in U.S.  No. of Other Approved  PSMA Radioligand  Therapies in the U.S. at  the time the Regulatory  Approval for the Licensed  Product in the Initial  Indication is Approved in  the U.S.  Regulatory Milestone  Payment  No delay or delay of less  than 12 months beyond  Target NDA Approval Date  One or more $250.0M  Delay of 12 months or more,  but less than 18 months,  beyond Target NDA  Approval Date  One $237.5M  Delay of 12 months or more,  but less than 18 months,  beyond Target NDA  Approval Date  Two or more $225.0M  Delay of 18 months or  more, but less than 24  months, beyond Target  NDA Approval Date  One $225.0M  





 






   50  [***] = Indicates confidential information omitted from the exhibit.  Time at which the  Regulatory Approval for  the Licensed Product in the  Initial Indication is  approved in U.S.  No. of Other Approved  PSMA Radioligand  Therapies in the U.S. at  the time the Regulatory  Approval for the Licensed  Product in the Initial  Indication is Approved in  the U.S.  Regulatory Milestone  Payment  Delay of 18 months or  more, but less than 24  months, beyond Target  NDA Approval Date  Two or more $200.0M  Delay of 24 months or more,  but less than 36 months,  beyond Target NDA  Approval Date  One $200.0M  Delay of 24 months or more,  but less than 36 months,  beyond Target NDA  Approval Date  Two or more $150.0M    Notwithstanding anything to the contrary in this Agreement, in the event that the Regulatory  Approval for the Licensed Product in the Initial Indication in U.S. occurs thirty six (36) months or  more beyond the Target NDA Approval Date, the Parties will, each acting reasonably and in good  faith, negotiate and potentially finalize and agree upon the amount of a Regulatory Milestone  Payment payable and any other adjustments to the economics under this Agreement and the  Manufacture and Supply Agreement as may be appropriate and mutually agreed so as to make the  arrangements thereunder economically viable for each Party.  In the event that the Parties cannot  reach mutually agreeable arrangements within thirty (30) days of such approval, then either Party  can initiate arbitration under Section 14.1.4.  (ii) If the Regulatory Milestone Payment actually earned under Section  9.2.1(i) is less than $250.0M (the amount by which $250.0M exceeds the Regulatory Milestone  Payment actually earned, the “Regulatory Milestone Catch-Up Amount”), then LANTHEUS will  pay to POINT, in the aggregate, up to the Regulatory Milestone Catch-Up Amount, as set forth in  and subject to the conditions in the table below, which amount(s) will be payable pursuant to  Section 9.3.2:  Annual Net Sales   Achieved Timing Condition  Percentage of   Regulatory Milestone   Catch-Up Amount  





 






   51  [***] = Indicates confidential information omitted from the exhibit.  Three Hundred Million   U.S. Dollars  (US$300,000,000)  Within two (2) years of  First Commercial Sale in  the U.S.  25%  Five Hundred Million   U.S. Dollars  (US$500,000,000)  Within four (4) years of  First Commercial Sale in  the U.S.  35%  Six Hundred Million   U.S. Dollars  (US$600,000,000)  Within five (5) years of  First Commercial Sale in  the U.S.  40%  Seven Hundred Fifty Million   U.S. Dollars  (US$750,000,000)  Anytime  Any remaining, unpaid portion  of the Regulatory Milestone  Catch-Up Amount    (iii) $25.0M, upon LANTHEUS’ receipt of approval of the first  Regulatory Approval of a Licensed Product in the Initial Indication in any of Germany, France,  Spain or Italy; provided that fifty percent (50%) of the Development Costs and Regulatory Costs  incurred by LANTHEUS directly to obtain and maintain Regulatory Approval in such countries  will be deducted from this $25,000,000 Regulatory Milestone Payment provided that this  Regulatory Milestone Payment shall not be less than $12,500,000;   (iv) $2.0M, upon LANTHEUS’ receipt of approval of the first  Regulatory Approval of a Licensed Product in the Initial Indication in any Middle Eastern country;   (v) $2.0M, upon LANTHEUS’ receipt of approval of the second  Regulatory Approval of a Licensed Product in the Initial Indication in a Middle Eastern country  (other than the one specified in clause (iv) above); and  (vi) $2.0M, upon LANTHEUS’ receipt of approval of the first  Regulatory Approval of a Licensed Product in the Initial Indication in any African country.  9.2.2. Notwithstanding the foregoing: the Regulatory Milestone Payments under  Section 9.2.1(iii)-(vi) will be owed to POINT only if LANTHEUS itself or an Affiliate  Commercializes the Licensed Product in such country; and in the event that a LANTHEUS  Sublicensee or Distributor Commercializes the Licensed Product in such country, then no such  Regulatory Milestone Payments will be owed to POINT, but rather the applicable portion of the  Net Sublicense Proceeds received by LANTHEUS from such LANTHEUS Licensee or Distributor  will be owed to POINT in accordance with Section 6.1.4(ii).  9.2.3. Only one Regulatory Milestone Payment will be paid for Regulatory  Approval of the Licensed Product in the Initial Indication for each of the U.S. (Section 9.2.1(i)  above), EMA countries (Section 9.2.1(iii) above), the first Middle Eastern country (Section  9.2.1(iv) above), the second Middle Eastern country (Section 9.2.1(v) above), and African  countries (Section 9.2.1(a)(vi) above).  





 






   52  [***] = Indicates confidential information omitted from the exhibit.  9.2.4. LANTHEUS will pay to POINT any earned Regulatory Milestone Payment  within fifteen (15) Business Days of the applicable Regulatory Approval actually being received  by LANTHEUS; provided that any payment of all or any portion of the Regulatory Milestone  Catch-Up Amount will be paid pursuant to Section 9.3.2.  9.3. Royalties.    9.3.1. Royalty Payments.  As further consideration of the grant of the licenses set  forth in Section 6.1 and the performance of POINT’s other obligations hereunder:  (i) until LANTHEUS achieves a Return Hurdle of Five Hundred  Million U.S. Dollars (US$500,000,000), LANTHEUS will pay to POINT royalty payments at the  rate of twenty percent (20%) of Eligible Net Sales of Licensed Products in the Territory during the  applicable Royalty Term; and  (ii) beginning in the first full Calendar Quarter following achievement  of the Return Hurdle, LANTHEUS will pay to POINT royalty payments at the rate of twenty  percent (20%) of Net Sales of Licensed Products in the Territory during the applicable Royalty  Term.     Examples calculating hypothetical royalty payments under this Section 9.3.1 are set forth in  Exhibit D.  9.3.2. Commercialization Milestones.  LANTHEUS will make milestone  payments to POINT for the first Calendar Year in which annual Net Sales meet or exceed the  annual Net Sales thresholds set forth below (and subject to increase for any Regulatory Milestone  Catch-Up Amount contemplated by Section 9.2.1(ii)):  Annual Net Sales Threshold Annual Net Sales Milestone Payment  One Hundred Fifty Million U.S. Dollars  (US$150,000,000)  Fifty Million U.S. Dollars  (US$50,000,000)  Three Hundred Million U.S. Dollars  (US$300,000,000)  Fifty Million U.S. Dollars  (US$50,000,000)  Five Hundred Million U.S. Dollars  (US$500,000,000)  Two Hundred Eighty Million U.S. Dollars  (US$280,000,000)  Six Hundred Million U.S. Dollars  (US$600,000,000)  One Hundred Fifty Million U.S. Dollars  (US$150,000,000)  One Billion U.S. Dollars  (US$1,000,000,000)  Two Hundred Fifty Million U.S. Dollars  (US$250,000,000)  Two Billion U.S. Dollars  (US$2,000,000,000)  Five Hundred Million U.S. Dollars  (US$500,000,000)  





 






   53  [***] = Indicates confidential information omitted from the exhibit.    For clarity, (i) each of the Annual Net Sales Milestone Payments will be paid only once (i.e., in  the first year in which annual Net Sales achieve the threshold level); and (ii) no more than one  Annual Net Sales Milestone Payment will be earned in a single Calendar Year; in such a case, only  the first Annual Net Sales Milestone Payment earned will be payable for that Calendar Year.  The  second (and further subsequent) Annual Net Sales Milestone achieved will be payable for the  following Calendar Year, and so forth.  LANTHEUS will pay POINT any amount due under this  Section 9.3.2 within five (5) Business Days after filing its Form 10-K with the Securities and  Exchange Commission reporting its audited financial results for that Calendar Year, but in no  event will be delayed beyond March 31st of that next Calendar Year.  9.3.3. Duration of Royalty Payments.  LANTHEUS will pay Royalties to  POINT, as set forth herein, on a country-by-country basis as applicable, during the period  commencing on the First Commercial Sale of the Licensed Product in a country and ending on the  later of (i) the expiration of all Valid Claims of the Licensed Patents that Cover the use or sale of  the Licensed Product in that country or (ii) ten (10) years after the First Commercial Sale of such  Licensed Product in that country (any such period with respect to that country, a “Royalty Term”).   Following expiration of the Royalty Term for any Licensed Product in a country, no further  royalties will be payable in respect of sales of such Licensed Product in such country and,  thereafter, the license granted to LANTHEUS under Section 6.1.2 with respect to such Licensed  Product in such country will be fully paid-up (other than for Commercial Milestones earned  thereafter), perpetual, irrevocable and royalty-free.  9.3.4. Cumulative Royalties.  The obligation to pay royalties under this  Agreement will be imposed only once with respect to a single unit of the Licensed Product  regardless of how many Valid Claims of the Licensed Patents Cover the use or sale of such  Licensed Product in the applicable country.  9.3.5. No Valid Claim.  On a country-by-country basis, in any country in which  a Licensed Product is Commercialized and there are no remaining Valid Claims of the Licensed  Patents that Cover the use or sale of the Licensed Product in such country, the royalties payable to  POINT on Eligible Net Sales or Net Sales, as applicable, of the Licensed Product pursuant to  Section 9.3.1(i) will be reduced to ten percent (10%) for the Licensed Product.   9.3.6. Generic Competition.  Notwithstanding anything to the contrary, on a  country-by-country basis, upon the first commercial sale of a PNT-2002 Product specifically  approved as a generic version of Licensed Product by a Third Party in such country (a “Generic  Entry”), the royalty rate under Section 9.3.1 for sales in such country shall be reduced (starting in  the first full Calendar Year following Generic Entry) to the least of:   (i) fifty percent (50%);   (ii) the royalty rate under Section 9.3.1, multiplied by ((A) one (1),  minus (B) two (2) times the ASP Percentage Decrease in that country (with this Clause (B)  expressed as a decimal)); or  





 






   54  [***] = Indicates confidential information omitted from the exhibit.  (iii) in the event that LANTHEUS’ average Gross Margin for the  Licensed Product in that country in any full Calendar Year following such Generic Entry is less  than thirty percent (30%), the royalty rate (which in no event will be less than zero percent (0%))  that would have been necessary to achieve an average Gross Margin equal to thirty percent (30%).    9.3.7. Third Party Payment Obligations. If, after the Effective Date,  LANTHEUS or its Affiliates or Sublicensees are required to make any payments (including  upfront fees, milestones or royalties) to a Third Party to obtain rights to any intellectual property  that is reasonably necessary to Exploit the Licensed Product in the Field in the Territory, then  LANTHEUS may deduct up to fifty percent (50%) of such Third Party payments from any Royalty  payments due to POINT under Section 9.3.1 with respect to such Licensed Product and such  country; provided, however, if such Third Party Payments relate to the Manufacture of the  Licensed Product, LANTHEUS may deduct one hundred percent (100%) of such Third Party  payments from any Royalty payments due to POINT.  9.3.8. Royalty Floor.  Notwithstanding anything to the contrary herein, in no  event during the applicable Royalty Term for a Licensed Product in a country of the Territory will  the royalties payable to POINT under Section 9.3.1 for such Licensed Product in such country in  a given Calendar Quarter be reduced by the application of the reductions and offsets described in  Section 9.3.7 fall below ten percent (10%) of the total Eligible Net Sales or Net Sales, as  applicable, or, in the case of reductions and offsets described in Section 9.3.5, fall below five  percent (5%) of Eligible Net Sales or Net Sales, as applicable, for the Licensed Product in such  Calendar Quarter; provided, however, that any reductions or offsets that are not used to reduce  royalty payments hereunder in a given Calendar Quarter as a result of the foregoing limitations  may be carried over to reduce royalty payments due under Section 9.3.1 in subsequent Calendar  Quarters.   9.4. Reporting and Paying Net Sales.  For each Calendar Quarter for which royalties  are payable by LANTHEUS to POINT pursuant to Section 9.3.1, LANTHEUS will deliver to  POINT, within forty five (45) days after the end of each such Calendar Quarter, an estimated report  prepared in good faith providing in reasonable detail (i) an accounting of all Net Sales made on a  country-by-country basis in the Territory during such Calendar Quarter, including the amount of  gross sales of Licensed Products and the aggregate allowable deductions therefrom, (ii) the number  of units of Licensed Products sold, (iii) the currency conversion rates used, (iv) the U.S. Dollar- equivalent of such Net Sales during such Calendar Quarter and (v) a calculation of the amount of  royalty payment due on such Net Sales and will pay POINT the royalties due under Section 9.3.1(i)  with respect to such Calendar Quarter as provided for in such report.  Each report delivered  hereunder will be considered Confidential Information of LANTHEUS, subject to the terms and  conditions of Article 8.   9.5. Records and Reporting; Audits.    9.5.1. Records and Reporting.  Each Party will keep, and will cause its Affiliates  and Sublicensees and other licensees to keep, such accurate and complete financial, accounting  and other records (including time records) as are necessary to determine the amounts due to POINT  or LANTHEUS under this Agreement (including the amounts and calculations of the financial  terms expressly defined in this Agreement) and any adjustments to the Dose Price.  Records of  





 






   55  [***] = Indicates confidential information omitted from the exhibit.  such measures will be retained by each Party or any of its Affiliates and Sublicensees (in such  capacity, the “Recording Party”) for three (3) years following the end of the Calendar Year to  which they pertain.  9.5.2. Audits.  During normal business hours and with reasonable advance notice  to the Recording Party, such records will be made available for inspection, review and audit, at the  request and expense of the other Party (the “Auditing Party”), by an independent certified public  accountant, appointed by such Auditing Party and reasonably acceptable to the Recording Party,  for the sole purpose of verifying the accuracy of the Recording Party’s records specified in Section  9.5.1; provided, however, that such audits may not be performed by the Auditing Party more than  once per Calendar Year (unless cause exists), that such audits may only cover records pertaining  to any period commencing not more than two (2) Calendar Years prior to the date of such audit,  and that such Auditing Party will not be permitted to audit the same period of time more than once.   Such accountants, prior to any review hereunder, will enter into an appropriate confidentiality  agreement with the Recording Party on mutually acceptable terms and will be instructed not to  reveal to the Auditing Party the details of their review, except for (i) such information as is required  to be disclosed under this Agreement and (ii) such information presented in a summary fashion as  is necessary to report the accountants’ conclusions to the Auditing Party.  The report prepared by  such accountants will be sent or otherwise provided to the Recording Party by such accountants at  the same time it is sent or otherwise provided to the Auditing Party.  All costs and expenses  incurred in connection with performing any such audit will be paid by the Auditing Party, unless  the audit uncovers a net underpayment of amounts owed or overreporting of expenses by a  Recording Party of five percent (5%) of total amounts owed or expenses reported by such  Recording Party for any Calendar Year period covered by the audit, in which case the Recording  Party will bear the full cost of such audit.  If either Party is found to have been underpaid any  amounts payable to such Party hereunder or to have overpaid to the other Party any amounts  payable hereunder, such first Party will be entitled to recover any undisputed discrepancy, plus  interest calculated in accordance with Section 9.7, within forty-five (45) days after receipt of such  audit report.  If either Party disagrees with any discrepancy identified during the course of any  audit conducted pursuant to this Section 9.5.2, then either Party may submit the issue for resolution  in accordance with Article 14.   9.6. Manner of Payments.  All sums due to POINT or LANTHEUS under this Article  9 will be payable in U.S. Dollars (as contemplated by Section 9.8) by bank wire transfer in  immediately available funds to such bank account(s) as POINT and LANTHEUS, respectively,  will designate from time to time.  Each Party will notify the other Party as to the date and amount  of any such wire transfer to the other Party at least two (2) Business Days prior to such transfer.  9.7. Interest on Late Payments.  Without limitation on other available rights or  remedies, any payments or portions thereof due hereunder that are not paid within five (5) days  following the date such payments are due under this Agreement will bear interest at the lower of  (i) the Prime Rate as determined by Bank of America in effect on the due date, or (ii) the maximum  rate permitted by Applicable Law, calculated on the number of days such payment is delinquent.   9.8. Currency of Payments/Exchange Rates.  All payments to be made under this  Agreement will be made in U.S. Dollars.  The Royalty Payments due on Net Sales, Net Sublicense  Proceeds and the price for any applicable Licensed Product sold in the Territory (other than in the  





 






   56  [***] = Indicates confidential information omitted from the exhibit.  U.S.) will be calculated on the basis of the local currency sales figures translated into U.S. Dollars  according to LANTHEUS’s standard currency translation methodology. The methodology  employed by LANTHEUS will be that methodology used by LANTHEUS in the translation of its  foreign currency operating results for external reporting and will be consistent with GAAP.  9.9. Taxes.    9.9.1. Withholding. Each Party will make all payments to the other Party under  this Agreement without deduction or withholding except to the extent that any such deduction or  withholding is required by Applicable Law.   9.9.2. Payment of Taxes.  Any tax required to be withheld by Applicable Law on  amounts payable under this Agreement will promptly be paid by the withholding Party on behalf  of the other Party to the appropriate Governmental Authority, and the withholding Party will  promptly furnish the other Party with proof of payment of such tax within ten (10) Business Days  of such payment.  The withholding Party will give the other Party ten (10) Business Days’ advance  notice of its intention to begin withholding any such tax in advance of such withholding.  9.9.3. Cooperation and Documentation.  LANTHEUS and POINT will  reasonably cooperate (i) in all respects necessary to take advantage of any treaty or double taxation  agreements or similar agreements as may, from time to time, be available in order for the payments  under this Agreement or the Manufacture and Supply Agreement to be made without any  deduction or withholding, (ii) with respect to producing all documentation required by any  Governmental Authority as reasonably requested by LANTHEUS or POINT, as applicable, to  secure a reduction in the rate of applicable withholding taxes or to secure a credit or refund for  withheld taxes, and (iii) to enable the reduction or recovery, as permitted by Applicable Law, of  withholding taxes, value added taxes, or similar obligations resulting from payments made under  this Agreement, such reduction or recovery to be for the benefit of the Party bearing such  withholding tax or value added taxes.  9.9.4. Value Added Tax.  The Party making payment to the other Party will pay  and otherwise be responsible for all value added taxes and transfer taxes and/or taxes of equivalent  effect in connection with any payment made to the other Party pursuant to this Agreement, for all  applicable sales, goods and services. For the avoidance of doubt, customs and import duties and  levies and/or taxes of equivalent effect arising out or in connection with the supply of the Licensed  Products by or on behalf of POINT to LANTHEUS all be borne and paid in full by LANTHEUS.  9.9.5. Withholding Representation.  Each Party represents that, as of the  Execution Date, it has no Knowledge of a requirement under Applicable Law, and so it has no  present intention, to withhold taxes on payments due to the other Party under this Agreement.  ARTICLE 10    REPRESENTATIONS AND WARRANTIES; COVENANTS; DISCLAIMER  10.1. Disclaimer.  EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT,  EACH PARTY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR  





 






   57  [***] = Indicates confidential information omitted from the exhibit.  IMPLIED, INCLUDING WARRANTIES OF COMMERCIAL UTILITY, MERCHANT- ABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR SCOPE OF PATENT  RIGHTS OR NON-INFRINGEMENT OF THIRD-PARTY INTELLECTUAL PROPERTY  RIGHTS.  Each Party acknowledges and agrees that nothing in this Agreement will be construed  as representing any estimate or projection of (a) the successful Development or Commercialization  of any Licensed Product under this Agreement, (b) the number of Licensed Products that will or  may be successfully Developed or Commercialized under this Agreement, (c) anticipated sales or  the actual value of any Licensed Products that may be successfully Developed or Commercialized  under this Agreement or (d) the damages, if any, that may be payable if this Agreement is  terminated for any reason. Without limiting the foregoing, LANTHEUS makes no representation,  warranty or covenant, either express or implied, that (i) it will successfully Develop,  Commercialize or continue to Commercialize any Licensed Product in any country, (ii) if  Commercialized, that any Licensed Product will achieve any particular sales level, whether in any  individual country or cumulatively throughout the Territory or (iii) other than is expressly required  under this Agreement, that it will devote, or cause to be devoted, any level of diligence or resources  to Developing or Commercializing any Licensed Product in any country, or in the Territory in  general.  10.2. Mutual Representations, Warranties and Covenants.  Each Party represents,  warrants and covenants to the other as of each of the Execution Date and the Effective Date as  follows:  10.2.1. it is duly organized, validly existing, and in good standing under the  Applicable Laws of the jurisdiction in which it is organized, and has full corporate or limited  liability company power and authority and the legal right to own and operate its property and assets  and to carry on its business as it is now being conducted and as contemplated in this Agreement,  including the right to grant the licenses granted by it hereunder;  10.2.2. this Agreement has been duly executed and delivered by such Party and  constitutes the valid and binding obligation of such Party, enforceable against such Party in  accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent  conveyance, insolvency, reorganization, moratorium and other Applicable Laws relating to or  affecting creditors’ rights generally and by general equitable principles;  10.2.3. such Party has the full right, power and authority to execute, deliver and  perform this Agreement;  10.2.4. the execution, delivery and performance of this Agreement have been duly  authorized by all necessary action on the part of such Party, its respective officers and directors  and its respective stockholders or members;  10.2.5. the execution, delivery and performance of this Agreement neither  breaches, violates, contravenes or constitutes a default under any contracts, arrangements or  commitments to which such Party is a party or by which it is bound, nor violates any order or  Applicable Law of any court or Governmental Authority having authority over it; and  





 






   58  [***] = Indicates confidential information omitted from the exhibit.  10.2.6. such Party has not entered into, and will not enter into, any contract,  arrangement or commitment in the future that conflicts with or violates any term or provision of  this Agreement.   10.3. LANTHEUS Representations and Warranties. LANTHEUS further represents  and warrants to POINT as of each of the Execution Date and the Effective Date as follows:  10.3.1. LANTHEUS will use Commercially Reasonable Efforts to Commercialize  the Licensed Product in the Territory in accordance with this Agreement;   10.3.2. LANTHEUS has and will have the full right, power and authority to grant,  and is not required to obtain the consent of any Third Party to grant, the rights and licenses granted  to POINT under Article 6;  10.3.3. LANTHEUS has complied and will comply in all material respects with all  Applicable Laws in connection with its performance under this Agreement, including in the  Exploitation (including Manufacture, as applicable) of the Licensed Product in the Field in the  Territory; and  10.3.4. LANTHEUS will not use any employee or consultant who is or has  been debarred by the FDA or any other Regulatory Authority, or, to LANTHEUS’s Knowledge,  who is or has been the subject of debarment proceedings by the FDA or any such Regulatory  Authority.  10.4. POINT Representations and Warranties.  POINT further represents and  warrants to LANTHEUS as of each of the Execution Date and the Effective Date as follows:   10.4.1. Exhibit B contains a complete and correct list of all Patent Rights  Controlled by POINT or its Affiliates as of such date that are necessary or useful for the  Exploitation of the Licensed Product in the Field in the Territory, as contemplated by this  Agreement;  10.4.2. POINT has and will have the full right, power and authority to  grant, and is not required to obtain the consent of any Third Party to grant, the rights and licenses  granted to LANTHEUS under Article 6;  10.4.3. POINT owns the entire right, title and interest in and to the  Licensed Patents and the Licensed Know-How, free of any encumbrance, lien, charge, license  grant, option grant or other burden;  10.4.4. POINT has complied and will comply in all material respects with  all Applicable Laws, including, with respect to any issued patents and pending patent applications,  any disclosure requirements of the United States Patent and Trademark Office or any other  Governmental Authority, in connection with the Prosecution of the Licensed Patents and has  timely paid all filing and renewal fees payable with respect thereto;  10.4.5. POINT has obtained, or caused its Affiliates, as applicable, to  obtain, assignments from the inventors of all inventorship rights to the Licensed Patents, and all  





 






   59  [***] = Indicates confidential information omitted from the exhibit.  such assignments are valid and enforceable, and the inventorship of the Licensed Patents is  properly identified on each patent or patent application;  10.4.6. to POINT’s Knowledge, no Third Party is infringing any Licensed  Patent;  10.4.7. to POINT’s Knowledge, the Exploitation of the Licensed Products  in the Field in the Territory does not and will not infringe any Patent Right of any Third Party;   10.4.8. POINT has not received any notice of any claims, and there are no  judgments or settlements against or owed by POINT or, to POINT’s Knowledge, any pending or  threatened claims or litigation, in each case, claiming that a Patent Right owned by such Third  Party would be infringed by Exploitation of the Licensed Products in the Field in the Territory;  10.4.9. to POINT’s Knowledge, POINT has the right to use, and to permit  LANTHEUS, LANTHEUS’s Affiliates and LANTHEUS’s Sublicensees to use, the Licensed  Know-How for all expressly permitted purposes under this Agreement;   10.4.10. to POINT’s Knowledge, the Manufacture of the Licensed Product  as conducted as of such date does not and will not infringe any Patent Right of any Third Party or  misappropriate any Know-How of any Third Party;  10.4.11. POINT and its Affiliates have taken commercially reasonable  measures consistent with industry practices to protect the secrecy, confidentiality and value of all  Licensed Know-How that constitutes trade secrets under Applicable Law (including requiring all  employees, consultants and independent contractors to execute binding and enforceable  agreements requiring all such employees, consultants and independent contractors to maintain the  confidentiality of such Licensed Know-How) and, to POINT’s Knowledge, such Licensed Know- How has not been used, disclosed to or discovered by any Third Party except pursuant to such  confidentiality agreements and to POINT’s Knowledge, there has not been a breach by any party  to such confidentiality agreements;   10.4.12. except as set forth on Schedule 10.4.12, the issued Licensed Patents are,  to POINT’s Knowledge, valid and enforceable, and no Third Party has made any claim in writing  against POINT or its Affiliates asserting the invalidity, unenforceability or non-infringement of  any issued Licensed Patents (including, by way of example, through the institution or written threat  of institution of interference, nullity, opposition, inter partes or post-grant review or similar  invalidity proceedings before the United States Patent and Trademark Office or any analogous  foreign Governmental Authority);  10.4.13. the Licensed Patents and Licensed Know-How are not subject to any  funding agreement with any Governmental Authority or any other Third Party, and are not subject  to the requirements of the Bayh-Dole Act or any similar provision of any Applicable Law;   10.4.14. neither POINT nor any of its Affiliates (i) are subject to any obligation to  or with any Third Party that causes POINT or its Affiliates not to Control (or otherwise not have  rights to) any Patent Right or Know-How that would, but for such obligation, be included in the  Licensed Patents or the Licensed Know-How or (ii) hold for use or otherwise have rights to, but  





 






   60  [***] = Indicates confidential information omitted from the exhibit.  do not Control, any Patent Rights or Know-How that would otherwise be included in the Licensed  Patents or Licensed Know-How if such Patent Rights or Know-How were Controlled by POINT  or an Affiliate;  10.4.15. of which POINT has received notice or which, to POINT’s Knowledge is  otherwise pending or threatened, there is no action, claim, demand, suit, proceeding, arbitration,  grievance, citation, summons, subpoena, inquiry or investigation of any nature, civil, criminal,  regulatory or otherwise, in law or in equity, pending or, to POINT’s Knowledge, threatened, with  any judicial or arbitrative body against POINT or any of its Affiliates in connection with the  Licensed Patents, the Licensed Know-How or the Licensed Product;  10.4.16. the Development and Manufacture of the Licensed Product have been and  will be conducted in all material respects in accordance with Applicable Law; and  10.4.17. in the Development and Manufacture of the Licensed Product, POINT has  not used any employee or consultant who is or has been debarred by the FDA or any other  Regulatory Authority, or, to POINT’s Knowledge, who is or has been the subject of debarment  proceedings by the FDA or any such Regulatory Authority.  ARTICLE 11    INTERIM COVENANTS  11.1. Conduct of Licensed Product Related Activities.  11.1.1. From and after the Execution Date until the earlier of the Closing or the  termination of this Agreement in accordance with its terms, POINT will, and POINT will cause its  Affiliates to, except as expressly contemplated by this Agreement, as required by Applicable Law,  or as consented to in advance in writing by LANTHEUS (it being agreed that any request for a  consent will not conditioned or delayed), (i) operate those portions of its business relating to, or  otherwise reasonably affecting, the Licensed Product in the ordinary course in all material respects,  including in accordance with the Manufacturing, Development and Regulatory Plan, and (ii) use  commercially reasonable efforts to maintain and preserve intact in all material respects those  portions of its business organization, operations, assets, properties (including intellectual property)  and material business relations relating to, or that would otherwise reasonably expected to have a  negative impact on, the Development, Manufacturing and Commercialization of the Licensed  Product in the Territory or the transactions and other activities contemplated by this Agreement  (collectively, the “Licensed Product Business”).  11.1.2. Without limiting the generality of the foregoing, from and after the  date of this Agreement until the earlier of the Closing or the termination of this Agreement in  accordance with its terms, POINT will, and POINT will cause its Affiliates to, except as expressly  contemplated by this Agreement, as required by Applicable Law, or as consented to in advance in  writing by LANTHEUS, not do any of the following:  (i) transfer, issue, sell, grant, license or otherwise directly or indirectly  dispose of, or subject to a lien or other encumbrance, any portion of the Licensed Product Business;   





 






   61  [***] = Indicates confidential information omitted from the exhibit.  (ii) enter into any written agreement (i) pursuant to which a Third Party  will perform any of the obligations or other activities contemplated by this Agreement or the Work  Plans to be performed by LANTHEUS at or after Closing, or (ii) that, by its terms, at any point in  the future, will impose any monetary or non-monetary obligations on LANTHEUS or any of its  Affiliates, Sublicensees or Distributors or will encumber or interfere with LANTHEUS’ rights  under this Agreement or any Manufacture and Supply Agreement;  (iii) authorize, recommend, propose or announce an intention to adopt,  or otherwise effect, a plan of complete or partial liquidation, dissolution, restructuring,  recapitalization, reorganization or similar transaction involving or otherwise affecting the Licensed  Product Business; or  (iv) enter into any written agreements to take, or cause to be taken, any  of the actions set forth in this Section 11.1.  11.2. Efforts to Consummate.  11.2.1. Subject to the terms and conditions herein provided, each of the  Parties will use reasonable best efforts to take, or cause to be taken, all actions and to do, or  cause to be done, all things reasonably necessary or advisable to consummate and make  effective as promptly as reasonably practicable the Closing and transactions contemplated  by this Agreement (including the satisfaction, but not waiver, of the closing conditions set  forth in Article 12 and, to execute and deliver any ancillary agreement or document when  required pursuant to this Agreement).  Without limiting the generality of the foregoing, each  of the Parties will use reasonable best efforts to obtain, file with or deliver to, as applicable,  any consents or approvals of any Governmental Authority or Third Party necessary, proper  or advisable to consummate the Closing and transactions contemplated by this Agreement.   LANTHEUS, on the one hand, and POINT, on the other hand, will pay fifty percent (50%)  of the HSR Act filing fee; provided, further, that each Party will bear its out-of-pocket costs  and expenses in connection with the preparation of any such consents or approvals.   11.2.2. Each Party will (i) make any appropriate filings pursuant to the HSR  Act with respect to the transactions contemplated by this Agreement promptly (and in any  event within fourteen (14) days following the Execution Date and (ii) respond as promptly  as reasonably practicable to any requests by any Governmental Authority for additional  information and documentary material that may be requested pursuant to the HSR Act.   LANTHEUS will promptly inform POINT of any communication between LANTHEUS,  on the one hand, and any Governmental Authority, on the other hand, and POINT will  promptly inform LANTHEUS of any communication between POINT, on the one hand,  and any Governmental Authority, on the other hand, in either case, regarding any of the  transactions contemplated by this Agreement.  Without limiting the foregoing, each Party  and its respective Affiliates will not withdraw its filing under the HSR Act, extend any  waiting period, review period or comparable period under the HSR Act or enter into any  agreement with any Governmental Authority to delay the consummation of, or not to  consummate, the transactions contemplated hereby, except with the prior written consent of  the other Party.    





 






   62  [***] = Indicates confidential information omitted from the exhibit.  11.2.3.   Nothing in this Section 11.2 or otherwise in this Agreement  obligates any Party or any of its Affiliates to agree to (i) sell, license or otherwise dispose  of, or hold separate and agree to sell, license or otherwise dispose of, any entities, assets,  lines of business or facilities of any such Party or any of its Affiliates or any entity, facility,  line of business or asset of such Party or any of its Affiliates, (ii) terminate, amend or assign  existing relationships and contractual rights or obligations, (iii) amend, assign or terminate  existing licenses or other agreements, or (iv) enter into new licenses or other agreements.   No Party will agree to any of the foregoing measures with respect to any other Party or any  of its Affiliates, except with the other Party’s prior written consent.  11.2.4. From and after the date of this Agreement until the earlier of the  Closing or termination of this Agreement in accordance with its terms, LANTHEUS, on the  one hand, and POINT, on the other hand, will give legal counsel for POINT (in the case of  LANTHEUS) or LANTHEUS (in the case of POINT), a reasonable opportunity to review  in advance, and consider in good faith the views of the other in connection with, any  proposed written substantive communication to any Governmental Authority relating to the  transactions contemplated by this Agreement.  Each of the Parties agrees not to participate  in any substantive meeting or discussion, either in person or by telephone with any  Governmental Authority in connection with the transactions contemplated by this  Agreement unless it consults with the other Party in advance and, to the extent not prohibited  by such Governmental Authority, gives such other Party the opportunity to attend and  participate in such meeting or discussion.   11.2.5. Notwithstanding anything to the contrary in the Agreement, in the  event that this Section 11.2 conflicts with any other covenant or agreement in this Article  11 that is intended to specifically address any subject matter, then such other covenant or  agreement will govern and control solely to the extent of such conflict.  11.3. Exclusive Dealings Relating to the Licensed Product.  From the Execution Date  until the earlier of the Closing or the termination of this Agreement in accordance with its terms,  POINT will not, and will cause its Affiliates and its and their respective directors, officers,  employees, agents and other representatives (collectively, its “Representatives”) not to, directly or  indirectly: (i) solicit, initiate, encourage (including by means of furnishing or disclosing  information), facilitate, discuss or negotiate, directly or indirectly, any inquiry, proposal or offer  (written or oral) with respect to an Alternate License Proposal; (ii) furnish or disclose any non- public information to any Person in connection with, or that could reasonably be expected to lead  to, an Alternate License Proposal; (iii) enter into any written agreement or other arrangement or  understanding regarding an Alternate License Proposal; or (v) otherwise cooperate in any way  with, or assist or participate in, or knowingly facilitate or encourage any effort or attempt by any  Person to do or seek to do any of the foregoing.  POINT agrees to (A) notify LANTHEUS promptly  upon receipt of any Alternate License Proposal and (B) keep LANTHEUS reasonably informed  on a current basis of any modifications to such offer or information. POINT will immediately cease  and cause to be terminated any and all existing activities, discussions or negotiations with any  Persons (other than LANTHEUS) conducted prior to or as of the date hereof by POINT or any of  its Subsidiaries, and will cause its Representatives to cease and cause to be terminated any and all  existing activities, discussions or negotiations, that would reasonably be expected to lead to an  Alternate License Proposal, and will, as promptly as practicable, terminate access by each such  





 






   63  [***] = Indicates confidential information omitted from the exhibit.  Person and its Representatives to any online or other data rooms containing any non-public  information in respect of POINT or any of its Affiliates for the purpose of permitting such Persons  to evaluate a potential Alternate License Proposal.  For clarity, POINT will not have the right to  terminate this Agreement as a result of any Alternate License Proposal, and any actions taken by  any of POINT’s Representatives that are inconsistent with this Section 11.3 will be deemed to be  a material breach of this Section 11.3 by POINT.  ARTICLE 12    CONDITIONS TO CONSUMMATION OF THE TRANSACTIONS   CONTEMPLATED BY THIS AGREEMENT  12.1. Conditions to the Obligations of the Parties to Close.  The obligations of the  Parties to consummate and close the transactions contemplated by this Agreement (the “Closing”)  (the date on which the Closing is consummated, the “Effective Date”) are subject to the satisfaction  or, if permitted by Applicable Law, waiver by the Party for whose benefit such condition exists of  the following conditions:  12.1.1. the applicable waiting period under the HSR Act relating to the transactions  contemplated by this Agreement will have expired or been terminated; and  12.1.2. no Applicable Law issued by any court of competent jurisdiction or other  Governmental Authority or other legal restraint or prohibition preventing the consummation of the  transactions contemplated by this Agreement will be in effect.  12.2. Other Conditions to the Obligations of LANTHEUS to Close. The obligations  of the LANTHEUS to consummate the transactions contemplated by this Agreement are subject  to the satisfaction or, if permitted by applicable Law, waiver by LANTHEUS of the following  further conditions:  12.2.1. POINT’s representations and warranties set forth in this Agreement will be  true and correct (without giving effect to any limitation as to “materiality” or any similar  limitation) in all material respects as of the Effective Date, as though made on and as of the  Effective Date (except to the extent that any such representation and warranty is made as of an  earlier date, in which case such representation and warranty will be true and correct in all material  respects as of such earlier date); and  12.2.2. POINT will have performed and complied with, in all material respects, the  covenants and agreements required to be performed or complied with by POINT under this  Agreement at or prior to the Closing.  12.3. Other Conditions to the Obligations of POINT to Close.  The obligations of  POINT to consummate the transactions contemplated by this Agreement are subject to the  satisfaction or, if permitted by applicable Law, waiver by POINT of the following further  conditions:  12.3.1. LANTHEUS’ representations and warranties set forth in this Agreement  will be true and correct (without giving effect to any limitation as to “materiality” or any similar  





 






   64  [***] = Indicates confidential information omitted from the exhibit.  limitation) in all material respects as of the Effective Date, as though made on and as of the  Effective Date (except to the extent that any such representation and warranty is made as of an  earlier date, in which case such representation and warranty will be true and correct in all material  respects as of such earlier date); and  12.3.2. LANTHEUS will have performed and complied with, in all material  respects, the covenants and agreements required to be performed or complied with by POINT  under this Agreement at or prior to the Closing.  12.4. Frustration of Closing Conditions. Neither Party may rely on the failure of any  condition set forth in this Article 12 to be satisfied if such failure was proximately caused by that  Party’s failure to use reasonable best efforts to cause the Closing to occur, as required by Section  11.2.  12.5. Closing.  The Parties will effect the Closing within four (4) Business Days of  conditions of each Party’s obligations to consummate the transactions contemplated by this  Agreement being satisfied or, if permitted by applicable Law, waived.  ARTICLE 13    LIABILITY  13.1. Limitation of Liability.  EXCEPT FOR (i) LIABILITY FOR EITHER PARTY’S  BREACH OF Article 8, (ii) THE PARTIES’ INDEMNIFICATION OBLIGATIONS  PURSUANT TO SECTIONS 13.2 AND 13.3 OR (iii) ANY LIABILITY ARISING FROM A  PARTY’S FRAUD, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, NEITHER  PARTY WILL BE LIABLE TO THE OTHER PARTY OR ANY OF SUCH OTHER PARTY’S  REPRESENTATIVES OR STOCKHOLDERS FOR ANY INDIRECT, INCIDENTAL,  SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES OR LOST  PROFITS OR LOST REVENUES ARISING OUT OF OR RESULTING FROM THIS  AGREEMENT, REGARDLESS OF WHETHER IT HAS BEEN INFORMED OF THE  POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES OR THE TYPE OF CLAIM,  CONTRACT OR TORT (INCLUDING NEGLIGENCE).   13.2. LANTHEUS Indemnification.  From and after the Effective Date, LANTHEUS  will indemnify, defend and hold harmless POINT and its Affiliates and their respective directors,  officers, employees and agents (each a “POINT Indemnified Party”) from and against all costs,  losses, liabilities, expenses (including reasonable attorneys’ fees, experts’ fees and other costs of  investigation or defense at any stage of the proceedings) and damages (collectively, “Losses”) to  the extent relating to a claim, action or demand by a Third Party or Governmental Authority  (“Claim”) to the extent caused by, arising out of or resulting from:  13.2.1. any material breach of this Agreement by LANTHEUS;  13.2.2. the violation of any Applicable Law by or on behalf of LANTHEUS, its  Affiliates or LANTHEUS Sublicensees;  





 






   65  [***] = Indicates confidential information omitted from the exhibit.  13.2.3. any Development, Commercialization or other Exploitation (including  Manufacturing, as applicable) of the Licensed Product in the Field in the Territory by or on behalf  of LANTHEUS, its Affiliates or LANTHEUS Sublicensees, including use of Licensed Products  by Third Parties;   13.2.4. a trademark infringement action pursuant to Section 7.9.2; or  13.2.5. the fraud, gross negligence or willful misconduct of any LANTHEUS  Indemnified Party;  in each case, except to the extent such Claim is subject to an indemnification, defense or hold  harmless obligation of POINT set forth in Section 13.3 or in any Manufacture and Supply  Agreement.  13.3. POINT Indemnification.  From and after the Effective Date, POINT will  indemnify, defend and hold harmless LANTHEUS and its Affiliates and their respective directors,  officers, employees and agents (each a “LANTHEUS Indemnified Party”) from and against all  Losses to the extent relating to a Claim to the extent caused by, arising out of or resulting from:  13.3.1. any material breach of this Agreement by POINT;  13.3.2. the violation of any Applicable Law by or on behalf of POINT or its  Affiliates or licensees; or  13.3.3. the Development or Manufacturing of the Licensed Product by or on behalf  of POINT or its Affiliates or their licensees;  13.3.4. the Manufacture of any Clinical Supplies or Commercial Supplies  (including any Claim that POINT’s Manufacturing of Licensed Product infringes, violates or  misappropriates any intellectual property rights of a Third Party);   in each case, except to the extent such Claim is subject to an indemnification, defense or hold  harmless obligation of LANTHEUS set forth in Section 13.2 or in any Manufacture and Supply  Agreement.   13.4. Indemnification Procedures.  In the event of any Claim against any POINT  Indemnified Party or LANTHEUS Indemnified Party (individually, an “Indemnitee”), the  Indemnitee will promptly notify the other Party in writing of the Claim and the indemnifying Party  will manage and control, at its sole expense, the defense of the Claim and any settlement thereof.   The Indemnitee will cooperate with the indemnifying Party and may, at its option and expense, be  represented in any such action or proceeding.  The indemnifying Party will not be liable for any  settlements, litigation costs or expenses incurred by any Indemnitee without the indemnifying  Party’s prior written authorization.  Notwithstanding the foregoing, if the indemnifying Party  believes that any of the exceptions to its obligation of indemnification of the Indemnitees set forth  in Sections 13.2 or 13.3, as applicable, may apply, the indemnifying Party will promptly notify the  Indemnitees, which may be represented in any such action or proceeding by separate counsel at  their expense; provided, however, that the indemnifying Party will be responsible for payment of  such expenses if the Indemnitees are ultimately determined to be entitled to indemnification from  





 






   66  [***] = Indicates confidential information omitted from the exhibit.  the indemnifying Party.  Notwithstanding any other provision of this Article 13 to the contrary, no  Indemnitee under this Agreement will be required to waive a conflict of interest under any  applicable rules of professional ethics or responsibility if such waiver would be required for a  single law firm to defend both the indemnifying Party and one or more Indemnitees.  In such case,  the indemnifying Party will provide a defense of the affected Indemnitees through a separate law  firm reasonably acceptable to the affected Indemnitees at the indemnifying Party’s expense.   Except with the approval of an Indemnitee, which approval will not be unreasonably withheld,  conditioned or delayed, the indemnifying Party will not consent to entry of any judgment or enter  into any settlement that would admit any wrongdoing by, or result in injunctive or other relief  being imposed against, an Indemnitee.  13.5. Cooperation.  The indemnified Party and each Indemnitee will, at the  indemnifying Party’s expense, provide reasonable cooperation in the defense or prosecution of any  action or proceeding with respect to which it is being indemnified 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 by the indemnifying Party  in connection with such action or proceeding.  Such cooperation will include access during normal  business hours afforded to the indemnifying Party to, and reasonable retention by the indemnified  Party and the Indemnitee of, records and information that are reasonably relevant to such action or  proceeding, and making Indemnitees 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.  13.6. Insurance.  As of the Effective Date, each Party will procure and maintain, at its  sole cost and expense, commercial general liability insurance and products liability coverage in  amounts not less than, (i) prior to First Commercial Sale, [***] U.S. Dollars (US$[***]) per  incident and [***] U.S. Dollars (US$[***]) in the annual aggregate and, (ii) thereafter, [***] U.S.  Dollars (US$[***]) per incident and [***] U.S. Dollars (US$[***]) in the annual aggregate.  In  the event of an indemnification claim pursuant to Sections 13.2 or 13.3 above, such insurance will  be primary to any insurance owned, secured or put in place by the Indemnitee.  All such policies  will be written by insurance companies with an A.M. Best’s rating (or its equivalent) of A-VII or  higher.  In the event that any of these policies are written on a claims-made basis, then such policies  will be maintained during the Term and until the later of (A) three (3) years after expiration of  Term or (B) sixty (60) days following expiration of all applicable statutes of limitation for any  potential Claims that may be indemnified Losses pursuant to Sections 13.2 or 13.3, as applicable.   Upon written request, each Party will provide the other Party with a certificate of insurance  attesting to such coverage.  The minimum amounts of insurance coverage required under this  Section 13.6 will not be construed to create a limit of either Party’s liability with respect to its  indemnification obligation under Sections 13.2 or 13.3 above, as applicable.    ARTICLE 14    DISPUTE RESOLUTION  14.1. Disputes.    





 






   67  [***] = Indicates confidential information omitted from the exhibit.  14.1.1. Objective.    (i) The Parties recognize that disputes, controversies or claims arising  out of or relating to this Agreement or the Manufacture and Supply Agreements, or the  interpretation, breach, termination or invalidity hereof or thereof (each a “Dispute”), may from  time to time occur during the Term.  It is the objective of the Parties to establish procedures to  facilitate the resolution of Disputes occurring with respect to this Agreement or the Manufacture  and Supply Agreements, in an expedient manner by mutual cooperation and without resorting to  litigation.  To accomplish this objective, the Parties agree to follow the procedures set forth in this  Article 14 if and when a Dispute occurs with respect to this Agreement or the Manufacture and  Supply Agreements.    (ii) Notwithstanding the foregoing or anything to the contrary in this  Agreement, with respect to any matter under this Agreement: (a) if this Agreement expressly  provides that such matter is subject to a Party’s sole discretion, then such discretion will apply;  and (b) with respect to any matter occurring pre-Closing, such matter will not be subject to dispute  resolution under this Article 14.  14.1.2. Escalation.  With respect to any Dispute under this Agreement (which has  not been resolved by the ESC within thirty (30) days, if applicable), other than any Dispute relating  to the scope, validity or enforceability of a Licensed Patent or a Collaboration Patent (which may  only be determined in accordance with Section 14.3 hereof), either Party (the “Complaining  Party”) may present such Dispute for resolution by the Chief Executive Officer of each of POINT  (“POINT Senior Management”) and LANTHEUS (“LANTHEUS Senior Management” and,  together with POINT Senior Management, “Senior Management”) by providing a dispute notice  (the “Dispute Notice”) to Senior Management of the other Party.  The Dispute Notice will  concisely set forth the Dispute, the Parties’ respective positions, and the specific relief requested.   Within ten (10) days after receipt of a Dispute Notice, the Party receiving the Dispute Notice (the  “Responding Party”) will provide a concise written response (the “Response”) to such Dispute  Notice to Senior Management and the Complaining Party. Senior Management will attempt to  resolve such Dispute within ten (10) days after receipt by Senior Management of the Response.  In  the event that Senior Management cannot resolve a Dispute within the ten (10)-day period, unless  otherwise agreed by the Parties, such Dispute may be resolved as contemplated by Section 2.2.4(i)  or Section 2.2.4(ii), if applicable, or referred by either Party to arbitration in accordance with  Section 14.1.3 upon written notice to the other Party.    14.1.3. Arbitration.  Except as otherwise provided in this Agreement, the Parties  agree that any Dispute referred for arbitration by a Party pursuant to Section 14.1 will be resolved  through binding arbitration in accordance with the rules of the American Arbitration Association,  as amended from time to time (the “AAA Rules”).  If either Party receives a Breach Notice, then  any associated time to cure will be stayed pending the resolution of the issue pursuant to this  Section 14.1.3.  Any Dispute, aside from those seeking equitable relief, will be submitted to a sole  arbitrator, appointed pursuant to the AAA Rules.  Any suit seeking equitable relief will be heard  by a court of competent jurisdiction pursuant to Section 14.2.  The arbitrator will render a written  opinion setting forth findings of fact and conclusions of law with the reasons therefor stated.   Arbitration pursuant to this Section 14.1.3 will be governed by the Federal Arbitration Act, 9  U.S.C. §§ 1-16, and judgment upon the award rendered by the arbitrators may be entered by any  





 






   68  [***] = Indicates confidential information omitted from the exhibit.  court having jurisdiction thereof.  The arbitration proceedings for all Disputes will be conducted  in Wilmington, Delaware and will be conducted in English.  Each Party will continue to perform  its obligations under the Agreement pending final resolution of any Dispute unless to do so would  be impossible or impracticable under the circumstances.  The Parties agree that they will share  equally the cost of the arbitration filing and hearing fees, and the cost of the arbitrators.  The losing  Party will bear its own and the winning Party’s reasonable attorneys’ fees and associated costs and  expenses.   14.1.4. Resolution of Certain Economic Disputes.  In the event that:  (i) (x) the Regulatory Approval for the Licensed Product in the Initial  Indication in U.S. occurs thirty six (36) months or more beyond the Target NDA Approval Date  and (y) the Parties fail to reach mutually agreeable arrangements regarding the amount of a  Regulatory Milestone Payment payable and any other adjustments to the economics under this  Agreement and the Manufacture and Supply Agreement within the thirty (30) day period specified  under Section 9.2.1(i); or   (ii) (x) the Parties are unable to unanimously determine whether or not  there have been sales of Specified Product Candidate outside of the CSPC Indication or, (y) that  there have been such sales, but the Parties cannot determine the proper amount that POINT should  pay to LANTHEUS to compensate it for such sales, under Section 6.4.3;     then, in any such case, either Party may submit the dispute for resolution to a nationally recognized  life sciences accounting or valuation firm (as long as the individuals at such firm involved in  resolving the dispute are independent of Parties and their respective Affiliates) (the “Independent  Arbiter”) which, acting as experts and not arbitrators, will resolve such disputes as follows:  (A) each of the Parties will have the opportunity to submit  written briefs (with supporting data and other information) in support of  its respective position in regards to the disputed items and one (1) week to  review and respond in writing to the other Party’s initial briefs;   (B) the Independent Arbiter will decide, in reference to the  terms and conditions of this Agreement, only the items under dispute by  the Parties and only within the aggregate values assigned by each of the  Parties to those items on an aggregate basis; and  (C) the Independent Arbiter will make a determination as soon  as practicable within forty five (45) days after its engagement (or such  other time as the Parties agree in writing), and its resolution of the  disputed items will be final and binding upon, will be nonappealable by,  the Parties;   (D) the fees and expenses of the Independent Arbiter will be  paid by the Parties in proportion to the difference between the aggregate  value determined by the Independent Arbiter, to aggregate value each  Party assigned to all disputed items in the aggregate (as calculated by the  





 






   69  [***] = Indicates confidential information omitted from the exhibit.  Independent Arbiter, which calculation will be final and binding upon,  will be nonappealable by, the Parties).  14.2. Jurisdiction.  The Parties agree to the exclusive jurisdiction of the federal courts  located in the State of Delaware for the purposes of enforcing awards entered pursuant to this  Article 14 and for enforcing the agreements reflected in this Article 14.   14.3. Determination of Disputes Relating to Patents.  Notwithstanding anything to the  contrary herein, any Dispute relating to the determination of scope, validity or enforceability of a  Licensed Patent or a Collaboration Patent will be submitted exclusively to the national court or  other tribunal having jurisdiction over the disputed patent.  14.4. Equitable Relief.  The Parties agree that irreparable harm may occur in the event  any of the provisions of Article 6, Article 7 or Article 8 are not performed in accordance with the  terms of this Agreement or are otherwise breached and that money damages may not be a sufficient  remedy for such a breach of this Agreement.  Therefore, in addition to, and not in limitation of,  any other remedy available to either Party, a Party will be entitled to seek, at its sole expense,  injunctive relief or other equitable relief in the event of any such breach or threatened breach of  this Agreement by the other Party from a court of competent jurisdiction, and such an action may  be filed and maintained notwithstanding any ongoing arbitration proceeding.  Such remedies, and  all other remedies provided for in this Agreement, will be cumulative and not exclusive and will  be in addition to any other remedies a Party may have under Applicable Law or in equity or  otherwise.   ARTICLE 15    TERM  15.1. Term.  This Agreement will commence as of the Execution Date and, unless sooner  terminated as provided in Article 16, will continue in effect until the expiration of the last Royalty  Term as set forth in Section 9 (such period, the “Term”).   ARTICLE 16    TERMINATION  16.1. Termination Prior to Closing.  This Agreement may be terminated, and the  transactions contemplated by this Agreement may be abandoned, at any time prior to the Closing,  as follows:  16.1.1. by mutual written consent of LANTHEUS and POINT;  16.1.2. POINT’s receipt of written notice from LANTHEUS, that the  representations or warranties set forth in Article 10 are not true and correct or if POINT has failed  to perform any covenant or agreement on the part of POINT set forth in this Agreement, in either  case, such that the condition to Closing set forth in either Section 12.1 or Section 12.2 could not  be satisfied and such breach or breaches causing such representations or warranties not to be so  true and correct, or such failures to perform such covenant or agreement, as applicable, is (or are)  





 






   70  [***] = Indicates confidential information omitted from the exhibit.  not cured or cannot be cured within the earlier of (i) thirty (30) days after written notice thereof is  delivered to POINT by LANTHEUS, and (ii) the Termination Date; provided, however, that  LANTHEUS is not then in breach of this Agreement so as to prevent the condition to Closing set  forth in either Section 12.1 or Section 12.3 from being satisfied;  16.1.3. LANTHEUS’s receipt of written notice from POINT, that the  representations or warranties set forth in Article 10 are not true and correct or if LANTHEUS has  failed to perform any covenant or agreement on the part of LANTHEUS set forth in this  Agreement, in either case, such that the condition to Closing set forth in either Section 12.1 or  Section 12.3 could not be satisfied and such breach or breaches causing such representations or  warranties not to be true and correct, or such failures to perform such covenant or agreement, as  applicable, is (or are) not cured or cannot be cured within the earlier of (i) thirty (30) days after  written notice thereof is delivered to LANTHEUS by POINT and (ii) the Termination Date;  provided, however, POINT is not then in breach of this Agreement so as to prevent the condition  to Closing set forth in Section 12.1 or Section 12.2 from being satisfied;  16.1.4. a Party’s receipt of written notice from the other Party (either LANTHEUS  or POINT), if the transactions contemplated by this Agreement will not have been consummated  on or prior to June 30, 2023 (the “Termination Date”); provided, that if on the Termination Date  the condition set forth in Section 12.1.1 shall not have been satisfied but all the other conditions to  Closing set forth in Article 12 have been satisfied (other than those conditions that by their nature  cannot be satisfied until the Effective Date), then LANTHEUS, at its sole discretion, may elect to  pay to POINT a fee of One Hundred Million U.S. Dollars (US$100,000,000) (the “Extension  Fee”) by wire transfer of immediately available funds, provided that the Parties understand and  agree that the Extension Fee shall be non-refundable regardless of whether the conditions set forth  in Section 12.1.1 are ever satisfied, and if LANTHEUS has paid the Extension Fee by no later than  June 30, 2023, then the Termination Date shall be extended to (and including) August 31, 2023  (and in the case of such extension, any reference to the Termination Date in any other provision of  this Agreement shall be a reference to the Termination Date, as extended); provided that (A) the  provisions of Article 14 shall not apply to a Party’s right to terminate this Agreement pursuant to  this Section 16.1.4 and a Party’s sole and exclusive remedy in connection with a termination  pursuant to this Section 16.1.4 shall be for such Party to seek damages in a court of competent  jurisdiction; and (B) the right to terminate this Agreement pursuant to this Section 16.1.4 will not  be available to a Party if that Party’s breach of any of its covenants or obligations under this  Agreement will have proximately caused the failure to consummate the transactions contemplated  by this Agreement on or before the Termination Date; and  16.1.5. a Party’s receipt of written notice from the other Party (LANTHEUS or  POINT), in the event of the issuance of any final order, decree or judgment or adoption of any  Applicable Law by any Governmental Authority that makes illegal, enjoins or prohibits the  transactions effected by this Agreement and such order, decree, judgment or enforcement of the  Applicable Law or other action will have become final and nonappealable.  16.1.6. Notwithstanding anything herein to the contrary, and for the  avoidance of doubt, any termination under this Section 16.1 shall not be subject to the Escalation  Procedure set forth in Section 2.2.  





 






   71  [***] = Indicates confidential information omitted from the exhibit.  16.2. Termination after Closing. This Agreement may be terminated at any time  following Closing, as follows:  16.2.1. Right to Terminate for Government Prohibition.  Either Party will have  the right to terminate this Agreement, on a country-by-country-basis, effective immediately upon  written notice to the other Party, following the issuance of any order, decree or judgment or  adoption of any Applicable Law by any Governmental Authority in such country that makes  illegal, enjoins or prohibits the transactions effected by this Agreement and such order, decree,  judgment or enforcement of the Applicable Law or other action will have become final and non- appealable.  16.2.2. LANTHEUS’s Right to Terminate for Convenience.    (i) LANTHEUS may terminate this Agreement in its entirety, for any  reason or for no reason, upon thirty (30) days’ prior written notice to POINT, provided that such  notice may only be given within sixty (60) days after either (A) the first meeting with FDA  subsequent to achieving Top Line Data in the PNT-2002 Clinical Trial (the “First Pre-NDA Filing  Meeting”) or (B) an Approval Failure.  (ii) LANTHEUS may terminate this Agreement in its entirety or on a  country-by-country basis, for any reason or for no reason, upon thirty (30) days’ prior written  notice to POINT, provided that such notice is given may only be given on or after the third (3rd)  anniversary of the First Commercial Sale of Licensed Product in the U.S.  16.2.3. Right to Terminate for Breach of Other Party.  Upon the exhaustion of  the Escalation Procedure, either Party will have the right to terminate this Agreement, on a country- by-country-basis, upon ninety (90) days written notice to the other Party, for the other Party’s  material breach of this Agreement with respect to such country that remains uncured after thirty  (30) days’ initial written notice thereof.  16.2.4. Right to Terminate Upon Bankruptcy.  Either Party may, in addition to  any other remedies available to it under Applicable Law or in equity, terminate this Agreement,  on a country-by-country-basis, effective immediately upon written notice to the other Party, in the  event (i) the other Party has made an assignment for the benefit of its creditors; (ii) there has been  appointed an administrator, trustee or receiver for the other Party or for all or a substantial part of  its property; or (iii) any case or proceeding has been commenced or other action taken by or against  the other Party in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up,  arrangement, composition or readjustment of its debts or any other relief under any bankruptcy,  insolvency, reorganization or other similar act or Applicable Law of any jurisdiction now or  hereafter in effect (each, an “Insolvency Event”), and any such event has continued for sixty (60)  days undismissed.   16.3. Effects of Termination.    16.3.1. Accrued Rights.  Expiration or termination of this Agreement will not  relieve the Parties of any liability that accrued hereunder prior to the effective date of such  expiration or termination, nor preclude either Party from pursuing all rights and remedies it may  have hereunder or at law or in equity (which rights and remedies will be cumulative and not  





 






   72  [***] = Indicates confidential information omitted from the exhibit.  exclusive), and any such termination will be without prejudice to the rights of either Party against  the other.  16.3.2. Pre-Closing Termination.  In the event of the termination of this  Agreement pursuant to Section 16.1, this entire Agreement will forthwith become void with the  exception of Sections 13.1, 14.4, 16.3.1, 16.3.4, and this Section 16.3.2 and Articles 1, 8 and 17,  and any other provisions which, by their nature, are intended to survive, each of which will survive  such termination and remain valid and binding obligations of the Parties.    16.3.3. Post-Closing Termination or Expiration.  In the event of the termination  of this Agreement pursuant to Section 16.2 or expiration of this Agreement, this entire Agreement  will forthwith become void with the exception of Sections 2.2.4, 3.4.1 (only the fourth sentence),  3.4.2, 5.6.2-.4, 6.1.5, 6.4, 9.4-9.9, 10.1, 16.3.1, 16.3.3-.4, and this Section 16.3.2 and Articles 1, 7,  8, 13, 14 and 17, and any other provisions which, by their nature, are intended to survive, each of  which will survive such termination or expiration and remain valid and binding obligations of the  Parties.  In addition:   (i) LANTHEUS Breach or Termination for Convenience.  In the  event that, (i) subject to the exhaustion of the Escalation Procedure, POINT terminates this  Agreement for LANTHEUS’ breach under Section 16.2.3 or (ii) LANTHEUS terminates this  Agreement for convenience under Section 16.2.2, all licenses and rights granted by a Party to the  other Party hereunder with respect to the applicable country or countries in the Territory, will  terminate.   (ii) POINT Insolvency.  Subject to the exhaustion of the Escalation  Procedure, in the event that LANTHEUS terminates this Agreement for POINT’s Insolvency  Event, all licenses and rights granted by POINT will survive solely for the period in which such  rights and licenses would have been in effect had the Insolvency Event not occurred.   (iii) Licensed Product Rights. In the event of a termination (but not  expiration) of this Agreement in its entirety or on a country-by-country basis under 16.3.3(i),  LANTHEUS shall reasonably promptly and in an orderly manner:   (A) transfer to POINT all applicable ongoing Clinical Trials  being conducted in the applicable portion of the Territory by the Parties for the Licensed Product  as of the effective date of termination, if permitted by Applicable Law and the applicable  Regulatory Authorities (or any data monitoring review board or internal safety review board), and  provide cooperation reasonably requested by POINT in connection with such transfer;   (B) transfer and assign to POINT all applicable Regulatory  Approvals and related Regulatory Filings in the applicable portion of the Territory in  LANTHEUS’s name, possession and Control as of the effective date of such termination as further  set forth in Section 3.4.1;   (C) transfer to POINT a true and complete copy of (a) all  applicable data and results generated from any Development activities conducted by or on behalf  of LANTHEUS with respect to the Licensed Product prior to the effective date of such termination,  (b) all applicable Trial Master Files (including any Trial Master File plans, tables of contents or  





 






   73  [***] = Indicates confidential information omitted from the exhibit.  indices and any evidence or certification of related quality checks) or equivalents thereof, for all  completed or ongoing Clinical Trials of the Licensed Product conducted by or on behalf of  LANTHEUS and (c) all other tangible embodiments of the Collaboration Know-How or  improvements, modifications or updates made by LANTHEUS to Licensed Know-How, including  the Manufacturing Know-How and all documentation related thereto (if any), in each case, to the  extent relating to the applicable portion of the Territory and in LANTHEUS’s possession and  Control as of the effective date of termination of this Agreement; and  (D) grant to POINT a non-exclusive, perpetual, royalty free,  irrevocable and freely sublicensable license to Collaboration Know-How and Collaboration Patent  Rights, in each case, to POINT, its Affiliates and Sublicensees to Exploit the Licensed Product in  the Field in the applicable portion of the Territory.   (iv) Post-Termination Transition Plan; Third Party Contracts. In  the event of termination (but not expiration) of this Agreement in its entirety or on a country-by- country basis, the Parties will reasonably cooperate with each other to ensure a smooth and orderly  transition to POINT or POINT’s designee of ongoing Exploitation of the Licensed Product in the  Territory, including taking the actions specified in a mutually agreed plan, which the Parties each  acting reasonably and cooperating in good faith will develop, for such transfer. LANTHEUS shall  transfer to POINT all data, information, technology, and any other materials provided to  LANTHEUS by POINT under this Agreement or any Manufacture and Supply Agreement to the  extent necessary to permit POINT to Exploit, including continuing any ongoing  Commercialization of, the Licensed Product, as set forth in such mutually agreed post-termination  transition plan.  Notwithstanding the generality of the foregoing, LANTHEUS shall transfer and  assign to POINT, at POINT’s election, any and all agreements with a Third Party as selected by  POINT, including any agreement with Distributor(s), contract manufacturing organizations or any  other vendor or supplier, that is necessary to continue the Exploitation, including the  Manufacturing, of the Licensed Products in the Territory for the terminated portion of the  Agreement.    (v) Costs of Licensed Product Reversion to POINT.  POINT will be  responsible for all costs and expenses incurred in connection with the activities set forth in Section  16.3.3(iii), unless POINT terminates this Agreement pursuant to Section 16.1.3 (LANTHEUS pre- Closing material breach), 16.2.3 (post-Closing material breach) or 16.2.4 (post-Closing  bankruptcy) or LANTHEUS terminates this Agreement pursuant to Section 16.2.2 (for  convenience), in which such case, LANTHEUS will be responsible for such costs and expenses.   (vi) Surviving Sublicensee.  Following the effective date of any  termination of this Agreement, at the request of any LANTHEUS Sublicensee who is not then in  breach of its LANTHEUS Sublicense Agreement and is otherwise in good standing, POINT will  assume LANTHEUS’s rights and obligations, including the right to receive all payments  thereunder, under such LANTHEUS Sublicense Agreement between LANTHEUS and such  LANTHEUS Sublicensee effective as of the date of termination of the LANTHEUS Sublicense  Agreement granted to Sublicensee by LANTHEUS, and LANTHEUS will be released of any  further obligations thereunder.   16.3.4. Bankruptcy.    





 






   74  [***] = Indicates confidential information omitted from the exhibit.  (i) All rights and licenses granted under or pursuant to this Agreement  by each Party are, and will otherwise be deemed to be, for purposes of Section 365(n) of the  Bankruptcy Code or analogous provisions of Applicable Law outside the U.S., licenses of right to  “intellectual property” as defined under Section 101 of the Bankruptcy Code or analogous  provisions of Applicable Law outside the U.S. (hereinafter “IP”).  The Parties agree that each  Party, as licensees of rights under this Agreement, will retain and may fully exercise all of its rights  and elections under the Bankruptcy Code or any other provisions of Applicable Law outside the  U.S. that provide similar protection for IP.  Upon an Insolvency Event of a Party that has not been  dismissed within sixty (60) days, the other Party will further be entitled to a complete duplicate of  (or complete access to, as appropriate) any files relating to the IP, including but not limited to  patent file histories and correspondence related thereto, if not already in such other Party’s  possession, will be promptly delivered to such other Party, which shall be entitled to continue to  exercise its license under this Agreement.  Each Party acknowledges and agrees that  “embodiments” of such IP within the meaning of Section 365(n) include, without limitation,  laboratory notebooks, product samples and inventory, research studies and data, all Regulatory  Approvals and rights of reference therein, and all embodiments of any Licensed Know-How.  If  (a) a case under the Bankruptcy Code is commenced by or against a Party, (b) this Agreement is  rejected as provided in the Bankruptcy Code, and (c) the other Party elects to retain its rights  hereunder as provided in Section 365(n) of the Bankruptcy Code, the Party experiencing an  Insolvency Event and its successors and assigns (including a trustee) will not interfere with  LANTHEUS’s rights under this Agreement, or any agreement supplemental hereto, to such IP  (including such embodiments), including any right to obtain such IP (or such embodiments) from  another entity, to the extent provided in Section 365(n) of the Bankruptcy Code.  (ii) All rights, powers and remedies of LANTHEUS provided  herein are in addition to and not in substitution for any and all other rights, powers and remedies  now or hereafter existing at law or in equity (including the Bankruptcy Code) in the event of the  commencement of a case under the Bankruptcy Code with respect to POINT. The Parties agree  that they intend the following rights to extend to the maximum extent permitted by law, and to be  enforceable under Bankruptcy Code Section 365(n) upon any rejection of this Agreement: (a) the  right of access to any IP (including all embodiments thereof) of POINT or any Third Party with  whom POINT contracts to perform any of its obligations under this Agreement; and (b) the right  to contract directly with any such Third Party to complete the contracted work.    ARTICLE 17    GENERAL PROVISIONS  17.1. Notices.  All notices, reports, requests or demands required or permitted under this  Agreement will be sent by hand, overnight courier or email, properly addressed to the respective  Parties as follows:  If to POINT: Point Biopharma, Inc.  4850 West 78th Street  





 






   75  [***] = Indicates confidential information omitted from the exhibit.  Indianapolis, IN 46268  Attention:  Joe McCann, CEO  Email: [***]  With a copy to:    Attention: Matthew Vincent, SVP BD   Email: [***]    If to LANTHEUS: c/o Lantheus Holdings, Inc.  331 Treble Cove Road  North Billerica, MA 01862  Attention: Etienne Montagut, Chief Business Officer   Email: [***]    With a copy at the same address to:    Attention: Daniel Niedzwiecki, General Counsel  Email: [***]    or to such physical or email address or addresses as the Parties hereto may designate for such  purposes during the Term.  Notices will be deemed to have been sufficiently given or made upon  actual receipt.    17.2. Non-Solicit. Except as set forth in this Section 17.2, each Party agrees that during  the Term and for one (1) year thereafter, neither Party shall, and shall cause its Affiliates not to,  directly or indirectly, do any of the following: (A) induce or attempt to induce any employee of  the other Party or any of its Affiliates who was an employee of the other Party or any of its  Affiliates, during the Term, to leave the employ of the other Party or any of its Affiliates or in any  way interfere with the relationship  between the other Party or any of its Affiliates and any such  employee, or (B) solicit, offer employment to, otherwise attempt to hire, employ, or otherwise  engage as an employee, independent contractor, or otherwise, any such employee; provided, that  the foregoing shall not prevent general solicitations for employees or public advertisements of  employment opportunities, provided that such general solicitations, public advertisements and  recruitment efforts are not directed at any person who was an employee of the other Party or any  of its Affiliates during the Term. The foregoing shall not apply to any such activities occurring  more than six (6) months following the termination of the employee’s employ by the other Party.   17.3. Governing Law; Venue.  This Agreement and all questions regarding the  existence, validity, interpretation, breach or performance of this Agreement will be governed by  and construed in accordance with the laws of the State of Delaware (other than its choice of law  principles).  17.4. Entire Agreement; Amendment.  This Agreement, together with the Exhibits  hereto and the Manufacture and Supply Agreement(s), represent the entire agreement between the  Parties regarding the subject matter hereof, and supersedes all prior or contemporaneous written  or oral promises or representations relating such subject matter not incorporated herein (including  the Confidentiality Agreement).  The Parties are not relying, and have not relied, on any  representations or warranties whatsoever regarding the subject matter of this Agreement, express  





 






   76  [***] = Indicates confidential information omitted from the exhibit.  or implied, except for the representations and warranties set forth in this Agreement.  No  amendment or modification of the terms and conditions of this Agreement will be binding on either  Party unless reduced to writing referencing this Agreement and signed by a duly authorized officer  of each Party.    17.4.1. Binding Effect and Assignment.  This Agreement will be binding upon and inure  to the benefit of the Parties hereto and their respective successors and permitted assigns.  This  Agreement will not be assignable by either Party without the other Party’s prior written consent;  provided, however, that either Party may assign its rights or obligations under this Agreement (in  whole or in part), without the other Party’s written consent but with notice to the other Party, to an  Affiliate.  If any Affiliate to which a Party has assigned its rights or obligations under this  Agreement thereafter ceases to be an Affiliate of such Party, then such assignment will be deemed  to require the consent of the other Party pursuant to this Section 17.4.1.  To the extent that the  assigning Party survives as a legal entity, the assigning Party will remain responsible for (i) causing  the performance by its Affiliated assignee of this Agreement or any obligations hereunder so  assigned to such Affiliated assignee and (ii) the performance by its non-Affiliated assignee of this  Agreement or any obligations hereunder so assigned to such non-Affiliated assignee.  Subject to  Section 17.5, either Party may also assign this Agreement (in whole or in part) without the other  Party’s written consent, but with notice to the other Party, to any successor pursuant to a Change  of Control, and either Party may assign this Agreement (in whole or in part), without the other  Party’s written consent but with notice to the other Party in connection with the sale or other  transfer to a Third Party of all or substantially all of such Party’s assets to which this Agreement  relates (however such a transaction is structured).   17.5. Change of Control of POINT Involving a Major Competitor.  In the event (a)  POINT undergoes a Change of Control transaction resulting in a Major Competitor having control  over POINT, (b) POINT assigns its rights under this Agreement (or its rights to the Licensed  Patents) to a Major Competitor, whether in whole or in part, or (c) a Third Party completes a  foreclosure on, or POINT otherwise assigns for the benefit of creditors, ownership of the Licensed  Product (or any rights therein) as a result of any lien, mortgage, security interest, or similar  encumbrance, then, at LANTHEUS’ option, any or all of the following will apply: (i) ARTICLE  2 (Governance) will cease to have any effect; (ii) Section 3.1.2(b) (License to POINT) will not  apply to any Patent Rights or Know-How that comes into the Control of LANTHEUS after such  event; (iii) the ESC, all JSCs and the Patent Committee will be disbanded and LANTHEUS will  thereafter have sole discretion and final decision-making authority coming under the purview  thereof; (iv) Section 5.6.2(A) will not apply (unless LANTHEUS consents in advance writing);  (v) all of Section 5.3, the Requirements Commitment in Section 5.6.5, the parenthetical “(but  subject to Section 6.1.3 with respect to Manufacturing)” in Section 6.1.2, all of Section 6.1.3, the  fourth sentence of Section 6.1.5(i), will be deemed to be deleted in their entirety and LANTHEUS  will have the right to Manufacture or have Manufactured, as the case may be, Licensed Product in  the Territory; and (v) the restrictions on LANTHEUS’ and its Sublicensees’ abilities to access and  use POINT Manufacturing Know-How solely for purposes of Manufacturing the Licensed Product  in the Field in the Territory will no longer apply.  For the avoidance of doubt, the consent of  LANTHEUS shall not be required for a Change of Control of POINT, or sale of all or substantially  all of POINT’s assets to which this Agreement relates (however such a transaction is structured).  





 






   77  [***] = Indicates confidential information omitted from the exhibit.  17.6. Sale of the POINT Patent Rights.  During the Term, if POINT intends to sell, to  any Third Party the POINT Patent Rights, other than in connection with a Change of Control, then  POINT will first notify LANTHEUS in writing prior to providing such notice to or engaging in  discussions with any Third Party. LANTHEUS will have ninety (90) days to inform POINT  whether or not it wishes to engage in negotiations with POINT with respect to such sale. If  LANTHEUS so notifies POINT in writing within such ninety (90) day period, then for a period of  one hundred twenty (120) days the Parties will negotiate exclusively and in good faith the terms  and conditions of purchase and sale agreement for the POINT Patent Rights. If (a) LANTHEUS  does not provide written notice to POINT indicating its desire to enter into negotiations with  POINT within ninety (90) days of receiving POINT’s offer notice, or (b) LANTHEUS and POINT  cannot agree on the terms of a definitive agreement within one hundred twenty (120) days, then,  in either case ((a) or (b)), POINT will be free to sell to a Third Party the POINT Patent Rights;  provided that, in the case of (b) above, during the twelve (12) month period following the  conclusion of the negotiations between the Parties, POINT will not sell to any Third Party the  POINT Patent Rights on terms and conditions that are more favorable in the aggregate to the  applicable Third Party than the terms and conditions last proposed by POINT to LANTHEUS  during the one hundred twenty (120) day negotiation period.    17.7. Remedies.   Except as otherwise expressly provided herein, any and all remedies  provided herein will be deemed cumulative with and not exclusive of any other remedy conferred  hereby, or by law or equity upon such Party, and the exercise by a Party of any one remedy will  not preclude the exercise of any other remedy.  The Parties agree that irreparable damage for which  monetary damages, even if available, would not be an adequate remedy, would occur in the event  that the Parties do not perform their respective obligations under the provisions of this Agreement  (including failing to take such actions as are required of them hereunder to consummate and close  the transactions contemplated by this Agreement) in accordance with their specific terms or  otherwise breach such provisions. It is accordingly agreed that the Parties shall be entitled to seek  an injunction or injunctions, specific performance and other equitable relief to prevent breaches of  this Agreement and to enforce specifically the terms and provisions of this Agreement, in each  case, without posting a bond or undertaking and without proof of damages and this being in  addition to any other remedy to which they are entitled at law or in equity.  Each of the Parties  agrees that it will not oppose the granting of an injunction, specific performance and other  equitable relief when expressly available pursuant to the terms of this Agreement on the basis that  the other parties have an adequate remedy at law or an award of specific performance is not an  appropriate remedy for any reason at law or equity.   17.8. Waiver.  No provision of this Agreement will be waived by any act, omission or  knowledge of a Party or its agents or employees except by an instrument in writing expressly  waiving such provision and signed by a duly authorized officer of the waiving Party.  A waiver by  either Party of any of the terms and conditions of this Agreement in any instance will not be  deemed or construed to be a waiver of such term or condition for the future, or of any other term  or condition hereof.    17.9. Severability.  If any part of this Agreement will be found to be invalid, illegal or  unenforceable under Applicable Law in any jurisdiction, such part will be ineffective only to the  extent of such invalidity, illegality or unenforceability in such jurisdiction, without in any way  affecting the remaining parts of this Agreement in that jurisdiction or the validity, legality or  





 






   78  [***] = Indicates confidential information omitted from the exhibit.  enforceability of the Agreement as a whole in any other jurisdiction.  In addition, the part that is  ineffective will be reformed in a mutually agreeable manner so as to as nearly approximate the  intent of the Parties as possible.  17.10. Force Majeure.  Neither Party will be held liable or responsible to the other Party  or be deemed to have breached or defaulted under this Agreement for failure or delay in performing  its obligations hereunder (except for payment of amounts previously invoiced or otherwise  payable) to the extent, and as long as, such failure or delay is caused by or results from causes  beyond the reasonable control of the affected Party (a “Force Majeure Delay”), including to the  extent beyond the reasonable control of the affected Party: supply chain shortages, supplier, or  vendor failures, fire, floods, embargoes, national emergencies, security risks, industry-wide  strikes, lockouts, or labor disputes, war, civil commotions, terrorism, acts of God (including  without limitation hurricanes, floods, earthquakes, tornadoes, or other natural disasters), acts or  restrictions of a Governmental Authority (other than actual or alleged violations of Applicable  Law or Regulatory Approvals), an epidemic or pandemic or other public health crisis, curtailment  of transportation facilities, or judicial orders or decrees.  In the event of a Force Majeure Delay,  the affected Party will give prompt notice thereof to the other Party (to the extent possible), will  use commercially reasonable efforts to mitigate the adverse consequences thereof and will resume  performance hereunder with dispatch whenever the consequences of the Force Majeure Delay have  been mitigated. The Party so affected will provide the other Party a good faith estimate of the  continuing timing and effect of the Force Majeure Delay and the duration of the affected Party’s  nonperformance and the Parties will discuss such matters in the ESC.   17.11. Ambiguities.  Ambiguities, if any, in this Agreement will not be construed against  any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.  17.12. Headings.  Headings are for the convenience of reference only and will not control  the construction or interpretation of any of the provisions of this Agreement.  17.13. No Partnership.  Nothing in this Agreement is intended or will be deemed to  constitute a partnership, agency, or joint venture relationship between the Parties.  Notwithstanding  any of the provisions of this Agreement, neither Party will at any time enter into, incur, or hold  itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party,  any commitment, expense, or liability whatsoever.  17.14. No Third Party Beneficiaries.  No Person other than POINT, LANTHEUS and  their respective successors and permitted assigns will be deemed an intended beneficiary  hereunder or have any right to enforce any provision of this Agreement.  17.15. Performance by an Affiliate.  Each of LANTHEUS and POINT acknowledges  that obligations under this Agreement may be performed by qualified Affiliates of LANTHEUS  and POINT.  Each of LANTHEUS and POINT will remain responsible for any obligations of such  Party under this Agreement undertaken by one or more of its Affiliates. For the avoidance of doubt,  none of the obligations contained in this Agreement shall extend or apply to any product or  intellectual property Controlled by any Third Party with which POINT undergoes a Change of  Control, or any such product or intellectual property of an Affiliate of such Third-Party acquiror,  in any case, which is in production or existence at the time of the Change of Control, in any case,  





 






   79  [***] = Indicates confidential information omitted from the exhibit.  provided neither POINT or any of its controlled Affiliates becomes involved or otherwise  participates in the development, manufacture, commercialization or other exploitation thereof  during the Term and for a period of three (3) years thereafter.  17.16. Parent Guarantee.  Lantheus Guarantor hereby unconditionally and irrevocably  guarantees the prompt (i) payment of all amounts due from, and (ii) performance of all of the  obligations of, Lantheus under and in accordance with this Agreement.  This is a guaranty of  payment and performance and not of collection.    17.17. Further Assurances.  Each Party agrees to do and perform all such further acts  and things and will execute and deliver such other agreements, certificates, instruments and  documents necessary or that the requesting Party may deem advisable in order to carry out the  intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise  confirm its rights hereunder.  17.18. Counterparts and Signatures.  This Agreement may be executed in two or more  counterparts, each of which will be deemed an original for all purposes, but all of which together  will constitute one and the same instrument.  Signatures provided by facsimile transmission, in  Portable Document Format (PDF) sent by electronic mail, or via DocuSign or similar services will  be deemed to be original signatures.     [SIGNATURE PAGE FOLLOWS]    





 






  SIGNATURE PAGE TO LICENSE AND COLLABORATION AGREEMENT  IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed and  delivered by its duly authorized representatives to be effective as of the Execution Date.  POINT  POINT BIOPHARMA, INC.    By:  /s/ Joe McCann   Name:  Joe McCann   Title:  CEO   Date:  11/11/2022     LANTHEUS   LANTHEUS TWO, LLC    By:  /s/ Mary Anne Heino   Name: Mary Anne Heino   Title: President/CEO   Date: 11/11/2022     For purposes of Section 17.16 only:    LANTHEUS GUARANTOR    LANTHEUS MEDICAL IMAGING, INC.    By:  /s/ Mary Anne Heino   Name: Mary Anne Heino   Title: President/CEO   Date: 11/11/2022           





 






  A-1  [***] = Indicates confidential information omitted from the exhibit.  EXHIBIT A    PNT-2002        





 






    B-1  [***] = Indicates confidential information omitted from the exhibit.  EXHIBIT B  POINT Licensed Patents  U.S. Application 63/051,335  Title: RADIOPHARMACEUTICAL AND METHODS  Filed:  July 13, 2020    U.S. Application 63/143,664  Title: RADIOPHARMACEUTICAL AND METHODS  Filed:  January 29, 2021    International Application PCT/IB21/00467   (WO2022/013610, published January 20, 2022))  Title: RADIOPHARMACEUTICAL AND METHODS  Filed:  July 13, 2021    U.S. Application 17/162,856  Now US PATENT 11,129,912  Title: RADIOPHARMACEUTICAL AND METHODS  Filed:  January 29, 2021    U.S. Application 17/374,984  Now US PATENT 11,491,246  Title: RADIOPHARMACEUTICAL AND METHODS  Filed:  July 13, 2021    U.S. Application 17/486,875  Title: RADIOPHARMACEUTICAL AND METHODS  Filed:  September 27, 2021    U.S. Application [***]  Title: RADIOPHARMACEUTICAL AND METHODS  Filed:  [***]    U.S. Application [***]  Title: RADIOPHARMACEUTICAL TREATMENT METHODS AND USE  Filed:  [***]    U.S. Application [***]  Title: METHODS AND FORMULATIONS OF TAXANES IN COMBINATION WITH  PSMA-TARGETED RADIOPHARMACEUTICALS  Filed:  [***]      





 






    C-1  [***] = Indicates confidential information omitted from the exhibit.     EXHIBIT C  Certain Terms and Conditions of Manufacture and Supply Agreement     Purchase Price. means the price to be charged by POINT for Licensed Product  Manufactured and supplied hereunder    o Initial Purchase Price: $[***] per patient dose, EX WORKS     Forecasts.  By a designated Business Day prior to the start of each calendar month  during the Term, LANTHEUS shall submit to POINT a good faith, estimated rolling  forecast of the quantity of Licensed Products LANTHEUS expects to order during such  month and each of the succeeding [***] ([***]) calendar months, with the first [***]  ([***]) months of each forecast be broken to weekly forecasts (each such forecast, a  “Forecast”).  Each Forecast shall be non-binding, with the exception of the portion of  such Forecast covering the first TBD calendar weeks reflected therein, which shall be  considered binding on both parties and a firm order for the Licensed Products (a “Firm  Order”).  POINT shall notify LANTHEUS in writing as soon as reasonably practicable  if at any time POINT has reason to believe that it will not be able to fill a Firm Order  pursuant to the terms and conditions of this Manufacture and Supply Agreement.   LANTHEUS may revise the quantity of expected purchases of Licensed Products for  all the other months included in such Forecast.    Invoices and Payment.  POINT shall invoice LANTHEUS on a monthly basis for  the relevant Purchase Price for the quantity of Licensed Product actually delivered.   Payments shall be made by LANTHEUS within [***] ([***]) days from the date of  invoice.  All invoices and payments required to be paid hereunder shall be in United  States Dollars and all such payments shall be made electronically in immediately  available funds to an account designated by POINT, unless the Parties agree to settle  such payments through other means.     Lantheus will support a recycling program for the Lead Pigs used in shipping.     





 






    D-1  [***] = Indicates confidential information omitted from the exhibit.  EXHIBIT D    Royalty Payment Examples        Example of Royalty Payment Calculation Prior to Achieving the Return Hurdle:  If, for example, in the second Calendar Year after the Trigger Year:   The Return Hurdle has not yet been achieved,   the Licensed Product generates Gross Profit of $220 million, and   the Gross Profit Margin Percentage is 80%,  then the royalty payable to POINT for the second Calendar Year would be $25 million,  calculated as follows:   Excess Gross Profit = $220 million (Gross Profit), minus $120 million (Gross Profit  Hurdle for the second year after the Trigger Year) = $100 million   Eligible Net Sales = $100 million (Excess Gross Profit), divided by 80% (Gross Profit  Margin Percentage) = $125 million   Pre-Return Hurdle Royalty = 20% of $125 million (Eligible Net Sales) = $25 million.    Example of Contribution to Return Hurdle Calculation:  If, for example, using the same financial metrics for the second Calendar Year after the Trigger  Year above, then the contribution to cumulative Gross Profit for measuring the Return Hurdle  would be $195 million for that year, calculated as follows:   Contribution to Return Hurdle for second Calendar Year after Trigger Year = $220  million (the cumulative amount of Gross Profit earned in that year), minus $25M (the  cumulative amount of royalties paid to POINT in that year ) = $195 million for that year 





 






    E-1  [***] = Indicates confidential information omitted from the exhibit.     Exhibit E  Investigator-Initiated Research (IIR)    Institution Indication Concept Design Support  Cornell – Tagawa  NCT04886986  mCRPC  PNT2002 +  225Ac-J591    PI 3+3 dose  escalation with  expansion  Primary Endpoint:  MTD/PSA   N:  3-24  [***]  [***] [***] [***]  [***]  [***]  [***]  [***]         





 






    [***] = Indicates confidential information omitted from the exhibit.  Schedule 10.4.12    [***]